Noninvasive auricular vagus nerve stimulation (VNS) is no more effective than placebo at controlling symptoms of rheumatoid arthritis, according to a new study. But experts emphasize that these results do not mean trials of different forms of VNS will have the same fate.

VNS offers a potential additional therapy for autoimmune disease beyond disease-modifying antirheumatic drugs, explained first author Matthew Baker, MD, clinical chief, division of immunology and rheumatology, Stanford (Calif.) University, and colleagues.

“The principle of VNS is based upon the inflammatory reflex, which describes a primitive connection between the nervous system and immune system,” the authors write. Signals sent down the vagus nerve to the splenic nerve stimulate immune cells in the spleen, which ultimately results in blocking production of inflammatory cytokines such as tumor necrosis factor. “It is hypothesized that this reduction in systemic inflammation can be harnessed for the treatment of diseases such as RA,” they continue, and smaller studies suggest this treatment could benefit patients.

In a previous 12-week, open-label trial, 17 patients with RA who were implanted with a VNS device on the left cervical vagus nerve saw improvement in RA symptoms, as well as a decrease in TNF production. Noninvasive devices that stimulate the auricular branch of the vagus nerve have also shown some promise. A sham-controlled study of 18 patients with systemic lupus erythematosus (SLE) found that patients who received transcutaneous auricular VNS reported reduced musculoskeletal pain over just 4 days. An open-label study of 30 patients with RA showed clinically significant reductions in disease activity score of 28 joints with C-reactive protein (DAS28-CRP) and clinical improvement in American College of Rheumatology responses over 12 weeks. Additional trials have also demonstrated this positive effect of noninvasive VNS on RA symptoms, but all studies conducted thus far have been relatively small or uncontrolled, Dr. Baker said.
 

Results of latest trial

In this new trial, published online in Arthritis & Rheumatology, researchers enrolled 113 patients with active RA who had inadequate responses or intolerance to conventional synthetic DMARDs and were naïve to biologic or targeted synthetic DMARDs. All patients were given an auricular vagus nerve stimulator via a custom-molded earpiece that was controlled by a smartphone app. Patients wore the device for 15 minutes each day. When worn and turned on, the device generated electrical signals delivered transcutaneously to the cymba concha, a region of the ear connected to the auricular branch of the vagus nerve. This stimulation is imperceptible to patients, Dr. Baker explained. “For the sham arm, we simply did not turn the device on at all,” he said. A subject in the sham arm would use the same device on a 15-minute timer, but no stimulation was given.

After 12 weeks, researchers found no statistically significant difference between the treatment and sham arms in achieving 20% improvement in ACR response criteria or mean change in DAS28-CRP. A total of 17 patients, including 12 in the treatment arm, reported adverse events during the study, and all events were categorized as mild to moderate.

While the research team was “obviously disappointed” about the results, Dr. Baker said, negative findings in trials also are important. “The real value of our study is pointing out the need for large controlled, sham-controlled studies,” he said, especially for potential treatments with a lot of enthusiasm behind them.
 

Results don’t seal the fate of other VNS approaches

“As a properly controlled trial, the results are impressively negative,” writes Roy Fleischmann, MD, clinical professor of medicine, University of Texas Southwestern Medical Center, and codirector, Metroplex Clinical Research Center, both in Dallas, in an editorial about the study. Many of the previous studies looking at this therapy in RA were open label, which could bias the results, he argued. The biggest question, he noted, is if other blinded, sham-controlled trials looking at VNS devices will show similar results.

By itself, this finding does not imply that other VNS devices will be unsuccessful, argued Jonathan Kay, MD, the Timothy S. and Elaine L. Peterson chair in rheumatology, and professor of medicine and population and quantitative health sciences, UMass Chan Medical School and UMass Memorial Medical Center, both in Worcester, Mass. He is also an investigator for the RESET-RA trial, a randomized, sham-controlled trial that will assess the safety and efficacy of an implantable VNS device in an estimated 250 patients with RA. He was not involved with Dr. Baker’s work.

“Auricular VNS is delivered more distally than cervical or splenic nerve stimulation,” Dr. Kay said, and the potential effect of these other forms of VNS may have different outcomes.

Cynthia Aranow, MD, rheumatologist and director of the Clinical Autoimmunity Center of Excellence at Feinstein Institutes for Medical Research, Manhasset, New York, agreed with Dr. Kay, noting that direct VNS stimulation via implantable device and transcutaneous stimulation through the skin are not comparable. She also is unaffiliated with the study.

“This group conducted a well-designed, sham-controlled study of a reasonable number of patients and over a reasonable period of time and observed no significant differences between those participants receiving true and those participants receiving sham stimulation,” she wrote in an email. “However, it’s important to point out that the stimulation settings used in this study were kHz (kilohertz) which is 1,000 times greater than the settings used in multiple other studies in which transauricular VNS has been shown to be clinically effective, including studies in long COVID, tinnitus, SLE, cluster headaches, erosive hand osteoarthritis, pediatric kidney disease, among others,” she said.

The role for VNS treatment, whether direct stimulation via implantable device or transcutaneous, in autoimmune and inflammatory diseases “remains to be determined by future studies,” she said.

The study was funded by Nesos. Dr. Baker received personal fees from Nesos during the study. Dr. Kay has received consulting fees from AbbVie, Boehringer Ingelheim, Celltrion Healthcare, and several other pharmaceutical companies. Dr. Aranow reports no relevant financial relationships.

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

Noninvasive auricular vagus nerve stimulation (VNS) is no more effective than placebo at controlling symptoms of rheumatoid arthritis, according to a new study. But experts emphasize that these results do not mean trials of different forms of VNS will have the same fate.

VNS offers a potential additional therapy for autoimmune disease beyond disease-modifying antirheumatic drugs, explained first author Matthew Baker, MD, clinical chief, division of immunology and rheumatology, Stanford (Calif.) University, and colleagues.

“The principle of VNS is based upon the inflammatory reflex, which describes a primitive connection between the nervous system and immune system,” the authors write. Signals sent down the vagus nerve to the splenic nerve stimulate immune cells in the spleen, which ultimately results in blocking production of inflammatory cytokines such as tumor necrosis factor. “It is hypothesized that this reduction in systemic inflammation can be harnessed for the treatment of diseases such as RA,” they continue, and smaller studies suggest this treatment could benefit patients.

In a previous 12-week, open-label trial, 17 patients with RA who were implanted with a VNS device on the left cervical vagus nerve saw improvement in RA symptoms, as well as a decrease in TNF production. Noninvasive devices that stimulate the auricular branch of the vagus nerve have also shown some promise. A sham-controlled study of 18 patients with systemic lupus erythematosus (SLE) found that patients who received transcutaneous auricular VNS reported reduced musculoskeletal pain over just 4 days. An open-label study of 30 patients with RA showed clinically significant reductions in disease activity score of 28 joints with C-reactive protein (DAS28-CRP) and clinical improvement in American College of Rheumatology responses over 12 weeks. Additional trials have also demonstrated this positive effect of noninvasive VNS on RA symptoms, but all studies conducted thus far have been relatively small or uncontrolled, Dr. Baker said.
 

Results of latest trial

In this new trial, published online in Arthritis & Rheumatology, researchers enrolled 113 patients with active RA who had inadequate responses or intolerance to conventional synthetic DMARDs and were naïve to biologic or targeted synthetic DMARDs. All patients were given an auricular vagus nerve stimulator via a custom-molded earpiece that was controlled by a smartphone app. Patients wore the device for 15 minutes each day. When worn and turned on, the device generated electrical signals delivered transcutaneously to the cymba concha, a region of the ear connected to the auricular branch of the vagus nerve. This stimulation is imperceptible to patients, Dr. Baker explained. “For the sham arm, we simply did not turn the device on at all,” he said. A subject in the sham arm would use the same device on a 15-minute timer, but no stimulation was given.

After 12 weeks, researchers found no statistically significant difference between the treatment and sham arms in achieving 20% improvement in ACR response criteria or mean change in DAS28-CRP. A total of 17 patients, including 12 in the treatment arm, reported adverse events during the study, and all events were categorized as mild to moderate.

While the research team was “obviously disappointed” about the results, Dr. Baker said, negative findings in trials also are important. “The real value of our study is pointing out the need for large controlled, sham-controlled studies,” he said, especially for potential treatments with a lot of enthusiasm behind them.
 

Results don’t seal the fate of other VNS approaches

“As a properly controlled trial, the results are impressively negative,” writes Roy Fleischmann, MD, clinical professor of medicine, University of Texas Southwestern Medical Center, and codirector, Metroplex Clinical Research Center, both in Dallas, in an editorial about the study. Many of the previous studies looking at this therapy in RA were open label, which could bias the results, he argued. The biggest question, he noted, is if other blinded, sham-controlled trials looking at VNS devices will show similar results.

By itself, this finding does not imply that other VNS devices will be unsuccessful, argued Jonathan Kay, MD, the Timothy S. and Elaine L. Peterson chair in rheumatology, and professor of medicine and population and quantitative health sciences, UMass Chan Medical School and UMass Memorial Medical Center, both in Worcester, Mass. He is also an investigator for the RESET-RA trial, a randomized, sham-controlled trial that will assess the safety and efficacy of an implantable VNS device in an estimated 250 patients with RA. He was not involved with Dr. Baker’s work.

“Auricular VNS is delivered more distally than cervical or splenic nerve stimulation,” Dr. Kay said, and the potential effect of these other forms of VNS may have different outcomes.

Cynthia Aranow, MD, rheumatologist and director of the Clinical Autoimmunity Center of Excellence at Feinstein Institutes for Medical Research, Manhasset, New York, agreed with Dr. Kay, noting that direct VNS stimulation via implantable device and transcutaneous stimulation through the skin are not comparable. She also is unaffiliated with the study.

“This group conducted a well-designed, sham-controlled study of a reasonable number of patients and over a reasonable period of time and observed no significant differences between those participants receiving true and those participants receiving sham stimulation,” she wrote in an email. “However, it’s important to point out that the stimulation settings used in this study were kHz (kilohertz) which is 1,000 times greater than the settings used in multiple other studies in which transauricular VNS has been shown to be clinically effective, including studies in long COVID, tinnitus, SLE, cluster headaches, erosive hand osteoarthritis, pediatric kidney disease, among others,” she said.

The role for VNS treatment, whether direct stimulation via implantable device or transcutaneous, in autoimmune and inflammatory diseases “remains to be determined by future studies,” she said.

The study was funded by Nesos. Dr. Baker received personal fees from Nesos during the study. Dr. Kay has received consulting fees from AbbVie, Boehringer Ingelheim, Celltrion Healthcare, and several other pharmaceutical companies. Dr. Aranow reports no relevant financial relationships.

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

Noninvasive auricular vagus nerve stimulation (VNS) is no more effective than placebo at controlling symptoms of rheumatoid arthritis, according to a new study. But experts emphasize that these results do not mean trials of different forms of VNS will have the same fate.

VNS offers a potential additional therapy for autoimmune disease beyond disease-modifying antirheumatic drugs, explained first author Matthew Baker, MD, clinical chief, division of immunology and rheumatology, Stanford (Calif.) University, and colleagues.

“The principle of VNS is based upon the inflammatory reflex, which describes a primitive connection between the nervous system and immune system,” the authors write. Signals sent down the vagus nerve to the splenic nerve stimulate immune cells in the spleen, which ultimately results in blocking production of inflammatory cytokines such as tumor necrosis factor. “It is hypothesized that this reduction in systemic inflammation can be harnessed for the treatment of diseases such as RA,” they continue, and smaller studies suggest this treatment could benefit patients.

In a previous 12-week, open-label trial, 17 patients with RA who were implanted with a VNS device on the left cervical vagus nerve saw improvement in RA symptoms, as well as a decrease in TNF production. Noninvasive devices that stimulate the auricular branch of the vagus nerve have also shown some promise. A sham-controlled study of 18 patients with systemic lupus erythematosus (SLE) found that patients who received transcutaneous auricular VNS reported reduced musculoskeletal pain over just 4 days. An open-label study of 30 patients with RA showed clinically significant reductions in disease activity score of 28 joints with C-reactive protein (DAS28-CRP) and clinical improvement in American College of Rheumatology responses over 12 weeks. Additional trials have also demonstrated this positive effect of noninvasive VNS on RA symptoms, but all studies conducted thus far have been relatively small or uncontrolled, Dr. Baker said.
 

Results of latest trial

In this new trial, published online in Arthritis & Rheumatology, researchers enrolled 113 patients with active RA who had inadequate responses or intolerance to conventional synthetic DMARDs and were naïve to biologic or targeted synthetic DMARDs. All patients were given an auricular vagus nerve stimulator via a custom-molded earpiece that was controlled by a smartphone app. Patients wore the device for 15 minutes each day. When worn and turned on, the device generated electrical signals delivered transcutaneously to the cymba concha, a region of the ear connected to the auricular branch of the vagus nerve. This stimulation is imperceptible to patients, Dr. Baker explained. “For the sham arm, we simply did not turn the device on at all,” he said. A subject in the sham arm would use the same device on a 15-minute timer, but no stimulation was given.

After 12 weeks, researchers found no statistically significant difference between the treatment and sham arms in achieving 20% improvement in ACR response criteria or mean change in DAS28-CRP. A total of 17 patients, including 12 in the treatment arm, reported adverse events during the study, and all events were categorized as mild to moderate.

While the research team was “obviously disappointed” about the results, Dr. Baker said, negative findings in trials also are important. “The real value of our study is pointing out the need for large controlled, sham-controlled studies,” he said, especially for potential treatments with a lot of enthusiasm behind them.
 

Results don’t seal the fate of other VNS approaches

“As a properly controlled trial, the results are impressively negative,” writes Roy Fleischmann, MD, clinical professor of medicine, University of Texas Southwestern Medical Center, and codirector, Metroplex Clinical Research Center, both in Dallas, in an editorial about the study. Many of the previous studies looking at this therapy in RA were open label, which could bias the results, he argued. The biggest question, he noted, is if other blinded, sham-controlled trials looking at VNS devices will show similar results.

By itself, this finding does not imply that other VNS devices will be unsuccessful, argued Jonathan Kay, MD, the Timothy S. and Elaine L. Peterson chair in rheumatology, and professor of medicine and population and quantitative health sciences, UMass Chan Medical School and UMass Memorial Medical Center, both in Worcester, Mass. He is also an investigator for the RESET-RA trial, a randomized, sham-controlled trial that will assess the safety and efficacy of an implantable VNS device in an estimated 250 patients with RA. He was not involved with Dr. Baker’s work.

“Auricular VNS is delivered more distally than cervical or splenic nerve stimulation,” Dr. Kay said, and the potential effect of these other forms of VNS may have different outcomes.

Cynthia Aranow, MD, rheumatologist and director of the Clinical Autoimmunity Center of Excellence at Feinstein Institutes for Medical Research, Manhasset, New York, agreed with Dr. Kay, noting that direct VNS stimulation via implantable device and transcutaneous stimulation through the skin are not comparable. She also is unaffiliated with the study.

“This group conducted a well-designed, sham-controlled study of a reasonable number of patients and over a reasonable period of time and observed no significant differences between those participants receiving true and those participants receiving sham stimulation,” she wrote in an email. “However, it’s important to point out that the stimulation settings used in this study were kHz (kilohertz) which is 1,000 times greater than the settings used in multiple other studies in which transauricular VNS has been shown to be clinically effective, including studies in long COVID, tinnitus, SLE, cluster headaches, erosive hand osteoarthritis, pediatric kidney disease, among others,” she said.

The role for VNS treatment, whether direct stimulation via implantable device or transcutaneous, in autoimmune and inflammatory diseases “remains to be determined by future studies,” she said.

The study was funded by Nesos. Dr. Baker received personal fees from Nesos during the study. Dr. Kay has received consulting fees from AbbVie, Boehringer Ingelheim, Celltrion Healthcare, and several other pharmaceutical companies. Dr. Aranow reports no relevant financial relationships.

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

Key clinical point: Adherence and persistence to adjuvant hormone therapy was associated with improved survival outcomes in older women with hormone receptor-positive (HR+) breast cancer (BC).

Major finding: The risk for all-cause mortality reduced by 25% in patients with vs without cumulative adherence to hormone therapy (hazard ratio [HR] 0.75; P < .001) and decreased by 11% for every 1-year increase in persistence (HR 0.89; P < .001). Each 1-year increase in persistence to hormone therapy also significantly improved breast cancer-specific mortality (HR 0.63; P < .001).

Study details: Findings are from a retrospective analysis of the Surveillance, Epidemiology, and End Results (SEER) data linked with US Medicare claims that included 25,796 older women with HR+ BC who were ≥66 years old and received adjuvant hormone therapy.

Disclosures: This study was partly supported by a grant from the Lilly Endowment, Inc. The authors declared no conflicts of interest.

Source: Zheng D and Thomas J 3rd. Survival benefits associated with being adherent and having longer persistence to adjuvant hormone therapy across up to five years among U.S. Medicare population with breast cancer. Breast Cancer Res Treat. 2023;201:89-104 (Jun 16). Doi: 10.1007/s10549-023-06992-2

Key clinical point: Adherence and persistence to adjuvant hormone therapy was associated with improved survival outcomes in older women with hormone receptor-positive (HR+) breast cancer (BC).

Major finding: The risk for all-cause mortality reduced by 25% in patients with vs without cumulative adherence to hormone therapy (hazard ratio [HR] 0.75; P < .001) and decreased by 11% for every 1-year increase in persistence (HR 0.89; P < .001). Each 1-year increase in persistence to hormone therapy also significantly improved breast cancer-specific mortality (HR 0.63; P < .001).

Study details: Findings are from a retrospective analysis of the Surveillance, Epidemiology, and End Results (SEER) data linked with US Medicare claims that included 25,796 older women with HR+ BC who were ≥66 years old and received adjuvant hormone therapy.

Disclosures: This study was partly supported by a grant from the Lilly Endowment, Inc. The authors declared no conflicts of interest.

Source: Zheng D and Thomas J 3rd. Survival benefits associated with being adherent and having longer persistence to adjuvant hormone therapy across up to five years among U.S. Medicare population with breast cancer. Breast Cancer Res Treat. 2023;201:89-104 (Jun 16). Doi: 10.1007/s10549-023-06992-2

Key clinical point: Adherence and persistence to adjuvant hormone therapy was associated with improved survival outcomes in older women with hormone receptor-positive (HR+) breast cancer (BC).

Major finding: The risk for all-cause mortality reduced by 25% in patients with vs without cumulative adherence to hormone therapy (hazard ratio [HR] 0.75; P < .001) and decreased by 11% for every 1-year increase in persistence (HR 0.89; P < .001). Each 1-year increase in persistence to hormone therapy also significantly improved breast cancer-specific mortality (HR 0.63; P < .001).

Study details: Findings are from a retrospective analysis of the Surveillance, Epidemiology, and End Results (SEER) data linked with US Medicare claims that included 25,796 older women with HR+ BC who were ≥66 years old and received adjuvant hormone therapy.

Disclosures: This study was partly supported by a grant from the Lilly Endowment, Inc. The authors declared no conflicts of interest.

Source: Zheng D and Thomas J 3rd. Survival benefits associated with being adherent and having longer persistence to adjuvant hormone therapy across up to five years among U.S. Medicare population with breast cancer. Breast Cancer Res Treat. 2023;201:89-104 (Jun 16). Doi: 10.1007/s10549-023-06992-2

Key clinical point: Although patients with early breast cancer (BC) can undergo immediate breast reconstruction (IBR) after mastectomy, those with invasive BC should be made aware of the possibility of local recurrence (LR) if they have undergone skin- or nipple-sparing mastectomy (SSM/NSM), have not received radiotherapy, or had lymphovascular invasion or cancer at the surgical margin.

Major finding: The rate of 7-year LR was generally low (3.6%) but was higher in invasive vs non-invasive BC (4.3% vs 2.1%; P < .001). SSM/NSM (P < .001), lymphovascular invasion (P = .005), cancer at the surgical margin (P < .001), and no radiotherapy (P = .003) were associated with worse LR rates in invasive BC.

Study details: This retrospective, observational study included 4153 patients with early BC who underwent mastectomy with IBR, of which 2851 and 1272 patients had invasive and non-invasive BC, respectively.

Disclosures: This study was supported by a grant from the scientific committee of the Japanese Breast Cancer Society. The authors declared no conflicts of interest.

Source: Ogiya A et al, on behalf of Collaborative Study Group of Scientific Research of the Japanese Breast Cancer Society. Long-term outcomes of breast cancer patients with local recurrence after mastectomy undergoing immediate breast reconstruction: A retrospective multi-institutional study of 4153 cases. Ann Surg Oncol. 2023 (Jul 5). Doi: 10.1245/s10434-023-13832-6

Key clinical point: Although patients with early breast cancer (BC) can undergo immediate breast reconstruction (IBR) after mastectomy, those with invasive BC should be made aware of the possibility of local recurrence (LR) if they have undergone skin- or nipple-sparing mastectomy (SSM/NSM), have not received radiotherapy, or had lymphovascular invasion or cancer at the surgical margin.

Major finding: The rate of 7-year LR was generally low (3.6%) but was higher in invasive vs non-invasive BC (4.3% vs 2.1%; P < .001). SSM/NSM (P < .001), lymphovascular invasion (P = .005), cancer at the surgical margin (P < .001), and no radiotherapy (P = .003) were associated with worse LR rates in invasive BC.

Study details: This retrospective, observational study included 4153 patients with early BC who underwent mastectomy with IBR, of which 2851 and 1272 patients had invasive and non-invasive BC, respectively.

Disclosures: This study was supported by a grant from the scientific committee of the Japanese Breast Cancer Society. The authors declared no conflicts of interest.

Source: Ogiya A et al, on behalf of Collaborative Study Group of Scientific Research of the Japanese Breast Cancer Society. Long-term outcomes of breast cancer patients with local recurrence after mastectomy undergoing immediate breast reconstruction: A retrospective multi-institutional study of 4153 cases. Ann Surg Oncol. 2023 (Jul 5). Doi: 10.1245/s10434-023-13832-6

Key clinical point: Although patients with early breast cancer (BC) can undergo immediate breast reconstruction (IBR) after mastectomy, those with invasive BC should be made aware of the possibility of local recurrence (LR) if they have undergone skin- or nipple-sparing mastectomy (SSM/NSM), have not received radiotherapy, or had lymphovascular invasion or cancer at the surgical margin.

Major finding: The rate of 7-year LR was generally low (3.6%) but was higher in invasive vs non-invasive BC (4.3% vs 2.1%; P < .001). SSM/NSM (P < .001), lymphovascular invasion (P = .005), cancer at the surgical margin (P < .001), and no radiotherapy (P = .003) were associated with worse LR rates in invasive BC.

Study details: This retrospective, observational study included 4153 patients with early BC who underwent mastectomy with IBR, of which 2851 and 1272 patients had invasive and non-invasive BC, respectively.

Disclosures: This study was supported by a grant from the scientific committee of the Japanese Breast Cancer Society. The authors declared no conflicts of interest.

Source: Ogiya A et al, on behalf of Collaborative Study Group of Scientific Research of the Japanese Breast Cancer Society. Long-term outcomes of breast cancer patients with local recurrence after mastectomy undergoing immediate breast reconstruction: A retrospective multi-institutional study of 4153 cases. Ann Surg Oncol. 2023 (Jul 5). Doi: 10.1245/s10434-023-13832-6

Key clinical point: Invasive lobular carcinoma (ILC), the most common special histological type of breast cancer (BC), had poorer survival outcomes than invasive ductal carcinoma (IDC) and no-lobular special type BC.

Major finding: Patients with ILC vs no-lobular special type BC and IDC had the shortest duration of both disease-free survival (197.2 vs 216.7 and 226.5 months, respectively) and overall survival (209.8 vs 227.9 and 233.2 months, respectively), and ILC vs IDC was associated with significantly worse overall survival (hazard ratio 1.45; P = .045).

Study details: Findings are from a retrospective study including 2157 patients with invasive carcinoma of the breast who were categorized into IDC (n = 1814), ILC (n = 193), and no-lobular special type BC (n = 150).

Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.

Source: Cosar R et al. Classifying invasive lobular carcinoma as special type breast cancer may be reducing its treatment success: A comparison of survival among invasive lobular carcinoma, invasive ductal carcinoma, and no-lobular special type breast cancer. PLoS One. 2023;18(7):e0283445 (Jul 10). Doi: 10.1371/journal.pone.0283445

Key clinical point: Invasive lobular carcinoma (ILC), the most common special histological type of breast cancer (BC), had poorer survival outcomes than invasive ductal carcinoma (IDC) and no-lobular special type BC.

Major finding: Patients with ILC vs no-lobular special type BC and IDC had the shortest duration of both disease-free survival (197.2 vs 216.7 and 226.5 months, respectively) and overall survival (209.8 vs 227.9 and 233.2 months, respectively), and ILC vs IDC was associated with significantly worse overall survival (hazard ratio 1.45; P = .045).

Study details: Findings are from a retrospective study including 2157 patients with invasive carcinoma of the breast who were categorized into IDC (n = 1814), ILC (n = 193), and no-lobular special type BC (n = 150).

Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.

Source: Cosar R et al. Classifying invasive lobular carcinoma as special type breast cancer may be reducing its treatment success: A comparison of survival among invasive lobular carcinoma, invasive ductal carcinoma, and no-lobular special type breast cancer. PLoS One. 2023;18(7):e0283445 (Jul 10). Doi: 10.1371/journal.pone.0283445

Key clinical point: Invasive lobular carcinoma (ILC), the most common special histological type of breast cancer (BC), had poorer survival outcomes than invasive ductal carcinoma (IDC) and no-lobular special type BC.

Major finding: Patients with ILC vs no-lobular special type BC and IDC had the shortest duration of both disease-free survival (197.2 vs 216.7 and 226.5 months, respectively) and overall survival (209.8 vs 227.9 and 233.2 months, respectively), and ILC vs IDC was associated with significantly worse overall survival (hazard ratio 1.45; P = .045).

Study details: Findings are from a retrospective study including 2157 patients with invasive carcinoma of the breast who were categorized into IDC (n = 1814), ILC (n = 193), and no-lobular special type BC (n = 150).

Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.

Source: Cosar R et al. Classifying invasive lobular carcinoma as special type breast cancer may be reducing its treatment success: A comparison of survival among invasive lobular carcinoma, invasive ductal carcinoma, and no-lobular special type breast cancer. PLoS One. 2023;18(7):e0283445 (Jul 10). Doi: 10.1371/journal.pone.0283445

Key clinical point: A higher body mass index (BMI) was not linked directly to survival outcomes but was linked to worse prognostic clinicopathologic variables in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) invasive lobular carcinoma (ILC) of the breast.

Major finding: Although BMI was not directly associated with disease-free survival and overall survival outcomes (both P = .08), a higher BMI was associated with larger tumor size (≥2 cm; P < .001), higher tumor grade (grade 3; P = .014), nodal involvement (P < .001), and multifocal BC (P = .01), which indicated significantly worsened prognosis.

Study details: This multicenter, retrospective study included 2490 patients with ER+/HER2− ILC of the breast, of which 1410, 712, and 368 patients were lean, overweight, and obese, respectively.

Disclosures: This study was funded by the Luxembourg Cancer Foundation and other sources. The authors declared no conflicts of interest.

Source: Baelen KV, Nguyen H-L, et al. Association of body mass index with clinicopathological features and survival in patients with primary invasive lobular breast cancer. Eur J Cancer. 2023;112988 (Jul 12). Doi: 10.1016/j.ejca.2023.112988

Key clinical point: A higher body mass index (BMI) was not linked directly to survival outcomes but was linked to worse prognostic clinicopathologic variables in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) invasive lobular carcinoma (ILC) of the breast.

Major finding: Although BMI was not directly associated with disease-free survival and overall survival outcomes (both P = .08), a higher BMI was associated with larger tumor size (≥2 cm; P < .001), higher tumor grade (grade 3; P = .014), nodal involvement (P < .001), and multifocal BC (P = .01), which indicated significantly worsened prognosis.

Study details: This multicenter, retrospective study included 2490 patients with ER+/HER2− ILC of the breast, of which 1410, 712, and 368 patients were lean, overweight, and obese, respectively.

Disclosures: This study was funded by the Luxembourg Cancer Foundation and other sources. The authors declared no conflicts of interest.

Source: Baelen KV, Nguyen H-L, et al. Association of body mass index with clinicopathological features and survival in patients with primary invasive lobular breast cancer. Eur J Cancer. 2023;112988 (Jul 12). Doi: 10.1016/j.ejca.2023.112988

Key clinical point: A higher body mass index (BMI) was not linked directly to survival outcomes but was linked to worse prognostic clinicopathologic variables in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) invasive lobular carcinoma (ILC) of the breast.

Major finding: Although BMI was not directly associated with disease-free survival and overall survival outcomes (both P = .08), a higher BMI was associated with larger tumor size (≥2 cm; P < .001), higher tumor grade (grade 3; P = .014), nodal involvement (P < .001), and multifocal BC (P = .01), which indicated significantly worsened prognosis.

Study details: This multicenter, retrospective study included 2490 patients with ER+/HER2− ILC of the breast, of which 1410, 712, and 368 patients were lean, overweight, and obese, respectively.

Disclosures: This study was funded by the Luxembourg Cancer Foundation and other sources. The authors declared no conflicts of interest.

Source: Baelen KV, Nguyen H-L, et al. Association of body mass index with clinicopathological features and survival in patients with primary invasive lobular breast cancer. Eur J Cancer. 2023;112988 (Jul 12). Doi: 10.1016/j.ejca.2023.112988

Key clinical point: Adjuvant radiotherapy treatment interruption for a greater number of days was associated with worsened survival outcomes in patients with nonmetastatic triple-negative breast cancer (TNBC).

Major finding: As little as 2-5 days of treatment interruption worsened the overall survival outcomes in patients with TNBC compared with 0-1 day (hazard ratio [HR] 1.069; 95% CI 1.002-1.140), with the mortality risk increasing further in case of 6-10 days (HR 1.236; 95% CI 1.137-1.345) and 11-15 days (HR 1.259; 95% CI 1.112-1.415) of treatment interruption.

Study details: This study analyzed the data of 35,845 patients with nonmetastatic TNBC from the US National Cancer Database who had received external beam radiation therapy and had an overall survival of at least 12 months.

Disclosures: This study was partly funded by the US National Institutes of Health/National Cancer Institute (NIH/NCI) Cancer Center support grant. The authors declared no conflicts of interest.

Source: Chow R et al. Effect of treatment interruptions on overall survival in patients with triple negative breast cancer. J Natl Cancer Inst. 2023 (Jul 3). Doi: 10.1093/jnci/djad127

Key clinical point: Adjuvant radiotherapy treatment interruption for a greater number of days was associated with worsened survival outcomes in patients with nonmetastatic triple-negative breast cancer (TNBC).

Major finding: As little as 2-5 days of treatment interruption worsened the overall survival outcomes in patients with TNBC compared with 0-1 day (hazard ratio [HR] 1.069; 95% CI 1.002-1.140), with the mortality risk increasing further in case of 6-10 days (HR 1.236; 95% CI 1.137-1.345) and 11-15 days (HR 1.259; 95% CI 1.112-1.415) of treatment interruption.

Study details: This study analyzed the data of 35,845 patients with nonmetastatic TNBC from the US National Cancer Database who had received external beam radiation therapy and had an overall survival of at least 12 months.

Disclosures: This study was partly funded by the US National Institutes of Health/National Cancer Institute (NIH/NCI) Cancer Center support grant. The authors declared no conflicts of interest.

Source: Chow R et al. Effect of treatment interruptions on overall survival in patients with triple negative breast cancer. J Natl Cancer Inst. 2023 (Jul 3). Doi: 10.1093/jnci/djad127

Key clinical point: Adjuvant radiotherapy treatment interruption for a greater number of days was associated with worsened survival outcomes in patients with nonmetastatic triple-negative breast cancer (TNBC).

Major finding: As little as 2-5 days of treatment interruption worsened the overall survival outcomes in patients with TNBC compared with 0-1 day (hazard ratio [HR] 1.069; 95% CI 1.002-1.140), with the mortality risk increasing further in case of 6-10 days (HR 1.236; 95% CI 1.137-1.345) and 11-15 days (HR 1.259; 95% CI 1.112-1.415) of treatment interruption.

Study details: This study analyzed the data of 35,845 patients with nonmetastatic TNBC from the US National Cancer Database who had received external beam radiation therapy and had an overall survival of at least 12 months.

Disclosures: This study was partly funded by the US National Institutes of Health/National Cancer Institute (NIH/NCI) Cancer Center support grant. The authors declared no conflicts of interest.

Source: Chow R et al. Effect of treatment interruptions on overall survival in patients with triple negative breast cancer. J Natl Cancer Inst. 2023 (Jul 3). Doi: 10.1093/jnci/djad127

Key clinical point: Female patients with meningioma have approximately 10-fold higher odds of developing breast cancer (BC) and should be screened more often for BC.

Major finding: Compared with the general population, the prevalence of BC was considerably higher in female patients with meningioma (odds ratio 9.87; 95% CI 7.31-13.32).

Study details: Findings are from a meta-analysis of 18 studies including patients diagnosed with intracranial or spinal meningioma or BC or both.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Degeneffe A et al. The association between meningioma and breast cancer: A systematic review and meta-analysis. JAMA Netw Open. 2023;6(6):e2318620 (Jun 16). Doi: 10.1001/jamanetworkopen.2023.18620

Key clinical point: Female patients with meningioma have approximately 10-fold higher odds of developing breast cancer (BC) and should be screened more often for BC.

Major finding: Compared with the general population, the prevalence of BC was considerably higher in female patients with meningioma (odds ratio 9.87; 95% CI 7.31-13.32).

Study details: Findings are from a meta-analysis of 18 studies including patients diagnosed with intracranial or spinal meningioma or BC or both.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Degeneffe A et al. The association between meningioma and breast cancer: A systematic review and meta-analysis. JAMA Netw Open. 2023;6(6):e2318620 (Jun 16). Doi: 10.1001/jamanetworkopen.2023.18620

Key clinical point: Female patients with meningioma have approximately 10-fold higher odds of developing breast cancer (BC) and should be screened more often for BC.

Major finding: Compared with the general population, the prevalence of BC was considerably higher in female patients with meningioma (odds ratio 9.87; 95% CI 7.31-13.32).

Study details: Findings are from a meta-analysis of 18 studies including patients diagnosed with intracranial or spinal meningioma or BC or both.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Degeneffe A et al. The association between meningioma and breast cancer: A systematic review and meta-analysis. JAMA Netw Open. 2023;6(6):e2318620 (Jun 16). Doi: 10.1001/jamanetworkopen.2023.18620

Key clinical point: Adherence to a Mediterranean diet before being diagnosed with breast cancer (BC) may improve survival outcomes, particularly in postmenopausal women.

Major finding: A low vs medium adherence to Mediterranean diet was associated with a 13% higher risk for all-cause mortality (hazard ratio [HR] 1.13;  95% CI 1.01-1.26). The risk for overall mortality reduced by 8% (HR 0.92;  95% CI 0.87-0.97) for every 3-unit increase in the adapted relative Mediterranean diet score, with the association sustaining in case of postmenopausal women only.

Study details: Findings are from an analysis including 13,270 women with incident BC from a prospective, multicenter European cohort of 318,686 women.

Disclosures: This study was funded by the AECC Scientific Foundation. The authors declared no conflicts of interest.

Source: Castro-Espin C et al. Association of Mediterranean diet with survival after breast cancer diagnosis in women from nine European countries: Results from the EPIC cohort study. BMC Med. 2023;21:225 (Jun 26). Doi: 10.1186/s12916-023-02934-3

Key clinical point: Adherence to a Mediterranean diet before being diagnosed with breast cancer (BC) may improve survival outcomes, particularly in postmenopausal women.

Major finding: A low vs medium adherence to Mediterranean diet was associated with a 13% higher risk for all-cause mortality (hazard ratio [HR] 1.13;  95% CI 1.01-1.26). The risk for overall mortality reduced by 8% (HR 0.92;  95% CI 0.87-0.97) for every 3-unit increase in the adapted relative Mediterranean diet score, with the association sustaining in case of postmenopausal women only.

Study details: Findings are from an analysis including 13,270 women with incident BC from a prospective, multicenter European cohort of 318,686 women.

Disclosures: This study was funded by the AECC Scientific Foundation. The authors declared no conflicts of interest.

Source: Castro-Espin C et al. Association of Mediterranean diet with survival after breast cancer diagnosis in women from nine European countries: Results from the EPIC cohort study. BMC Med. 2023;21:225 (Jun 26). Doi: 10.1186/s12916-023-02934-3

Key clinical point: Adherence to a Mediterranean diet before being diagnosed with breast cancer (BC) may improve survival outcomes, particularly in postmenopausal women.

Major finding: A low vs medium adherence to Mediterranean diet was associated with a 13% higher risk for all-cause mortality (hazard ratio [HR] 1.13;  95% CI 1.01-1.26). The risk for overall mortality reduced by 8% (HR 0.92;  95% CI 0.87-0.97) for every 3-unit increase in the adapted relative Mediterranean diet score, with the association sustaining in case of postmenopausal women only.

Study details: Findings are from an analysis including 13,270 women with incident BC from a prospective, multicenter European cohort of 318,686 women.

Disclosures: This study was funded by the AECC Scientific Foundation. The authors declared no conflicts of interest.

Source: Castro-Espin C et al. Association of Mediterranean diet with survival after breast cancer diagnosis in women from nine European countries: Results from the EPIC cohort study. BMC Med. 2023;21:225 (Jun 26). Doi: 10.1186/s12916-023-02934-3

Key clinical point: Findings from this real-world study supported the previous evidence for improved clinical outcomes on adding pertuzumab to trastuzumab plus neoadjuvant chemotherapy (TCT) in patients with human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer (BC).

Major finding: The pathological complete response (odds ratio 1.74; P = .032) and 5-year event-free survival (hazard ratio, 2.22; P = .041) rates were significantly worsened in patients receiving TCT vs pertuzumab+TCT. The incidence of serious adverse events did not differ significantly between both groups.

Study details: Findings are from a retrospective, observational study including 271 patients with HER2+ stage II-III BC who received TCT with (n = 137) or without pertuzumab (n = 134).

Disclosures: This study did not declare the source of funding. The authors declared no conflicts of interest.

Source: Fabbri A et al. Pathologic response and survival after neoadjuvant chemotherapy with or without pertuzumab in patients with HER2-positive breast cancer: The Neopearl nationwide collaborative study. Front Oncol. 2023;13:1177681 (Jun 27). Doi: 10.3389/fonc.2023.1177681

Key clinical point: Findings from this real-world study supported the previous evidence for improved clinical outcomes on adding pertuzumab to trastuzumab plus neoadjuvant chemotherapy (TCT) in patients with human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer (BC).

Major finding: The pathological complete response (odds ratio 1.74; P = .032) and 5-year event-free survival (hazard ratio, 2.22; P = .041) rates were significantly worsened in patients receiving TCT vs pertuzumab+TCT. The incidence of serious adverse events did not differ significantly between both groups.

Study details: Findings are from a retrospective, observational study including 271 patients with HER2+ stage II-III BC who received TCT with (n = 137) or without pertuzumab (n = 134).

Disclosures: This study did not declare the source of funding. The authors declared no conflicts of interest.

Source: Fabbri A et al. Pathologic response and survival after neoadjuvant chemotherapy with or without pertuzumab in patients with HER2-positive breast cancer: The Neopearl nationwide collaborative study. Front Oncol. 2023;13:1177681 (Jun 27). Doi: 10.3389/fonc.2023.1177681

Key clinical point: Findings from this real-world study supported the previous evidence for improved clinical outcomes on adding pertuzumab to trastuzumab plus neoadjuvant chemotherapy (TCT) in patients with human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer (BC).

Major finding: The pathological complete response (odds ratio 1.74; P = .032) and 5-year event-free survival (hazard ratio, 2.22; P = .041) rates were significantly worsened in patients receiving TCT vs pertuzumab+TCT. The incidence of serious adverse events did not differ significantly between both groups.

Study details: Findings are from a retrospective, observational study including 271 patients with HER2+ stage II-III BC who received TCT with (n = 137) or without pertuzumab (n = 134).

Disclosures: This study did not declare the source of funding. The authors declared no conflicts of interest.

Source: Fabbri A et al. Pathologic response and survival after neoadjuvant chemotherapy with or without pertuzumab in patients with HER2-positive breast cancer: The Neopearl nationwide collaborative study. Front Oncol. 2023;13:1177681 (Jun 27). Doi: 10.3389/fonc.2023.1177681

Key clinical point: According to an analysis of two large prospective US-based cohorts, the consumption of olive oil was not associated with an increased risk for breast cancer (BC) among women.

Major finding: Compared with women who never or rarely consumed olive oil, those with the highest consumption of olive oil (>1/2 tablespoon/day or >7 g/day) did not report an increased risk of developing BC (hazard ratio 1.01;  95% CI 0.93-1.09).

Study details: Findings are from an analysis of two large prospective cohorts of women who were free of cancer at baseline, the Nurses’ Health Study (n = 71,330) and Nurses’ Health Study II (n = 93,295), of whom 9638 women developed invasive BC after 3,744,068 person-years of follow-up.

Disclosures: This study was supported by the US National Institutes of Health and other sources. The authors declared no conflicts of interest.

Source: Romanos-Nanclares A et al. Consumption of olive oil and risk of breast cancer in U.S. women: Results from the Nurses' Health Studies. Br J Cancer. 2023 (Jun 13). Doi: 10.1038/s41416-023-02306-x

Key clinical point: According to an analysis of two large prospective US-based cohorts, the consumption of olive oil was not associated with an increased risk for breast cancer (BC) among women.

Major finding: Compared with women who never or rarely consumed olive oil, those with the highest consumption of olive oil (>1/2 tablespoon/day or >7 g/day) did not report an increased risk of developing BC (hazard ratio 1.01;  95% CI 0.93-1.09).

Study details: Findings are from an analysis of two large prospective cohorts of women who were free of cancer at baseline, the Nurses’ Health Study (n = 71,330) and Nurses’ Health Study II (n = 93,295), of whom 9638 women developed invasive BC after 3,744,068 person-years of follow-up.

Disclosures: This study was supported by the US National Institutes of Health and other sources. The authors declared no conflicts of interest.

Source: Romanos-Nanclares A et al. Consumption of olive oil and risk of breast cancer in U.S. women: Results from the Nurses' Health Studies. Br J Cancer. 2023 (Jun 13). Doi: 10.1038/s41416-023-02306-x

Key clinical point: According to an analysis of two large prospective US-based cohorts, the consumption of olive oil was not associated with an increased risk for breast cancer (BC) among women.

Major finding: Compared with women who never or rarely consumed olive oil, those with the highest consumption of olive oil (>1/2 tablespoon/day or >7 g/day) did not report an increased risk of developing BC (hazard ratio 1.01;  95% CI 0.93-1.09).

Study details: Findings are from an analysis of two large prospective cohorts of women who were free of cancer at baseline, the Nurses’ Health Study (n = 71,330) and Nurses’ Health Study II (n = 93,295), of whom 9638 women developed invasive BC after 3,744,068 person-years of follow-up.

Disclosures: This study was supported by the US National Institutes of Health and other sources. The authors declared no conflicts of interest.

Source: Romanos-Nanclares A et al. Consumption of olive oil and risk of breast cancer in U.S. women: Results from the Nurses' Health Studies. Br J Cancer. 2023 (Jun 13). Doi: 10.1038/s41416-023-02306-x