奈达铂或顺铂联合紫杉醇同步放化疗治疗中晚期宫颈癌的临床疗效观察

Clinical study of chemotherapy with nedaplatin or cisplatin plus paclitaxel concurrent radiotherapy in the treatment of middle-advanced stage uterine cervical cancer

目的探讨奈达铂或顺铂与紫杉醇联合同步放化疗治疗中晚期宫颈癌的疗效及不良反应。方法试验组（NDP/PXT＋RT）34例,采用奈达铂20 mg/m2静脉滴注＋紫杉醇35 mg/m^2静脉滴注,每周1次,同期行放射治疗（外照射＋后装治疗）,共6周。对照组（DDP/PXT＋RT）34例,顺铂20 mg/m^2静脉滴注＋紫杉醇35 mg/m^2静脉滴注,每周1次,同期行放射治疗（外照射＋后装治疗）,共6周。观察其短期疗效、不良反应、中位无进展生存时间（PFS）、总生存期（OS）。结果 NDP/PXT＋RT组和DDP/PXT＋RT组的有效率（RR）分别为97.0%、94.1%,无统计学差异（P=0.781）,两组的主要不良反应均为骨髓抑制和胃肠系统不良反应,Ⅰ-Ⅳ级中性白细胞减少发生率分别为58.8%（20/34）和85.2%（29/34）,P=0.048;Ⅰ-Ⅳ级贫血发生率分别为67.7%（23/34）和64.7%（22/34）（P=0.04）,恶心、呕吐发生率分别为88.2%（30/34）和91.1%（31/34）,无统计学差异（P=0.456）。两组的中位PFS分别为22.6个月、20个月,差异无统计学意义（P=0.442）,两组1年OS率分别为88.4%、71.4%,3年OS率分别为59.4%、50%,差异无统计学意义（P=0.406）。结论奈达铂＋紫杉醇同步放射治疗（NDP/PXT＋RT）治疗中晚期宫颈癌能够提高患者生存率。在不良反应方面,奈达铂较顺铂的毒性相对小,依从性好。

Objective This study retrospectively compared nedaplatin andpaclitaxel （NDP/PXT） concurrent radiotherapy regimens with cisplatin and paclitaxel （CDDP/PXT） concurrent radiotherapy regimens for efficacy and adverse events, in patients with middle-advanced stage uterine cervical cancer. Methods Sixty-eight patients with stages Ⅲ-Ⅳa middle-advanced uterine cervical cancer randomly received NDP/PXT＋RT regimen （n=34） or DDP/PXT＋RT regimen （n=34）. NDP/PXT was administered intravenously （NDP, 20 mg/m^2 on day 1, PXT, 35 mg/m^2 on days 1） every one week, total six weeks. CDDP/PXT was also administered intravenously （CDDP, 20 mg/m^2 on day 1; CPT, 35 mg/m^2 on days 1）, radiotherapy （RT） included external beam radiotherapy to pelvic and 192^Ir brachytherapy. The clinical response and toxicities were evaluated every two cycles, and the short-term response was evaluated after completion of 6 cycles of concurrent chemotherapy. PFS （progress free survival） and OS （overall survival） were calculated. Results The overall response rate of NDP/PXT＋RT regimen was not statistically significant than that of DDP/PXT＋RT regimen （97.0% vs. 94.1%, P=0.781）. The major adverse reactions of two regimen were adverse hematologic and gastrointestinal system neutropenia, which was 58.8% and 85.2%, P=0.048; anemia, 67.7% and 64.7% （P=0.04）; nausea and vomiting 88.2% and 91.1% （P=0.456）; Patients were treated with NDP/PXT＋RT and DDP/PXT＋RT in 34 cases each. No significant difference was observed in progression-free survival （22.6 months vs. 20 months） and the 1-year overall survival （88.4% vs. 71.4%） or 3-year overall survival （59.4% vs. 50%）. Conclusion Accordingly, NDP/PXT＋RT indicated mild toxicity, and was therefore equally effective and less toxic than DDP/PXT＋RT in the treatment of middle-advanced stage uterine cervical cancer.