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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.
Austin 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
Austin Health, Studley Rd, Heidelberg, Victoria, 3084, Australia
Issue Date: 1-Jun-2010
Publication information: Journal 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.
Gov't Doc #: 20516443
DOI: 10.1200/JCO.2009.27.7723
Journal: Journal of Clinical Oncology
Type: Journal Article
Subjects: Adult
Aged, 80 and over
Antibodies, Monoclonal.administration & dosage.adverse effects
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols.adverse effects.therapeutic use
Colorectal Neoplasms.drug therapy.pathology
Deoxycytidine.administration & dosage.adverse effects.analogs & derivatives
Diarrhea.chemically induced
Fluorouracil.administration & dosage.adverse effects.analogs & derivatives
Hypotension.chemically induced
Kaplan-Meier Estimate
Middle Aged
Mitomycin.administration & dosage.adverse effects
Neoplasm Metastasis
Quality of Life
Thrombocytopenia.chemically induced
Treatment Outcome
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