Phase I Study of Docetaxel Plus Nedaplatin in Patients With Metastatic or Recurrent Esophageal Squamous Cell Carcinoma After Cisplatin Plus 5-Fluorouracil Treatment. (February 2016)

• Record Type: Journal Article
• Authors: Kajiura, Shinya; Hosokawa, Ayumu; Yoshita, Hiroki; Ueda, Yuko; Ueda, Akira; Mihara, Hiroshi; Ando, Takayuki; Fujinami, Haruka; Nishikawa, Jun; Ogawa, Kohei; Minemura, Masami; Sugiyama, Toshiro
• Is Part Of: American journal of clinical oncology. Volume 39:Number 1(2016)
• Publication Date: 2016-02
• Subjects: esophageal cancer -- second-line chemotherapy -- docetaxel -- nedaplatin; Cancer -- Treatment -- Periodicals; Oncology -- Periodicals; Tumors -- Periodicals; 616.994005
• DOI: 10.1097/COC.0000000000000018
• Languages: English
• ISSNs: 0277-3732

Abstract

Abstract : Objectives: 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. Methods: Patients with metastatic or recurrent esophageal SCC after treatment with cisplatin plus 5-fluorouracil received docetaxel (50 or 60 mg/m 2 ) plus nedaplatin (70 mg/m 2 ) on day 1 every 4 weeks. The recommended dose was based on dose-limiting toxicities defined during the first cycle. Results: 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/m 2 docetaxel, 70 mg/m 2 nedaplatin) but not at dose level 0 (50 mg/m 2 docetaxel, 70 mg/m 2 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. Conclusions: 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/m 2 docetaxel (day 1) plus 70 mg/m 2 nedaplatin (day 1) every 4 weeks in a phase II study.