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, Hye Jin Kim, Keon Uk Park, Jung Hye Kwon, Ji Youn Han, Mi Jung Kim, Yung Jue Bang

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30 Citations (Scopus)


Background: The aim of this study was to examine the efficacy and safety of everolimus in patients with progressiveunresectable adenoid cystic carcinoma (ACC).Methods: Histologically confirmed ACC patients with documented disease progression within 12 months prior tothe study entry were eligible. Everolimus was given at a dose of 10 mg daily until progression or occurrence ofunacceptable 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 confidenceinterval [CI], 47.7 to infinity). Median PFS duration was 11.2 months (95% CI, 3.6 to 15.8). Complete or partial responsewas not achieved. Twenty-seven (79.4%, 95% CI, 63.2 to 89.6) patients showed stable disease (SD). Tumor shrinkagewithin 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-PETscans available, 8 patients (44.4%) showed a partial metabolic response, defined as a ≥25% reduction in maximumstandardized uptake values (SUVmax). The most common adverse events were stomatitis, anemia, asthenia, andleukopenia. 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.

Original languageEnglish
Article number795
JournalBMC cancer
Issue number1
Publication statusPublished - 2014 Nov 3

Bibliographical note

Funding Information:
This work was supported in part by a research grant from Novartis. We thank Professor Seokyung Hahn (Medical Research Collaboration Center, Seoul National University Hospital, Seoul, Republic of Korea) for the consultation in statistical analyses.

Publisher Copyright:
© 2014 Kim et al.

All Science Journal Classification (ASJC) codes

  • Oncology
  • Genetics
  • Cancer Research


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