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Improved survival with combined gemcitabine and S ‐1 for locally advanced pancreatic cancer: pooled analysis of three randomized studies
Author(s) -
Yanagimoto Hiroaki,
Ishii Hiroshi,
Nakai Yousuke,
Ozaka Masato,
Ikari Takaaki,
Koike Kazuhiko,
Ueno Hideki,
Ioka Tatsuya,
Satoi Sohei,
Sho Masayuki,
Okusaka Takuji,
Tanaka Masao,
Shimokawa Toshio,
Kwon AHon,
Isayama Hiroyuki
Publication year - 2014
Publication title -
journal of hepato‐biliary‐pancreatic sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.63
H-Index - 60
eISSN - 1868-6982
pISSN - 1868-6974
DOI - 10.1002/jhbp.130
Subject(s) - gemcitabine , pancreatic cancer , oncology , medicine , pooled analysis , cancer , randomized controlled trial , meta analysis
Background The long‐term prognosis for localized pancreatic cancer ( PC ) remains poor. Three randomized trials (GEST phase III, JACCRO PC‐01 phase II and GEMSAP phase II) evaluated gemcitabine ( G em) with or without S ‐1 for patients with metastatic and locally advanced PC . A pooled analysis based on published data examined whether G em with S ‐1 ( GS ) is superior to G em alone in overall survival ( OS ) in patients with locally advanced PC . Methods Data were extracted on 193 patients: 31 ( JACCRO ), 28 ( GEMSAP ), and 134 ( GEST ). OS was used for primary endpoint and progression‐free survival ( PFS ) was used for secondary endpoint. A general variance‐based method was used to estimate the pooled HR and 95% CI between GS ( n = 96) and G em ( n = 97). Results Meta‐analysis demonstrated that the overall risk of death was significantly different between the two chemotherapies (hazard ratio = 0.673, 95% confidence interval: 0.488–0.929, P = 0.016). The median PFSs for GS and GEM in the JACCRO , GEMSAP , and GEST studies were 12.0, 12.6, and 10.7 months, and 4.1, 8.1, and 6.2 months, respectively ( P = 0.001). The random‐effect pooled estimate for 165 patients showed the objective response rate ( ORR ) in the GS group (28.4%) was better in the G em group (8.3%, P = 0.001). Conclusions GS improved ORR , PFS and OS in patients with locally advanced PC over G em alone. GS could become one of the front‐line chemotherapeutic agents.