Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer

David Cunningham, Ian Chau, Deborah D. Stocken, Juan W. Valle, David Smith, William Steward, Peter G. Harper, Janet Dunn, Catrin Tudur-Smith, Julia West, Stephen Falk, Adrian Crellin, Fawzi Adab, Joyce Thompson, Pauline Leonard, Joe Ostrowski, Martin Eatock, Werner Scheithauer, Richard Herrmann, John P. Neoptolemos

    Research output: Contribution to journalArticlepeer-review


    Purpose: Both gemcitabine (GEM) and fluoropyrimidines are valuable treatment for advanced pancreatic cancer. This open-label study was designed to compare the overall survival (OS) of patients randomly assigned to GEM alone or GEM plus capecitabine (GEM-CAP). Patients and Methods: Patients with previously untreated histologically or cytologically proven locally advanced or metastatic carcinoma of the pancreas with a performance status ≤ 2 were recruited. Patients were randomly assigned to GEM or GEM-CAP. The primary outcome measure was survival. Meta-analysis of published studies was also conducted. Results: Between May 2002 and January 2005, 533 patients were randomly assigned to GEM (n = 266) and GEM-CAP (n = 267) arms. GEM-CAP significantly improved objective response rate (19.1% v 12.4%; P = .034) and progression-free survival (hazard ratio [HR], 0.78; 95% CI, 0.66 to 0.93; P = .004) and was associated with a trend toward improved OS (HR, 0.86; 95% CI, 0.72 to 1.02; P = .08) compared with GEM alone. This trend for OS benefit for GEM-CAP was consistent across different prognostic subgroups according to baseline stratification factors (stage and performance status) and remained after adjusting for these stratification factors (P = .077). Moreover, the meta-analysis of two additional studies involving 935 patients showed a significant survival benefit in favor of GEM-CAP (HR, 0.86; 95% CI, 0.75 to 0.98; P = .02) with no intertrial heterogeneity. Conclusion: On the basis of our trial and the meta-analysis, GEM-CAP should be considered as one of the standard first-line options in locally advanced and metastatic pancreatic cancer. © 2009 by American Society of Clinical Oncology.
    Original languageEnglish
    Pages (from-to)5513-5518
    Number of pages5
    JournalJournal of Clinical Oncology
    Issue number33
    Publication statusPublished - 20 Nov 2009


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