Sadamoto Zenda1, Takashi Kojima2, Ken Kato3, Sachiko Izumi4, Taijiro Ozawa5, Naomi Kiyota6, Chikatoshi Katada7, Takahiro Tsushima8, Yoshinori Ito9, Tetsuo Akimoto10, Yasuhisa Hasegawa5, Miyuki Kanamaru10, Hiroyuki Daiko11. 1. Department of Radiation Oncology, National Cancer Center Hospital East, Chiba, Japan. Electronic address: szenda@east.ncc.go.jp. 2. Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan. 3. Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. 4. Department of Radiation Oncology, Tokyo Women's Medical University, Tokyo, Japan. 5. Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Aichi, Japan. 6. Department of Medical Oncology and Hematology, Kobe University Hospital, Hyogo, Japan. 7. Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan. 8. Department of Gastrointestinal Endoscopy and Oncology, Shizuoka Cancer Center Hospital, Shizuoka, Japan. 9. Division of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan. 10. Department of Radiation Oncology, National Cancer Center Hospital East, Chiba, Japan. 11. Department of Surgery, National Cancer Center Hospital East, Chiba, Japan.
Abstract
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/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. 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.
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/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. 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.
Authors: Nina-Sophie Hegemann; Rebecca Koepple; Franziska Walter; David Boeckle; Wolfgang P Fendler; Martin Kurt Angele; Stefan Boeck; Claus Belka; Falk Roeder Journal: Strahlenther Onkol Date: 2018-01-18 Impact factor: 3.621
Authors: Armando De Virgilio; Andrea Costantino; Carlo Castoro; Giuseppe Spriano; Bianca Maria Festa; Giuseppe Mercante; Davide Franceschini; Ciro Franzese; Marta Scorsetti; Andrea Marrari; Raffaele Cavina; Salvatore Marano Journal: J Cancer Res Clin Oncol Date: 2022-03-02 Impact factor: 4.553
Authors: Armando De Virgilio; Andrea Costantino; Carlo Castoro; Giuseppe Spriano; Bianca Maria Festa; Giuseppe Mercante; Davide Franceschini; Ciro Franzese; Marta Scorsetti; Andrea Marrari; Raffaele Cavina; Salvatore Marano Journal: Eur Arch Otorhinolaryngol Date: 2022-08-15 Impact factor: 3.236