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BMC Cancer. 2014 Nov 3;14:795. doi: 10.1186/1471-2407-14-795.

A multicenter phase II study of everolimus in patients with progressive unresectable adenoid cystic carcinoma.

Author information

1
Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 110-744, Republic of Korea. bangyj@snu.ac.kr.

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.

PMID:
25362970
PMCID:
PMC4228069
DOI:
10.1186/1471-2407-14-795
[Indexed for MEDLINE]
Free PMC Article

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