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HER2+ BC: Crofelemer fails to prevent any grade chemotherapy-induced diarrhea in phase 2

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Key clinical point: Crofelemer failed to reduce the incidence rate of any grade chemotherapy-induced diarrhea (CID) in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received trastuzumab, pertuzumab, and a taxane.

Major finding: During cycle 2 of chemotherapy, a similar proportion of patients reported any grade diarrhea for ≥2 consecutive days (P = .742), but the rate of grade ≥2 diarrhea was significantly reduced (8.0% vs 39.1%; P = .0196) in the crofelemer vs no scheduled prophylactic medication treatment group.

Study details: Findings are from the phase 2 HALT-D study including 51 patients with HER2+ BC who were randomly assigned to receive 125 mg crofelemer or no scheduled prophylactic medication during cycles 1 and 2 of chemotherapy/HER2-targeted therapy.

Disclosures: This study was supported by Genentech, Inc., and other sources. The authors declared serving as consultants, advisors or receiving honoraria, research funding, consulting fees, speaking fees, or travel support from several sources, including Genentech.

Source: Pohlmann PR et al. HALT-D: A randomized open-label phase II study of crofelemer for the prevention of chemotherapy-induced diarrhea in patients with HER2-positive breast cancer receiving trastuzumab, pertuzumab, and a taxane. Breast Cancer Res Treat. 2022;196(3):571-581 (Oct 25). Doi: 10.1007/s10549-022-06743-9

 

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Key clinical point: Crofelemer failed to reduce the incidence rate of any grade chemotherapy-induced diarrhea (CID) in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received trastuzumab, pertuzumab, and a taxane.

Major finding: During cycle 2 of chemotherapy, a similar proportion of patients reported any grade diarrhea for ≥2 consecutive days (P = .742), but the rate of grade ≥2 diarrhea was significantly reduced (8.0% vs 39.1%; P = .0196) in the crofelemer vs no scheduled prophylactic medication treatment group.

Study details: Findings are from the phase 2 HALT-D study including 51 patients with HER2+ BC who were randomly assigned to receive 125 mg crofelemer or no scheduled prophylactic medication during cycles 1 and 2 of chemotherapy/HER2-targeted therapy.

Disclosures: This study was supported by Genentech, Inc., and other sources. The authors declared serving as consultants, advisors or receiving honoraria, research funding, consulting fees, speaking fees, or travel support from several sources, including Genentech.

Source: Pohlmann PR et al. HALT-D: A randomized open-label phase II study of crofelemer for the prevention of chemotherapy-induced diarrhea in patients with HER2-positive breast cancer receiving trastuzumab, pertuzumab, and a taxane. Breast Cancer Res Treat. 2022;196(3):571-581 (Oct 25). Doi: 10.1007/s10549-022-06743-9

 

Key clinical point: Crofelemer failed to reduce the incidence rate of any grade chemotherapy-induced diarrhea (CID) in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received trastuzumab, pertuzumab, and a taxane.

Major finding: During cycle 2 of chemotherapy, a similar proportion of patients reported any grade diarrhea for ≥2 consecutive days (P = .742), but the rate of grade ≥2 diarrhea was significantly reduced (8.0% vs 39.1%; P = .0196) in the crofelemer vs no scheduled prophylactic medication treatment group.

Study details: Findings are from the phase 2 HALT-D study including 51 patients with HER2+ BC who were randomly assigned to receive 125 mg crofelemer or no scheduled prophylactic medication during cycles 1 and 2 of chemotherapy/HER2-targeted therapy.

Disclosures: This study was supported by Genentech, Inc., and other sources. The authors declared serving as consultants, advisors or receiving honoraria, research funding, consulting fees, speaking fees, or travel support from several sources, including Genentech.

Source: Pohlmann PR et al. HALT-D: A randomized open-label phase II study of crofelemer for the prevention of chemotherapy-induced diarrhea in patients with HER2-positive breast cancer receiving trastuzumab, pertuzumab, and a taxane. Breast Cancer Res Treat. 2022;196(3):571-581 (Oct 25). Doi: 10.1007/s10549-022-06743-9

 

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ER+ BC: Elderly patients can opt for endocrine monotherapy and avoid local invasive treatment

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Key clinical point: In elderly patients who received endocrine monotherapy for breast cancer (BC), the risk of dying due to other conditions was more than twice the risk for eventually requiring invasive local treatment.

Major finding: Within 5 years, 28% of patients required invasive local treatment (surgery or radiotherapy) and the overall mortality risk (overall survival 42%) was >2 times higher than the risk of undergoing invasive local treatment.

Study details: Findings are from a retrospective cohort study including 91 elderly (≥70 years) female patients with estrogen receptor-positive (ER+) BC who received endocrine monotherapy as a definitive treatment.

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

Source: Gooijer SA et al. Long-term outcome of sustained endocrine monotherapy for elderly breast cancer patients. Ann Surg Oncol. 2022 (Nov 3). Doi: 10.1245/s10434-022-12662-2

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Key clinical point: In elderly patients who received endocrine monotherapy for breast cancer (BC), the risk of dying due to other conditions was more than twice the risk for eventually requiring invasive local treatment.

Major finding: Within 5 years, 28% of patients required invasive local treatment (surgery or radiotherapy) and the overall mortality risk (overall survival 42%) was >2 times higher than the risk of undergoing invasive local treatment.

Study details: Findings are from a retrospective cohort study including 91 elderly (≥70 years) female patients with estrogen receptor-positive (ER+) BC who received endocrine monotherapy as a definitive treatment.

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

Source: Gooijer SA et al. Long-term outcome of sustained endocrine monotherapy for elderly breast cancer patients. Ann Surg Oncol. 2022 (Nov 3). Doi: 10.1245/s10434-022-12662-2

Key clinical point: In elderly patients who received endocrine monotherapy for breast cancer (BC), the risk of dying due to other conditions was more than twice the risk for eventually requiring invasive local treatment.

Major finding: Within 5 years, 28% of patients required invasive local treatment (surgery or radiotherapy) and the overall mortality risk (overall survival 42%) was >2 times higher than the risk of undergoing invasive local treatment.

Study details: Findings are from a retrospective cohort study including 91 elderly (≥70 years) female patients with estrogen receptor-positive (ER+) BC who received endocrine monotherapy as a definitive treatment.

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

Source: Gooijer SA et al. Long-term outcome of sustained endocrine monotherapy for elderly breast cancer patients. Ann Surg Oncol. 2022 (Nov 3). Doi: 10.1245/s10434-022-12662-2

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Increased risk for second primary lung cancer in breast cancer patients

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Key clinical point: Women with breast cancer (BC), especially those with low-grade malignancy, had a greater risk of developing a second primary lung cancer.

Major finding: The risk for second primary lung cancer was 1.4 (95% CI 1.25-1.55) times higher in patients with BC compared with the general population, with estrogen receptor-negative BC, low Ki67 levels, and no lymph node metastasis (all P = .01) being significant risk factors. Among patients who developed lung cancer, the rate of epidermal growth factor receptor mutation was high (78.5%).

Study details: This study analyzed the data of 9179 patients with BC, of which 6512 patients had undergone diagnostic chest computed tomography and 55 patients were diagnosed with a second primary lung cancer.

Disclosures: This study was supported by the National Key Research and Development Program of China and other sources. The authors declared no conflicts of interest.

Source: Zeng T et al. High rate of epidermal growth factor receptor-mutated primary lung cancer in patients with primary breast cancer. Front Oncol. 2022;12:985734 (Oct 13). Doi: 10.3389/fonc.2022.985734

 

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Key clinical point: Women with breast cancer (BC), especially those with low-grade malignancy, had a greater risk of developing a second primary lung cancer.

Major finding: The risk for second primary lung cancer was 1.4 (95% CI 1.25-1.55) times higher in patients with BC compared with the general population, with estrogen receptor-negative BC, low Ki67 levels, and no lymph node metastasis (all P = .01) being significant risk factors. Among patients who developed lung cancer, the rate of epidermal growth factor receptor mutation was high (78.5%).

Study details: This study analyzed the data of 9179 patients with BC, of which 6512 patients had undergone diagnostic chest computed tomography and 55 patients were diagnosed with a second primary lung cancer.

Disclosures: This study was supported by the National Key Research and Development Program of China and other sources. The authors declared no conflicts of interest.

Source: Zeng T et al. High rate of epidermal growth factor receptor-mutated primary lung cancer in patients with primary breast cancer. Front Oncol. 2022;12:985734 (Oct 13). Doi: 10.3389/fonc.2022.985734

 

Key clinical point: Women with breast cancer (BC), especially those with low-grade malignancy, had a greater risk of developing a second primary lung cancer.

Major finding: The risk for second primary lung cancer was 1.4 (95% CI 1.25-1.55) times higher in patients with BC compared with the general population, with estrogen receptor-negative BC, low Ki67 levels, and no lymph node metastasis (all P = .01) being significant risk factors. Among patients who developed lung cancer, the rate of epidermal growth factor receptor mutation was high (78.5%).

Study details: This study analyzed the data of 9179 patients with BC, of which 6512 patients had undergone diagnostic chest computed tomography and 55 patients were diagnosed with a second primary lung cancer.

Disclosures: This study was supported by the National Key Research and Development Program of China and other sources. The authors declared no conflicts of interest.

Source: Zeng T et al. High rate of epidermal growth factor receptor-mutated primary lung cancer in patients with primary breast cancer. Front Oncol. 2022;12:985734 (Oct 13). Doi: 10.3389/fonc.2022.985734

 

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Elevated breast cancer risk in thyroid cancer survivors partly due to I-131 treatment

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Elevated breast cancer risk in thyroid cancer survivors partly due to 131I treatment

Key clinical point: The risk of developing breast cancer (BC) was slightly elevated in women who received treatment for thyroid cancer, with increasing cumulative 131I activity being an important risk factor.

Major finding: Compared with the general population, the risk for BC was 1.5 times higher in thyroid cancer survivors (standardized incidence ratio 1.52; 95% CI 1.36-1.69). Although 131I treatment did not increase the risk for subsequent BC, the risk increased with increasing cumulative 131I activity (excess relative risk per 100 mCi 17%; 95% CI 2%-38%).

Study details: This pooled analysis included 8475 women who were treated for differentiated thyroid cancer, of which 62% received radiotherapy with 131I.

Disclosures: This study was supported by grants from the European Commission and other sources. The authors declared no conflicts of interest.

Source: Tran TVT et al. Breast cancer risk among thyroid cancer survivors and the role of I-131 treatment. Br J Cancer. 2022 (Oct 12). Doi: 10.1038/s41416-022-01982-5

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Key clinical point: The risk of developing breast cancer (BC) was slightly elevated in women who received treatment for thyroid cancer, with increasing cumulative 131I activity being an important risk factor.

Major finding: Compared with the general population, the risk for BC was 1.5 times higher in thyroid cancer survivors (standardized incidence ratio 1.52; 95% CI 1.36-1.69). Although 131I treatment did not increase the risk for subsequent BC, the risk increased with increasing cumulative 131I activity (excess relative risk per 100 mCi 17%; 95% CI 2%-38%).

Study details: This pooled analysis included 8475 women who were treated for differentiated thyroid cancer, of which 62% received radiotherapy with 131I.

Disclosures: This study was supported by grants from the European Commission and other sources. The authors declared no conflicts of interest.

Source: Tran TVT et al. Breast cancer risk among thyroid cancer survivors and the role of I-131 treatment. Br J Cancer. 2022 (Oct 12). Doi: 10.1038/s41416-022-01982-5

Key clinical point: The risk of developing breast cancer (BC) was slightly elevated in women who received treatment for thyroid cancer, with increasing cumulative 131I activity being an important risk factor.

Major finding: Compared with the general population, the risk for BC was 1.5 times higher in thyroid cancer survivors (standardized incidence ratio 1.52; 95% CI 1.36-1.69). Although 131I treatment did not increase the risk for subsequent BC, the risk increased with increasing cumulative 131I activity (excess relative risk per 100 mCi 17%; 95% CI 2%-38%).

Study details: This pooled analysis included 8475 women who were treated for differentiated thyroid cancer, of which 62% received radiotherapy with 131I.

Disclosures: This study was supported by grants from the European Commission and other sources. The authors declared no conflicts of interest.

Source: Tran TVT et al. Breast cancer risk among thyroid cancer survivors and the role of I-131 treatment. Br J Cancer. 2022 (Oct 12). Doi: 10.1038/s41416-022-01982-5

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Proton-pump-inhibitors can be used with ribociclib in metastatic BC

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Key clinical point: Concomitant use of ribociclib and proton-pump-inhibitors (PPI) did not affect survival outcomes in a real-world population of patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (mBC).

Major finding: Progression-free survival was similar among users vs nonusers of PPI in the overall population (hazard ratio [HR] 1.18; P = .594) and in the subgroup of patients with endocrine-sensitive (HR 1.22; 95% CI 0.63-2.39) and endocrine-resistant (HR 1.37; 95% CI 0.30-6.16) BC.

Study details: Findings are from a retrospective cohort study including 128 patients with HR+/HER2− mBC who received ribociclib+endocrine therapy with (n = 50) or without (n = 78) concomitant PPI.

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

Source: Re MD et al. Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib. Breast. 2022;66:157-161 (Oct 15). Doi: 10.1016/j.breast.2022.10.005

 

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Key clinical point: Concomitant use of ribociclib and proton-pump-inhibitors (PPI) did not affect survival outcomes in a real-world population of patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (mBC).

Major finding: Progression-free survival was similar among users vs nonusers of PPI in the overall population (hazard ratio [HR] 1.18; P = .594) and in the subgroup of patients with endocrine-sensitive (HR 1.22; 95% CI 0.63-2.39) and endocrine-resistant (HR 1.37; 95% CI 0.30-6.16) BC.

Study details: Findings are from a retrospective cohort study including 128 patients with HR+/HER2− mBC who received ribociclib+endocrine therapy with (n = 50) or without (n = 78) concomitant PPI.

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

Source: Re MD et al. Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib. Breast. 2022;66:157-161 (Oct 15). Doi: 10.1016/j.breast.2022.10.005

 

Key clinical point: Concomitant use of ribociclib and proton-pump-inhibitors (PPI) did not affect survival outcomes in a real-world population of patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (mBC).

Major finding: Progression-free survival was similar among users vs nonusers of PPI in the overall population (hazard ratio [HR] 1.18; P = .594) and in the subgroup of patients with endocrine-sensitive (HR 1.22; 95% CI 0.63-2.39) and endocrine-resistant (HR 1.37; 95% CI 0.30-6.16) BC.

Study details: Findings are from a retrospective cohort study including 128 patients with HR+/HER2− mBC who received ribociclib+endocrine therapy with (n = 50) or without (n = 78) concomitant PPI.

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

Source: Re MD et al. Concomitant administration of proton pump inhibitors does not significantly affect clinical outcomes in metastatic breast cancer patients treated with ribociclib. Breast. 2022;66:157-161 (Oct 15). Doi: 10.1016/j.breast.2022.10.005

 

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Invasive BC: Severe chemotherapy-induced peripheral neuropathy with nab-paclitaxel

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Key clinical point: Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) was associated with a higher incidence of chemotherapy-induced peripheral neuropathy (CIPN) than docetaxel or paclitaxel in women with invasive breast cancer (BC).

Major finding: The risk for patient-reported CIPN was lower in the paclitaxel (hazard ratio [HR] 0.59; P = .008) and docetaxel (HR 0.65; P = .02) groups compared with the nab-paclitaxel group, with lesser sensory discomfort being reported by patients receiving paclitaxel (HR 0.44) or docetaxel (HR 0.52; both P < .001) vs nab-paclitaxel.

Study details: Findings are from a prospective cohort study including 1234 patients with invasive BC who received taxane-containing chemotherapy, of which 23.9%, 41.7%, and 34.4% of patients received nab-paclitaxel, paclitaxel, and docetaxel, respectively.

Disclosures: This study was supported by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences. Dr. Xu declared receiving personal fees from several sources.

Source: Mo H et al. Association of taxane type with patient-reported chemotherapy-induced peripheral neuropathy among patients with breast cancer. JAMA Netw Open. 2022;5(11):e2239788 (Nov 2). Doi: 10.1001/jamanetworkopen.2022.39788

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Key clinical point: Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) was associated with a higher incidence of chemotherapy-induced peripheral neuropathy (CIPN) than docetaxel or paclitaxel in women with invasive breast cancer (BC).

Major finding: The risk for patient-reported CIPN was lower in the paclitaxel (hazard ratio [HR] 0.59; P = .008) and docetaxel (HR 0.65; P = .02) groups compared with the nab-paclitaxel group, with lesser sensory discomfort being reported by patients receiving paclitaxel (HR 0.44) or docetaxel (HR 0.52; both P < .001) vs nab-paclitaxel.

Study details: Findings are from a prospective cohort study including 1234 patients with invasive BC who received taxane-containing chemotherapy, of which 23.9%, 41.7%, and 34.4% of patients received nab-paclitaxel, paclitaxel, and docetaxel, respectively.

Disclosures: This study was supported by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences. Dr. Xu declared receiving personal fees from several sources.

Source: Mo H et al. Association of taxane type with patient-reported chemotherapy-induced peripheral neuropathy among patients with breast cancer. JAMA Netw Open. 2022;5(11):e2239788 (Nov 2). Doi: 10.1001/jamanetworkopen.2022.39788

Key clinical point: Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) was associated with a higher incidence of chemotherapy-induced peripheral neuropathy (CIPN) than docetaxel or paclitaxel in women with invasive breast cancer (BC).

Major finding: The risk for patient-reported CIPN was lower in the paclitaxel (hazard ratio [HR] 0.59; P = .008) and docetaxel (HR 0.65; P = .02) groups compared with the nab-paclitaxel group, with lesser sensory discomfort being reported by patients receiving paclitaxel (HR 0.44) or docetaxel (HR 0.52; both P < .001) vs nab-paclitaxel.

Study details: Findings are from a prospective cohort study including 1234 patients with invasive BC who received taxane-containing chemotherapy, of which 23.9%, 41.7%, and 34.4% of patients received nab-paclitaxel, paclitaxel, and docetaxel, respectively.

Disclosures: This study was supported by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences. Dr. Xu declared receiving personal fees from several sources.

Source: Mo H et al. Association of taxane type with patient-reported chemotherapy-induced peripheral neuropathy among patients with breast cancer. JAMA Netw Open. 2022;5(11):e2239788 (Nov 2). Doi: 10.1001/jamanetworkopen.2022.39788

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Late detection and worse outcomes in invasive lobular vs ductal carcinomas of the breast

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Key clinical point: Invasive lobular carcinomas (ILC) are often detected at more advanced stages and have worse survival outcomes than invasive ductal carcinomas (IDC).

Major finding: ILCs vs IDC were more frequently diagnosed at later stages (stage III and IV; 20.7% vs 10.4%), with more lymph node involvement (N2 and 3; 9.9% vs 5.5%), and at larger sizes (T3 and 4; 14.7% vs 4.0%; all P < .001). Among patients with estrogen receptor-positive and human epidermal growth factor receptor 2-negative breast cancer (BC), ILC vs IDC were associated with worse overall survival (hazard ratio [HR] 1.32; P < .001) and disease-free survival (HR 1.18; P = .03).

Study details: Findings are from a retrospective cohort study, the Great Lakes Breast Cancer Consortium, including 33,662 patients with BC, of which 10.7% of patients had ILC and 89.3% of patients had IDC.

Disclosures: This work was supported by the Breast Cancer Research Foundation and other sources. The authors declared no conflicts of interest.

Source: Oesterreich S et al. Clinicopathological features and outcomes comparing patients with invasive ductal and lobular breast cancer. J Natl Cancer Inst. 2022 (Oct 14). Doi: 10.1093/jnci/djac157

 

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Key clinical point: Invasive lobular carcinomas (ILC) are often detected at more advanced stages and have worse survival outcomes than invasive ductal carcinomas (IDC).

Major finding: ILCs vs IDC were more frequently diagnosed at later stages (stage III and IV; 20.7% vs 10.4%), with more lymph node involvement (N2 and 3; 9.9% vs 5.5%), and at larger sizes (T3 and 4; 14.7% vs 4.0%; all P < .001). Among patients with estrogen receptor-positive and human epidermal growth factor receptor 2-negative breast cancer (BC), ILC vs IDC were associated with worse overall survival (hazard ratio [HR] 1.32; P < .001) and disease-free survival (HR 1.18; P = .03).

Study details: Findings are from a retrospective cohort study, the Great Lakes Breast Cancer Consortium, including 33,662 patients with BC, of which 10.7% of patients had ILC and 89.3% of patients had IDC.

Disclosures: This work was supported by the Breast Cancer Research Foundation and other sources. The authors declared no conflicts of interest.

Source: Oesterreich S et al. Clinicopathological features and outcomes comparing patients with invasive ductal and lobular breast cancer. J Natl Cancer Inst. 2022 (Oct 14). Doi: 10.1093/jnci/djac157

 

Key clinical point: Invasive lobular carcinomas (ILC) are often detected at more advanced stages and have worse survival outcomes than invasive ductal carcinomas (IDC).

Major finding: ILCs vs IDC were more frequently diagnosed at later stages (stage III and IV; 20.7% vs 10.4%), with more lymph node involvement (N2 and 3; 9.9% vs 5.5%), and at larger sizes (T3 and 4; 14.7% vs 4.0%; all P < .001). Among patients with estrogen receptor-positive and human epidermal growth factor receptor 2-negative breast cancer (BC), ILC vs IDC were associated with worse overall survival (hazard ratio [HR] 1.32; P < .001) and disease-free survival (HR 1.18; P = .03).

Study details: Findings are from a retrospective cohort study, the Great Lakes Breast Cancer Consortium, including 33,662 patients with BC, of which 10.7% of patients had ILC and 89.3% of patients had IDC.

Disclosures: This work was supported by the Breast Cancer Research Foundation and other sources. The authors declared no conflicts of interest.

Source: Oesterreich S et al. Clinicopathological features and outcomes comparing patients with invasive ductal and lobular breast cancer. J Natl Cancer Inst. 2022 (Oct 14). Doi: 10.1093/jnci/djac157

 

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gBRCA1/2pv-associated HER2− early BC: Adjuvant olaparib improves OS in the long run

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Key clinical point: The prespecified second interim analysis of the OlympiA trial revealed a significant improvement in overall survival (OS) with adjuvant olaparib vs placebo in patients with pathogenic variants in BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative (HER2−), early breast cancer (BC).

Major finding: After a median follow-up of 3.5 years, OS improved significantly (hazard ratio 0.68; P = .009) and improvement in 4-year invasive disease-free survival was maintained (82.7% vs 75.4%) in the olaparib vs placebo group. No new safety signals were identified.

Study details: Findings are from the double-blind, phase 3, OlympiA study including 1836 patients with gBRCA1/2pv-associated high-risk, HER2−, early BC who were randomly assigned to receive olaparib or placebo in the adjuvant setting.

Disclosures: This work was supported by the US National Institutes of Health. Some authors declared receiving research funding, honoraria, consulting fees, compensation, accommodations and travel expenses, and royalties from and having other ties with several sources.

Source: Geyer CE Jr et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high risk, early breast cancer. Ann Oncol. 2022 (Oct 10). Doi: 10.1016/j.annonc.2022.09.159

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Key clinical point: The prespecified second interim analysis of the OlympiA trial revealed a significant improvement in overall survival (OS) with adjuvant olaparib vs placebo in patients with pathogenic variants in BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative (HER2−), early breast cancer (BC).

Major finding: After a median follow-up of 3.5 years, OS improved significantly (hazard ratio 0.68; P = .009) and improvement in 4-year invasive disease-free survival was maintained (82.7% vs 75.4%) in the olaparib vs placebo group. No new safety signals were identified.

Study details: Findings are from the double-blind, phase 3, OlympiA study including 1836 patients with gBRCA1/2pv-associated high-risk, HER2−, early BC who were randomly assigned to receive olaparib or placebo in the adjuvant setting.

Disclosures: This work was supported by the US National Institutes of Health. Some authors declared receiving research funding, honoraria, consulting fees, compensation, accommodations and travel expenses, and royalties from and having other ties with several sources.

Source: Geyer CE Jr et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high risk, early breast cancer. Ann Oncol. 2022 (Oct 10). Doi: 10.1016/j.annonc.2022.09.159

Key clinical point: The prespecified second interim analysis of the OlympiA trial revealed a significant improvement in overall survival (OS) with adjuvant olaparib vs placebo in patients with pathogenic variants in BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative (HER2−), early breast cancer (BC).

Major finding: After a median follow-up of 3.5 years, OS improved significantly (hazard ratio 0.68; P = .009) and improvement in 4-year invasive disease-free survival was maintained (82.7% vs 75.4%) in the olaparib vs placebo group. No new safety signals were identified.

Study details: Findings are from the double-blind, phase 3, OlympiA study including 1836 patients with gBRCA1/2pv-associated high-risk, HER2−, early BC who were randomly assigned to receive olaparib or placebo in the adjuvant setting.

Disclosures: This work was supported by the US National Institutes of Health. Some authors declared receiving research funding, honoraria, consulting fees, compensation, accommodations and travel expenses, and royalties from and having other ties with several sources.

Source: Geyer CE Jr et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high risk, early breast cancer. Ann Oncol. 2022 (Oct 10). Doi: 10.1016/j.annonc.2022.09.159

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Radiotherapy increases risk for thoracic angiosarcoma in breast cancer survivors

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Key clinical point: Patients who had survived breast cancer (BC) were more likely to develop soft tissue sarcoma if they received radiotherapy.

Major finding: A very small fraction of BC survivors (~0.1%) developed thoracic soft tissue sarcoma, with radiotherapy being the strongest risk factor in the Kaiser Permanente (KP) cohort (relative risk [RR] 8.1; P = .0052) and the Surveillance, Epidemiology, and End Results (SEER) 13 registries cohort (RR 3.0; P < .0001).

Study details: This retrospective study of data sourced from two cohorts, the KP cohort (n = 15,940) and the SEER 13 registries cohort (n = 457,300) and included patients who had BC surgery and survived ≥1 year after BC diagnosis.

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

Source: Veiga LHS et al. Treatment-related thoracic soft tissue sarcomas in US breast cancer survivors: A retrospective cohort study. Lancet Oncol. 2022;23(11):1451-1464 (Oct 11). Doi: 10.1016/S1470-2045(22)00561-7

 

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Key clinical point: Patients who had survived breast cancer (BC) were more likely to develop soft tissue sarcoma if they received radiotherapy.

Major finding: A very small fraction of BC survivors (~0.1%) developed thoracic soft tissue sarcoma, with radiotherapy being the strongest risk factor in the Kaiser Permanente (KP) cohort (relative risk [RR] 8.1; P = .0052) and the Surveillance, Epidemiology, and End Results (SEER) 13 registries cohort (RR 3.0; P < .0001).

Study details: This retrospective study of data sourced from two cohorts, the KP cohort (n = 15,940) and the SEER 13 registries cohort (n = 457,300) and included patients who had BC surgery and survived ≥1 year after BC diagnosis.

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

Source: Veiga LHS et al. Treatment-related thoracic soft tissue sarcomas in US breast cancer survivors: A retrospective cohort study. Lancet Oncol. 2022;23(11):1451-1464 (Oct 11). Doi: 10.1016/S1470-2045(22)00561-7

 

Key clinical point: Patients who had survived breast cancer (BC) were more likely to develop soft tissue sarcoma if they received radiotherapy.

Major finding: A very small fraction of BC survivors (~0.1%) developed thoracic soft tissue sarcoma, with radiotherapy being the strongest risk factor in the Kaiser Permanente (KP) cohort (relative risk [RR] 8.1; P = .0052) and the Surveillance, Epidemiology, and End Results (SEER) 13 registries cohort (RR 3.0; P < .0001).

Study details: This retrospective study of data sourced from two cohorts, the KP cohort (n = 15,940) and the SEER 13 registries cohort (n = 457,300) and included patients who had BC surgery and survived ≥1 year after BC diagnosis.

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

Source: Veiga LHS et al. Treatment-related thoracic soft tissue sarcomas in US breast cancer survivors: A retrospective cohort study. Lancet Oncol. 2022;23(11):1451-1464 (Oct 11). Doi: 10.1016/S1470-2045(22)00561-7

 

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Exceptional responders to neoadjuvant systemic therapy may omit breast cancer surgery

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Key clinical point: Breast cancer (BC) surgery may be eliminated in patients with early-stage triple-negative BC (TNBC) or human epidermal growth factor receptor 2-positive (HER2+) BC who have achieved pathological complete response (pCR) after neoadjuvant systemic therapy (NST).

Major finding: After a median follow-up of 26.4 months, there were no incidences of ipsilateral breast tumor recurrence in the 31 patients who had achieved a pCR on percutaneous image-guided vacuum-assisted core biopsy (VACB) after NST.

Study details: Findings are from a multicenter, single-arm, phase 2 study including 50 patients with invasive HER2+ BC or TNBC who received percutaneous image-guided VACB after NST.

Disclosures: This study was funded by the US National Cancer Institute. Some authors declared serving in leadership roles or receiving consulting fees, honorarium, royalties, or research funding from several sources.

Source: Kuerer HM et al. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: A multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022 (Oct 25). Doi: 10.1016/S1470-2045(22)00613-1

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Key clinical point: Breast cancer (BC) surgery may be eliminated in patients with early-stage triple-negative BC (TNBC) or human epidermal growth factor receptor 2-positive (HER2+) BC who have achieved pathological complete response (pCR) after neoadjuvant systemic therapy (NST).

Major finding: After a median follow-up of 26.4 months, there were no incidences of ipsilateral breast tumor recurrence in the 31 patients who had achieved a pCR on percutaneous image-guided vacuum-assisted core biopsy (VACB) after NST.

Study details: Findings are from a multicenter, single-arm, phase 2 study including 50 patients with invasive HER2+ BC or TNBC who received percutaneous image-guided VACB after NST.

Disclosures: This study was funded by the US National Cancer Institute. Some authors declared serving in leadership roles or receiving consulting fees, honorarium, royalties, or research funding from several sources.

Source: Kuerer HM et al. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: A multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022 (Oct 25). Doi: 10.1016/S1470-2045(22)00613-1

Key clinical point: Breast cancer (BC) surgery may be eliminated in patients with early-stage triple-negative BC (TNBC) or human epidermal growth factor receptor 2-positive (HER2+) BC who have achieved pathological complete response (pCR) after neoadjuvant systemic therapy (NST).

Major finding: After a median follow-up of 26.4 months, there were no incidences of ipsilateral breast tumor recurrence in the 31 patients who had achieved a pCR on percutaneous image-guided vacuum-assisted core biopsy (VACB) after NST.

Study details: Findings are from a multicenter, single-arm, phase 2 study including 50 patients with invasive HER2+ BC or TNBC who received percutaneous image-guided VACB after NST.

Disclosures: This study was funded by the US National Cancer Institute. Some authors declared serving in leadership roles or receiving consulting fees, honorarium, royalties, or research funding from several sources.

Source: Kuerer HM et al. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: A multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022 (Oct 25). Doi: 10.1016/S1470-2045(22)00613-1

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