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Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial
Open accessAbstract
BACKGROUND Gemcitabine plus cisplatin (GC) is the standard treatment for advanced biliary tract cancer (BTC); however, it causes nausea, vomiting, and anorexia, and requires hydration. Gemcitabine plus S-1 (GS) reportedly has equal to, or better, efficacy and an acceptable toxicity profile. We aimed to confirm the non-inferiority of GS to GC for patients with advanced/recurrent BTC in terms of overall survival (OS). PATIENTS AND METHODS We undertook a Phase III randomized trial in 33 institutions in Japan. Eligibility criteria included chemotherapy-naïve patients with recurrent or unresectable BTC, an Eastern Cooperative Oncology Group Performance Status of 0-1, and adequate organ function. The calculated sample size was 350 with a 1-sided alpha of 5%, a power of 80%, and non-inferiority margin hazard ratio of 1.155. The primary endpoint was OS, while the secondary endpoints included progression-free survival (PFS), response rate (RR), adverse events (AEs), and clinically significant AEs defined as grade ≥2 fatigue, anorexia, nausea, vomiting, oral mucositis, or diarrhea. RESULTS Between May 2013 and March 2016, 354 patients were enrolled. GS was found to be non-inferior to GC (median OS: 13.4 months with GC and 15.1 months with GS, hazard ratio [HR], 0.945; 90% confidence interval [CI], 0.78-1.15; P=0.046 for non-inferiority). The median PFS was 5.8 months with GC and 6.8 months with GS (HR, 0.86, 95% CI, 0.70-1.07). The RR was 32.4% with GC and 29.8% with GS. Both treatments were generally well-tolerated. Clinically significant AEs were observed in 35.1% of patients in the GC arm and 29.9% in the GS arm. CONCLUSIONS GS, which does not require hydration, should be considered a new, convenient standard of care option for patients with advanced/recurrent BTC.This trial has been registered with the UMIN Clinical Trials Registry (http://www.umin.ac.jp/ctr/index.htm), number UMIN000010667.ORCID : https://orcid.org/0000-0002-6560-7503.
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“A phase III trial has reported that the combination of gemcitabine with S-1 (Gem-S1) is non-inferior to Gem-Cis with a median overall survival (OS) of 15.1 and 13.4 months, respectively (HR = 0.945, 90% CI: 0.78–1.15, non-inferiority p = 0.046) [89].”
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Metadata
- Authors
- Morizane, C., Okusaka, T., Mizusawa, J., Katayama, H., Ueno, M., Ikeda, M., Ozaka, M., Okano, N., Sugimori, K., Fukutomi, A., Hara, H., Mizuno, N., Yanagimoto, H., Wada, K., Tobimatsu, K., Yane, K., Nakamori, S., Yamaguchi, H., Asagi, A., Yukisawa, S., Kojima, Y., Kawabe, K., Kawamoto, Y., Sugimoto, R., Iwai, T., Nakamura, K., Miyakawa, H., Yamashita, T., Hosokawa, A., Ioka, T., Kato, N., Shioji, K., Shimizu, K., Nakagohri, T., Kamata, K., Ishii, H., & Furuse, J.
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2019-12
- Volume
- 30
- Issue
- 12
- Pages
- 1950-1958
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2977982707
- Cited by
- 322
- References
- 18
- FWCI
- 29.17
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Morizane, C., Okusaka, T., Mizusawa, J., Katayama, H., Ueno, M., Ikeda, M., Ozaka, M., Okano, N., Sugimori, K., Fukutomi, A., Hara, H., Mizuno, N., Yanagimoto, H., Wada, K., Tobimatsu, K., Yane, K., Nakamori, S., Yamaguchi, H., Asagi, A., . . . Furuse, J. (2019). Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Annals of Oncology. https://doi.org/10.1093/annonc/mdz402
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