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Meta-analysis of Randomized Controlled Trials

Giovanni Butturini, MD; Deborah D. Stocken, BSc; Moritz N. Wente, MD; Hans Jeekel, MD; Johaness H. G. Klinkenbijl, MD; Kåre E. Bakkevold, MD; Tadahiro Takada, MD; Hirano Amano, MD; Christos Dervenis, MD; Claudio Bassi, MD; Markus W. Büchler, MD; John P. Neoptolemos, MD; for the Pancreatic Cancer Meta-analysis Group

Arch Surg. 2008;143(1):75-83.

Objective  To assess the influence of resection margins and adjuvant chemoradiotherapy or chemotherapy on survival for patients with pancreatic cancer by meta-analysis of individual data from randomized controlled trials.

Data Sources  Structured MEDLINE search for published studies.

Study Selection  A meta-analysis of published randomized controlled trials and individual data.

Data Extraction  Individual data were obtained from 4 recently published trials (875 patients: 278 [32%] with R1 and 591 [68%] with R0 resections).

Data Synthesis  Kaplan-Meier estimates of survival were compared using log-rank analyses. Pooled hazard ratios of the effects of chemoradiotherapy and chemotherapy treatments on the risk of death were calculated separately and across groups according to resection margins status. Six hundred ninety-eight patients (80%) had died, with a median follow-up of 44 months in the surviving patients. Resection margin involvement was not a significant factor for survival (hazard ratio [HR], 1.10; 95% confidence interval [CI], 0.94-1.29; log-rank ² = 1.4; P = .24). The 2- and 5-year survival rates, respectively, were 33% and 16% for R0 patients and 29% and 15% for R1 patients. Chemoradiotherapy in R1 patients resulted in a 28% reduction in the risk of death (HR, 0.72; 95% CI, 0.47-1.10) compared with a 19% increased risk in R0 patients (HR, 1.19; 95% CI, 0.95-1.49). Chemotherapy in R1 patients had a 4% increased risk of death (HR, 1.04; 95% CI, 0.78-1.40) compared with a 35% reduction in risk in the R0 subgroup (HR, 0.65; 95% CI, 0.53-0.80).

Conclusion  Adjuvant chemotherapy but not chemoradiotherapy should be the standard of care for patients with either R0 or R1 resections for pancreatic cancer.

Author Affiliations: University of Verona, Verona, Italy (Drs Butturini and Bassi); Cancer Research United Kingdom Clinical Trials Unit, University of Birmingham, Birmingham, England (Ms Stocken); University of Heidelberg, Heidelberg, Germany (Drs Wente and Büchler); University Hospital Rotterdam, Rotterdam, the Netherlands (Drs Jeekel and Klinkenbijl); University of Bergen, Bergen, Norway (Dr Bakkevold); Teikyo University School of Medicine, Tokyo, Japan (Drs Takada and Amano); Agia Olga Hospital, Athens, Greece (Dr Dervenis); and University of Liverpool, Liverpool, England (Dr Neoptolemos).

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Arch Surg. 2008;143(1):83.
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