紫杉醇联合顺铂治疗晚期食管鳞癌临床观察

Clinical observation of paclitaxel and cisplatin protocol for treatment patients with advanced or metastatic squamous-cell carcinoma of the esophagus （ESCC）

目的观察紫杉醇联合顺铂治疗晚期食管鳞癌的疗效及不良反应。方法用紫杉醇注射液175mg／m2静脉滴注3h，第1天；顺铂25mg／m2，静脉滴注，第1—3天。该方案治疗25例晚期食管鳞癌，3周为1个周期。结果25例患者共完成化疗周期数为104个，其中完全缓解1例（4．1％），部分缓解10例（41．7％），稳定9例（37．5％），进展4例（16．7％），总有效率为45．8％（11／24）。至末次随访，死亡20例，全组中位生存期11．0个月（95％CI：8．35—13．65个月），1年生存率37．3％。12例治疗有效病例的中位生存期为12．5个月（95％CI：9．11～15．90个月），治疗无效病例的中位生存期为8．0个月（95％CI：5．50—9．50个月）。获治疗有效病例的中位生存期显著好于无效病例（P：0．022）。主要毒副反应有：白细胞减少（Ⅲ度7例，Ⅳ度1例）、中性粒细胞减少（Ⅲ度5例，Ⅳ度1例）、血小板下降（Ⅲ度1例）和脱发（Ⅱ度19例）。结论紫杉醇联合顺铂方案治疗晚期食管癌有效安全，可作为晚期食管鳞癌首选化疗方案。

Objective To evaluate the efficacy and safety of paclitaxel plus cisplatin combination in treatment patients with advanced or metastatic squamous-cell carcinoma of the esophagus （ ESCC）. Methods Twenty-five patients with advanced or metastatic ESCC received paclitaxel 175mg/m2 by 3-hour infusion on day 1 and cisplatin 25mg/m2 by infusion on day 1 - 3.3 weeks as one cycle. Results Twenty-four patients were eligible to be evaluated the efficacy and safety. The overall response rate was 45.8% with complete and partial response rates of 4.1% and 41.7% ,respectively. The median survival time of all patients was 11 months （95% CI：8.35 -13.65 months）. There was significant difference in the median overall survival between the patients who had showed response versus those who bad not （ P = 0. 022）. Median survival was 12.5 months （95% C1：9.11 - 15.90 months） and 8 months （ 95 % CI ： 5.50 - 9.50 months） ,respectively. The 1-year survival probability was 37.3%. The most common toxicities were leukopenia, neutropenia,thrombocytopenia and alopecia. Conclusion The effect of paclitaxel and cisplatin which seems beneficial as first-line therapy in advanced squamous-cell carcinoma of the esophagus had a high effective rate with acceptable toxicity.