Morris Mitchell, Blessing John A, Monk Bradley J, McGehee Ramon, Moore David H
Department of Gynecologic Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.
J Clin Oncol. 2004 Aug 15;22(16):3340-4. doi: 10.1200/JCO.2004.12.006.
To evaluate the efficacy and toxicity of intravenous cisplatin and vinorelbine as combination chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the cervix.
Between August 1997 and January 2001, 73 patients with advanced or recurrent squamous cell carcinoma of the cervix were entered onto this study. Eligible patients had received no prior therapeutic chemotherapy, except when administered concurrent with primary radiation therapy. The initial doses administered were cisplatin 75 mg/m(2) every 4 weeks and vinorelbine 30 mg/m(2) weekly. Subsequent doses were unchanged, reduced, escalated, or omitted according to observed toxicity and protocol guidelines. Patients were evaluated for response and toxicity using standard Gynecologic Oncology Group criteria.
Of 73 patients, 67 were eligible and assessable. The overall response rate was 30% (five complete and 15 partial responses). The overall median response duration was 5.5+ months. The major toxicity was neutropenia, with 16% grade 3 and 67% grade 4 reported. Gastrointestinal and neurotoxicity were infrequent and mild.
The combination of cisplatin and vinorelbine has moderate activity in advanced or recurrent squamous cell carcinoma of the cervix. Additional study of this regimen in a phase III setting is justified in this patient population.
评估静脉注射顺铂和长春瑞滨联合化疗对晚期或复发性宫颈鳞状细胞癌患者的疗效和毒性。
1997年8月至2001年1月期间，73例晚期或复发性宫颈鳞状细胞癌患者进入本研究。符合条件的患者除与原发性放射治疗同时进行外，未接受过先前的治疗性化疗。初始给药剂量为每4周给予顺铂75mg/m²，每周给予长春瑞滨30mg/m²。随后的剂量根据观察到的毒性和方案指南保持不变、减少、增加或省略。使用标准的妇科肿瘤学组标准评估患者的反应和毒性。
73例患者中，67例符合条件且可评估。总缓解率为30%（5例完全缓解和15例部分缓解）。总中位缓解持续时间为5.5 +个月。主要毒性为中性粒细胞减少，报告3级为16%，4级为67%。胃肠道和神经毒性不常见且轻微。
顺铂和长春瑞滨联合用药对晚期或复发性宫颈鳞状细胞癌具有中等活性。在这一患者群体中，对该方案进行III期进一步研究是合理的。
