Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: results of the Australasian gastrointestinal trials group randomized phase III MAX study

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dc.contributor.authorTebbutt, N.
dc.contributor.authorWilson, K.
dc.contributor.authorGebski, V.
dc.contributor.authorCummins, M.
dc.contributor.authorZannino, D.
dc.contributor.authorvan Hazel, G.
dc.contributor.authorRobinson, B.
dc.contributor.authorBroad, A.
dc.contributor.authorGanju, V.
dc.contributor.authorAckland, S.
dc.contributor.authorForgeson, G.
dc.contributor.authorCunningham, D.
dc.contributor.authorSaunders, M.
dc.contributor.authorStockler, M.
dc.contributor.authorChua, Y.
dc.contributor.authorZalcberg, J.
dc.contributor.authorSimes, R.
dc.contributor.authorPrice, T.
dc.date.issued2010
dc.description.abstractPurpose: 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.
dc.description.statementofresponsibilityNiall 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 and Timothy J. Price
dc.identifier.citationJournal of Clinical Oncology, 2010; 28(19):3191-3198
dc.identifier.doi10.1200/JCO.2009.27.7723
dc.identifier.issn0732-183X
dc.identifier.issn1527-7755
dc.identifier.orcidPrice, T. [0000-0002-3922-2693]
dc.identifier.urihttp://hdl.handle.net/2440/63820
dc.language.isoen
dc.publisherAmer Soc Clinical Oncology
dc.rights© 2010 by American Society of Clinical Oncology
dc.source.urihttps://doi.org/10.1200/jco.2009.27.7723
dc.subjectHumans
dc.subjectColorectal Neoplasms
dc.subjectNeoplasm Metastasis
dc.subjectHypotension
dc.subjectThrombocytopenia
dc.subjectDiarrhea
dc.subjectMitomycin
dc.subjectFluorouracil
dc.subjectDeoxycytidine
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectAntibodies, Monoclonal
dc.subjectTreatment Outcome
dc.subjectQuality of Life
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectAustralasia
dc.subjectFemale
dc.subjectMale
dc.subjectKaplan-Meier Estimate
dc.subjectAntibodies, Monoclonal, Humanized
dc.subjectBevacizumab
dc.subjectCapecitabine
dc.titleCapecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: results of the Australasian gastrointestinal trials group randomized phase III MAX study
dc.typeJournal article
pubs.publication-statusPublished

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