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Key clinical point: The addition of oral alisertib to a reduced dose of weekly paclitaxel improves progression-free survival (PFS) compared with paclitaxel alone in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.
Major finding: At a median follow-up of 22 months, the median PFS was 10.2 months with paclitaxel plus alisertib vs. 7.1 months with paclitaxel alone (hazard ratio, 0.56; P = .005) in the patients with ER+, HER2-negative disease. Grade 3-4 adverse event rate was higher with paclitaxel plus alisertib vs. paclitaxel alone (84.8% vs. 48.6%).
Study details: A phase 2, open-label, randomized study of 139 patients with metastatic breast cancer who received either paclitaxel or paclitaxel plus alisertib.
Disclosures: The study was supported by a research grant from Takeda Pharmaceuticals. Dr. O’Shaughnessy and Dr. Andorsky declared receiving personal fees, consulting and/or serving on steering committee meetings for various sources.
Source: O'Shaughnessy J et al. JAMA Netw Open. 2021 Apr 20. doi: 10.1001/jamanetworkopen.2021.4103.
Key clinical point: The addition of oral alisertib to a reduced dose of weekly paclitaxel improves progression-free survival (PFS) compared with paclitaxel alone in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.
Major finding: At a median follow-up of 22 months, the median PFS was 10.2 months with paclitaxel plus alisertib vs. 7.1 months with paclitaxel alone (hazard ratio, 0.56; P = .005) in the patients with ER+, HER2-negative disease. Grade 3-4 adverse event rate was higher with paclitaxel plus alisertib vs. paclitaxel alone (84.8% vs. 48.6%).
Study details: A phase 2, open-label, randomized study of 139 patients with metastatic breast cancer who received either paclitaxel or paclitaxel plus alisertib.
Disclosures: The study was supported by a research grant from Takeda Pharmaceuticals. Dr. O’Shaughnessy and Dr. Andorsky declared receiving personal fees, consulting and/or serving on steering committee meetings for various sources.
Source: O'Shaughnessy J et al. JAMA Netw Open. 2021 Apr 20. doi: 10.1001/jamanetworkopen.2021.4103.
Key clinical point: The addition of oral alisertib to a reduced dose of weekly paclitaxel improves progression-free survival (PFS) compared with paclitaxel alone in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.
Major finding: At a median follow-up of 22 months, the median PFS was 10.2 months with paclitaxel plus alisertib vs. 7.1 months with paclitaxel alone (hazard ratio, 0.56; P = .005) in the patients with ER+, HER2-negative disease. Grade 3-4 adverse event rate was higher with paclitaxel plus alisertib vs. paclitaxel alone (84.8% vs. 48.6%).
Study details: A phase 2, open-label, randomized study of 139 patients with metastatic breast cancer who received either paclitaxel or paclitaxel plus alisertib.
Disclosures: The study was supported by a research grant from Takeda Pharmaceuticals. Dr. O’Shaughnessy and Dr. Andorsky declared receiving personal fees, consulting and/or serving on steering committee meetings for various sources.
Source: O'Shaughnessy J et al. JAMA Netw Open. 2021 Apr 20. doi: 10.1001/jamanetworkopen.2021.4103.