转移性或复发性食管鳞状细胞癌患者化疗联合放疗与单纯化疗的前瞻性非随机研究

[Prospective non-randomized study of chemotherapy combined with radiotherapy versus chemotherapy alone in patients with metastatic or relapsed esophageal squamous cell carcinoma].

作者信息

Zhang Xiao-Dong, Shen Lin, Li Jie, Li Yan, Li Jian, Zhang Xiao-Tian, Jin Mao-Lin

机构信息

Department of Gastrointestinal Medicine, Clinical Cancer Institute, Beijing Cancer Hospital, Peking University, Beijing 100036, China.

出版信息

Zhonghua Zhong Liu Za Zhi. 2007 Jun;29(6):474-7.

PMID:17974288

Abstract

OBJECTIVE

To investigate the time to progression (TTP) and overall survival in patients with previously untreated metastatic or relapsed esophageal squamous cell carcinoma treated with chemotherapy (paclitaxel plus cisplatin) combined with radiotherapy versus chemotherapy alone, and also to evaluate the efficacy and toxicity of the regimen.

METHODS

In this prospective and non-randomized study, 47 patients with definite measurable lesion and having no previous chemotherapy were enrolled. All patients were treated with paclitaxel 175 mg/m2 by 2-hour iv infusion on d1 and cisplatin 75 mg/m2 by iv infusion on d1, which were repeated every 21 days. After 2-6 cycles of chemotherapy, those who gained CR, PR or SD were non-randomly assinged into radiotherapy group (group A) or non-radiotherapy group (group B).

RESULTS

Totally, 47 patients were enrolled into this study, and all of them were valuable for response. One patient achieved complete response (CR), 19 partial response (PR), 24 stable disease (SD), and 3 were found to have disease progression (PD). The overall response rate of chemotherapy was 42.6% (95% CI, 0.28-0.58). Twenty-one of these 47 patients were sequentially treated with radiotherapy. The median survival and TTP was 13 months and 10 months in the group A , versus 11 months and 5 months in the group B (P < 0.024, P < 0.015), respectively. The most common toxicities were neutropenia and alopecia. There were no grade 4 clinical toxicity and treatment-related death in this series. Systemic adverse effects frequently occurred during radiotherapy were esophagitis and fatigue, which were tolerable.

CONCLUSION

The combined therapy using chemotherapy (paclitaxel + cisplatin) followed by radiotherapy is effective, tolerable, and statistically superior to chemotherapy alone in patients with metastatic or relapsed esophageal squamous cell carcinoma.

摘要

目的

探讨接受化疗（紫杉醇联合顺铂）联合放疗与单纯化疗的既往未治疗的转移性或复发性食管鳞状细胞癌患者的疾病进展时间（TTP）和总生存期，并评估该方案的疗效和毒性。

方法

在这项前瞻性非随机研究中，纳入47例有明确可测量病灶且既往未接受过化疗的患者。所有患者均在第1天接受静脉滴注2小时的紫杉醇175mg/m²和顺铂75mg/m²静脉滴注，每21天重复一次。化疗2 - 6周期后，获得完全缓解（CR）、部分缓解（PR）或疾病稳定（SD）的患者被非随机分为放疗组（A组）或非放疗组（B组）。

结果

本研究共纳入47例患者，所有患者对反应均有价值。1例患者达到完全缓解（CR），19例部分缓解（PR），24例疾病稳定（SD），3例疾病进展（PD）。化疗的总缓解率为42.6%（95%CI，0.28 - 0.58）。这47例患者中有21例序贯接受放疗。A组的中位生存期和TTP分别为13个月和10个月，而B组分别为11个月和5个月（P < 0.024，P < 0.015）。最常见的毒性反应是中性粒细胞减少和脱发。本系列中无4级临床毒性反应和治疗相关死亡。放疗期间常见的全身不良反应为食管炎和疲劳，均可耐受。