Kajiura Shinya, Hosokawa Ayumu, Yoshita Hiroki, Ueda Yuko, Ueda Akira, Mihara Hiroshi, Ando Takayuki, Fujinami Haruka, Nishikawa Jun, Ogawa Kohei, Minemura Masami, Sugiyama Toshiro
Departments of *Gastroenterology and Hematology, Faculty of Medicine †Department of Medical Oncology, University of Toyama, 2630 Sugitani, Toyama-shi, Toyama-ken 930-0194, Japan.
Am J Clin Oncol. 2016 Feb;39(1):13-7. doi: 10.1097/COC.0000000000000018.
To date, no second-line chemotherapy regimen for esophageal squamous cell carcinoma (SCC) has been established. This clinical trial aimed to assess the optimum dose of docetaxel plus nedaplatin (cis-diammine-glycolate platinum) as second-line chemotherapy.
Patients with metastatic or recurrent esophageal SCC after treatment with cisplatin plus 5-fluorouracil received docetaxel (50 or 60 mg/m) plus nedaplatin (70 mg/m²) on day 1 every 4 weeks. The recommended dose was based on dose-limiting toxicities defined during the first cycle.
From February 2009 to November 2011, 9 patients were enrolled in the study. Their median age was 62 years (range, 58 to 72 y). Six patients had undergone radiotherapy and 4 had undergone surgical resection of primary lesions. Dose-limiting toxicities were observed in 2 patients at dose level 1 (60 mg/m² docetaxel, 70 mg/m² nedaplatin) but not at dose level 0 (50 mg/m² docetaxel, 70 mg/m nedaplatin). Thus, the maximum tolerated dose was established at dose level 1. No severe nonhematological toxicity was observed. No patient achieved complete response, but 2 (22%; 95% confidence interval, 0%-49%) achieved partial response and 3 had stable disease. Median progression-free and overall survival times were 2.1 and 9.5 months, respectively.
Docetaxel plus nedaplatin chemotherapy seems to be a safe and feasible second-line regimen for the treatment of esophageal SCC. We recommend the administration of 50 mg/m² docetaxel (day 1) plus 70 mg/m² nedaplatin (day 1) every 4 weeks in a phase II study.
迄今为止，尚未确立食管鳞状细胞癌（SCC）的二线化疗方案。本临床试验旨在评估多西他赛联合奈达铂（顺二氨二醇铂）作为二线化疗的最佳剂量。
接受顺铂加5-氟尿嘧啶治疗后出现转移性或复发性食管SCC的患者，每4周在第1天接受多西他赛（50或6mg/m²）加奈达铂（70mg/m²）治疗。推荐剂量基于第一个周期中定义的剂量限制性毒性。
2009年2月至2011年11月，9例患者纳入本研究。他们的中位年龄为62岁（范围58至72岁）。6例患者接受过放疗，4例患者接受过原发灶手术切除。在剂量水平1（多西他赛60mg/m²，奈达铂70mg/m²）的2例患者中观察到剂量限制性毒性，但在剂量水平0（多西他赛50mg/m²，奈达铂70mg/m²）未观察到。因此，最大耐受剂量确定为剂量水平1。未观察到严重的非血液学毒性。没有患者达到完全缓解，但2例（22%；95%置信区间，0%-49%）达到部分缓解，3例病情稳定。中位无进展生存期和总生存期分别为2.1个月和9.5个月。
多西他赛联合奈达铂化疗似乎是治疗食管SCC的一种安全可行的二线方案。我们建议在II期研究中每4周给予50mg/m²多西他赛（第1天）加70mg/m²奈达铂（第1天）。
