A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study

Nakai, Yousuke; Isayama, Hiroyuki; Sasaki, Takashi; Sasahira, Naoki; Tsujino, Takeshi; Toda, Nobuo; Kogure, Hirofumi; Matsubara, Saburo; Ito, Yukiko; Togawa, Osamu; Arizumi, Toshihiko; Hirano, Keisuke; Tada, Minoru; Omata, Masao; Koike, Kazuhiko

doi:10.1038/bjc.2012.183

Cited by 98 publications

(80 citation statements)

References 27 publications

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“…Ozaka et al reported that the median OS for GEM combined with S-1 was 13.7 months and 8.0 months for GEM alone. Nakai et al (2012) observed that the median OS for GEM combined with S-1 was 13.5 months and 8. 8 months for GEMalone.…”

Section: Discussionmentioning

confidence: 98%

“…There were no publication biasesdetected by Egger test for the studies in all of our analysis, in the primary endpoint of OS (t=0.74, p=0.474) and PFS (t=0.35, p=0.738) (Higgins et al, 2002;Higgins et al, 2003;Huai et al, 2013). Each article included in the composition of the funnel plot did not find significant bias (Berlin et al, 2002;Scheithauer et al, 2003;Ohkawa et al, 2004;Di Costanzo et al, 2005;Riess et al, 2005;Herrmann et al, 2007;Bernhard et al, 2008;Cunningham et al, 2009;Nakai et al, 2012;Ozaka et al, 2012;Ueno et al, 2013;Sudo et al, 2014).…”

Section: Influent Analysis and Publication Bias Evaluationmentioning

confidence: 93%

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An Updated Meta-analysis and System Review:is Gemcitabine+Fluoropyrimidine in Combination a Better Therapy Versus Gemcitabine Alone for Advanced and Unresectable Pancreatic Cancer?

Zhao²,

Wang³

et al. 2015

Asian Pacific Journal of Cancer Prevention

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Background: Pancreatic cancer ranks fourth in deaths caused by cancers throughout the world. Gemcitabine chemotherapy is the primary method of treatment of advanced pancreatic cancer, and in asco2014, it is still firstline chemotherapy. Howeve,r gemcitabine+fluorouracil regimens are also licensed and widely used worldwide. Clinical trials are the best way to evaluate drug efficacy. In this study, we performed a systematic review and a meta-analysis of randomized controlled trials (RCTs) to assess whether gemcitabine+fluoropyrimidine combination therapy improves the prognosis of unresectable pancreatic cancer compared with gemcitabine treatment alone. Materials and Methods: A quantitative up-to-date meta-analysis was undertaken to investigate the efficacy of gemcitabine-based combination treatment compared with gemcitabine monotherapy for locally advanced or metastatic pancreatic cancer. Inclusion was limited to high-quality randomized clinical trials. Results: A total of 12 studies were included in the present analysis, with a total of 3,038 patients recruited.

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Section: Discussionmentioning

confidence: 98%

Section: Influent Analysis and Publication Bias Evaluationmentioning

confidence: 93%

An Updated Meta-analysis and System Review:is Gemcitabine+Fluoropyrimidine in Combination a Better Therapy Versus Gemcitabine Alone for Advanced and Unresectable Pancreatic Cancer?

Zhao²,

Wang³

et al. 2015

Asian Pacific Journal of Cancer Prevention

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“…A phase 2 trial of S-1 for advanced metastatic pancreatic cancer have shown a response rate of 37.5% and the median time to progression and the overall survival time were 3.7 months and 9.2 months [10]. Moreover, multicenter randomized phase 2 trials of a combination of gemcitabine and S-1 (GS) for advanced metastatic pancreatic cancer showed the significant superiority of GS in response rate and progression free survival, but not in overall survival when compared to gemcitabine alone [11,12]. GS as neoadjuvant therapy in patients with resectable or borderline resectable pancreatic cancer may be effective with respect to progression and survival.…”

Section: Introductionmentioning

confidence: 99%

Breast Cancer Vaccine: Are We There Yet?

Chablani¹

2013

J Bioequiv Availab

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“…Four eligible trials were identified (23)(24)(25)(26). Characteristics of these trials, including chemotherapy regimens and outcome measures, are summarized in Table 1.…”

Section: Characteristics Of Included Trialsmentioning

confidence: 99%

“…Until now, four English published RCTs have been performed to evaluate the survival efficacy between gemcitabine plus S-1 (GS) and gemcitabine monotherapy as first-line chemotherapy in UAPC patients (23)(24)(25)(26). Whether GS could improve treatment efficacy for UAPC was controversial in these four trials.…”

Section: Introductionmentioning

confidence: 99%

Gemcitabine plus S-1: a hopeful frontline treatment for Asian patients with unresectable advanced pancreatic cancer

Cao

Kuang

et al. 2015

Jpn. J. Clin. Oncol.

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Objective: Gemcitabine-based chemotherapy is widely used for unresectable advanced pancreatic cancer which contains locally advanced and metastatic pancreatic cancer. We performed metaanalysis to examine whether gemcitabine plus S-1 could improve treatment efficacy as first-line chemotherapy for those patients when compared with gemcitabine alone. Methods: STATA was used to estimate the summary hazard ratios or odds ratios and their 95% confidence intervals. Heterogeneity among trials was examined by Cochran's χ 2 test. Publication bias was evaluated by Begg's and Egger's tests. Subgroup analysis based on the extent of disease was performed.Results: Four randomized controlled trials including 878 Asian patients were analyzed. In total metaanalysis, gemcitabine plus S-1 significantly improved overall survival (hazard ratio, 0.82; 95% confidence interval, 0.70-0.96; P = 0.015), progression-free survival (hazard ratio, 0.64; 95% confidence interval, 0.55-0.74; P < 0.001), overall response rate (odds ratio, 3.00; 95% confidence interval, 2.04-4.41; P < 0.001) and disease control rate (odds ratio, 1.78; 95% confidence interval, 1.32 to 2.39; P < 0.001), and was associated with more but manageable hematologic (leukocytopenia, neutropenia, thrombocytopenia) and non-hematologic (diarrhea, stomatitis, nausea, rash) adverse events. In subgroup analysis, gemcitabine plus S-1, comparing with gemcitabine, significantly improved overall survival in locally advanced patients (hazard ratio, 0.69; 95% confidence interval, 0.48 to 0.99; P = 0.022) but not in metastatic patients (hazard ratio, 0.75; 95% confidence interval, 0.46-1.23; P = 0.256).Conclusion: This meta-analysis confirmed the survival benefits of gemcitabine plus S-1 as first-line treatment for unresectable advanced pancreatic cancer at least in Asia, while good Eastern Cooperative Oncology group performance status was warranted. Importantly, we highlighted the significant overall survival benefit of gemcitabine plus S-1 in locally advanced patients but not in metastatic patients.

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A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study

Cited by 98 publications

References 27 publications

An Updated Meta-analysis and System Review:is Gemcitabine+Fluoropyrimidine in Combination a Better Therapy Versus Gemcitabine Alone for Advanced and Unresectable Pancreatic Cancer?

An Updated Meta-analysis and System Review:is Gemcitabine+Fluoropyrimidine in Combination a Better Therapy Versus Gemcitabine Alone for Advanced and Unresectable Pancreatic Cancer?

Breast Cancer Vaccine: Are We There Yet?

Gemcitabine plus S-1: a hopeful frontline treatment for Asian patients with unresectable advanced pancreatic cancer

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