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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 | Affiliation: | niall.tebbutt@ludwig.edu.au 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 | URI: | https://ahro.austin.org.au/austinjspui/handle/1/11049 | DOI: | 10.1200/JCO.2009.27.7723 | Journal: | Journal of Clinical Oncology | URL: | https://pubmed.ncbi.nlm.nih.gov/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 |
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