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Journal of Clinical Oncology, Vol 22, No 7 (April 1), 2004: pp. 1209-1214
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.11.037
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Survival of Patients With Advanced Colorectal Cancer Improves With the Availability of Fluorouracil-Leucovorin, Irinotecan, and Oxaliplatin in the Course of Treatment

Axel Grothey, Daniel Sargent, Richard M. Goldberg, Hans-Joachim Schmoll

From the Divisions of Medical Oncology and Biostatistics, Mayo Clinic, Rochester, MN; Division of Oncology, University of North Carolina, Chapel Hill, NC; and Department of Hematology/Oncology, University of Halle, Halle, Germany

Address reprint requests to Axel Grothey, MD, Division of Medical Oncology, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: grothey.axel{at}mayo.edu

PURPOSE: Fluorouracil (FU)-leucovorin (LV), irinotecan, and oxaliplatin administered alone or in combination have proven effective in the treatment of advanced colorectal cancer (CRC). Combination protocols using FU-LV with either irinotecan or oxaliplatin are currently regarded as standard first-line therapies in this disease. However, the importance of the availability of all three active cytotoxic agents, FU-LV, irinotecan, and oxaliplatin, on overall survival (OS) has not yet been evaluated.

MATERIALS AND METHODS: We analyzed data from seven recently published phase III trials in advanced CRC to correlate the percentage of patients receiving second-line therapy and the percentage of patients receiving all three agents with the reported median OS, using a weighted analysis.

RESULTS: The reported median OS is significantly correlated with the percentage of patients who received all three drugs in the course of their disease (P = .0008) but not with the percentage of patients who received any second-line therapy (P = .19). In addition, the use of combination protocols as first-line therapy was associated with a significant improvement in median survival of 3.5 months (95% CI, 1.27 to 5.73 months; P = .0083).

CONCLUSION: Our results support the strategy of making these three active drugs available to all patients with advanced CRC who are candidates for such therapy to maximize OS. In addition, our findings suggest that, with the availability of effective salvage options, OS should no longer be regarded as the most appropriate end point by which to assess the efficacy of a palliative first-line treatment in CRC.

Supported in part by Public Health Services grant No. CA-25224 from the National Cancer Institute to the Mayo Clinic in support of the North Central Cancer Treatment Group.

Authors' disclosures of potential conflicts of interest are found at the end of this article.




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