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Phase III Randomized Comparison of Gemcitabine Versus Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic Cancer

Open access
Cunningham, David, Chau, Ian, Stocken, Deborah D., Valle, Juan W., Smith, David, Steward, William, Harper, Peter G., Dunn, Janet, Tudur-Smith, Catrin, West, Julia, Falk, Stephen, Crellin, Adrian, Adab, Fawzi, Thompson, Joyce, Leonard, Pauline, Ostrowski, Joe, Eatock, Martin, Scheithauer, Werner, Herrmann, Richard, Neoptolemos, John P.·2009·Journal of Clinical Oncology

Abstract

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.

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Metadata

Authors
Cunningham, D., Chau, I., Stocken, D. D., Valle, J. W., Smith, D., Steward, W., Harper, P. G., Dunn, J., Tudur-Smith, C., West, J., Falk, S., Crellin, A., Adab, F., Thompson, J., Leonard, P., Ostrowski, J., Eatock, M., Scheithauer, W., Herrmann, R., & Neoptolemos, J. P.
Venue
Journal of Clinical Oncology
Published
2009-11-20
Volume
27
Issue
33
Pages
5513-5518
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2083452953
Cited by
823
References
6
FWCI
31.93
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Phase III Randomized Comparison of Gemcitabine Versus Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic Cancer. https://app.cochat.ai/papers/10.1200/jco.2009.24.2446
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Cunningham, D., Chau, I., Stocken, D. D., Valle, J. W., Smith, D., Steward, W., Harper, P. G., Dunn, J., Tudur-Smith, C., West, J., Falk, S., Crellin, A., Adab, F., Thompson, J., Leonard, P., Ostrowski, J., Eatock, M., Scheithauer, W., Herrmann, R., & Neoptolemos, J. P. (2009). Phase III Randomized Comparison of Gemcitabine Versus Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2009.24.2446

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.