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dc.contributor.authorTebbutt, Niall C
dc.contributor.authorWilson, Kate
dc.contributor.authorGebski, Val
dc.contributor.authorCummins, Michelle M
dc.contributor.authorZannino, Diana
dc.contributor.authorVan Hazel, Guy A
dc.contributor.authorRobinson, Bridget
dc.contributor.authorBroad, Adam
dc.contributor.authorGanju, Vinod
dc.contributor.authorAckland, Stephen P
dc.contributor.authorForgeson, Garry
dc.contributor.authorCunningham, David
dc.contributor.authorSaunders, Mark P
dc.contributor.authorStockler, Martin R
dc.contributor.authorChua, Y J
dc.contributor.authorZalcberg, John R
dc.contributor.authorSimes, R John
dc.contributor.authorPrice, Timothy J
dc.date.accessioned2010-08-11T10:53:02Z
dc.date.available2010-08-11T10:53:02Z
dc.date.issued2010-07-01
dc.identifier.citationCapecitabine, 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 Oncolen
dc.identifier.issn1527-7755
dc.identifier.pmid20516443
dc.identifier.doi10.1200/JCO.2009.27.7723
dc.identifier.urihttp://hdl.handle.net/10541/109457
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.language.isoenen
dc.subjectColorectal Canceren
dc.subjectCancer Treatmenten
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshColorectal Neoplasms
dc.subject.meshMitomycin
dc.subject.meshNeoplasm Metastasis
dc.subject.meshQuality of Life
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.en
dc.contributor.departmentAustin Health, Studley Rd, Heidelberg, Victoria, 3084, Australia.en
dc.identifier.journalJournal of Clinical Oncologyen
html.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.


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