476 Background: Multiple treatment options are available for patients with advanced renal cell carcinoma (RCC). However, the safety and efficacy data of these agents in elderly patients are limited. In this study, the data, which prospectively collected practical use of sorafenib amongst all RCC patients as a nationwide post-marketing surveillance, were analyzed using propensity-matched cohorts. Methods: A total of 3,255 patients with advanced RCC were enrolled and 772 patients selected by propensity score were matched for <75 (n=386) and ≥75 year old patients (n=386). Progression free survival (PFS), tumor response, adverse events (AEs), doses of sorafenib, and estimated glomerular filtration rate (eGFR) were analyzed. Results: The median PFS in <75 and ≥75 year old patients was 233 days (194, 274) vs. 219 days (190, 263), respectively. The mean starting dose (702 mg vs. 688 mg) and median treatment duration (222 days vs. 175 days) were similar in two groups, but mean dose intensity (70.3% vs. 61.4%, p<0.001) was lower in ≥75 year old patients than that in <75 year old patients. Complete response rates were 0.9% and 3.7%, partial response rates were 27.9% and 27.1%, stable disease rates were 58.4% and 55.6%, progressive disease rates were 12.8% and 12.8% in <75 and ≥75 year old patients, respectively. Objective response rate (CR+PR) was comparable in both groups (28.8% and 30.8%). Safety was analyzed for 772 patients, and any grade AEs observed ≥20% were hand-foot skin reaction (HFSR) (55.8%), hypertension (36.7%), rash (27.4%), and increase in lipase / amylase (26.2%), and diarrhea (21.8%). The common serious AEs were rash (7.4%), HFSR (6.0%), hepatic dysfunction (5.6%), cytopenia (4.9%), and hypertension (2.8%). The incidence of these common AEs was similar between the two groups. The discontinuation due to AE and drug related death rates were 65.3% vs. 74.9% (p<0.01) and 3.4% vs. 4.9% in <75 and ≥75 year old patients, respectively. In both groups, the eGFR value did not change from the baseline, and even slightly increased after 12 months of sorafenib treatment. Conclusions: This study indicated that sorafenib provides clinical benefits and is tolerable amongst patients with advanced RCC regardless of age.
Elderly patients (pts) with advanced Renal Cell Carcinoma (aRCC) treated with Nivolumab (N): A subgroup analysis from the WITNESS real-world study in France