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Title

Optimisation of irinotecan dose in the treatment of patients with metastatic colorectal cancer after 5-FU failure: results from a multinational, randomised phase II study

Authors
Van Cutsem, E
Dirix, L
Van Laethem, J-L
Van Belle, S
Borner, M
Gonzalez Baron, M
Morant, R
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Published in British Journal of Cancer. 2005, vol. 92, no. 6, p. 1055-62
Abstract Although irinotecan 350 mg m(-2) is a standard option for relapsed/refractory advanced colorectal cancer, there is some evidence that suggests that a higher dose may be more effective, with acceptable tolerability, following 5-fluorouracil (5-FU). This study assessed the optimal dosing strategy for irinotecan, along with treatment efficacy and safety. A total of 164 patients with metastatic colorectal cancer progressing after failure on 5-FU or raltitrexed received either 350 mg m(-2) irinotecan (Group A; n=36) or 250, 350 or 500 mg m(-2), according to individual patient tolerance (Group B; n=62) or based on risk factor optimisation (Group C; n=66). There were no complete responses. There was a trend towards a higher overall response rate in Group B (13%) than in Groups A (8%) and C (9%). Tumour control growth rate was high in all three groups: 58% in group A, 60% in Group B and 50% in Group C. A total of 34% of patients in Group B and 9% in Group C were able to receive a dose of 500 mg m(-2). Median duration of response and time to progression were significantly longer in Groups A and B compared with Group C. No significant between-group differences for any adverse events were seen, although there was a small trend towards better tolerability in Group B. Individual dose escalation based on patient tolerance may allow more patients to receive a higher irinotecan dose without causing additional toxicity and can be an appropriate patient management strategy.
Keywords AdultAgedCamptothecin/administration & dosage/adverse effects/analogs & derivatives/pharmacokineticsColorectal Neoplasms/drug therapyFemaleFluorouracil/therapeutic useHumansMaleMiddle AgedNeoplasm MetastasisTreatment Failure
Identifiers
PMID: 15756271
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Research group Groupe Roth Arnaud (oncologie) (285)
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VAN CUTSEM, E et al. Optimisation of irinotecan dose in the treatment of patients with metastatic colorectal cancer after 5-FU failure: results from a multinational, randomised phase II study. In: British Journal of Cancer, 2005, vol. 92, n° 6, p. 1055-62. https://archive-ouverte.unige.ch/unige:40810

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Deposited on : 2014-10-09

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