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S-1 plus cisplatin holds promise of becoming a standard first-line treatment for patients with advanced gastric cancer, researchers have concluded.
The investigators presented findings from the phase III SPIRITS (S-1 Plus cisplatin versus S-1 In RCT In the Treatment for Stomach cancer) trial, published early online in Lancet Oncology.
S-1 (TS-1, Taiho Pharmaceuticals, Japan) is an orally active combination of tegafur (a prodrug converted by cells to fluorouracil), gimeracil (an inhibitor of dihydropyrimidine dehydrogenase, which degrades fluorouracil), and oteracil (which inhibits phosphorylation of fluorouracil in the GI tract, reducing GI toxic effects of fluorouracil).
The study involved chemotherapy-naive patients with advanced gastric cancer enrolled in 2002-4 at 38 centres in Japan.
They were randomised to receive either combination treatment with S-1 plus cisplatin, or S-1 alone.
The primary endpoint was overall survival and secondary endpoints were progression-free survival, proportions of responders, and safety.
An intention-to-treat analysis found that:
The drug is currently used in Japan for treating gastric, colorectal, head and neck, non-small cell lung, metastatic breast and pancreatic cancers, and is in phase III clinical development in other countries.
Sanofi-Aventis is collaborating on and leading clinical development and commercialisation of S-1 in Europe and the USA.