title: Safety and efficacy of sunitinib in patients from Italy with metastatic renal cell carcinoma: final results from an expanded-access trial.
abstract: OBJECTIVE
  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%).
  
  
  CONCLUSIONS
  In a large population of Italian mRCC patients, sunitinib had a manageable safety profile and encouraging efficacy.
authors.affiliation: San Camillo Forlanini Hospital, Rome, Italy.
authors.forename: Cora N
authors.initials: CN
authors.lastname: Sternberg
authors.forename: Fabio
authors.initials: F
authors.lastname: Calabrò
authors.forename: Sergio
authors.initials: S
authors.lastname: Bracarda
authors.forename: Giacomo
authors.initials: G
authors.lastname: Cartenì
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lo Re
authors.forename: Enzo M
authors.initials: EM
authors.lastname: Ruggeri
authors.forename: Umberto
authors.initials: U
authors.lastname: Basso
authors.forename: Giampietro
authors.initials: G
authors.lastname: Gasparini
authors.forename: Libero
authors.initials: L
authors.lastname: Ciuffreda
authors.forename: Vittorio
authors.initials: V
authors.lastname: Ferrari
authors.forename: Andrea
authors.initials: A
authors.lastname: Bonetti
authors.forename: Elena
authors.initials: E
authors.lastname: Fea
authors.forename: Donatello
authors.initials: D
authors.lastname: Gasparro
authors.forename: Davide
authors.initials: D
authors.lastname: Tassinari
authors.forename: Roberto
authors.initials: R
authors.lastname: Labianca
authors.forename: Cristina
authors.initials: C
authors.lastname: Masini
authors.forename: Kolette
authors.initials: K
authors.lastname: Fly
authors.forename: Ke
authors.initials: K
authors.lastname: Zhang
authors.forename: Subramanian
authors.initials: S
authors.lastname: Hariharan
authors.forename: Barbara
authors.initials: B
authors.lastname: Capaccetti
authors.forename: Camillo
authors.initials: C
authors.lastname: Porta
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001247:Asthenia / Q000139:chemically induced; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary; D057176:Compassionate Use Trials; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004408:Dysgeusia / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D015994:Incidence; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007558:Italy; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013280:Stomatitis / Q000139:chemically induced; D000077210:Sunitinib; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib