Adjuvant S-1 for Resected Pancreatic Cancer

Summary and Comment |
June 27, 2016

Adjuvant S-1 for Resected Pancreatic Cancer

  1. David H. Ilson, MD, PhD

Overall survival was significantly better with S-1 versus gemcitabine.

  1. David H. Ilson, MD, PhD

Adjuvant chemotherapy with either 5-FU/leucovorin or gemcitabine, with or without postoperative radiotherapy, modestly improves survival compared with surgery alone in patients with resected pancreatic cancer. Despite advances in the systemic treatment of metastatic disease, little progress has been made in the postsurgical treatment of this disease.

Investigators from Japan now report the results of an industry-sponsored, multicenter, randomized, open-label, noninferiority phase III trial (JASPAC 01) comparing adjuvant weekly gemcitabine to oral S-1 in 378 patients with resected pancreatic cancer. Most patients had R0 resection (86%–88%), T3 disease (88%), and node-positive disease (62%–64%); a minority (23%–19%) had CA 19-9 elevation prior to treatment.

Median overall survival (the primary outcome) strongly favored S-1 over gemcitabine (46.5 vs. 25.5 months; hazard ratio, 0.57; P<0.0001 for noninferiority and P<0.0001 for superiority), as did 5-year overall survival (43.6% vs. 24.2%; P<0.0001). Grade 3 or 4 neutropenia was higher with gemcitabine (72% vs. 13%; P<0.001), and more patients discontinued gemcitabine versus S-1 prior to therapy completion (42% vs. 28%; P=0.005), with similar rates of discontinuation for toxicity (21%–25%) but more early recurrences with gemcitabine (13% vs. 5%).

Comment

Adjuvant therapy with either a fluorinated pyrimidine or gemcitabine improves survival after resection of pancreatic adenocarcinoma. The superiority of S-1 over gemcitabine in JASPAC 01 is surprising given the therapeutic equivalence between fluorinated pyrimidine-based therapy and gemcitabine seen in Western trials. Japanese patients tolerate higher doses of S-1 than Western patients, and a repeat trial comparing S-1 to gemcitabine will not likely be conducted in the West. Recent data from the ESPAC-4 trial in the U.K. indicate superiority for the combination of capecitabine and gemcitabine compared with gemcitabine alone as adjuvant therapy, and this may emerge as the new therapy standard in the West.

Editor Disclosures at Time of Publication

  • Disclosures for David H. Ilson, MD, PhD at time of publication Consultant / Advisory board Amgen; Eli Lilly–ImClone; Macrogenics; Bayer Speaker’s bureau Genentech/Roche Grant / Research support Bayer; Amgen; Bristol-Myers Squibb

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