Oncology Medical News about Irinotecan, Gefitinib, Solid tumors

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Tyrosine kinase inhibitor enhances the bioavailability of oral irinotecan in pediatric patients with refractory solid tumors
Journal of Clinical Oncology, 08/25/09

Furman WL et al. – Study reports that IV irinotecan given with 12 days of oral gefitinib is well tolerated in children; one partial response was observed. Gefitinib significantly enhanced the bioavailability of oral irinotecan; this combination warrants further investigation.

Methods

Main objectives of this study were to assess:
- Max.-tolerated dosages (MTDs), and dose-limiting toxicities (DLTs) of the EGFR inhibitor gefitinib and of IV irinotecan when administered together in children with refractory solid tumors
- Effect of gefitinib on the pharmacokinetics of IV irinotecan and on the bioavailability of a single oral dose of irinotecan
IV irinotecan (15 or 20 mg/m2) was given daily for 5 days of 2 consecutive wks
Oral gefitinib (150 or 112.5 mg/m2) was concomitantly given daily for 12 or 21 days
A single oral dose of irinotecan was given on day 9 of course 2 to allow pharmacokinetic analysis

Results

29 pts with recurrent solid tumors; 21-day regimen of oral gefitinib with irinotecan was not tolerated
Diarrhea was the most common DLT
MTD of combination regimen was 15 mg/m2/d of IV irinotecan for 5 days of 2 consecutive wks and 112.5 mg/m2/d of gefitinib given for 12 days
Gefitinib increased the bioavailability of oral irinotecan by 4-fold over that observed in historical controls
This reduced the apparent clearance of irinotecan and SN-38 by 37% and 38%, respectively
A partial response was observed in a patient with refractory Ewing sarcoma

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