Efficacy and Safety of Everolimus in Korean Patients with Metastatic Renal Cell Carcinoma Following Treatment Failure with a Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor
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PurposeThe purpose of this study is to assess the efficacy and safety of everolimus in Koreanpatients with metastatic renal cell carcinoma (mRCC) for whom initial treatment with avascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) has failed. Materials and MethodsEligible patients with mRCC (any histology) who had progressed on or were intolerant ofVEGFr-TKI therapy received oral everolimus (10 mg dose once daily). Tumor response wasreassessed according to Response Evaluation Criteria in Solid Tumors (RECIST). ResultsThis study included 100 patients with a median follow-up duration of 10.2 months, a medianprogression-free survival (PFS) of 4.2 months (95% confidence interval [CI], 3.4 to 5.0months), and an overall survival of 10.1 months (95% CI, 6.9 to 13.3 months). The mostcommon grade 3 or greater adverse events (AEs) overall were anemia (13%), pneumonitis(9%), hyperglycemia (8%), and stomatitis (6%). While the incidence of pneumonitis wassimilar (26 cases, 26%) to the reported incidence in Western patients, the Koreanpresentations were more severe: 10 patients permanently discontinued everolimus due topneumonitis, including two deaths on treatment. Statistically significant relationships wereestablished between biologic toxicities, hyperglycemia and anemia, and PFS (hyperglycemiavs. non-hyperglycemia: hazard ratio [HR], 0.61; p=0.055 and anemia vs. non-anemia: HR,0.51; p=0.021). ConclusionEverolimus was effective in Korean patients with mRCC who had failed initial VEGFr-TKItherapy. While everolimus was well tolerated in general and the AE incidence of this studywas similar to those of previous reports, severe pneumonitis was common. Hyperglycemiaand anemia showed significant correlation with PFS and thus may be potentially useful asprognostic indicators.
Abstract
PurposeThe purpose of this study is to assess the efficacy and safety of everolimus in Koreanpatients with metastatic renal cell carcinoma (mRCC) for whom initial treatment with avascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) has failed. Materials and MethodsEligible patients with mRCC (any histology) who had progressed on or were intolerant ofVEGFr-TKI therapy received oral everolimus (10 mg dose once daily). Tumor response wasreassessed according to Response Evaluation Criteria in Solid Tumors (RECIST). ResultsThis study included 100 patients with a median follow-up duration of 10.2 months, a medianprogression-free survival (PFS) of 4.2 months (95% confidence interval [CI], 3.4 to 5.0months), and an overall survival of 10.1 months (95% CI, 6.9 to 13.3 months). The mostcommon grade 3 or greater adverse events (AEs) overall were anemia (13%), pneumonitis(9%), hyperglycemia (8%), and stomatitis (6%). While the incidence of pneumonitis wassimilar (26 cases, 26%) to the reported incidence in Western patients, the Koreanpresentations were more severe: 10 patients permanently discontinued everolimus due topneumonitis, including two deaths on treatment. Statistically significant relationships wereestablished between biologic toxicities, hyperglycemia and anemia, and PFS (hyperglycemiavs. non-hyperglycemia: hazard ratio [HR], 0.61; p=0.055 and anemia vs. non-anemia: HR,0.51; p=0.021). ConclusionEverolimus was effective in Korean patients with mRCC who had failed initial VEGFr-TKItherapy. While everolimus was well tolerated in general and the AE incidence of this studywas similar to those of previous reports, severe pneumonitis was common. Hyperglycemiaand anemia showed significant correlation with PFS and thus may be potentially useful asprognostic indicators.
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