الفهرس | Only 14 pages are availabe for public view |
Abstract This study was performed to assess the treatment outcomes of combination chemotherapy (vinorelbine + capecitabine) followed by the same combination or followed by seqential single agent (docetaxel) in Egyptian women with HER-2 negative metastatic breast cancer (MBC). Patients with HER-2/neu negative MBC previously treated with anthracycline in the adjuvant setting were enrolled in this prospective phase II study. Patients received vinorelbine 25mg/m2 on day 1& 8 and capecitabine 825mg/m2 twice daily day 1-14 (Navcap) every 3 weeks for 4 cycles. Patients with complete response (CR), partial response (PR) and stable disease (SD) were randomized to two arms. Arm 1 received another 4 cycles of Navcap and arm 2 received docetaxel 25mg/m2 weekly for 12 weeks. from March 2011 to April 2014, 35 patients were enrolled in the study. Patients with PR& SD (31 patients) were randomized to arm 1 (16 patients) and arm 2 (15 patients). The overall response rate was 50% and 60% in arm1 & 2 respectively. With a median follow-up 15 months, the median time to tumor progression was 13&12 months and median survival were 17& 16 months for arm 1& 2 respectively. The most frequent treatment related toxicities were in arm 1: grade 3/4 neutropenia 12.5%, anemia 6.25% and grade 2 nausea& vomiting 12.5%. In arm 2, grade 3/4 neutropenia 6.7%, anemia 6.7% and grade 2 alopecia in 13.3% were reported. Conclusion In conclusion, combination therapy regimens with capcitabine and vinorelbine (Navcap) and the Navcap followed by weekly docetaxel regimens were well-tolerated and effective in Egyptian women with HER-2/neu negative metastatic breast cancer. A future research is needed to define patients who may benefit from a combination therapy or combination regimen followed by sequential single agent therapy. |