DO NOT COMBINE SUNTINIB AND TEMSIROLIMUS

Clin Genitourin Cancer. 2009 Jan;7(1):24-7.

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Phase I study combining treatment with temsirolimus and sunitinib malate in patients with advanced renal cell carcinoma.

Patel PH, Senico PL, Curiel RE, Motzer RJ.

Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021, USA.

PURPOSE: Concurrent inhibition of multiple oncogenic signaling pathways might improve the efficacy of anticancer agents and abrogate resistance mechanisms. This phase I study evaluated temsirolimus in combination with sunitinib in patients with advanced RCC. PATIENTS AND METHODS: Eligibility included advanced RCC and or= 7 days) were observed in 2 of 3 patients. One patient experienced grade 3 rash during week 3, which led to treatment discontinuation. A second patient had grade 3 thrombocytopenia (platelet count, 48,000/microL), cellulitis, and gout during week 3 and was hospitalized; platelets recovered to 109,000/microL 4 days after discontinuation of protocol therapy. A third patient experienced rash, asthenia, diarrhea, stomatitis, constipation, fever, and rectal hemorrhage, all of which were mild in severity. The study was terminated because of dose-limiting toxicity observed at low starting doses of both agents. CONCLUSION: Concomitant use of I.V. temsirolimus 15 mg weekly and oral sunitinib 25 mg daily (4 weeks on, 2 weeks off) is not recommended.