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JASPAC 01 found that six months of the oral fluoropyrimidine S-1 after pancreatic cancer surgery nearly doubled five-year survival compared with gemcitabine in Japanese patients, 44 against 24 percent, which made S-1 the adjuvant standard in Japan; the result has never been tested in Western patients, who metabolise the drug differently.
JASPAC 01 randomised 385 patients between April 2007 and June 2010 to gemcitabine (1,000 mg/m2 on days 1, 8 and 15 of a 28-day cycle, up to six cycles) or S-1 (40 to 60 mg twice daily by body surface area for 28 days of a 42-day cycle, up to four cycles). The trial was designed to show non-inferiority (margin 1.25) and was stopped early in September 2012 when the interim analysis met the pre-specified criteria. With follow-up to January 2016 the hazard ratio for death was 0.57 (95 percent confidence interval 0.44 to 0.72; p below 0.0001 for both non-inferiority and superiority), with five-year overall survival 44.1 percent on S-1 against 24.4 percent on gemcitabine. Grade 3 or 4 leucopenia, neutropenia and transaminase rises were commoner with gemcitabine, stomatitis and diarrhoea with S-1. S-1 (tegafur, gimeracil and oteracil) is licensed in Europe as Teysuno for gastric and colorectal cancer only, and the authors asked for the result to be confirmed in non-Asian patients before it is adopted outside Japan; the corpus's adjuvant row cites it as the Japanese standard beside modified FOLFIRINOX and gemcitabine plus capecitabine.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
385 randomised.
5-year rate; 95% CI 36.9 to 51.1 · 5-year rate; 95% CI 18.6 to 30.8
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (per-protocol population)primary | Adjuvant S-1 | 187 | 44.1% | 0.57 (0.44 to 0.72) | <0.0001 | link |
| Adjuvant gemcitabine | 190 | 24.4% |
Shares ESPAC-4, PRODIGE 24 / CCTG PA6, Resectable pancreatic ductal adenocarcinoma, Gemcitabine.
Shares CONKO-001, ESPAC-4, Neoadjuvant / adjuvant / perioperative, Resectable pancreatic ductal adenocarcinoma.
Shares ESPAC-4, Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Pancreatic ductal adenocarcinoma.
Shares CONKO-001, Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Pancreatic ductal adenocarcinoma.
Shares CONKO-001, Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Cytotoxic chemotherapy.
Shares PRODIGE 24 / CCTG PA6, Neoadjuvant / adjuvant / perioperative, Resectable pancreatic ductal adenocarcinoma, Gemcitabine.
Shares Tegafur, gimeracil and oteracil (S-1), Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Cytotoxic chemotherapy.
Shares PRODIGE 24 / CCTG PA6, Neoadjuvant / adjuvant / perioperative, Resectable pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy.