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Feasibility study of two schedules of sunitinib in combination with pemetrexed in patients with advanced solid tumors
Isamu Okamoto1, Toshio Shimizu, Masaki Miyazaki
1Department of Medical Oncology, Kinki University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan. chi-okamoto@dotd.med.kindai.ac.jp
Background:
Sunitinib is an oral multitargeted tyrosine kinase inhibitor of vascular endothelial growth factor and platelet-derived growth factor receptors, as well as of other receptor types. We have performed a feasibility study to investigate the safety of sunitinib in combination with pemetrexed for treatment of advanced refractory solid tumors.
Methods:
Sunitinib was administered once daily on a continuous daily dosing (CDD) schedule (37.5 mg/day) or a 2-weeks-on, 1-week-off treatment schedule (50 mg/day, Schedule 2/1) in combination with pemetrexed at 500 mg/m(2) on day 1 of repeated 21-day cycles.
Results:
Twelve patients were enrolled in the study: six on the CDD schedule and six on Schedule 2/1. None of the treated patients experienced a dose-limiting toxicity. Toxicities were manageable and similar in type to those observed in monotherapy studies of sunitinib and pemetrexed. Pharmacokinetic analysis did not reveal any substantial drug-drug interaction. One patient with squamous cell lung cancer showed a partial response and five patients had stable disease.
Conclusions:
Combination therapy with sunitinib administered on Schedule 2/1 (50 mg/day) or a CDD schedule (37.5 mg/day) together with standard-dose pemetrexed (500 mg/m(2)) was well tolerated in previously treated patients with advanced solid tumors.
Insights
This study found that combining sunitinib (a tyrosine kinase inhibitor) with pemetrexed is safe and well-tolerated for advanced solid tumors. The combination therapy showed manageable toxicities, similar to individual drug treatments.
Area of Science:
- Oncology
- Pharmacology
Background:
- Sunitinib targets vascular endothelial growth factor and platelet-derived growth factor receptors.
- Investigated the safety of sunitinib in combination with pemetrexed for advanced refractory solid tumors.
Purpose of the Study:
- To assess the feasibility and safety of combining sunitinib with pemetrexed.
- To evaluate different dosing schedules for sunitinib in combination therapy.
Main Methods:
- Sunitinib administered daily (37.5 mg/day) or 2-weeks-on/1-week-off (50 mg/day) with pemetrexed (500 mg/m(2)).
- Feasibility study involving twelve patients with advanced refractory solid tumors.
Main Results:
- No dose-limiting toxicities observed in twelve patients.
- Toxicities were manageable and consistent with monotherapy.
- Pharmacokinetic analysis showed no significant drug-drug interactions.
- One partial response and five stable disease cases observed.
Conclusions:
- Combination therapy with sunitinib and pemetrexed is well-tolerated in patients with advanced solid tumors.
- Both continuous daily dosing and 2-weeks-on/1-week-off schedules of sunitinib are feasible.
