News Release


Phase III Clinical Trial (CATS TRIAL) for Non-small-cell Lung Cancer Non-inferiority of TS-1 + Cisplatin Treatment Verified Presented to the American Society of Clinical Oncology (ASCO) (06/06/2012)

Tokyo, June 6, 2012 – Taiho Pharmaceutical Co., Ltd. announced on June 5 U.S. time at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) the results of a CDDP AND TS-1 TRIAL (CATS). (Abstract No. 7515)

The trial was carried out by The Tokyo Cooperative Oncology Group (TCOG), a non-profit corporation. It was a Phase III clinical trial for untreated advanced non-small-cell lung cancer that compared TS-1 + cisplatin treatment with the standard docetaxel + cisplatin treatment. This trial verified the non-inferiority of the overall survival (OS) time for TS-1 + cisplatin treatment.

Trial Results

  • The non-inferiority of the primary object of evaluation in this study, the overall survival (OS) time, for the TS-1 + cisplatin group in comparison with the docetaxel + cisplatin group was verified. (HR=1.013; 96.4% CI, 0.837-1.227)
  • In terms of safety, the TS-1 + cisplatin group had lower incidence rates than docetaxel + cisplatin. Details are as follows:
    Hair loss: docetaxel + cisplatin group, 59.3%; TS-1 + cisplatin group, 12.3%
    Grade 3 and above febrile neutropenia: docetaxel + cisplatin, 7.4%; TS-1 + cisplatin, 1.0%
    Grade 3 and above neutropenia: docetaxel + cisplatin, 73.4%; TS-1 + cisplatin, 22.9%
    Grade 3 and above infection: docetaxel + cisplatin, 14.5%; TS-1 + cisplatin, 5.3%.
  • The results of a quality of life (QOL) evaluation performed using EORTC QLQ-C30 Global Health Status/QOL showed that the TS-1 + cisplatin group had a satisfactory QOL.

“TS-1 + cisplatin is as effective as docetaxel + cisplatin, which is one of the standard treatments,” said Shoji Kudo, director of Fukujuji Hospital, Japan Anti-Tuberculosis Association, the principal investigator of this study. “It has a low incidence rate of the side-effect known as febrile neutropenia and provides superior QOL to patients.”

This trial was the second trial of the Phase III clinical trial held in Japan that demonstrated TS-1’s efficacy against non-small-cell lung cancer. The first trial was a LETS Study (WJOG 3605). The second trial indicates that TS-1 is a new treatment option for both medical facilities engaged in the treatment of cancer and patients receiving such treatment. Taiho Pharmaceutical will continue developing treatments in the lung cancer field.

About the CATS TRIAL

This trial was a Phase III clinical trial that compared a docetaxel + cisplatin group (3–6 courses of 3–4 weeks each of docetaxel 60 mg/m2 on the first day and cisplatin 80 mg/m2 I.V.) and a TS-1 + cisplatin group (3–6 courses of 4–5 weeks each of TS-1 80 mg/m2/day twice a day orally for the first to the twenty-first day, and cisplatin 60 mg/m2 I.V. on the eighth day). Sixty-six medical facilities in Japan participated in the study with 608 registered cases from April 2007 to December 2008.

About the LETS Study

Thirty medical facilities in Japan participated in the LETS Study Phase III clinical trial for non-small-cell lung cancer. The non-inferiority of the overall survival (OS) time of a carboplatin + TS-1 group in comparison to a carboplatin + paclitaxel group was verified (Journal of Clinical Oncology 28(36)5240 - 5246, 2010).

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