Two different first-line 5-fluorouracil regimens with or without oxaliplatin in patients with metastatic colorectal cancer
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Background Oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (LV) are standard first-line treatments for patients with metastatic colorectal cancer (mCRC). The aim of this multicentre, open-label, phase IIIb study was to assess the addition of oxaliplatin to two different 5-FU regimens.Patients and methods Patients with previously untreated mCRC were randomised to arm A [two-weekly oxaliplatin 85 mg/m(2) + either continuous intravenous infusion (CIV) of 5-FU without LV or two-weekly bolus and CIV 5-FU + LV (LV5FU2)] or arm B (5-FU CIV or LV5FU2 alone). Irinotecan monotherapy was planned on progression.Results A total of 725 patients were enrolled. After a fixed follow-up of 2 years for each patient, 2-year survival rates were 27.3% and 24.8% in arms A and B, respectively (hazard ratio 0.93; 95% confidence interval 0.78-1.10). The addition of oxaliplatin significantly improved response rates (54.1 versus 29.8%; P < 0.0001) and median progression-free survival (7.9 versus 5.9 months; P < 0.0001). The most common grade 3-4 toxic effects were neutropenia (arm A, 33%; arm B, 5%), diarrhoea (arm A, 14%; arm B, 8%), and fatigue (arm A, 9%; arm B, 8%).Conclusions Despite improved rates of tumour control, these results failed to demonstrate a survival benefit from the addition of oxaliplatin to infused 5-FU and lend further support to the use of sequential monotherapy in some patients with mCRC.
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No clear improvement in survival was detected in mice treated with 5FU alone or in combination with dasatinib.
“We repeated the experiment with 5FU, another drug that is commonly used for late stage CRC tumors [31], but no clear improvement in survival was detected in mice that were treated with 5FU alone or in combination with dasatinib (Figure 5B).”
From Dasatinib, a Src inhibitor, sensitizes liver metastatic colorectal carcinoma to oxaliplatin in tumors with high levels of phospho-Src (2016) · cites this paper as [31]
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- Authors
- Cunningham, D., Sirohi, B., Pluzanska, A., Utracka-Hutka, B., Zaluski, J., Glynne-Jones, R., Koralewski, P., Bridgewater, J., Mainwaring, P., Wasan, H., Wang, J.-Y., Szczylik, C., Clingan, P., Chan, R. T. T., Tabah-Fisch, I., & Cassidy, J.
- Affiliations
- Royal Marsden Hospital (GB)
- Medical University of Lodz (PL)
- The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
- North Middlesex Hospital (GB)
- Mater Health Services (AU)
- Hammersmith Hospital (GB)
- Chang Gung University (TW)
- Central Clinical Hospital (PL)
- Queen Mary Hospital (CN)
- Sanofi (France) (FR)
- Cancer Research UK (GB)
- Corresponding author
- Cunningham, D.
- ORCID
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2009-02
- Volume
- 20
- Issue
- 2
- Pages
- 244-250
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2156147330
- Cited by
- 62
- References
- 29
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 8 · 2022: 2 · 2021: 3 · 2019: 2 · 2018: 3 · 2017: 3 · 2016: 2 · 2015: 5 · 2014: 4 · 2013: 3 · 2012: 7
- FWCI
- 2.99
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- Research Online (University of Wollongong) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Sanofi
- National Institute for Health and Care Research (NF-SI-0507-10154)
- 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, oxaliplatin, 5-fluorouracil, leucovorin, first-line chemotherapy, continuous intravenous infusion, sequential monotherapy, irinotecan, progression-free survival, response rate, neutropenia, toxicity
- MeSH terms
- Irinotecan, Oxaliplatin, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Leucovorin, Diarrhea, Dose-Response Relationship, Drug, Drug Administration Schedule, Fatigue, Fluorouracil, Follow-Up Studies, Humans, Infusions, Intravenous, Neoplasm Metastasis, Neutropenia, Organoplatinum Compounds, Time Factors, Colorectal Neoplasms, Survival Analysis, Treatment Outcome, Disease Progression, Disease-Free Survival
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