Multicenter Phase 2 Study of Cisplatin and 5-Fluorouracil With Concurrent Radiation Therapy as an Organ Preservation Approach in Patients With Squamous Cell Carcinoma of the Cervical Esophagus

作者：Zenda Sadamoto^*; Kojima Takashi; Kato Ken; Izumi Sachiko; Ozawa Taijiro; Kiyota Naomi; Katada Chikatoshi; Tsushima Takahiro; Ito Yoshinori; Akimoto Tetsuo; Hasegawa Yasuhisa; Kanamaru Miyuki; Daiko Hiroyuki

来源：International Journal of Radiation Oncology, Biology, Physics, 2016, 96(5): 976-984.

DOI：10.1016/j.ijrobp.2016.08.045

• 5-fluorouracil (5-FU)
• Adjuvant chemotherapy
• Cervical esophagus
• Concurrent radiation therapy
• Hematologic toxicity
• Organ preservation
• Prospective study
• Squamous cell carcinoma

Purpose: To clarify, in a multicenter, single-arm, phase 2 study (UMIN Clinical Trials Registry no. UMIN000001439), the clinical profile of chemoradiotherapy (CRT) for cervical esophageal cancer.
Patients and Methods: Patients with operable cervical esophageal cancer, excluding candidates for endoscopic resection, were enrolled. Protocol treatment consisted of CRT and adjuvant chemotherapy (CT). First, patients received concurrent CRT with 5-fluorouracil (5-FU) plus cisplatin (CDDP). Chemotherapy consisted of 5-FU at 700 mg/m(2) intravenous on days 1 to 4 and CDDP at 70 mg/m(2) intravenous on day 1, repeated every 4 weeks for 2 cycles. Radiation therapy consisted of 60 Gy in 30 fractions. After completion of CRT, 2 additional cycles of CT with 5-FU (800 mg/m(2), days 1-5) and CDDP (80 mg/m(2), day 1) were repeated at a 4-week interval. The primary endpoint was 3-year overall survival.
Results: Thirty patients were enrolled across 8 institutions in Japan, consisting of 26 men and 4 women with a median age of 64.5 years (range, 50-75 years). No grade 4 hematologic toxicity was seen in the CRT phase, and 1 grade 4 thrombocytopenia was seen in the CT phase. Grade 3 nonhematologic acute toxicities in the CRT phase were nausea (10%), mucositis (13.3%), and dysphagia (13.3%). No treatment-related death in either phase occurred. Overall complete response rate was 73%, and 3-year overall and laryngectomy-free survival were 66.5% and 52.5%, respectively. Regarding T4 disease, 3-year overall and laryngectomy-free survival were 58.3% and 38.5%, respectively.
Conclusions: This study, the first prospective study for cervical esophageal cancer, showed that CRT has sufficient efficacy and safety for use as an alternative to surgery for these patients.

• 出版日期2016-12-1