Key clinical point: A focal boost to external beam radiotherapy (EBRT) improves local failure-free survival (LFS) and regional/distant metastasis-free survival (rdMFS) in patients with localized high-risk prostate cancer.

Major finding: At a median follow-up of 72 months, focal boost improved LFS (adjusted hazard ratio [aHR], 0.33; P = .01) and rdMFS (aHR, 0.56; P = .02). A higher dose to the tumor resulted in lower LFS and rdMFS rates.

Study details: A phase 3, multicenter, randomized controlled FLAME trial of 571 patients with intermediate- or high-risk localized prostate cancer who were randomly assigned to receive EBRT with or without an additional boost of up to 95 Gy to the macroscopic tumor.

Disclosures: This study was supported by the Dutch Cancer Society. The authors reported no conflict of interests.

Source: Groen VH et al. Eur Urol. 2021 Dec 22. doi: 10.1016/j.eururo.2021.12.012.

Key clinical point: A focal boost to external beam radiotherapy (EBRT) improves local failure-free survival (LFS) and regional/distant metastasis-free survival (rdMFS) in patients with localized high-risk prostate cancer.

Major finding: At a median follow-up of 72 months, focal boost improved LFS (adjusted hazard ratio [aHR], 0.33; P = .01) and rdMFS (aHR, 0.56; P = .02). A higher dose to the tumor resulted in lower LFS and rdMFS rates.

Study details: A phase 3, multicenter, randomized controlled FLAME trial of 571 patients with intermediate- or high-risk localized prostate cancer who were randomly assigned to receive EBRT with or without an additional boost of up to 95 Gy to the macroscopic tumor.

Disclosures: This study was supported by the Dutch Cancer Society. The authors reported no conflict of interests.

Source: Groen VH et al. Eur Urol. 2021 Dec 22. doi: 10.1016/j.eururo.2021.12.012.

Key clinical point: A focal boost to external beam radiotherapy (EBRT) improves local failure-free survival (LFS) and regional/distant metastasis-free survival (rdMFS) in patients with localized high-risk prostate cancer.

Major finding: At a median follow-up of 72 months, focal boost improved LFS (adjusted hazard ratio [aHR], 0.33; P = .01) and rdMFS (aHR, 0.56; P = .02). A higher dose to the tumor resulted in lower LFS and rdMFS rates.

Study details: A phase 3, multicenter, randomized controlled FLAME trial of 571 patients with intermediate- or high-risk localized prostate cancer who were randomly assigned to receive EBRT with or without an additional boost of up to 95 Gy to the macroscopic tumor.

Disclosures: This study was supported by the Dutch Cancer Society. The authors reported no conflict of interests.

Source: Groen VH et al. Eur Urol. 2021 Dec 22. doi: 10.1016/j.eururo.2021.12.012.

Key clinical point: In patients with high-risk nonmetastatic prostate cancer, adding abiraterone acetate and prednisolone to androgen deprivation therapy (ADT) prolongs survival vs ADT alone.

Major finding: Add-on abiraterone acetate plus prednisolone to ADT vs ADT alone significantly improved metastasis-free survival (MFS; hazard ratio [HR], 0.53; P < .0001) and overall survival (HR, 0.60; P < .0001). There was no difference in MFS when enzalutamide and abiraterone acetate were administered concurrently vs abiraterone acetate alone (interaction HR, 1.02; P = .91).

Study details: A meta-analysis of 2 phase 3 STAMPEDE trials including 1,974 patients with high-risk nonmetastatic prostate cancer randomly assigned to ADT alone or ADT plus abiraterone acetate and prednisolone with or without enzalutamide.

Disclosures: This work was supported by Cancer Research UK, UK Medical Research Council, Swiss Group for Clinical Cancer Research, and others. The authors received personal fees, honoraria, grants, travel support, royalty, nonfinancial support, and payments or held patents outside this work.

Source: Attard G et al. Lancet. 2021 Dec 23. doi: 10.1016/S0140-6736(21)02437-5.

Key clinical point: In patients with high-risk nonmetastatic prostate cancer, adding abiraterone acetate and prednisolone to androgen deprivation therapy (ADT) prolongs survival vs ADT alone.

Major finding: Add-on abiraterone acetate plus prednisolone to ADT vs ADT alone significantly improved metastasis-free survival (MFS; hazard ratio [HR], 0.53; P < .0001) and overall survival (HR, 0.60; P < .0001). There was no difference in MFS when enzalutamide and abiraterone acetate were administered concurrently vs abiraterone acetate alone (interaction HR, 1.02; P = .91).

Study details: A meta-analysis of 2 phase 3 STAMPEDE trials including 1,974 patients with high-risk nonmetastatic prostate cancer randomly assigned to ADT alone or ADT plus abiraterone acetate and prednisolone with or without enzalutamide.

Disclosures: This work was supported by Cancer Research UK, UK Medical Research Council, Swiss Group for Clinical Cancer Research, and others. The authors received personal fees, honoraria, grants, travel support, royalty, nonfinancial support, and payments or held patents outside this work.

Source: Attard G et al. Lancet. 2021 Dec 23. doi: 10.1016/S0140-6736(21)02437-5.

Key clinical point: In patients with high-risk nonmetastatic prostate cancer, adding abiraterone acetate and prednisolone to androgen deprivation therapy (ADT) prolongs survival vs ADT alone.

Major finding: Add-on abiraterone acetate plus prednisolone to ADT vs ADT alone significantly improved metastasis-free survival (MFS; hazard ratio [HR], 0.53; P < .0001) and overall survival (HR, 0.60; P < .0001). There was no difference in MFS when enzalutamide and abiraterone acetate were administered concurrently vs abiraterone acetate alone (interaction HR, 1.02; P = .91).

Study details: A meta-analysis of 2 phase 3 STAMPEDE trials including 1,974 patients with high-risk nonmetastatic prostate cancer randomly assigned to ADT alone or ADT plus abiraterone acetate and prednisolone with or without enzalutamide.

Disclosures: This work was supported by Cancer Research UK, UK Medical Research Council, Swiss Group for Clinical Cancer Research, and others. The authors received personal fees, honoraria, grants, travel support, royalty, nonfinancial support, and payments or held patents outside this work.

Source: Attard G et al. Lancet. 2021 Dec 23. doi: 10.1016/S0140-6736(21)02437-5.

Key clinical point: Compared with fulvestrant alone, addition of sapanisertib to fulvestrant led to numerical but not statistically significant improvement in progression-free survival (PFS) in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC), but with increased toxicity.

Major finding: Median PFS was 3.5 months with only fulvestrant vs 7.2 months with fulvestrant+sapanisertib daily (QD; hazard ratio [HR], 0.77; 95% CI, 0.47-1.26) and 5.6 months with fulvestrant+sapanisertib weekly (QW; HR, 0.88; 95% CI, 0.53-1.45) arms. Fulvestrant+sapanisertib vs fulvestrant alone was associated with higher grade ≥3 treatment-related treatment-emergent adverse events (>50% vs none).

Study details: Findings are from a phase 2 study including 141 postmenopausal women with ER+/HER2− advanced or metastatic BC who were randomly assigned to fulvestrant, fulvestrant+sapanisertib QD, or fulvestrant+sapanisertib QW.

Disclosures: This study was funded by Millennium Pharmaceuticals. The authors declared serving in the advisory committee and speaker’s bureau and/or receiving consulting fees, grants, funds, honoraria, and travel expenses from Millennium Pharmaceuticals and other sources. Five authors declared being employees and/or shareholders of Millennium Pharmaceuticals.

Source: García-Sáenz JÁ et al. Clin Cancer Res. 2022 Jan 3. doi: 10.1158/1078-0432.CCR-21-2652.

Key clinical point: Compared with fulvestrant alone, addition of sapanisertib to fulvestrant led to numerical but not statistically significant improvement in progression-free survival (PFS) in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC), but with increased toxicity.

Major finding: Median PFS was 3.5 months with only fulvestrant vs 7.2 months with fulvestrant+sapanisertib daily (QD; hazard ratio [HR], 0.77; 95% CI, 0.47-1.26) and 5.6 months with fulvestrant+sapanisertib weekly (QW; HR, 0.88; 95% CI, 0.53-1.45) arms. Fulvestrant+sapanisertib vs fulvestrant alone was associated with higher grade ≥3 treatment-related treatment-emergent adverse events (>50% vs none).

Study details: Findings are from a phase 2 study including 141 postmenopausal women with ER+/HER2− advanced or metastatic BC who were randomly assigned to fulvestrant, fulvestrant+sapanisertib QD, or fulvestrant+sapanisertib QW.

Disclosures: This study was funded by Millennium Pharmaceuticals. The authors declared serving in the advisory committee and speaker’s bureau and/or receiving consulting fees, grants, funds, honoraria, and travel expenses from Millennium Pharmaceuticals and other sources. Five authors declared being employees and/or shareholders of Millennium Pharmaceuticals.

Source: García-Sáenz JÁ et al. Clin Cancer Res. 2022 Jan 3. doi: 10.1158/1078-0432.CCR-21-2652.

Key clinical point: Compared with fulvestrant alone, addition of sapanisertib to fulvestrant led to numerical but not statistically significant improvement in progression-free survival (PFS) in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC), but with increased toxicity.

Major finding: Median PFS was 3.5 months with only fulvestrant vs 7.2 months with fulvestrant+sapanisertib daily (QD; hazard ratio [HR], 0.77; 95% CI, 0.47-1.26) and 5.6 months with fulvestrant+sapanisertib weekly (QW; HR, 0.88; 95% CI, 0.53-1.45) arms. Fulvestrant+sapanisertib vs fulvestrant alone was associated with higher grade ≥3 treatment-related treatment-emergent adverse events (>50% vs none).

Study details: Findings are from a phase 2 study including 141 postmenopausal women with ER+/HER2− advanced or metastatic BC who were randomly assigned to fulvestrant, fulvestrant+sapanisertib QD, or fulvestrant+sapanisertib QW.

Disclosures: This study was funded by Millennium Pharmaceuticals. The authors declared serving in the advisory committee and speaker’s bureau and/or receiving consulting fees, grants, funds, honoraria, and travel expenses from Millennium Pharmaceuticals and other sources. Five authors declared being employees and/or shareholders of Millennium Pharmaceuticals.

Source: García-Sáenz JÁ et al. Clin Cancer Res. 2022 Jan 3. doi: 10.1158/1078-0432.CCR-21-2652.

Key clinical point: With an extended median follow-up of 53.5 months, ribociclib+endocrine therapy (ET) continued to prolong survival vs placebo+ET in pre-/perimenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: Ribociclib vs placebo prolonged the median overall survival in overall population (58.7 months vs 48 months; hazard ratio [HR], 0.76; 95% CI, 0.61-0.96) and in women aged <40 years (51.3 months vs 40.5 months; HR, 0.65; 95% CI, 0.43-0.98). No new safety signals were identified.

Study details: Findings are from an exploratory analysis of phase 3 MONALEESA-7 trial including 672 pre- or perimenopausal women with HR+/HER2− advanced BC who were randomly assigned to ET+ribociclib or ET+placebo.

Disclosures: This study was funded by Novartis Pharmaceuticals Corporation. The authors reported receiving grants, nonfinancial support, and advisory and personal fees from Novartis and other sources. Six authors declared being employees and shareholders of Novartis.

Source: Lu YS et al. Clin Cancer Res. 2021 Dec 29. doi: 10.1158/1078-0432.CCR-21-3032.

Key clinical point: With an extended median follow-up of 53.5 months, ribociclib+endocrine therapy (ET) continued to prolong survival vs placebo+ET in pre-/perimenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: Ribociclib vs placebo prolonged the median overall survival in overall population (58.7 months vs 48 months; hazard ratio [HR], 0.76; 95% CI, 0.61-0.96) and in women aged <40 years (51.3 months vs 40.5 months; HR, 0.65; 95% CI, 0.43-0.98). No new safety signals were identified.

Study details: Findings are from an exploratory analysis of phase 3 MONALEESA-7 trial including 672 pre- or perimenopausal women with HR+/HER2− advanced BC who were randomly assigned to ET+ribociclib or ET+placebo.

Disclosures: This study was funded by Novartis Pharmaceuticals Corporation. The authors reported receiving grants, nonfinancial support, and advisory and personal fees from Novartis and other sources. Six authors declared being employees and shareholders of Novartis.

Source: Lu YS et al. Clin Cancer Res. 2021 Dec 29. doi: 10.1158/1078-0432.CCR-21-3032.

Key clinical point: With an extended median follow-up of 53.5 months, ribociclib+endocrine therapy (ET) continued to prolong survival vs placebo+ET in pre-/perimenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: Ribociclib vs placebo prolonged the median overall survival in overall population (58.7 months vs 48 months; hazard ratio [HR], 0.76; 95% CI, 0.61-0.96) and in women aged <40 years (51.3 months vs 40.5 months; HR, 0.65; 95% CI, 0.43-0.98). No new safety signals were identified.

Study details: Findings are from an exploratory analysis of phase 3 MONALEESA-7 trial including 672 pre- or perimenopausal women with HR+/HER2− advanced BC who were randomly assigned to ET+ribociclib or ET+placebo.

Disclosures: This study was funded by Novartis Pharmaceuticals Corporation. The authors reported receiving grants, nonfinancial support, and advisory and personal fees from Novartis and other sources. Six authors declared being employees and shareholders of Novartis.

Source: Lu YS et al. Clin Cancer Res. 2021 Dec 29. doi: 10.1158/1078-0432.CCR-21-3032.

Key clinical point: Low vs high expression of tumor-specific thyroid hormone receptor alpha-2 (THRα-2) was associated with unfavorable tumor characteristics and higher breast cancer-specific mortality in women with invasive breast cancer.

Major finding: Low vs high THRα-2 expression was associated with estrogen receptor (ER) negativity (odds ratio [OR], 4.04; 95% CI, 2.28-7.15), tumor size of >20-50 mm (OR, 2.20; 95% CI, 1.39-3.49), and high risk for breast cancer-specific mortality in the overall population (hazard ratio [HR], 1.38; 95% CI, 0.96-1.99) and among women with ER-positive tumors (adjusted HR, 1.31; 95% CI, 1.01-1.73).

Study details: Findings are from a follow-up of a population-based cohort, the Malmö Diet and Cancer Study consisting of 17,035 women, of which 654 women with invasive breast cancer and evaluable tumor tissue were included in the present study.

Disclosures: This study was funded by the Swedish Cancer Society, Gunnar Nilsson Cancer Foundation, Ernhold Lundström Foundation, and other sources. The authors declared no conflict of interests.

Source: Sandsveden M et al. Breast Cancer Res. 2021 Dec 20. doi: 10.1186/s13058-021-01496-7.

Key clinical point: Low vs high expression of tumor-specific thyroid hormone receptor alpha-2 (THRα-2) was associated with unfavorable tumor characteristics and higher breast cancer-specific mortality in women with invasive breast cancer.

Major finding: Low vs high THRα-2 expression was associated with estrogen receptor (ER) negativity (odds ratio [OR], 4.04; 95% CI, 2.28-7.15), tumor size of >20-50 mm (OR, 2.20; 95% CI, 1.39-3.49), and high risk for breast cancer-specific mortality in the overall population (hazard ratio [HR], 1.38; 95% CI, 0.96-1.99) and among women with ER-positive tumors (adjusted HR, 1.31; 95% CI, 1.01-1.73).

Study details: Findings are from a follow-up of a population-based cohort, the Malmö Diet and Cancer Study consisting of 17,035 women, of which 654 women with invasive breast cancer and evaluable tumor tissue were included in the present study.

Disclosures: This study was funded by the Swedish Cancer Society, Gunnar Nilsson Cancer Foundation, Ernhold Lundström Foundation, and other sources. The authors declared no conflict of interests.

Source: Sandsveden M et al. Breast Cancer Res. 2021 Dec 20. doi: 10.1186/s13058-021-01496-7.

Key clinical point: Low vs high expression of tumor-specific thyroid hormone receptor alpha-2 (THRα-2) was associated with unfavorable tumor characteristics and higher breast cancer-specific mortality in women with invasive breast cancer.

Major finding: Low vs high THRα-2 expression was associated with estrogen receptor (ER) negativity (odds ratio [OR], 4.04; 95% CI, 2.28-7.15), tumor size of >20-50 mm (OR, 2.20; 95% CI, 1.39-3.49), and high risk for breast cancer-specific mortality in the overall population (hazard ratio [HR], 1.38; 95% CI, 0.96-1.99) and among women with ER-positive tumors (adjusted HR, 1.31; 95% CI, 1.01-1.73).

Study details: Findings are from a follow-up of a population-based cohort, the Malmö Diet and Cancer Study consisting of 17,035 women, of which 654 women with invasive breast cancer and evaluable tumor tissue were included in the present study.

Disclosures: This study was funded by the Swedish Cancer Society, Gunnar Nilsson Cancer Foundation, Ernhold Lundström Foundation, and other sources. The authors declared no conflict of interests.

Source: Sandsveden M et al. Breast Cancer Res. 2021 Dec 20. doi: 10.1186/s13058-021-01496-7.

Key clinical point: In this real-world population, low expression of human epidermal growth factor receptor 2 (HER2) did not affect the prognosis of metastatic breast cancer (BC).

Major finding: HER2-low vs HER2-negative disease had no significant effect on the overall survival, neither in hormone receptor-positive (hazard ratio [HR], 0.89; P = .171) nor in triple-negative (HR, 0.92; P = .585) subgroups.

Study details: Findings are from an analysis of 1,973 patients with metastatic BC from the metastatic BC-Registry of the Austrian Study Group of Medical Tumor Therapy (AGMT). Among evaluable patients, 20.3% were HER2-positive, 35.2% were HER2-low, and 44.5% were completely HER2-negative.

Disclosures: The AGMT-MBC-registry is supported by grants from Roche, Daiichi Sankyo, Pfizer, and AstraZeneca. The authors declared expert testimony and/or receiving honoraria, research grants, and travel support from several sources.

Source: Gampenrieder SP et al. Breast Cancer Res. 2021 Dec 14. doi: 10.1186/s13058-021-01492-x.

Key clinical point: In this real-world population, low expression of human epidermal growth factor receptor 2 (HER2) did not affect the prognosis of metastatic breast cancer (BC).

Major finding: HER2-low vs HER2-negative disease had no significant effect on the overall survival, neither in hormone receptor-positive (hazard ratio [HR], 0.89; P = .171) nor in triple-negative (HR, 0.92; P = .585) subgroups.

Study details: Findings are from an analysis of 1,973 patients with metastatic BC from the metastatic BC-Registry of the Austrian Study Group of Medical Tumor Therapy (AGMT). Among evaluable patients, 20.3% were HER2-positive, 35.2% were HER2-low, and 44.5% were completely HER2-negative.

Disclosures: The AGMT-MBC-registry is supported by grants from Roche, Daiichi Sankyo, Pfizer, and AstraZeneca. The authors declared expert testimony and/or receiving honoraria, research grants, and travel support from several sources.

Source: Gampenrieder SP et al. Breast Cancer Res. 2021 Dec 14. doi: 10.1186/s13058-021-01492-x.

Key clinical point: In this real-world population, low expression of human epidermal growth factor receptor 2 (HER2) did not affect the prognosis of metastatic breast cancer (BC).

Major finding: HER2-low vs HER2-negative disease had no significant effect on the overall survival, neither in hormone receptor-positive (hazard ratio [HR], 0.89; P = .171) nor in triple-negative (HR, 0.92; P = .585) subgroups.

Study details: Findings are from an analysis of 1,973 patients with metastatic BC from the metastatic BC-Registry of the Austrian Study Group of Medical Tumor Therapy (AGMT). Among evaluable patients, 20.3% were HER2-positive, 35.2% were HER2-low, and 44.5% were completely HER2-negative.

Disclosures: The AGMT-MBC-registry is supported by grants from Roche, Daiichi Sankyo, Pfizer, and AstraZeneca. The authors declared expert testimony and/or receiving honoraria, research grants, and travel support from several sources.

Source: Gampenrieder SP et al. Breast Cancer Res. 2021 Dec 14. doi: 10.1186/s13058-021-01492-x.

Key clinical point: Replacing trastuzumab+taxane with trastuzumab emtansine (T-DM1) did not improve survival in high-risk human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (BC).

Major finding: The risk for invasive disease-free survival was not significantly different between trastuzumab+taxane+pertuzumab and T-DM1+pertuzumab arms in the overall population (stratified hazard ratio [sHR], 0.98; 95% CI, 0.72-1.32) and the node-positive subpopulation (sHR, 0.97; 95% CI, 0.71-1.32) along with similar rates of grade 3 or higher and serious adverse events.

Study details: Findings are from the phase 3 KAITLIN study, including 1,846 patients with HER2-positive early BC who were randomly assigned to receive T-DM1+pertuzumab or trastuzumab+taxane+pertuzumab after surgery and anthracycline chemotherapy.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors declared serving as consultant, speaker, and/or receiving honorarium, funding, and travel expense from several sources. Some authors were employed and/or held stocks in various sources.

Source: Krop IE et al. J Clin Oncol. 2021 Dec 10. doi: 10.1200/JCO.21.00896.

Key clinical point: Replacing trastuzumab+taxane with trastuzumab emtansine (T-DM1) did not improve survival in high-risk human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (BC).

Major finding: The risk for invasive disease-free survival was not significantly different between trastuzumab+taxane+pertuzumab and T-DM1+pertuzumab arms in the overall population (stratified hazard ratio [sHR], 0.98; 95% CI, 0.72-1.32) and the node-positive subpopulation (sHR, 0.97; 95% CI, 0.71-1.32) along with similar rates of grade 3 or higher and serious adverse events.

Study details: Findings are from the phase 3 KAITLIN study, including 1,846 patients with HER2-positive early BC who were randomly assigned to receive T-DM1+pertuzumab or trastuzumab+taxane+pertuzumab after surgery and anthracycline chemotherapy.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors declared serving as consultant, speaker, and/or receiving honorarium, funding, and travel expense from several sources. Some authors were employed and/or held stocks in various sources.

Source: Krop IE et al. J Clin Oncol. 2021 Dec 10. doi: 10.1200/JCO.21.00896.

Key clinical point: Replacing trastuzumab+taxane with trastuzumab emtansine (T-DM1) did not improve survival in high-risk human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (BC).

Major finding: The risk for invasive disease-free survival was not significantly different between trastuzumab+taxane+pertuzumab and T-DM1+pertuzumab arms in the overall population (stratified hazard ratio [sHR], 0.98; 95% CI, 0.72-1.32) and the node-positive subpopulation (sHR, 0.97; 95% CI, 0.71-1.32) along with similar rates of grade 3 or higher and serious adverse events.

Study details: Findings are from the phase 3 KAITLIN study, including 1,846 patients with HER2-positive early BC who were randomly assigned to receive T-DM1+pertuzumab or trastuzumab+taxane+pertuzumab after surgery and anthracycline chemotherapy.

Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors declared serving as consultant, speaker, and/or receiving honorarium, funding, and travel expense from several sources. Some authors were employed and/or held stocks in various sources.

Source: Krop IE et al. J Clin Oncol. 2021 Dec 10. doi: 10.1200/JCO.21.00896.

Key clinical point: Palbociclib+fulvestrant prolonged progression-free survival (PFS) compared with placebo+fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-sensitive advanced breast cancer (BC).

Major finding: Palbociclib+fulvestrant vs placebo+fulvestrant improved 1-year PFS (83.5% vs 71.9%) and reduced the risk for progressive disease by 45% (hazard ratio [HR], 0.55; 80% CI, 0.36-0.83). Grade 3 or higher adverse events were reported by 80.9% vs 37.9% of patients in palbociclib/fulvestrant vs placebo/fulvestrant arms.

Study details: This was a phase 2 FLIPPER study of 189 postmenopausal women with HR-positive, HER2-negative, endocrine-sensitive advanced BC who were randomly assigned to palbociclib+fulvestrant or placebo+fulvestrant.

Disclosures: This study was funded by GEICAM Spanish Breast Cancer Group, AstraZeneca, and Pfizer. The authors reported receiving research grants, advisory board fees, consulting fees, honoraria, and travel and accommodation support from several sources.

Source: Albanell J et al. Eur J Cancer. 2021 Dec 11. doi: 10.1016/j.ejca.2021.11.010.

Key clinical point: Palbociclib+fulvestrant prolonged progression-free survival (PFS) compared with placebo+fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-sensitive advanced breast cancer (BC).

Major finding: Palbociclib+fulvestrant vs placebo+fulvestrant improved 1-year PFS (83.5% vs 71.9%) and reduced the risk for progressive disease by 45% (hazard ratio [HR], 0.55; 80% CI, 0.36-0.83). Grade 3 or higher adverse events were reported by 80.9% vs 37.9% of patients in palbociclib/fulvestrant vs placebo/fulvestrant arms.

Study details: This was a phase 2 FLIPPER study of 189 postmenopausal women with HR-positive, HER2-negative, endocrine-sensitive advanced BC who were randomly assigned to palbociclib+fulvestrant or placebo+fulvestrant.

Disclosures: This study was funded by GEICAM Spanish Breast Cancer Group, AstraZeneca, and Pfizer. The authors reported receiving research grants, advisory board fees, consulting fees, honoraria, and travel and accommodation support from several sources.

Source: Albanell J et al. Eur J Cancer. 2021 Dec 11. doi: 10.1016/j.ejca.2021.11.010.

Key clinical point: Palbociclib+fulvestrant prolonged progression-free survival (PFS) compared with placebo+fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-sensitive advanced breast cancer (BC).

Major finding: Palbociclib+fulvestrant vs placebo+fulvestrant improved 1-year PFS (83.5% vs 71.9%) and reduced the risk for progressive disease by 45% (hazard ratio [HR], 0.55; 80% CI, 0.36-0.83). Grade 3 or higher adverse events were reported by 80.9% vs 37.9% of patients in palbociclib/fulvestrant vs placebo/fulvestrant arms.

Study details: This was a phase 2 FLIPPER study of 189 postmenopausal women with HR-positive, HER2-negative, endocrine-sensitive advanced BC who were randomly assigned to palbociclib+fulvestrant or placebo+fulvestrant.

Disclosures: This study was funded by GEICAM Spanish Breast Cancer Group, AstraZeneca, and Pfizer. The authors reported receiving research grants, advisory board fees, consulting fees, honoraria, and travel and accommodation support from several sources.

Source: Albanell J et al. Eur J Cancer. 2021 Dec 11. doi: 10.1016/j.ejca.2021.11.010.

Key clinical point: Women with metastatic breast cancer (BC) with long-term response to first-line human epidermal growth factor receptor 2 (HER2)-targeted therapy who achieved no evidence of disease (NED) showed improved survival than those with residual disease (RES).

Major finding: Women with NED vs RES achieved longer median progression-free survival (not reached vs 3.08 years; P < .001) and superior overall survival (not reached vs 5.38 years; P < .001) with premenopausal status (P = .006) and de novo metastases (P = .002) associated with higher chances of achieving NED.

Study details: Findings are from a retrospective study including 103 women with HER2-positive metastatic BC who received first-line chemotherapy+trastuzumab or taxane+trastuzumab+pertuzumab and showed a response duration ≥2-fold higher than those observed in pivotal trials.

Disclosures: This study did not report any source of funding. The authors declared serving as a member of a trial steering committee and/or receiving honoraria, funding, consultancy, and advisory fees from several sources.

Source: Veitch Z et al. Br J Cancer. 2021 Dec 20. doi: 10.1038/s41416-021-01676-4.

Key clinical point: Women with metastatic breast cancer (BC) with long-term response to first-line human epidermal growth factor receptor 2 (HER2)-targeted therapy who achieved no evidence of disease (NED) showed improved survival than those with residual disease (RES).

Major finding: Women with NED vs RES achieved longer median progression-free survival (not reached vs 3.08 years; P < .001) and superior overall survival (not reached vs 5.38 years; P < .001) with premenopausal status (P = .006) and de novo metastases (P = .002) associated with higher chances of achieving NED.

Study details: Findings are from a retrospective study including 103 women with HER2-positive metastatic BC who received first-line chemotherapy+trastuzumab or taxane+trastuzumab+pertuzumab and showed a response duration ≥2-fold higher than those observed in pivotal trials.

Disclosures: This study did not report any source of funding. The authors declared serving as a member of a trial steering committee and/or receiving honoraria, funding, consultancy, and advisory fees from several sources.

Source: Veitch Z et al. Br J Cancer. 2021 Dec 20. doi: 10.1038/s41416-021-01676-4.

Key clinical point: Women with metastatic breast cancer (BC) with long-term response to first-line human epidermal growth factor receptor 2 (HER2)-targeted therapy who achieved no evidence of disease (NED) showed improved survival than those with residual disease (RES).

Major finding: Women with NED vs RES achieved longer median progression-free survival (not reached vs 3.08 years; P < .001) and superior overall survival (not reached vs 5.38 years; P < .001) with premenopausal status (P = .006) and de novo metastases (P = .002) associated with higher chances of achieving NED.

Study details: Findings are from a retrospective study including 103 women with HER2-positive metastatic BC who received first-line chemotherapy+trastuzumab or taxane+trastuzumab+pertuzumab and showed a response duration ≥2-fold higher than those observed in pivotal trials.

Disclosures: This study did not report any source of funding. The authors declared serving as a member of a trial steering committee and/or receiving honoraria, funding, consultancy, and advisory fees from several sources.

Source: Veitch Z et al. Br J Cancer. 2021 Dec 20. doi: 10.1038/s41416-021-01676-4.

Key clinical point: Addition of tucatinib to trastuzumab and capecitabine continued to improve survival along with good tolerability in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (BC) who progressed on HER2-targeted therapies.

Major finding: Addition of tucatinib to trastuzumab and capecitabine significantly improved overall survival (hazard ratio [HR] for death, 0.73; P = .004) and progression-free survival (HR for disease-progression or death, 0.57; P < .00001) compared with placebo. Rates of grade 3 or higher adverse events (AEs) were similar between treatment arms, with only 5.9% of patients discontinuing treatment because of AEs.

Study details: These are the final outcomes from the phase 2 HER2CLIMB study including 612 patients with HER2-positive metastatic BC who progressed on trastuzumab, pertuzumab, and trastuzumab emtansine and were randomly assigned to tucatinib or placebo, each in combination with trastuzumab and capecitabine.

Disclosures: This work was supported by Seagen Inc. and Merck Sharp & Dohme Corp. Four authors declared being employees of Seagen and other sources, and other authors reported ties with various sources.

Source: Curigliano G et al. Ann Oncol. 2021 Dec 22. doi: 10.1016/j.annonc.2021.12.005.

Key clinical point: Addition of tucatinib to trastuzumab and capecitabine continued to improve survival along with good tolerability in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (BC) who progressed on HER2-targeted therapies.

Major finding: Addition of tucatinib to trastuzumab and capecitabine significantly improved overall survival (hazard ratio [HR] for death, 0.73; P = .004) and progression-free survival (HR for disease-progression or death, 0.57; P < .00001) compared with placebo. Rates of grade 3 or higher adverse events (AEs) were similar between treatment arms, with only 5.9% of patients discontinuing treatment because of AEs.

Study details: These are the final outcomes from the phase 2 HER2CLIMB study including 612 patients with HER2-positive metastatic BC who progressed on trastuzumab, pertuzumab, and trastuzumab emtansine and were randomly assigned to tucatinib or placebo, each in combination with trastuzumab and capecitabine.

Disclosures: This work was supported by Seagen Inc. and Merck Sharp & Dohme Corp. Four authors declared being employees of Seagen and other sources, and other authors reported ties with various sources.

Source: Curigliano G et al. Ann Oncol. 2021 Dec 22. doi: 10.1016/j.annonc.2021.12.005.

Key clinical point: Addition of tucatinib to trastuzumab and capecitabine continued to improve survival along with good tolerability in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (BC) who progressed on HER2-targeted therapies.

Major finding: Addition of tucatinib to trastuzumab and capecitabine significantly improved overall survival (hazard ratio [HR] for death, 0.73; P = .004) and progression-free survival (HR for disease-progression or death, 0.57; P < .00001) compared with placebo. Rates of grade 3 or higher adverse events (AEs) were similar between treatment arms, with only 5.9% of patients discontinuing treatment because of AEs.

Study details: These are the final outcomes from the phase 2 HER2CLIMB study including 612 patients with HER2-positive metastatic BC who progressed on trastuzumab, pertuzumab, and trastuzumab emtansine and were randomly assigned to tucatinib or placebo, each in combination with trastuzumab and capecitabine.

Disclosures: This work was supported by Seagen Inc. and Merck Sharp & Dohme Corp. Four authors declared being employees of Seagen and other sources, and other authors reported ties with various sources.

Source: Curigliano G et al. Ann Oncol. 2021 Dec 22. doi: 10.1016/j.annonc.2021.12.005.