Researchers from Japan involved in a multicenter clinical trial have reported that oral S-1 is non-inferior to 5-Fluorouracil (5-FU) or Camptosar® (irinotecan) and Platinol® (cisplatin) for treatment of metastatic gastric cancer. The details of this randomized study were published early on-line in Lancet Oncology on October 8, 2009.[1]
S-1 is an oral agent that is converted to 5-FU in the body. It also contains gimeracil, which helps to inhibit the degradation of 5-FU in the body, and oteracil, which helps to reduce gastrointestinal side effects normally caused by 5-FU. S-1 has demonstrated effectiveness in several cancers and is widely used in Japan and other Asian countries. S-1 is not approved in the United States but is in Phase III clinical testing.
A previous Japanese study published in the New England Journal of Medicine reported that S-1 was effective for adjuvant therapy of gastric cancer (see first item of related news). At three years overall survival was 80% for patients treated with S-1 compared with 70% for those treated with surgery only. Side effects associated with S-1 included nausea, diarrhea, and weight loss. Researchers from Japan have also reported that the combination of S-1 plus Platinol is superior to S-1 alone for the treatment of advanced gastric cancer (see second related news item).
The current study randomly allocated 704 patients with unresectable or recurrent gastric adenocarcinoma to receive one of three chemotherapy regimens: continuous infusion of 5-FU, Camptosar and Platinol, or S-1. All but three patients were chemotherapy naïve. The following table summarizes the main findings of this trial:
| 5-FU | Camptosar/Platinol | S-1 |
Number of Patients | 234 | 236 | 234 |
Median Overall Survival | 10.8 months | 12.3 months | 11.4 months |
Treatment-related Deaths | 0 | 3 | 1 |
2-year Overall Survival | 14% | 18% | 21% |
Comments: These and other data support the concept that oral S-1 can be substituted for intravenous 5-FU for the palliative treatment of gastric cancer.
Related News:
Adjuvant Therapy with New Oral Fluoropyrimidine Improves Survival for Resected Gastric Cancer (11/07/2007)
S-1 Plus Platinol® Effective for Advanced Gastric Cancer (2/22/2008)
Reference:
[1] Boku H, Yamamoto S, Fukuda H, et al. Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomized phase 3 study. Lancet Oncology 2009;e-pub on October 8.
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