Annals of Oncology Advance Access originally published online on July 27, 2006
Annals of Oncology 2006 17(10):1523-1528; doi:10.1093/annonc/mdl179
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© 2006 European Society for Medical Oncology
gastrointestinal tumors |
Randomised study of sequential versus combination chemotherapy with capecitabine, irinotecan and oxaliplatin in advanced colorectal cancer, an interim safety analysis. A Dutch Colorectal Cancer Group (DCCG) phase III study
1 Radboud University Nijmegen Medical Centre, Nijmegen
2 Netherlands Cancer Institute (NKI), Biometrics Department, Amsterdam
3 Rijnstate Hospital, Arnhem
4 Atrium Medical Centre, Heerlen
5 Isala Hospital, Zwolle
6 Maasland Hospital, Sittard
7 Martini Hospital, Groningen
8 Meander Hospital, Amersfoort
9 Maxima Medical Centre, Veldhoven
10 Comprehensive Cancer Centre East (IKO), Nijmegen, The Netherlands
*Correspondence to: Prof. C. J. A. Punt, Department of Medical Oncology, Radboud University Nijmegen Medical Centre, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands. Tel: +31-24-3610353; Fax: +31-24-3540788; E-mail: c.punt{at}onco.umcn.nl
Background: Results on overall survival in randomised studies of mono- versus combination chemotherapy in advanced colorectal cancer patients may have been biased by an imbalance in salvage treatments. This is the first randomised study that evaluates sequential versus combination chemotherapy with a fluoropyrimidine, irinotecan and oxaliplatin.
Patients and methods: A total of 820 patients were randomised between first-line capecitabine, second-line irinotecan and third-line capecitabine + oxaliplatin (arm A) versus first-line capecitabine + irinotecan, and second-line capecitabine + oxaliplatin (arm B). The primary end point was overall survival. We present the results of an interim analysis on the safety data in the first 400 patients.
Results: In first-line the incidence of grade 3–4 diarrhoea, nausea, vomiting and febrile neutropenia was significantly higher in arm B. However, when toxicity over all lines was considered only grade 3 hand–foot syndrome occurred more frequently in arm A (12% versus 6%, respectively, P = 0.041). The incidence of cardiovascular toxicity was low. In two out of five patients with sudden death (one in arm A, four in arm B) cardiovascular risk factors were present.
Conclusions: Both treatment arms had an acceptable safety profile. These data imply that the results on survival will be the major determinant for the selection of either strategy. Capecitabine plus irinotecan appears to be a feasible first-line treatment for patients with advanced colorectal carcinoma.
Key words: advanced colorectal cancer, capecitabine, chemotherapy, irinotecan, oxaliplatin, safety
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