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01.08.2012 | PHASE II STUDIES | Ausgabe 4/2012

Investigational New Drugs 4/2012

Pilot study of adjuvant chemotherapy with 3-week combination of S-1 and cisplatin for patients with stage II-IV (M0) gastric cancer

Zeitschrift:
Investigational New Drugs > Ausgabe 4/2012
Autoren:
Byung Woog Kang, Jong Gwang Kim, Yee Soo Chae, Yoo Jin Lee, Soo Jung Lee, Joon Ho Moon, Sang Kyun Sohn, Min Kyu Jung, Seong Woo Jeon, Yun-Jin Jang, Jongduk Seo, Yong Hyun Lee, Ohkyung Kwon, Ho Young Chung, Wansik Yu
Wichtige Hinweise
Jong Gwang Kim and Wansik Yu contributed equally to this work.

Summary

Purpose The feasibility of a 3-week combination of S-1 and cisplatin as an adjuvant chemotherapy for patients with curatively resected gastric cancer was investigated. Experimental design Korean patients with stage II-IV (M0) gastric adenocarcinoma who underwent a gastrectomy with D2 lymph node resection were enrolled. The S-1 was administered orally at 80 mg/m2 divided into two daily doses for 14 days, while the cisplatin was administered at 60 mg/m2 intravenously over 2 h every 21 days. The patients received a maximum of six cycles. Results From January 2006 to July 2010, 74 patients were included in this study. The median patient age was 56 years (range, 22–71), and 51.4% (38/74) of the patients had a performance status of 0. The median number of chemotherapy cycles administered was 6 (range, 1–6). The median relative dose intensity was 86.4% for S-1 and 80.0% for cisplatin. With a median follow-up duration of 13.9 months, the median relapse-free survival (RFS) and overall survival (OS) have not yet been reached. Fifteen relapses (20.3%) were documented. Plus, the estimated RFS rate was 60.5% at 3 years. The treatments were generally well tolerated. The most frequently observed grade 3–4 hematological toxicity was neutropenia (35.1%), and only 1 cycle of neutropenic fever occurred. The most frequently observed grade 3–4 non-hematological toxicities were nausea (4.1%) and asthenia (4.1%), and all the other grade 3–4 non-hematological toxicities were observed in less than 3% of the patients. Conclusions Postoperative adjuvant S-1 plus cisplatin for 18 weeks was found to be feasible for patients with stage II-IV (M0) gastric adenocarcinoma following complete surgical resection.

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