TY - JOUR
T1 - Randomised phase II trial of S-1 plus oxaliplatin vs S-1 in patients with gemcitabine-refractory pancreatic cancer
AU - Ohkawa, S.
AU - Okusaka, T.
AU - Isayama, H.
AU - Fukutomi, A.
AU - Yamaguchi, K.
AU - Ikeda, M.
AU - Funakoshi, A.
AU - Nagase, M.
AU - Hamamoto, Y.
AU - Nakamori, S.
AU - Tsuchiya, Y.
AU - Baba, H.
AU - Ishii, H.
AU - Omuro, Y.
AU - Sho, M.
AU - Matsumoto, S.
AU - Yamada, N.
AU - Yanagimoto, H.
AU - Unno, M.
AU - Ichikawa, Y.
AU - Takahashi, S.
AU - Watanabe, G.
AU - Wakabayashi, G.
AU - Egawa, N.
AU - Tsuda, M.
AU - Hosotani, R.
AU - Hamada, C.
AU - Hyodo, I.
N1 - Funding Information:
This study was supported by Yakult Honsha Co., Ltd. We thank all patients, clinicians, and support staff who participated in this study. We are grateful to Yuh Sakata, Fumitaka Nagamura, and Satoshi Morita for their helpful advice as members of the IDMC, and Atsushi Sato, Kunihisa Miyakawa and Kouki Yoshikawa as members of the Independent Review Committee. We also thank Yuki Tanaka for his helpful advice.
Publisher Copyright:
© 2015 Cancer Research UK.
PY - 2015/4/28
Y1 - 2015/4/28
N2 - Background:This randomised, open-label, multicenter phase II study compared progression-free survival (PFS) of S-1 plus oxaliplatin (SOX) with that of S-1 alone in patients with gemcitabine-refractory pancreatic cancer.Methods:Patients with confirmed progressive disease following the first-line treatment with a gemcitabine-based regimen were randomised to receive either S-1 (80/100/120 mg day -1 based on body surface area (BSA), orally, days 1-28, every 6 weeks) or SOX (S-1 80/100/120 mg day -1 based on BSA, orally, days 1-14, plus oxaliplatin 100 mg m -2, intravenously, day 1, every 3 weeks). The primary end point was PFS.Results:Between January 2009 and July 2010, 271 patients were randomly allocated to either S-1 (n=135) or SOX (n=136). Median PFS for S-1 and SOX were 2.8 and 3.0 months, respectively (hazard ratio (HR)=0.84; 95% confidence interval (CI), 0.65-1.08; stratified log-rank test P=0.18). Median overall survival (OS) was 6.9 vs 7.4 months (HR=1.03; 95% CI, 0.79-1.34; stratified log-rank test P=0.82). The response rate (RR) was 11.5% vs 20.9% (P=0.04). The major grade 3/4 toxicities (S-1 and SOX) were neutropenia (11.4% and 8.1%), thrombocytopenia (4.5% and 10.3%) and anorexia (12.9% and 14.7%).Conclusions:Although SOX showed an advantage in RR, it provided no significant improvement in PFS or OS compared with S-1 alone.
AB - Background:This randomised, open-label, multicenter phase II study compared progression-free survival (PFS) of S-1 plus oxaliplatin (SOX) with that of S-1 alone in patients with gemcitabine-refractory pancreatic cancer.Methods:Patients with confirmed progressive disease following the first-line treatment with a gemcitabine-based regimen were randomised to receive either S-1 (80/100/120 mg day -1 based on body surface area (BSA), orally, days 1-28, every 6 weeks) or SOX (S-1 80/100/120 mg day -1 based on BSA, orally, days 1-14, plus oxaliplatin 100 mg m -2, intravenously, day 1, every 3 weeks). The primary end point was PFS.Results:Between January 2009 and July 2010, 271 patients were randomly allocated to either S-1 (n=135) or SOX (n=136). Median PFS for S-1 and SOX were 2.8 and 3.0 months, respectively (hazard ratio (HR)=0.84; 95% confidence interval (CI), 0.65-1.08; stratified log-rank test P=0.18). Median overall survival (OS) was 6.9 vs 7.4 months (HR=1.03; 95% CI, 0.79-1.34; stratified log-rank test P=0.82). The response rate (RR) was 11.5% vs 20.9% (P=0.04). The major grade 3/4 toxicities (S-1 and SOX) were neutropenia (11.4% and 8.1%), thrombocytopenia (4.5% and 10.3%) and anorexia (12.9% and 14.7%).Conclusions:Although SOX showed an advantage in RR, it provided no significant improvement in PFS or OS compared with S-1 alone.
KW - S-1
KW - SOX
KW - chemotherapy
KW - oxaliplatin
KW - pancreatic cancer
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U2 - 10.1038/bjc.2015.103
DO - 10.1038/bjc.2015.103
M3 - Article
C2 - 25880004
AN - SCOPUS:84928769997
SN - 0007-0920
VL - 112
SP - 1428
EP - 1434
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 9
ER -
