Phase 2 study of dovitinib in patients with metastatic or unresectable adenoid cystic carcinoma

Bhumsuk Keam, Sung Bae Kim, Seong Hoon Shin, Byoung Chul Cho, Keun Wook Lee, Min Kyoung Kim, Hwan Jung Yun, Se Hoon Lee, Dok Hyun Yoon, Yung Jue Bang

Research output: Contribution to journalArticle

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Abstract

BACKGROUND The objective of this study was to evaluate the efficacy and safety of dovitinib in patients with adenoid cystic carcinoma (ACC). METHODS ACC patients with documented disease progression within the past 12 months were eligible. Patients received oral dovitinib (500 mg once daily for 5 consecutive days followed by a 2-day rest every week) until disease progression or unacceptable toxicities. The primary endpoint was the probability of 4-month progression-free survival (PFS). Metabolic response was evaluated with positron emission tomography (PET)/computed tomography (CT) scans performed at the baseline and after 8 weeks of treatment. RESULTS Between September 2011 and April 2013, 32 patients with metastatic and/or unresectable ACC were enrolled in this prospective, multicenter trial. The 4-month PFS probability was 80.4%, and the median PFS was 6.0 months (95% confidence interval, 4.4-7.6 months). Tumor shrinkage was observed in 22 patients (68.8%), and 1 patient had a confirmed partial response. The disease control rate was 96.9%. Among 26 patients with PET/CT scans both before and after treatment (at 8 weeks), the metabolic activity of ACC was reduced in 13 patients (50.0%), and 5 patients (19.2%) achieved a metabolic partial response, which was defined as a ≥25% reduction in maximum standardized uptake values. Common grade 3 and 4 adverse events were asthenia (50.0%) and neutropenia (25.0%). CONCLUSIONS Dovitinib shows modest antitumor activity in the treatment of ACC. Cancer 2015;121:2612-2617.

Original languageEnglish
Pages (from-to)2612-2617
Number of pages6
JournalCancer
Volume121
Issue number15
DOIs
Publication statusPublished - 2015 Aug 1

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Adenoid Cystic Carcinoma
Disease-Free Survival
Disease Progression
4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one
Asthenia
Neutropenia
Multicenter Studies
Neoplasms
Therapeutics
Confidence Intervals
Safety

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Keam, B., Kim, S. B., Shin, S. H., Cho, B. C., Lee, K. W., Kim, M. K., ... Bang, Y. J. (2015). Phase 2 study of dovitinib in patients with metastatic or unresectable adenoid cystic carcinoma. Cancer, 121(15), 2612-2617. https://doi.org/10.1002/cncr.29401
Keam, Bhumsuk ; Kim, Sung Bae ; Shin, Seong Hoon ; Cho, Byoung Chul ; Lee, Keun Wook ; Kim, Min Kyoung ; Yun, Hwan Jung ; Lee, Se Hoon ; Yoon, Dok Hyun ; Bang, Yung Jue. / Phase 2 study of dovitinib in patients with metastatic or unresectable adenoid cystic carcinoma. In: Cancer. 2015 ; Vol. 121, No. 15. pp. 2612-2617.
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abstract = "BACKGROUND The objective of this study was to evaluate the efficacy and safety of dovitinib in patients with adenoid cystic carcinoma (ACC). METHODS ACC patients with documented disease progression within the past 12 months were eligible. Patients received oral dovitinib (500 mg once daily for 5 consecutive days followed by a 2-day rest every week) until disease progression or unacceptable toxicities. The primary endpoint was the probability of 4-month progression-free survival (PFS). Metabolic response was evaluated with positron emission tomography (PET)/computed tomography (CT) scans performed at the baseline and after 8 weeks of treatment. RESULTS Between September 2011 and April 2013, 32 patients with metastatic and/or unresectable ACC were enrolled in this prospective, multicenter trial. The 4-month PFS probability was 80.4{\%}, and the median PFS was 6.0 months (95{\%} confidence interval, 4.4-7.6 months). Tumor shrinkage was observed in 22 patients (68.8{\%}), and 1 patient had a confirmed partial response. The disease control rate was 96.9{\%}. Among 26 patients with PET/CT scans both before and after treatment (at 8 weeks), the metabolic activity of ACC was reduced in 13 patients (50.0{\%}), and 5 patients (19.2{\%}) achieved a metabolic partial response, which was defined as a ≥25{\%} reduction in maximum standardized uptake values. Common grade 3 and 4 adverse events were asthenia (50.0{\%}) and neutropenia (25.0{\%}). CONCLUSIONS Dovitinib shows modest antitumor activity in the treatment of ACC. Cancer 2015;121:2612-2617.",
author = "Bhumsuk Keam and Kim, {Sung Bae} and Shin, {Seong Hoon} and Cho, {Byoung Chul} and Lee, {Keun Wook} and Kim, {Min Kyoung} and Yun, {Hwan Jung} and Lee, {Se Hoon} and Yoon, {Dok Hyun} and Bang, {Yung Jue}",
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Keam, B, Kim, SB, Shin, SH, Cho, BC, Lee, KW, Kim, MK, Yun, HJ, Lee, SH, Yoon, DH & Bang, YJ 2015, 'Phase 2 study of dovitinib in patients with metastatic or unresectable adenoid cystic carcinoma', Cancer, vol. 121, no. 15, pp. 2612-2617. https://doi.org/10.1002/cncr.29401

Phase 2 study of dovitinib in patients with metastatic or unresectable adenoid cystic carcinoma. / Keam, Bhumsuk; Kim, Sung Bae; Shin, Seong Hoon; Cho, Byoung Chul; Lee, Keun Wook; Kim, Min Kyoung; Yun, Hwan Jung; Lee, Se Hoon; Yoon, Dok Hyun; Bang, Yung Jue.

In: Cancer, Vol. 121, No. 15, 01.08.2015, p. 2612-2617.

Research output: Contribution to journalArticle

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T1 - Phase 2 study of dovitinib in patients with metastatic or unresectable adenoid cystic carcinoma

AU - Keam, Bhumsuk

AU - Kim, Sung Bae

AU - Shin, Seong Hoon

AU - Cho, Byoung Chul

AU - Lee, Keun Wook

AU - Kim, Min Kyoung

AU - Yun, Hwan Jung

AU - Lee, Se Hoon

AU - Yoon, Dok Hyun

AU - Bang, Yung Jue

PY - 2015/8/1

Y1 - 2015/8/1

N2 - BACKGROUND The objective of this study was to evaluate the efficacy and safety of dovitinib in patients with adenoid cystic carcinoma (ACC). METHODS ACC patients with documented disease progression within the past 12 months were eligible. Patients received oral dovitinib (500 mg once daily for 5 consecutive days followed by a 2-day rest every week) until disease progression or unacceptable toxicities. The primary endpoint was the probability of 4-month progression-free survival (PFS). Metabolic response was evaluated with positron emission tomography (PET)/computed tomography (CT) scans performed at the baseline and after 8 weeks of treatment. RESULTS Between September 2011 and April 2013, 32 patients with metastatic and/or unresectable ACC were enrolled in this prospective, multicenter trial. The 4-month PFS probability was 80.4%, and the median PFS was 6.0 months (95% confidence interval, 4.4-7.6 months). Tumor shrinkage was observed in 22 patients (68.8%), and 1 patient had a confirmed partial response. The disease control rate was 96.9%. Among 26 patients with PET/CT scans both before and after treatment (at 8 weeks), the metabolic activity of ACC was reduced in 13 patients (50.0%), and 5 patients (19.2%) achieved a metabolic partial response, which was defined as a ≥25% reduction in maximum standardized uptake values. Common grade 3 and 4 adverse events were asthenia (50.0%) and neutropenia (25.0%). CONCLUSIONS Dovitinib shows modest antitumor activity in the treatment of ACC. Cancer 2015;121:2612-2617.

AB - BACKGROUND The objective of this study was to evaluate the efficacy and safety of dovitinib in patients with adenoid cystic carcinoma (ACC). METHODS ACC patients with documented disease progression within the past 12 months were eligible. Patients received oral dovitinib (500 mg once daily for 5 consecutive days followed by a 2-day rest every week) until disease progression or unacceptable toxicities. The primary endpoint was the probability of 4-month progression-free survival (PFS). Metabolic response was evaluated with positron emission tomography (PET)/computed tomography (CT) scans performed at the baseline and after 8 weeks of treatment. RESULTS Between September 2011 and April 2013, 32 patients with metastatic and/or unresectable ACC were enrolled in this prospective, multicenter trial. The 4-month PFS probability was 80.4%, and the median PFS was 6.0 months (95% confidence interval, 4.4-7.6 months). Tumor shrinkage was observed in 22 patients (68.8%), and 1 patient had a confirmed partial response. The disease control rate was 96.9%. Among 26 patients with PET/CT scans both before and after treatment (at 8 weeks), the metabolic activity of ACC was reduced in 13 patients (50.0%), and 5 patients (19.2%) achieved a metabolic partial response, which was defined as a ≥25% reduction in maximum standardized uptake values. Common grade 3 and 4 adverse events were asthenia (50.0%) and neutropenia (25.0%). CONCLUSIONS Dovitinib shows modest antitumor activity in the treatment of ACC. Cancer 2015;121:2612-2617.

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