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

BMC Cancer

Dong-Wan Kim¹  Do-Youn Oh¹  Seong Hoon Shin⁹  Jin Hyoung Kang¹⁰  Byoung Chul Cho⁸  Joo-Seop Chung⁴  HyeJin Kim⁷  Keon Uk Park⁵  Jung Hye Kwon⁶  Ji-Youn Han²  Mi-Jung Kim³  Yung-Jue Bang¹ 

[1] Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea

[2] National Cancer Center, Gyeonggi-do, Republic of Korea

[3] Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 110-744, Republic of Korea

[4] Pusan National University Hospital, Seoul, Republic of Korea

[5] Keimyung University Dongsan Hospital, Daegu, Republic of Korea

[6] Hallym University Medical Center, Seoul, Republic of Korea

[7] Seoul Veterans Hospital, Seoul, Republic of Korea

[8] Yonsei Cancer Center, Seoul, Republic of Korea

[9] Kosin University Gospel Hospital, Busan, Republic of Korea

[10] Catholic University Seoul St. Mary’s Hospital, Seoul, Republic of Korea

关键词: Clinical trial;    RAD001;    Everolimus;    Adenoid cystic carcinoma;   

Others  :  1120942
DOI  :  10.1186/1471-2407-14-795

 received in 2014-05-02, accepted in 2014-10-23,  发布年份 2014

【 摘 要 】

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

【 授权许可】

   
2014 Kim et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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Figure 3.

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