Authors: Banu, Eugeniu¹; Banu, Adela¹; Fodor, Andrei²; Landi, Bruno³; Rougier, Philippe⁴; Chatellier, Gilles⁵; Andrieu, Jean-Marie¹; Oudard, Stephane¹

Source: Drugs & Aging, Volume 24, Number 10, 2007 , pp. 865-879(15)

Publisher: Adis International

Abstract:

Objective: To evaluate the impact on overall survival at 6, 12 and 18 months of gemcitabine-based doublets compared with gemcitabine alone in patients with advanced and metastatic pancreatic cancer.

Methods: We conducted a systematic review and meta-analysis of published data on the use of gemcitabine-based doublets compared with gemcitabine alone in chemotherapy-naive patients with advanced and metastatic pancreatic cancer treated in randomised controlled phase II-III trials with overall survival as the principal or secondary endpoint. To this end, a literature search was performed using Cochrane methodology. The relative risks with 95% confidence intervals were estimated based on adjusted number of deaths and patients at risk according to the extent of follow-up and censoring. Twenty-three randomised clinical trials including 5886 patients met the inclusion criteria. In these trials, 2932 patients were randomly assigned to receive gemcitabine-based doublets and 2954 patients to receive gemcitabine alone.

Results: Gemcitabine-based doublets were associated with small but significant reductions in the risk of death at 6, 12 and 18 months of 8% (95% CI 3, 13), 4% (95% CI 2, 7) and 3% (95% CI 1, 5), respectively (p < 0.005 for all timepoints). No heterogeneity between studies was observed. Subgroup analyses showed an overall survival benefit for gemcitabine-based doublets in clinical trials testing the same planned dose intensity of gemcitabine in comparative arms, using platinum salt-based protocols and with survival as the primary endpoint.

Conclusion: This meta-analysis of data obtained from randomised controlled phase II-III trials of patients with advanced pancreatic cancer showed a small but significant improvement in overall survival for patients receiving gemcitabine-based doublets compared with gemcitabine alone.

Keywords: Gemcitabine; Pancreatic cancer

Document Type: Research article

Affiliations: 1: 1 Medical Oncology Department, Georges Pompidou European Hospital, Paris, France 2: 2 Department of Radiotherapy, European Institute of Cancer, Milan, Italy 3: 3 Hepatogastroenterology Unit, Georges Pompidou European Hospital, Paris, France 4: 4 Medical Oncology Department, Ambroise Pare Hospital, Boulogne-Billancourt, France 5: 5 Clinical Research Unit, Georges Pompidou European Hospital, Paris, France

Publication date: 2007-01-01

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