Safety and efficacy of sunitinib in patients from Italy with metastatic renal cell carcinoma: Final results from an expanded-access trial

Cora N. Sternberg, Fabio Calabrò, Sergio Bracarda, Giacomo Cartenì, Giovanni Lo Re, Enzo M. Ruggeri, Umberto Basso, Giampietro Gasparini, Libero Ciuffreda, Vittorio Ferrari, Andrea Bonetti, Elena Fea, Donatello Gasparro, Davide Tassinari, Roberto Labianca, Cristina Masini, Kolette Fly, Ke Zhang, Subramanian Hariharan, Barbara CapaccettiCamillo Porta

Research output: Contribution to journalArticlepeer-review


Objectives: Patients with metastatic renal cell carcinoma (mRCC) received sunitinib in a global expanded-access program (EAP). Here, we report the efficacy and safety results for the EAP subpopulation in Italy. Methods: Patients ≥18 years old with previously treated or treatment-naïve mRCC received oral sunitinib 50 mg/day on a 4-weeks-on/2-weeks-off schedule. Tumor measurements were scheduled per local practice (using Response Evaluation Criteria in Solid Tumors). Safety was regularly assessed. Results: A total of 521 patients participated, including 40% aged ≥65 years, 11% with an Eastern Cooperative Oncology Group performance status ≥2, 14% with non-clear cell RCC, and 11% with brain metastases. The median treatment duration and posttreatment follow-up were 7.4 and 12.3 months, respectively. The objective response rate was 12%, and the median progression-free and overall survival was 9.1 and 27.2 months, respectively. 514 patients (99%) discontinued treatment; reasons included death (17%), nonresponse (46%), or adverse events (AEs; 13%). The most common any-grade treatment-related AEs were asthenia (44%, plus 15% reporting fatigue), thrombocytopenia and stomatitis (both 37%), diarrhea (36%), mucosal inflammation (29%), hypertension (26%), and dysgeusia (25%). The most common grade 3/4 treatment-related AEs were thrombocytopenia (10%), asthenia (9%, plus 3% reporting fatigue), neutropenia, stomatitis (both 6%), and hypertension (5%). Conclusion: In a large population of Italian mRCC patients, sunitinib had a manageable safety profile and encouraging efficacy.

Original languageEnglish
Pages (from-to)273-280
Number of pages8
Issue number5
Publication statusPublished - May 6 2015


  • Expanded-access program
  • Receptor tyrosine kinase inhibitor
  • Renal cell carcinoma
  • Safety
  • Sunitinib malate
  • Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)


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