title: Effect of temsirolimus versus interferon-alpha on outcome of patients with advanced renal cell carcinoma of different tumor histologies.
abstract: Purpose Exploratory subgroup analyses from the phase 3 global advanced renal cell carcinoma (ARCC) trial were conducted to assess the influence of tumor histology on outcome of patients treated with temsirolimus (Torisel) or interferon-alpha (IFN). Patients and methods Patients with ARCC including clear cell and other types such as papillary and chromophobe histologies received either IFN (3 million units [MU] subcutaneously three times weekly, escalating to 18 MU) or temsirolimus (25 mg intravenously weekly). Results Approximately 80% of patients had clear cell and 20% of patients had other histologies, the majority of which were papillary. Patients with clear cell and other RCC histologies, treated with temsirolimus, demonstrated comparable median overall and progression-free survival. In contrast, patients with other RCC histologies, treated with IFN, demonstrated shorter median overall and progression-free survival than patients with clear cell RCC. Hazard ratios for death for treatment with temsirolimus versus IFN were less than 1 for patients regardless of tumor histology. For patients treated with temsirolimus, 59% with clear cell and 68% with other RCC histologies experienced tumor reductions. For patients treated with IFN, 35% with clear cell and 14% with other RCC histologies had tumor reductions. However, temsirolimus did not appear to improve the objective response rate compared to IFN. Temsirolimus resulted in a superior clinical benefit rate compared with IFN, regardless of tumor histology. Conclusion Temsirolimus appears to be efficacious in patients with clear cell and non-clear cell histologies and can, therefore, be used for the treatment of all types of RCC.
authors.affiliation: Montefiore Medical Center-North Division/New York Medical College, 600 East 233rd Street, Bronx, NY, 10466, USA. jpd4401@aol.com
authors.forename: Janice P
authors.initials: JP
authors.lastname: Dutcher
authors.forename: Paul
authors.initials: P
authors.lastname: de Souza
authors.forename: David
authors.initials: D
authors.lastname: McDermott
authors.forename: Robert A
authors.initials: RA
authors.lastname: Figlin
authors.forename: Anna
authors.initials: A
authors.lastname: Berkenblit
authors.forename: Alexandra
authors.initials: A
authors.lastname: Thiele
authors.forename: Mizue
authors.initials: M
authors.lastname: Krygowski
authors.forename: Andrew
authors.initials: A
authors.lastname: Strahs
authors.forename: Jay
authors.initials: J
authors.lastname: Feingold
authors.forename: Gary
authors.initials: G
authors.lastname: Hudes
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D016898:Interferon-alpha; C401859:temsirolimus; D020123:Sirolimus