Key clinical point: Adjuvant radiation therapy (RT) alone or in combination with endocrine therapy (ET) was associated with a lower risk for recurrence than ET alone in older women with early node-negative, human receptor-positive (HR+) breast cancer (BC). In addition, most older women with stage I HR+ breast cancers continue to receive radiation, at higher rates than patients with node-negative stage II tumors.

Major finding: Compared with ET alone, use of RT+ET (hazard ratio [HR], 0.62; P less than .0001) and RT alone (HR, 0.75; P less than .0001) was associated with a lower risk for recurrence at a median follow-up of 48 months. RT was received by 65.5% of patients, with no decrease over time. However, patients with T2 vs. T1 tumors remained less likely to receive RT (odds ratio, 0.83; P = .0024).

Study details: This study evaluated the use of adjuvant RT (n=2,046), ET (n=2,407), or RT+ET (n=4,643) after breast-conserving therapeutic surgery in older women (age at diagnosis, 66 years or more) with T1-2 node-negative, HR+ BC.

Disclosures: This study was supported by grants from the Cancer Information and Population Health Resource, UNC Lineberger Comprehensive Cancer Center, and the American Society for Radiation Oncology. Some of the study investigators reported employment and ownership in various pharmaceutical companies.

Source: Reeder-Hayes KE et al. J Geriatr Oncol. 2021 Feb 4. doi: 10.1016/j.jgo.2021.01.003.

Key clinical point: Adjuvant radiation therapy (RT) alone or in combination with endocrine therapy (ET) was associated with a lower risk for recurrence than ET alone in older women with early node-negative, human receptor-positive (HR+) breast cancer (BC). In addition, most older women with stage I HR+ breast cancers continue to receive radiation, at higher rates than patients with node-negative stage II tumors.

Major finding: Compared with ET alone, use of RT+ET (hazard ratio [HR], 0.62; P less than .0001) and RT alone (HR, 0.75; P less than .0001) was associated with a lower risk for recurrence at a median follow-up of 48 months. RT was received by 65.5% of patients, with no decrease over time. However, patients with T2 vs. T1 tumors remained less likely to receive RT (odds ratio, 0.83; P = .0024).

Study details: This study evaluated the use of adjuvant RT (n=2,046), ET (n=2,407), or RT+ET (n=4,643) after breast-conserving therapeutic surgery in older women (age at diagnosis, 66 years or more) with T1-2 node-negative, HR+ BC.

Disclosures: This study was supported by grants from the Cancer Information and Population Health Resource, UNC Lineberger Comprehensive Cancer Center, and the American Society for Radiation Oncology. Some of the study investigators reported employment and ownership in various pharmaceutical companies.

Source: Reeder-Hayes KE et al. J Geriatr Oncol. 2021 Feb 4. doi: 10.1016/j.jgo.2021.01.003.

Key clinical point: Adjuvant radiation therapy (RT) alone or in combination with endocrine therapy (ET) was associated with a lower risk for recurrence than ET alone in older women with early node-negative, human receptor-positive (HR+) breast cancer (BC). In addition, most older women with stage I HR+ breast cancers continue to receive radiation, at higher rates than patients with node-negative stage II tumors.

Major finding: Compared with ET alone, use of RT+ET (hazard ratio [HR], 0.62; P less than .0001) and RT alone (HR, 0.75; P less than .0001) was associated with a lower risk for recurrence at a median follow-up of 48 months. RT was received by 65.5% of patients, with no decrease over time. However, patients with T2 vs. T1 tumors remained less likely to receive RT (odds ratio, 0.83; P = .0024).

Study details: This study evaluated the use of adjuvant RT (n=2,046), ET (n=2,407), or RT+ET (n=4,643) after breast-conserving therapeutic surgery in older women (age at diagnosis, 66 years or more) with T1-2 node-negative, HR+ BC.

Disclosures: This study was supported by grants from the Cancer Information and Population Health Resource, UNC Lineberger Comprehensive Cancer Center, and the American Society for Radiation Oncology. Some of the study investigators reported employment and ownership in various pharmaceutical companies.

Source: Reeder-Hayes KE et al. J Geriatr Oncol. 2021 Feb 4. doi: 10.1016/j.jgo.2021.01.003.

Key clinical point: Locoregional surgery of the primary tumor vs. no surgery significantly improved locoregional progression-free survival (PFS) in patients with de novo stage IV breast cancer.

Major finding: Locoregional PFS was significantly longer with locoregional surgery vs. no surgery (hazard ratio, 0.23; P less than .001).

Study details: Findings are from a meta-analysis of 1,110 patients from 6 prospective clinical trials and 353 patients from a cohort study that assessed effects of locoregional surgery vs. no surgery in de novo stage IV breast cancer.

Disclosures: This study was supported by grants from the National Science and Technology Major Project, Sun Yat-Sen Memorial Hospital, the National Natural Science Foundation of Guangdong Province, Guangzhou Science and Technology Major Program, the Guangdong Science and Technology Department, Sun Yat-Sen University Clinical Research 5010 Program, and Sun Yat-Sen Clinical Research Cultivating Program. The authors declared no conflicts of interest.

Source: Yu Y et al. Ann Surg Oncol. 2021 Feb 3. doi: 10.1245/s10434-021-09650-3.

Key clinical point: Locoregional surgery of the primary tumor vs. no surgery significantly improved locoregional progression-free survival (PFS) in patients with de novo stage IV breast cancer.

Major finding: Locoregional PFS was significantly longer with locoregional surgery vs. no surgery (hazard ratio, 0.23; P less than .001).

Study details: Findings are from a meta-analysis of 1,110 patients from 6 prospective clinical trials and 353 patients from a cohort study that assessed effects of locoregional surgery vs. no surgery in de novo stage IV breast cancer.

Disclosures: This study was supported by grants from the National Science and Technology Major Project, Sun Yat-Sen Memorial Hospital, the National Natural Science Foundation of Guangdong Province, Guangzhou Science and Technology Major Program, the Guangdong Science and Technology Department, Sun Yat-Sen University Clinical Research 5010 Program, and Sun Yat-Sen Clinical Research Cultivating Program. The authors declared no conflicts of interest.

Source: Yu Y et al. Ann Surg Oncol. 2021 Feb 3. doi: 10.1245/s10434-021-09650-3.

Key clinical point: Locoregional surgery of the primary tumor vs. no surgery significantly improved locoregional progression-free survival (PFS) in patients with de novo stage IV breast cancer.

Major finding: Locoregional PFS was significantly longer with locoregional surgery vs. no surgery (hazard ratio, 0.23; P less than .001).

Study details: Findings are from a meta-analysis of 1,110 patients from 6 prospective clinical trials and 353 patients from a cohort study that assessed effects of locoregional surgery vs. no surgery in de novo stage IV breast cancer.

Disclosures: This study was supported by grants from the National Science and Technology Major Project, Sun Yat-Sen Memorial Hospital, the National Natural Science Foundation of Guangdong Province, Guangzhou Science and Technology Major Program, the Guangdong Science and Technology Department, Sun Yat-Sen University Clinical Research 5010 Program, and Sun Yat-Sen Clinical Research Cultivating Program. The authors declared no conflicts of interest.

Source: Yu Y et al. Ann Surg Oncol. 2021 Feb 3. doi: 10.1245/s10434-021-09650-3.

Key clinical point: Rates of local recurrence were higher with accelerated partial breast irradiation (APBI) than whole breast irradiation (WBI) in patients receiving breast-conservation treatment for early-stage breast cancer. Rate of distant metastasis, overall survival (OS), and disease-free survival (DFS) were similar.

Major finding: Patients receiving APBI vs. WBI had significantly higher rates of local recurrence (hazard ratio [HR], 1.46; P = .0002). DFS (HR, 1.11; P = .09), OS (HR, 1.11; P = .09), and distant metastasis (HR, 1.17; P = .11) were not different between the groups.

Study details: Findings are from a meta-analysis of 10 randomized controlled trials including 15,500 patients with early-stage breast cancer, including 7,758 patients in APBI and 7,742 patients in WBI groups.

Disclosures: No funding source was identified. The authors declared no conflicts of interest.

Source: Xiang X et al. Radiat Oncol. 2021 Feb 2. doi: 10.1186/s13014-021-01752-2.

Key clinical point: Rates of local recurrence were higher with accelerated partial breast irradiation (APBI) than whole breast irradiation (WBI) in patients receiving breast-conservation treatment for early-stage breast cancer. Rate of distant metastasis, overall survival (OS), and disease-free survival (DFS) were similar.

Major finding: Patients receiving APBI vs. WBI had significantly higher rates of local recurrence (hazard ratio [HR], 1.46; P = .0002). DFS (HR, 1.11; P = .09), OS (HR, 1.11; P = .09), and distant metastasis (HR, 1.17; P = .11) were not different between the groups.

Study details: Findings are from a meta-analysis of 10 randomized controlled trials including 15,500 patients with early-stage breast cancer, including 7,758 patients in APBI and 7,742 patients in WBI groups.

Disclosures: No funding source was identified. The authors declared no conflicts of interest.

Source: Xiang X et al. Radiat Oncol. 2021 Feb 2. doi: 10.1186/s13014-021-01752-2.

Key clinical point: Rates of local recurrence were higher with accelerated partial breast irradiation (APBI) than whole breast irradiation (WBI) in patients receiving breast-conservation treatment for early-stage breast cancer. Rate of distant metastasis, overall survival (OS), and disease-free survival (DFS) were similar.

Major finding: Patients receiving APBI vs. WBI had significantly higher rates of local recurrence (hazard ratio [HR], 1.46; P = .0002). DFS (HR, 1.11; P = .09), OS (HR, 1.11; P = .09), and distant metastasis (HR, 1.17; P = .11) were not different between the groups.

Study details: Findings are from a meta-analysis of 10 randomized controlled trials including 15,500 patients with early-stage breast cancer, including 7,758 patients in APBI and 7,742 patients in WBI groups.

Disclosures: No funding source was identified. The authors declared no conflicts of interest.

Source: Xiang X et al. Radiat Oncol. 2021 Feb 2. doi: 10.1186/s13014-021-01752-2.

Key clinical point: Addition of palbociclib to adjuvant endocrine therapy (ET) vs. ET alone failed to improve invasive disease-free survival (IDFS) in patients with early-stage hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2−) breast cancer.

Major finding: At the median follow-up of 23.7 months, 3-year IDFS was similar for palbociclib + ET and ET alone groups (88.2% vs. 88.5%; hazard ratio, 0.93; log-rank P = .51). Serious adverse events occurred in 12.4% of patients on palbociclib + ET vs. 7.6% on ET alone.

Study details: Findings are from the second interim analysis of the ongoing phase 3 PALLAS trial that randomly allocated 5,760 patients with stage II-III HR+ and HER2− breast cancer to receive either 2 years of palbociclib in addition to ongoing standard adjuvant ET (n = 2,883) or ongoing standard adjuvant ET alone (n = 2,877).

Disclosures: PALLAS trial was cosponsored by the Alliance Foundation Trials and the Austrian Breast and Colorectal Cancer Study Group, in collaboration with Eastern Cooperative Oncology Group, the National Surgical Adjuvant Breast and Bowel Project, the German Breast Group, and the Breast International Group, with funding from Pfizer. The lead author reported receiving personal fees from Eisai, Lilly, and Novartis. Some of the coinvestigators reported ties with various pharmaceutical companies including Pfizer.

Source: Mayer EL et al. Lancet Oncol. 2021 Jan 15. doi: 10.1016/S1470-2045(20)30642-2.

Key clinical point: Addition of palbociclib to adjuvant endocrine therapy (ET) vs. ET alone failed to improve invasive disease-free survival (IDFS) in patients with early-stage hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2−) breast cancer.

Major finding: At the median follow-up of 23.7 months, 3-year IDFS was similar for palbociclib + ET and ET alone groups (88.2% vs. 88.5%; hazard ratio, 0.93; log-rank P = .51). Serious adverse events occurred in 12.4% of patients on palbociclib + ET vs. 7.6% on ET alone.

Study details: Findings are from the second interim analysis of the ongoing phase 3 PALLAS trial that randomly allocated 5,760 patients with stage II-III HR+ and HER2− breast cancer to receive either 2 years of palbociclib in addition to ongoing standard adjuvant ET (n = 2,883) or ongoing standard adjuvant ET alone (n = 2,877).

Disclosures: PALLAS trial was cosponsored by the Alliance Foundation Trials and the Austrian Breast and Colorectal Cancer Study Group, in collaboration with Eastern Cooperative Oncology Group, the National Surgical Adjuvant Breast and Bowel Project, the German Breast Group, and the Breast International Group, with funding from Pfizer. The lead author reported receiving personal fees from Eisai, Lilly, and Novartis. Some of the coinvestigators reported ties with various pharmaceutical companies including Pfizer.

Source: Mayer EL et al. Lancet Oncol. 2021 Jan 15. doi: 10.1016/S1470-2045(20)30642-2.

Key clinical point: Addition of palbociclib to adjuvant endocrine therapy (ET) vs. ET alone failed to improve invasive disease-free survival (IDFS) in patients with early-stage hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2−) breast cancer.

Major finding: At the median follow-up of 23.7 months, 3-year IDFS was similar for palbociclib + ET and ET alone groups (88.2% vs. 88.5%; hazard ratio, 0.93; log-rank P = .51). Serious adverse events occurred in 12.4% of patients on palbociclib + ET vs. 7.6% on ET alone.

Study details: Findings are from the second interim analysis of the ongoing phase 3 PALLAS trial that randomly allocated 5,760 patients with stage II-III HR+ and HER2− breast cancer to receive either 2 years of palbociclib in addition to ongoing standard adjuvant ET (n = 2,883) or ongoing standard adjuvant ET alone (n = 2,877).

Disclosures: PALLAS trial was cosponsored by the Alliance Foundation Trials and the Austrian Breast and Colorectal Cancer Study Group, in collaboration with Eastern Cooperative Oncology Group, the National Surgical Adjuvant Breast and Bowel Project, the German Breast Group, and the Breast International Group, with funding from Pfizer. The lead author reported receiving personal fees from Eisai, Lilly, and Novartis. Some of the coinvestigators reported ties with various pharmaceutical companies including Pfizer.

Source: Mayer EL et al. Lancet Oncol. 2021 Jan 15. doi: 10.1016/S1470-2045(20)30642-2.

Key clinical point: Margetuximab + chemotherapy vs. trastuzumab + chemotherapy improved progression-free survival (PFS) with an acceptable safety profile in patients with ERBB2-positive advanced breast cancer (ERBB2+ ABC) who progressed on 2 or more prior anti-ERBB2 therapies.

Major finding: Margetuximab + chemotherapy prolonged PFS with a 24% relative risk reduction vs. trastuzumab + chemotherapy (median PFS, 5.8 vs. 4.9 months; hazard ratio, 0.76; P = .03). Safety was comparable between the groups. Infusion-related reactions were higher with margetuximab vs. trastuzumab (13.3% vs. 3.4%; P less than .001) but were mostly prevalent at cycle 1 and resolved within 24 hours.

Study details: Findings are from the phase 3 SOPHIA trial including 536 patients with ERBB2+ ABC who had progressive disease after 2 or more prior anti-ERBB2 therapies. Patients were randomly allocated to receive either margetuximab + chemotherapy (n = 266) or trastuzumab + chemotherapy (n = 270).

Disclosures: This study was supported by MacroGenics, Inc. The lead author reported ties with MacroGenics, Roche, Pfizer, Novartis, Lilly, Merck, Seattle Genetics, Odonate Therapeutics, Eisai, Sermonix Pharmaceuticals, Immunomedics, Daiichi Sankyo, Puma, and Samsung. Other investigators reported owning stocks of, being an employee of, receiving support from, and/or consulting for various pharmaceutical companies including MacroGenics.

Source: Rugo HS et al. JAMA Oncol. 2021 Jan 22. doi: 10.1001/jamaoncol.2020.7932.

Key clinical point: Margetuximab + chemotherapy vs. trastuzumab + chemotherapy improved progression-free survival (PFS) with an acceptable safety profile in patients with ERBB2-positive advanced breast cancer (ERBB2+ ABC) who progressed on 2 or more prior anti-ERBB2 therapies.

Major finding: Margetuximab + chemotherapy prolonged PFS with a 24% relative risk reduction vs. trastuzumab + chemotherapy (median PFS, 5.8 vs. 4.9 months; hazard ratio, 0.76; P = .03). Safety was comparable between the groups. Infusion-related reactions were higher with margetuximab vs. trastuzumab (13.3% vs. 3.4%; P less than .001) but were mostly prevalent at cycle 1 and resolved within 24 hours.

Study details: Findings are from the phase 3 SOPHIA trial including 536 patients with ERBB2+ ABC who had progressive disease after 2 or more prior anti-ERBB2 therapies. Patients were randomly allocated to receive either margetuximab + chemotherapy (n = 266) or trastuzumab + chemotherapy (n = 270).

Disclosures: This study was supported by MacroGenics, Inc. The lead author reported ties with MacroGenics, Roche, Pfizer, Novartis, Lilly, Merck, Seattle Genetics, Odonate Therapeutics, Eisai, Sermonix Pharmaceuticals, Immunomedics, Daiichi Sankyo, Puma, and Samsung. Other investigators reported owning stocks of, being an employee of, receiving support from, and/or consulting for various pharmaceutical companies including MacroGenics.

Source: Rugo HS et al. JAMA Oncol. 2021 Jan 22. doi: 10.1001/jamaoncol.2020.7932.

Key clinical point: Margetuximab + chemotherapy vs. trastuzumab + chemotherapy improved progression-free survival (PFS) with an acceptable safety profile in patients with ERBB2-positive advanced breast cancer (ERBB2+ ABC) who progressed on 2 or more prior anti-ERBB2 therapies.

Major finding: Margetuximab + chemotherapy prolonged PFS with a 24% relative risk reduction vs. trastuzumab + chemotherapy (median PFS, 5.8 vs. 4.9 months; hazard ratio, 0.76; P = .03). Safety was comparable between the groups. Infusion-related reactions were higher with margetuximab vs. trastuzumab (13.3% vs. 3.4%; P less than .001) but were mostly prevalent at cycle 1 and resolved within 24 hours.

Study details: Findings are from the phase 3 SOPHIA trial including 536 patients with ERBB2+ ABC who had progressive disease after 2 or more prior anti-ERBB2 therapies. Patients were randomly allocated to receive either margetuximab + chemotherapy (n = 266) or trastuzumab + chemotherapy (n = 270).

Disclosures: This study was supported by MacroGenics, Inc. The lead author reported ties with MacroGenics, Roche, Pfizer, Novartis, Lilly, Merck, Seattle Genetics, Odonate Therapeutics, Eisai, Sermonix Pharmaceuticals, Immunomedics, Daiichi Sankyo, Puma, and Samsung. Other investigators reported owning stocks of, being an employee of, receiving support from, and/or consulting for various pharmaceutical companies including MacroGenics.

Source: Rugo HS et al. JAMA Oncol. 2021 Jan 22. doi: 10.1001/jamaoncol.2020.7932.

Key clinical point: Paclitaxel dose reduction does not necessarily result in improved neuropathy outcomes in patients with breast cancer prescribed weekly paclitaxel schedules.

Major finding: Patients receiving reduced-dose vs. full-dose paclitaxel had worse patient-reported symptom burden (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity, 40.2 vs. 45.9) and clinical neuropathy outcomes (Total Neuropathy Score clinical version, 4.3 vs. 3.3; all P less than .05).

Study details: Findings are from the assessment of women with breast cancer prescribed weekly paclitaxel (80 mg/m²) for 12 weeks. Posttreatment outcomes were assessed at 3.6 months in 105 women who underwent subsequent dose reduction.

Disclosures: This study was supported by grants from the Cancer Institute NSW Program and National Health and Medical Research Council of Australia. M Friedlander reported ties with various pharmaceutical companies. The other authors did not have any financial disclosures.

Source: Timmins HC et al. Oncologist. 2021 Feb 1. doi: 10.1002/onco.13697.

Key clinical point: Paclitaxel dose reduction does not necessarily result in improved neuropathy outcomes in patients with breast cancer prescribed weekly paclitaxel schedules.

Major finding: Patients receiving reduced-dose vs. full-dose paclitaxel had worse patient-reported symptom burden (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity, 40.2 vs. 45.9) and clinical neuropathy outcomes (Total Neuropathy Score clinical version, 4.3 vs. 3.3; all P less than .05).

Study details: Findings are from the assessment of women with breast cancer prescribed weekly paclitaxel (80 mg/m²) for 12 weeks. Posttreatment outcomes were assessed at 3.6 months in 105 women who underwent subsequent dose reduction.

Disclosures: This study was supported by grants from the Cancer Institute NSW Program and National Health and Medical Research Council of Australia. M Friedlander reported ties with various pharmaceutical companies. The other authors did not have any financial disclosures.

Source: Timmins HC et al. Oncologist. 2021 Feb 1. doi: 10.1002/onco.13697.

Key clinical point: Paclitaxel dose reduction does not necessarily result in improved neuropathy outcomes in patients with breast cancer prescribed weekly paclitaxel schedules.

Major finding: Patients receiving reduced-dose vs. full-dose paclitaxel had worse patient-reported symptom burden (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity, 40.2 vs. 45.9) and clinical neuropathy outcomes (Total Neuropathy Score clinical version, 4.3 vs. 3.3; all P less than .05).

Study details: Findings are from the assessment of women with breast cancer prescribed weekly paclitaxel (80 mg/m²) for 12 weeks. Posttreatment outcomes were assessed at 3.6 months in 105 women who underwent subsequent dose reduction.

Disclosures: This study was supported by grants from the Cancer Institute NSW Program and National Health and Medical Research Council of Australia. M Friedlander reported ties with various pharmaceutical companies. The other authors did not have any financial disclosures.

Source: Timmins HC et al. Oncologist. 2021 Feb 1. doi: 10.1002/onco.13697.

Key clinical point: Intensive screening for distant metastasis during posttreatment follow-up was not associated with improved overall survival (OS) in disease-free patients initially diagnosed with nonmetastatic breast cancer.

Major finding: OS was not significantly different among patients receiving intensive vs. less intensive screening (adjusted hazard ratio, 1.21; P = .124).

Study details: This retrospective study evaluated the effect of intensive (n=199) vs. less intensive (n=199) screening on survival in 398 patients initially diagnosed with nonmetastatic, resectable breast cancer who eventually developed distant metastasis after initial curative treatment.

Disclosures: This study was supported by grants received by the Korea Health Industry Development Institute funded by the Ministry of Health & Welfare, Republic of Korea, and the National Research Foundation of Korea grant funded by the Ministry of Science and ICT, Republic of Korea. The authors declared no conflicts of interest.

Source: Cheun J-H et al. Sci Rep. 2021 Feb 2. doi: 10.1038/s41598-021-82485-w.

Key clinical point: Intensive screening for distant metastasis during posttreatment follow-up was not associated with improved overall survival (OS) in disease-free patients initially diagnosed with nonmetastatic breast cancer.

Major finding: OS was not significantly different among patients receiving intensive vs. less intensive screening (adjusted hazard ratio, 1.21; P = .124).

Study details: This retrospective study evaluated the effect of intensive (n=199) vs. less intensive (n=199) screening on survival in 398 patients initially diagnosed with nonmetastatic, resectable breast cancer who eventually developed distant metastasis after initial curative treatment.

Disclosures: This study was supported by grants received by the Korea Health Industry Development Institute funded by the Ministry of Health & Welfare, Republic of Korea, and the National Research Foundation of Korea grant funded by the Ministry of Science and ICT, Republic of Korea. The authors declared no conflicts of interest.

Source: Cheun J-H et al. Sci Rep. 2021 Feb 2. doi: 10.1038/s41598-021-82485-w.

Key clinical point: Intensive screening for distant metastasis during posttreatment follow-up was not associated with improved overall survival (OS) in disease-free patients initially diagnosed with nonmetastatic breast cancer.

Major finding: OS was not significantly different among patients receiving intensive vs. less intensive screening (adjusted hazard ratio, 1.21; P = .124).

Study details: This retrospective study evaluated the effect of intensive (n=199) vs. less intensive (n=199) screening on survival in 398 patients initially diagnosed with nonmetastatic, resectable breast cancer who eventually developed distant metastasis after initial curative treatment.

Disclosures: This study was supported by grants received by the Korea Health Industry Development Institute funded by the Ministry of Health & Welfare, Republic of Korea, and the National Research Foundation of Korea grant funded by the Ministry of Science and ICT, Republic of Korea. The authors declared no conflicts of interest.

Source: Cheun J-H et al. Sci Rep. 2021 Feb 2. doi: 10.1038/s41598-021-82485-w.

Key clinical point: By opting initially for breast-conserving therapy (BCT) over mastectomy, majority of women with T1-2 node-negative breast cancer with positive sentinel lymph node (SLN) can avoid completion axillary lymph node dissection (cALND), often done in mastectomy.

Major finding: Patients treated with mastectomy vs. BCT were more likely to receive cALND after positive SLN (71% vs. 26.6%; P less than .001). Extracapsular extension (ECE) in the SLN was observed in 31.6% of patients treated with mastectomy and cALND. However, remaining 68.4% of patients without ECE in the SLN could have avoided cALND if they had chosen BCT initially.

Study details: Findings are from an analysis of 306 women with T1-2 clinically node-negative breast cancer with metastases in the SLN who were treated with mastectomy (n=107) or BCT (n=199).

Disclosures: Programmatic support was provided by the Fashion Footwear Charitable Foundation of New York, Inc., the Margie and Robert E. Peterson Foundation, and the Linda and Jim Lippman. ML Smidt reported receiving a grant from Servier Pharma. The remaining authors had no disclosures.

Source: Vane MLG et al. Ann Surg Oncol. 2021 Feb 14. doi: 10.1245/s10434-021-09674-9. 

Key clinical point: By opting initially for breast-conserving therapy (BCT) over mastectomy, majority of women with T1-2 node-negative breast cancer with positive sentinel lymph node (SLN) can avoid completion axillary lymph node dissection (cALND), often done in mastectomy.

Major finding: Patients treated with mastectomy vs. BCT were more likely to receive cALND after positive SLN (71% vs. 26.6%; P less than .001). Extracapsular extension (ECE) in the SLN was observed in 31.6% of patients treated with mastectomy and cALND. However, remaining 68.4% of patients without ECE in the SLN could have avoided cALND if they had chosen BCT initially.

Study details: Findings are from an analysis of 306 women with T1-2 clinically node-negative breast cancer with metastases in the SLN who were treated with mastectomy (n=107) or BCT (n=199).

Disclosures: Programmatic support was provided by the Fashion Footwear Charitable Foundation of New York, Inc., the Margie and Robert E. Peterson Foundation, and the Linda and Jim Lippman. ML Smidt reported receiving a grant from Servier Pharma. The remaining authors had no disclosures.

Source: Vane MLG et al. Ann Surg Oncol. 2021 Feb 14. doi: 10.1245/s10434-021-09674-9. 

Key clinical point: By opting initially for breast-conserving therapy (BCT) over mastectomy, majority of women with T1-2 node-negative breast cancer with positive sentinel lymph node (SLN) can avoid completion axillary lymph node dissection (cALND), often done in mastectomy.

Major finding: Patients treated with mastectomy vs. BCT were more likely to receive cALND after positive SLN (71% vs. 26.6%; P less than .001). Extracapsular extension (ECE) in the SLN was observed in 31.6% of patients treated with mastectomy and cALND. However, remaining 68.4% of patients without ECE in the SLN could have avoided cALND if they had chosen BCT initially.

Study details: Findings are from an analysis of 306 women with T1-2 clinically node-negative breast cancer with metastases in the SLN who were treated with mastectomy (n=107) or BCT (n=199).

Disclosures: Programmatic support was provided by the Fashion Footwear Charitable Foundation of New York, Inc., the Margie and Robert E. Peterson Foundation, and the Linda and Jim Lippman. ML Smidt reported receiving a grant from Servier Pharma. The remaining authors had no disclosures.

Source: Vane MLG et al. Ann Surg Oncol. 2021 Feb 14. doi: 10.1245/s10434-021-09674-9. 

Type 3 von Willebrand disease (VWD) is rare, but this form of the disease is associated with severe bleeding, particularly in muscles and joints, a bleeding disorders expert said.

“There’s a virtually complete deficiency in von Willebrand factor [in type 3 disease], so usually it’s defined as below 5 or in some studies below 3 IU/dL, but also due to the very low levels of von Willebrand factor, there’s also a very low level of factor VIII,” said Jeroen Eikenboom, MD, PhD, from Leiden (the Netherlands) University Medical Center.

“The inheritance pattern is autosomal recessive, and the prevalence is about 1 in a million,” he said during the annual congress of the European Association for Haemophilia and Allied Disorders.

Erik Adolf von Willenbrand, MD, PhD, first described this form of VWD in a family from the Åland Islands, an autonomous region of Finland. The disease, later discovered to be caused in this family by a cytosine deletion in exon 18 of the von Willebrand factor (VWF) gene, was associated with fatal bleeding events in several family members.

“As VWF is the carrier protein of factor VIII, the very low VWF level leads to a strongly reduced factor VIII level, comparable to the levels seen in mild to moderate hemophilia A. As a consequence, VWD type 3 has the combined characteristics of a primary as well as a secondary hemostasis defect,” Dr. Eikenboom explained in an abstract accompanying his talk.

Compared with VWD type 1 or 2, type 3 VWD is associated with bleeding episodes more commonly seen in patients with hemophilia A, notably mucocutaneous bleeding, bleeding after trauma or during surgery, and bleeding into joints and/or muscles.
 

Treatment

The goals of treatment for patients with type 3 VWD are to correct the dual hemostasis defects of impaired platelet adhesion because of low VWF levels, and the intrinsic coagulation defect because of levels of factor VIII.

Desmopressin is not effective in type 3 VWD, Dr. Eikenboom said, so treatment requires the use of either plasma-derived VWF, with or without factor VIII, or recombinant VWF.

In the United States, the only standalone VWF concentrate approved by the Food and Drug Administration is a recombinant product (Vonvendi), Three other human plasma–derived concentrates containing both VWF and factor VIII are also licensed (Alpanate, Humate-P, Wilate).

Clinicians prescribing the combined factor concentrates need to be aware of differences in pharmacokinetics between the products.

For example, following infusion of Wilate, which has equal amounts of von Willebrand factor and factor VIII, there is an increase in circulation of both von Willebrand factor and factor VIII and a similar decline in each factor over time.

In contrast, following an infusion of Humate-P, which contains lower levels of factor VIII, “interestingly, you see a secondary rise of factor VIII in Humate-P–infused patients, whereas the secondary rise is not visible in the Wilate patients,” he said.

Approximately 22% of patients with type 3 VWD also receive prophylaxis with VWF concentrate, which has been shown to decrease the median annualized bleeding rate from 25% to 6.1%.

Dr. Eikenboom cautioned that 5%-10% of patients with type 3 VWD may develop allo-antibodies against VWF concentrates, which can complicate treatment and carries risk of anaphylactic shock.

“It’s also been mentioned in literature that there may be an association with partial or complete von Willebrand factor gene deletions or nonsense mutations and the development of allo-antibodies,” he said.
 

Prophylaxis burdensome but helpful

Veronica H. Flood, MD, from the Medical College of Wisconsin, Milwaukee, who specializes in the treatment of patients with von Willebrand disease, follows a number of both girls and boys with type 3 VWD.

“Those are the people who will have bleeding into their joints, and for the girls, worse periods than some of those with other types of von Willebrand disease, and it is true that if you want to stop their bleeding, you cannot use desmopressin like we use in most other von Willebrand patients. They will need factor, although for the heavy menstrual bleeding you can use hormones or tranexamic acid – there are some other options for that,” she said in an interview.

She also noted that type 3 von Willebrand disease can be highly variable. For patients with especially frequent joint bleeding, her center recommends prophylaxis.

“Prophylaxis can be very burdensome for patients. You’re talking about IV therapy several times a week, but it’s very helpful for the joint bleeds. Episodic prophylaxis can be very helpful for heavy menstrual bleeding, and we actually have type 2, type 3, and some type 1 patients with bad enough nose bleeds that they end up on prophylaxis,” she said.

Patients with gastrointestinal bleeding are the most challenging to care for, she noted.

“You can put them on factor prophylaxis, but even that isn’t always enough to help some adults with bad GI bleeding, and we’re investigating other options for that,” she said.

Dr. Eikenboom disclosed research support from CSL Behring and honoraria (directed to his institution) for educational activities sponsored by Roche and Celgene. Dr. Flood reported having no conflicts of interest to disclose.

Type 3 von Willebrand disease (VWD) is rare, but this form of the disease is associated with severe bleeding, particularly in muscles and joints, a bleeding disorders expert said.

“There’s a virtually complete deficiency in von Willebrand factor [in type 3 disease], so usually it’s defined as below 5 or in some studies below 3 IU/dL, but also due to the very low levels of von Willebrand factor, there’s also a very low level of factor VIII,” said Jeroen Eikenboom, MD, PhD, from Leiden (the Netherlands) University Medical Center.

“The inheritance pattern is autosomal recessive, and the prevalence is about 1 in a million,” he said during the annual congress of the European Association for Haemophilia and Allied Disorders.

Erik Adolf von Willenbrand, MD, PhD, first described this form of VWD in a family from the Åland Islands, an autonomous region of Finland. The disease, later discovered to be caused in this family by a cytosine deletion in exon 18 of the von Willebrand factor (VWF) gene, was associated with fatal bleeding events in several family members.

“As VWF is the carrier protein of factor VIII, the very low VWF level leads to a strongly reduced factor VIII level, comparable to the levels seen in mild to moderate hemophilia A. As a consequence, VWD type 3 has the combined characteristics of a primary as well as a secondary hemostasis defect,” Dr. Eikenboom explained in an abstract accompanying his talk.

Compared with VWD type 1 or 2, type 3 VWD is associated with bleeding episodes more commonly seen in patients with hemophilia A, notably mucocutaneous bleeding, bleeding after trauma or during surgery, and bleeding into joints and/or muscles.
 

Treatment

The goals of treatment for patients with type 3 VWD are to correct the dual hemostasis defects of impaired platelet adhesion because of low VWF levels, and the intrinsic coagulation defect because of levels of factor VIII.

Desmopressin is not effective in type 3 VWD, Dr. Eikenboom said, so treatment requires the use of either plasma-derived VWF, with or without factor VIII, or recombinant VWF.

In the United States, the only standalone VWF concentrate approved by the Food and Drug Administration is a recombinant product (Vonvendi), Three other human plasma–derived concentrates containing both VWF and factor VIII are also licensed (Alpanate, Humate-P, Wilate).

Clinicians prescribing the combined factor concentrates need to be aware of differences in pharmacokinetics between the products.

For example, following infusion of Wilate, which has equal amounts of von Willebrand factor and factor VIII, there is an increase in circulation of both von Willebrand factor and factor VIII and a similar decline in each factor over time.

In contrast, following an infusion of Humate-P, which contains lower levels of factor VIII, “interestingly, you see a secondary rise of factor VIII in Humate-P–infused patients, whereas the secondary rise is not visible in the Wilate patients,” he said.

Approximately 22% of patients with type 3 VWD also receive prophylaxis with VWF concentrate, which has been shown to decrease the median annualized bleeding rate from 25% to 6.1%.

Dr. Eikenboom cautioned that 5%-10% of patients with type 3 VWD may develop allo-antibodies against VWF concentrates, which can complicate treatment and carries risk of anaphylactic shock.

“It’s also been mentioned in literature that there may be an association with partial or complete von Willebrand factor gene deletions or nonsense mutations and the development of allo-antibodies,” he said.
 

Prophylaxis burdensome but helpful

Veronica H. Flood, MD, from the Medical College of Wisconsin, Milwaukee, who specializes in the treatment of patients with von Willebrand disease, follows a number of both girls and boys with type 3 VWD.

“Those are the people who will have bleeding into their joints, and for the girls, worse periods than some of those with other types of von Willebrand disease, and it is true that if you want to stop their bleeding, you cannot use desmopressin like we use in most other von Willebrand patients. They will need factor, although for the heavy menstrual bleeding you can use hormones or tranexamic acid – there are some other options for that,” she said in an interview.

She also noted that type 3 von Willebrand disease can be highly variable. For patients with especially frequent joint bleeding, her center recommends prophylaxis.

“Prophylaxis can be very burdensome for patients. You’re talking about IV therapy several times a week, but it’s very helpful for the joint bleeds. Episodic prophylaxis can be very helpful for heavy menstrual bleeding, and we actually have type 2, type 3, and some type 1 patients with bad enough nose bleeds that they end up on prophylaxis,” she said.

Patients with gastrointestinal bleeding are the most challenging to care for, she noted.

“You can put them on factor prophylaxis, but even that isn’t always enough to help some adults with bad GI bleeding, and we’re investigating other options for that,” she said.

Dr. Eikenboom disclosed research support from CSL Behring and honoraria (directed to his institution) for educational activities sponsored by Roche and Celgene. Dr. Flood reported having no conflicts of interest to disclose.

Type 3 von Willebrand disease (VWD) is rare, but this form of the disease is associated with severe bleeding, particularly in muscles and joints, a bleeding disorders expert said.

“There’s a virtually complete deficiency in von Willebrand factor [in type 3 disease], so usually it’s defined as below 5 or in some studies below 3 IU/dL, but also due to the very low levels of von Willebrand factor, there’s also a very low level of factor VIII,” said Jeroen Eikenboom, MD, PhD, from Leiden (the Netherlands) University Medical Center.

“The inheritance pattern is autosomal recessive, and the prevalence is about 1 in a million,” he said during the annual congress of the European Association for Haemophilia and Allied Disorders.

Erik Adolf von Willenbrand, MD, PhD, first described this form of VWD in a family from the Åland Islands, an autonomous region of Finland. The disease, later discovered to be caused in this family by a cytosine deletion in exon 18 of the von Willebrand factor (VWF) gene, was associated with fatal bleeding events in several family members.

“As VWF is the carrier protein of factor VIII, the very low VWF level leads to a strongly reduced factor VIII level, comparable to the levels seen in mild to moderate hemophilia A. As a consequence, VWD type 3 has the combined characteristics of a primary as well as a secondary hemostasis defect,” Dr. Eikenboom explained in an abstract accompanying his talk.

Compared with VWD type 1 or 2, type 3 VWD is associated with bleeding episodes more commonly seen in patients with hemophilia A, notably mucocutaneous bleeding, bleeding after trauma or during surgery, and bleeding into joints and/or muscles.
 

Treatment

The goals of treatment for patients with type 3 VWD are to correct the dual hemostasis defects of impaired platelet adhesion because of low VWF levels, and the intrinsic coagulation defect because of levels of factor VIII.

Desmopressin is not effective in type 3 VWD, Dr. Eikenboom said, so treatment requires the use of either plasma-derived VWF, with or without factor VIII, or recombinant VWF.

In the United States, the only standalone VWF concentrate approved by the Food and Drug Administration is a recombinant product (Vonvendi), Three other human plasma–derived concentrates containing both VWF and factor VIII are also licensed (Alpanate, Humate-P, Wilate).

Clinicians prescribing the combined factor concentrates need to be aware of differences in pharmacokinetics between the products.

For example, following infusion of Wilate, which has equal amounts of von Willebrand factor and factor VIII, there is an increase in circulation of both von Willebrand factor and factor VIII and a similar decline in each factor over time.

In contrast, following an infusion of Humate-P, which contains lower levels of factor VIII, “interestingly, you see a secondary rise of factor VIII in Humate-P–infused patients, whereas the secondary rise is not visible in the Wilate patients,” he said.

Approximately 22% of patients with type 3 VWD also receive prophylaxis with VWF concentrate, which has been shown to decrease the median annualized bleeding rate from 25% to 6.1%.

Dr. Eikenboom cautioned that 5%-10% of patients with type 3 VWD may develop allo-antibodies against VWF concentrates, which can complicate treatment and carries risk of anaphylactic shock.

“It’s also been mentioned in literature that there may be an association with partial or complete von Willebrand factor gene deletions or nonsense mutations and the development of allo-antibodies,” he said.
 

Prophylaxis burdensome but helpful

Veronica H. Flood, MD, from the Medical College of Wisconsin, Milwaukee, who specializes in the treatment of patients with von Willebrand disease, follows a number of both girls and boys with type 3 VWD.

“Those are the people who will have bleeding into their joints, and for the girls, worse periods than some of those with other types of von Willebrand disease, and it is true that if you want to stop their bleeding, you cannot use desmopressin like we use in most other von Willebrand patients. They will need factor, although for the heavy menstrual bleeding you can use hormones or tranexamic acid – there are some other options for that,” she said in an interview.

She also noted that type 3 von Willebrand disease can be highly variable. For patients with especially frequent joint bleeding, her center recommends prophylaxis.

“Prophylaxis can be very burdensome for patients. You’re talking about IV therapy several times a week, but it’s very helpful for the joint bleeds. Episodic prophylaxis can be very helpful for heavy menstrual bleeding, and we actually have type 2, type 3, and some type 1 patients with bad enough nose bleeds that they end up on prophylaxis,” she said.

Patients with gastrointestinal bleeding are the most challenging to care for, she noted.

“You can put them on factor prophylaxis, but even that isn’t always enough to help some adults with bad GI bleeding, and we’re investigating other options for that,” she said.

Dr. Eikenboom disclosed research support from CSL Behring and honoraria (directed to his institution) for educational activities sponsored by Roche and Celgene. Dr. Flood reported having no conflicts of interest to disclose.

Key clinical point: The 6-year follow-up data from APHINITY trial confirm invasive disease-free survival (IDFS) benefits of adding pertuzumab to adjuvant trastuzumab and chemotherapy in node-positive human epidermal growth factor receptor 2-positive (HER2+) early breast cancer.

Major finding: At 6 years, IDFS was longer in pertuzumab vs. placebo (91% vs. 88%; hazard ratio [HR], 0.76; 95% CI, 0.64-0.91) group, particularly in node-positive cohort (HR, 0.72; 95% CI, 0.59-0.87) but not in node-negative cohort. The overall survival analysis did not reach the required statistical significance (HR, 0.85; P = .17).

Study details: Findings are from a second interim analysis of the phase 3 APHINITY trial including 4,805 patients with node-positive or high-risk node-negative HER2+ breast cancer randomly allocated to receive chemotherapy with either 1 year of trastuzumab + placebo (n = 2,404) or trastuzumab + pertuzumab (n = 2,400) post-surgery.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd/Genentech. The lead author reported ties with AstraZeneca, Lilly, MSD, Novartis, Pfizer, Debiopharm Group, Odonate Therapeutics, Menarini, Seattle Genetics, Camel-IDS, Immunomedics, Roche/Genentech, Immutep, Radius Health, Synthon, Servier, Oncolytics, and EU Cancer Mission Board. Other investigators declared ties with various pharmaceutical companies including Roche/Genentech.

Source: Piccart M et al. J Clin Oncol. 2021 Feb 4. doi: 10.1200/JCO.20.01204.

Key clinical point: The 6-year follow-up data from APHINITY trial confirm invasive disease-free survival (IDFS) benefits of adding pertuzumab to adjuvant trastuzumab and chemotherapy in node-positive human epidermal growth factor receptor 2-positive (HER2+) early breast cancer.

Major finding: At 6 years, IDFS was longer in pertuzumab vs. placebo (91% vs. 88%; hazard ratio [HR], 0.76; 95% CI, 0.64-0.91) group, particularly in node-positive cohort (HR, 0.72; 95% CI, 0.59-0.87) but not in node-negative cohort. The overall survival analysis did not reach the required statistical significance (HR, 0.85; P = .17).

Study details: Findings are from a second interim analysis of the phase 3 APHINITY trial including 4,805 patients with node-positive or high-risk node-negative HER2+ breast cancer randomly allocated to receive chemotherapy with either 1 year of trastuzumab + placebo (n = 2,404) or trastuzumab + pertuzumab (n = 2,400) post-surgery.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd/Genentech. The lead author reported ties with AstraZeneca, Lilly, MSD, Novartis, Pfizer, Debiopharm Group, Odonate Therapeutics, Menarini, Seattle Genetics, Camel-IDS, Immunomedics, Roche/Genentech, Immutep, Radius Health, Synthon, Servier, Oncolytics, and EU Cancer Mission Board. Other investigators declared ties with various pharmaceutical companies including Roche/Genentech.

Source: Piccart M et al. J Clin Oncol. 2021 Feb 4. doi: 10.1200/JCO.20.01204.

Key clinical point: The 6-year follow-up data from APHINITY trial confirm invasive disease-free survival (IDFS) benefits of adding pertuzumab to adjuvant trastuzumab and chemotherapy in node-positive human epidermal growth factor receptor 2-positive (HER2+) early breast cancer.

Major finding: At 6 years, IDFS was longer in pertuzumab vs. placebo (91% vs. 88%; hazard ratio [HR], 0.76; 95% CI, 0.64-0.91) group, particularly in node-positive cohort (HR, 0.72; 95% CI, 0.59-0.87) but not in node-negative cohort. The overall survival analysis did not reach the required statistical significance (HR, 0.85; P = .17).

Study details: Findings are from a second interim analysis of the phase 3 APHINITY trial including 4,805 patients with node-positive or high-risk node-negative HER2+ breast cancer randomly allocated to receive chemotherapy with either 1 year of trastuzumab + placebo (n = 2,404) or trastuzumab + pertuzumab (n = 2,400) post-surgery.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd/Genentech. The lead author reported ties with AstraZeneca, Lilly, MSD, Novartis, Pfizer, Debiopharm Group, Odonate Therapeutics, Menarini, Seattle Genetics, Camel-IDS, Immunomedics, Roche/Genentech, Immutep, Radius Health, Synthon, Servier, Oncolytics, and EU Cancer Mission Board. Other investigators declared ties with various pharmaceutical companies including Roche/Genentech.

Source: Piccart M et al. J Clin Oncol. 2021 Feb 4. doi: 10.1200/JCO.20.01204.