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Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: Results of the Australasian Gastrointestinal Trials Group randomized phase III MAX study

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.; Price, Tim; Simes, John; Coates, Alan; O'Connell, Diane; Brown, Chris; Hague, Wendy; France, Alyson; Hicks, Sian; James, Rebecca; Masson, Ruby; O'Connell, Rachel; Pike, Rhana; Shoulder, Julia
Publisher Information: American Society of Clinical Oncology
Publication Year: 2010
Collection: The University of Queensland: UQ eSpace
Subject Terms: Cancer Research; Oncology; 1306 Cancer Research; 2730 Oncology
Description: Purpose: 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.
Document Type: article in journal/newspaper
Language: English
ISSN: 1527-7755; 0732-183X
Availability: https://espace.library.uq.edu.au/view/UQ:723701
Accession Number: edsbas.48DBC525
Database: BASE