Shamseddine Ali I, Otrock Zaher K, Khalifeh Mohamad J, Yassine Hanan R, Charafeddine Maya, Abdel-Khalek Zeina, Chehal Aref, Bitar Nizar, Jalloul Rahif, Dheiny Moussa, Dandashi Azzam, Wehbeh Mahmoud, El-Saghir Nagi S
American University of Beirut Medical Center, Beirut, Lebanon.
Oncology. 2006;70(5):330-8. doi: 10.1159/000097945. Epub 2006 Dec 12.
We tested a sequential combination regimen using cisplatin and vinorelbine (PVn) followed by docetaxel as first-line chemotherapy in a phase II clinical trial in metastatic breast cancer (MBC).
Thirty-five patients were enrolled. Cisplatin 80 mg/m(2) was given on day 1 and vinorelbine 30 mg/m(2) on days 1 and 8 every 3 weeks for 4 cycles. Responding patients received docetaxel 75 mg/m(2) every 21 days for a maximum of 4 cycles. Three patients were excluded from analysis because of death unrelated to treatment.
After a median follow-up of 14 months, 32 patients completed the study. The overall response rate was 53.1%. Complete remission was seen in 5 patients (15.6%), partial response in 12 (37.5%), stable disease in 6 (18.75%), and progressive disease in 9 patients (28.1%). Median time to disease progression was 8 months (range 1-24). At 24 months, 12 (37.5%) patients were alive. A total of 183 cycles were administered. Febrile neutropenia was observed in 4 patients (2.2%). Grade II nephrotoxicity occurred in 12 cycles (6.5%) and grade III vomiting in 31/183 cycles (16.9%).
PVn is a feasible non-anthracycline option as first-line chemotherapy in patients with metastatic breast cancer and has acceptable toxicity. The sequential addition of 4 cycles of docetaxel following 4 cycles of PVn did not improve the overall response rate and results.
在一项转移性乳腺癌（MBC）的II期临床试验中，我们测试了一种序贯联合方案，即先用顺铂和长春瑞滨（PVn），随后使用多西他赛作为一线化疗方案。
共纳入35例患者。每3周为一个周期，第1天给予顺铂80mg/m²，第1天和第8天给予长春瑞滨30mg/m²，共进行4个周期。有反应的患者每21天接受多西他赛75mg/m²治疗，最多4个周期。3例患者因与治疗无关的死亡被排除在分析之外。
中位随访14个月后，32例患者完成了研究。总缓解率为53.1%。5例患者（15.6%）完全缓解，12例（37.5%）部分缓解，6例（18.75%）病情稳定，9例患者（28.1%）病情进展。疾病进展的中位时间为8个月（范围1 - 24个月）。24个月时，12例（37.5%）患者存活。共进行了183个周期的治疗。4例患者（2.2%）出现发热性中性粒细胞减少。12个周期（6.5%）出现II级肾毒性，31/183个周期（16.9%）出现III级呕吐。
PVn作为转移性乳腺癌患者的一线化疗方案是一种可行的非蒽环类选择，且毒性可接受。在4个周期的PVn之后序贯添加4个周期的多西他赛并未提高总缓解率和疗效。
