GEMCITABINE PLUS PACLITAXEL VERSUS PACLITAXEL MONOTHERAPY IN PATIENTS WITH METASTATIC BREAST CANCER

Purpose: Combination chemotherapy regimens for metastatic breast cancer (MDC) are more active than single agents but they are associated with more treatment-related side effects. The objective of this study was to compare the treatment outcomes of combination chemotherapy with single agent as a first line for the treatment of MBC patients in a phase III prospective study. Patients and Methods: Patients with MBC after adjuvant anthracyclines were randomized to paclitaxel 135 mg/m2 on day 1 plus gemcitabine 1000 mg/m2 days 1& 8 or to paclitaxel at the same dose on day 1 (both arms administered every 21 days). The primary end points were response rate (RR), progression-free survival (PFS) and overall survival (OS). Secondary end point was Toxicity. Results: From April 2010 to February 2012, a total of 70 patients who treated at Clinical Oncology Department, Assiut were enrolled. Paclitaxel plus gemcitabine significantly increased the response rate (43% vs. 29 %, P= .02) and prolong PFS (median, 8 vs. 7 months, P=.03) and OS (median, 15 vs. 12 months, P= .03). Grade 3/4 leucopenia (23% vs. 9%, p=0.04), nausea and vomiting (6% vs. 0%) were more frequent in patients receiving paclitaxel plus gemcitabineon. Patients with performance status 0, hormonal receptor negative and disease-free interval ​