671P - A phase II trial of definitive chemoradiotherapy with S-1 and cisplatin for locally advanced oesophageal cancer

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anticancer agents
Oesophageal Cancer
Surgical oncology
Therapy
Biological therapy
Radiation oncology
Presenter Hiroaki Iwase
Authors H. Iwase1, M. Shimada2, T. Tsuzuki2, N. Ryuge3, Y. Kida3, B. Kato3, M. Esaki3, Y. Tanaka3, N. Urata3
  • 1National Hospital Organization Nagoya Medical Center, 460-0001 - Nagoya/JP
  • 2Gastroenterology, National Hospital Organization Nagoya Medical Center, 460-0001 - Nagoya/JP
  • 3Gastroenterology, National Hospital Organization Nagoya Medical Centre, Nagoya/JP

Abstract

Objectives

S-1 is an orally active fluoropyrimidine with low gastrointestinal toxicity, capable of enhancing the efficacy of radiotherapy. We report a phase II study of chemoradiotherapy (CRT) combined with S-1 plus cisplatin for locally advanced esophageal cancer (LAEC).

Methods

CRT comprised two courses: 30-Gy radiotherapy over 3 weeks, plus daily oral S-1 (80 mg/m2/day) for 2 weeks, and a 24-h cisplatin infusion (70 mg/m2) on Day 8. A second identical course was administered after a 2-week break. If patients could not swallow the oral S-1 capsule, it was administered in powder form. In patients who showed an objective response to CRT, at least 2 courses of chemotherapy with S-1 and cisplatin were administered.

Results

Eighty-three patients participated, 12 with Stage II and 71 with Stage III LAEC. Seventy-seven patients (92.7%) completed CRT. The most frequent adverse events were Grades 3 and 4 neutropenia (38.6%); thrombocytopenia (13.3%), and anemia (9.6%). One patient died on Day 20 from febrile bone marrow aplasia. Non-hematological adverse events were mild. The most common were Grade 2 nausea (32.5%); esophageal pain and oral mucositis (16.9% each); and renal dysfunction (10.8%). Adverse events from the first course of CRT resolved during the 2 weeks interval. Complete response rates in patients with Stage II and Stage III LAEC were 91.7% and 67.6%, respectively. No relapse occurred in patients with Stage II disease, and relapses occurred in 21 (43.8%) of 48 patients with Stage III disease who achieved CR. Median PFS for patients with Stage II and III patients was 6.6 and 1.6 years, respectively. Median survival time was 7 years for Stage II and 2.6 years for Stage III LAEC.

Conclusions

CRT combined with S-1 plus cisplatin showed promising safety and efficacy, as well as potential to become a standard treatment for LAEC.

Disclosure

All authors have declared no conflicts of interest.