Cited by 413Colorectal Cancer Treatments and StudiesColorectal Cancer Surgical TreatmentsIntraperitoneal and Appendiceal Malignancies

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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

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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.·2010·Journal of Clinical Oncology

DOI 10.1200/jco.2009.27.7723

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Abstract

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.

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Authors: Tebbutt, N. C., Wilson, K., Gebski, V. J., Cummins, M. M., Zannino, D., van Hazel, G. A., Robinson, B., Broad, A., Ganju, V., Ackland, S. P., Forgeson, G., Cunningham, D., Saunders, M. P., Stockler, M. R., Chua, Y., Zalcberg, J. R., Simes, R. J., & Price, T. J.
Affiliations: The University of Sydney (AU)
From Austin Health; Peter MacCallum Cancer Centre; Frankston Hospital, Melbourne; National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney; Sir Charles Gairdner Hospital, Perth; Geelong Hospital, Geelong; Canberra Hospital, Canberra; Queen Elizabeth Hospital, Adelaide; Calvary Mater Newcastle Hospital, Newcastle, Australia; Royal Marsden Hospital, London; Christie Hospital, Manchester, United Kingdom; Christchurch Hospital, Christchurch; and Palmerston North...
ORCID: Tebbutt, Niall C.
Wilson, Kate
Gebski, Val J.
Cummins, Michelle M.
Zannino, Diana
Robinson, Bridget
Ganju, Vinod
Ackland, Stephen P.
Cunningham, David
Saunders, Mark P.
Stockler, Martin R.
Zalcberg, John R.
Simes, R. John
Price, Timothy J.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2010-07-01
Volume: 28
Issue: 19
Pages: 3191-3198
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2009.27.7723
OpenAlex: W2122152991
Cited by: 413
References: 20
Citations by year: 2026: 4 · 2025: 11 · 2024: 18 · 2023: 19 · 2022: 15 · 2021: 19 · 2020: 25 · 2019: 23 · 2018: 23 · 2017: 29 · 2016: 45 · 2015: 39 · 2014: 39 · 2013: 47 · 2012: 28
FWCI: 16.42
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
UWA Profiles and Research Repository (UWA) (submittedVersion)
Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
NOVA (University of Newcastle Australia) (submittedVersion)
Funders: National Institute for Health and Care Research (NF-SI-0507-10154)
Cancer Australia
Cancer Institute NSW
National Health and Medical Research Council
Topics: Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
Health Sciences › Medicine › Surgery › Intraperitoneal and Appendiceal Malignancies
Keywords: metastatic colorectal cancer, capecitabine, bevacizumab, mitomycin C, first-line chemotherapy, progression-free survival, overall survival, quality of life, treatment toxicity, anti-VEGF therapy
MeSH terms: Bevacizumab, Capecitabine, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Deoxycytidine, Diarrhea, Female, Fluorouracil, Humans, Hypotension, Male, Middle Aged, Neoplasm Metastasis, Quality of Life, Thrombocytopenia, Colorectal Neoplasms, Mitomycin, Treatment Outcome, Australasia, Kaplan-Meier Estimate, Antibodies, Monoclonal, Humanized

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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

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