Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: Results of the Australasian Gastrointestinal Trials Group randomized phase III MAX study

Niall C. Tebbutt, Kate Wilson, Val J. Gebski, Michelle M. Cummins, Diana Zannino, Guy A. Van Hazel, Bridget Robinson, Adam Broad, Vinod Ganju, Stephen P. Ackland, Garry Forgeson, David Cunningham, Mark P. Saunders, Martin R. Stockler, Yujo Chua, John R. Zalcberg, R. John Simes, Timothy J. Price

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Abstract

Purpose: To determine whether adding bevacizumab, with or without mitomycin, to capecitabine monotherapy improves progression-free survival (PFS) in patients with metastatic colorectal cancer (mCRC) in an open-label, three-arm randomized trial. Patients and Methods: Overall, 471 patients in Australia, New Zealand, and the United Kingdom with previously untreated, unresectable mCRC were randomly assigned to the following: capecitabine; capecitabine plus bevacizumab (CB); or capecitabine, bevacizumab, and mitomycin (CBM). We compared CB with capecitabine and CBM with capecitabine for progression-free survival (PFS). Secondary end points included overall survival (OS), toxicity, response rate (RR), and quality of life (QOL). Results: Median PFS was 5.7 months for capecitabine, 8.5 months for CB, and 8.4 months for CBM (capecitabine v CB: hazard ratio [HR], 0.63; 95% CI, 0.50 to 0.79; P < .001; C v CBM: HR, 0.59; 95% CI, 0.47 to 0.75; P < .001). After a median follow-up of 31 months, median OS was 18.9 months for capecitabine and was 16.4 months for CBM; these data were not significantly different. Toxicity rates were acceptable, and all treatment regimens well tolerated. Bevacizumab toxicities were similar to those in previous studies. Measures of overall QOL were similar in all groups. Conclusion: Adding bevacizumab to capecitabine, with or without mitomycin, significantly improves PFS without major additional toxicity or impairment of QOL.

Original languageEnglish
Pages (from-to)3191-3198
Number of pages8
JournalJournal of Clinical Oncology
Volume28
Issue number19
DOIs
Publication statusPublished - 1 Jul 2010
Externally publishedYes

Keywords

  • Australian Gastrointestinal Trials
  • bevacizumab
  • capecitabine monotherapy
  • mitomycin
  • QOL

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    Tebbutt, N. C., Wilson, K., Gebski, V. J., Cummins, M. M., Zannino, D., Van Hazel, G. A., Robinson, B., Broad, A., Ganju, V., Ackland, S. P., Forgeson, G., Cunningham, D., Saunders, M. P., Stockler, M. R., Chua, Y., Zalcberg, J. R., Simes, R. J., & Price, T. J. (2010). Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: Results of the Australasian Gastrointestinal Trials Group randomized phase III MAX study. Journal of Clinical Oncology, 28(19), 3191-3198. https://doi.org/10.1200/JCO.2009.27.7723