Annals of Oncology Advance Access published online on October 14, 2008
Annals of Oncology, doi:10.1093/annonc/mdn638
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Two different first-line 5-fluorouracil regimens with or without oxaliplatin in patients with metastatic colorectal cancer
1 Department of Medicine, Royal Marsden Hospital, London and Surrey, UK
2 Medical University bej Chemotherapy Szpital Akademii Medycznej im, M. Kopernika, Oddzial Chemioterapii, ul. Paderewskiego, Lodz, Poland
3 Comprehensive Cancer Centre, Maria Sklodowska-Curie Memorial Institute, Branch Gliwice, Wybrze
e Armii Krajowej, Gliwice, Poland
4 Wielkopolskie Centrum Onkologii, Klinika Chemioterapii, Garbary, Poznan, Poland
5 Department of Radiotherapy, Mount Vernon Hospital, Northwood, UK
6 Rydygier Memorial Hospital, Krakow-Nowa Huta, Poland
7 Department of Medical Oncology, North Middlesex Hospital, London, UK
8 Mater Health Services, Mater Adult Hospital, South Brisbane, Australia
9 Department of Clinical Oncology, Hammersmith Hospital, London, UK
10 Department of Surgery, Chang Gung University, Chang Gung Memorial Hospital, Sec. West, Jiapu Rd., Puzih City, Ciayi County, Taiwan(R.O.C.)
11 Central Clinical Hospital of Military Medical Academy, Klinika Onkologii, CSK WAM SP ZOZ, ul. Szaszerow, Warsaw, Poland
12 Southern Medical Day Care Centre, Wollongong, NSW, Crown St, Wollongong, NSW, Australia
13 Department of Clinical Oncology, Queen Mary Hospital, Pokfulam, Hong Kong
14 Global Oncology, sanofi-aventis, Paris, France
15 Department of Medical Oncology, Cancer Research UK, University of Glasgow, Scotland, UK
* Correspondence to: Prof. D. Cunningham, Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT, UK. Tel: +44-20-8661-3156; Fax: +44-20-8643-9414; E-mail: david.cunningham{at}rmh.nhs.uk
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/m2 + 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.
colorectal cancer, 5-fluorouracil, leucovorin, metastatic, oxaliplatin, phase III
Received for publication May 12, 2008. Revision received July 16, 2008. Accepted for publication August 22, 2008.
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