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
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- 作者：Sadamoto Zenda ; MD ; PhD&lowast ; ; szenda@east.ncc.go.jp ; Takashi Kojima ; MD&dagger ; ; Ken Kato ; MD ; PhD&Dagger ; ; Sachiko Izumi ; MD ; PhD§ ; ; Taijiro Ozawa ; MD‖ ; Naomi Kiyota ; MD ; PhD¶ ; ; Chikatoshi Katada ; MD ; PhD# ; Takahiro Tsushima ; MD&lowast ; &lowast ; ; Yoshinori Ito ; MD&dagger ; &dagger ; ; Tetsuo Akimoto ; MD ; PhD&lowast ; ; Yasuhisa Hasegawa ; MD ; PhD‖ ; Miyuki Kanamaru ; BSc&lowast ; ; Hiroyuki Daiko ; MD&Dagger ; &Dagger ;
- 刊名：International Journal of Radiation Oncology*Biology*Physics
- 出版年：2016
- 出版时间：1 December 2016
- 年：2016
- 卷：96
- 期：5
- 页码：976-984
- 全文大小：565 K
- 卷排序：96
文摘
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 MethodsPatients 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/m2 intravenous on days 1 to 4 and CDDP at 70 mg/m2 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/m2, days 1-5) and CDDP (80 mg/m2, day 1) were repeated at a 4-week interval. The primary endpoint was 3-year overall survival.ResultsThirty 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.ConclusionsThis 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.