S-Space College of Medicine/School of Medicine (의과대학/대학원) Cancer Research Institute (암연구소) Journal Papers (저널논문_암연구소)
A multicenter phase II study of everolimus in patients with progressive unresectable adenoid cystic carcinoma
- Kim, Dong-Wan; Oh, Do-Youn; Shin, Seong Hoon; Kang, Jin Hyoung; Cho, Byoung Chul; Chung, Joo-Seop; Kim, HyeJin; Park, Keon Uk; Kwon, Jung Hye; Han, Ji-Youn; Kim, Mi-Jung; Bang, Yung-Jue
- Issue Date
- BMC Cancer, Vol.14, p. 795
- 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.