A multicenter phase II study of everolimus in patients with progressive unresectable adenoid cystic carcinoma
- Dong-Wan Kim; Do-Youn Oh; Seong Hoon Shin; Jin Hyoung Kang; Byoung Chul Cho; Joo-Seop Chung; HyeJin Kim; Keon Uk Park; Jung Hye Kwon; Ji-Youn Han; Mi-Jung Kim; Yung-Jue Bang
- Dept. of Internal Medicine (내과학)
- Issue Date
- BMC Cancer, Vol.14(1) : 795-795, 2014
- BACKGROUND: The aim of this study was to examine the efficacy and safety of everolimus in patients with progressive unresectable adenoid cystic carcinoma (ACC).
METHODS: Histologically confirmed ACC patients with documented disease progression within 12 months prior to the study entry were eligible. Everolimus was given at a dose of 10 mg daily until progression or occurrence of unacceptable toxicities. The primary endpoint was a 4-month progression-free survival (PFS).
RESULTS: A total of 34 patients were enrolled. The 4-month PFS probability was 65.5% (95% one-sided confidence interval [CI], 47.7 to infinity). Median PFS duration was 11.2 months (95% CI, 3.6 to 15.8). Complete or partial response was not achieved. Twenty-seven (79.4%, 95% CI, 63.2 to 89.6) patients showed stable disease (SD). Tumor shrinkage within SD criteria was observed in 15 patients (44.1%) and SD lasting 6 months was observed in 13 patients (38.2%). Four patients had disease progression. Among the 18 patients with both pre- and post-treatment (at 8 weeks) FDG-PET scans available, 8 patients (44.4%) showed a partial metabolic response, defined as a ≥25% reduction in maximum standardized uptake values (SUVmax). The most common adverse events were stomatitis, anemia, asthenia, and leukopenia. No unexpected everolimus related toxicities were reported.
CONCLUSIONS: Everolimus showed promising efficacy and good tolerability in progressive unresectable ACC.
TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01152840.
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- 1. Journal Papers (연구논문) > 1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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