Background: In clinical trials with no upper age limit, the proportion of older patients is usually small, probablyreflecting the more conservative approach adopted by clinicians when treating the elderly. An exploratoryanalysis of elderly patients in the RECORD-1 Trial showed that patients ≥ 65 y.o. had superior median PFS thanoverall RECORD-1 population (5.4 months and 4.9 months, respectively). We investigated the efficacy, relativebenefit and safety of Everolimus (EVE) as sequential therapy after failure of VEGFr-TKI therapy for olderpatients with metastatic renal cell cancer (mRCC), in daily practice. Materials and
Methods: 172 consecutiveIRB approved patients with mRCC (median age 65, M:F 135/37, 78% clear cell) who received salvage EVE at39 tertiary institutions between October 2009 and August 2011 were included in this analysis. Some 31% hadprogressed on sunitinib, 22% on sorafenib, 1% on axitinib, 41% on sequential therapy, and 5% had receivedother therapy. Patients with brain metastases were not included and 95% of the patients had a ECOG (EasternCooperative Oncology Group) performance status (PS) of 0 or 1. Previous radiotherapy was an exclusioncriterion, but prior chemotherapy was permitted. Adequate organ function and hematologic parameters weremandatory. EVE administration was approved by the institutional review board at each participating institutionand signed informed consent was obtained from all patients.
Results: Median time of the whole cohort to lastfollow-up was 3.5 months (range 0.4-15.2 months). Forty four percent were continuing to take EVE at last followup.There were 86 (50%) patients ≥ 65 y.o. and 86 (50%) <65 y.o. The percentage of patients who showed PR/SD was higher in the older group than in the younger one (5.9%/61.2% vs 1.2%/46.5%, respectively). Mediansurvival of older patients was also significantly longer (3.5 +/- 0.31 vs 3.1 +/- 0.34, hazard ratio=0.45, CI; 0.255-0.802). Analysis using Cox regression model adjusted for gender, PS, number of metastases, site of metastases,histology, smoking history and age detected an association between age and PFS (p=0.011). The frequency ofadverse events in elderly patients treated with EVE was no greater than that in younger patients, although suchtoxicity may have had a greater impact on their quality of life.
Conclusions: Older patients should not generallybe excluded from accepted therapies (mTOR inhibitors after failure of VEGFr-TKI therapy) for mRCC.