Abstract:
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.
journal_name
BMC Cancerjournal_title
BMC cancerauthors
Kim DW,Oh DY,Shin SH,Kang JH,Cho BC,Chung JS,Kim H,Park KU,Kwon JH,Han JY,Kim MJ,Bang YJdoi
10.1186/1471-2407-14-795subject
Has Abstractpub_date
2014-11-03 00:00:00pages
795issn
1471-2407pii
1471-2407-14-795journal_volume
14pub_type
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