Phase III trial of everolimus in metastatic renal cell carcinoma: subgroup
analysis of Japanese patients from RECORD-1.
Author(s): Tsukamoto T, Shinohara N, Tsuchiya N, Hamamoto Y, Maruoka M, Fujimoto H, Niwakawa
M, Uemura H, Usami M, Terai A, Kanayama HO, Sumiyoshi Y, Eto M, Akaza H.
Affiliation(s): Sapporo Medical University, Sapporo, Japan.
Publication date & source: 2011, Jpn J Clin Oncol. , 41(1):17-24
OBJECTIVE: To assess the efficacy and safety of everolimus in Japanese patients
with metastatic renal cell carcinoma.
METHODS: A subgroup analysis of the pivotal Phase III, randomized, double-blind,
placebo-controlled trial of everolimus 10 mg/day in patients with disease
progression after treatment with sorafenib, sunitinib or both assessed outcomes
in Japanese participants. Results were compared with those for the overall study
population.
RESULTS: The final trial analysis included 24 Japanese patients (everolimus, n=
15; placebo, n = 9). Median progression-free survival in the Japanese
subpopulation was 5.75 months (95% confidence interval, 4.90 months to not
reached) with everolimus and 3.61 months (95% confidence interval, 1.91-9.03
months) with placebo (hazard ratio, 0.19; 95% confidence interval, 0.05-0.83).
Median overall survival was not reached with everolimus and was 14.9 months (95%
confidence interval, 11.0-16.8 months) with placebo (hazard ratio, 0.30; 95%
confidence interval, 0.07-1.27). Overall, efficacy and safety were similar when
comparing the Japanese and overall populations. In the Japanese subpopulation,
the most common adverse events with everolimus were stomatitis, infections and
rash. Four Japanese subjects (27%) developed Grade 1 (n = 2) or 2 (n = 2)
pneumonitis (all reversible and allowing for continuation of therapy, after
interruption, steroids and dose reduction for both Grade 2 cases), with a lower
pneumonitis incidence of 14% in the overall population (albeit associated with a
Grade 3 incidence of 4%).
CONCLUSIONS: These findings suggest that the demonstrated benefits of everolimus
in the overall trial population are similar in Japanese patients with metastatic
renal cell carcinoma.
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