Updated results from GEST study: a randomized, three-arm phase III study for advanced pancreatic cancer

PURPOSE: The GEST study showed non-inferiority of S-1 but not superiority of gemcitabine plus S-1 (GS) to gemcitabine alone for overall survival with the data by the cut-off date of 31st July in 2010 for chemo-naïve patients with advanced pancreatic cancer. We considered it important to determine wh...

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Detalles Bibliográficos
Autores principales: Okusaka, Takuji, Miyakawa, H., Fujii, H., Nakamori, S., Satoh, T., Hamamoto, Y., Ito, T., Maguchi, H., Matsumoto, S., Ueno, H., Ioka, T., Boku, N., Egawa, S., Hatori, T., Furuse, J., Mizumoto, K., Ohkawa, S., Yamaguchi, T., Yamao, K., Funakoshi, A., Chen, J. S., Cheng, A. L., Sato, A., Ohashi, Y., Tanaka, M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2017
Materias:
Original Article – Clinical Oncology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5427167/
https://www.ncbi.nlm.nih.gov/pubmed/28210843
http://dx.doi.org/10.1007/s00432-017-2349-y
Descripción
Sumario:PURPOSE: The GEST study showed non-inferiority of S-1 but not superiority of gemcitabine plus S-1 (GS) to gemcitabine alone for overall survival with the data by the cut-off date of 31st July in 2010 for chemo-naïve patients with advanced pancreatic cancer. We considered it important to determine whether S-1 maintains non-inferiority after a long-term follow-up in the GEST study and to obtain a firm positive conclusion. In addition, it may be an interesting challenge to explore the efficacious profile of GS in the long-term follow-up study. Using the data from the follow-up period, background and efficacy in patients from Taiwan and Japan, as well as the rates of tumor shrinkage in locally advanced and metastatic patients (Waterfall plot) were also analyzed. METHODS: The results of the primary analysis were reconfirmed, and subset analysis of overall survival and progression-free survival was performed based on the overall survival data updated by the cut-off date of 31st July in 2011. RESULTS: The median follow-up period was 29.8 months, and 795 deaths occurred (95.6%). The median overall survival was 8.8 months for gemcitabine, 9.7 months for S-1 (hazard ratio [HR], 0.96; 97.5% confidence interval [CI], 0.79–1.17), and 9.9 months for GS (HR 0.91; 97.5% CI 0.75–1.11). In patients with performance status (PS) 0, the median overall survival was 9.8 months for gemcitabine, 10.9 months for S-1, and 10.5 months for GS. In patients with PS 1, the median overall survival was 6.2 months for gemcitabine, 6.3 months for S-1, and 9.6 months for GS. CONCLUSION: Our survey reconfirmed the non-inferiority of S-1 to gemcitabine and showed S-1 can be used as one of the standard treatment options for advanced pancreatic cancer. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00498225. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00432-017-2349-y) contains supplementary material, which is available to authorized users.

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