Phase II study of sorafenib in patients with sunitinib-refractory metastatic renal cell cancer

Giuseppe Di Lorenzo, Giacomo Cartenì, Riccardo Autorino, Gianni Bruni, Marianna Tudini, Mimma Rizzo, Michele Aieta, Antonio Gonnella, Pasquale Rescigno, Sisto Perdonà, Gianluca Giannarini, Sandro Pignata, Nicola Longo, Giovannella Palmieri, Ciro Imbimbo, Michele De Laurentiis, Vincenzo Mirone, Corrado Ficorella, Sabino De Placido

Research output: Contribution to journalArticlepeer-review


Purpose: No previous prospective trials have been reported with sorafenib in patients with sunitinibrefractory 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.

Original languageEnglish
Pages (from-to)4469-4474
Number of pages6
JournalJournal of Clinical Oncology
Issue number27
Publication statusPublished - Sept 20 2009

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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