一项关于紫杉醇和顺铂同步放化疗治疗不可切除食管鳞状细胞癌的II期研究。

A Phase II Study of Concurrent Chemoradiotherapy With Paclitaxel and Cisplatin for Inoperable Esophageal Squamous Cell Carcinoma.

作者信息

Tang Hua-Rong, Ma Hai-Feng, An Shi-Min, Badakhshi Harun, Deng Jia-Ying, Zhang Jun-Hua, Chen Yun, Zhang Zhen, Guo Xiao-Mao, Jiang Guo-Liang, Zhao Kuai-Le

机构信息

*Department of Radiation Oncology, Fudan University, Shanghai Cancer Center §Department of Pharmacology and Chemical Biology, Shanghai Jiao Tong University School of Medicine ¶Department of Oncology, Shanghai Medical College, Fudan University, Shanghai †Department of Radiation Oncology, The First People's Hospital of Zhenjiang, Jiangsu Provence ‡Department of Radiation Oncology, Dongyang People's Hospital, Zhejiang Province, China ∥Department of Radiation Oncology, Charité School of Medicine and Centre for Cancer Medicine, Berlin, Germany.

出版信息

Am J Clin Oncol. 2016 Aug;39(4):350-4. doi: 10.1097/COC.0000000000000069.

DOI:10.1097/COC.0000000000000069

PMID:24732811

Abstract

OBJECTIVES

A phase II study was performed to investigate the efficacy and the safety of a 3-week schedule of paclitaxel (PTX) plus cisplatin (DDP) combined with concurrent radiotherapy for esophageal squamous cell cancer.

PATIENTS AND METHODS

Patients with newly diagnosed esophageal squamous cell cancer who had histologic proof of local-regional carcinoma of the esophagus, a Karnofsky performance status of 80 or greater, and normal liver, renal, and bone marrow functions were enrolled in the phase II trial. Chemotherapy consisted of DDP (25 mg/m/d) for 3 days plus PTX (175 mg/m) given for 3 hours, every 3 weeks for 4 cycles. The total dose of concurrent radiation with 68.4 Gy/44 Fx (late course-accelerated radiotherapy) or 61.2 Gy/34 Fx (conventional radiotherapy) was given at the first day of chemotherapy.

RESULTS

Between July 2008 and November 2011, 76 patients were enrolled in this trial. The median age was 58 years (range, 37 to 74 y). The stages were stage II (21 patients), stage III (27 patients), and stage IV (28 patients). A total of 89.5% (68/76) and 63.2% (48/76) patients completed ≥2 cycles and all 4 cycles of chemotherapy, respectively. With the median follow-up of 36 months, the overall median survival time was 28.5 months and the progression-free survival time was 14.7 months. One- and 3-year survival rates were 75% and 41%, respectively. Neutropenia grade 3 and 4 occurred in 30.3% and 31.6% of the patients, respectively.

CONCLUSIONS

Radiotherapy concurrent with a 3-week schedule of PTX and DDP resulted in an encouraging overall survival rate, but a relatively higher hematological toxicity.

摘要

目的

开展一项II期研究，以调查紫杉醇（PTX）联合顺铂（DDP）3周方案同步放疗治疗食管鳞状细胞癌的疗效和安全性。

患者与方法

新诊断的食管鳞状细胞癌患者，有食管局部区域癌的组织学证据，卡氏评分80分及以上，肝、肾和骨髓功能正常，纳入该II期试验。化疗方案为DDP（25mg/m²/天），连用3天，加PTX（175mg/m²），静脉滴注3小时，每3周1次，共4个周期。同步放疗总剂量为68.4Gy/44次分割（后程加速放疗）或61.2Gy/34次分割（常规放疗），于化疗第1天开始给予。

结果

2008年7月至2011年11月，76例患者纳入本试验。中位年龄58岁（范围37至74岁）。分期为II期（21例患者）、III期（27例患者）和IV期（28例患者）。分别有89.5%（68/76）和63.2%（48/76）的患者完成了≥2个周期和全部4个周期的化疗。中位随访36个月，总中位生存时间为28.5个月，无进展生存时间为14.7个月。1年和3年生存率分别为75%和41%。3/4级中性粒细胞减少分别发生在30.3%和31.6%的患者中。