2015年4月
Randomised phase II trial of S-1 plus oxaliplatin vs S-1 in patients with gemcitabine-refractory pancreatic cancer
BRITISH JOURNAL OF CANCER
- 巻
- 112
- 号
- 9
- 開始ページ
- 1428
- 終了ページ
- 1434
- 記述言語
- 英語
- 掲載種別
- 研究論文(学術雑誌)
- DOI
- 10.1038/bjc.2015.103
- 出版者・発行元
- NATURE PUBLISHING GROUP
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.
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.
- リンク情報
- ID情報
-
- DOI : 10.1038/bjc.2015.103
- ISSN : 0007-0920
- eISSN : 1532-1827
- PubMed ID : 25880004
- Web of Science ID : WOS:000353659800002