Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma Journal Article
| Authors: | Motzer, R. J.; Hutson, T. E.; Tomczak, P.; Michaelson, M. D.; Bukowski, R. M.; Oudard, S.; Negrier, S.; Szczylik, C.; Pili, R.; Bjarnason, G. A.; Garcia-del-Muro, X.; Sosman, J. A.; Solska, E.; Wilding, G.; Thompson, J. A.; Kim, S. T.; Chen, I.; Huang, X.; Figlin, R. A. |
| Article Title: | Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma |
| Abstract: | PurposeA randomized, phase III trial demonstrated superiority of sunitinib over interferon alfa (IFN-α) in progression-free survival (primary end point) as first-line treatment for metastatic renal cell carcinoma (RCC). Final survival analyses and updated results are reported.Patients and MethodsSeven hundred fifty treatment-naïve patients with metastatic clear cell RCC were randomly assigned to sunitinib 50 mg orally once daily on a 4 weeks on, 2 weeks off dosing schedule or to IFN-α 9 MU subcutaneously thrice weekly. Overall survival was compared by two-sided log-rank and Wilcoxon tests. Progression-free survival, response, and safety end points were assessed with updated follow-up.ResultsMedian overall survival was greater in the sunitinib group than in the IFN-α group (26.4 v 21.8 months, respectively; hazard ratio [HR] = 0.821; 95% CI, 0.673 to 1.001; P =.051) per the primary analysis of unstratified log-rank test (P =.013 per unstratified Wilcoxon test). By stratified log-rank test, the HR was 0.818 (95% CI, 0.669 to 0.999; P =.049). Within the IFN-α group, 33% of patients received sunitinib, and 32% received other vascular endothelial growth factor-signaling inhibitors after discontinuation from the trial. Median progression-free survival was 11 months for sunitinib compared with 5 months for IFN-α (P <.001). Objective response rate was 47% for sunitinib compared with 12% for IFN-α (P <.001). The most commonly reported sunitinib-related grade 3 adverse events included hypertension (12%), fatigue (11%), diarrhea (9%), and hand-foot syndrome (9%).ConclusionSunitinib demonstrates longer overall survival compared with IFN-α plus improvement in response and progression-free survival in the first-line treatment of patients with metastatic RCC. The overall survival highlights an improved prognosis in patients with RCC in the era of targeted therapy. © 2023 American Society of Clinical Oncology. All rights reserved. |
| Keywords: | vasculotropin; adult; cancer survival; controlled study; major clinical study; overall survival; constipation; neutropenia; sunitinib; cancer growth; diarrhea; drug efficacy; drug safety; hypertension; hypophosphatemia; side effect; treatment duration; alpha interferon; follow up; cancer grading; anorexia; progression free survival; anemia; leukopenia; mucosa inflammation; randomized controlled trial; stomatitis; thrombocytopenia; vomiting; myalgia; abdominal pain; arthralgia; asthenia; chill; dyspnea; fever; lymphocytopenia; rash; alanine aminotransferase; alkaline phosphatase; aspartate aminotransferase; bilirubin; acute kidney failure; heart infarction; peripheral edema; xerostomia; erythema; cancer fatigue; creatine kinase; skin discoloration; headache; phase 3 clinical trial; hypothyroidism; alpha2a interferon; gastroesophageal reflux; dyspepsia; flatulence; glossodynia; hand foot syndrome; dry skin; alopecia; epistaxis; brain hemorrhage; uric acid; amylase; mouth pain; dysgeusia; triacylglycerol lipase; respiratory failure; decreased appetite; metastatic renal cell carcinoma; body weight loss; stomach hemorrhage; human; male; female; article; vegf signaling |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 41 |
| Issue: | 11 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2023-04-10 |
| Start Page: | 1965 |
| End Page: | 1971 |
| Language: | English |
| DOI: | 10.1200/jco.22.02623 |
| PUBMED: | 37018919 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- MSK corresponding author is Robert Motzer -- Reprint of 2009 edition, see DOI: 10.1200/jco.2008.20.1293 -- Export Date: 1 May 2023 -- Source: Scopus |
