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Temsirolimus, Interferon Alfa, or Both for Advanced Renal-Cell Carcinoma
- Source :
- New England Journal of Medicine. 356:2271-2281
- Publication Year :
- 2007
- Publisher :
- Massachusetts Medical Society, 2007.
-
Abstract
- Interferon alfa is widely used for metastatic renal-cell carcinoma but has limited efficacy and tolerability. Temsirolimus, a specific inhibitor of the mammalian target of rapamycin kinase, may benefit patients with this disease.In this multicenter, phase 3 trial, we randomly assigned 626 patients with previously untreated, poor-prognosis metastatic renal-cell carcinoma to receive 25 mg of intravenous temsirolimus weekly, 3 million U of interferon alfa (with an increase to 18 million U) subcutaneously three times weekly, or combination therapy with 15 mg of temsirolimus weekly plus 6 million U of interferon alfa three times weekly. The primary end point was overall survival in comparisons of the temsirolimus group and the combination-therapy group with the interferon group.Patients who received temsirolimus alone had longer overall survival (hazard ratio for death, 0.73; 95% confidence interval [CI], 0.58 to 0.92; P=0.008) and progression-free survival (P0.001) than did patients who received interferon alone. Overall survival in the combination-therapy group did not differ significantly from that in the interferon group (hazard ratio, 0.96; 95% CI, 0.76 to 1.20; P=0.70). Median overall survival times in the interferon group, the temsirolimus group, and the combination-therapy group were 7.3, 10.9, and 8.4 months, respectively. Rash, peripheral edema, hyperglycemia, and hyperlipidemia were more common in the temsirolimus group, whereas asthenia was more common in the interferon group. There were fewer patients with serious adverse events in the temsirolimus group than in the interferon group (P=0.02).As compared with interferon alfa, temsirolimus improved overall survival among patients with metastatic renal-cell carcinoma and a poor prognosis. The addition of temsirolimus to interferon did not improve survival. (ClinicalTrials.gov number, NCT00065468 [ClinicalTrials.gov].).
- Subjects :
- Adult
Male
Oncology
medicine.medical_specialty
Combination therapy
Alpha interferon
Antineoplastic Agents
Pazopanib
Ridaforolimus
chemistry.chemical_compound
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Carcinoma, Renal Cell
Protein Kinase Inhibitors
Interferon alfa
Aged
Proportional Hazards Models
Aged, 80 and over
Sirolimus
business.industry
TOR Serine-Threonine Kinases
Interferon-alpha
General Medicine
Middle Aged
Prognosis
Hematologic Diseases
Survival Analysis
Kidney Neoplasms
Temsirolimus
Surgery
Axitinib
Tolerability
chemistry
Female
business
Protein Kinases
medicine.drug
Subjects
Details
- ISSN :
- 15334406 and 00284793
- Volume :
- 356
- Database :
- OpenAIRE
- Journal :
- New England Journal of Medicine
- Accession number :
- edsair.doi.dedup.....a107cabf7dba014c06a3affe36ed53a2