Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer

Sudo, Kentaro; Ishihara, Takeshi; Hirata, Nobuto; Ozawa, Fumiaki; Ohshima, Tadashi; Azemoto, Ryosaku; Sakai, Kenji; Nihei, Takeshi; Nishino, Tomoya; Nakagawa, Akihiko; Nakamura, Kazuyoshi; Hara, Taro; Tada, Motohisa; Mikata, Rintaro; Tawada, Katsunobu; Yokosuka, Osamu; Nakaji, So; Yamaguchi, Taketo

doi:10.1007/s00280-013-2368-6

Cited by 43 publications

(39 citation statements)

References 23 publications

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“…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: 62%

“…Ueno et al presented that the median OS for GEM combined with S-1 was 10.1 months and 8.8 months for GEMalone. Sudo et al (2014) showed that the median OS for GEM combined with S-1 was 8.6 months and 8.6 months for GEMalone. And in our conclusion, we found that there was significantly better :http://dx.doi.org/10.7314/APJCP.2015.16.14.5681 Gemcitabine+Fluoropyrimidine Combinations for Advanced Pancreatic Cancer -an Updated Meta-Analysis outcome in Group Gem + S-1 vs. Gem (HR,0.83;95% CI,p=0.011;).…”

Section: Discussionmentioning

confidence: 99%

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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: Influent Analysis and Publication Bias Evaluationmentioning

confidence: 62%

Section: Discussionmentioning

confidence: 99%

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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“…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%

“…Computed Tomography or magnetic resonance imaging scans were performed at the baseline. The response was assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0 (23)(24)(25)(26).…”

Section: Characteristics Of Included Trialsmentioning

confidence: 99%

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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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Comparative Outcomes of First-Line Chemotherapy for Metastatic Pancreatic Cancer Among the Regimens Used in Japan

et al. 2022

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IMPORTANCE Various first-line chemotherapy treatment regimens for patients with metastatic pancreatic cancer have been approved in Japan, including gemcitabine (GEM); fluorouracil, leucovorin, irinotecan, and oxaliplatin combination (FOLFIRINOX); GEM plus albumin-bound paclitaxel (GEM+NPTX), and S-1 (tegafur + gimeracil + oteracil). However, direct comparisons of these chemotherapy regimens are limited. OBJECTIVETo assess the short-term and long-term outcomes associated with first-line chemotherapy regimens for metastatic pancreatic cancer compared with chemotherapy regimens recommended in Japanese guidelines. DATA SOURCES In this systematic review and network meta-analysis, the bibliographic databases PubMed, Cochrane Library, and Web of Science, as well as medical journals published between January 1, 2002, and December 31, 2018, were searched for clinical trials comparing chemotherapy regimens. STUDY SELECTION Randomized 2-arm clinical trials evaluating first-line chemotherapy for advanced or metastatic pancreatic cancer were included. DATA EXTRACTION AND SYNTHESIS The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Extension Statement for Reporting of Systematic Reviews IncorporatingNetwork Meta-analyses of Health Care Interventions was followed for data abstractions. Data were pooled using a random-effects model. The SIGN 50 Quality Assessment Instrument was used to assess the risk of bias and overall study quality of the selected trials. MAIN OUTCOMES AND MEASURESThe primary end point was overall survival (OS), and the secondary end point was progression-free survival (PFS) compared with GEM for first-line chemotherapy for metastatic pancreatic cancer. The Kaplan-Meier curve of GEM from the literature and the estimated hazard ratios (HRs) were used to model the long-term associations to calculate the area under the curve (AUC) (person-months) for OS and PFS of each chemotherapy. Sensitivity analyses with multiple functional models were conducted to confirm the long-term estimations. RESULTS A total of 22 regimens (25 studies) for OS and a total of 18 regimens (21 studies) for PFS were identified from literature. The total number of participants was 10 186, with 5856 male (57.5%) and 4330 female (42.5%). The FOLFIRINOX and GEM+NPTX regimens were associated with reduction in the risk of death, with an HR of 0.57 (95% CI, 0.41-0.79) and 0.72 (95% CI, 0.55-0.95) compared with GEM, respectively. The curve estimation also showed that FOLFIRINOX had the largest AUC for survival at 15.49 person-months (range, 13.84-15.51 person-months), followed by (continued) Key Points Question What are the comparative short-term and long-term outcomes associated with first-line chemotherapy regimens for patients with metastatic pancreatic cancer, and how do they compare with chemotherapy regimens recommended in Japanese guidelines? Findings In this systematic review and network meta-analysis of 25 randomized clinical trials assessing firstline chemotherapy regimens for advanced or metastatic pancreati...

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Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer

Abstract: GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.

Cited by 43 publications

References 23 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?

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

Comparative Outcomes of First-Line Chemotherapy for Metastatic Pancreatic Cancer Among the Regimens Used in Japan

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