IngentaConnect Short-time infusion of oxaliplatin in combination with capecitabi...

Authors: Pfeiffer, P.; Sørbye, H.; Ehrsson, H.; Fokstuen, T.; Mortensen, J. P.; Baltesgard, L.; Tveit, K. M.; Øgreid, D.; Starkhammar, H.; Wallin, I.; Qvortrup, C.; Glimelius, B.

Source: Annals of Oncology, Volume 17, Number 2, February 2006 , pp. 252-258(7)

Publisher: Oxford University Press

Abstract:

Background: The efficacy of oxaliplatin combined with capecitabine (XELOX) as second-line therapy in patients with advanced colorectal cancer (ACRC) resistant to irinotecan is not well established. Oxaliplatin induces acute, cold-induced neuropathy in most patients. The incidence is claimed to be infusion rate-dependent and therefore a 2-h infusion is recommended.

Patients and methods: For practical and economic reasons, but also for patient's convenience, we performed a phase II study to examine XELOX<inf>30</inf> (capecitabine 1000 mg/m² orally twice daily on days 1–14 and oxaliplatin 130 mg/m² as a 30 min infusion on day 1) in patients with ACRC resistant to irinotecan. In addition the pharmacokinetics of oxaliplatin was studied.

Results: From November 2002 to September 2003, 70 patients with ACRC were treated with XELOX<inf>30</inf>. Median age was 62 (range 33–74 years) years and median performance status was 1 (range 0–2). The median number of courses was four (range 1–12) and median cumulative dose of oxaliplatin was 530 (range 125–1560 ) mg/m². The response rate was 17% (95% CI 10–23), median time to progression (TTP) was 5.4 months (95% CI 4.6–6.4) and median survival 9.5 months (95% CI 8.5–11.2). White blood cell count (WBC) and performance status were significantly correlated to TTP. Neurotoxicity was moderate: grade 1 56%, grade 2 17% and grade 3 6%. Other grade 3 toxicities were nausea/vomiting 9%, diarrhoea 14% and PPE 8%. The maximum blood concentration and total body clearance of oxaliplatin was higher than previously reported in studies examining 2-h infusions, but the volume of distribution and terminal half-life was in close agreement with previous results.

Conclusion: XELOX<inf>30</inf> is a very convenient second-line regimen in ACRC with an activity and safety profile similar to other oxaliplatin schedules.

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Short-time infusion of oxaliplatin in combination with capecitabine (XELOX30) as second-line therapy in patients with advanced colorectal cancer after failure to irinotecan and 5-fluorouracil

Short-time infusion of oxaliplatin in combination with capecitabine (XELOX₃₀) as second-line therapy in patients with advanced colorectal cancer after failure to irinotecan and 5-fluorouracil