Patient & Survivor Care

SAN ANTONIO — Axillary lymph node dissection is the current standard of care in breast cancer when metastases are found in sentinel lymph nodes after neoadjuvant chemotherapy.

However, what to do when isolated tumor cells instead of outright metastases are found in sentinel nodes is an open question. Some surgeons opt for a full axillary dissection while others do not, and there is no standard of care, explained Giacomo Montagna, MD, a breast cancer surgeon at Memorial Sloan Kettering Cancer Center, New York City.

The study led and presented by Dr. Montagna at the San Antonio Breast Cancer Symposium brings some much-needed clarity to the issue.

The researchers found no difference in 5-year axillary or invasive recurrence rates whether women had axillary dissections or not. The findings argue strongly against “routine axillary lymph node dissection” — with its considerable morbidities — “in patients with residual isolated tumor cells after neoadjuvant chemotherapy,” Dr. Montagna said.

Study discussant Elizabeth Mittendorf, MD, PhD, a breast cancer surgeon at Brigham and Women’s Hospital, Boston, agreed.

“It appears that the presence of isolated tumor cells in the sentinel nodes does not negatively impact oncologic outcomes. These additional data allow us to debunk some of the surgical dogma we grew up with, specifically that lymph node dissection is required for either survival or local control,” Dr. Mittendorf said.

However, there was concern among audience members that the information gleaned from a full dissection might still be needed to guide follow-on adjuvant therapy decisions.

Dr. Mittendorf didn’t think so. Although additional positive lymph nodes were found in almost a third of women who had axillary dissections in the review, the majority of involved nodes simply had more isolated tumor cells; macrometastases were found in just 5% of cases.

So, for most patients, additional information from axillary dissections is “unlikely needed to inform adjuvant therapy, and in fact,” based on the 5% figure, “we are thinking we would have to do well over a hundred lymph node dissections in such patients to inform treatment recommendations for fewer than five. This comes at the cost of fair morbidity,” she said.

Study details

The retrospective study, dubbed OPBC05/EUBREAST-14R/ICARO, included 583 women with cT1-4 N0-3 breast cancer treated at 62 centers in 18 countries. The majority of subjects were from the United States and Europe.

Every patient was found to have isolated tumor cells (ITCs) in their sentinel lymph nodes after neoadjuvant chemotherapy (NAC), which generally included anthracycline and taxane-based regimens. The majority of patients did not have a pathologic complete response to NAC.

Overall, 182 patients (31%) had a subsequent axillary lymph node dissection; the rest did not.

Dissections were more common in the presence of lymphovascular invasion and N2/N3 disease as well as when fewer lymph nodes were removed and when ITCs were found during surgery on frozen section, which was the case in a quarter of patients.

Additional positive nodes were found in 30% of patients in the dissection group and consisted of more nodes with ITCs in 18%, micrometastases in 7%, and macrometastases in 5%. Receptor status and nodal status at presentation did not have an impact on the likelihood of finding macrometastases.

The main finding of the study was that there were no statistically significant differences in recurrence outcomes between the two groups.

The 5-year rate of isolated axillary recurrence was 1.7% with axillary lymph node dissection (ALND) versus 1.1% without it. The 5-year rate of any invasive recurrence was 16% in the ALND arm and 19% in the no-dissection group.

The median age in the study was 48 years. The majority of patients (57%) had clinical T2 tumors. Most were HR positive and either HER2 negative (41%) or HER2 positive (28%).

Regional nodal radiation was more common in the ALND group, 82% versus 75%. The dissection arm had a mean of 2.8 sentinel lymph nodes removed versus 3.5 in the no-dissection group.

“The likelihood of finding additional positive lymph nodes in patients with residual ITCs after NAC is lower than in patients with residual micro- and macrometastases. In the majority of cases, they contain ITCs. Nodal recurrence after omission of ALND is rare in this population,” the investigators concluded in their abstract.

The work was funded by EUBREAST. Dr. Montagna doesn’t have any disclosures. Dr. Mittendorf has several industry ties, including being an advisor for Roche, AstraZeneca, and Moderna and a speaker for Merck.

SAN ANTONIO — Axillary lymph node dissection is the current standard of care in breast cancer when metastases are found in sentinel lymph nodes after neoadjuvant chemotherapy.

However, what to do when isolated tumor cells instead of outright metastases are found in sentinel nodes is an open question. Some surgeons opt for a full axillary dissection while others do not, and there is no standard of care, explained Giacomo Montagna, MD, a breast cancer surgeon at Memorial Sloan Kettering Cancer Center, New York City.

The study led and presented by Dr. Montagna at the San Antonio Breast Cancer Symposium brings some much-needed clarity to the issue.

The researchers found no difference in 5-year axillary or invasive recurrence rates whether women had axillary dissections or not. The findings argue strongly against “routine axillary lymph node dissection” — with its considerable morbidities — “in patients with residual isolated tumor cells after neoadjuvant chemotherapy,” Dr. Montagna said.

Study discussant Elizabeth Mittendorf, MD, PhD, a breast cancer surgeon at Brigham and Women’s Hospital, Boston, agreed.

“It appears that the presence of isolated tumor cells in the sentinel nodes does not negatively impact oncologic outcomes. These additional data allow us to debunk some of the surgical dogma we grew up with, specifically that lymph node dissection is required for either survival or local control,” Dr. Mittendorf said.

However, there was concern among audience members that the information gleaned from a full dissection might still be needed to guide follow-on adjuvant therapy decisions.

Dr. Mittendorf didn’t think so. Although additional positive lymph nodes were found in almost a third of women who had axillary dissections in the review, the majority of involved nodes simply had more isolated tumor cells; macrometastases were found in just 5% of cases.

So, for most patients, additional information from axillary dissections is “unlikely needed to inform adjuvant therapy, and in fact,” based on the 5% figure, “we are thinking we would have to do well over a hundred lymph node dissections in such patients to inform treatment recommendations for fewer than five. This comes at the cost of fair morbidity,” she said.

Study details

The retrospective study, dubbed OPBC05/EUBREAST-14R/ICARO, included 583 women with cT1-4 N0-3 breast cancer treated at 62 centers in 18 countries. The majority of subjects were from the United States and Europe.

Every patient was found to have isolated tumor cells (ITCs) in their sentinel lymph nodes after neoadjuvant chemotherapy (NAC), which generally included anthracycline and taxane-based regimens. The majority of patients did not have a pathologic complete response to NAC.

Overall, 182 patients (31%) had a subsequent axillary lymph node dissection; the rest did not.

Dissections were more common in the presence of lymphovascular invasion and N2/N3 disease as well as when fewer lymph nodes were removed and when ITCs were found during surgery on frozen section, which was the case in a quarter of patients.

Additional positive nodes were found in 30% of patients in the dissection group and consisted of more nodes with ITCs in 18%, micrometastases in 7%, and macrometastases in 5%. Receptor status and nodal status at presentation did not have an impact on the likelihood of finding macrometastases.

The main finding of the study was that there were no statistically significant differences in recurrence outcomes between the two groups.

The 5-year rate of isolated axillary recurrence was 1.7% with axillary lymph node dissection (ALND) versus 1.1% without it. The 5-year rate of any invasive recurrence was 16% in the ALND arm and 19% in the no-dissection group.

The median age in the study was 48 years. The majority of patients (57%) had clinical T2 tumors. Most were HR positive and either HER2 negative (41%) or HER2 positive (28%).

Regional nodal radiation was more common in the ALND group, 82% versus 75%. The dissection arm had a mean of 2.8 sentinel lymph nodes removed versus 3.5 in the no-dissection group.

“The likelihood of finding additional positive lymph nodes in patients with residual ITCs after NAC is lower than in patients with residual micro- and macrometastases. In the majority of cases, they contain ITCs. Nodal recurrence after omission of ALND is rare in this population,” the investigators concluded in their abstract.

The work was funded by EUBREAST. Dr. Montagna doesn’t have any disclosures. Dr. Mittendorf has several industry ties, including being an advisor for Roche, AstraZeneca, and Moderna and a speaker for Merck.

SAN ANTONIO — Axillary lymph node dissection is the current standard of care in breast cancer when metastases are found in sentinel lymph nodes after neoadjuvant chemotherapy.

However, what to do when isolated tumor cells instead of outright metastases are found in sentinel nodes is an open question. Some surgeons opt for a full axillary dissection while others do not, and there is no standard of care, explained Giacomo Montagna, MD, a breast cancer surgeon at Memorial Sloan Kettering Cancer Center, New York City.

The study led and presented by Dr. Montagna at the San Antonio Breast Cancer Symposium brings some much-needed clarity to the issue.

The researchers found no difference in 5-year axillary or invasive recurrence rates whether women had axillary dissections or not. The findings argue strongly against “routine axillary lymph node dissection” — with its considerable morbidities — “in patients with residual isolated tumor cells after neoadjuvant chemotherapy,” Dr. Montagna said.

Study discussant Elizabeth Mittendorf, MD, PhD, a breast cancer surgeon at Brigham and Women’s Hospital, Boston, agreed.

“It appears that the presence of isolated tumor cells in the sentinel nodes does not negatively impact oncologic outcomes. These additional data allow us to debunk some of the surgical dogma we grew up with, specifically that lymph node dissection is required for either survival or local control,” Dr. Mittendorf said.

However, there was concern among audience members that the information gleaned from a full dissection might still be needed to guide follow-on adjuvant therapy decisions.

Dr. Mittendorf didn’t think so. Although additional positive lymph nodes were found in almost a third of women who had axillary dissections in the review, the majority of involved nodes simply had more isolated tumor cells; macrometastases were found in just 5% of cases.

So, for most patients, additional information from axillary dissections is “unlikely needed to inform adjuvant therapy, and in fact,” based on the 5% figure, “we are thinking we would have to do well over a hundred lymph node dissections in such patients to inform treatment recommendations for fewer than five. This comes at the cost of fair morbidity,” she said.

Study details

The retrospective study, dubbed OPBC05/EUBREAST-14R/ICARO, included 583 women with cT1-4 N0-3 breast cancer treated at 62 centers in 18 countries. The majority of subjects were from the United States and Europe.

Every patient was found to have isolated tumor cells (ITCs) in their sentinel lymph nodes after neoadjuvant chemotherapy (NAC), which generally included anthracycline and taxane-based regimens. The majority of patients did not have a pathologic complete response to NAC.

Overall, 182 patients (31%) had a subsequent axillary lymph node dissection; the rest did not.

Dissections were more common in the presence of lymphovascular invasion and N2/N3 disease as well as when fewer lymph nodes were removed and when ITCs were found during surgery on frozen section, which was the case in a quarter of patients.

Additional positive nodes were found in 30% of patients in the dissection group and consisted of more nodes with ITCs in 18%, micrometastases in 7%, and macrometastases in 5%. Receptor status and nodal status at presentation did not have an impact on the likelihood of finding macrometastases.

The main finding of the study was that there were no statistically significant differences in recurrence outcomes between the two groups.

The 5-year rate of isolated axillary recurrence was 1.7% with axillary lymph node dissection (ALND) versus 1.1% without it. The 5-year rate of any invasive recurrence was 16% in the ALND arm and 19% in the no-dissection group.

The median age in the study was 48 years. The majority of patients (57%) had clinical T2 tumors. Most were HR positive and either HER2 negative (41%) or HER2 positive (28%).

Regional nodal radiation was more common in the ALND group, 82% versus 75%. The dissection arm had a mean of 2.8 sentinel lymph nodes removed versus 3.5 in the no-dissection group.

“The likelihood of finding additional positive lymph nodes in patients with residual ITCs after NAC is lower than in patients with residual micro- and macrometastases. In the majority of cases, they contain ITCs. Nodal recurrence after omission of ALND is rare in this population,” the investigators concluded in their abstract.

The work was funded by EUBREAST. Dr. Montagna doesn’t have any disclosures. Dr. Mittendorf has several industry ties, including being an advisor for Roche, AstraZeneca, and Moderna and a speaker for Merck.

TOPLINE:

Routine clinical examination detects only 2.2% of second breast cancers during 10-year follow-up in women undergoing posttreatment surveillance after ductal carcinoma in situ (DCIS).

METHODOLOGY:

• National Comprehensive Cancer Network guidelines recommend DCIS surveillance with a physical exam every 6-12 months for 5 years and then annually with a mammogram every 12 months. Research, however, suggested clinical breast exams only detect 15% of second breast cancers.
• A retrospective cohort study of 1550 female members of Kaiser Permanente Northern California diagnosed with unilateral DCIS between January 1, 2008, and January 1, 2011, who were followed until 2021.
• Patients who developed a second breast cancer within 10 years of follow-up were identified from the electronic health records. The detection methods were categorized into three groups: Patient-detected, physician-detected, and imaging-detected.

TAKEAWAY:

• During follow-up, 11.5% of women developed a second breast cancer with a median time to diagnosis of 57 months. Among patients with second breast cancers, 43.0% were ipsilateral, 54.8% were contralateral, and 2.2% presented with distant metastases.
• Overall, patients had a median of five mammograms between years 1 and 6 of surveillance and a median of seven clinic visits with most providers completing a clinical examination during the visit.
• Second breast cancers were detected through imaging in 74.3% of cases compared with 20.1% detected by patients and only 2.2% detected by physicians during physical exams. The remaining 3.4% were detected incidentally from plastic surgery procedures unrelated to oncologic surveillance.
• Mammogram detected 99.2% of cases (132 of 133 cases) identified by imaging.

IN PRACTICE:

“Our findings highlight the importance of mammogram screening and patient education regarding self-detection and can inform future NCCN recommendations for DCIS survivorship care,” the authors concluded, adding that “decreasing the need for in-person breast examinations could allow for other effective methods of survivorship monitoring.”

SOURCE:

This study, led by Bethany T. Waites of Kaiser Permanente San Francisco Medical Center, San Francisco, California, was published online on December 28 in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The retrospective design may have introduced selection bias or confounding. The study’s follow-up period until 2021, including the initial 18 months of the COVID-19 pandemic, may have affected surveillance patterns.

DISCLOSURES:

This study was supported by the Kaiser Permanente Northern California Graduate Medical Education program. The authors declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Routine clinical examination detects only 2.2% of second breast cancers during 10-year follow-up in women undergoing posttreatment surveillance after ductal carcinoma in situ (DCIS).

METHODOLOGY:

• National Comprehensive Cancer Network guidelines recommend DCIS surveillance with a physical exam every 6-12 months for 5 years and then annually with a mammogram every 12 months. Research, however, suggested clinical breast exams only detect 15% of second breast cancers.
• A retrospective cohort study of 1550 female members of Kaiser Permanente Northern California diagnosed with unilateral DCIS between January 1, 2008, and January 1, 2011, who were followed until 2021.
• Patients who developed a second breast cancer within 10 years of follow-up were identified from the electronic health records. The detection methods were categorized into three groups: Patient-detected, physician-detected, and imaging-detected.

TAKEAWAY:

• During follow-up, 11.5% of women developed a second breast cancer with a median time to diagnosis of 57 months. Among patients with second breast cancers, 43.0% were ipsilateral, 54.8% were contralateral, and 2.2% presented with distant metastases.
• Overall, patients had a median of five mammograms between years 1 and 6 of surveillance and a median of seven clinic visits with most providers completing a clinical examination during the visit.
• Second breast cancers were detected through imaging in 74.3% of cases compared with 20.1% detected by patients and only 2.2% detected by physicians during physical exams. The remaining 3.4% were detected incidentally from plastic surgery procedures unrelated to oncologic surveillance.
• Mammogram detected 99.2% of cases (132 of 133 cases) identified by imaging.

IN PRACTICE:

“Our findings highlight the importance of mammogram screening and patient education regarding self-detection and can inform future NCCN recommendations for DCIS survivorship care,” the authors concluded, adding that “decreasing the need for in-person breast examinations could allow for other effective methods of survivorship monitoring.”

SOURCE:

This study, led by Bethany T. Waites of Kaiser Permanente San Francisco Medical Center, San Francisco, California, was published online on December 28 in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The retrospective design may have introduced selection bias or confounding. The study’s follow-up period until 2021, including the initial 18 months of the COVID-19 pandemic, may have affected surveillance patterns.

DISCLOSURES:

This study was supported by the Kaiser Permanente Northern California Graduate Medical Education program. The authors declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Routine clinical examination detects only 2.2% of second breast cancers during 10-year follow-up in women undergoing posttreatment surveillance after ductal carcinoma in situ (DCIS).

METHODOLOGY:

• National Comprehensive Cancer Network guidelines recommend DCIS surveillance with a physical exam every 6-12 months for 5 years and then annually with a mammogram every 12 months. Research, however, suggested clinical breast exams only detect 15% of second breast cancers.
• A retrospective cohort study of 1550 female members of Kaiser Permanente Northern California diagnosed with unilateral DCIS between January 1, 2008, and January 1, 2011, who were followed until 2021.
• Patients who developed a second breast cancer within 10 years of follow-up were identified from the electronic health records. The detection methods were categorized into three groups: Patient-detected, physician-detected, and imaging-detected.

TAKEAWAY:

• During follow-up, 11.5% of women developed a second breast cancer with a median time to diagnosis of 57 months. Among patients with second breast cancers, 43.0% were ipsilateral, 54.8% were contralateral, and 2.2% presented with distant metastases.
• Overall, patients had a median of five mammograms between years 1 and 6 of surveillance and a median of seven clinic visits with most providers completing a clinical examination during the visit.
• Second breast cancers were detected through imaging in 74.3% of cases compared with 20.1% detected by patients and only 2.2% detected by physicians during physical exams. The remaining 3.4% were detected incidentally from plastic surgery procedures unrelated to oncologic surveillance.
• Mammogram detected 99.2% of cases (132 of 133 cases) identified by imaging.

IN PRACTICE:

“Our findings highlight the importance of mammogram screening and patient education regarding self-detection and can inform future NCCN recommendations for DCIS survivorship care,” the authors concluded, adding that “decreasing the need for in-person breast examinations could allow for other effective methods of survivorship monitoring.”

SOURCE:

This study, led by Bethany T. Waites of Kaiser Permanente San Francisco Medical Center, San Francisco, California, was published online on December 28 in the Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

The retrospective design may have introduced selection bias or confounding. The study’s follow-up period until 2021, including the initial 18 months of the COVID-19 pandemic, may have affected surveillance patterns.

DISCLOSURES:

This study was supported by the Kaiser Permanente Northern California Graduate Medical Education program. The authors declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Surgery or radiation for advanced prostate cancer may improve survival but at the cost of treatment-related adverse effects, including gastrointestinal (GI) as well as sexual and urinary conditions, that may persist for years, a study of US veterans showed.

METHODOLOGY:

Recent evidence suggested that in men with advanced prostate cancer, local therapy with radical prostatectomy or radiation may improve survival outcomes; however, data on the long-term side effects from these local options were limited.

The retrospective cohort included 5502 men (mean age, 68 years) diagnosed with advanced (T4, N1, and/or M1) prostate cancer.

A total of 1705 men (31%) received initial local treatment, consisting of radical prostatectomy, (55%), radiation (39%), or both (5.6%), while 3797 (69%) opted for initial nonlocal treatment (hormone therapy, chemotherapy, or both). 

The main outcomes were treatment-related adverse effects, including GI, chronic pain, sexual dysfunction, and urinary symptoms, assessed at three timepoints after initial treatment — up to 1 year, between 1 and 2 years, and between 2 and 5 years.

TAKEAWAY:

Overall, 916 men (75%) who had initial local treatment and 897 men (67%) with initial nonlocal therapy reported at least one adverse condition up to 5 years after initial treatment.

In the first year after initial treatment, local therapy was associated with a higher prevalence of GI (9% vs 3%), pain (60% vs 38%), sexual (37% vs 8%), and urinary (46.5% vs 18%) conditions. Men receiving local therapy were more likely to experience GI (adjusted odds ratio [aOR], 4.08), pain (aOR, 1.57), sexual (aOR, 2.96), and urinary (aOR, 2.25) conditions.

Between 2 and 5 years after local therapy, certain conditions remained more prevalent — 7.8% vs 4.2% for GI, 40% vs 13% for sexual, and 40.5% vs 26% for urinary issues. Men receiving local vs nonlocal therapy were more likely to experience GI (aOR, 2.39), sexual (aOR, 3.36), and urinary (aOR, 1.39) issues over the long term.

The researchers found no difference in the prevalence of constitutional conditions such as hot flashes (36.5% vs 34.4%) in the first year following initial local or nonlocal therapy. However, local treatment followed by any secondary treatment was associated with a higher likelihood of developing constitutional conditions at 1-2 years (aOR, 1.50) and 2-5 years (aOR, 1.78) after initial treatment.

IN PRACTICE:

“These results suggest that patients and clinicians should consider the adverse effects of local treatment” alongside the potential for enhanced survival when making treatment decisions in the setting of advanced prostate cancer, the authors explained. Careful informed decision-making by both patients and practitioners is especially important because “there are currently no established guidelines regarding the use of local treatment among men with advanced prostate cancer.”

SOURCE:

The study, with first author Saira Khan, PhD, MPH, Washington University School of Medicine in St. Louis, Missouri, was published online in JAMA Network Open.

LIMITATIONS:

The authors noted that the study was limited by its retrospective design. Men who received local treatment were, on average, younger; older or lesser healthy patients who received local treatment may experience worse adverse effects than observed in the study. The study was limited to US veterans.

DISCLOSURES:

The study was supported by a grant from the US Department of Defense. The authors have no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Surgery or radiation for advanced prostate cancer may improve survival but at the cost of treatment-related adverse effects, including gastrointestinal (GI) as well as sexual and urinary conditions, that may persist for years, a study of US veterans showed.

METHODOLOGY:

Recent evidence suggested that in men with advanced prostate cancer, local therapy with radical prostatectomy or radiation may improve survival outcomes; however, data on the long-term side effects from these local options were limited.

The retrospective cohort included 5502 men (mean age, 68 years) diagnosed with advanced (T4, N1, and/or M1) prostate cancer.

A total of 1705 men (31%) received initial local treatment, consisting of radical prostatectomy, (55%), radiation (39%), or both (5.6%), while 3797 (69%) opted for initial nonlocal treatment (hormone therapy, chemotherapy, or both). 

The main outcomes were treatment-related adverse effects, including GI, chronic pain, sexual dysfunction, and urinary symptoms, assessed at three timepoints after initial treatment — up to 1 year, between 1 and 2 years, and between 2 and 5 years.

TAKEAWAY:

Overall, 916 men (75%) who had initial local treatment and 897 men (67%) with initial nonlocal therapy reported at least one adverse condition up to 5 years after initial treatment.

In the first year after initial treatment, local therapy was associated with a higher prevalence of GI (9% vs 3%), pain (60% vs 38%), sexual (37% vs 8%), and urinary (46.5% vs 18%) conditions. Men receiving local therapy were more likely to experience GI (adjusted odds ratio [aOR], 4.08), pain (aOR, 1.57), sexual (aOR, 2.96), and urinary (aOR, 2.25) conditions.

Between 2 and 5 years after local therapy, certain conditions remained more prevalent — 7.8% vs 4.2% for GI, 40% vs 13% for sexual, and 40.5% vs 26% for urinary issues. Men receiving local vs nonlocal therapy were more likely to experience GI (aOR, 2.39), sexual (aOR, 3.36), and urinary (aOR, 1.39) issues over the long term.

The researchers found no difference in the prevalence of constitutional conditions such as hot flashes (36.5% vs 34.4%) in the first year following initial local or nonlocal therapy. However, local treatment followed by any secondary treatment was associated with a higher likelihood of developing constitutional conditions at 1-2 years (aOR, 1.50) and 2-5 years (aOR, 1.78) after initial treatment.

IN PRACTICE:

“These results suggest that patients and clinicians should consider the adverse effects of local treatment” alongside the potential for enhanced survival when making treatment decisions in the setting of advanced prostate cancer, the authors explained. Careful informed decision-making by both patients and practitioners is especially important because “there are currently no established guidelines regarding the use of local treatment among men with advanced prostate cancer.”

SOURCE:

The study, with first author Saira Khan, PhD, MPH, Washington University School of Medicine in St. Louis, Missouri, was published online in JAMA Network Open.

LIMITATIONS:

The authors noted that the study was limited by its retrospective design. Men who received local treatment were, on average, younger; older or lesser healthy patients who received local treatment may experience worse adverse effects than observed in the study. The study was limited to US veterans.

DISCLOSURES:

The study was supported by a grant from the US Department of Defense. The authors have no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Surgery or radiation for advanced prostate cancer may improve survival but at the cost of treatment-related adverse effects, including gastrointestinal (GI) as well as sexual and urinary conditions, that may persist for years, a study of US veterans showed.

METHODOLOGY:

Recent evidence suggested that in men with advanced prostate cancer, local therapy with radical prostatectomy or radiation may improve survival outcomes; however, data on the long-term side effects from these local options were limited.

The retrospective cohort included 5502 men (mean age, 68 years) diagnosed with advanced (T4, N1, and/or M1) prostate cancer.

A total of 1705 men (31%) received initial local treatment, consisting of radical prostatectomy, (55%), radiation (39%), or both (5.6%), while 3797 (69%) opted for initial nonlocal treatment (hormone therapy, chemotherapy, or both). 

The main outcomes were treatment-related adverse effects, including GI, chronic pain, sexual dysfunction, and urinary symptoms, assessed at three timepoints after initial treatment — up to 1 year, between 1 and 2 years, and between 2 and 5 years.

TAKEAWAY:

Overall, 916 men (75%) who had initial local treatment and 897 men (67%) with initial nonlocal therapy reported at least one adverse condition up to 5 years after initial treatment.

In the first year after initial treatment, local therapy was associated with a higher prevalence of GI (9% vs 3%), pain (60% vs 38%), sexual (37% vs 8%), and urinary (46.5% vs 18%) conditions. Men receiving local therapy were more likely to experience GI (adjusted odds ratio [aOR], 4.08), pain (aOR, 1.57), sexual (aOR, 2.96), and urinary (aOR, 2.25) conditions.

Between 2 and 5 years after local therapy, certain conditions remained more prevalent — 7.8% vs 4.2% for GI, 40% vs 13% for sexual, and 40.5% vs 26% for urinary issues. Men receiving local vs nonlocal therapy were more likely to experience GI (aOR, 2.39), sexual (aOR, 3.36), and urinary (aOR, 1.39) issues over the long term.

The researchers found no difference in the prevalence of constitutional conditions such as hot flashes (36.5% vs 34.4%) in the first year following initial local or nonlocal therapy. However, local treatment followed by any secondary treatment was associated with a higher likelihood of developing constitutional conditions at 1-2 years (aOR, 1.50) and 2-5 years (aOR, 1.78) after initial treatment.

IN PRACTICE:

“These results suggest that patients and clinicians should consider the adverse effects of local treatment” alongside the potential for enhanced survival when making treatment decisions in the setting of advanced prostate cancer, the authors explained. Careful informed decision-making by both patients and practitioners is especially important because “there are currently no established guidelines regarding the use of local treatment among men with advanced prostate cancer.”

SOURCE:

The study, with first author Saira Khan, PhD, MPH, Washington University School of Medicine in St. Louis, Missouri, was published online in JAMA Network Open.

LIMITATIONS:

The authors noted that the study was limited by its retrospective design. Men who received local treatment were, on average, younger; older or lesser healthy patients who received local treatment may experience worse adverse effects than observed in the study. The study was limited to US veterans.

DISCLOSURES:

The study was supported by a grant from the US Department of Defense. The authors have no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Overall survival among US patients with resected stage II or III gastric cancer differs by race and ethnicity, with Asian and Hispanic patients demonstrating better overall survival than White and Black patients.

METHODOLOGY:

• Studies have revealed disparities in gastric cancer outcomes among different racial and ethnic groups in the United States, but the reasons are unclear.
• To better understand the disparities, researchers analyzed survival outcomes by race and ethnicity, treatment type, and a range of other factors.
• The retrospective analysis included 6938 patients with clinical stages IIA-IIIC gastric adenocarcinoma who underwent partial or total gastrectomy between 2006 and 2019, excluding those with a history of cancer. Patient data came from the National Cancer Database, which covers about 70% of all new cancer diagnoses.
• The researchers compared factors, including race and ethnicity, surgical margins, and lymph nodes, as well as treatment modality (neoadjuvant or adjuvant chemotherapy only, neoadjuvant or adjuvant chemoradiation only, or perioperative chemotherapy with radiation or surgical care only).
• Just over half of the patients (53.6%) were White, 24.3% were Black, 17.8% were Hispanic, 15.8% were Asian, and 2.6% were other race or ethnicity (information was missing for 4.8%). White patients were more likely to be older and insured; Black and White patients had more comorbidities than Asian and Hispanic patients.

TAKEAWAY:

• Perioperative chemotherapy was associated with improved overall survival (hazard ratio [HR], 0.79), while surgical resection alone (HR, 1.79), more positive lymph nodes (HR, 2.95 for 10 or more), and positive surgical margins were associated with the biggest decreases in overall survival.
• Asian and Hispanic patients had significantly better overall survival (HR, 0.64 and 0.77, respectively) than White patients.
• In general, Black and White patients had similar overall survival (HR, 0.96), except among Black patients who received neoadjuvant therapy — these patients had better overall survival than White patients (HR, 0.78).
• Black and Asian patients were more likely to be downstaged or achieve a pathologic complete response after neoadjuvant therapy (34.4% and 35.3%, respectively) than White (28.4%) and Hispanic patients (30.8%).

IN PRACTICE:

The authors found that “Asian and Hispanic race and ethnicity were independently associated with improved [overall survival] compared with Black and White race,” even after adjusting for variables including multimodality treatment regimen and response to neoadjuvant therapy.

The authors explained that overall Asian and Black patients responded more favorably to neoadjuvant therapy, demonstrating significantly higher rates of downstaging or pathologic complete response, which may help explain why Black patients demonstrated better overall survival than White patients who received neoadjuvant therapy.

SOURCE:

The research, led by Steve Kwon, MD, MPH, of Roger Williams Medical Center and Boston University, Providence, Rhode Island, was published online on December 21 in JAMA Network Open.

LIMITATIONS:

The analysis is constrained by the database, which may limit the generalizability of the findings. The authors determined the response to neoadjuvant therapy by comparing clinical stage with postoperative pathologic stage.

DISCLOSURES:

No funding was declared. No relevant financial relationships were declared.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Overall survival among US patients with resected stage II or III gastric cancer differs by race and ethnicity, with Asian and Hispanic patients demonstrating better overall survival than White and Black patients.

METHODOLOGY:

• Studies have revealed disparities in gastric cancer outcomes among different racial and ethnic groups in the United States, but the reasons are unclear.
• To better understand the disparities, researchers analyzed survival outcomes by race and ethnicity, treatment type, and a range of other factors.
• The retrospective analysis included 6938 patients with clinical stages IIA-IIIC gastric adenocarcinoma who underwent partial or total gastrectomy between 2006 and 2019, excluding those with a history of cancer. Patient data came from the National Cancer Database, which covers about 70% of all new cancer diagnoses.
• The researchers compared factors, including race and ethnicity, surgical margins, and lymph nodes, as well as treatment modality (neoadjuvant or adjuvant chemotherapy only, neoadjuvant or adjuvant chemoradiation only, or perioperative chemotherapy with radiation or surgical care only).
• Just over half of the patients (53.6%) were White, 24.3% were Black, 17.8% were Hispanic, 15.8% were Asian, and 2.6% were other race or ethnicity (information was missing for 4.8%). White patients were more likely to be older and insured; Black and White patients had more comorbidities than Asian and Hispanic patients.

TAKEAWAY:

• Perioperative chemotherapy was associated with improved overall survival (hazard ratio [HR], 0.79), while surgical resection alone (HR, 1.79), more positive lymph nodes (HR, 2.95 for 10 or more), and positive surgical margins were associated with the biggest decreases in overall survival.
• Asian and Hispanic patients had significantly better overall survival (HR, 0.64 and 0.77, respectively) than White patients.
• In general, Black and White patients had similar overall survival (HR, 0.96), except among Black patients who received neoadjuvant therapy — these patients had better overall survival than White patients (HR, 0.78).
• Black and Asian patients were more likely to be downstaged or achieve a pathologic complete response after neoadjuvant therapy (34.4% and 35.3%, respectively) than White (28.4%) and Hispanic patients (30.8%).

IN PRACTICE:

The authors found that “Asian and Hispanic race and ethnicity were independently associated with improved [overall survival] compared with Black and White race,” even after adjusting for variables including multimodality treatment regimen and response to neoadjuvant therapy.

The authors explained that overall Asian and Black patients responded more favorably to neoadjuvant therapy, demonstrating significantly higher rates of downstaging or pathologic complete response, which may help explain why Black patients demonstrated better overall survival than White patients who received neoadjuvant therapy.

SOURCE:

The research, led by Steve Kwon, MD, MPH, of Roger Williams Medical Center and Boston University, Providence, Rhode Island, was published online on December 21 in JAMA Network Open.

LIMITATIONS:

The analysis is constrained by the database, which may limit the generalizability of the findings. The authors determined the response to neoadjuvant therapy by comparing clinical stage with postoperative pathologic stage.

DISCLOSURES:

No funding was declared. No relevant financial relationships were declared.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Overall survival among US patients with resected stage II or III gastric cancer differs by race and ethnicity, with Asian and Hispanic patients demonstrating better overall survival than White and Black patients.

METHODOLOGY:

• Studies have revealed disparities in gastric cancer outcomes among different racial and ethnic groups in the United States, but the reasons are unclear.
• To better understand the disparities, researchers analyzed survival outcomes by race and ethnicity, treatment type, and a range of other factors.
• The retrospective analysis included 6938 patients with clinical stages IIA-IIIC gastric adenocarcinoma who underwent partial or total gastrectomy between 2006 and 2019, excluding those with a history of cancer. Patient data came from the National Cancer Database, which covers about 70% of all new cancer diagnoses.
• The researchers compared factors, including race and ethnicity, surgical margins, and lymph nodes, as well as treatment modality (neoadjuvant or adjuvant chemotherapy only, neoadjuvant or adjuvant chemoradiation only, or perioperative chemotherapy with radiation or surgical care only).
• Just over half of the patients (53.6%) were White, 24.3% were Black, 17.8% were Hispanic, 15.8% were Asian, and 2.6% were other race or ethnicity (information was missing for 4.8%). White patients were more likely to be older and insured; Black and White patients had more comorbidities than Asian and Hispanic patients.

TAKEAWAY:

• Perioperative chemotherapy was associated with improved overall survival (hazard ratio [HR], 0.79), while surgical resection alone (HR, 1.79), more positive lymph nodes (HR, 2.95 for 10 or more), and positive surgical margins were associated with the biggest decreases in overall survival.
• Asian and Hispanic patients had significantly better overall survival (HR, 0.64 and 0.77, respectively) than White patients.
• In general, Black and White patients had similar overall survival (HR, 0.96), except among Black patients who received neoadjuvant therapy — these patients had better overall survival than White patients (HR, 0.78).
• Black and Asian patients were more likely to be downstaged or achieve a pathologic complete response after neoadjuvant therapy (34.4% and 35.3%, respectively) than White (28.4%) and Hispanic patients (30.8%).

IN PRACTICE:

The authors found that “Asian and Hispanic race and ethnicity were independently associated with improved [overall survival] compared with Black and White race,” even after adjusting for variables including multimodality treatment regimen and response to neoadjuvant therapy.

The authors explained that overall Asian and Black patients responded more favorably to neoadjuvant therapy, demonstrating significantly higher rates of downstaging or pathologic complete response, which may help explain why Black patients demonstrated better overall survival than White patients who received neoadjuvant therapy.

SOURCE:

The research, led by Steve Kwon, MD, MPH, of Roger Williams Medical Center and Boston University, Providence, Rhode Island, was published online on December 21 in JAMA Network Open.

LIMITATIONS:

The analysis is constrained by the database, which may limit the generalizability of the findings. The authors determined the response to neoadjuvant therapy by comparing clinical stage with postoperative pathologic stage.

DISCLOSURES:

No funding was declared. No relevant financial relationships were declared.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Imposing a new prior authorization requirement increased the likelihood that older patients with cancer will delay or stop filling their prescription for oral anticancer drugs, a new study showed.

METHODOLOGY:

• Prior authorization requirements, especially in oncology, continue to increase, but how these policies affect patients’ access to care remains less clear.
• Researchers analyzed Medicare Part D claims from 2010 to 2020 to assess the effects of prior authorization changes on prescriptions fills for 1 of 11 oral anticancer drugs.
• The study included 2495 patients filling a prescription for these medications prior to their health plan imposing a new prior authorization policy and 22,641 patients filling prescriptions for the same drugs with no change in prior authorization policy (control).
• Beneficiaries had at least three 30-day fills in the 120 days before the new prior authorization policy was established on January 1 and continued to be enrolled in the same plan 120 days after the policy change.
• The researchers focused on how often patients discontinued their therapy within 120 days following a prior authorization policy change, as well as the time to fill a prescription after this change.

TAKEAWAY:

• Patients subjected to a new prior authorization policy on an established drug had a sevenfold higher likelihood of stopping the drug within 120 days than those who had no change in prior authorization requirements (adjusted odds ratio, 7.1).
• The adjusted probability of discontinuing an oral cancer regimen within 120 days after an index date of January 1 (when most health plan policy changes occur) was 5.8% for those with a new prior authorization policy vs 1.4% for the control group.
• A new prior authorization requirement was also associated with an average 10-day delay to refill the first prescription following the policy change (P < .001).
• The probability of a delay of more than 30 days was 22% after a policy change vs 7% after no policy change.

IN PRACTICE:

“Our results suggest concerns about delayed and foregone care related to prior authorization are warranted,” the authors said. Overall, this study found that “prior authorization wasted time and undermined the policy priorities of access to care and oral anticancer drug adherence for patients who were regular users of a particular medication.”

SOURCE:

The study by Michael Anna Kyle, PhD, RN, and Nancy Keating, MD, MPH, with Harvard Medical School, Boston, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study did not look at patients starting new oral anticancer drugs, which may come with more complex prior authorization processes and create more significant access issues. The results are also limited to patients taking 1 of 11 oral anticancer agents in Medicare Part D.

DISCLOSURES:

Funding for the study was provided by the National Cancer Institute. The authors reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Imposing a new prior authorization requirement increased the likelihood that older patients with cancer will delay or stop filling their prescription for oral anticancer drugs, a new study showed.

METHODOLOGY:

• Prior authorization requirements, especially in oncology, continue to increase, but how these policies affect patients’ access to care remains less clear.
• Researchers analyzed Medicare Part D claims from 2010 to 2020 to assess the effects of prior authorization changes on prescriptions fills for 1 of 11 oral anticancer drugs.
• The study included 2495 patients filling a prescription for these medications prior to their health plan imposing a new prior authorization policy and 22,641 patients filling prescriptions for the same drugs with no change in prior authorization policy (control).
• Beneficiaries had at least three 30-day fills in the 120 days before the new prior authorization policy was established on January 1 and continued to be enrolled in the same plan 120 days after the policy change.
• The researchers focused on how often patients discontinued their therapy within 120 days following a prior authorization policy change, as well as the time to fill a prescription after this change.

TAKEAWAY:

• Patients subjected to a new prior authorization policy on an established drug had a sevenfold higher likelihood of stopping the drug within 120 days than those who had no change in prior authorization requirements (adjusted odds ratio, 7.1).
• The adjusted probability of discontinuing an oral cancer regimen within 120 days after an index date of January 1 (when most health plan policy changes occur) was 5.8% for those with a new prior authorization policy vs 1.4% for the control group.
• A new prior authorization requirement was also associated with an average 10-day delay to refill the first prescription following the policy change (P < .001).
• The probability of a delay of more than 30 days was 22% after a policy change vs 7% after no policy change.

IN PRACTICE:

“Our results suggest concerns about delayed and foregone care related to prior authorization are warranted,” the authors said. Overall, this study found that “prior authorization wasted time and undermined the policy priorities of access to care and oral anticancer drug adherence for patients who were regular users of a particular medication.”

SOURCE:

The study by Michael Anna Kyle, PhD, RN, and Nancy Keating, MD, MPH, with Harvard Medical School, Boston, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study did not look at patients starting new oral anticancer drugs, which may come with more complex prior authorization processes and create more significant access issues. The results are also limited to patients taking 1 of 11 oral anticancer agents in Medicare Part D.

DISCLOSURES:

Funding for the study was provided by the National Cancer Institute. The authors reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Imposing a new prior authorization requirement increased the likelihood that older patients with cancer will delay or stop filling their prescription for oral anticancer drugs, a new study showed.

METHODOLOGY:

• Prior authorization requirements, especially in oncology, continue to increase, but how these policies affect patients’ access to care remains less clear.
• Researchers analyzed Medicare Part D claims from 2010 to 2020 to assess the effects of prior authorization changes on prescriptions fills for 1 of 11 oral anticancer drugs.
• The study included 2495 patients filling a prescription for these medications prior to their health plan imposing a new prior authorization policy and 22,641 patients filling prescriptions for the same drugs with no change in prior authorization policy (control).
• Beneficiaries had at least three 30-day fills in the 120 days before the new prior authorization policy was established on January 1 and continued to be enrolled in the same plan 120 days after the policy change.
• The researchers focused on how often patients discontinued their therapy within 120 days following a prior authorization policy change, as well as the time to fill a prescription after this change.

TAKEAWAY:

• Patients subjected to a new prior authorization policy on an established drug had a sevenfold higher likelihood of stopping the drug within 120 days than those who had no change in prior authorization requirements (adjusted odds ratio, 7.1).
• The adjusted probability of discontinuing an oral cancer regimen within 120 days after an index date of January 1 (when most health plan policy changes occur) was 5.8% for those with a new prior authorization policy vs 1.4% for the control group.
• A new prior authorization requirement was also associated with an average 10-day delay to refill the first prescription following the policy change (P < .001).
• The probability of a delay of more than 30 days was 22% after a policy change vs 7% after no policy change.

IN PRACTICE:

“Our results suggest concerns about delayed and foregone care related to prior authorization are warranted,” the authors said. Overall, this study found that “prior authorization wasted time and undermined the policy priorities of access to care and oral anticancer drug adherence for patients who were regular users of a particular medication.”

SOURCE:

The study by Michael Anna Kyle, PhD, RN, and Nancy Keating, MD, MPH, with Harvard Medical School, Boston, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study did not look at patients starting new oral anticancer drugs, which may come with more complex prior authorization processes and create more significant access issues. The results are also limited to patients taking 1 of 11 oral anticancer agents in Medicare Part D.

DISCLOSURES:

Funding for the study was provided by the National Cancer Institute. The authors reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Mark Lewis, MD, saw the pain in his patient’s body. The man’s gastrointestinal tumor had metastasized to his bones. Even breathing had become agonizing.

It was a Friday afternoon. Dr. Lewis could see his patient would struggle to make it through the weekend without some pain relief.

When this happens, “the clock is ticking,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Health in Salt Lake City, Utah. “A patient, especially one with more advanced disease, only has so much time to wait for care.”

Dr. Lewis sent in an electronic request for an opioid prescription to help ease his patient’s pain through the weekend. Once the prescription had gone through, Dr. Lewis told his patient the medication should be ready to pick up at his local pharmacy.

Dr. Lewis left work that Friday feeling a little lighter, knowing the pain medication would help his patient over the weekend.

Moments after walking into the clinic on Monday morning, Dr. Lewis received an unexpected message: “Your patient is in the hospital.”

The events of the weekend soon unfolded.

Dr. Lewis learned that when his patient went to the pharmacy to pick up his pain medication, the pharmacist told him the prescription required prior authorization.

The patient left the pharmacy empty-handed. Hours later, he was in the emergency room (ER) in extreme pain — the exact situation Dr. Lewis had been trying to avoid.

Dr. Lewis felt a sense of powerlessness in that moment.

“I had been left in the dark,” he said. The oncologist-patient relationship is predicated on trust and “that trust is eroded when I can’t give my patients the care they need,” he explained. “I can’t stand overpromising and underdelivering to them.”

Dr. Lewis had received no communication from the insurer that the prescription required prior authorization, no red flag that the request had been denied, and no notification to call the insurer.

Although physicians may need to tread carefully when prescribing opioids over the long term, “this was simply a prescription for 2-3 days of opioids for the exact patient who the drugs were developed to benefit,” Dr. Lewis said. But instead, “he ended up in ER with a pain crisis.”

Prior authorization delays like this often mean patients pay the price.

“These delays are not trivial,” Dr. Lewis said.

A recent study, presented at the ASCO Quality Care Symposium in October, found that among 3304 supportive care prescriptions requiring prior authorization, insurance companies denied 8% of requests, with final denials taking as long as 78 days. Among approved prescriptions, about 40% happened on the same day, while the remaining took anywhere from 1 to 54 days.

Denying or delaying necessary and cost-effective care, even briefly, can harm patients and lead to higher costs. A 2022 survey from the American Medical Association found that instead of reducing low-value care as insurance companies claim, prior authorization often leads to higher overall use of healthcare resources. More specifically, almost half of physicians surveyed said that prior authorization led to an ER visit or need for immediate care.

In this patient’s case, filling the opioid prescription that Friday would have cost no more than $300, possibly as little as $30. The ER visit to manage the patient’s pain crisis costs thousands.

The major issue overall, Dr. Lewis said, is the disconnect between the time spent waiting for prior authorization approvals and the necessity of these treatments. Dr. Lewis says even standard chemotherapy often requires prior authorization.

“The currency we all share is time,” Dr. Lewis said. “But it often feels like there’s very little urgency on insurance company side to approve a treatment, which places a heavy weight on patients and physicians.”

“It just shouldn’t be this hard,” he said.

A version of this article appeared on Medscape.com as part of the Gatekeepers of Care series on issues oncologists and people with cancer face navigating health insurance company requirements. Read more about the series here. Please email [email protected] to share experiences with prior authorization or other challenges receiving care.

Mark Lewis, MD, saw the pain in his patient’s body. The man’s gastrointestinal tumor had metastasized to his bones. Even breathing had become agonizing.

It was a Friday afternoon. Dr. Lewis could see his patient would struggle to make it through the weekend without some pain relief.

When this happens, “the clock is ticking,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Health in Salt Lake City, Utah. “A patient, especially one with more advanced disease, only has so much time to wait for care.”

Dr. Lewis sent in an electronic request for an opioid prescription to help ease his patient’s pain through the weekend. Once the prescription had gone through, Dr. Lewis told his patient the medication should be ready to pick up at his local pharmacy.

Dr. Lewis left work that Friday feeling a little lighter, knowing the pain medication would help his patient over the weekend.

Moments after walking into the clinic on Monday morning, Dr. Lewis received an unexpected message: “Your patient is in the hospital.”

The events of the weekend soon unfolded.

Dr. Lewis learned that when his patient went to the pharmacy to pick up his pain medication, the pharmacist told him the prescription required prior authorization.

The patient left the pharmacy empty-handed. Hours later, he was in the emergency room (ER) in extreme pain — the exact situation Dr. Lewis had been trying to avoid.

Dr. Lewis felt a sense of powerlessness in that moment.

“I had been left in the dark,” he said. The oncologist-patient relationship is predicated on trust and “that trust is eroded when I can’t give my patients the care they need,” he explained. “I can’t stand overpromising and underdelivering to them.”

Dr. Lewis had received no communication from the insurer that the prescription required prior authorization, no red flag that the request had been denied, and no notification to call the insurer.

Although physicians may need to tread carefully when prescribing opioids over the long term, “this was simply a prescription for 2-3 days of opioids for the exact patient who the drugs were developed to benefit,” Dr. Lewis said. But instead, “he ended up in ER with a pain crisis.”

Prior authorization delays like this often mean patients pay the price.

“These delays are not trivial,” Dr. Lewis said.

A recent study, presented at the ASCO Quality Care Symposium in October, found that among 3304 supportive care prescriptions requiring prior authorization, insurance companies denied 8% of requests, with final denials taking as long as 78 days. Among approved prescriptions, about 40% happened on the same day, while the remaining took anywhere from 1 to 54 days.

Denying or delaying necessary and cost-effective care, even briefly, can harm patients and lead to higher costs. A 2022 survey from the American Medical Association found that instead of reducing low-value care as insurance companies claim, prior authorization often leads to higher overall use of healthcare resources. More specifically, almost half of physicians surveyed said that prior authorization led to an ER visit or need for immediate care.

In this patient’s case, filling the opioid prescription that Friday would have cost no more than $300, possibly as little as $30. The ER visit to manage the patient’s pain crisis costs thousands.

The major issue overall, Dr. Lewis said, is the disconnect between the time spent waiting for prior authorization approvals and the necessity of these treatments. Dr. Lewis says even standard chemotherapy often requires prior authorization.

“The currency we all share is time,” Dr. Lewis said. “But it often feels like there’s very little urgency on insurance company side to approve a treatment, which places a heavy weight on patients and physicians.”

“It just shouldn’t be this hard,” he said.

A version of this article appeared on Medscape.com as part of the Gatekeepers of Care series on issues oncologists and people with cancer face navigating health insurance company requirements. Read more about the series here. Please email [email protected] to share experiences with prior authorization or other challenges receiving care.

Mark Lewis, MD, saw the pain in his patient’s body. The man’s gastrointestinal tumor had metastasized to his bones. Even breathing had become agonizing.

It was a Friday afternoon. Dr. Lewis could see his patient would struggle to make it through the weekend without some pain relief.

When this happens, “the clock is ticking,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Health in Salt Lake City, Utah. “A patient, especially one with more advanced disease, only has so much time to wait for care.”

Dr. Lewis sent in an electronic request for an opioid prescription to help ease his patient’s pain through the weekend. Once the prescription had gone through, Dr. Lewis told his patient the medication should be ready to pick up at his local pharmacy.

Dr. Lewis left work that Friday feeling a little lighter, knowing the pain medication would help his patient over the weekend.

Moments after walking into the clinic on Monday morning, Dr. Lewis received an unexpected message: “Your patient is in the hospital.”

The events of the weekend soon unfolded.

Dr. Lewis learned that when his patient went to the pharmacy to pick up his pain medication, the pharmacist told him the prescription required prior authorization.

The patient left the pharmacy empty-handed. Hours later, he was in the emergency room (ER) in extreme pain — the exact situation Dr. Lewis had been trying to avoid.

Dr. Lewis felt a sense of powerlessness in that moment.

“I had been left in the dark,” he said. The oncologist-patient relationship is predicated on trust and “that trust is eroded when I can’t give my patients the care they need,” he explained. “I can’t stand overpromising and underdelivering to them.”

Dr. Lewis had received no communication from the insurer that the prescription required prior authorization, no red flag that the request had been denied, and no notification to call the insurer.

Although physicians may need to tread carefully when prescribing opioids over the long term, “this was simply a prescription for 2-3 days of opioids for the exact patient who the drugs were developed to benefit,” Dr. Lewis said. But instead, “he ended up in ER with a pain crisis.”

Prior authorization delays like this often mean patients pay the price.

“These delays are not trivial,” Dr. Lewis said.

A recent study, presented at the ASCO Quality Care Symposium in October, found that among 3304 supportive care prescriptions requiring prior authorization, insurance companies denied 8% of requests, with final denials taking as long as 78 days. Among approved prescriptions, about 40% happened on the same day, while the remaining took anywhere from 1 to 54 days.

Denying or delaying necessary and cost-effective care, even briefly, can harm patients and lead to higher costs. A 2022 survey from the American Medical Association found that instead of reducing low-value care as insurance companies claim, prior authorization often leads to higher overall use of healthcare resources. More specifically, almost half of physicians surveyed said that prior authorization led to an ER visit or need for immediate care.

In this patient’s case, filling the opioid prescription that Friday would have cost no more than $300, possibly as little as $30. The ER visit to manage the patient’s pain crisis costs thousands.

The major issue overall, Dr. Lewis said, is the disconnect between the time spent waiting for prior authorization approvals and the necessity of these treatments. Dr. Lewis says even standard chemotherapy often requires prior authorization.

“The currency we all share is time,” Dr. Lewis said. “But it often feels like there’s very little urgency on insurance company side to approve a treatment, which places a heavy weight on patients and physicians.”

“It just shouldn’t be this hard,” he said.

A version of this article appeared on Medscape.com as part of the Gatekeepers of Care series on issues oncologists and people with cancer face navigating health insurance company requirements. Read more about the series here. Please email [email protected] to share experiences with prior authorization or other challenges receiving care.

SAN ANTONIO — Axillary lymph node dissection may be unnecessary if breast cancer patients with one or two positive sentinel lymph nodes plan to have adjuvant nodal radiation, according to a major Scandinavian trial presented at the San Antonio Breast Cancer Symposium.

“It means that you don’t need to dissect the axilla if you” are going to “radiate the axilla.” “For the U.S., that’s the conclusion because there are still centers that do both, and that’s out,” lead investigator Jana de Boniface, MD, PhD, a breast cancer surgeon at the Karolinska Institutet, Stockholm, said in an interview.

The study added to a persistent theme at this year’s meeting, protecting breast cancer patients from doing too much and causing unnecessary harm. Some even wondered if 5 years of endocrine therapy is necessary.

Dr. Boniface shared her thoughts after presenting the Scandinavian trial, SENOMAC, which she led.

SENOMAC randomized 1,204 patients with one or two positive sentinel lymph nodes to axillary dissection; 1,335 with the same finding were randomized to no dissection.

Subjects had clinically T1-3, N0 primary breast cancer. About 89% in both arms went on to adjuvant radiation, including nodal radiation, and almost all also went on to systemic therapy, which included endocrine therapy in over 90%. Only about 2% of subjects had neoadjuvant therapy.

At a median follow-up of nearly 4 years, recurrence-free survival was virtually identical in both groups, with 8% of patients in the dissection arm and 7.1% in the no-dissection group having recurrences. Estimated 5-year recurrence-free survival was just shy of 90% in both groups. Skipping dissection was strongly non-inferior to having one (P < .001).

SENOMAC “clearly shows that you don’t need to dissect the axilla if you have one to two positive sentinel lymph nodes” so long as patients have adjuvant nodal radiation. Recurrence-free survival “curves practically overlap, and we cannot see any difference between the two groups,” Dr. Boniface said.

Meanwhile, the dissection group fared worse on patient reported outcomes. Overall survival outcomes, the primary endpoint of the trial, are expected within 2 years.

The goal of the trial, the largest to date to look into the issue, was to fill gaps in the literature. Similar outcomes were reported around a decade ago in patients with low sentinel lymph node burdens, but the extensive exclusion criteria raised questions about general applicability.

In contrast, SENOMAC was widely inclusive. Over a third of patients had mastectomies, over a third had sentinel lymph node extracapsular extension, almost 6% had T3 disease, almost 20% had lobular carcinoma, 40% were 65 years or older, and tumors were as large as 15.5 cm.

The findings held regardless of those and other factors on subgroup analyses, including estrogen receptor and HER2 status and the number of additional positive nodes retrieved in the dissection group.

Andrea V. Barrio, MD, the study discussant and a breast cancer surgeon at Memorial Sloan Kettering Cancer Center, New York, agreed with the message from SENOMAC.

“Based on this, ALND [axillary lymph node dissection] should not be considered standard in patients with clinical T1-3, N0 breast cancer with one to two positive sentinel nodes, with or without microscopic extracapsular extension, undergoing lumpectomy or mastectomy,” provided nodal adjuvant radiotherapy is indicated, she said.

Although adjuvant nodal radiation for patients with one to three positive sentinel nodes is standard of care in Denmark and Sweden, where most of the patients in SENOMAC were located, practices vary widely in the United States. If adjuvant radiation isn’t used, “then ALND [is still] indicated,” Dr. Barrio said, but in either case, “only one is needed.”

In keeping with the de-escalation theme at the 2023 symposium, both Dr. Boniface and Dr. Barrio noted that trials are now underway to find patients who can avoid any axillary treatment at all if they have just one or two positive sentinel lymph nodes.

Preoperative axillary ultrasound was mandatory in SENOMAC and patients with non-palpable suspicious axillary lymph nodes were enrolled.

Thirty-six were positive on fine needle aspiration and randomized into the study, but when asked, Dr. Boniface didn’t have the data immediately at hand on how they fared.

The work was funded by the Swedish Research Council, Nordic Cancer Union, and others. Dr. Boniface and Dr. Barrio didn’t have any disclosures.

SAN ANTONIO — Axillary lymph node dissection may be unnecessary if breast cancer patients with one or two positive sentinel lymph nodes plan to have adjuvant nodal radiation, according to a major Scandinavian trial presented at the San Antonio Breast Cancer Symposium.

“It means that you don’t need to dissect the axilla if you” are going to “radiate the axilla.” “For the U.S., that’s the conclusion because there are still centers that do both, and that’s out,” lead investigator Jana de Boniface, MD, PhD, a breast cancer surgeon at the Karolinska Institutet, Stockholm, said in an interview.

The study added to a persistent theme at this year’s meeting, protecting breast cancer patients from doing too much and causing unnecessary harm. Some even wondered if 5 years of endocrine therapy is necessary.

Dr. Boniface shared her thoughts after presenting the Scandinavian trial, SENOMAC, which she led.

SENOMAC randomized 1,204 patients with one or two positive sentinel lymph nodes to axillary dissection; 1,335 with the same finding were randomized to no dissection.

Subjects had clinically T1-3, N0 primary breast cancer. About 89% in both arms went on to adjuvant radiation, including nodal radiation, and almost all also went on to systemic therapy, which included endocrine therapy in over 90%. Only about 2% of subjects had neoadjuvant therapy.

At a median follow-up of nearly 4 years, recurrence-free survival was virtually identical in both groups, with 8% of patients in the dissection arm and 7.1% in the no-dissection group having recurrences. Estimated 5-year recurrence-free survival was just shy of 90% in both groups. Skipping dissection was strongly non-inferior to having one (P < .001).

SENOMAC “clearly shows that you don’t need to dissect the axilla if you have one to two positive sentinel lymph nodes” so long as patients have adjuvant nodal radiation. Recurrence-free survival “curves practically overlap, and we cannot see any difference between the two groups,” Dr. Boniface said.

Meanwhile, the dissection group fared worse on patient reported outcomes. Overall survival outcomes, the primary endpoint of the trial, are expected within 2 years.

The goal of the trial, the largest to date to look into the issue, was to fill gaps in the literature. Similar outcomes were reported around a decade ago in patients with low sentinel lymph node burdens, but the extensive exclusion criteria raised questions about general applicability.

In contrast, SENOMAC was widely inclusive. Over a third of patients had mastectomies, over a third had sentinel lymph node extracapsular extension, almost 6% had T3 disease, almost 20% had lobular carcinoma, 40% were 65 years or older, and tumors were as large as 15.5 cm.

The findings held regardless of those and other factors on subgroup analyses, including estrogen receptor and HER2 status and the number of additional positive nodes retrieved in the dissection group.

Andrea V. Barrio, MD, the study discussant and a breast cancer surgeon at Memorial Sloan Kettering Cancer Center, New York, agreed with the message from SENOMAC.

“Based on this, ALND [axillary lymph node dissection] should not be considered standard in patients with clinical T1-3, N0 breast cancer with one to two positive sentinel nodes, with or without microscopic extracapsular extension, undergoing lumpectomy or mastectomy,” provided nodal adjuvant radiotherapy is indicated, she said.

Although adjuvant nodal radiation for patients with one to three positive sentinel nodes is standard of care in Denmark and Sweden, where most of the patients in SENOMAC were located, practices vary widely in the United States. If adjuvant radiation isn’t used, “then ALND [is still] indicated,” Dr. Barrio said, but in either case, “only one is needed.”

In keeping with the de-escalation theme at the 2023 symposium, both Dr. Boniface and Dr. Barrio noted that trials are now underway to find patients who can avoid any axillary treatment at all if they have just one or two positive sentinel lymph nodes.

Preoperative axillary ultrasound was mandatory in SENOMAC and patients with non-palpable suspicious axillary lymph nodes were enrolled.

Thirty-six were positive on fine needle aspiration and randomized into the study, but when asked, Dr. Boniface didn’t have the data immediately at hand on how they fared.

The work was funded by the Swedish Research Council, Nordic Cancer Union, and others. Dr. Boniface and Dr. Barrio didn’t have any disclosures.

SAN ANTONIO — Axillary lymph node dissection may be unnecessary if breast cancer patients with one or two positive sentinel lymph nodes plan to have adjuvant nodal radiation, according to a major Scandinavian trial presented at the San Antonio Breast Cancer Symposium.

“It means that you don’t need to dissect the axilla if you” are going to “radiate the axilla.” “For the U.S., that’s the conclusion because there are still centers that do both, and that’s out,” lead investigator Jana de Boniface, MD, PhD, a breast cancer surgeon at the Karolinska Institutet, Stockholm, said in an interview.

The study added to a persistent theme at this year’s meeting, protecting breast cancer patients from doing too much and causing unnecessary harm. Some even wondered if 5 years of endocrine therapy is necessary.

Dr. Boniface shared her thoughts after presenting the Scandinavian trial, SENOMAC, which she led.

SENOMAC randomized 1,204 patients with one or two positive sentinel lymph nodes to axillary dissection; 1,335 with the same finding were randomized to no dissection.

Subjects had clinically T1-3, N0 primary breast cancer. About 89% in both arms went on to adjuvant radiation, including nodal radiation, and almost all also went on to systemic therapy, which included endocrine therapy in over 90%. Only about 2% of subjects had neoadjuvant therapy.

At a median follow-up of nearly 4 years, recurrence-free survival was virtually identical in both groups, with 8% of patients in the dissection arm and 7.1% in the no-dissection group having recurrences. Estimated 5-year recurrence-free survival was just shy of 90% in both groups. Skipping dissection was strongly non-inferior to having one (P < .001).

SENOMAC “clearly shows that you don’t need to dissect the axilla if you have one to two positive sentinel lymph nodes” so long as patients have adjuvant nodal radiation. Recurrence-free survival “curves practically overlap, and we cannot see any difference between the two groups,” Dr. Boniface said.

Meanwhile, the dissection group fared worse on patient reported outcomes. Overall survival outcomes, the primary endpoint of the trial, are expected within 2 years.

The goal of the trial, the largest to date to look into the issue, was to fill gaps in the literature. Similar outcomes were reported around a decade ago in patients with low sentinel lymph node burdens, but the extensive exclusion criteria raised questions about general applicability.

In contrast, SENOMAC was widely inclusive. Over a third of patients had mastectomies, over a third had sentinel lymph node extracapsular extension, almost 6% had T3 disease, almost 20% had lobular carcinoma, 40% were 65 years or older, and tumors were as large as 15.5 cm.

The findings held regardless of those and other factors on subgroup analyses, including estrogen receptor and HER2 status and the number of additional positive nodes retrieved in the dissection group.

Andrea V. Barrio, MD, the study discussant and a breast cancer surgeon at Memorial Sloan Kettering Cancer Center, New York, agreed with the message from SENOMAC.

“Based on this, ALND [axillary lymph node dissection] should not be considered standard in patients with clinical T1-3, N0 breast cancer with one to two positive sentinel nodes, with or without microscopic extracapsular extension, undergoing lumpectomy or mastectomy,” provided nodal adjuvant radiotherapy is indicated, she said.

Although adjuvant nodal radiation for patients with one to three positive sentinel nodes is standard of care in Denmark and Sweden, where most of the patients in SENOMAC were located, practices vary widely in the United States. If adjuvant radiation isn’t used, “then ALND [is still] indicated,” Dr. Barrio said, but in either case, “only one is needed.”

In keeping with the de-escalation theme at the 2023 symposium, both Dr. Boniface and Dr. Barrio noted that trials are now underway to find patients who can avoid any axillary treatment at all if they have just one or two positive sentinel lymph nodes.

Preoperative axillary ultrasound was mandatory in SENOMAC and patients with non-palpable suspicious axillary lymph nodes were enrolled.

Thirty-six were positive on fine needle aspiration and randomized into the study, but when asked, Dr. Boniface didn’t have the data immediately at hand on how they fared.

The work was funded by the Swedish Research Council, Nordic Cancer Union, and others. Dr. Boniface and Dr. Barrio didn’t have any disclosures.

SAN ANTONIO — Researchers have likely solved the key problem with using olanzapine to prevent nausea and vomiting in chemotherapy patients.

Although it’s highly effective in combination with standard antiemetic therapy, olanzapine at the standard dose of 10 mg makes people too drowsy. “This has prevented its widespread use in clinical practice,” medical oncologist Jyoti Bajpai, DM, of Tata Memorial Cancer Centre, Mumbai, India, explained at the San Antonio Breast Cancer Symposium.

She and her colleagues had a simple idea: Reduce the dose to 2.5 mg instead of 10 mg to prevent the problem. In a randomized trial with 267 patients that Dr. Bajpai presented at the meeting, they found that the lower dose was just as effective for nausea and vomiting prophylaxis, and it greatly reduced daytime somnolence.

“This merits consideration as an antiemetic regimen of choice for highly emetogenic chemotherapy.” The findings are “practice changing,” Dr. Bajpai, the lead investigator, said.

Laura Huppert, MD, a breast oncologist at the University of California, San Francisco, wasn’t surprised by the finding.

She said she and her colleagues at UCSF use a lot of olanzapine for nausea and vomiting prophylaxis. Like the team in India, they have found that 2.5 mg is effective and causes far less sleepiness. Some patients require 5 mg, but the full 10-mg dose is rarely needed.

Although the approach is familiar at UCSF, Dr. Huppert said she doesn’t think a lot of oncologists outside of academic centers know that olanzapine is “really helpful” and that “you don’t need a high dose.” It’s “a very good clinical pearl” and “definitely a new message for some,” she said in an interview.

Over 90% of the subjects in the study were women with breast cancer. Other cancers included sarcoma, germ cell tumors, and head and neck cancer. Subjects were scheduled for their first chemotherapy session with anthracycline-cyclophosphamide and high-dose cisplatin.

The trial randomized 135 patients to 10 mg of olanzapine and 132 to 2.5mg for 5 days, starting the day of their session. They were also on standard triple-antiemetic therapy (selective serotonin receptor (5-HT3) antagonist, neurokinin-1 receptor antagonist, and single-dose dexamethasone).

There were no significant differences between the two arms regarding nausea and vomiting, which patients tracked in daily journals using symptom severity and visual analog scales.

For instance, 44.7% in the 2.5-mg arm and 43.7% in the 10-mg arm reported no vomiting, no use of rescue medications, and no or only mild nausea (P = .87). Results were similar in the first 24 hours as well as on subsequent days.

There was also no difference in the proportion of patients who did have an emetic episode or needed rescue medication: 49.2% in the 2.5-mg arm versus 48.9% with 10 mg (P = .954).

Where the two groups split was on the incidence of daytime somnolence, which was reported by 65.2% of patients in the low-dose arm but 89.6% in the standard-dose group (P < .001). During the first 24 hours, 4.5% of low-dose patients reported severe somnolence versus 40% with 10-mg dosing (P < .001).

The overall incidence declined over the remaining study days, but the differences between the two groups were comparable. On day 5, for instance, 0.8% of low-dose patients but 8.1% of standard-dose patients reported severe somnolence (P = .004).

Low-dose patients also reported less appetite suppression.

The work was supported by the Progressive Ladies Welfare Association. Dr. Bajpai didn’t have any disclosures. Dr. Huppert is an adviser for AstraZeneca.

SAN ANTONIO — Researchers have likely solved the key problem with using olanzapine to prevent nausea and vomiting in chemotherapy patients.

Although it’s highly effective in combination with standard antiemetic therapy, olanzapine at the standard dose of 10 mg makes people too drowsy. “This has prevented its widespread use in clinical practice,” medical oncologist Jyoti Bajpai, DM, of Tata Memorial Cancer Centre, Mumbai, India, explained at the San Antonio Breast Cancer Symposium.

She and her colleagues had a simple idea: Reduce the dose to 2.5 mg instead of 10 mg to prevent the problem. In a randomized trial with 267 patients that Dr. Bajpai presented at the meeting, they found that the lower dose was just as effective for nausea and vomiting prophylaxis, and it greatly reduced daytime somnolence.

“This merits consideration as an antiemetic regimen of choice for highly emetogenic chemotherapy.” The findings are “practice changing,” Dr. Bajpai, the lead investigator, said.

Laura Huppert, MD, a breast oncologist at the University of California, San Francisco, wasn’t surprised by the finding.

She said she and her colleagues at UCSF use a lot of olanzapine for nausea and vomiting prophylaxis. Like the team in India, they have found that 2.5 mg is effective and causes far less sleepiness. Some patients require 5 mg, but the full 10-mg dose is rarely needed.

Although the approach is familiar at UCSF, Dr. Huppert said she doesn’t think a lot of oncologists outside of academic centers know that olanzapine is “really helpful” and that “you don’t need a high dose.” It’s “a very good clinical pearl” and “definitely a new message for some,” she said in an interview.

Over 90% of the subjects in the study were women with breast cancer. Other cancers included sarcoma, germ cell tumors, and head and neck cancer. Subjects were scheduled for their first chemotherapy session with anthracycline-cyclophosphamide and high-dose cisplatin.

The trial randomized 135 patients to 10 mg of olanzapine and 132 to 2.5mg for 5 days, starting the day of their session. They were also on standard triple-antiemetic therapy (selective serotonin receptor (5-HT3) antagonist, neurokinin-1 receptor antagonist, and single-dose dexamethasone).

There were no significant differences between the two arms regarding nausea and vomiting, which patients tracked in daily journals using symptom severity and visual analog scales.

For instance, 44.7% in the 2.5-mg arm and 43.7% in the 10-mg arm reported no vomiting, no use of rescue medications, and no or only mild nausea (P = .87). Results were similar in the first 24 hours as well as on subsequent days.

There was also no difference in the proportion of patients who did have an emetic episode or needed rescue medication: 49.2% in the 2.5-mg arm versus 48.9% with 10 mg (P = .954).

Where the two groups split was on the incidence of daytime somnolence, which was reported by 65.2% of patients in the low-dose arm but 89.6% in the standard-dose group (P < .001). During the first 24 hours, 4.5% of low-dose patients reported severe somnolence versus 40% with 10-mg dosing (P < .001).

The overall incidence declined over the remaining study days, but the differences between the two groups were comparable. On day 5, for instance, 0.8% of low-dose patients but 8.1% of standard-dose patients reported severe somnolence (P = .004).

Low-dose patients also reported less appetite suppression.

The work was supported by the Progressive Ladies Welfare Association. Dr. Bajpai didn’t have any disclosures. Dr. Huppert is an adviser for AstraZeneca.

SAN ANTONIO — Researchers have likely solved the key problem with using olanzapine to prevent nausea and vomiting in chemotherapy patients.

Although it’s highly effective in combination with standard antiemetic therapy, olanzapine at the standard dose of 10 mg makes people too drowsy. “This has prevented its widespread use in clinical practice,” medical oncologist Jyoti Bajpai, DM, of Tata Memorial Cancer Centre, Mumbai, India, explained at the San Antonio Breast Cancer Symposium.

She and her colleagues had a simple idea: Reduce the dose to 2.5 mg instead of 10 mg to prevent the problem. In a randomized trial with 267 patients that Dr. Bajpai presented at the meeting, they found that the lower dose was just as effective for nausea and vomiting prophylaxis, and it greatly reduced daytime somnolence.

“This merits consideration as an antiemetic regimen of choice for highly emetogenic chemotherapy.” The findings are “practice changing,” Dr. Bajpai, the lead investigator, said.

Laura Huppert, MD, a breast oncologist at the University of California, San Francisco, wasn’t surprised by the finding.

She said she and her colleagues at UCSF use a lot of olanzapine for nausea and vomiting prophylaxis. Like the team in India, they have found that 2.5 mg is effective and causes far less sleepiness. Some patients require 5 mg, but the full 10-mg dose is rarely needed.

Although the approach is familiar at UCSF, Dr. Huppert said she doesn’t think a lot of oncologists outside of academic centers know that olanzapine is “really helpful” and that “you don’t need a high dose.” It’s “a very good clinical pearl” and “definitely a new message for some,” she said in an interview.

Over 90% of the subjects in the study were women with breast cancer. Other cancers included sarcoma, germ cell tumors, and head and neck cancer. Subjects were scheduled for their first chemotherapy session with anthracycline-cyclophosphamide and high-dose cisplatin.

The trial randomized 135 patients to 10 mg of olanzapine and 132 to 2.5mg for 5 days, starting the day of their session. They were also on standard triple-antiemetic therapy (selective serotonin receptor (5-HT3) antagonist, neurokinin-1 receptor antagonist, and single-dose dexamethasone).

There were no significant differences between the two arms regarding nausea and vomiting, which patients tracked in daily journals using symptom severity and visual analog scales.

For instance, 44.7% in the 2.5-mg arm and 43.7% in the 10-mg arm reported no vomiting, no use of rescue medications, and no or only mild nausea (P = .87). Results were similar in the first 24 hours as well as on subsequent days.

There was also no difference in the proportion of patients who did have an emetic episode or needed rescue medication: 49.2% in the 2.5-mg arm versus 48.9% with 10 mg (P = .954).

Where the two groups split was on the incidence of daytime somnolence, which was reported by 65.2% of patients in the low-dose arm but 89.6% in the standard-dose group (P < .001). During the first 24 hours, 4.5% of low-dose patients reported severe somnolence versus 40% with 10-mg dosing (P < .001).

The overall incidence declined over the remaining study days, but the differences between the two groups were comparable. On day 5, for instance, 0.8% of low-dose patients but 8.1% of standard-dose patients reported severe somnolence (P = .004).

Low-dose patients also reported less appetite suppression.

The work was supported by the Progressive Ladies Welfare Association. Dr. Bajpai didn’t have any disclosures. Dr. Huppert is an adviser for AstraZeneca.

Measuring serum hormone concentrations in postmenopausal women at high risk for developing breast cancer may help identify those most likely to benefit from preventive treatment with an aromatase inhibitor, according to findings from a case-control study using data from a large breast cancer prevention trial.

In the randomized, placebo-controlled IBIS-II prevention trial of 3864 women aged 40-70 years at increased risk for developing breast cancer, treatment with the aromatase inhibitor anastrozole was associated with a 49% reduction in breast cancer incidence. At median follow-up of 131 months, breast cancer occurred in 85 (4.4%) versus 165 (8.5%) of patients in the anastrozole and placebo arms, respectively.

A preplanned case-control study involving 212 participants from the anastrozole group (72 cases and 140 controls) and 416 from the placebo group (142 cases and 274 controls), showed a significant trend toward increasing breast cancer risk with increasing estradiol-to-sex hormone binding globulin (SHBG) ratio in the placebo group, but not in the anastrozole group (trend per quartile, 1.25 vs 1.06), reported Jack Cuzick, PhD, of the Wolfson Institute of Population Health, Queen Mary University of London, UK, and colleagues.

A weaker but still significant effect was observed for the testosterone-SHBG ratio in the placebo group (trend, 1.21), but again, no such effect was seen in the anastrozole group (trend, 1.18).

A relative benefit was seen for anastrozole in estradiol concentration quartiles 2, 3, and 4 (relative risk [RR], 0.55, 0.54, and 0.56, respectively), but not in quartile 1.

The findings were published online December 6 in The Lancet Oncology.

Study participants were recruited from 153 breast cancer treatment centers across 18 countries and randomized in a 1:1 ratio to receive 1 mg of oral anastrozole daily or placebo. For the case-control analysis, the investigators looked at the effects of baseline estradiol to SHBG ratio on the development of all breast cancers, including ductal carcinoma in situ. They also assessed the relative benefit of anastrozole versus placebo.

Case patients were those diagnosed with breast cancer after trial entry through data cutoff on October 22, 2019, and who had not used hormone replacement therapy within 3 months of trial entry or during the trial. Controls were participants without breast cancer who were randomly selected and matched according to treatment group, age, and follow-up time.

“Although the association between estradiol and breast cancer risk is well established, less is known about whether the concentrations of these hormones have an effect on the efficacy of preventive therapy with selective estrogen receptor modulators or aromatase inhibitors in women at increased risk of developing breast cancer,” the investigators noted, explaining that in the current analysis, they “tested the hypothesis that, for women with a low estradiol–SHBG ratio, anastrozole would provide little or no reduction in the risk of breast cancer.”

The results from the placebo group “confirm the increasing risk of breast cancer associated with higher estradiol and testosterone concentrations, and a decreasing risk associated with increasing SHBG concentrations in women who were not randomly allocated to receive anastrozole,” they said.

“However, to our knowledge, this is the first report of the effect of low concentrations of estradiol or testosterone on a lack of response to aromatase inhibitor treatment, either as a preventive measure or in the adjuvant setting,” they added. “These data provide support for the hypothesis that preventive therapy with an aromatase inhibitor is likely to be most effective for women with higher estradiol-to-SHBG ratios and, conversely, of little or no benefit for those with low estradiol-to-SHBG ratios.”

Thus, measurement of estradiol and SHBG concentrations might be helpful in making decisions about using inhibitors both for treatment and prevention, they continued, underscoring the importance of using assays sensitive enough to measure low estradiol concentrations in the plasma in postmenopausal women.

“We used a very sensitive liquid chromatography–tandem mass spectroscopy assay (lower limit of sensitivity of 3 pmol/L), which allowed us to accurately measure the low concentrations of estradiol and SHBG in the serum samples from our population of postmenopausal women. Wider use of this type of assay or a similar assay will be necessary to implement any of the actions suggested by this study,” they explained.

The findings “suggest a potential role for measuring estradiol, testosterone, and SHBG more widely, both in determining which individuals are at high risk and the likely response to endocrine treatment,” they concluded, noting that measuring serum hormones is inexpensive and, if used more routinely in high-risk clinics and for treatment of early breast cancer, could “substantially improve disease management.”

This study was funded by Cancer Research UK, National Health and Medical Research Council (Australia), Breast Cancer Research Foundation, and DaCosta Fund. Dr. Cuzick reported receiving royalties from Cancer Research UK for commercial use of the IBIS (Tyrer-Cuzick) breast cancer risk evaluation software.

Measuring serum hormone concentrations in postmenopausal women at high risk for developing breast cancer may help identify those most likely to benefit from preventive treatment with an aromatase inhibitor, according to findings from a case-control study using data from a large breast cancer prevention trial.

In the randomized, placebo-controlled IBIS-II prevention trial of 3864 women aged 40-70 years at increased risk for developing breast cancer, treatment with the aromatase inhibitor anastrozole was associated with a 49% reduction in breast cancer incidence. At median follow-up of 131 months, breast cancer occurred in 85 (4.4%) versus 165 (8.5%) of patients in the anastrozole and placebo arms, respectively.

A preplanned case-control study involving 212 participants from the anastrozole group (72 cases and 140 controls) and 416 from the placebo group (142 cases and 274 controls), showed a significant trend toward increasing breast cancer risk with increasing estradiol-to-sex hormone binding globulin (SHBG) ratio in the placebo group, but not in the anastrozole group (trend per quartile, 1.25 vs 1.06), reported Jack Cuzick, PhD, of the Wolfson Institute of Population Health, Queen Mary University of London, UK, and colleagues.

A weaker but still significant effect was observed for the testosterone-SHBG ratio in the placebo group (trend, 1.21), but again, no such effect was seen in the anastrozole group (trend, 1.18).

A relative benefit was seen for anastrozole in estradiol concentration quartiles 2, 3, and 4 (relative risk [RR], 0.55, 0.54, and 0.56, respectively), but not in quartile 1.

The findings were published online December 6 in The Lancet Oncology.

Study participants were recruited from 153 breast cancer treatment centers across 18 countries and randomized in a 1:1 ratio to receive 1 mg of oral anastrozole daily or placebo. For the case-control analysis, the investigators looked at the effects of baseline estradiol to SHBG ratio on the development of all breast cancers, including ductal carcinoma in situ. They also assessed the relative benefit of anastrozole versus placebo.

Case patients were those diagnosed with breast cancer after trial entry through data cutoff on October 22, 2019, and who had not used hormone replacement therapy within 3 months of trial entry or during the trial. Controls were participants without breast cancer who were randomly selected and matched according to treatment group, age, and follow-up time.

“Although the association between estradiol and breast cancer risk is well established, less is known about whether the concentrations of these hormones have an effect on the efficacy of preventive therapy with selective estrogen receptor modulators or aromatase inhibitors in women at increased risk of developing breast cancer,” the investigators noted, explaining that in the current analysis, they “tested the hypothesis that, for women with a low estradiol–SHBG ratio, anastrozole would provide little or no reduction in the risk of breast cancer.”

The results from the placebo group “confirm the increasing risk of breast cancer associated with higher estradiol and testosterone concentrations, and a decreasing risk associated with increasing SHBG concentrations in women who were not randomly allocated to receive anastrozole,” they said.

“However, to our knowledge, this is the first report of the effect of low concentrations of estradiol or testosterone on a lack of response to aromatase inhibitor treatment, either as a preventive measure or in the adjuvant setting,” they added. “These data provide support for the hypothesis that preventive therapy with an aromatase inhibitor is likely to be most effective for women with higher estradiol-to-SHBG ratios and, conversely, of little or no benefit for those with low estradiol-to-SHBG ratios.”

Thus, measurement of estradiol and SHBG concentrations might be helpful in making decisions about using inhibitors both for treatment and prevention, they continued, underscoring the importance of using assays sensitive enough to measure low estradiol concentrations in the plasma in postmenopausal women.

“We used a very sensitive liquid chromatography–tandem mass spectroscopy assay (lower limit of sensitivity of 3 pmol/L), which allowed us to accurately measure the low concentrations of estradiol and SHBG in the serum samples from our population of postmenopausal women. Wider use of this type of assay or a similar assay will be necessary to implement any of the actions suggested by this study,” they explained.

The findings “suggest a potential role for measuring estradiol, testosterone, and SHBG more widely, both in determining which individuals are at high risk and the likely response to endocrine treatment,” they concluded, noting that measuring serum hormones is inexpensive and, if used more routinely in high-risk clinics and for treatment of early breast cancer, could “substantially improve disease management.”

This study was funded by Cancer Research UK, National Health and Medical Research Council (Australia), Breast Cancer Research Foundation, and DaCosta Fund. Dr. Cuzick reported receiving royalties from Cancer Research UK for commercial use of the IBIS (Tyrer-Cuzick) breast cancer risk evaluation software.

Measuring serum hormone concentrations in postmenopausal women at high risk for developing breast cancer may help identify those most likely to benefit from preventive treatment with an aromatase inhibitor, according to findings from a case-control study using data from a large breast cancer prevention trial.

In the randomized, placebo-controlled IBIS-II prevention trial of 3864 women aged 40-70 years at increased risk for developing breast cancer, treatment with the aromatase inhibitor anastrozole was associated with a 49% reduction in breast cancer incidence. At median follow-up of 131 months, breast cancer occurred in 85 (4.4%) versus 165 (8.5%) of patients in the anastrozole and placebo arms, respectively.

A preplanned case-control study involving 212 participants from the anastrozole group (72 cases and 140 controls) and 416 from the placebo group (142 cases and 274 controls), showed a significant trend toward increasing breast cancer risk with increasing estradiol-to-sex hormone binding globulin (SHBG) ratio in the placebo group, but not in the anastrozole group (trend per quartile, 1.25 vs 1.06), reported Jack Cuzick, PhD, of the Wolfson Institute of Population Health, Queen Mary University of London, UK, and colleagues.

A weaker but still significant effect was observed for the testosterone-SHBG ratio in the placebo group (trend, 1.21), but again, no such effect was seen in the anastrozole group (trend, 1.18).

A relative benefit was seen for anastrozole in estradiol concentration quartiles 2, 3, and 4 (relative risk [RR], 0.55, 0.54, and 0.56, respectively), but not in quartile 1.

The findings were published online December 6 in The Lancet Oncology.

Study participants were recruited from 153 breast cancer treatment centers across 18 countries and randomized in a 1:1 ratio to receive 1 mg of oral anastrozole daily or placebo. For the case-control analysis, the investigators looked at the effects of baseline estradiol to SHBG ratio on the development of all breast cancers, including ductal carcinoma in situ. They also assessed the relative benefit of anastrozole versus placebo.

Case patients were those diagnosed with breast cancer after trial entry through data cutoff on October 22, 2019, and who had not used hormone replacement therapy within 3 months of trial entry or during the trial. Controls were participants without breast cancer who were randomly selected and matched according to treatment group, age, and follow-up time.

“Although the association between estradiol and breast cancer risk is well established, less is known about whether the concentrations of these hormones have an effect on the efficacy of preventive therapy with selective estrogen receptor modulators or aromatase inhibitors in women at increased risk of developing breast cancer,” the investigators noted, explaining that in the current analysis, they “tested the hypothesis that, for women with a low estradiol–SHBG ratio, anastrozole would provide little or no reduction in the risk of breast cancer.”

The results from the placebo group “confirm the increasing risk of breast cancer associated with higher estradiol and testosterone concentrations, and a decreasing risk associated with increasing SHBG concentrations in women who were not randomly allocated to receive anastrozole,” they said.

“However, to our knowledge, this is the first report of the effect of low concentrations of estradiol or testosterone on a lack of response to aromatase inhibitor treatment, either as a preventive measure or in the adjuvant setting,” they added. “These data provide support for the hypothesis that preventive therapy with an aromatase inhibitor is likely to be most effective for women with higher estradiol-to-SHBG ratios and, conversely, of little or no benefit for those with low estradiol-to-SHBG ratios.”

Thus, measurement of estradiol and SHBG concentrations might be helpful in making decisions about using inhibitors both for treatment and prevention, they continued, underscoring the importance of using assays sensitive enough to measure low estradiol concentrations in the plasma in postmenopausal women.

“We used a very sensitive liquid chromatography–tandem mass spectroscopy assay (lower limit of sensitivity of 3 pmol/L), which allowed us to accurately measure the low concentrations of estradiol and SHBG in the serum samples from our population of postmenopausal women. Wider use of this type of assay or a similar assay will be necessary to implement any of the actions suggested by this study,” they explained.

The findings “suggest a potential role for measuring estradiol, testosterone, and SHBG more widely, both in determining which individuals are at high risk and the likely response to endocrine treatment,” they concluded, noting that measuring serum hormones is inexpensive and, if used more routinely in high-risk clinics and for treatment of early breast cancer, could “substantially improve disease management.”

This study was funded by Cancer Research UK, National Health and Medical Research Council (Australia), Breast Cancer Research Foundation, and DaCosta Fund. Dr. Cuzick reported receiving royalties from Cancer Research UK for commercial use of the IBIS (Tyrer-Cuzick) breast cancer risk evaluation software.

SAN ANTONIO — The antibody-drug conjugate trastuzumab emtansine (T-DM1) does not improve survival outcomes compared with the standard of care in older patients with advanced human epidermal growth factor receptor 2–positive (HER2+) breast cancer, although toxicity is much lower, results from the HERB TEA study show.

Overall, the standard-of-care triple regimen of monoclonal antibodies pertuzumab and trastuzumab plus docetaxel remains the “first-line treatment for HER2-positive advanced breast cancer, regardless of age,” said study author Akihiko Shimomura, MD, PhD, who presented the findings (abstract RF02-04) on December 7 at the San Antonio Breast Cancer Symposium.

However, he noted that the standard-of-care regimen appears to be “intolerable mentally and physically” in those older than 65 years, and “impairs” quality of life. 

Therefore a “new standard treatment with less toxicity and noninferior efficacy for older patients is needed,” said Dr. Shimomura, Department of Breast and Medical Oncology, National Center for Global Health and Medicine, Tokyo.

Dr. Shimomura and colleagues recruited patients aged 65 years or older with advanced HER2+ breast cancer who had received no prior chemotherapy for metastatic breast cancer and had a good performance status.

Patients were randomly assigned to either pertuzumab and trastuzumab plus docetaxel or T-DM1 until disease progression. The planned sample size was 250 patients, but the study was terminated after 148 participants were recruited because an interim analysis showed that T-DM1 failed to show noninferiority.

Among 75 patients assigned to the standard-of-care regimen, the mean age was 71 years, with 64% aged 65-74 years. Sixty-five percent had stage IV disease, and 35% had relapsed. These baseline characteristics were similar among the 73 patients given T-DM1.

At the data cutoff of June 15, 2023, the median progression-free survival was comparable between the two groups, at 15.6 months with the triple therapy vs 11.3 months with T-DM1 (hazard ratio [HR], 1.358; P =.1236).

There was also no significant difference in overall survival between the two groups (HR, 1.263; P =.95322).

However, T-DM1 failed to meet its primary endpoint of noninferiority to pertuzumab and trastuzumab plus docetaxel, defined as a hazard ratio for overall survival of 1.35.

Nevertheless, T-DM1 was associated with significantly less toxicity than the standard-of care-regimen, with rates of grade 3 or worse adverse events of 36.1% vs 56.8%, Shimomura reported.

The most common hematologic adverse events with the triple therapy were leukopenia (34.2%) and neutropenia (52.0%), whereas thrombocytopenia was the most common event with T-DM1 (16.7%).

Liver toxicities were also increased with the antibody-drug conjugate, whereas fatigue, diarrhea, and appetite loss were more frequently seen with the standard-of-care regimen.

Although T-DM1 did not achieve noninferiority, given its lower toxicity profile, a “detailed analysis, including geriatric assessment, is needed to identify the patient population for whom T-DM1 may be used as first line treatment,” said Shimomura.

Virginia Kaklamani, MD, codirector of the SABCS and leader of the Breast Cancer Program at the UT Health San Antonio Cancer Center, Texas, said in an interview that the trial shows T-DM1 could be “a good alternative to our first line therapy in HER2+ metastatic breast cancer” for some patients.

“It is, however, unlikely to change the standard of care due to several changes in the field including the results from the KATHERINE trial and the DESTINY-Breast trials,” she said. 

The study was funded by the Japanese National Cancer Center. Dr. Shimomura declares relationships with Daiichi Sankyo, Pfizer, AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd, Eli Lilly Japan K.K., MSD Co. Ltd, Eisai Co. Ltd, Gilead Sciences, and Taiho Pharmaceutical Co. Ltd.
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — The antibody-drug conjugate trastuzumab emtansine (T-DM1) does not improve survival outcomes compared with the standard of care in older patients with advanced human epidermal growth factor receptor 2–positive (HER2+) breast cancer, although toxicity is much lower, results from the HERB TEA study show.

Overall, the standard-of-care triple regimen of monoclonal antibodies pertuzumab and trastuzumab plus docetaxel remains the “first-line treatment for HER2-positive advanced breast cancer, regardless of age,” said study author Akihiko Shimomura, MD, PhD, who presented the findings (abstract RF02-04) on December 7 at the San Antonio Breast Cancer Symposium.

However, he noted that the standard-of-care regimen appears to be “intolerable mentally and physically” in those older than 65 years, and “impairs” quality of life. 

Therefore a “new standard treatment with less toxicity and noninferior efficacy for older patients is needed,” said Dr. Shimomura, Department of Breast and Medical Oncology, National Center for Global Health and Medicine, Tokyo.

Dr. Shimomura and colleagues recruited patients aged 65 years or older with advanced HER2+ breast cancer who had received no prior chemotherapy for metastatic breast cancer and had a good performance status.

Patients were randomly assigned to either pertuzumab and trastuzumab plus docetaxel or T-DM1 until disease progression. The planned sample size was 250 patients, but the study was terminated after 148 participants were recruited because an interim analysis showed that T-DM1 failed to show noninferiority.

Among 75 patients assigned to the standard-of-care regimen, the mean age was 71 years, with 64% aged 65-74 years. Sixty-five percent had stage IV disease, and 35% had relapsed. These baseline characteristics were similar among the 73 patients given T-DM1.

At the data cutoff of June 15, 2023, the median progression-free survival was comparable between the two groups, at 15.6 months with the triple therapy vs 11.3 months with T-DM1 (hazard ratio [HR], 1.358; P =.1236).

There was also no significant difference in overall survival between the two groups (HR, 1.263; P =.95322).

However, T-DM1 failed to meet its primary endpoint of noninferiority to pertuzumab and trastuzumab plus docetaxel, defined as a hazard ratio for overall survival of 1.35.

Nevertheless, T-DM1 was associated with significantly less toxicity than the standard-of care-regimen, with rates of grade 3 or worse adverse events of 36.1% vs 56.8%, Shimomura reported.

The most common hematologic adverse events with the triple therapy were leukopenia (34.2%) and neutropenia (52.0%), whereas thrombocytopenia was the most common event with T-DM1 (16.7%).

Liver toxicities were also increased with the antibody-drug conjugate, whereas fatigue, diarrhea, and appetite loss were more frequently seen with the standard-of-care regimen.

Although T-DM1 did not achieve noninferiority, given its lower toxicity profile, a “detailed analysis, including geriatric assessment, is needed to identify the patient population for whom T-DM1 may be used as first line treatment,” said Shimomura.

Virginia Kaklamani, MD, codirector of the SABCS and leader of the Breast Cancer Program at the UT Health San Antonio Cancer Center, Texas, said in an interview that the trial shows T-DM1 could be “a good alternative to our first line therapy in HER2+ metastatic breast cancer” for some patients.

“It is, however, unlikely to change the standard of care due to several changes in the field including the results from the KATHERINE trial and the DESTINY-Breast trials,” she said. 

The study was funded by the Japanese National Cancer Center. Dr. Shimomura declares relationships with Daiichi Sankyo, Pfizer, AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd, Eli Lilly Japan K.K., MSD Co. Ltd, Eisai Co. Ltd, Gilead Sciences, and Taiho Pharmaceutical Co. Ltd.
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — The antibody-drug conjugate trastuzumab emtansine (T-DM1) does not improve survival outcomes compared with the standard of care in older patients with advanced human epidermal growth factor receptor 2–positive (HER2+) breast cancer, although toxicity is much lower, results from the HERB TEA study show.

Overall, the standard-of-care triple regimen of monoclonal antibodies pertuzumab and trastuzumab plus docetaxel remains the “first-line treatment for HER2-positive advanced breast cancer, regardless of age,” said study author Akihiko Shimomura, MD, PhD, who presented the findings (abstract RF02-04) on December 7 at the San Antonio Breast Cancer Symposium.

However, he noted that the standard-of-care regimen appears to be “intolerable mentally and physically” in those older than 65 years, and “impairs” quality of life. 

Therefore a “new standard treatment with less toxicity and noninferior efficacy for older patients is needed,” said Dr. Shimomura, Department of Breast and Medical Oncology, National Center for Global Health and Medicine, Tokyo.

Dr. Shimomura and colleagues recruited patients aged 65 years or older with advanced HER2+ breast cancer who had received no prior chemotherapy for metastatic breast cancer and had a good performance status.

Patients were randomly assigned to either pertuzumab and trastuzumab plus docetaxel or T-DM1 until disease progression. The planned sample size was 250 patients, but the study was terminated after 148 participants were recruited because an interim analysis showed that T-DM1 failed to show noninferiority.

Among 75 patients assigned to the standard-of-care regimen, the mean age was 71 years, with 64% aged 65-74 years. Sixty-five percent had stage IV disease, and 35% had relapsed. These baseline characteristics were similar among the 73 patients given T-DM1.

At the data cutoff of June 15, 2023, the median progression-free survival was comparable between the two groups, at 15.6 months with the triple therapy vs 11.3 months with T-DM1 (hazard ratio [HR], 1.358; P =.1236).

There was also no significant difference in overall survival between the two groups (HR, 1.263; P =.95322).

However, T-DM1 failed to meet its primary endpoint of noninferiority to pertuzumab and trastuzumab plus docetaxel, defined as a hazard ratio for overall survival of 1.35.

Nevertheless, T-DM1 was associated with significantly less toxicity than the standard-of care-regimen, with rates of grade 3 or worse adverse events of 36.1% vs 56.8%, Shimomura reported.

The most common hematologic adverse events with the triple therapy were leukopenia (34.2%) and neutropenia (52.0%), whereas thrombocytopenia was the most common event with T-DM1 (16.7%).

Liver toxicities were also increased with the antibody-drug conjugate, whereas fatigue, diarrhea, and appetite loss were more frequently seen with the standard-of-care regimen.

Although T-DM1 did not achieve noninferiority, given its lower toxicity profile, a “detailed analysis, including geriatric assessment, is needed to identify the patient population for whom T-DM1 may be used as first line treatment,” said Shimomura.

Virginia Kaklamani, MD, codirector of the SABCS and leader of the Breast Cancer Program at the UT Health San Antonio Cancer Center, Texas, said in an interview that the trial shows T-DM1 could be “a good alternative to our first line therapy in HER2+ metastatic breast cancer” for some patients.

“It is, however, unlikely to change the standard of care due to several changes in the field including the results from the KATHERINE trial and the DESTINY-Breast trials,” she said. 

The study was funded by the Japanese National Cancer Center. Dr. Shimomura declares relationships with Daiichi Sankyo, Pfizer, AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd, Eli Lilly Japan K.K., MSD Co. Ltd, Eisai Co. Ltd, Gilead Sciences, and Taiho Pharmaceutical Co. Ltd.
 

A version of this article appeared on Medscape.com.