Breast Cancer ICYMI

Among high-risk early breast cancer patients, delivery of a radiation boost to the tumor bed during whole breast irradiation was just as safe and effective as delivering the boost sequentially after whole breast irradiation ended. The findings from the phase 3 clinical trial are a boon to patient convenience.

“These findings are indeed practice changing. This was a well-designed trial that looked at shortening treatment from six to three weeks. They showed equivalent local control and importantly, a good cosmetic outcome over time,” said Kathleen Horst, MD, who served as a discussant during a presentation given by Frank Vicini, MD, FASTRO, GenesisCare, during the annual meeting of the American Society for Radiation Oncology.

“This is substantially more convenient. It’s cost effective both for the health care system and individual patients. Importantly, our patients come in for treatment every day and they’re taking time from work which means they have to arrange for childcare and transportation. So, this makes a big difference for these patients,” said Dr. Horst, who is a professor of radiation oncology at Stanford (Calif.) Medicine and director of well-being in the radiation department at Stanford Medicine.

“One of the things that was surprising is that I think all of us were thinking this might be a more toxic regimen, but as Dr. Vicini showed, it was equally effective over time with minimal toxicity and cosmesis was stable over time, which is important. Importantly, it included patient-reported outcomes, not just the physician-reported outcomes. Broadly, I think these findings are applicable for many patients, including all patients who are receiving whole breast radiotherapy with an added boost. I think over time this is going to improve the quality of life of our patients. It represents an innovative change that everyone is going to be excited to embrace,” Dr. Horst said.

Previous randomized controlled trials showed that an additional radiation dose to the tumor bed following lumpectomy and whole breast irradiation reduces the relative risk of local recurrence by about 35%. However, this increases treatment time for patients who have already endured an extensive regimen. For whole breast irradiation, hypofractionated radiation in 15-16 fractions over 3 weeks has comparable recurrence rates as a 5-week regimen, but the relevant trials did not examine the effect hypofractionation may have on a radiation boost to the tumor bed of high-risk patients. Because of this lack of evidence, current practice calls for the boost to remain sequential in five to eight fractions after completion of whole breast irradiation, which adds 1 week to a 1.5 week–long treatment.

The study included 2,262 patients who were randomized to receive a sequential boost or a concomitant boost. After a median follow-up of 7.4 years, there were 54 ipsilateral breast recurrence (IBR) events. The estimated 7-year risk of IBR was 2.2% in the sequential boost and 2.6% in the concurrent risk group (hazard ratio, 1.32; noninferiority test P = .039). Approximately 60% of patients received adjuvant chemotherapy.

Grade 3 or higher adverse events were similar with a frequency of 3.3% in the sequential group and 3.5% in the concurrent group (P = .79). The researchers used the Global Cosmetic Score (GCS) to assess outcomes from the perspective of both physicians and patients. 86% of physicians rated the outcome as excellent/good in the sequential group versus 82% in the concurrent group (P = .33).

“For high-risk early-stage breast cancer patients undergoing breast conservation, a concurrent boost with hypofractionated whole breast irradiation – compared to a sequential boost – results in noninferior local recurrence rates with no significant difference in toxicity, noninferior patient rated cosmesis, and no significant difference in physician rated cosmesis. The entire treatment was delivered in three weeks, even for high-risk patients. Just as critical, the use of target volume based radiation planning for [three-dimensional conformal or IMRT whole breast irradiation assessed by dose volume analysis is feasible, and resulted in very low toxicity in the treatment arms, regardless of the fractionation schedule, or the boost delivery,” Dr. Vincini said.

No conflicts of interest were disclosed for Dr. Horst or Dr. Vicini.

Among high-risk early breast cancer patients, delivery of a radiation boost to the tumor bed during whole breast irradiation was just as safe and effective as delivering the boost sequentially after whole breast irradiation ended. The findings from the phase 3 clinical trial are a boon to patient convenience.

“These findings are indeed practice changing. This was a well-designed trial that looked at shortening treatment from six to three weeks. They showed equivalent local control and importantly, a good cosmetic outcome over time,” said Kathleen Horst, MD, who served as a discussant during a presentation given by Frank Vicini, MD, FASTRO, GenesisCare, during the annual meeting of the American Society for Radiation Oncology.

“This is substantially more convenient. It’s cost effective both for the health care system and individual patients. Importantly, our patients come in for treatment every day and they’re taking time from work which means they have to arrange for childcare and transportation. So, this makes a big difference for these patients,” said Dr. Horst, who is a professor of radiation oncology at Stanford (Calif.) Medicine and director of well-being in the radiation department at Stanford Medicine.

“One of the things that was surprising is that I think all of us were thinking this might be a more toxic regimen, but as Dr. Vicini showed, it was equally effective over time with minimal toxicity and cosmesis was stable over time, which is important. Importantly, it included patient-reported outcomes, not just the physician-reported outcomes. Broadly, I think these findings are applicable for many patients, including all patients who are receiving whole breast radiotherapy with an added boost. I think over time this is going to improve the quality of life of our patients. It represents an innovative change that everyone is going to be excited to embrace,” Dr. Horst said.

Previous randomized controlled trials showed that an additional radiation dose to the tumor bed following lumpectomy and whole breast irradiation reduces the relative risk of local recurrence by about 35%. However, this increases treatment time for patients who have already endured an extensive regimen. For whole breast irradiation, hypofractionated radiation in 15-16 fractions over 3 weeks has comparable recurrence rates as a 5-week regimen, but the relevant trials did not examine the effect hypofractionation may have on a radiation boost to the tumor bed of high-risk patients. Because of this lack of evidence, current practice calls for the boost to remain sequential in five to eight fractions after completion of whole breast irradiation, which adds 1 week to a 1.5 week–long treatment.

The study included 2,262 patients who were randomized to receive a sequential boost or a concomitant boost. After a median follow-up of 7.4 years, there were 54 ipsilateral breast recurrence (IBR) events. The estimated 7-year risk of IBR was 2.2% in the sequential boost and 2.6% in the concurrent risk group (hazard ratio, 1.32; noninferiority test P = .039). Approximately 60% of patients received adjuvant chemotherapy.

Grade 3 or higher adverse events were similar with a frequency of 3.3% in the sequential group and 3.5% in the concurrent group (P = .79). The researchers used the Global Cosmetic Score (GCS) to assess outcomes from the perspective of both physicians and patients. 86% of physicians rated the outcome as excellent/good in the sequential group versus 82% in the concurrent group (P = .33).

“For high-risk early-stage breast cancer patients undergoing breast conservation, a concurrent boost with hypofractionated whole breast irradiation – compared to a sequential boost – results in noninferior local recurrence rates with no significant difference in toxicity, noninferior patient rated cosmesis, and no significant difference in physician rated cosmesis. The entire treatment was delivered in three weeks, even for high-risk patients. Just as critical, the use of target volume based radiation planning for [three-dimensional conformal or IMRT whole breast irradiation assessed by dose volume analysis is feasible, and resulted in very low toxicity in the treatment arms, regardless of the fractionation schedule, or the boost delivery,” Dr. Vincini said.

No conflicts of interest were disclosed for Dr. Horst or Dr. Vicini.

Among high-risk early breast cancer patients, delivery of a radiation boost to the tumor bed during whole breast irradiation was just as safe and effective as delivering the boost sequentially after whole breast irradiation ended. The findings from the phase 3 clinical trial are a boon to patient convenience.

“These findings are indeed practice changing. This was a well-designed trial that looked at shortening treatment from six to three weeks. They showed equivalent local control and importantly, a good cosmetic outcome over time,” said Kathleen Horst, MD, who served as a discussant during a presentation given by Frank Vicini, MD, FASTRO, GenesisCare, during the annual meeting of the American Society for Radiation Oncology.

“This is substantially more convenient. It’s cost effective both for the health care system and individual patients. Importantly, our patients come in for treatment every day and they’re taking time from work which means they have to arrange for childcare and transportation. So, this makes a big difference for these patients,” said Dr. Horst, who is a professor of radiation oncology at Stanford (Calif.) Medicine and director of well-being in the radiation department at Stanford Medicine.

“One of the things that was surprising is that I think all of us were thinking this might be a more toxic regimen, but as Dr. Vicini showed, it was equally effective over time with minimal toxicity and cosmesis was stable over time, which is important. Importantly, it included patient-reported outcomes, not just the physician-reported outcomes. Broadly, I think these findings are applicable for many patients, including all patients who are receiving whole breast radiotherapy with an added boost. I think over time this is going to improve the quality of life of our patients. It represents an innovative change that everyone is going to be excited to embrace,” Dr. Horst said.

Previous randomized controlled trials showed that an additional radiation dose to the tumor bed following lumpectomy and whole breast irradiation reduces the relative risk of local recurrence by about 35%. However, this increases treatment time for patients who have already endured an extensive regimen. For whole breast irradiation, hypofractionated radiation in 15-16 fractions over 3 weeks has comparable recurrence rates as a 5-week regimen, but the relevant trials did not examine the effect hypofractionation may have on a radiation boost to the tumor bed of high-risk patients. Because of this lack of evidence, current practice calls for the boost to remain sequential in five to eight fractions after completion of whole breast irradiation, which adds 1 week to a 1.5 week–long treatment.

The study included 2,262 patients who were randomized to receive a sequential boost or a concomitant boost. After a median follow-up of 7.4 years, there were 54 ipsilateral breast recurrence (IBR) events. The estimated 7-year risk of IBR was 2.2% in the sequential boost and 2.6% in the concurrent risk group (hazard ratio, 1.32; noninferiority test P = .039). Approximately 60% of patients received adjuvant chemotherapy.

Grade 3 or higher adverse events were similar with a frequency of 3.3% in the sequential group and 3.5% in the concurrent group (P = .79). The researchers used the Global Cosmetic Score (GCS) to assess outcomes from the perspective of both physicians and patients. 86% of physicians rated the outcome as excellent/good in the sequential group versus 82% in the concurrent group (P = .33).

“For high-risk early-stage breast cancer patients undergoing breast conservation, a concurrent boost with hypofractionated whole breast irradiation – compared to a sequential boost – results in noninferior local recurrence rates with no significant difference in toxicity, noninferior patient rated cosmesis, and no significant difference in physician rated cosmesis. The entire treatment was delivered in three weeks, even for high-risk patients. Just as critical, the use of target volume based radiation planning for [three-dimensional conformal or IMRT whole breast irradiation assessed by dose volume analysis is feasible, and resulted in very low toxicity in the treatment arms, regardless of the fractionation schedule, or the boost delivery,” Dr. Vincini said.

No conflicts of interest were disclosed for Dr. Horst or Dr. Vicini.

A total of 126 patients were included in the full analysis set; median progression-free survival (PFS) was 18.8 months, overall response rate was 64.3%, and the safety profile was similar to prior studies. The median PFS in this observational study was comparable to a median PFS of 16.9 months in the CLEOPTRA study among 88 patients with prior (neo)adjuvant trastuzumab. HELENA also demonstrated similar PFS results for the hormone receptor (HR)-negative and HR-positive (HR+) subgroups (19.4 months vs 18.2 months), as well as for patients with nonvisceral and visceral metastases (20.5 months vs 18.0 months). These findings provide further support for use of the THP regimen as first-line treatment in the real-world setting for patients with HER2+ MBC and prior receipt of trastuzumab.

Adjuvant endocrine therapy (ET) is associated with a survival benefit for early-stage HR+ breast cancer; however, the absolute degree of benefit depends on various clinicopathologic features.² Although it generally has a manageable toxicity profile, some side effects carry more significant consequences (thromboembolism, endometrial carcinoma, osteoporosis), and some of the more common ones can affect routine quality of life (hot flashes, vaginal dryness, arthralgia).

A retrospective observational study including 5545 patients with pT1a-b estrogen receptor-positive (ER+) breast cancer demonstrated improvements in disease-free survival (DFS) and recurrence-free survival (RFS) among those who received ET vs those who did not receive ET after 5 and 7 years of follow-up (DFS: increases of 2.5% and 3.3%; RFS: increases of 1.9% and 4.3%) (Houvenaeghel et al). Among all patients, absence of ET was associated with decreased DFS (hazard ratio [HR] 1.275; P = .047) but no difference in RFS or OS. Patients with pT1a-b ER+ grade 2-3 tumors (n = 2363) experienced decreased DFS (HR 1.502, P = .049) without ET; however, those with pT1a-b ER+ grade 1 tumors did not experience a negative effect on DFS without ET.

These results provide further support for the survival improvements seen with adjuvant ET — although the relative benefit may be fairly modest — and that ET omission is a relevant consideration in patients with comorbidities or tolerance issues, particularly those with pT1a-b grade 1 tumors.

Advancements in breast cancer therapies have led to improvements in survival outcomes, and it is therefore increasingly essential to recognize risks for other cancer types in breast cancer survivors. Male breast cancer is rare, and although clinical management for the most part mirrors that of female breast cancer, it is important to be aware of potential differences in this population, including risks for subsequent non-breast primary cancers.³

A meta-analysis including eight retrospective cohort studies with male breast cancer survivors reported the standardized incidence ratio (SIR), which compares the incidence of non-breast second primary cancers (SPC) among men with first primary breast cancer vs the expected incidence of non-breast primary cancers in the general male population. The summary SIR estimate was 1.27 (95% CI 1.03-1.56), with increased risk for certain SPCs: colorectal (SIR 1.29; 95% CI 1.03-1.61), pancreatic (SIR 1.64; 95% CI 1.05-2.55), and thyroid (SIR 5.58; 95% CI 1.04-30.05) (Allen et al). Additionally, men diagnosed with breast cancer before 50 years of age were observed to have increased SPC risk compared with men who were older than 50 years at breast cancer onset (SIR 1.50 vs 1.14; P = .040).

This study highlights the importance of genetic assessment for men diagnosed with breast cancer, so they can be appropriately counseled on subsequent cancer risk. It also stimulates thinking regarding other potential contributing factors to the observed increased SPC risk among male breast cancer survivors, including the effect of various treatments, hormonal influences, and significant family history.

Studies have shown that older women derive a survival benefit with adjuvant chemotherapy; however, they may be at increased risk of experiencing toxicities owing to physical functioning and comorbidities.⁴ A comprehensive geriatric assessment is key, and it is also beneficial for identifying which patients have a higher likelihood of clinical decline after chemotherapy.

A prospective study including 295 robust women age ≥ 65 years with stage I-III breast cancer treated with chemotherapy showed that 26% had a chemotherapy-induced decline in frailty status; patients with high interleukin-6 (IL-6) and C-reactive protein (CRP) inflammatory markers before chemotherapy had a more than threefold odds of experiencing a chemotherapy-induced decline in frailty compared with those with low IL-6 and CRP (odds ratio 3.52; 95% CI 1.55-8.01; P = .003) (Ji et al).

These findings support the relationship between inflammation, aging, and chemotherapy-induced functional decline. Further research is warranted to identify whether there are specific drugs that are implicated, methods to enhance anti-inflammatory effects, and any downstream effect on breast cancer outcomes of these patients.

Additional References

1. Swain SM, Miles D, Kim SB, et al; CLEOPATRA study group. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): End-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21:519-530. Doi: 10.1016/S1470-2045(19)30863-0
2. Ma SJ, Oladeru OT, Singh AK. Association of endocrine therapy with overall survival in women with small, hormone receptor-positive, ERBB2-negative breast cancer. JAMA Netw Open. 2020;3:e2013973. Doi: 10.1001/jamanetworkopen.2020.13973
3. Pritzlaff M, Summerour P, McFarland R, et al. Male breast cancer in a multi-gene panel testing cohort: Insights and unexpected results. Breast Cancer Res Treat. 2017;161:575-586. Doi: 10.1007/s10549-016-4085-4
4. Tamirisa N, Lin H, Shen Y, et al. Association of chemotherapy with survival in elderly patients with multiple comorbidities and estrogen receptor-positive, node-positive breast cancer. JAMA Oncol. 2020;6:1548-155 Doi: 10.1001/jamaoncol.2020.2388

A total of 126 patients were included in the full analysis set; median progression-free survival (PFS) was 18.8 months, overall response rate was 64.3%, and the safety profile was similar to prior studies. The median PFS in this observational study was comparable to a median PFS of 16.9 months in the CLEOPTRA study among 88 patients with prior (neo)adjuvant trastuzumab. HELENA also demonstrated similar PFS results for the hormone receptor (HR)-negative and HR-positive (HR+) subgroups (19.4 months vs 18.2 months), as well as for patients with nonvisceral and visceral metastases (20.5 months vs 18.0 months). These findings provide further support for use of the THP regimen as first-line treatment in the real-world setting for patients with HER2+ MBC and prior receipt of trastuzumab.

Adjuvant endocrine therapy (ET) is associated with a survival benefit for early-stage HR+ breast cancer; however, the absolute degree of benefit depends on various clinicopathologic features.² Although it generally has a manageable toxicity profile, some side effects carry more significant consequences (thromboembolism, endometrial carcinoma, osteoporosis), and some of the more common ones can affect routine quality of life (hot flashes, vaginal dryness, arthralgia).

A retrospective observational study including 5545 patients with pT1a-b estrogen receptor-positive (ER+) breast cancer demonstrated improvements in disease-free survival (DFS) and recurrence-free survival (RFS) among those who received ET vs those who did not receive ET after 5 and 7 years of follow-up (DFS: increases of 2.5% and 3.3%; RFS: increases of 1.9% and 4.3%) (Houvenaeghel et al). Among all patients, absence of ET was associated with decreased DFS (hazard ratio [HR] 1.275; P = .047) but no difference in RFS or OS. Patients with pT1a-b ER+ grade 2-3 tumors (n = 2363) experienced decreased DFS (HR 1.502, P = .049) without ET; however, those with pT1a-b ER+ grade 1 tumors did not experience a negative effect on DFS without ET.

These results provide further support for the survival improvements seen with adjuvant ET — although the relative benefit may be fairly modest — and that ET omission is a relevant consideration in patients with comorbidities or tolerance issues, particularly those with pT1a-b grade 1 tumors.

Advancements in breast cancer therapies have led to improvements in survival outcomes, and it is therefore increasingly essential to recognize risks for other cancer types in breast cancer survivors. Male breast cancer is rare, and although clinical management for the most part mirrors that of female breast cancer, it is important to be aware of potential differences in this population, including risks for subsequent non-breast primary cancers.³

A meta-analysis including eight retrospective cohort studies with male breast cancer survivors reported the standardized incidence ratio (SIR), which compares the incidence of non-breast second primary cancers (SPC) among men with first primary breast cancer vs the expected incidence of non-breast primary cancers in the general male population. The summary SIR estimate was 1.27 (95% CI 1.03-1.56), with increased risk for certain SPCs: colorectal (SIR 1.29; 95% CI 1.03-1.61), pancreatic (SIR 1.64; 95% CI 1.05-2.55), and thyroid (SIR 5.58; 95% CI 1.04-30.05) (Allen et al). Additionally, men diagnosed with breast cancer before 50 years of age were observed to have increased SPC risk compared with men who were older than 50 years at breast cancer onset (SIR 1.50 vs 1.14; P = .040).

This study highlights the importance of genetic assessment for men diagnosed with breast cancer, so they can be appropriately counseled on subsequent cancer risk. It also stimulates thinking regarding other potential contributing factors to the observed increased SPC risk among male breast cancer survivors, including the effect of various treatments, hormonal influences, and significant family history.

Studies have shown that older women derive a survival benefit with adjuvant chemotherapy; however, they may be at increased risk of experiencing toxicities owing to physical functioning and comorbidities.⁴ A comprehensive geriatric assessment is key, and it is also beneficial for identifying which patients have a higher likelihood of clinical decline after chemotherapy.

A prospective study including 295 robust women age ≥ 65 years with stage I-III breast cancer treated with chemotherapy showed that 26% had a chemotherapy-induced decline in frailty status; patients with high interleukin-6 (IL-6) and C-reactive protein (CRP) inflammatory markers before chemotherapy had a more than threefold odds of experiencing a chemotherapy-induced decline in frailty compared with those with low IL-6 and CRP (odds ratio 3.52; 95% CI 1.55-8.01; P = .003) (Ji et al).

These findings support the relationship between inflammation, aging, and chemotherapy-induced functional decline. Further research is warranted to identify whether there are specific drugs that are implicated, methods to enhance anti-inflammatory effects, and any downstream effect on breast cancer outcomes of these patients.

Additional References

1. Swain SM, Miles D, Kim SB, et al; CLEOPATRA study group. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): End-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21:519-530. Doi: 10.1016/S1470-2045(19)30863-0
2. Ma SJ, Oladeru OT, Singh AK. Association of endocrine therapy with overall survival in women with small, hormone receptor-positive, ERBB2-negative breast cancer. JAMA Netw Open. 2020;3:e2013973. Doi: 10.1001/jamanetworkopen.2020.13973
3. Pritzlaff M, Summerour P, McFarland R, et al. Male breast cancer in a multi-gene panel testing cohort: Insights and unexpected results. Breast Cancer Res Treat. 2017;161:575-586. Doi: 10.1007/s10549-016-4085-4
4. Tamirisa N, Lin H, Shen Y, et al. Association of chemotherapy with survival in elderly patients with multiple comorbidities and estrogen receptor-positive, node-positive breast cancer. JAMA Oncol. 2020;6:1548-155 Doi: 10.1001/jamaoncol.2020.2388

A total of 126 patients were included in the full analysis set; median progression-free survival (PFS) was 18.8 months, overall response rate was 64.3%, and the safety profile was similar to prior studies. The median PFS in this observational study was comparable to a median PFS of 16.9 months in the CLEOPTRA study among 88 patients with prior (neo)adjuvant trastuzumab. HELENA also demonstrated similar PFS results for the hormone receptor (HR)-negative and HR-positive (HR+) subgroups (19.4 months vs 18.2 months), as well as for patients with nonvisceral and visceral metastases (20.5 months vs 18.0 months). These findings provide further support for use of the THP regimen as first-line treatment in the real-world setting for patients with HER2+ MBC and prior receipt of trastuzumab.

Adjuvant endocrine therapy (ET) is associated with a survival benefit for early-stage HR+ breast cancer; however, the absolute degree of benefit depends on various clinicopathologic features.² Although it generally has a manageable toxicity profile, some side effects carry more significant consequences (thromboembolism, endometrial carcinoma, osteoporosis), and some of the more common ones can affect routine quality of life (hot flashes, vaginal dryness, arthralgia).

A retrospective observational study including 5545 patients with pT1a-b estrogen receptor-positive (ER+) breast cancer demonstrated improvements in disease-free survival (DFS) and recurrence-free survival (RFS) among those who received ET vs those who did not receive ET after 5 and 7 years of follow-up (DFS: increases of 2.5% and 3.3%; RFS: increases of 1.9% and 4.3%) (Houvenaeghel et al). Among all patients, absence of ET was associated with decreased DFS (hazard ratio [HR] 1.275; P = .047) but no difference in RFS or OS. Patients with pT1a-b ER+ grade 2-3 tumors (n = 2363) experienced decreased DFS (HR 1.502, P = .049) without ET; however, those with pT1a-b ER+ grade 1 tumors did not experience a negative effect on DFS without ET.

These results provide further support for the survival improvements seen with adjuvant ET — although the relative benefit may be fairly modest — and that ET omission is a relevant consideration in patients with comorbidities or tolerance issues, particularly those with pT1a-b grade 1 tumors.

Advancements in breast cancer therapies have led to improvements in survival outcomes, and it is therefore increasingly essential to recognize risks for other cancer types in breast cancer survivors. Male breast cancer is rare, and although clinical management for the most part mirrors that of female breast cancer, it is important to be aware of potential differences in this population, including risks for subsequent non-breast primary cancers.³

A meta-analysis including eight retrospective cohort studies with male breast cancer survivors reported the standardized incidence ratio (SIR), which compares the incidence of non-breast second primary cancers (SPC) among men with first primary breast cancer vs the expected incidence of non-breast primary cancers in the general male population. The summary SIR estimate was 1.27 (95% CI 1.03-1.56), with increased risk for certain SPCs: colorectal (SIR 1.29; 95% CI 1.03-1.61), pancreatic (SIR 1.64; 95% CI 1.05-2.55), and thyroid (SIR 5.58; 95% CI 1.04-30.05) (Allen et al). Additionally, men diagnosed with breast cancer before 50 years of age were observed to have increased SPC risk compared with men who were older than 50 years at breast cancer onset (SIR 1.50 vs 1.14; P = .040).

This study highlights the importance of genetic assessment for men diagnosed with breast cancer, so they can be appropriately counseled on subsequent cancer risk. It also stimulates thinking regarding other potential contributing factors to the observed increased SPC risk among male breast cancer survivors, including the effect of various treatments, hormonal influences, and significant family history.

Studies have shown that older women derive a survival benefit with adjuvant chemotherapy; however, they may be at increased risk of experiencing toxicities owing to physical functioning and comorbidities.⁴ A comprehensive geriatric assessment is key, and it is also beneficial for identifying which patients have a higher likelihood of clinical decline after chemotherapy.

A prospective study including 295 robust women age ≥ 65 years with stage I-III breast cancer treated with chemotherapy showed that 26% had a chemotherapy-induced decline in frailty status; patients with high interleukin-6 (IL-6) and C-reactive protein (CRP) inflammatory markers before chemotherapy had a more than threefold odds of experiencing a chemotherapy-induced decline in frailty compared with those with low IL-6 and CRP (odds ratio 3.52; 95% CI 1.55-8.01; P = .003) (Ji et al).

These findings support the relationship between inflammation, aging, and chemotherapy-induced functional decline. Further research is warranted to identify whether there are specific drugs that are implicated, methods to enhance anti-inflammatory effects, and any downstream effect on breast cancer outcomes of these patients.

Additional References

1. Swain SM, Miles D, Kim SB, et al; CLEOPATRA study group. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): End-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21:519-530. Doi: 10.1016/S1470-2045(19)30863-0
2. Ma SJ, Oladeru OT, Singh AK. Association of endocrine therapy with overall survival in women with small, hormone receptor-positive, ERBB2-negative breast cancer. JAMA Netw Open. 2020;3:e2013973. Doi: 10.1001/jamanetworkopen.2020.13973
3. Pritzlaff M, Summerour P, McFarland R, et al. Male breast cancer in a multi-gene panel testing cohort: Insights and unexpected results. Breast Cancer Res Treat. 2017;161:575-586. Doi: 10.1007/s10549-016-4085-4
4. Tamirisa N, Lin H, Shen Y, et al. Association of chemotherapy with survival in elderly patients with multiple comorbidities and estrogen receptor-positive, node-positive breast cancer. JAMA Oncol. 2020;6:1548-155 Doi: 10.1001/jamaoncol.2020.2388

Drugs commonly used to treat erectile dysfunction (ED) are not associated with a decreased risk of Alzheimer’s disease and related dementias (ADRD), new research shows.

The findings contradict results from a previous study that suggested that individuals who take sildenafil (Viagra) were significantly less likely to develop Alzheimer’s.

The new research, part of a larger effort to identify existing medications that could be repurposed to treat ADRD, employed a study design that reduced the risk for potential bias that may have influenced the earlier findings, the investigators note.

“That study came out last fall and was widely covered in the media, and we thought there were some methodological shortcomings that might have explained the results,” lead investigator Rishi Desai, PhD, assistant professor of medicine at Harvard Medical School and an associate epidemiologist at Brigham and Women’s Hospital, both in Boston, said in an interview.

The new study was published online in Brain Communications.


 

Not the final word?

Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, a drug class that includes the ED drugs sildenafil and tadalafil (Cialis), improve memory and cognitive function and reduce amyloid burden. But studies in humans have yielded conflicting results.*

Although the new research and the work published last year both drew on Medicare data, they examined different patient populations.

The first study compared those who took sildenafil for any reason to those who did not take it. That design likely resulted in an analysis of a comparison of individuals with ED – the most common indication for sildenafil – to generally older individuals with diabetes or hypertension, Dr. Desai said.

In contrast, the current study included only those with pulmonary arterial hypertension (PAH), which is also an indication for PDE5 inhibitors. The researchers compared ADRD incidence in those who took PDE5 inhibitors with the incidence among those who took a different medication to treat their PAH. They used propensity matching to create two groups with similar characteristics and examined the data using four analytic strategies.

The investigators found no significant difference between groups in the incidence of ADRD, regardless of the strategy they used. Cell culture studies also revealed no protective effect from PDE5 inhibitors.

“No study of this kind should claim the final word,” Dr. Desai said. “It is extremely difficult to nail down causality from these types of data sources.”
 

Impressive study design

Commenting on the findings, David Knopman, MD, professor of neurology at Mayo Clinic, Rochester, Minn., described the study design as “impressive” for its efforts to minimize bias, a key limitation in the previous study.

“It was always the case that the claims about sildenafil needed further developmental work prior to testing the drug in randomized controlled trials,” Dr. Knopman said. “The evidence for the use of the drug was never sufficient for clinicians to use it in their patients.”

The study was funded by National Institute on Aging. Dr. Desai is an investigator who receives research grants from Bayer, Vertex, and Novartis that were given to the Brigham and Women’s Hospital for unrelated projects. Dr. Knopman has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Correction, 11/3/22: An earlier version of this article misstated the abbreviation for phosphodiesterase-5. It is PDE-5.

Drugs commonly used to treat erectile dysfunction (ED) are not associated with a decreased risk of Alzheimer’s disease and related dementias (ADRD), new research shows.

The findings contradict results from a previous study that suggested that individuals who take sildenafil (Viagra) were significantly less likely to develop Alzheimer’s.

The new research, part of a larger effort to identify existing medications that could be repurposed to treat ADRD, employed a study design that reduced the risk for potential bias that may have influenced the earlier findings, the investigators note.

“That study came out last fall and was widely covered in the media, and we thought there were some methodological shortcomings that might have explained the results,” lead investigator Rishi Desai, PhD, assistant professor of medicine at Harvard Medical School and an associate epidemiologist at Brigham and Women’s Hospital, both in Boston, said in an interview.

The new study was published online in Brain Communications.


 

Not the final word?

Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, a drug class that includes the ED drugs sildenafil and tadalafil (Cialis), improve memory and cognitive function and reduce amyloid burden. But studies in humans have yielded conflicting results.*

Although the new research and the work published last year both drew on Medicare data, they examined different patient populations.

The first study compared those who took sildenafil for any reason to those who did not take it. That design likely resulted in an analysis of a comparison of individuals with ED – the most common indication for sildenafil – to generally older individuals with diabetes or hypertension, Dr. Desai said.

In contrast, the current study included only those with pulmonary arterial hypertension (PAH), which is also an indication for PDE5 inhibitors. The researchers compared ADRD incidence in those who took PDE5 inhibitors with the incidence among those who took a different medication to treat their PAH. They used propensity matching to create two groups with similar characteristics and examined the data using four analytic strategies.

The investigators found no significant difference between groups in the incidence of ADRD, regardless of the strategy they used. Cell culture studies also revealed no protective effect from PDE5 inhibitors.

“No study of this kind should claim the final word,” Dr. Desai said. “It is extremely difficult to nail down causality from these types of data sources.”
 

Impressive study design

Commenting on the findings, David Knopman, MD, professor of neurology at Mayo Clinic, Rochester, Minn., described the study design as “impressive” for its efforts to minimize bias, a key limitation in the previous study.

“It was always the case that the claims about sildenafil needed further developmental work prior to testing the drug in randomized controlled trials,” Dr. Knopman said. “The evidence for the use of the drug was never sufficient for clinicians to use it in their patients.”

The study was funded by National Institute on Aging. Dr. Desai is an investigator who receives research grants from Bayer, Vertex, and Novartis that were given to the Brigham and Women’s Hospital for unrelated projects. Dr. Knopman has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Correction, 11/3/22: An earlier version of this article misstated the abbreviation for phosphodiesterase-5. It is PDE-5.

Drugs commonly used to treat erectile dysfunction (ED) are not associated with a decreased risk of Alzheimer’s disease and related dementias (ADRD), new research shows.

The findings contradict results from a previous study that suggested that individuals who take sildenafil (Viagra) were significantly less likely to develop Alzheimer’s.

The new research, part of a larger effort to identify existing medications that could be repurposed to treat ADRD, employed a study design that reduced the risk for potential bias that may have influenced the earlier findings, the investigators note.

“That study came out last fall and was widely covered in the media, and we thought there were some methodological shortcomings that might have explained the results,” lead investigator Rishi Desai, PhD, assistant professor of medicine at Harvard Medical School and an associate epidemiologist at Brigham and Women’s Hospital, both in Boston, said in an interview.

The new study was published online in Brain Communications.


 

Not the final word?

Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, a drug class that includes the ED drugs sildenafil and tadalafil (Cialis), improve memory and cognitive function and reduce amyloid burden. But studies in humans have yielded conflicting results.*

Although the new research and the work published last year both drew on Medicare data, they examined different patient populations.

The first study compared those who took sildenafil for any reason to those who did not take it. That design likely resulted in an analysis of a comparison of individuals with ED – the most common indication for sildenafil – to generally older individuals with diabetes or hypertension, Dr. Desai said.

In contrast, the current study included only those with pulmonary arterial hypertension (PAH), which is also an indication for PDE5 inhibitors. The researchers compared ADRD incidence in those who took PDE5 inhibitors with the incidence among those who took a different medication to treat their PAH. They used propensity matching to create two groups with similar characteristics and examined the data using four analytic strategies.

The investigators found no significant difference between groups in the incidence of ADRD, regardless of the strategy they used. Cell culture studies also revealed no protective effect from PDE5 inhibitors.

“No study of this kind should claim the final word,” Dr. Desai said. “It is extremely difficult to nail down causality from these types of data sources.”
 

Impressive study design

Commenting on the findings, David Knopman, MD, professor of neurology at Mayo Clinic, Rochester, Minn., described the study design as “impressive” for its efforts to minimize bias, a key limitation in the previous study.

“It was always the case that the claims about sildenafil needed further developmental work prior to testing the drug in randomized controlled trials,” Dr. Knopman said. “The evidence for the use of the drug was never sufficient for clinicians to use it in their patients.”

The study was funded by National Institute on Aging. Dr. Desai is an investigator who receives research grants from Bayer, Vertex, and Novartis that were given to the Brigham and Women’s Hospital for unrelated projects. Dr. Knopman has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Correction, 11/3/22: An earlier version of this article misstated the abbreviation for phosphodiesterase-5. It is PDE-5.

There’s some good overall news in a large analysis that looked at whether a mother’s COVID-19 infection or birth during the pandemic could affect a baby’s brain development.

Researchers studied 21,419 infants who had neurodevelopmental screening during the pandemic (from January 2020 to January 2021) and compared them with babies born before the pandemic (2015-2019).

They found in an analysis of eight studies that, generally, brain development in infants ages 6-12 months old was not changed by COVID-19.
 

Communication skill scores lower than prepandemic

However, one area did see a significant difference when they looked at answers to the Ages and Stages Questionnaire, 3rd edition (ASQ-3): Scores were lower in communication skills.

Compared with the prepandemic babies, the pandemic group of babies was more likely to have communication impairment (odds were 1.7 times higher).

Additionally, mothers’ SARS-CoV-2 infection was not associated with significant differences in any neurodevelopment sector in offspring, with one exception: Odds were 3.5 times higher for fine motor impairment in the pandemic baby group.

The babies in this study were either exposed in the womb to the SARS-CoV-2 infection or screened during the pandemic regardless of whether they were exposed to the virus.

The study, led by Kamran Hessami, MD, with the Maternal Fetal Care Center at Boston Children’s Hospital and Harvard Medical School in Boston, was published in JAMA Network Open.
 

Potential reasons for lower communication skills

The study points to some factors of the pandemic that may be tied to impaired communication skills.

“Higher levels of COVID-19–related stress were reported for both mothers and fathers of infants aged 0-6 months and were associated with insensitive parenting practices, including decreased emotional responsiveness in only mothers, which could lessen the reciprocal exchanges that support language development in early childhood,” they write. “Additionally, opportunities to promote language and social development through new experiences outside the home, including visits with extended family and friends or attendance at a child care center, were lessened for many during the pandemic.”

Viviana M. Fajardo Martinez, MD, with neonatal/perinatal medicine at University of California, Los Angeles, Health, told this publication her team is also studying child development before and after the pandemic over a 3-year period, and delayed communication skills is something she is seeing in clinic there.

She says some parents have been concerned, saying their babies aren’t talking enough or are behind in vocabulary.
 

Babies can catch up after 12 months

One thing she tells parents is that babies who are a bit delayed at 12 months can catch up.

Up to 18 months, they can catch up, she said, adding that they can be reevaluated then for improvement. If, at that point, the baby is not catching up, “that’s when we refer for early intervention,” she said.

Dr. Martinez also tells parents concerned about their infant’s communication skills that it’s important to talk, read, and sing to their child. She said amid pandemic stress, corners may have been cut in asking children to use language skills.

For instance, if a child points to an apple, a stressed parent may just give the child the apple instead of asking the child to request it by name and repeat the word several times.

She also said a limitation of this study is the use of the ASQ-3 questionnaire, which is filled out by parents. Answers are subjective, she notes, and sometimes differ between one child’s two parents. The questionnaire was commonly used during the pandemic because a more objective, professional evaluation has been more difficult.

However, a measure like the Bayley Scales of Infant and Toddler Development Screening Test adds objectivity and will likely give a better picture as research progresses, Dr. Martinez said. 
 

Some information missing

Andréane Lavallée, PhD, and Dani Dumitriu, MD, PhD, both with the department of pediatrics at Columbia University, New York, write in an invited commentary that the overall positive message of the study “should not make researchers complacent” and results should be viewed with caution.

They point out that the precise effects of this novel virus are still unclear and the age group and variables studied may not tell the whole story.

“It should be noted that this systematic review did not consider timing of exposure during pregnancy, maternal infection severity, or exposure to various SARS-CoV-2 variants – all factors that could eventually be proven to contribute to subtle adverse neurodevelopmental outcomes,” they write.

Additionally, past pandemics “such as the 1918 Spanish flu, 1964 rubella, and 2009 H1N1” have taught researchers to watch for increases in diagnoses such as autism spectrum disorder (ASD) and schizophrenia in subsequent years.

“ASD is generally diagnosed at age 3-5 years (and often not until early teens), while schizophrenia is generally diagnosed in mid-to-late 20s,” the editorialists point out. The authors agree and emphasize the need for long-term studies.

Authors report no relevant financial relationships. Editorialist Dr. Dumitriu reports grants from National Institute of Mental Health, the U.S. Centers for Disease Control and Prevention, and the W. K. Kellogg Foundation; and has received gift funds from Einhorn Collaborative during the conduct of the study to the Nurture Science Program, for which Dr Dumitriu serves as director. Dr. Dumitriu received personal fees from Medela outside the submitted work; and is the corresponding author for one of the studies (Shuffrey et al., 2022) included in the systematic review conducted by Dr. Hessami et al. Dr. Lavallée reports grants from the Canadian Institutes of Health Research. Dr. Martinez reports no relevant financial relationships.
 

There’s some good overall news in a large analysis that looked at whether a mother’s COVID-19 infection or birth during the pandemic could affect a baby’s brain development.

Researchers studied 21,419 infants who had neurodevelopmental screening during the pandemic (from January 2020 to January 2021) and compared them with babies born before the pandemic (2015-2019).

They found in an analysis of eight studies that, generally, brain development in infants ages 6-12 months old was not changed by COVID-19.
 

Communication skill scores lower than prepandemic

However, one area did see a significant difference when they looked at answers to the Ages and Stages Questionnaire, 3rd edition (ASQ-3): Scores were lower in communication skills.

Compared with the prepandemic babies, the pandemic group of babies was more likely to have communication impairment (odds were 1.7 times higher).

Additionally, mothers’ SARS-CoV-2 infection was not associated with significant differences in any neurodevelopment sector in offspring, with one exception: Odds were 3.5 times higher for fine motor impairment in the pandemic baby group.

The babies in this study were either exposed in the womb to the SARS-CoV-2 infection or screened during the pandemic regardless of whether they were exposed to the virus.

The study, led by Kamran Hessami, MD, with the Maternal Fetal Care Center at Boston Children’s Hospital and Harvard Medical School in Boston, was published in JAMA Network Open.
 

Potential reasons for lower communication skills

The study points to some factors of the pandemic that may be tied to impaired communication skills.

“Higher levels of COVID-19–related stress were reported for both mothers and fathers of infants aged 0-6 months and were associated with insensitive parenting practices, including decreased emotional responsiveness in only mothers, which could lessen the reciprocal exchanges that support language development in early childhood,” they write. “Additionally, opportunities to promote language and social development through new experiences outside the home, including visits with extended family and friends or attendance at a child care center, were lessened for many during the pandemic.”

Viviana M. Fajardo Martinez, MD, with neonatal/perinatal medicine at University of California, Los Angeles, Health, told this publication her team is also studying child development before and after the pandemic over a 3-year period, and delayed communication skills is something she is seeing in clinic there.

She says some parents have been concerned, saying their babies aren’t talking enough or are behind in vocabulary.
 

Babies can catch up after 12 months

One thing she tells parents is that babies who are a bit delayed at 12 months can catch up.

Up to 18 months, they can catch up, she said, adding that they can be reevaluated then for improvement. If, at that point, the baby is not catching up, “that’s when we refer for early intervention,” she said.

Dr. Martinez also tells parents concerned about their infant’s communication skills that it’s important to talk, read, and sing to their child. She said amid pandemic stress, corners may have been cut in asking children to use language skills.

For instance, if a child points to an apple, a stressed parent may just give the child the apple instead of asking the child to request it by name and repeat the word several times.

She also said a limitation of this study is the use of the ASQ-3 questionnaire, which is filled out by parents. Answers are subjective, she notes, and sometimes differ between one child’s two parents. The questionnaire was commonly used during the pandemic because a more objective, professional evaluation has been more difficult.

However, a measure like the Bayley Scales of Infant and Toddler Development Screening Test adds objectivity and will likely give a better picture as research progresses, Dr. Martinez said. 
 

Some information missing

Andréane Lavallée, PhD, and Dani Dumitriu, MD, PhD, both with the department of pediatrics at Columbia University, New York, write in an invited commentary that the overall positive message of the study “should not make researchers complacent” and results should be viewed with caution.

They point out that the precise effects of this novel virus are still unclear and the age group and variables studied may not tell the whole story.

“It should be noted that this systematic review did not consider timing of exposure during pregnancy, maternal infection severity, or exposure to various SARS-CoV-2 variants – all factors that could eventually be proven to contribute to subtle adverse neurodevelopmental outcomes,” they write.

Additionally, past pandemics “such as the 1918 Spanish flu, 1964 rubella, and 2009 H1N1” have taught researchers to watch for increases in diagnoses such as autism spectrum disorder (ASD) and schizophrenia in subsequent years.

“ASD is generally diagnosed at age 3-5 years (and often not until early teens), while schizophrenia is generally diagnosed in mid-to-late 20s,” the editorialists point out. The authors agree and emphasize the need for long-term studies.

Authors report no relevant financial relationships. Editorialist Dr. Dumitriu reports grants from National Institute of Mental Health, the U.S. Centers for Disease Control and Prevention, and the W. K. Kellogg Foundation; and has received gift funds from Einhorn Collaborative during the conduct of the study to the Nurture Science Program, for which Dr Dumitriu serves as director. Dr. Dumitriu received personal fees from Medela outside the submitted work; and is the corresponding author for one of the studies (Shuffrey et al., 2022) included in the systematic review conducted by Dr. Hessami et al. Dr. Lavallée reports grants from the Canadian Institutes of Health Research. Dr. Martinez reports no relevant financial relationships.
 

There’s some good overall news in a large analysis that looked at whether a mother’s COVID-19 infection or birth during the pandemic could affect a baby’s brain development.

Researchers studied 21,419 infants who had neurodevelopmental screening during the pandemic (from January 2020 to January 2021) and compared them with babies born before the pandemic (2015-2019).

They found in an analysis of eight studies that, generally, brain development in infants ages 6-12 months old was not changed by COVID-19.
 

Communication skill scores lower than prepandemic

However, one area did see a significant difference when they looked at answers to the Ages and Stages Questionnaire, 3rd edition (ASQ-3): Scores were lower in communication skills.

Compared with the prepandemic babies, the pandemic group of babies was more likely to have communication impairment (odds were 1.7 times higher).

Additionally, mothers’ SARS-CoV-2 infection was not associated with significant differences in any neurodevelopment sector in offspring, with one exception: Odds were 3.5 times higher for fine motor impairment in the pandemic baby group.

The babies in this study were either exposed in the womb to the SARS-CoV-2 infection or screened during the pandemic regardless of whether they were exposed to the virus.

The study, led by Kamran Hessami, MD, with the Maternal Fetal Care Center at Boston Children’s Hospital and Harvard Medical School in Boston, was published in JAMA Network Open.
 

Potential reasons for lower communication skills

The study points to some factors of the pandemic that may be tied to impaired communication skills.

“Higher levels of COVID-19–related stress were reported for both mothers and fathers of infants aged 0-6 months and were associated with insensitive parenting practices, including decreased emotional responsiveness in only mothers, which could lessen the reciprocal exchanges that support language development in early childhood,” they write. “Additionally, opportunities to promote language and social development through new experiences outside the home, including visits with extended family and friends or attendance at a child care center, were lessened for many during the pandemic.”

Viviana M. Fajardo Martinez, MD, with neonatal/perinatal medicine at University of California, Los Angeles, Health, told this publication her team is also studying child development before and after the pandemic over a 3-year period, and delayed communication skills is something she is seeing in clinic there.

She says some parents have been concerned, saying their babies aren’t talking enough or are behind in vocabulary.
 

Babies can catch up after 12 months

One thing she tells parents is that babies who are a bit delayed at 12 months can catch up.

Up to 18 months, they can catch up, she said, adding that they can be reevaluated then for improvement. If, at that point, the baby is not catching up, “that’s when we refer for early intervention,” she said.

Dr. Martinez also tells parents concerned about their infant’s communication skills that it’s important to talk, read, and sing to their child. She said amid pandemic stress, corners may have been cut in asking children to use language skills.

For instance, if a child points to an apple, a stressed parent may just give the child the apple instead of asking the child to request it by name and repeat the word several times.

She also said a limitation of this study is the use of the ASQ-3 questionnaire, which is filled out by parents. Answers are subjective, she notes, and sometimes differ between one child’s two parents. The questionnaire was commonly used during the pandemic because a more objective, professional evaluation has been more difficult.

However, a measure like the Bayley Scales of Infant and Toddler Development Screening Test adds objectivity and will likely give a better picture as research progresses, Dr. Martinez said. 
 

Some information missing

Andréane Lavallée, PhD, and Dani Dumitriu, MD, PhD, both with the department of pediatrics at Columbia University, New York, write in an invited commentary that the overall positive message of the study “should not make researchers complacent” and results should be viewed with caution.

They point out that the precise effects of this novel virus are still unclear and the age group and variables studied may not tell the whole story.

“It should be noted that this systematic review did not consider timing of exposure during pregnancy, maternal infection severity, or exposure to various SARS-CoV-2 variants – all factors that could eventually be proven to contribute to subtle adverse neurodevelopmental outcomes,” they write.

Additionally, past pandemics “such as the 1918 Spanish flu, 1964 rubella, and 2009 H1N1” have taught researchers to watch for increases in diagnoses such as autism spectrum disorder (ASD) and schizophrenia in subsequent years.

“ASD is generally diagnosed at age 3-5 years (and often not until early teens), while schizophrenia is generally diagnosed in mid-to-late 20s,” the editorialists point out. The authors agree and emphasize the need for long-term studies.

Authors report no relevant financial relationships. Editorialist Dr. Dumitriu reports grants from National Institute of Mental Health, the U.S. Centers for Disease Control and Prevention, and the W. K. Kellogg Foundation; and has received gift funds from Einhorn Collaborative during the conduct of the study to the Nurture Science Program, for which Dr Dumitriu serves as director. Dr. Dumitriu received personal fees from Medela outside the submitted work; and is the corresponding author for one of the studies (Shuffrey et al., 2022) included in the systematic review conducted by Dr. Hessami et al. Dr. Lavallée reports grants from the Canadian Institutes of Health Research. Dr. Martinez reports no relevant financial relationships.
 

The nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) unexpectedly showed that it might protect against incident infective pneumonia and COVID-19. The finding was based on secondary analyses run on more than 13,000 people enrolled in the two pivotal trials for finerenone.

Finerenone was approved by the Food and Drug Administration in 2021 for slowing progressive renal dysfunction and preventing cardiovascular events in adults with type 2 diabetes and chronic kidney disease (CKD).
 

‘Striking reduction in the risk of pneumonia’

The “striking reduction in risk of pneumonia” in a new analysis suggests that “the propagation of pulmonary infection into lobar or bronchial consolidation may be reduced by finerenone,” write Bertram Pitt, MD, and coauthors in a report published on October 26 in JAMA Network Open.

They also suggest that if further studies confirm that finerenone treatment reduces complications from pneumonia and COVID-19, it would have “significant medical implications,” especially because of the limited treatment options now available for complications from COVID-19.

The new analyses used the FIDELITY dataset, a prespecified merging of results from the FIDELIO-DKD and FIGARO-DKD trials, which together enrolled 13,026 people with type 2 diabetes and CKD, as determined on the basis of the patients’ having a urine albumin-to-creatinine ratio of at least 30 mg/g.

The primary outcomes of these trials showed that treatment with finerenone led to significant slowing of the progression of CKD and a significant reduction in the incidence of cardiovascular events, compared with placebo during median follow-up of 3 years.

The new, secondary analyses focused on the 6.0% of participants in whom there was evidence of pneumonia and the 1.6% in whom there was evidence of having COVID-19. Pneumonia was the most common serious adverse event in the two trials, a finding consistent with the documented risk for pneumonia faced by people with CKD.
 

Finerenone linked with a 29% relative reduction in pneumonia

When analyzed by treatment, the incidence of pneumonia was 4.7% among those who received finerenone and 6.7% among those who received placebo. This translated into a significant relative risk reduction of 29% associated with finerenone treatment.

Analysis of COVID-19 adverse events showed a 1.3% incidence among those who received finerenone and a 1.8% incidence among those in the placebo group, which translated into a significant 27% relative risk reduction linked with finerenone treatment.

In contrast, the data showed no reduced incidence of several other respiratory infections among the finerenone recipients, including nasopharyngitis, bronchitis, and influenza. The data also showed no signal that pneumonia or COVID-19 was more severe among the people who did not receive finerenone, nor did finerenone treatment appear to affect pneumonia recovery.
 

Analysis based on adverse events reports

These secondary analyses are far from definitive. The authors relied on pneumonia and COVID-19 being reported as adverse events. Each investigator diagnosed pneumonia at their discretion, and the trials did not specify diagnostic criteria. The authors also acknowledge that testing for COVID-19 was “not widespread” and that one of the two pivotal trials largely ran prior to the onset of the COVID-19 pandemic so that only 6 participants developed COVID-19 symptoms out of more than 5,700 enrolled.

The authors hypothesize that several actions of finerenone might potentially help mediate an effect on pneumonia and COVID-19: improvements in pulmonary inflammation and fibrosis, upregulation of expression of angiotensin converting enzyme 2, and amelioration of right heart pressure and pulmonary congestion. Also, antagonizing the mineralocorticoid receptor on monocytes and macrophages may block macrophage infiltration and accumulation of active macrophages, which can mediate the pulmonary tissue damage caused by COVID-19.

The FIDELIO-DKD and FIGARO-DKD trials and the FIDELITY combined database were sponsored by Bayer, the company that markets finerenone (Kerendia). Dr. Pitt has received personal fees from Bayer and personal fees and stock options from numerous other companies. Several coauthors reported having a financial relationship with Bayer, as well as with other companies.

A version of this article first appeared on Medscape.com.

The nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) unexpectedly showed that it might protect against incident infective pneumonia and COVID-19. The finding was based on secondary analyses run on more than 13,000 people enrolled in the two pivotal trials for finerenone.

Finerenone was approved by the Food and Drug Administration in 2021 for slowing progressive renal dysfunction and preventing cardiovascular events in adults with type 2 diabetes and chronic kidney disease (CKD).
 

‘Striking reduction in the risk of pneumonia’

The “striking reduction in risk of pneumonia” in a new analysis suggests that “the propagation of pulmonary infection into lobar or bronchial consolidation may be reduced by finerenone,” write Bertram Pitt, MD, and coauthors in a report published on October 26 in JAMA Network Open.

They also suggest that if further studies confirm that finerenone treatment reduces complications from pneumonia and COVID-19, it would have “significant medical implications,” especially because of the limited treatment options now available for complications from COVID-19.

The new analyses used the FIDELITY dataset, a prespecified merging of results from the FIDELIO-DKD and FIGARO-DKD trials, which together enrolled 13,026 people with type 2 diabetes and CKD, as determined on the basis of the patients’ having a urine albumin-to-creatinine ratio of at least 30 mg/g.

The primary outcomes of these trials showed that treatment with finerenone led to significant slowing of the progression of CKD and a significant reduction in the incidence of cardiovascular events, compared with placebo during median follow-up of 3 years.

The new, secondary analyses focused on the 6.0% of participants in whom there was evidence of pneumonia and the 1.6% in whom there was evidence of having COVID-19. Pneumonia was the most common serious adverse event in the two trials, a finding consistent with the documented risk for pneumonia faced by people with CKD.
 

Finerenone linked with a 29% relative reduction in pneumonia

When analyzed by treatment, the incidence of pneumonia was 4.7% among those who received finerenone and 6.7% among those who received placebo. This translated into a significant relative risk reduction of 29% associated with finerenone treatment.

Analysis of COVID-19 adverse events showed a 1.3% incidence among those who received finerenone and a 1.8% incidence among those in the placebo group, which translated into a significant 27% relative risk reduction linked with finerenone treatment.

In contrast, the data showed no reduced incidence of several other respiratory infections among the finerenone recipients, including nasopharyngitis, bronchitis, and influenza. The data also showed no signal that pneumonia or COVID-19 was more severe among the people who did not receive finerenone, nor did finerenone treatment appear to affect pneumonia recovery.
 

Analysis based on adverse events reports

These secondary analyses are far from definitive. The authors relied on pneumonia and COVID-19 being reported as adverse events. Each investigator diagnosed pneumonia at their discretion, and the trials did not specify diagnostic criteria. The authors also acknowledge that testing for COVID-19 was “not widespread” and that one of the two pivotal trials largely ran prior to the onset of the COVID-19 pandemic so that only 6 participants developed COVID-19 symptoms out of more than 5,700 enrolled.

The authors hypothesize that several actions of finerenone might potentially help mediate an effect on pneumonia and COVID-19: improvements in pulmonary inflammation and fibrosis, upregulation of expression of angiotensin converting enzyme 2, and amelioration of right heart pressure and pulmonary congestion. Also, antagonizing the mineralocorticoid receptor on monocytes and macrophages may block macrophage infiltration and accumulation of active macrophages, which can mediate the pulmonary tissue damage caused by COVID-19.

The FIDELIO-DKD and FIGARO-DKD trials and the FIDELITY combined database were sponsored by Bayer, the company that markets finerenone (Kerendia). Dr. Pitt has received personal fees from Bayer and personal fees and stock options from numerous other companies. Several coauthors reported having a financial relationship with Bayer, as well as with other companies.

A version of this article first appeared on Medscape.com.

The nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) unexpectedly showed that it might protect against incident infective pneumonia and COVID-19. The finding was based on secondary analyses run on more than 13,000 people enrolled in the two pivotal trials for finerenone.

Finerenone was approved by the Food and Drug Administration in 2021 for slowing progressive renal dysfunction and preventing cardiovascular events in adults with type 2 diabetes and chronic kidney disease (CKD).
 

‘Striking reduction in the risk of pneumonia’

The “striking reduction in risk of pneumonia” in a new analysis suggests that “the propagation of pulmonary infection into lobar or bronchial consolidation may be reduced by finerenone,” write Bertram Pitt, MD, and coauthors in a report published on October 26 in JAMA Network Open.

They also suggest that if further studies confirm that finerenone treatment reduces complications from pneumonia and COVID-19, it would have “significant medical implications,” especially because of the limited treatment options now available for complications from COVID-19.

The new analyses used the FIDELITY dataset, a prespecified merging of results from the FIDELIO-DKD and FIGARO-DKD trials, which together enrolled 13,026 people with type 2 diabetes and CKD, as determined on the basis of the patients’ having a urine albumin-to-creatinine ratio of at least 30 mg/g.

The primary outcomes of these trials showed that treatment with finerenone led to significant slowing of the progression of CKD and a significant reduction in the incidence of cardiovascular events, compared with placebo during median follow-up of 3 years.

The new, secondary analyses focused on the 6.0% of participants in whom there was evidence of pneumonia and the 1.6% in whom there was evidence of having COVID-19. Pneumonia was the most common serious adverse event in the two trials, a finding consistent with the documented risk for pneumonia faced by people with CKD.
 

Finerenone linked with a 29% relative reduction in pneumonia

When analyzed by treatment, the incidence of pneumonia was 4.7% among those who received finerenone and 6.7% among those who received placebo. This translated into a significant relative risk reduction of 29% associated with finerenone treatment.

Analysis of COVID-19 adverse events showed a 1.3% incidence among those who received finerenone and a 1.8% incidence among those in the placebo group, which translated into a significant 27% relative risk reduction linked with finerenone treatment.

In contrast, the data showed no reduced incidence of several other respiratory infections among the finerenone recipients, including nasopharyngitis, bronchitis, and influenza. The data also showed no signal that pneumonia or COVID-19 was more severe among the people who did not receive finerenone, nor did finerenone treatment appear to affect pneumonia recovery.
 

Analysis based on adverse events reports

These secondary analyses are far from definitive. The authors relied on pneumonia and COVID-19 being reported as adverse events. Each investigator diagnosed pneumonia at their discretion, and the trials did not specify diagnostic criteria. The authors also acknowledge that testing for COVID-19 was “not widespread” and that one of the two pivotal trials largely ran prior to the onset of the COVID-19 pandemic so that only 6 participants developed COVID-19 symptoms out of more than 5,700 enrolled.

The authors hypothesize that several actions of finerenone might potentially help mediate an effect on pneumonia and COVID-19: improvements in pulmonary inflammation and fibrosis, upregulation of expression of angiotensin converting enzyme 2, and amelioration of right heart pressure and pulmonary congestion. Also, antagonizing the mineralocorticoid receptor on monocytes and macrophages may block macrophage infiltration and accumulation of active macrophages, which can mediate the pulmonary tissue damage caused by COVID-19.

The FIDELIO-DKD and FIGARO-DKD trials and the FIDELITY combined database were sponsored by Bayer, the company that markets finerenone (Kerendia). Dr. Pitt has received personal fees from Bayer and personal fees and stock options from numerous other companies. Several coauthors reported having a financial relationship with Bayer, as well as with other companies.

A version of this article first appeared on Medscape.com.

“We eat first with our eyes.” 

The Roman foodie Apicius is thought to have uttered those words in the 1st century A.D. Now, some 2,000 years later, scientists may be proving him right. 

Massachusetts Institute of Technology researchers have discovered a previously unknown part of the brain that lights up when we see food. Dubbed the “ventral food component,” this part resides in the brain’s visual cortex, in a region known to play a role in identifying faces, scenes, and words. 

The study, published in the journal Current Biology, involved using artificial intelligence (AI) technology to build a computer model of this part of the brain. Similar models are emerging across fields of research to simulate and study complex systems of the body. A computer model of the digestive system was recently used to determine the best body position for taking a pill. 

“The research is still cutting-edge,” says study author Meenakshi Khosla, PhD. “There’s a lot more to be done to understand whether this region is the same or different in different individuals, and how it is modulated by experience or familiarity with different kinds of foods.”

Pinpointing those differences could provide insights into how people choose what they eat, or even help us learn what drives eating disorders, Dr. Khosla says. 

Part of what makes this study unique was the researchers’ approach, dubbed “hypothesis neutral.” Instead of setting out to prove or disprove a firm hypothesis, they simply started exploring the data to see what they could find. The goal: To go beyond “the idiosyncratic hypotheses scientists have already thought to test,” the paper says. So, they began sifting through a public database called the Natural Scenes Dataset, an inventory of brain scans from eight volunteers viewing 56,720 images. 

As expected, the software analyzing the dataset spotted brain regions already known to be triggered by images of faces, bodies, words, and scenes. But to the researchers’ surprise, the analysis also revealed a previously unknown part of the brain that seemed to be responding to images of food. 

“Our first reaction was, ‘That’s cute and all, but it can’t possibly be true,’ ” Dr. Khosla says. 

To confirm their discovery, the researchers used the data to train a computer model of this part of the brain, a process that takes less than an hour. Then they fed the model more than 1.2 million new images. 

Sure enough, the model lit up in response to food. Color didn’t matter – even black-and-white food images triggered it, though not as strongly as color ones. And the model could tell the difference between food and objects that looked like food: a banana versus a crescent moon, or a blueberry muffin versus a puppy with a muffin-like face. 

From the human data, the researchers found that some people responded slightly more to processed foods like pizza than unprocessed foods like apples. They hope to explore how other things, such as liking or disliking a food, may affect a person’s response to that food. 

This technology could open up other areas of research as well. Dr. Khosla hopes to use it to explore how the brain responds to social cues like body language and facial expressions. 

For now, Dr. Khosla has already begun to verify the computer model in real people by scanning the brains of a new set of volunteers. “We collected pilot data in a few subjects recently and were able to localize this component,” she says. 

A version of this article first appeared on Medscape.com.

“We eat first with our eyes.” 

The Roman foodie Apicius is thought to have uttered those words in the 1st century A.D. Now, some 2,000 years later, scientists may be proving him right. 

Massachusetts Institute of Technology researchers have discovered a previously unknown part of the brain that lights up when we see food. Dubbed the “ventral food component,” this part resides in the brain’s visual cortex, in a region known to play a role in identifying faces, scenes, and words. 

The study, published in the journal Current Biology, involved using artificial intelligence (AI) technology to build a computer model of this part of the brain. Similar models are emerging across fields of research to simulate and study complex systems of the body. A computer model of the digestive system was recently used to determine the best body position for taking a pill. 

“The research is still cutting-edge,” says study author Meenakshi Khosla, PhD. “There’s a lot more to be done to understand whether this region is the same or different in different individuals, and how it is modulated by experience or familiarity with different kinds of foods.”

Pinpointing those differences could provide insights into how people choose what they eat, or even help us learn what drives eating disorders, Dr. Khosla says. 

Part of what makes this study unique was the researchers’ approach, dubbed “hypothesis neutral.” Instead of setting out to prove or disprove a firm hypothesis, they simply started exploring the data to see what they could find. The goal: To go beyond “the idiosyncratic hypotheses scientists have already thought to test,” the paper says. So, they began sifting through a public database called the Natural Scenes Dataset, an inventory of brain scans from eight volunteers viewing 56,720 images. 

As expected, the software analyzing the dataset spotted brain regions already known to be triggered by images of faces, bodies, words, and scenes. But to the researchers’ surprise, the analysis also revealed a previously unknown part of the brain that seemed to be responding to images of food. 

“Our first reaction was, ‘That’s cute and all, but it can’t possibly be true,’ ” Dr. Khosla says. 

To confirm their discovery, the researchers used the data to train a computer model of this part of the brain, a process that takes less than an hour. Then they fed the model more than 1.2 million new images. 

Sure enough, the model lit up in response to food. Color didn’t matter – even black-and-white food images triggered it, though not as strongly as color ones. And the model could tell the difference between food and objects that looked like food: a banana versus a crescent moon, or a blueberry muffin versus a puppy with a muffin-like face. 

From the human data, the researchers found that some people responded slightly more to processed foods like pizza than unprocessed foods like apples. They hope to explore how other things, such as liking or disliking a food, may affect a person’s response to that food. 

This technology could open up other areas of research as well. Dr. Khosla hopes to use it to explore how the brain responds to social cues like body language and facial expressions. 

For now, Dr. Khosla has already begun to verify the computer model in real people by scanning the brains of a new set of volunteers. “We collected pilot data in a few subjects recently and were able to localize this component,” she says. 

A version of this article first appeared on Medscape.com.

“We eat first with our eyes.” 

The Roman foodie Apicius is thought to have uttered those words in the 1st century A.D. Now, some 2,000 years later, scientists may be proving him right. 

Massachusetts Institute of Technology researchers have discovered a previously unknown part of the brain that lights up when we see food. Dubbed the “ventral food component,” this part resides in the brain’s visual cortex, in a region known to play a role in identifying faces, scenes, and words. 

The study, published in the journal Current Biology, involved using artificial intelligence (AI) technology to build a computer model of this part of the brain. Similar models are emerging across fields of research to simulate and study complex systems of the body. A computer model of the digestive system was recently used to determine the best body position for taking a pill. 

“The research is still cutting-edge,” says study author Meenakshi Khosla, PhD. “There’s a lot more to be done to understand whether this region is the same or different in different individuals, and how it is modulated by experience or familiarity with different kinds of foods.”

Pinpointing those differences could provide insights into how people choose what they eat, or even help us learn what drives eating disorders, Dr. Khosla says. 

Part of what makes this study unique was the researchers’ approach, dubbed “hypothesis neutral.” Instead of setting out to prove or disprove a firm hypothesis, they simply started exploring the data to see what they could find. The goal: To go beyond “the idiosyncratic hypotheses scientists have already thought to test,” the paper says. So, they began sifting through a public database called the Natural Scenes Dataset, an inventory of brain scans from eight volunteers viewing 56,720 images. 

As expected, the software analyzing the dataset spotted brain regions already known to be triggered by images of faces, bodies, words, and scenes. But to the researchers’ surprise, the analysis also revealed a previously unknown part of the brain that seemed to be responding to images of food. 

“Our first reaction was, ‘That’s cute and all, but it can’t possibly be true,’ ” Dr. Khosla says. 

To confirm their discovery, the researchers used the data to train a computer model of this part of the brain, a process that takes less than an hour. Then they fed the model more than 1.2 million new images. 

Sure enough, the model lit up in response to food. Color didn’t matter – even black-and-white food images triggered it, though not as strongly as color ones. And the model could tell the difference between food and objects that looked like food: a banana versus a crescent moon, or a blueberry muffin versus a puppy with a muffin-like face. 

From the human data, the researchers found that some people responded slightly more to processed foods like pizza than unprocessed foods like apples. They hope to explore how other things, such as liking or disliking a food, may affect a person’s response to that food. 

This technology could open up other areas of research as well. Dr. Khosla hopes to use it to explore how the brain responds to social cues like body language and facial expressions. 

For now, Dr. Khosla has already begun to verify the computer model in real people by scanning the brains of a new set of volunteers. “We collected pilot data in a few subjects recently and were able to localize this component,” she says. 

A version of this article first appeared on Medscape.com.

SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.

These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).

Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.

To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”

Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”

Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”

She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.

The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”

For more about the initiative, visit the VA PX SharePoint.

The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.

Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”

In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable. 

In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.

Dr. Valdez-Boyle reported no disclosures.

SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.

These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).

Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.

To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”

Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”

Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”

She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.

The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”

For more about the initiative, visit the VA PX SharePoint.

The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.

Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”

In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable. 

In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.

Dr. Valdez-Boyle reported no disclosures.

SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.

These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).

Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.

To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”

Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”

Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”

She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.

The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”

For more about the initiative, visit the VA PX SharePoint.

The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.

Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”

In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable. 

In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.

Dr. Valdez-Boyle reported no disclosures.

New efficacy and safety data from the monarchE study show that chemotherapy administered before treatment with abemaciclib and estrogen therapy, led to a clinically meaningful improvement in invasive disease-free survival and distant relapse-free survival for women with HR-positive, ERBB2-negative, node-positive, early breast cancer at high risk of recurrence.

The study was published earlier this year in JAMA Oncology.

Neoadjuvant chemotherapy is often provided to such patients in hopes of achieving breast-conserving surgery. Although pathologic complete response rates can be higher than 50% after chemotherapy treatment in triple-negative and ERBB2-positive breast cancer, most patients with HR-positive and ERBB2-negative breast cancer have residual tumor at surgery after neoadjuvant chemotherapy, which is associated with an increased risk of recurrence.

Adjuvant estrogen therapy can reduce the risk of recurrence in this population, but a significant hazard remains.

“To our knowledge, abemaciclib is the first agent added to standard adjuvant estrogen therapy that has been shown to reduce the risk of recurrence in patients with HR-positive, ERBB2-negative early breast cancer with residual disease after neoadjuvant chemotherapy,” wrote the authors, who were led by Miguel Martin, MD, PhD, Hospital General Universitario Gregorio Marañon, Spain.

In 2021, Food and Drug Administration approved abemaciclib (Verzenio, Lilly) with endocrine therapy for the treatment of HR-positive/ERBB2-negative, node-positive, high-risk early breast cancer. Their decision was based on data from the monarchE study.

The study is at odds with the previously published Penelope-B study, which found no benefit from treatment with the CDK4/6 inhibitor palbociclib (Ibrance, Pfizer) after 42.8 months of follow-up. The authors suggest that the disparate outcomes may be due to pharmacological differences between the two drugs as well as different dosing schedules: In monarchE, patients received abemaciclib on a continuous basis, while patients in Penelope-B received palbociclib for 21 days, followed by 7 days off. The treatment duration was 2 years in monarchE and 1 year in Penelope-B. Abemaciclib can be dosed continuously because it is a stronger inhibitor of CDK4 versus CDK6 compared to abemaciclib, and in vitro studies suggest that continuous dosing could be a key factor in creating profound inhibition of DNA synthesis.

The monarchE study included 5,637 patients who were randomized to receive standard of care estrogen therapy for 5 years with or without abemaciclib (150 mg, twice per day) for 2 years; 36.5% received abemaciclib. The mean age was 49.9 years; 70.8% were White, 22.8% Asian, and 2.7% Black.

The abemaciclib group had a clinically and statistically significant benefit in invasive disease-free survival (IDFS) (hazard ratio, 0.61; nominal P < .001) and distant relapse-free survival (DRFS) (HR, 0.61; nominal P < .001). At 2 years, DRFS was 89.5% in the abemaciclib group and 82.8% in the estrogen therapy–only group. IDFS was 87.2% and 80.6%, respectively. Patients who underwent neoadjuvant chemotherapy had a similar safety profile to the estrogen therapy–only group, although there was a higher incidence of treatment-emergent adverse events. The most common were diarrhea, infections, neutropenia, and fatigue. The most frequent grade treatment-emergent adverse events (of at least 3) were neutropenia and leucopenia.

The researchers noted that patients who underwent neoadjuvant chemotherapy had a worse prognosis than the intent-to-treat arm, as evidenced by a higher risk of 2-year recurrence (19% versus 11%). Exploratory subgroup analyses revealed that treatment with abemaciclib and estrogen therapy conferred IDFS and DRFS benefits regardless of the pathological tumor size and number of positive axillary lymph nodes.

The study was limited by the fact that it was open label, and the subgroup analyses were not powered to find statistically significant associations.

Dr. Martin has received grants from Eli Lilly, which funded monarchE.

New efficacy and safety data from the monarchE study show that chemotherapy administered before treatment with abemaciclib and estrogen therapy, led to a clinically meaningful improvement in invasive disease-free survival and distant relapse-free survival for women with HR-positive, ERBB2-negative, node-positive, early breast cancer at high risk of recurrence.

The study was published earlier this year in JAMA Oncology.

Neoadjuvant chemotherapy is often provided to such patients in hopes of achieving breast-conserving surgery. Although pathologic complete response rates can be higher than 50% after chemotherapy treatment in triple-negative and ERBB2-positive breast cancer, most patients with HR-positive and ERBB2-negative breast cancer have residual tumor at surgery after neoadjuvant chemotherapy, which is associated with an increased risk of recurrence.

Adjuvant estrogen therapy can reduce the risk of recurrence in this population, but a significant hazard remains.

“To our knowledge, abemaciclib is the first agent added to standard adjuvant estrogen therapy that has been shown to reduce the risk of recurrence in patients with HR-positive, ERBB2-negative early breast cancer with residual disease after neoadjuvant chemotherapy,” wrote the authors, who were led by Miguel Martin, MD, PhD, Hospital General Universitario Gregorio Marañon, Spain.

In 2021, Food and Drug Administration approved abemaciclib (Verzenio, Lilly) with endocrine therapy for the treatment of HR-positive/ERBB2-negative, node-positive, high-risk early breast cancer. Their decision was based on data from the monarchE study.

The study is at odds with the previously published Penelope-B study, which found no benefit from treatment with the CDK4/6 inhibitor palbociclib (Ibrance, Pfizer) after 42.8 months of follow-up. The authors suggest that the disparate outcomes may be due to pharmacological differences between the two drugs as well as different dosing schedules: In monarchE, patients received abemaciclib on a continuous basis, while patients in Penelope-B received palbociclib for 21 days, followed by 7 days off. The treatment duration was 2 years in monarchE and 1 year in Penelope-B. Abemaciclib can be dosed continuously because it is a stronger inhibitor of CDK4 versus CDK6 compared to abemaciclib, and in vitro studies suggest that continuous dosing could be a key factor in creating profound inhibition of DNA synthesis.

The monarchE study included 5,637 patients who were randomized to receive standard of care estrogen therapy for 5 years with or without abemaciclib (150 mg, twice per day) for 2 years; 36.5% received abemaciclib. The mean age was 49.9 years; 70.8% were White, 22.8% Asian, and 2.7% Black.

The abemaciclib group had a clinically and statistically significant benefit in invasive disease-free survival (IDFS) (hazard ratio, 0.61; nominal P < .001) and distant relapse-free survival (DRFS) (HR, 0.61; nominal P < .001). At 2 years, DRFS was 89.5% in the abemaciclib group and 82.8% in the estrogen therapy–only group. IDFS was 87.2% and 80.6%, respectively. Patients who underwent neoadjuvant chemotherapy had a similar safety profile to the estrogen therapy–only group, although there was a higher incidence of treatment-emergent adverse events. The most common were diarrhea, infections, neutropenia, and fatigue. The most frequent grade treatment-emergent adverse events (of at least 3) were neutropenia and leucopenia.

The researchers noted that patients who underwent neoadjuvant chemotherapy had a worse prognosis than the intent-to-treat arm, as evidenced by a higher risk of 2-year recurrence (19% versus 11%). Exploratory subgroup analyses revealed that treatment with abemaciclib and estrogen therapy conferred IDFS and DRFS benefits regardless of the pathological tumor size and number of positive axillary lymph nodes.

The study was limited by the fact that it was open label, and the subgroup analyses were not powered to find statistically significant associations.

Dr. Martin has received grants from Eli Lilly, which funded monarchE.

New efficacy and safety data from the monarchE study show that chemotherapy administered before treatment with abemaciclib and estrogen therapy, led to a clinically meaningful improvement in invasive disease-free survival and distant relapse-free survival for women with HR-positive, ERBB2-negative, node-positive, early breast cancer at high risk of recurrence.

The study was published earlier this year in JAMA Oncology.

Neoadjuvant chemotherapy is often provided to such patients in hopes of achieving breast-conserving surgery. Although pathologic complete response rates can be higher than 50% after chemotherapy treatment in triple-negative and ERBB2-positive breast cancer, most patients with HR-positive and ERBB2-negative breast cancer have residual tumor at surgery after neoadjuvant chemotherapy, which is associated with an increased risk of recurrence.

Adjuvant estrogen therapy can reduce the risk of recurrence in this population, but a significant hazard remains.

“To our knowledge, abemaciclib is the first agent added to standard adjuvant estrogen therapy that has been shown to reduce the risk of recurrence in patients with HR-positive, ERBB2-negative early breast cancer with residual disease after neoadjuvant chemotherapy,” wrote the authors, who were led by Miguel Martin, MD, PhD, Hospital General Universitario Gregorio Marañon, Spain.

In 2021, Food and Drug Administration approved abemaciclib (Verzenio, Lilly) with endocrine therapy for the treatment of HR-positive/ERBB2-negative, node-positive, high-risk early breast cancer. Their decision was based on data from the monarchE study.

The study is at odds with the previously published Penelope-B study, which found no benefit from treatment with the CDK4/6 inhibitor palbociclib (Ibrance, Pfizer) after 42.8 months of follow-up. The authors suggest that the disparate outcomes may be due to pharmacological differences between the two drugs as well as different dosing schedules: In monarchE, patients received abemaciclib on a continuous basis, while patients in Penelope-B received palbociclib for 21 days, followed by 7 days off. The treatment duration was 2 years in monarchE and 1 year in Penelope-B. Abemaciclib can be dosed continuously because it is a stronger inhibitor of CDK4 versus CDK6 compared to abemaciclib, and in vitro studies suggest that continuous dosing could be a key factor in creating profound inhibition of DNA synthesis.

The monarchE study included 5,637 patients who were randomized to receive standard of care estrogen therapy for 5 years with or without abemaciclib (150 mg, twice per day) for 2 years; 36.5% received abemaciclib. The mean age was 49.9 years; 70.8% were White, 22.8% Asian, and 2.7% Black.

The abemaciclib group had a clinically and statistically significant benefit in invasive disease-free survival (IDFS) (hazard ratio, 0.61; nominal P < .001) and distant relapse-free survival (DRFS) (HR, 0.61; nominal P < .001). At 2 years, DRFS was 89.5% in the abemaciclib group and 82.8% in the estrogen therapy–only group. IDFS was 87.2% and 80.6%, respectively. Patients who underwent neoadjuvant chemotherapy had a similar safety profile to the estrogen therapy–only group, although there was a higher incidence of treatment-emergent adverse events. The most common were diarrhea, infections, neutropenia, and fatigue. The most frequent grade treatment-emergent adverse events (of at least 3) were neutropenia and leucopenia.

The researchers noted that patients who underwent neoadjuvant chemotherapy had a worse prognosis than the intent-to-treat arm, as evidenced by a higher risk of 2-year recurrence (19% versus 11%). Exploratory subgroup analyses revealed that treatment with abemaciclib and estrogen therapy conferred IDFS and DRFS benefits regardless of the pathological tumor size and number of positive axillary lymph nodes.

The study was limited by the fact that it was open label, and the subgroup analyses were not powered to find statistically significant associations.

Dr. Martin has received grants from Eli Lilly, which funded monarchE.

In the management of acute and chronic stroke, smartphone apps enhance communication between first responders and waiting hospital staff and reduce door-to-needle time, according to a literature review.

“In clinical practice, guideline-driven patient care is very important in improving diagnosis and outcomes, and apps provide a very practical and easy way to check available guidelines,” senior author Fabio Pilato, MD, a neurologist at Università Campus Bio-Medico, Rome, told this news organization.

The review was published  in the Journal of Stroke.
 

Reviewing the literature

“My colleagues and I wanted to discover whether smartphone apps, besides just facilitating communication between doctors and their patients, could improve patient care,” said Dr. Pilato. “We wanted to see if there were any apps that could guide clinical decisions according to guidelines and whether there were some being used in acute stroke management,” he added.

The investigators reviewed 43 studies of stroke-related mobile phone apps that were designed for the clinical management of stroke between June 1, 2007, when the first iPhone was introduced, and Jan. 31, 2022.

The apps were classified into the following three groups, according to their purpose: primary prevention apps, acute stroke management apps, and postacute stroke apps.
 

Prevention and management

The investigators found one primary prevention app, the Stroke Riskometer, that was based on an algorithm derived from the Framingham Stroke Risk Score and was designed to educate patients about diet, physical activity, and the warning signs of stroke. However, their review failed to show that the app was beneficial, compared with standard cardiovascular risk reduction.

Apps appeared to aid acute stroke management, according to the researchers. Prehospital apps, such as iLAMA, Smartphone-Assisted Pre-Hospital Medical Information System, FAST-ED, Egyptian Stroke Network, Act Fast, and the Mayo Clinic Acute Stroke Evaluation app were found to speed up stroke recognition, activate emergency medical services for speedier transport to the hospital, and facilitate communication with in-hospital stroke teams. All these prehospital apps reduced door-to-needle time.

The JOIN app also was shown to significantly reduce door-to-needle time, compared with no app support, in several studies. JOIN consists of a chat, a DICOM viewer, and an encrypted two-way video system for video calls between practitioners, as well as a milestones time stamp to record every step from home to hospital transportation to therapy onset. 

StopStroke, another app that focuses on instant communication among physicians and allows real-time sharing of clinical data of stroke patients, reduced door-to-image and door-to-needle time, compared with no app.

Act Fast, which uses a National Institutes of Health Stroke Scale (NIHSS) calculator, a thrombolysis checklist, and a toolbox to share images and notes among practitioners involved in the decision-making process, decreased door-to-needle time by 16 minutes, compared with no app.

In a study of medical residents, adherence to guidelines was higher in participants who used the Mayo Clinic Acute Stroke Evaluation app, compared with those who did not. Door-to-needle time also was reduced by 16 minutes in the app-assisted group, compared with controls.
 

Postacute stroke apps

The Rehabilitation Guardian app, consisting of a health reminder, consultation, health information, and patient diary, gives medical information and provides rehabilitation exercises. Patients can enter their clinical information, and the medical staff can access it and assist with the rehab process remotely.

As for apps for chronic management and secondary prevention, Dr. Pilato and colleagues found that the PRESTRO app, which combines motivational support for a healthy lifestyle and tells patients to take their medications and measure their blood pressure, successfully got patients to be more physically active, compared with those who did not use the app.

Another app for secondary prevention, the Korea University Health Monitoring System for Stroke (KUHMS2), reduced blood pressure and glucose levels in patients who used it, compared with those who did not.

Lose It, a weight loss app, is an electronic food journal that shows the values of the macronutrients of foods that the patient consumes, as well as a daily calorie count. The Engaging Everyday Activities app effectively reminds patients who have had transient ischemic attacks about daily activities that can reduce their risk for a recurrent attack.

Movies4Stroke features educational videos about first aid, rehabilitation, how to improve swallowing, and stroke risk factors.

AFib 2gether allows patients to enter their clinical data and calculates their annual stroke risk scores. The information is provided to a health care provider before the next visit to help the patient make an informed decision about anticoagulation therapy.

“We believe that the widespread use of smartphones and apps may improve patient care in every part of the world and in particular in those parts where updated guideline consultation is not readily available. However, in our study we found that apps to implement guidelines by a clinical decision support system are still lacking. Our hope is that these apps will increase in the future,” said Dr. Pilato.
 

No panacea

Commenting on this review for this article, Amy Guzik, MD, associate professor of neurology at Wake Forest University School of Medicine, Winston-Salem, N.C., said that all physicians are looking for opportunities to use technology, especially in stroke, to diagnose and treat patients in the best way they can.

“Figuring out ways to increase efficiency and get the word out to our patients is very important to us and is probably why there are so many apps out there,” said Dr. Guzik.

“There are some ways such apps could be particularly useful. One is in remote hospitals that might not have a neurologist. Helping with the diagnosis and determining what is a bad stroke that needs to go to a higher level of medical care, or whether it is something the local hospital could take care of, would be useful,” said Dr. Guzik.

“Also helping EMS figure out which hospital to go to, or once they are on their way, being able to talk to the neurologist or neurosurgeon or the emergency room doctor and make a plan before the patient gets here, so we can expedite care when the patient arrives, is where apps can be particularly useful,” she added.

There are limitations to what apps can do, however. In the case of stroke, patients may often have important barriers that do not allow them to use apps at all, she said.

“Regardless of how they are being taken care of, a lot of our stroke patients will have problems with technology. A stroke can make texting difficult. Patients may have language difficulties, weakness, or cognitive impairment. They are relying on caregivers. All of this makes it difficult for a tech solution to be the automatic solution, unless things are done in a thoughtful way to make sure that it is appropriate for stroke patients.

“Also, there are a lot of elderly patients who may not necessarily be the most tech savvy and do not have as much digital literacy as younger patients. Another limitation to consider is that some people may not even have easy access to technology. So we must make sure that this is all done with an equity focus,” said Dr. Guzik.

The study was funded by the Associazione Nazionale fra le Imprese Assicuratrici (ANIA). Dr. Pilato and Dr. Guzik reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In the management of acute and chronic stroke, smartphone apps enhance communication between first responders and waiting hospital staff and reduce door-to-needle time, according to a literature review.

“In clinical practice, guideline-driven patient care is very important in improving diagnosis and outcomes, and apps provide a very practical and easy way to check available guidelines,” senior author Fabio Pilato, MD, a neurologist at Università Campus Bio-Medico, Rome, told this news organization.

The review was published  in the Journal of Stroke.
 

Reviewing the literature

“My colleagues and I wanted to discover whether smartphone apps, besides just facilitating communication between doctors and their patients, could improve patient care,” said Dr. Pilato. “We wanted to see if there were any apps that could guide clinical decisions according to guidelines and whether there were some being used in acute stroke management,” he added.

The investigators reviewed 43 studies of stroke-related mobile phone apps that were designed for the clinical management of stroke between June 1, 2007, when the first iPhone was introduced, and Jan. 31, 2022.

The apps were classified into the following three groups, according to their purpose: primary prevention apps, acute stroke management apps, and postacute stroke apps.
 

Prevention and management

The investigators found one primary prevention app, the Stroke Riskometer, that was based on an algorithm derived from the Framingham Stroke Risk Score and was designed to educate patients about diet, physical activity, and the warning signs of stroke. However, their review failed to show that the app was beneficial, compared with standard cardiovascular risk reduction.

Apps appeared to aid acute stroke management, according to the researchers. Prehospital apps, such as iLAMA, Smartphone-Assisted Pre-Hospital Medical Information System, FAST-ED, Egyptian Stroke Network, Act Fast, and the Mayo Clinic Acute Stroke Evaluation app were found to speed up stroke recognition, activate emergency medical services for speedier transport to the hospital, and facilitate communication with in-hospital stroke teams. All these prehospital apps reduced door-to-needle time.

The JOIN app also was shown to significantly reduce door-to-needle time, compared with no app support, in several studies. JOIN consists of a chat, a DICOM viewer, and an encrypted two-way video system for video calls between practitioners, as well as a milestones time stamp to record every step from home to hospital transportation to therapy onset. 

StopStroke, another app that focuses on instant communication among physicians and allows real-time sharing of clinical data of stroke patients, reduced door-to-image and door-to-needle time, compared with no app.

Act Fast, which uses a National Institutes of Health Stroke Scale (NIHSS) calculator, a thrombolysis checklist, and a toolbox to share images and notes among practitioners involved in the decision-making process, decreased door-to-needle time by 16 minutes, compared with no app.

In a study of medical residents, adherence to guidelines was higher in participants who used the Mayo Clinic Acute Stroke Evaluation app, compared with those who did not. Door-to-needle time also was reduced by 16 minutes in the app-assisted group, compared with controls.
 

Postacute stroke apps

The Rehabilitation Guardian app, consisting of a health reminder, consultation, health information, and patient diary, gives medical information and provides rehabilitation exercises. Patients can enter their clinical information, and the medical staff can access it and assist with the rehab process remotely.

As for apps for chronic management and secondary prevention, Dr. Pilato and colleagues found that the PRESTRO app, which combines motivational support for a healthy lifestyle and tells patients to take their medications and measure their blood pressure, successfully got patients to be more physically active, compared with those who did not use the app.

Another app for secondary prevention, the Korea University Health Monitoring System for Stroke (KUHMS2), reduced blood pressure and glucose levels in patients who used it, compared with those who did not.

Lose It, a weight loss app, is an electronic food journal that shows the values of the macronutrients of foods that the patient consumes, as well as a daily calorie count. The Engaging Everyday Activities app effectively reminds patients who have had transient ischemic attacks about daily activities that can reduce their risk for a recurrent attack.

Movies4Stroke features educational videos about first aid, rehabilitation, how to improve swallowing, and stroke risk factors.

AFib 2gether allows patients to enter their clinical data and calculates their annual stroke risk scores. The information is provided to a health care provider before the next visit to help the patient make an informed decision about anticoagulation therapy.

“We believe that the widespread use of smartphones and apps may improve patient care in every part of the world and in particular in those parts where updated guideline consultation is not readily available. However, in our study we found that apps to implement guidelines by a clinical decision support system are still lacking. Our hope is that these apps will increase in the future,” said Dr. Pilato.
 

No panacea

Commenting on this review for this article, Amy Guzik, MD, associate professor of neurology at Wake Forest University School of Medicine, Winston-Salem, N.C., said that all physicians are looking for opportunities to use technology, especially in stroke, to diagnose and treat patients in the best way they can.

“Figuring out ways to increase efficiency and get the word out to our patients is very important to us and is probably why there are so many apps out there,” said Dr. Guzik.

“There are some ways such apps could be particularly useful. One is in remote hospitals that might not have a neurologist. Helping with the diagnosis and determining what is a bad stroke that needs to go to a higher level of medical care, or whether it is something the local hospital could take care of, would be useful,” said Dr. Guzik.

“Also helping EMS figure out which hospital to go to, or once they are on their way, being able to talk to the neurologist or neurosurgeon or the emergency room doctor and make a plan before the patient gets here, so we can expedite care when the patient arrives, is where apps can be particularly useful,” she added.

There are limitations to what apps can do, however. In the case of stroke, patients may often have important barriers that do not allow them to use apps at all, she said.

“Regardless of how they are being taken care of, a lot of our stroke patients will have problems with technology. A stroke can make texting difficult. Patients may have language difficulties, weakness, or cognitive impairment. They are relying on caregivers. All of this makes it difficult for a tech solution to be the automatic solution, unless things are done in a thoughtful way to make sure that it is appropriate for stroke patients.

“Also, there are a lot of elderly patients who may not necessarily be the most tech savvy and do not have as much digital literacy as younger patients. Another limitation to consider is that some people may not even have easy access to technology. So we must make sure that this is all done with an equity focus,” said Dr. Guzik.

The study was funded by the Associazione Nazionale fra le Imprese Assicuratrici (ANIA). Dr. Pilato and Dr. Guzik reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In the management of acute and chronic stroke, smartphone apps enhance communication between first responders and waiting hospital staff and reduce door-to-needle time, according to a literature review.

“In clinical practice, guideline-driven patient care is very important in improving diagnosis and outcomes, and apps provide a very practical and easy way to check available guidelines,” senior author Fabio Pilato, MD, a neurologist at Università Campus Bio-Medico, Rome, told this news organization.

The review was published  in the Journal of Stroke.
 

Reviewing the literature

“My colleagues and I wanted to discover whether smartphone apps, besides just facilitating communication between doctors and their patients, could improve patient care,” said Dr. Pilato. “We wanted to see if there were any apps that could guide clinical decisions according to guidelines and whether there were some being used in acute stroke management,” he added.

The investigators reviewed 43 studies of stroke-related mobile phone apps that were designed for the clinical management of stroke between June 1, 2007, when the first iPhone was introduced, and Jan. 31, 2022.

The apps were classified into the following three groups, according to their purpose: primary prevention apps, acute stroke management apps, and postacute stroke apps.
 

Prevention and management

The investigators found one primary prevention app, the Stroke Riskometer, that was based on an algorithm derived from the Framingham Stroke Risk Score and was designed to educate patients about diet, physical activity, and the warning signs of stroke. However, their review failed to show that the app was beneficial, compared with standard cardiovascular risk reduction.

Apps appeared to aid acute stroke management, according to the researchers. Prehospital apps, such as iLAMA, Smartphone-Assisted Pre-Hospital Medical Information System, FAST-ED, Egyptian Stroke Network, Act Fast, and the Mayo Clinic Acute Stroke Evaluation app were found to speed up stroke recognition, activate emergency medical services for speedier transport to the hospital, and facilitate communication with in-hospital stroke teams. All these prehospital apps reduced door-to-needle time.

The JOIN app also was shown to significantly reduce door-to-needle time, compared with no app support, in several studies. JOIN consists of a chat, a DICOM viewer, and an encrypted two-way video system for video calls between practitioners, as well as a milestones time stamp to record every step from home to hospital transportation to therapy onset. 

StopStroke, another app that focuses on instant communication among physicians and allows real-time sharing of clinical data of stroke patients, reduced door-to-image and door-to-needle time, compared with no app.

Act Fast, which uses a National Institutes of Health Stroke Scale (NIHSS) calculator, a thrombolysis checklist, and a toolbox to share images and notes among practitioners involved in the decision-making process, decreased door-to-needle time by 16 minutes, compared with no app.

In a study of medical residents, adherence to guidelines was higher in participants who used the Mayo Clinic Acute Stroke Evaluation app, compared with those who did not. Door-to-needle time also was reduced by 16 minutes in the app-assisted group, compared with controls.
 

Postacute stroke apps

The Rehabilitation Guardian app, consisting of a health reminder, consultation, health information, and patient diary, gives medical information and provides rehabilitation exercises. Patients can enter their clinical information, and the medical staff can access it and assist with the rehab process remotely.

As for apps for chronic management and secondary prevention, Dr. Pilato and colleagues found that the PRESTRO app, which combines motivational support for a healthy lifestyle and tells patients to take their medications and measure their blood pressure, successfully got patients to be more physically active, compared with those who did not use the app.

Another app for secondary prevention, the Korea University Health Monitoring System for Stroke (KUHMS2), reduced blood pressure and glucose levels in patients who used it, compared with those who did not.

Lose It, a weight loss app, is an electronic food journal that shows the values of the macronutrients of foods that the patient consumes, as well as a daily calorie count. The Engaging Everyday Activities app effectively reminds patients who have had transient ischemic attacks about daily activities that can reduce their risk for a recurrent attack.

Movies4Stroke features educational videos about first aid, rehabilitation, how to improve swallowing, and stroke risk factors.

AFib 2gether allows patients to enter their clinical data and calculates their annual stroke risk scores. The information is provided to a health care provider before the next visit to help the patient make an informed decision about anticoagulation therapy.

“We believe that the widespread use of smartphones and apps may improve patient care in every part of the world and in particular in those parts where updated guideline consultation is not readily available. However, in our study we found that apps to implement guidelines by a clinical decision support system are still lacking. Our hope is that these apps will increase in the future,” said Dr. Pilato.
 

No panacea

Commenting on this review for this article, Amy Guzik, MD, associate professor of neurology at Wake Forest University School of Medicine, Winston-Salem, N.C., said that all physicians are looking for opportunities to use technology, especially in stroke, to diagnose and treat patients in the best way they can.

“Figuring out ways to increase efficiency and get the word out to our patients is very important to us and is probably why there are so many apps out there,” said Dr. Guzik.

“There are some ways such apps could be particularly useful. One is in remote hospitals that might not have a neurologist. Helping with the diagnosis and determining what is a bad stroke that needs to go to a higher level of medical care, or whether it is something the local hospital could take care of, would be useful,” said Dr. Guzik.

“Also helping EMS figure out which hospital to go to, or once they are on their way, being able to talk to the neurologist or neurosurgeon or the emergency room doctor and make a plan before the patient gets here, so we can expedite care when the patient arrives, is where apps can be particularly useful,” she added.

There are limitations to what apps can do, however. In the case of stroke, patients may often have important barriers that do not allow them to use apps at all, she said.

“Regardless of how they are being taken care of, a lot of our stroke patients will have problems with technology. A stroke can make texting difficult. Patients may have language difficulties, weakness, or cognitive impairment. They are relying on caregivers. All of this makes it difficult for a tech solution to be the automatic solution, unless things are done in a thoughtful way to make sure that it is appropriate for stroke patients.

“Also, there are a lot of elderly patients who may not necessarily be the most tech savvy and do not have as much digital literacy as younger patients. Another limitation to consider is that some people may not even have easy access to technology. So we must make sure that this is all done with an equity focus,” said Dr. Guzik.

The study was funded by the Associazione Nazionale fra le Imprese Assicuratrici (ANIA). Dr. Pilato and Dr. Guzik reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Women with breast cancer who are taking adjuvant endocrine therapy to reduce the risk for recurrence often report that the side effects of dampening down estrogen, such as hot flashes and vaginal dryness, spoil their quality of life, and these side effects can lead to discontinuation of therapy.

But medical measures to address these side effects carry risks, as shown in the results of a new study from Denmark.

The use of vaginal estrogen therapy (VET) increased the risk for breast cancer recurrence by 39% in women with early estrogen receptor–positive breast cancer who were taking aromatase inhibitors (AIs).

There was no increase in the risk for recurrence in women who were using VET and taking tamoxifen or in women who were using VET and not taking any adjuvant endocrine therapy.

The finding was published in the Journal of the National Cancer Institute.

“Patients who are taking aromatase inhibitors should try alternative strategies for management of genitourinary symptoms because (VET) will likely increase their risk for breast cancer recurrence,” warn the authors of an accompanying editorial, Elizabeth J. Cathcart-Rake, MD, and Kathryn J. Ruddy, MD, oncologists at the Mayo Clinic, Rochester, Minn.

The use of oral estrogen treatment, known as menopausal hormone therapy (MHT), is also not recommended in breast cancer survivors being treated with AIs, the editorialists added.

The study did not find an increase in the risk for recurrence with MHT added onto AIs, but that finding comes from a very small subgroup of only 37 women.

“The absence of an obvious detrimental impact of MHT on breast cancer recurrence or mortality” in this study “is not particularly reassuring,” especially given higher systemic estrogen levels seen with MHT, Dr. Cathcart-Rake and Dr. Ruddy commented.
 

Differences between endocrine therapies

“Our study is, to our knowledge, the first to report a potential increased risk of recurrence in patients receiving AIs treated with VET,” say the investigators, led by Søren Cold, MD, an oncology researcher at Odense University Hospital, Denmark.

They suggest that women who are taking VET and AIs should be switched to tamoxifen after 2-3 years.

Speculating as to the apparent safety differences between the two endocrine therapies, Dr. Cold and colleagues explained that “AIs lower or nearly eliminate estrogen. As such, even a modest increase in circulating estrogens may” increase recurrence risk.

Tamoxifen, on the other hand, competes for estrogen receptor binding, so “a modest elevation of the very low serum estrogen levels” with hormone therapy “is not assumed to counteract the receptor blockade,” they said.
 

Study details

Study participants, obtained from a nationwide registry in Denmark, were diagnosed with early-stage, invasive, estrogen receptor–positive breast cancer from 1997 to 2004. Upfront treatment included surgery plus, in the majority of women, radiation.

The review identified 8,461 such women. After initial treatment for breast cancer, 2,410 went on to adjuvant endocrine therapy, including 2,007 with tamoxifen and 403 with an AI.

Across the entire study population, nearly 2,000 women took VET and 133 women took MHT, as assessed by having redeemed at least two prescriptions. The hormone therapies were used in women who were both on and those who were not on endocrine therapy.

Overall, breast cancer recurred in 1,333 women (16%) over a median follow-up of 9.8 years.

The investigators then analyzed the risk for recurrence in various subgroups.

The 39% higher risk for recurrence was found among the 822 women who used VET while taking an AI, compared with 2,520 women who received AIs alone.

Findings in the study were adjusted for numerous potential confounders, including age, tumor biology, and comorbidities.

Women were a median of 61 years of age (range, 35-91 years). Seventy-seven percent had invasive ductal carcinoma, and 43% were node-positive. Women on hormone therapy tended to be younger, have smaller tumors, and be less likely to have lymph node metastases.

The investigators excluded women who had taken hormone replacement before their breast cancer diagnosis.

The work was funded by the Danish Cancer Society. Dr. Cold reports no disclosures, but some co-authors reported relationships with Samsung, Novartis, Pfizer, and other companies. Dr. Cathcart-Rake and Dr. Ruddy report no disclosures.

A version of this article first appeared on Medscape.com.

Women with breast cancer who are taking adjuvant endocrine therapy to reduce the risk for recurrence often report that the side effects of dampening down estrogen, such as hot flashes and vaginal dryness, spoil their quality of life, and these side effects can lead to discontinuation of therapy.

But medical measures to address these side effects carry risks, as shown in the results of a new study from Denmark.

The use of vaginal estrogen therapy (VET) increased the risk for breast cancer recurrence by 39% in women with early estrogen receptor–positive breast cancer who were taking aromatase inhibitors (AIs).

There was no increase in the risk for recurrence in women who were using VET and taking tamoxifen or in women who were using VET and not taking any adjuvant endocrine therapy.

The finding was published in the Journal of the National Cancer Institute.

“Patients who are taking aromatase inhibitors should try alternative strategies for management of genitourinary symptoms because (VET) will likely increase their risk for breast cancer recurrence,” warn the authors of an accompanying editorial, Elizabeth J. Cathcart-Rake, MD, and Kathryn J. Ruddy, MD, oncologists at the Mayo Clinic, Rochester, Minn.

The use of oral estrogen treatment, known as menopausal hormone therapy (MHT), is also not recommended in breast cancer survivors being treated with AIs, the editorialists added.

The study did not find an increase in the risk for recurrence with MHT added onto AIs, but that finding comes from a very small subgroup of only 37 women.

“The absence of an obvious detrimental impact of MHT on breast cancer recurrence or mortality” in this study “is not particularly reassuring,” especially given higher systemic estrogen levels seen with MHT, Dr. Cathcart-Rake and Dr. Ruddy commented.
 

Differences between endocrine therapies

“Our study is, to our knowledge, the first to report a potential increased risk of recurrence in patients receiving AIs treated with VET,” say the investigators, led by Søren Cold, MD, an oncology researcher at Odense University Hospital, Denmark.

They suggest that women who are taking VET and AIs should be switched to tamoxifen after 2-3 years.

Speculating as to the apparent safety differences between the two endocrine therapies, Dr. Cold and colleagues explained that “AIs lower or nearly eliminate estrogen. As such, even a modest increase in circulating estrogens may” increase recurrence risk.

Tamoxifen, on the other hand, competes for estrogen receptor binding, so “a modest elevation of the very low serum estrogen levels” with hormone therapy “is not assumed to counteract the receptor blockade,” they said.
 

Study details

Study participants, obtained from a nationwide registry in Denmark, were diagnosed with early-stage, invasive, estrogen receptor–positive breast cancer from 1997 to 2004. Upfront treatment included surgery plus, in the majority of women, radiation.

The review identified 8,461 such women. After initial treatment for breast cancer, 2,410 went on to adjuvant endocrine therapy, including 2,007 with tamoxifen and 403 with an AI.

Across the entire study population, nearly 2,000 women took VET and 133 women took MHT, as assessed by having redeemed at least two prescriptions. The hormone therapies were used in women who were both on and those who were not on endocrine therapy.

Overall, breast cancer recurred in 1,333 women (16%) over a median follow-up of 9.8 years.

The investigators then analyzed the risk for recurrence in various subgroups.

The 39% higher risk for recurrence was found among the 822 women who used VET while taking an AI, compared with 2,520 women who received AIs alone.

Findings in the study were adjusted for numerous potential confounders, including age, tumor biology, and comorbidities.

Women were a median of 61 years of age (range, 35-91 years). Seventy-seven percent had invasive ductal carcinoma, and 43% were node-positive. Women on hormone therapy tended to be younger, have smaller tumors, and be less likely to have lymph node metastases.

The investigators excluded women who had taken hormone replacement before their breast cancer diagnosis.

The work was funded by the Danish Cancer Society. Dr. Cold reports no disclosures, but some co-authors reported relationships with Samsung, Novartis, Pfizer, and other companies. Dr. Cathcart-Rake and Dr. Ruddy report no disclosures.

A version of this article first appeared on Medscape.com.

Women with breast cancer who are taking adjuvant endocrine therapy to reduce the risk for recurrence often report that the side effects of dampening down estrogen, such as hot flashes and vaginal dryness, spoil their quality of life, and these side effects can lead to discontinuation of therapy.

But medical measures to address these side effects carry risks, as shown in the results of a new study from Denmark.

The use of vaginal estrogen therapy (VET) increased the risk for breast cancer recurrence by 39% in women with early estrogen receptor–positive breast cancer who were taking aromatase inhibitors (AIs).

There was no increase in the risk for recurrence in women who were using VET and taking tamoxifen or in women who were using VET and not taking any adjuvant endocrine therapy.

The finding was published in the Journal of the National Cancer Institute.

“Patients who are taking aromatase inhibitors should try alternative strategies for management of genitourinary symptoms because (VET) will likely increase their risk for breast cancer recurrence,” warn the authors of an accompanying editorial, Elizabeth J. Cathcart-Rake, MD, and Kathryn J. Ruddy, MD, oncologists at the Mayo Clinic, Rochester, Minn.

The use of oral estrogen treatment, known as menopausal hormone therapy (MHT), is also not recommended in breast cancer survivors being treated with AIs, the editorialists added.

The study did not find an increase in the risk for recurrence with MHT added onto AIs, but that finding comes from a very small subgroup of only 37 women.

“The absence of an obvious detrimental impact of MHT on breast cancer recurrence or mortality” in this study “is not particularly reassuring,” especially given higher systemic estrogen levels seen with MHT, Dr. Cathcart-Rake and Dr. Ruddy commented.
 

Differences between endocrine therapies

“Our study is, to our knowledge, the first to report a potential increased risk of recurrence in patients receiving AIs treated with VET,” say the investigators, led by Søren Cold, MD, an oncology researcher at Odense University Hospital, Denmark.

They suggest that women who are taking VET and AIs should be switched to tamoxifen after 2-3 years.

Speculating as to the apparent safety differences between the two endocrine therapies, Dr. Cold and colleagues explained that “AIs lower or nearly eliminate estrogen. As such, even a modest increase in circulating estrogens may” increase recurrence risk.

Tamoxifen, on the other hand, competes for estrogen receptor binding, so “a modest elevation of the very low serum estrogen levels” with hormone therapy “is not assumed to counteract the receptor blockade,” they said.
 

Study details

Study participants, obtained from a nationwide registry in Denmark, were diagnosed with early-stage, invasive, estrogen receptor–positive breast cancer from 1997 to 2004. Upfront treatment included surgery plus, in the majority of women, radiation.

The review identified 8,461 such women. After initial treatment for breast cancer, 2,410 went on to adjuvant endocrine therapy, including 2,007 with tamoxifen and 403 with an AI.

Across the entire study population, nearly 2,000 women took VET and 133 women took MHT, as assessed by having redeemed at least two prescriptions. The hormone therapies were used in women who were both on and those who were not on endocrine therapy.

Overall, breast cancer recurred in 1,333 women (16%) over a median follow-up of 9.8 years.

The investigators then analyzed the risk for recurrence in various subgroups.

The 39% higher risk for recurrence was found among the 822 women who used VET while taking an AI, compared with 2,520 women who received AIs alone.

Findings in the study were adjusted for numerous potential confounders, including age, tumor biology, and comorbidities.

Women were a median of 61 years of age (range, 35-91 years). Seventy-seven percent had invasive ductal carcinoma, and 43% were node-positive. Women on hormone therapy tended to be younger, have smaller tumors, and be less likely to have lymph node metastases.

The investigators excluded women who had taken hormone replacement before their breast cancer diagnosis.

The work was funded by the Danish Cancer Society. Dr. Cold reports no disclosures, but some co-authors reported relationships with Samsung, Novartis, Pfizer, and other companies. Dr. Cathcart-Rake and Dr. Ruddy report no disclosures.

A version of this article first appeared on Medscape.com.