Clinical Edge Journal Scan

Key clinical point: Nilotinib treatment resulted in an early and stable clearance of CD34+/lin-Ph+ cells from the bone marrow of patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP).

Major finding: At 3, 6, and 12 months, only 12.3% (95% confidence interval [CI], 5.5%-22.8%), 7% (95% CI, 2.3%-15.7%), and 0% (95% CI, 0.0%-5.0%) samples, respectively, showed residual CD34+/lin-Ph+ cells, indicating rapid and sustained clearance of these cells from the bone marrow of treated patients.

Study details: Findings are from a prospective, single-arm, PhilosoPhi34 study including 87 adult patients with newly diagnosed Philadelphia chromosome-positive CML-CP treated with nilotinib 300 mg twice daily.

Disclosures: This study was partly supported by Novartis. The authors declared no conflicts of interest.

Source: Pungolino E et al. Eur J Haematol. 2021 Jun 17. doi: 10.1111/ejh.13680.

Key clinical point: Nilotinib treatment resulted in an early and stable clearance of CD34+/lin-Ph+ cells from the bone marrow of patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP).

Major finding: At 3, 6, and 12 months, only 12.3% (95% confidence interval [CI], 5.5%-22.8%), 7% (95% CI, 2.3%-15.7%), and 0% (95% CI, 0.0%-5.0%) samples, respectively, showed residual CD34+/lin-Ph+ cells, indicating rapid and sustained clearance of these cells from the bone marrow of treated patients.

Study details: Findings are from a prospective, single-arm, PhilosoPhi34 study including 87 adult patients with newly diagnosed Philadelphia chromosome-positive CML-CP treated with nilotinib 300 mg twice daily.

Disclosures: This study was partly supported by Novartis. The authors declared no conflicts of interest.

Source: Pungolino E et al. Eur J Haematol. 2021 Jun 17. doi: 10.1111/ejh.13680.

Key clinical point: Nilotinib treatment resulted in an early and stable clearance of CD34+/lin-Ph+ cells from the bone marrow of patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP).

Major finding: At 3, 6, and 12 months, only 12.3% (95% confidence interval [CI], 5.5%-22.8%), 7% (95% CI, 2.3%-15.7%), and 0% (95% CI, 0.0%-5.0%) samples, respectively, showed residual CD34+/lin-Ph+ cells, indicating rapid and sustained clearance of these cells from the bone marrow of treated patients.

Study details: Findings are from a prospective, single-arm, PhilosoPhi34 study including 87 adult patients with newly diagnosed Philadelphia chromosome-positive CML-CP treated with nilotinib 300 mg twice daily.

Disclosures: This study was partly supported by Novartis. The authors declared no conflicts of interest.

Source: Pungolino E et al. Eur J Haematol. 2021 Jun 17. doi: 10.1111/ejh.13680.

Key clinical point: Dasatinib dose optimization by therapeutic drug monitoring (TDM) during treatment initiation in patients with newly diagnosed chronic myeloid leukemia (CML) was feasible and led to a significant reduction in pleural effusion (PIEff) without affecting molecular responses.

Major finding: Reduced incidence of all-grade PlEff was observed in patients with high trough concentration [(C)min] who underwent dasatinib dose optimization by TDM (TDM arm; 13.2%) vs those who continued with standard dose (control arm; 42.8%) and those with low (C)min assigned to observation (observation arm; 17.4%; P = .006), with no major effect on major molecular response (P = .978) across the 3 arms.

Study details: Findings are from the phase 2 OPTIM-dasatinib study including 287 patients with newly diagnosed, previously untreated (except with hydroxycarbamide) CML. Patients were initially started on dasatinib 100 mg/day. After 7-10 days, patients with low (C)min were assigned to the observation arm (n=207) and those with high (C)min (3 nmol/L or higher) were randomly assigned to either TDM (n=38) or control (n=42) arms.

Disclosures: This study was funded by Bristol-Myers Squibb. The lead author reported research funding from Bristol-Myers Squibb, Pfizer, and Incyte.

Source: Rousselot P et al. Br J Haematol. 2021 Jun 30. doi: 10.1111/bjh.17654.

Key clinical point: Dasatinib dose optimization by therapeutic drug monitoring (TDM) during treatment initiation in patients with newly diagnosed chronic myeloid leukemia (CML) was feasible and led to a significant reduction in pleural effusion (PIEff) without affecting molecular responses.

Major finding: Reduced incidence of all-grade PlEff was observed in patients with high trough concentration [(C)min] who underwent dasatinib dose optimization by TDM (TDM arm; 13.2%) vs those who continued with standard dose (control arm; 42.8%) and those with low (C)min assigned to observation (observation arm; 17.4%; P = .006), with no major effect on major molecular response (P = .978) across the 3 arms.

Study details: Findings are from the phase 2 OPTIM-dasatinib study including 287 patients with newly diagnosed, previously untreated (except with hydroxycarbamide) CML. Patients were initially started on dasatinib 100 mg/day. After 7-10 days, patients with low (C)min were assigned to the observation arm (n=207) and those with high (C)min (3 nmol/L or higher) were randomly assigned to either TDM (n=38) or control (n=42) arms.

Disclosures: This study was funded by Bristol-Myers Squibb. The lead author reported research funding from Bristol-Myers Squibb, Pfizer, and Incyte.

Source: Rousselot P et al. Br J Haematol. 2021 Jun 30. doi: 10.1111/bjh.17654.

Key clinical point: Dasatinib dose optimization by therapeutic drug monitoring (TDM) during treatment initiation in patients with newly diagnosed chronic myeloid leukemia (CML) was feasible and led to a significant reduction in pleural effusion (PIEff) without affecting molecular responses.

Major finding: Reduced incidence of all-grade PlEff was observed in patients with high trough concentration [(C)min] who underwent dasatinib dose optimization by TDM (TDM arm; 13.2%) vs those who continued with standard dose (control arm; 42.8%) and those with low (C)min assigned to observation (observation arm; 17.4%; P = .006), with no major effect on major molecular response (P = .978) across the 3 arms.

Study details: Findings are from the phase 2 OPTIM-dasatinib study including 287 patients with newly diagnosed, previously untreated (except with hydroxycarbamide) CML. Patients were initially started on dasatinib 100 mg/day. After 7-10 days, patients with low (C)min were assigned to the observation arm (n=207) and those with high (C)min (3 nmol/L or higher) were randomly assigned to either TDM (n=38) or control (n=42) arms.

Disclosures: This study was funded by Bristol-Myers Squibb. The lead author reported research funding from Bristol-Myers Squibb, Pfizer, and Incyte.

Source: Rousselot P et al. Br J Haematol. 2021 Jun 30. doi: 10.1111/bjh.17654.

Key clinical point: Suboptimal responses to a single dose of Pfizer-BioNTech BNT162b2 or AstraZeneca ChAdOx1 nCoV-19 vaccines in patients with chronic myeloid neoplasms including chronic myeloid leukemia (CML) highlight a potentially important immunocompromise in this patient population.

Major finding: At 14 days after single vaccination dose, patients with chronic myeloid blood cancers vs health care workers above 60 years of age had significantly lower seroconversion (58% vs 97%) and median anti-S antibody titer (75 vs 630; both P less than .0001). Among disease subgroups, seroconversion was highest in patients with CML (75%) and observed in 83% of patients with CML receiving imatinib.

Study details: Findings are from a real-world analysis of 60 patients with myeloid cancers, including 12 patients with CML and no evidence of prior COVID-19 infection, who received a single dose of either BNT162b2 or ChAdOx1 nCoV-19 vaccines.

Disclosures: This study was funded by the National Institute of Health Research Oxford Biomedical Research Centre. The authors declared no conflicts of interest.

Source: Chowdhury O et al. Br J Haematol. 2021 Jun 16. doi: 10.1111/bjh.17644.

Key clinical point: Suboptimal responses to a single dose of Pfizer-BioNTech BNT162b2 or AstraZeneca ChAdOx1 nCoV-19 vaccines in patients with chronic myeloid neoplasms including chronic myeloid leukemia (CML) highlight a potentially important immunocompromise in this patient population.

Major finding: At 14 days after single vaccination dose, patients with chronic myeloid blood cancers vs health care workers above 60 years of age had significantly lower seroconversion (58% vs 97%) and median anti-S antibody titer (75 vs 630; both P less than .0001). Among disease subgroups, seroconversion was highest in patients with CML (75%) and observed in 83% of patients with CML receiving imatinib.

Study details: Findings are from a real-world analysis of 60 patients with myeloid cancers, including 12 patients with CML and no evidence of prior COVID-19 infection, who received a single dose of either BNT162b2 or ChAdOx1 nCoV-19 vaccines.

Disclosures: This study was funded by the National Institute of Health Research Oxford Biomedical Research Centre. The authors declared no conflicts of interest.

Source: Chowdhury O et al. Br J Haematol. 2021 Jun 16. doi: 10.1111/bjh.17644.

Key clinical point: Suboptimal responses to a single dose of Pfizer-BioNTech BNT162b2 or AstraZeneca ChAdOx1 nCoV-19 vaccines in patients with chronic myeloid neoplasms including chronic myeloid leukemia (CML) highlight a potentially important immunocompromise in this patient population.

Major finding: At 14 days after single vaccination dose, patients with chronic myeloid blood cancers vs health care workers above 60 years of age had significantly lower seroconversion (58% vs 97%) and median anti-S antibody titer (75 vs 630; both P less than .0001). Among disease subgroups, seroconversion was highest in patients with CML (75%) and observed in 83% of patients with CML receiving imatinib.

Study details: Findings are from a real-world analysis of 60 patients with myeloid cancers, including 12 patients with CML and no evidence of prior COVID-19 infection, who received a single dose of either BNT162b2 or ChAdOx1 nCoV-19 vaccines.

Disclosures: This study was funded by the National Institute of Health Research Oxford Biomedical Research Centre. The authors declared no conflicts of interest.

Source: Chowdhury O et al. Br J Haematol. 2021 Jun 16. doi: 10.1111/bjh.17644.

Key clinical point: Chemotherapy is not associated with postmastectomy breast reconstruction surgical complications or with most surgery-related patient-reported outcomes.

Major finding: Compared with no chemotherapy, no difference was observed in the risk for any/major complication with either neoadjuvant (P = .68 and .46, respectively) or adjuvant (P = .15 and .053, respectively) chemotherapy in patients who received implant-based procedures. In patients who received autologous reconstruction, the risk for 2-year postoperative any/major complication was similar with neoadjuvant (P = .25 and .11, respectively) and adjuvant (P = .44 and .40, respectively) chemotherapy vs no chemotherapy. There were no differences across the chemotherapy groups for most BREAST-Q subscales.

Study details: A multicenter cohort study of 1,881 women who underwent postmastectomy breast reconstruction and were followed up for 2 years.

Disclosures: This study was supported by the National Cancer Institute. The authors did not report any conflicts of interest.

Source: Hart SE et al. JAMA Surg. 2021 Jun 23. doi: 10.1001/jamasurg.2021.2239.

Key clinical point: Chemotherapy is not associated with postmastectomy breast reconstruction surgical complications or with most surgery-related patient-reported outcomes.

Major finding: Compared with no chemotherapy, no difference was observed in the risk for any/major complication with either neoadjuvant (P = .68 and .46, respectively) or adjuvant (P = .15 and .053, respectively) chemotherapy in patients who received implant-based procedures. In patients who received autologous reconstruction, the risk for 2-year postoperative any/major complication was similar with neoadjuvant (P = .25 and .11, respectively) and adjuvant (P = .44 and .40, respectively) chemotherapy vs no chemotherapy. There were no differences across the chemotherapy groups for most BREAST-Q subscales.

Study details: A multicenter cohort study of 1,881 women who underwent postmastectomy breast reconstruction and were followed up for 2 years.

Disclosures: This study was supported by the National Cancer Institute. The authors did not report any conflicts of interest.

Source: Hart SE et al. JAMA Surg. 2021 Jun 23. doi: 10.1001/jamasurg.2021.2239.

Key clinical point: Chemotherapy is not associated with postmastectomy breast reconstruction surgical complications or with most surgery-related patient-reported outcomes.

Major finding: Compared with no chemotherapy, no difference was observed in the risk for any/major complication with either neoadjuvant (P = .68 and .46, respectively) or adjuvant (P = .15 and .053, respectively) chemotherapy in patients who received implant-based procedures. In patients who received autologous reconstruction, the risk for 2-year postoperative any/major complication was similar with neoadjuvant (P = .25 and .11, respectively) and adjuvant (P = .44 and .40, respectively) chemotherapy vs no chemotherapy. There were no differences across the chemotherapy groups for most BREAST-Q subscales.

Study details: A multicenter cohort study of 1,881 women who underwent postmastectomy breast reconstruction and were followed up for 2 years.

Disclosures: This study was supported by the National Cancer Institute. The authors did not report any conflicts of interest.

Source: Hart SE et al. JAMA Surg. 2021 Jun 23. doi: 10.1001/jamasurg.2021.2239.

Key clinical point: In the real-world setting, the overall survival (OS) with pertuzumab and trastuzumab emtansine (T-DM1) in patients with human epidermal growth factor hormone receptor 2 (HER2)-positive metastatic breast cancer is inferior to results from pivotal clinical trials.

Major finding: The OS with pertuzumab and T-DM1 was shorter than that reported in the pivotal clinical trials. In the pertuzumab cohort, OS was 43 months and time on treatment was 14 months. In the T-DM1 cohort, median OS and time on treatment were 15 months and 4 months, respectively.

Study details: A population-based retrospective cohort study of patients with ERBB2-positive metastatic breast cancer treated with first-line pertuzumab (n=795) or second-line T-DM1 (n=506).

Disclosures: This study was supported by the Canadian Institutes of Health Research. The authors received personal fees from various sources outside this work. Dr. CM Booth was supported as a Canada Research Chair in Population Cancer Care.

Source: Ethier JL et al. JAMA Oncol. 2021 Jul 8. doi: 10.1001/jamaoncol.2021.2140.

Key clinical point: In the real-world setting, the overall survival (OS) with pertuzumab and trastuzumab emtansine (T-DM1) in patients with human epidermal growth factor hormone receptor 2 (HER2)-positive metastatic breast cancer is inferior to results from pivotal clinical trials.

Major finding: The OS with pertuzumab and T-DM1 was shorter than that reported in the pivotal clinical trials. In the pertuzumab cohort, OS was 43 months and time on treatment was 14 months. In the T-DM1 cohort, median OS and time on treatment were 15 months and 4 months, respectively.

Study details: A population-based retrospective cohort study of patients with ERBB2-positive metastatic breast cancer treated with first-line pertuzumab (n=795) or second-line T-DM1 (n=506).

Disclosures: This study was supported by the Canadian Institutes of Health Research. The authors received personal fees from various sources outside this work. Dr. CM Booth was supported as a Canada Research Chair in Population Cancer Care.

Source: Ethier JL et al. JAMA Oncol. 2021 Jul 8. doi: 10.1001/jamaoncol.2021.2140.

Key clinical point: In the real-world setting, the overall survival (OS) with pertuzumab and trastuzumab emtansine (T-DM1) in patients with human epidermal growth factor hormone receptor 2 (HER2)-positive metastatic breast cancer is inferior to results from pivotal clinical trials.

Major finding: The OS with pertuzumab and T-DM1 was shorter than that reported in the pivotal clinical trials. In the pertuzumab cohort, OS was 43 months and time on treatment was 14 months. In the T-DM1 cohort, median OS and time on treatment were 15 months and 4 months, respectively.

Study details: A population-based retrospective cohort study of patients with ERBB2-positive metastatic breast cancer treated with first-line pertuzumab (n=795) or second-line T-DM1 (n=506).

Disclosures: This study was supported by the Canadian Institutes of Health Research. The authors received personal fees from various sources outside this work. Dr. CM Booth was supported as a Canada Research Chair in Population Cancer Care.

Source: Ethier JL et al. JAMA Oncol. 2021 Jul 8. doi: 10.1001/jamaoncol.2021.2140.

Key clinical point: Stereotactic ablative body radiotherapy (SABR) leads to long-term systemic disease control and survival in patients with oligometastatic breast cancer.

Major finding: The median follow-up was 50 months. Of the patients who progressed, 82% had new metastases and 18% experienced local failure. Median overall survival (OS) was 86 months, and progression-free survival (PFS) was 33 months. The receipt of SABR within 5 years of diagnosis (P = .004) and presence of triple-negative breast cancer (TNBC; P = .013) were associated with worse OS. Advanced T stage (P = .062) and TNBC (P = .013) were associated with worse PFS.

Study details: A retrospective study of patients with metastatic breast cancer who received SABR between 2008 and 2018.

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

Source: Wijetunga NA et al. Cancer Med. 2021 Jun 22. doi: 10.1002/cam4.4068.

Key clinical point: Stereotactic ablative body radiotherapy (SABR) leads to long-term systemic disease control and survival in patients with oligometastatic breast cancer.

Major finding: The median follow-up was 50 months. Of the patients who progressed, 82% had new metastases and 18% experienced local failure. Median overall survival (OS) was 86 months, and progression-free survival (PFS) was 33 months. The receipt of SABR within 5 years of diagnosis (P = .004) and presence of triple-negative breast cancer (TNBC; P = .013) were associated with worse OS. Advanced T stage (P = .062) and TNBC (P = .013) were associated with worse PFS.

Study details: A retrospective study of patients with metastatic breast cancer who received SABR between 2008 and 2018.

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

Source: Wijetunga NA et al. Cancer Med. 2021 Jun 22. doi: 10.1002/cam4.4068.

Key clinical point: Stereotactic ablative body radiotherapy (SABR) leads to long-term systemic disease control and survival in patients with oligometastatic breast cancer.

Major finding: The median follow-up was 50 months. Of the patients who progressed, 82% had new metastases and 18% experienced local failure. Median overall survival (OS) was 86 months, and progression-free survival (PFS) was 33 months. The receipt of SABR within 5 years of diagnosis (P = .004) and presence of triple-negative breast cancer (TNBC; P = .013) were associated with worse OS. Advanced T stage (P = .062) and TNBC (P = .013) were associated with worse PFS.

Study details: A retrospective study of patients with metastatic breast cancer who received SABR between 2008 and 2018.

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

Source: Wijetunga NA et al. Cancer Med. 2021 Jun 22. doi: 10.1002/cam4.4068.

Key clinical point: Denosumab improves bone-related outcomes in women with high-risk early-stage breast cancer.

Major finding: Denosumab was associated with longer time to first bone metastasis in patients younger than 50 years (hazard ratio [HR], 0.70; P = .018) and in premenopausal women (HR, 0.74; P = .038). Denosumab also delayed the risk for first fracture (HR, 0.76; P = .004) and first skeletal-related event (HR, 0.52; P = .001).

Study details: An exploratory analysis of randomized, placebo-controlled phase 3 D-CARE trial of 4,509 patients with stage II/III breast cancer randomly assigned to receive adjuvant/neoadjuvant chemotherapy with either denosumab or placebo.

Disclosures: This study was funded by Amgen Inc. Dr. R Coleman received lecture funding, steering committee fees, and travel expenses from various sources and reported stock ownership in Inbiomotion. Dr. Y. Zhou, Dr. D. Jandial, and Dr. B. Cadieux were employees of and/or shareholders in Amgen. The other authors have no competing interest.

Source: Coleman R et al. Adv Ther. 2021 Jun 29. doi: 10.1007/s12325-021-01812-9.

Key clinical point: Denosumab improves bone-related outcomes in women with high-risk early-stage breast cancer.

Major finding: Denosumab was associated with longer time to first bone metastasis in patients younger than 50 years (hazard ratio [HR], 0.70; P = .018) and in premenopausal women (HR, 0.74; P = .038). Denosumab also delayed the risk for first fracture (HR, 0.76; P = .004) and first skeletal-related event (HR, 0.52; P = .001).

Study details: An exploratory analysis of randomized, placebo-controlled phase 3 D-CARE trial of 4,509 patients with stage II/III breast cancer randomly assigned to receive adjuvant/neoadjuvant chemotherapy with either denosumab or placebo.

Disclosures: This study was funded by Amgen Inc. Dr. R Coleman received lecture funding, steering committee fees, and travel expenses from various sources and reported stock ownership in Inbiomotion. Dr. Y. Zhou, Dr. D. Jandial, and Dr. B. Cadieux were employees of and/or shareholders in Amgen. The other authors have no competing interest.

Source: Coleman R et al. Adv Ther. 2021 Jun 29. doi: 10.1007/s12325-021-01812-9.

Key clinical point: Denosumab improves bone-related outcomes in women with high-risk early-stage breast cancer.

Major finding: Denosumab was associated with longer time to first bone metastasis in patients younger than 50 years (hazard ratio [HR], 0.70; P = .018) and in premenopausal women (HR, 0.74; P = .038). Denosumab also delayed the risk for first fracture (HR, 0.76; P = .004) and first skeletal-related event (HR, 0.52; P = .001).

Study details: An exploratory analysis of randomized, placebo-controlled phase 3 D-CARE trial of 4,509 patients with stage II/III breast cancer randomly assigned to receive adjuvant/neoadjuvant chemotherapy with either denosumab or placebo.

Disclosures: This study was funded by Amgen Inc. Dr. R Coleman received lecture funding, steering committee fees, and travel expenses from various sources and reported stock ownership in Inbiomotion. Dr. Y. Zhou, Dr. D. Jandial, and Dr. B. Cadieux were employees of and/or shareholders in Amgen. The other authors have no competing interest.

Source: Coleman R et al. Adv Ther. 2021 Jun 29. doi: 10.1007/s12325-021-01812-9.

Key clinical point: The clinical benefit of ribociclib is maintained in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer who required dose reduction to manage adverse events.

Major finding: Ribociclib dose reductions were reported in 45.8% of patients; most were attributed to adverse reactions. The median progression-free survival was 24.8, 24.9, and 29.6 months for patients who received 71% or less, 72%-96%, and 97%-100% ribociclib relative dose intensity, respectively. The clinical benefit ratio was 87.6%, 76.8%, and 73.6%, respectively.

Study details: A pooled analysis of MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials evaluated the safety and impact of ribociclib dose reduction in 818 patients with HR-positive, HER2-negative advanced breast cancer.

Disclosures: The study was supported by Novartis Pharmaceuticals Corporation. The authors received grants, funding, and/or consulting/advisory/personal fees from various sources. Dr. JP Zarate, Dr. A Ridolfi, and Dr. KR Lorenc were employed by and owned stocks in Novartis.

Source: Burris HA et al. Br J Cancer. 2021 Jun 22. doi: 10.1038/s41416-021-01415-9.

Key clinical point: The clinical benefit of ribociclib is maintained in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer who required dose reduction to manage adverse events.

Major finding: Ribociclib dose reductions were reported in 45.8% of patients; most were attributed to adverse reactions. The median progression-free survival was 24.8, 24.9, and 29.6 months for patients who received 71% or less, 72%-96%, and 97%-100% ribociclib relative dose intensity, respectively. The clinical benefit ratio was 87.6%, 76.8%, and 73.6%, respectively.

Study details: A pooled analysis of MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials evaluated the safety and impact of ribociclib dose reduction in 818 patients with HR-positive, HER2-negative advanced breast cancer.

Disclosures: The study was supported by Novartis Pharmaceuticals Corporation. The authors received grants, funding, and/or consulting/advisory/personal fees from various sources. Dr. JP Zarate, Dr. A Ridolfi, and Dr. KR Lorenc were employed by and owned stocks in Novartis.

Source: Burris HA et al. Br J Cancer. 2021 Jun 22. doi: 10.1038/s41416-021-01415-9.

Key clinical point: The clinical benefit of ribociclib is maintained in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer who required dose reduction to manage adverse events.

Major finding: Ribociclib dose reductions were reported in 45.8% of patients; most were attributed to adverse reactions. The median progression-free survival was 24.8, 24.9, and 29.6 months for patients who received 71% or less, 72%-96%, and 97%-100% ribociclib relative dose intensity, respectively. The clinical benefit ratio was 87.6%, 76.8%, and 73.6%, respectively.

Study details: A pooled analysis of MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials evaluated the safety and impact of ribociclib dose reduction in 818 patients with HR-positive, HER2-negative advanced breast cancer.

Disclosures: The study was supported by Novartis Pharmaceuticals Corporation. The authors received grants, funding, and/or consulting/advisory/personal fees from various sources. Dr. JP Zarate, Dr. A Ridolfi, and Dr. KR Lorenc were employed by and owned stocks in Novartis.

Source: Burris HA et al. Br J Cancer. 2021 Jun 22. doi: 10.1038/s41416-021-01415-9.

Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, CT-P6, a trastuzumab biosimilar shows 3-year survival comparable with trastuzumab.

Major finding: Median disease-free survival (DFS), overall survival (OS), and progression-free survival (PFS) were not reached in either group. In the CT-P6 vs trastuzumab group, the 3-year DFS, PFS, and OS rates were 83% vs 83%, 81% vs 87%, and 93% vs 94%, respectively.

Study details: A randomized, double-blind, active-controlled, phase 3 equivalence trial of 549 patients with HER2‑positive early breast cancer who received neoadjuvant treatment with CT-P6 or trastuzumab with chemotherapy, followed by surgery. Patients were followed up for 3 years (n=528) after receiving adjuvant CT-P6 or trastuzumab.

Disclosures: The study was funded by Celltrion, Inc. The authors received grants and consulting/advisory fees from various sources. Dr. SJ Lee and Dr. S Kim were employees of and/or stockholders in Celltrion.

Source: Stebbing J et al. Breast Cancer Res Treat. 2021 Jun 20. doi: 10.1007/s10549-021-06240-5.

Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, CT-P6, a trastuzumab biosimilar shows 3-year survival comparable with trastuzumab.

Major finding: Median disease-free survival (DFS), overall survival (OS), and progression-free survival (PFS) were not reached in either group. In the CT-P6 vs trastuzumab group, the 3-year DFS, PFS, and OS rates were 83% vs 83%, 81% vs 87%, and 93% vs 94%, respectively.

Study details: A randomized, double-blind, active-controlled, phase 3 equivalence trial of 549 patients with HER2‑positive early breast cancer who received neoadjuvant treatment with CT-P6 or trastuzumab with chemotherapy, followed by surgery. Patients were followed up for 3 years (n=528) after receiving adjuvant CT-P6 or trastuzumab.

Disclosures: The study was funded by Celltrion, Inc. The authors received grants and consulting/advisory fees from various sources. Dr. SJ Lee and Dr. S Kim were employees of and/or stockholders in Celltrion.

Source: Stebbing J et al. Breast Cancer Res Treat. 2021 Jun 20. doi: 10.1007/s10549-021-06240-5.

Key clinical point: In patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, CT-P6, a trastuzumab biosimilar shows 3-year survival comparable with trastuzumab.

Major finding: Median disease-free survival (DFS), overall survival (OS), and progression-free survival (PFS) were not reached in either group. In the CT-P6 vs trastuzumab group, the 3-year DFS, PFS, and OS rates were 83% vs 83%, 81% vs 87%, and 93% vs 94%, respectively.

Study details: A randomized, double-blind, active-controlled, phase 3 equivalence trial of 549 patients with HER2‑positive early breast cancer who received neoadjuvant treatment with CT-P6 or trastuzumab with chemotherapy, followed by surgery. Patients were followed up for 3 years (n=528) after receiving adjuvant CT-P6 or trastuzumab.

Disclosures: The study was funded by Celltrion, Inc. The authors received grants and consulting/advisory fees from various sources. Dr. SJ Lee and Dr. S Kim were employees of and/or stockholders in Celltrion.

Source: Stebbing J et al. Breast Cancer Res Treat. 2021 Jun 20. doi: 10.1007/s10549-021-06240-5.

Key clinical point: Bisphosphonate therapy for 5 vs 2 years in patients with high-risk early breast cancer yields no added survival benefit and leads to increased risk for adverse events.

Major finding: There were no significant differences in disease-free survival (hazard ratio [HR], 0.97; P = .81), overall survival (HR, 0.98; P = .90), and distant disease-free survival (HR, 0.87; P = .38) between 5- and 2-year bisphosphonate treatment groups. The rate of adverse events was 46.2% with 5-year therapy and 27.2% with 2-year treatment.

Study details: A randomized phase 3, open-label SUCCESS A trial of 2,987 patients with high-risk early breast cancer randomly assigned to receive bisphosphonate zoledronate for either 5 or 2 years.

Disclosures: The study was supported by AstraZeneca, Chugai, Menarini Silicon Biosystems (formerly Veridex), Lilly, Novartis, and Sanofi-Aventis. The authors received honoraria, personal fees, research support, consulting fees, and travel grants from various sources.

Source: Friedl TWP et al. JAMA Oncol. 2021 Jun 24. doi: 10.1001/jamaoncol.2021.1854.

Key clinical point: Bisphosphonate therapy for 5 vs 2 years in patients with high-risk early breast cancer yields no added survival benefit and leads to increased risk for adverse events.

Major finding: There were no significant differences in disease-free survival (hazard ratio [HR], 0.97; P = .81), overall survival (HR, 0.98; P = .90), and distant disease-free survival (HR, 0.87; P = .38) between 5- and 2-year bisphosphonate treatment groups. The rate of adverse events was 46.2% with 5-year therapy and 27.2% with 2-year treatment.

Study details: A randomized phase 3, open-label SUCCESS A trial of 2,987 patients with high-risk early breast cancer randomly assigned to receive bisphosphonate zoledronate for either 5 or 2 years.

Disclosures: The study was supported by AstraZeneca, Chugai, Menarini Silicon Biosystems (formerly Veridex), Lilly, Novartis, and Sanofi-Aventis. The authors received honoraria, personal fees, research support, consulting fees, and travel grants from various sources.

Source: Friedl TWP et al. JAMA Oncol. 2021 Jun 24. doi: 10.1001/jamaoncol.2021.1854.

Key clinical point: Bisphosphonate therapy for 5 vs 2 years in patients with high-risk early breast cancer yields no added survival benefit and leads to increased risk for adverse events.

Major finding: There were no significant differences in disease-free survival (hazard ratio [HR], 0.97; P = .81), overall survival (HR, 0.98; P = .90), and distant disease-free survival (HR, 0.87; P = .38) between 5- and 2-year bisphosphonate treatment groups. The rate of adverse events was 46.2% with 5-year therapy and 27.2% with 2-year treatment.

Study details: A randomized phase 3, open-label SUCCESS A trial of 2,987 patients with high-risk early breast cancer randomly assigned to receive bisphosphonate zoledronate for either 5 or 2 years.

Disclosures: The study was supported by AstraZeneca, Chugai, Menarini Silicon Biosystems (formerly Veridex), Lilly, Novartis, and Sanofi-Aventis. The authors received honoraria, personal fees, research support, consulting fees, and travel grants from various sources.

Source: Friedl TWP et al. JAMA Oncol. 2021 Jun 24. doi: 10.1001/jamaoncol.2021.1854.