The addition of S-1 to gemcitabine-based chemotherapy improves survival with increased toxicity for patients with advanced pancreatic cancer: Combined meta-analysis of efficacy and safety profile

SummaryPurposeTo investigate the efficiency and safety profile of the addition of S-1 to gemcitabine (GEM)-based chemotherapy for advanced pancreatic cancer (APC).MethodsComputerized search was undertaken to identify randomized controlled trials of S-1 plus GEM versus GEM monotherapy in APC patients. The outcomes included overall survival (OS), progression-free survival (PFS), response rate, and toxicities.ResultsFive studies with 917 patients were included. Overall, there was a significant difference between the two regimens in terms of OS (HR = 0.83, 95%CI = 0.72–0.96, P = 0.01), PFS (HR = 0.64, 95%CI = 0.56–0.74, P < 0.0001), and overall response rate (ORR; RR = 2.36, 95%CI = 1.73–3.22, P < 0.00001). Occurrence of grade 3/4 hematological toxicities (neutropenia, thrombocytopenia) and non-hematological toxicities (diarrhea, nausea/vomit, rush, stomatitis/mucositis) were significantly higher with GEM/S-1 treatment.ConclusionsThis meta-analysis indicated a significant survival benefit with increased toxicity when S-1 was combined with GEM. GEM/S-1 might be an option of first-line chemotherapy for APC patients, at least in Asia.