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一项比较序贯放化疗与同步放化疗治疗不可切除局部晚期食管癌的随机研究。

A randomized study to compare sequential chemoradiotherapy with concurrent chemoradiotherapy for unresectable locally advanced esophageal cancer.

作者信息

Gupta Arunima, Roy Somnath, Majumdar Anup, Hazra Avijit, Mallik Chandrani

机构信息

Department of Radiotherapy, IPGMER & SSKM Hospital, Kolkata, West Bengal, India.

出版信息

Indian J Med Paediatr Oncol. 2014 Jan;35(1):54-9. doi: 10.4103/0971-5851.133722.

Abstract

BACKGROUND

Chemotherapy combined with radiotherapy can improve outcome in locally advanced esophageal cancer.

AIM

This study aimed to compare efficacy and toxicity between concurrent chemoradiotherapy (CCRT) and sequential chemoradiotherapy (SCRT) in unresectable, locally advanced, esophageal squamous cell carcinoma (ESSC).

MATERIALS AND METHODS

Forty-one patients with unresectable, locally advanced ESCC were randomized into two arms. In the CCRT arm (Arm A), 17 patients received 50.4 Gy at 1.8 Gy per fraction over 5.6 weeks along with concurrent cisplatin (75 mg m(-2) intravenously on day 1 and 5-fluorouracil (1000 mg m(-2) continuous intravenous infusion on days 1-4 starting on the first day of irradiation and given after 28 days. In the SCRT arm (Arm B), 20 patients received two cycles of chemotherapy, using the same schedule, followed by radiotherapy fractionated in a similar manner. The endpoints were tumor response, acute and late toxicities, and disease-free survival.

RESULTS

With a median follow up of 12.5 months, the complete response rate was 82.4% in Arm A and 35% in Arm B (P = 0.003). Statistically significant differences in frequencies of acute skin toxicity (P = 0.016), gastrointestinal toxicity (P = 0.005) and late radiation pneumonitis (P = 0.002) were found, with greater in the CCRT arm. A modest but non-significant difference was observed in median time to recurrence among complete responders in the two arms (Arm A 13 months and Arm B 15.5 months, P = 0.167) and there was also no significant difference between the Kaplan Meier survival plots (P = 0.641) of disease-free survival.

CONCLUSIONS

Compared to sequential chemoradiotherapy, concurrent chemoradiotherapy can significantly improve local control rate but with greater risk of adverse reactions.

摘要

背景

化疗联合放疗可改善局部晚期食管癌的治疗效果。

目的

本研究旨在比较同步放化疗(CCRT)与序贯放化疗(SCRT)在不可切除的局部晚期食管鳞状细胞癌(ESSC)中的疗效和毒性。

材料与方法

41例不可切除的局部晚期ESCC患者被随机分为两组。在CCRT组(A组),17例患者在5.6周内接受50.4 Gy照射,每次1.8 Gy,同时给予顺铂(第1天静脉注射75 mg/m²,第5天)和5-氟尿嘧啶(第1 - 4天持续静脉输注1000 mg/m²,从放疗第一天开始,28天后重复给药)。在SCRT组(B组),20例患者接受两个周期的化疗,方案相同,随后进行类似的分割放疗。观察终点为肿瘤反应、急性和晚期毒性以及无病生存期。

结果

中位随访12.5个月,A组完全缓解率为82.4%,B组为35%(P = 0.003)。在急性皮肤毒性(P = 0.016)、胃肠道毒性(P = 0.005)和晚期放射性肺炎(P = 0.002)的发生率上存在统计学显著差异,CCRT组更严重。两组完全缓解者的中位复发时间有适度但无统计学意义的差异(A组13个月,B组15.5个月,P = 0.167),无病生存期的Kaplan - Meier生存曲线之间也无显著差异(P = 0.641)。

结论

与序贯放化疗相比,同步放化疗可显著提高局部控制率,但不良反应风险更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b42/4080664/a7800d88b696/IJMPO-35-54-g001.jpg

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