Originally published as JCO Early Release 10.1200/JCO.2009.22.6480 on August 3 2009

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Phase II Study of Sorafenib in Patients With Sunitinib-Refractory Metastatic Renal Cell Cancer

From the Dipartimento di Endocrinologia ed Oncologia Clinica e Molecolare, and Sezione di Urologia, Università Federico II; Unità Operativa Complessa (UOC) Oncologia, Ospedale Cardarelli; Clinica Urologica, Seconda Università degli Studi; UOC Oncologia Urologica, INT Fondazione "G. Pascale", Napoli; UO Oncologia, Università Dell'Aquila, L'Aquila; Unità Operativa (UO) Oncologia Ospedale Oncologico Regionale, Rionero in Vulture, Potenza; and UO Urologia Universitaria, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.

Corresponding author: Giuseppe Di Lorenzo, MD, PhD, Dipartimento di Endocrinologia ed Oncologia Clinica e Molecolare, Università Federico II, Napoli, Italy; e-mail: giuseppedilorenzoncol{at}hotmail.com.

Purpose No previous prospective trials have been reported with sorafenib in patients with sunitinib-refractory metastatic renal cell cancer (MRCC). We conducted a multicenter study to determine the activity and tolerability of sorafenib as second-line therapy after sunitinib progression in MRCC.

Patients and Methods Between January 2006 and September 2008, 52 patients were enrolled onto this single-arm phase II study. All patients received sorafenib 400 mg orally twice a day until disease progression or intolerable toxicity. The primary end point was objective response rate (complete or partial response) evaluated every 8 weeks by use of the Response Evaluation Criteria in Solid Tumors; secondary end points were toxicity, time to progression (TTP), and overall survival (OS).

Results All patients were included in response and safety analyses. Partial responses were observed in 9.6% of patients (five of 52 patients; 95% CI, 5% to 17%) after two cycles. Grade 1 to 2 fatigue, diarrhea, nausea/vomiting, rash, and neutropenia were the most common side effects, noted in 16 (30.8%), 19 (36.5%), 20 (38.5%), 19 (36.5%), and 20 patients (38.5%), respectively. The most common grade 3 toxicity was diarrhea, noted in six patients (11.5%). Median TTP was 16 weeks (range, 8 to 40 weeks), and median OS was 32 weeks (range, 16 to 64 weeks).

Conclusion Although well tolerated, sorafenib shows limited efficacy in sunitinib-refractory MRCC. Further randomized trials comparing sorafenib with other drugs that target different biologic pathways are needed to define the best second-line treatment option in these patients.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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