Overall survival curve in the START trial
Credit: Dr Kazuhiro Yoshida
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An updated analysis of a Japanese phase III trial has shown that the combination of the oral fluoropyrimidine S-1 with docetaxel is beneficial for metastatic gastric cancer patients. S-1 is used as a standard treatment for advanced and recurrent gastric cancer in East Asia. The researchers reported at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna updated results from this study, which was reported initially in 2011.
The results had been reported through a planned analysis in 2011, however an independent biostatistician pointed out that a large number of censored cases led to an insufficient number of events for proper analysis. Now, Dr Kazuhiro Yoshida and colleagues present an updated analysis. They found that among the 635 patients analysed, the median survival time was 12.48 months in the combination therapy group compared to 10.78 months in patients who received S-1 alone.
Neutropenia was the most frequent adverse events in the docetaxel/S-1 arm with one death occurring from grade 4 thrombocytopenia.
According to Dr Yoshida, this combination is much better than S-1 monotherapy which is regarded as one of the standard therapies for metastatic gastric cancer in Japan.
The earlier SPIRITS trial also showed that S-1 plus cisplatin is a standard therapy for gastric cancer in Asia, Dr Yoshida noted. However, data from this study in Japanese patients demonstrated more promising overall survival with a larger number of patients compared to the SPIRITS trial. These data will have an impact on daily practice for gastric cancer patients.
Commenting on the study, Prof. Jean-Yves Douillard, ICO Centre Rene Gauducheau, France, Chair of the ESMO Educational Committee, not involved in the study, said that the START trial is a large study, meeting its primary end-point of improved survival showing a significant 17% reduction of the risk of death and a good median of 12.5 vs. 10.8 months in favour of the combination. Progression-free survival and overall response-rate were also significantly better in the combination arm.
The START study, with the combination of docetaxel and S-1, might represent an alternative to the platinum-containing regimens widely used in Europe, but would need first to be evaluated in Caucasian populations to assess feasibility and tolerance at doses of docetaxel usually used in Europe, and not at lower doses as routinely done in Japan.