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

Journal Article · Thu Dec 01 04:00:00 EST 2016 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/J.IJROBP.2016.08.045· OSTI ID:22645719

Zenda, Sadamoto ^[1]; Kojima, Takashi ^[2]; Kato, Ken ^[3]; Izumi, Sachiko ^[4]; Ozawa, Taijiro ^[5]; Kiyota, Naomi ^[6]; Katada, Chikatoshi ^[7]; Tsushima, Takahiro ^[8]; Ito, Yoshinori ^[9]; Akimoto, Tetsuo ^[1]; Hasegawa, Yasuhisa ^[5]; Kanamaru, Miyuki ^[1]; Daiko, Hiroyuki ^[10]

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1. Department of Radiation Oncology, National Cancer Center Hospital East, Chiba (Japan)
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 Surgery, National Cancer Center Hospital East, Chiba (Japan)

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{sup 2} intravenous on days 1 to 4 and CDDP at 70 mg/m{sup 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{sup 2}, days 1-5) and CDDP (80 mg/m{sup 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.

• OSTI ID: 22645719
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 5 Vol. 96; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

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NEOPLASMS
PATIENTS
PLATINUM COMPLEXES
RADIOTHERAPY