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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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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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“In contrast, the addition of bevacizumab to standard first‐line chemotherapy regimens significantly improved progression‐free survival.”
From Hypoxia signaling in cancer: Implications for therapeutic interventions (2023) · cites this paper as [273]
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Metadata
- 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
- Venue
- Journal of Clinical Oncology
- Published
- 2010-07-01
- Volume
- 28
- Issue
- 19
- Pages
- 3191-3198
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- 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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