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紫杉醇/洛铂与顺铂/5-氟尿嘧啶为基础的同步放化疗用于晚期不可切除食管癌的疗效和毒性特征比较

Comparison of efficacy and toxicity profiles between paclitaxel/lobapoatin- and cisplatin/5-fluorouracil-based concurrent chemoradiotherapy of advanced inoperable oesophageal cancer.

作者信息

Yang J-S, Wang T, Qiu M-Q, Li Q-L

机构信息

Department of Medical Oncology, Zaozhuang Municipal Hospital, Zaozhuang, China.

出版信息

Intern Med J. 2015 Jul;45(7):757-61. doi: 10.1111/imj.12773.

Abstract

BACKGROUND AND AIM

Current chemoradiotherapy doesn't usually effectively control oesophageal cancer progression. This study assessed the efficacy and toxicity profiles of paclitaxel/lobaplatin (TL)- and cisplatin/5-fluorouracil (PF)-based concurrent chemoradiotherapy (CCRT) in patients with advanced inoperable oesophageal cancer.

METHODS

A total of such 68 patients was recruited and randomised to receive TL or PF-based CCRT. Radiotherapy was given at a total dose of 60-70 Gy over 6 weeks. In the TL group of patients, paclitaxel 60 mg/m(2) was administered intravenously on day 1, 8 and 15 and lobaplatin 30 mg/m(2) was administered on day 2 in two cycles at 3-week intervals. In the PF group, cisplatin 75 mg/m(2) was administered intravenously on day 1, and 5-fluorouracil 500 mg/m(2) and leucovorin 200 mg/m(2) were administered intravenously daily for 5 days in two cycles at 3-week intervals. Adverse events, treatment response and follow-up data were collected.

RESULTS

The treatment response rates were 73.53% and 50.00% in the TL and PF groups respectively (P = 0.040). The median tumour progression-free survival (PFS) was 13.0 and 6.5 months in the TL and PF groups respectively (P = 0.034). Compared with PF group, the TL group demonstrated decreased grade 3/4 nausea and vomiting (5.88% vs 35.29%, P = 0.003), decreased granulocytopenia (11.76% vs 32.35%, P = 0.041) and platelet count reduction (32.5% vs 8.8%, P = 0.016).

CONCLUSIONS

The TL treatment regimen demonstrated higher efficacy with less overall toxicity in patients with advanced inoperable oesophageal cancer compared with the PF regimen. Further study is warranted to validate our current observations.

摘要

背景与目的

目前的放化疗通常无法有效控制食管癌进展。本研究评估了紫杉醇/洛铂(TL)方案和顺铂/5-氟尿嘧啶(PF)方案同步放化疗(CCRT)用于晚期不可切除食管癌患者的疗效和毒性特征。

方法

共招募68例此类患者,并随机分为接受基于TL或PF的CCRT。放疗总剂量为60 - 70 Gy,为期6周。在TL组患者中,紫杉醇60 mg/m²于第1、8和15天静脉给药,洛铂30 mg/m²于第2天给药,每3周为一个周期,共两个周期。在PF组中,顺铂75 mg/m²于第1天静脉给药,5-氟尿嘧啶500 mg/m²和亚叶酸钙200 mg/m²每天静脉给药,共5天,每3周为一个周期,共两个周期。收集不良事件、治疗反应和随访数据。

结果

TL组和PF组的治疗反应率分别为73.53%和50.00%(P = 0.040)。TL组和PF组的中位无肿瘤进展生存期(PFS)分别为13.0个月和6.5个月(P = 0.034)。与PF组相比,TL组3/4级恶心呕吐发生率降低(5.88%对35.29%,P = 0.003),粒细胞减少发生率降低(11.76%对32.35%,P = 0.041),血小板计数降低发生率降低(32.5%对8.8%,P = 0.016)。

结论

与PF方案相比,TL治疗方案在晚期不可切除食管癌患者中显示出更高的疗效和更低的总体毒性。有必要进行进一步研究以验证我们目前的观察结果。

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