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

Research output: Contribution to journalArticle

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Abstract

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
Volume14
Issue number1
DOIs
Publication statusPublished - 2014 Nov 3

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Adenoid Cystic Carcinoma
Disease-Free Survival
Disease Progression
Everolimus
Asthenia
Stomatitis
Anemia
Safety

All Science Journal Classification (ASJC) codes

  • Genetics
  • Oncology
  • Cancer Research

Cite this

Kim, Dong Wan ; Oh, Do Youn ; Shin, Seong Hoon ; Kang, Jin Hyoung ; Cho, Byoung Chul ; Chung, Joo Seop ; Kim, Hye Jin ; Park, Keon Uk ; Kwon, Jung Hye ; Han, Ji Youn ; Kim, Mi Jung ; Bang, Yung Jue. / A multicenter phase II study of everolimus in patients with progressive unresectable adenoid cystic carcinoma. In: BMC cancer. 2014 ; Vol. 14, No. 1.
@article{4a4ac7fec80047e08ec71b54c8bf3657,
title = "A multicenter phase II study of everolimus in patients with progressive unresectable adenoid cystic carcinoma",
abstract = "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.",
author = "Kim, {Dong Wan} and Oh, {Do Youn} and Shin, {Seong Hoon} and Kang, {Jin Hyoung} and Cho, {Byoung Chul} and Chung, {Joo Seop} and Kim, {Hye Jin} and Park, {Keon Uk} and Kwon, {Jung Hye} and Han, {Ji Youn} and Kim, {Mi Jung} and Bang, {Yung Jue}",
year = "2014",
month = "11",
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Kim, DW, Oh, DY, Shin, SH, Kang, JH, Cho, BC, Chung, JS, Kim, HJ, Park, KU, Kwon, JH, Han, JY, Kim, MJ & Bang, YJ 2014, 'A multicenter phase II study of everolimus in patients with progressive unresectable adenoid cystic carcinoma', BMC cancer, vol. 14, no. 1, 795. https://doi.org/10.1186/1471-2407-14-795

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

In: BMC cancer, Vol. 14, No. 1, 795, 03.11.2014.

Research output: Contribution to journalArticle

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T1 - A multicenter phase II study of everolimus in patients with progressive unresectable adenoid cystic carcinoma

AU - Kim, Dong Wan

AU - Oh, Do Youn

AU - Shin, Seong Hoon

AU - Kang, Jin Hyoung

AU - Cho, Byoung Chul

AU - Chung, Joo Seop

AU - Kim, Hye Jin

AU - Park, Keon Uk

AU - Kwon, Jung Hye

AU - Han, Ji Youn

AU - Kim, Mi Jung

AU - Bang, Yung Jue

PY - 2014/11/3

Y1 - 2014/11/3

N2 - 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.

AB - 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.

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