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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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Ann. Onc., August 1, 2006; 17(8): 1239 - 1248.
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G. Masi, L. Marcucci, F. Loupakis, E. Cerri, C. Barbara, S. Bursi, G. Allegrini, I. M. Brunetti, R. Murr, S. Ricci, et al.
First-line 5-fluorouracil/folinic acid, oxaliplatin and irinotecan (FOLFOXIRI) does not impair the feasibility and the activity of second line treatments in metastatic colorectal cancer
Ann. Onc., August 1, 2006; 17(8): 1249 - 1254.
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N. J. Meropol
Turning Point for Colorectal Cancer Clinical Trials
J. Clin. Oncol., July 20, 2006; 24(21): 3322 - 3324.
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G. Poston, R. Adam, and J.-N. Vauthey
Downstaging or Downsizing: Time for a New Staging System in Advanced Colorectal Cancer?
J. Clin. Oncol., June 20, 2006; 24(18): 2702 - 2706.
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A. D. Wagner, W. Grothe, J. Haerting, G. Kleber, A. Grothey, and W. E. Fleig
Chemotherapy in Advanced Gastric Cancer: A Systematic Review and Meta-Analysis Based on Aggregate Data
J. Clin. Oncol., June 20, 2006; 24(18): 2903 - 2909.
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S. Gill and D. Sargent
End points for adjuvant therapy trials: has the time come to accept disease-free survival as a surrogate end point for overall survival?
Oncologist, June 1, 2006; 11(6): 624 - 629.
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N. E. Kemeny, D. Niedzwiecki, D. R. Hollis, H.-J. Lenz, R. S. Warren, M. J. Naughton, J. C. Weeks, E. R. Sigurdson, J. E. Herndon II, C. Zhang, et al.
Hepatic Arterial Infusion Versus Systemic Therapy for Hepatic Metastases From Colorectal Cancer: A Randomized Trial of Efficacy, Quality of Life, and Molecular Markers (CALGB 9481)
J. Clin. Oncol., March 20, 2006; 24(9): 1395 - 1403.
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G. A. P. Hospers, M. Schaapveld, J. W. R. Nortier, J. Wils, A. van Bochove, R. S. de Jong, G. J. Creemers, Z. Erjavec, D. J. de Gooyer, P. H. Th. J. Slee, et al.
Randomised Phase III study of biweekly 24-h infusion of high-dose 5FU with folinic acid and oxaliplatin versus monthly plus 5-FU/folinic acid in first-line treatment of advanced colorectal cancer
Ann. Onc., March 1, 2006; 17(3): 443 - 449.
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C. D. Pond, K. M. Marshall, and L. R. Barrows
Identification of a small topoisomerase I-binding peptide that has synergistic antitumor activity with 9-aminocamptothecin.
Mol. Cancer Ther., March 1, 2006; 5(3): 739 - 745.
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B. Vincenzi, D. Santini, and G. Tonini
Lack of response of cetuximab plus oxaliplatin in advanced colorectal cancer patients resistant to both oxaliplatin and cetuximab plus irinotecan
Ann. Onc., March 1, 2006; 17(3): 527 - 528.
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P. Pfeiffer, H. Sorbye, H. Ehrsson, T. Fokstuen, J. P. Mortensen, L. Baltesgard, K. M. Tveit, D. Ogreid, H. Starkhammar, I. Wallin, et al.
Short-time infusion of oxaliplatin in combination with capecitabine (XELOX30) as second-line therapy in patients with advanced colorectal cancer after failure to irinotecan and 5-fluorouracil
Ann. Onc., February 1, 2006; 17(2): 252 - 258.
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A. Grothey and D. Sargent
Overall Survival of Patients With Advanced Colorectal Cancer Correlates With Availability of Fluorouracil, Irinotecan, and Oxaliplatin Regardless of Whether Doublet or Single-Agent Therapy Is Used First Line
J. Clin. Oncol., December 20, 2005; 23(36): 9441 - 9442.
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D. J. Sargent, H. S. Wieand, D. G. Haller, R. Gray, J. K. Benedetti, M. Buyse, R. Labianca, J. F. Seitz, C. J. O'Callaghan, G. Francini, et al.
Disease-Free Survival Versus Overall Survival As a Primary End Point for Adjuvant Colon Cancer Studies: Individual Patient Data From 20,898 Patients on 18 Randomized Trials
J. Clin. Oncol., December 1, 2005; 23(34): 8664 - 8670.
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G. J. Poston, R. Adam, S. Alberts, S. Curley, J. Figueras, D. Haller, F. Kunstlinger, G. Mentha, B. Nordlinger, Y. Patt, et al.
OncoSurge: A Strategy for Improving Resectability With Curative Intent in Metastatic Colorectal Cancer
J. Clin. Oncol., October 1, 2005; 23(28): 7125 - 7134.
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G. Gasparini, D. Gattuso, A. Morabito, R. Longo, F. Torino, R. Sarmiento, S. Vitale, T. Gamucci, and L. Mariani
Combined Therapy with Weekly Irinotecan, Infusional 5-Fluorouracil and the Selective COX-2 Inhibitor Rofecoxib Is a Safe and Effective Second-Line Treatment in Metastatic Colorectal Cancer
Oncologist, October 1, 2005; 10(9): 710 - 717.
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A. de Gramont
Rapid Evolution in Colorectal Cancer: Therapy Now and Over the Next Five Years
Oncologist, October 1, 2005; 10(suppl_2): 4 - 8.
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R. M. Goldberg
Advances in the Treatment of Metastatic Colorectal Cancer
Oncologist, October 1, 2005; 10(suppl_3): 40 - 48.
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S. J. Cohen, R. B. Cohen, and N. J. Meropol
Targeting Signal Transduction Pathways in Colorectal Cancer--More Than Skin Deep
J. Clin. Oncol., August 10, 2005; 23(23): 5374 - 5385.
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N Andre and W Schmiegel
CHEMORADIOTHERAPY FOR COLORECTAL CANCER
Gut, August 1, 2005; 54(8): 1194 - 1202.
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C. D. Blanke
Whither Irinotecan?
J. Clin. Oncol., August 1, 2005; 23(22): 4811 - 4814.
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G. Folprecht, A. Grothey, S. Alberts, H.-R. Raab, and C.-H. Kohne
Neoadjuvant treatment of unresectable colorectal liver metastases: correlation between tumour response and resection rates
Ann. Onc., August 1, 2005; 16(8): 1311 - 1319.
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H. Kelly and R. M. Goldberg
Systemic Therapy for Metastatic Colorectal Cancer: Current Options, Current Evidence
J. Clin. Oncol., July 10, 2005; 23(20): 4553 - 4560.
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F. F. Kabbinavar, J. Hambleton, R. D. Mass, H. I. Hurwitz, E. Bergsland, and S. Sarkar
Combined Analysis of Efficacy: The Addition of Bevacizumab to Fluorouracil/Leucovorin Improves Survival for Patients With Metastatic Colorectal Cancer
J. Clin. Oncol., June 1, 2005; 23(16): 3706 - 3712.
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A. Venook
Critical Evaluation of Current Treatments in Metastatic Colorectal Cancer
Oncologist, April 1, 2005; 10(4): 250 - 261.
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J. A. Meyerhardt and R. J. Mayer
Systemic Therapy for Colorectal Cancer
N. Engl. J. Med., February 3, 2005; 352(5): 476 - 487.
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G. Masi, G. Allegrini, S. Cupini, L. Marcucci, E. Cerri, I. Brunetti, E. Fontana, S. Ricci, M. Andreuccetti, and A. Falcone
First-line treatment of metastatic colorectal cancer with irinotecan, oxaliplatin and 5-fluorouracil/leucovorin (FOLFOXIRI): results of a phase II study with a simplified biweekly schedule
Ann. Onc., December 1, 2004; 15(12): 1766 - 1772.
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R. H. J. Mathijssen, F. A. de Jong, R. H. N. van Schaik, E. R. Lepper, L. E. Friberg, T. Rietveld, P. de Bruijn, W. J. Graveland, W. D. Figg, J. Verweij, et al.
Prediction of Irinotecan Pharmacokinetics by Use of Cytochrome P450 3A4 Phenotyping Probes
J Natl Cancer Inst, November 3, 2004; 96(21): 1585 - 1592.
[Abstract] [Full Text] [PDF]

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C. J. A. Punt
New options and old dilemmas in the treatment of patients with advanced colorectal cancer
Ann. Onc., October 1, 2004; 15(10): 1453 - 1459.
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R. Chan and D. J. Kerr
Can we individualise chemotherapy for colorectal cancer?
Ann. Onc., July 1, 2004; 15(7): 996 - 999.
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