BACKGROUND: Effective anthracycline-free combinations need to be evaluated in metastatic breast cancer (MBC), due to the increased number of patients treated with anthracycline-based adjuvant chemotherapy. PATIENTS AND METHODS: Patients with MBC were randomized to paclitaxel and carboplatin (PCb) every 3 weeks or docetaxel and gemcitabine (GDoc) every 3 weeks or weekly paclitaxel (Pw). Trastuzumab was given to patients with HER-2 over-expressing tumors. The primary endpoint of the study was survival. Quality of life (QoL) and cost were assessed. RESULTS: Totally, 416 eligible patients entered the study. Median survival times were 29.9 months for PCb, 26.9 for GDoc and 41.0 for Pw (P = 0.037). According to multivariate analysis, adjuvant chemotherapy, >1 metastatic sites, lack of maintenance hormonal therapy, and worse performance status (PS) were significant adverse prognostic factors for survival, while Pw when compared to GDoc improved survival (P = 0.03), as well as when compared to PCb in the subgroup of patients with PS = 1 (P = 0.01, treatment by PS interaction P = 0.03). No significant differences in terms of time to progression were found. Severe myelotoxicity and mucositis were more frequent with GDoc, while severe neuropathy with PCb and Pw. QoL changes did not differ significantly between treatment groups, while cost analysis favored Pw. CONCLUSIONS:Pw appears to be the most preferable choice among the 3 anthracycline-free taxanes-based regimens tested in the present study.
RCT Entities:
BACKGROUND: Effective anthracycline-free combinations need to be evaluated in metastatic breast cancer (MBC), due to the increased number of patients treated with anthracycline-based adjuvant chemotherapy. PATIENTS AND METHODS: Patients with MBC were randomized to paclitaxel and carboplatin (PCb) every 3 weeks or docetaxel and gemcitabine (GDoc) every 3 weeks or weekly paclitaxel (Pw). Trastuzumab was given to patients with HER-2 over-expressing tumors. The primary endpoint of the study was survival. Quality of life (QoL) and cost were assessed. RESULTS: Totally, 416 eligible patients entered the study. Median survival times were 29.9 months for PCb, 26.9 for GDoc and 41.0 for Pw (P = 0.037). According to multivariate analysis, adjuvant chemotherapy, >1 metastatic sites, lack of maintenance hormonal therapy, and worse performance status (PS) were significant adverse prognostic factors for survival, while Pw when compared to GDoc improved survival (P = 0.03), as well as when compared to PCb in the subgroup of patients with PS = 1 (P = 0.01, treatment by PS interaction P = 0.03). No significant differences in terms of time to progression were found. Severe myelotoxicity and mucositis were more frequent with GDoc, while severe neuropathy with PCb and Pw. QoL changes did not differ significantly between treatment groups, while cost analysis favored Pw. CONCLUSIONS: Pw appears to be the most preferable choice among the 3 anthracycline-free taxanes-based regimens tested in the present study.
Authors: Bruno Kovic; Xuejing Jin; Sean Alexander Kennedy; Mathieu Hylands; Michal Pedziwiatr; Akira Kuriyama; Huda Gomaa; Yung Lee; Morihiro Katsura; Masafumi Tada; Brian Y Hong; Sung Min Cho; Patrick Jiho Hong; Ashley M Yu; Yasmin Sivji; Augustin Toma; Li Xie; Ludwig Tsoi; Marcin Waligora; Manya Prasad; Neera Bhatnagar; Lehana Thabane; Michael Brundage; Gordon Guyatt; Feng Xie Journal: JAMA Intern Med Date: 2018-12-01 Impact factor: 21.873
Authors: Christina M Scribano; Jun Wan; Karla Esbona; John B Tucker; Amber Lasek; Amber S Zhou; Lauren M Zasadil; Ryan Molini; Jonathan Fitzgerald; Angela M Lager; Jennifer J Laffin; Kayla Correia-Staudt; Kari B Wisinski; Amye J Tevaarwerk; Ruth O'Regan; Stephanie M McGregor; Amy M Fowler; Richard J Chappell; Tim S Bugni; Mark E Burkard; Beth A Weaver Journal: Sci Transl Med Date: 2021-09-08 Impact factor: 17.956