Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)

Chigusa Morizane, Takuji Okusaka, Junki Mizusawa, Atsuo Takashima, Makoto Ueno, Masafumi Ikeda, Yasuo Hamamoto, Hiroshi Ishii, Narikazu Boku, Junji Furuse

Research output: Contribution to journalArticle

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Abstract

The oral fluoropyrimidine, S-1, combined with or without gemcitabine is considered to be a promising agent for treating advanced biliary tract cancer; gemcitabine plus cisplatin is the current standard regimen. This randomized phase II trial was designed to evaluate the safety and efficacy of two regimens: gemcitabine plus S-1 (GS) (gemcitabine: 1000 mg/m2, day 1 and day 8; S-1: 60 mg/m2, twice daily on days 1-14, repeated every 3 weeks); and S-1 (80 mg/m2, days 1-28, given orally twice daily for 4 weeks, followed by a 2-week rest, repeated every 6 weeks). The regimen with a higher 1-year survival would be selected for a subsequent phase III trial. Between February 2009 and April 2010, 101 patients were randomized. For the GS (n = 51) and S-1 (n = 50) arms, the 1-year survival was 52.9% (95% confidence interval, 38.5-65.5) and 40.0% (95% confidence interval, 26.5-53.1), and the median survival times were 12.5 and 9.0 months, respectively. Grade 3/4 hematological toxicities were more frequent in the GS arm (leucocytes 29.4%, neutrophils 60.8%, hemoglobin 11.8%, platelets 11.8%) than in the S-1 arm (leucocytes 2.0%, neutrophils 4.0%, hemoglobin 4.0%, platelets 4.0%). Although two treatment-related deaths occurred in the GS arm, all other grade 3/4 non-hematological toxicities were reversible. In conclusion, GS was considered to be more promising and was selected as the test regimen for a subsequent phase III trial comparing GS with gemcitabine plus cisplatin combination therapy. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001685 (http://www.umin.ac.jp/ctr/index.htm).

Original languageEnglish
Pages (from-to)1211-1216
Number of pages6
JournalCancer Science
Volume104
Issue number9
DOIs
Publication statusPublished - 2013 Sep 1
Externally publishedYes

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gemcitabine
Biliary Tract Neoplasms
Medical Oncology
Japan
Cisplatin
Survival
Hemoglobins
Neutrophils
Leukocytes
Blood Platelets
Confidence Intervals

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer : A Japan Clinical Oncology Group trial (JCOG 0805). / Morizane, Chigusa; Okusaka, Takuji; Mizusawa, Junki; Takashima, Atsuo; Ueno, Makoto; Ikeda, Masafumi; Hamamoto, Yasuo; Ishii, Hiroshi; Boku, Narikazu; Furuse, Junji.

In: Cancer Science, Vol. 104, No. 9, 01.09.2013, p. 1211-1216.

Research output: Contribution to journalArticle

Morizane, C, Okusaka, T, Mizusawa, J, Takashima, A, Ueno, M, Ikeda, M, Hamamoto, Y, Ishii, H, Boku, N & Furuse, J 2013, 'Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)', Cancer Science, vol. 104, no. 9, pp. 1211-1216. https://doi.org/10.1111/cas.12218
Morizane, Chigusa ; Okusaka, Takuji ; Mizusawa, Junki ; Takashima, Atsuo ; Ueno, Makoto ; Ikeda, Masafumi ; Hamamoto, Yasuo ; Ishii, Hiroshi ; Boku, Narikazu ; Furuse, Junji. / Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer : A Japan Clinical Oncology Group trial (JCOG 0805). In: Cancer Science. 2013 ; Vol. 104, No. 9. pp. 1211-1216.
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abstract = "The oral fluoropyrimidine, S-1, combined with or without gemcitabine is considered to be a promising agent for treating advanced biliary tract cancer; gemcitabine plus cisplatin is the current standard regimen. This randomized phase II trial was designed to evaluate the safety and efficacy of two regimens: gemcitabine plus S-1 (GS) (gemcitabine: 1000 mg/m2, day 1 and day 8; S-1: 60 mg/m2, twice daily on days 1-14, repeated every 3 weeks); and S-1 (80 mg/m2, days 1-28, given orally twice daily for 4 weeks, followed by a 2-week rest, repeated every 6 weeks). The regimen with a higher 1-year survival would be selected for a subsequent phase III trial. Between February 2009 and April 2010, 101 patients were randomized. For the GS (n = 51) and S-1 (n = 50) arms, the 1-year survival was 52.9{\%} (95{\%} confidence interval, 38.5-65.5) and 40.0{\%} (95{\%} confidence interval, 26.5-53.1), and the median survival times were 12.5 and 9.0 months, respectively. Grade 3/4 hematological toxicities were more frequent in the GS arm (leucocytes 29.4{\%}, neutrophils 60.8{\%}, hemoglobin 11.8{\%}, platelets 11.8{\%}) than in the S-1 arm (leucocytes 2.0{\%}, neutrophils 4.0{\%}, hemoglobin 4.0{\%}, platelets 4.0{\%}). Although two treatment-related deaths occurred in the GS arm, all other grade 3/4 non-hematological toxicities were reversible. In conclusion, GS was considered to be more promising and was selected as the test regimen for a subsequent phase III trial comparing GS with gemcitabine plus cisplatin combination therapy. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001685 (http://www.umin.ac.jp/ctr/index.htm).",
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AU - Takashima, Atsuo

AU - Ueno, Makoto

AU - Ikeda, Masafumi

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