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A pooled analysis of the efficacy and safety of sunitinib in elderly patients (pts) with metastatic renal cell carcinoma (mRCC).
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2011
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Elderly PatientsCancer ManagementPharmacotherapyLogistic AnalysisPre-clinical PharmacologyOncologyGenitourinary CancerClinical TrialsMrcc TreatmentDrug MonitoringCancer ResearchTherapeutic Drug MonitoringClinical TherapeuticCancer TreatmentPooled AnalysisPharmacologyTx SettingsUrologyMedian PfsMedicine
4604 Background: Sunitinib is approved multinationally for mRCC treatment (Tx), with demonstrated activity and tolerability in both the first- and second-line Tx settings. Here, we report a retrospective analysis of the efficacy and safety of sunitinib as a function of age in pts with mRCC from 6 clinical trials. Methods: Analyses included pooled data from 1,059 pts who received single-agent sunitinib on the approved 50 mg/d 4-week-on/2-week-off schedule (n=689; 65%) or at 37.5 mg continuous once-daily dosing (n=370; 35%), in both the first- (n=783; 74%) and second-line (n=276; 26%) Tx settings. Median progression-free survival (PFS) and overall survival (OS) were estimated by Kaplan-Meier method and compared between pts <70 vs. ≥70 yrs of age by log-rank test. Adverse event (AE) rates were also compared. Results: Of 1,059 pts, 857 (81%) were of age <70 yrs and 202 (19%) ≥70 yrs, with median ages of 57 and 73 yrs, respectively. 73% and 59% were male, but otherwise baseline characteristics were similar. Median PFS was similar in both groups (9.0 vs. 10.9 mo; HR, 0.85; 95% CI, 0.70–1.02; P=0.0830), as was median OS (23.3 vs. 23.7 mo; HR, 0.94; 95% CI, 0.76–1.15; P=0.5441). In addition, efficacy was similar by age regardless of Tx setting. In first-line pts <70 vs. ≥70 yrs, median PFS and OS were 9.9 mo (95% CI, 8.3–10.7) vs. 11.0 mo (95% CI, 9.0–14.7) and 23.5 mo (95% CI, 21.1–27.6) vs. 25.5 mo (95% CI, 21.6–38.4); in second-line pts, median PFS and OS were 8.1 mo (95% CI, 7.8–8.7) vs. 8.4 mo (95% CI, 6.3–14.2) and 20.1 mo (95% CI, 16.2–25.0) vs. 15.8 mo (95% CI, 13.7–23.9). Most Tx-emergent AEs occurred at similar rates in both age groups; however, some AEs were significantly less common in pts aged <70 vs. ≥70 yrs, including fatigue (59% vs. 69%), decreased appetite/weight (29% vs. 53%), cough (20% vs. 29%), peripheral edema (17% vs. 27%), anemia (17% vs. 25%), and thrombocytopenia (16% vs. 25%; all P<0.05). Hand–foot syndrome was more common in younger pts (32% vs. 24%; P<0.05). Conclusions: In pts with mRCC, the efficacy of sunitinib was comparable in the elderly population, deriving similar benefit as younger pts regardless of Tx setting. The AE profiles were also similar, although some AEs were more common in elderly pts.