Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: results of the Australasian Gastrointestinal Trials Group Randomized Phase III MAX Study.
Authors
Tebbutt, Niall CWilson, Kate
Gebski, Val
Cummins, Michelle M
Zannino, Diana
Van Hazel, Guy A
Robinson, Bridget
Broad, Adam
Ganju, Vinod
Ackland, Stephen P
Forgeson, Garry
Cunningham, David
Saunders, Mark P
Stockler, Martin R
Chua, Y J
Zalcberg, John R
Simes, R John
Price, Timothy J
Affiliation
Austin Health, Studley Rd, Heidelberg, Victoria, 3084, Australia.Issue Date
2010-07-01
Metadata
Show full item recordAbstract
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.Citation
Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: results of the Australasian Gastrointestinal Trials Group Randomized Phase III MAX Study. 2010, 28 (19):3191-8 J Clin OncolJournal
Journal of Clinical OncologyDOI
10.1200/JCO.2009.27.7723PubMed ID
20516443Language
enISSN
1527-7755ae974a485f413a2113503eed53cd6c53
10.1200/JCO.2009.27.7723
Scopus Count
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