Phase I study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer.

Takayama, T.; Sato, Y.; Sagawa, T.; Okamoto, T.; Nagashima, H.; Takahashi, Y.; Ohnuma, H.; Kuroiwa, G.; Miyanishi, K.; Takimoto, R.; Matsunaga, T.; Kato, J.; Yamaguchi, K.; Hirata, K.; Niitsu, Y.

The aim of this dose escalation study was to determine the maximum-tolerated dose (MTD), dose-limiting toxicities (DLTs) and preliminary efficacy of docetaxel, S-1 and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer. Seventeen patients received oral S-1 (40 mg m−2 bid) on days 1–14, intravenous cisplatin (60 mg m−2) and docetaxel (60, 70 or 80 mg m−2 depending on DLT) on day 8 every 3 weeks. The MTD of this combination was presumed to be docetaxel 70 mg m−2. At this dose level, 40% of the patients (two of five) developed grade 4 neutropenia and 20% (one of five) exhibited grade 3 nausea during the first course. Therefore, the recommended dose of docetaxel was defined as 60 mg m−2. The DLT was neutropenia. The response rate (RR) was 88.2% (15 of 17), consisting of one complete response and 14 partial responses. There were two stable diseases but no progressive disease. Of these 15 responders, four (23.5%) with high VEGF expression showed rapid tumour regression and achieved downstaging, leading to subsequent curative gastrectomy. Three of these have been disease free for about 3 years, suggesting a complete cure. In conclusion, this regimen was tolerable and showed a quite high RR, with an appreciable downstaging rate in metastatic gastric cancer.British Journal of Cancer (2007) 97, 851–856. doi:10.1038/sj.bjc.6603957 www.bjcancer.com Published online 11 September 2007

STOMACH cancer; METASTASIS; CANCER patients; CANCER treatment; DRUG therapy

British Journal of Cancer, 2007, Vol 97, Issue 7, p851

0007-0920

Academic Journal

10.1038/sj.bjc.6603957