Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/11049
Title: 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 C;Wilson, Kate;Gebski, Val J;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, Yujo;Zalcberg, John R;Simes, R John;Price, Timothy J
Affiliation: Austin Health, Studley Rd, Heidelberg, Victoria, 3084, Australia. niall.tebbutt@ludwig.edu.au
Issue Date: 1-Jun-2010
Citation: Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology 2010; 28(19): 3191-8
Abstract: 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.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).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.Adding bevacizumab to capecitabine, with or without mitomycin, significantly improves PFS without major additional toxicity or impairment of QOL.
Internal ID Number: 20516443
URI: http://ahro.austin.org.au/austinjspui/handle/1/11049
DOI: 10.1200/JCO.2009.27.7723
URL: http://www.ncbi.nlm.nih.gov/pubmed/20516443
Type: Journal Article
Subjects: Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal.administration & dosage.adverse effects
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols.adverse effects.therapeutic use
Australasia
Colorectal Neoplasms.drug therapy.pathology
Deoxycytidine.administration & dosage.adverse effects.analogs & derivatives
Diarrhea.chemically induced
Female
Fluorouracil.administration & dosage.adverse effects.analogs & derivatives
Humans
Hypotension.chemically induced
Kaplan-Meier Estimate
Male
Middle Aged
Mitomycin.administration & dosage.adverse effects
Neoplasm Metastasis
Quality of Life
Thrombocytopenia.chemically induced
Treatment Outcome
Appears in Collections:Journal articles

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