Multi-center Phase II Study of Cisplatin and 5-FU with Concurrent Radiotherapy as an Organ Preservation Approach in Patients with Squamous Cell Carcinoma of the Cervical Esophagus

Publication date: Available online 3 September 2016
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Sadamoto Zenda, Takashi Kojima, Ken Kato, Sachiko Izumi, Taijiro Ozawa, Naomi Kiyota, Chikatoshi Katada, Takahiro Tsushima, Yoshinori Ito, Tetsuo Akimoto, Yasuhisa Hasegawa, Miyuki Kanamaru, Hiroyuki Daiko
ObjectiveWe conducted a multi-center single-arm phase II study to clarify the clinical profile of chemoradiotherapy for cervical esophageal cancer. (UMIN-CTR: UMIN000001439).BackgroundChemoradiotherapy for cervical esophageal cancer has not been prospectively evaluated, limiting information on the clinical profile of this treatment.MethodsPatients with operable cervical esophageal cancer, excluding candidates for endoscopic resection, were enrolled. Protocol treatment consisted of CRT and adjuvant chemotherapy. First, patients received concurrent CRT with 5-FU plus CDDP. Chemotherapy consisted of 5-FU at 700 mg/m² i.v. on days 1-4 and CDDP at 70 mg/m² on day 1 i.v., repeated every 4 weeks for two cycles. Radiation therapy consisted of 60 Gy in 30 fractions. After completion of CRT, two additional cycles of chemotherapy 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. Primary endpoint was 3-year overall survival.ResultsThirty patients were enrolled across eight institutions in Japan, consisting of 26 males and 4 females with a median age of 64.5 years (range 50–75). No grade 4 hematologic toxicity was seen in the CRT phase and one grade 4 thrombocytopenia was seen in the CT phase. Grade 3 non-hematologic acute toxicities in the CRT phase were nausea (10%), mucositis (13.3%), and dysphagia (13.3%). No treatment-related death in both 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 chemoradiotherapy has sufficient efficacy and safety for use as an alternative to surgery for these patients.

Teaser

This multi-center phase II study is the first prospective study that showed chemoradiotherapy (5-FU/CDDP/RT) for cervical esophageal cancer has sufficient efficacy and safety for use as an alternative to surgery.


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