Evaluation of safety, pharmacokinetics, and efficacy of vorinostat, a histone deacetylase inhibitor, in the treatment of gastrointestinal (GI) cancer in a phase I clinical trial
Background Control of epigenetic changes using histone deacetylase inhibitors (HDACi) is thought to be a promising target in therapy of gastrointestinal (GI) cancer. In this study, we evaluated the safety, pharmacokinetics, and efficacy of two dosing regimens of vorinostat, an oral HDACi, in patient...
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Published in | International journal of clinical oncology Vol. 18; no. 1; pp. 87 - 95 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Japan
Springer Japan
01.02.2013
Springer Nature B.V |
Subjects | |
Online Access | Get full text |
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Abstract | Background
Control of epigenetic changes using histone deacetylase inhibitors (HDACi) is thought to be a promising target in therapy of gastrointestinal (GI) cancer. In this study, we evaluated the safety, pharmacokinetics, and efficacy of two dosing regimens of vorinostat, an oral HDACi, in patients with GI tumors.
Methods
Patients received either vorinostat 300 mg bid for 3 consecutive days followed by 4 rest days per cycle (
n
= 10) or vorinostat 400 mg qd for 21 consecutive days per cycle (
n
= 6). Pharmacokinetic parameters were assessed for the first treatment cycle. Efficacy was determined through evaluation of tumors and assessment of treatment response.
Results
The median treatment duration of 300 mg bid was 52.0 days and of 400 mg qd was 51.5 days. The most common drug-related adverse events were anorexia, nausea, fatigue, and hyperglycemia. Two patients taking 400 mg qd had dose-limiting toxicities (DLTs) of thrombocytopenia. No patients taking 300 mg bid experienced DLT. Five patients taking 300 mg bid and 2 patients taking 400 mg qd maintained stable disease for >8 weeks, with the maximum duration of 245 days. Mean drug exposure (±SD) was generally higher with 400 mg qd (area under the curve [AUC
0–∞
] of 7.75 ± 2.79 μM h on Day 1 post-dose) compared with 300 mg bid (AUC
0–∞
of 3.94 ± 1.56 μM h on Day 1 post-dose).
Conclusions
Vorinostat 300 mg bid for 3 consecutive days followed by 4 days of rest was better tolerated in patients with GI cancer than a higher once daily dose. Additionally, there were patients in both groups who achieved stable disease, most maintaining it for longer than 8 weeks, suggesting vorinostat as a possible active agent in the treatment of GI cancer. |
---|---|
AbstractList | Background
Control of epigenetic changes using histone deacetylase inhibitors (HDACi) is thought to be a promising target in therapy of gastrointestinal (GI) cancer. In this study, we evaluated the safety, pharmacokinetics, and efficacy of two dosing regimens of vorinostat, an oral HDACi, in patients with GI tumors.
Methods
Patients received either vorinostat 300 mg bid for 3 consecutive days followed by 4 rest days per cycle (
n
= 10) or vorinostat 400 mg qd for 21 consecutive days per cycle (
n
= 6). Pharmacokinetic parameters were assessed for the first treatment cycle. Efficacy was determined through evaluation of tumors and assessment of treatment response.
Results
The median treatment duration of 300 mg bid was 52.0 days and of 400 mg qd was 51.5 days. The most common drug-related adverse events were anorexia, nausea, fatigue, and hyperglycemia. Two patients taking 400 mg qd had dose-limiting toxicities (DLTs) of thrombocytopenia. No patients taking 300 mg bid experienced DLT. Five patients taking 300 mg bid and 2 patients taking 400 mg qd maintained stable disease for >8 weeks, with the maximum duration of 245 days. Mean drug exposure (±SD) was generally higher with 400 mg qd (area under the curve [AUC
0–∞
] of 7.75 ± 2.79 μM h on Day 1 post-dose) compared with 300 mg bid (AUC
0–∞
of 3.94 ± 1.56 μM h on Day 1 post-dose).
Conclusions
Vorinostat 300 mg bid for 3 consecutive days followed by 4 days of rest was better tolerated in patients with GI cancer than a higher once daily dose. Additionally, there were patients in both groups who achieved stable disease, most maintaining it for longer than 8 weeks, suggesting vorinostat as a possible active agent in the treatment of GI cancer. Control of epigenetic changes using histone deacetylase inhibitors (HDACi) is thought to be a promising target in therapy of gastrointestinal (GI) cancer. In this study, we evaluated the safety, pharmacokinetics, and efficacy of two dosing regimens of vorinostat, an oral HDACi, in patients with GI tumors. Patients received either vorinostat 300 mg bid for 3 consecutive days followed by 4 rest days per cycle (n = 10) or vorinostat 400 mg qd for 21 consecutive days per cycle (n = 6). Pharmacokinetic parameters were assessed for the first treatment cycle. Efficacy was determined through evaluation of tumors and assessment of treatment response. The median treatment duration of 300 mg bid was 52.0 days and of 400 mg qd was 51.5 days. The most common drug-related adverse events were anorexia, nausea, fatigue, and hyperglycemia. Two patients taking 400 mg qd had dose-limiting toxicities (DLTs) of thrombocytopenia. No patients taking 300 mg bid experienced DLT. Five patients taking 300 mg bid and 2 patients taking 400 mg qd maintained stable disease for >8 weeks, with the maximum duration of 245 days. Mean drug exposure (±SD) was generally higher with 400 mg qd (area under the curve [AUC^sub 0-∞^] of 7.75 ± 2.79 μM h on Day 1 post-dose) compared with 300 mg bid (AUC^sub 0-∞^ of 3.94 ± 1.56 μM h on Day 1 post-dose). Vorinostat 300 mg bid for 3 consecutive days followed by 4 days of rest was better tolerated in patients with GI cancer than a higher once daily dose. Additionally, there were patients in both groups who achieved stable disease, most maintaining it for longer than 8 weeks, suggesting vorinostat as a possible active agent in the treatment of GI cancer.[PUBLICATION ABSTRACT] Control of epigenetic changes using histone deacetylase inhibitors (HDACi) is thought to be a promising target in therapy of gastrointestinal (GI) cancer. In this study, we evaluated the safety, pharmacokinetics, and efficacy of two dosing regimens of vorinostat, an oral HDACi, in patients with GI tumors. Patients received either vorinostat 300 mg bid for 3 consecutive days followed by 4 rest days per cycle (n = 10) or vorinostat 400 mg qd for 21 consecutive days per cycle (n = 6). Pharmacokinetic parameters were assessed for the first treatment cycle. Efficacy was determined through evaluation of tumors and assessment of treatment response. The median treatment duration of 300 mg bid was 52.0 days and of 400 mg qd was 51.5 days. The most common drug-related adverse events were anorexia, nausea, fatigue, and hyperglycemia. Two patients taking 400 mg qd had dose-limiting toxicities (DLTs) of thrombocytopenia. No patients taking 300 mg bid experienced DLT. Five patients taking 300 mg bid and 2 patients taking 400 mg qd maintained stable disease for >8 weeks, with the maximum duration of 245 days. Mean drug exposure (±SD) was generally higher with 400 mg qd (area under the curve [AUC(0-∞)] of 7.75 ± 2.79 μM h on Day 1 post-dose) compared with 300 mg bid (AUC(0-∞) of 3.94 ± 1.56 μM h on Day 1 post-dose). Vorinostat 300 mg bid for 3 consecutive days followed by 4 days of rest was better tolerated in patients with GI cancer than a higher once daily dose. Additionally, there were patients in both groups who achieved stable disease, most maintaining it for longer than 8 weeks, suggesting vorinostat as a possible active agent in the treatment of GI cancer. |
Author | Hamaguchi, Tetsuya Shirao, Kuniaki Chin, Kensho Noguchi, Kazuo Mehta, Anish Hatake, Kiyohiko Otsuki, Tetsuya Doi, Toshihiko Ohtsu, Atsushi |
Author_xml | – sequence: 1 givenname: Toshihiko surname: Doi fullname: Doi, Toshihiko email: doi.toshi3@gmail.com organization: National Cancer Center Hospital East – sequence: 2 givenname: Tetsuya surname: Hamaguchi fullname: Hamaguchi, Tetsuya organization: National Cancer Center – sequence: 3 givenname: Kuniaki surname: Shirao fullname: Shirao, Kuniaki organization: Oita University – sequence: 4 givenname: Kensho surname: Chin fullname: Chin, Kensho organization: Cancer Institute Hospital of Japanese Foundation for Cancer Research – sequence: 5 givenname: Kiyohiko surname: Hatake fullname: Hatake, Kiyohiko organization: Cancer Institute Hospital of Japanese Foundation for Cancer Research – sequence: 6 givenname: Kazuo surname: Noguchi fullname: Noguchi, Kazuo organization: MSD K.K – sequence: 7 givenname: Tetsuya surname: Otsuki fullname: Otsuki, Tetsuya organization: MSD K.K – sequence: 8 givenname: Anish surname: Mehta fullname: Mehta, Anish organization: Merck Sharpe & Dohme Corp – sequence: 9 givenname: Atsushi surname: Ohtsu fullname: Ohtsu, Atsushi organization: National Cancer Center Hospital East |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/22234637$$D View this record in MEDLINE/PubMed |
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Copyright | Japan Society of Clinical Oncology 2012 Japan Society of Clinical Oncology 2013 |
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Keywords | Histone deacetylase inhibitor (HDACi) Gastrointestinal cancer Vorinostat Suberoylanilide hydroxamic acid (SAHA) |
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Control of epigenetic changes using histone deacetylase inhibitors (HDACi) is thought to be a promising target in therapy of gastrointestinal (GI)... Control of epigenetic changes using histone deacetylase inhibitors (HDACi) is thought to be a promising target in therapy of gastrointestinal (GI) cancer. In... |
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SubjectTerms | Aged Cancer Research Chemotherapy Clinical outcomes Clinical trials Dose-Response Relationship, Drug Drug-Related Side Effects and Adverse Reactions - chemically induced Female Gastric cancer Gastroenterology Gastrointestinal Neoplasms - blood Gastrointestinal Neoplasms - drug therapy Gastrointestinal Neoplasms - pathology Histone Deacetylase Inhibitors - administration & dosage Histone Deacetylase Inhibitors - adverse effects Histone Deacetylase Inhibitors - blood Histone Deacetylase Inhibitors - pharmacokinetics Humans Hydroxamic Acids - administration & dosage Hydroxamic Acids - adverse effects Hydroxamic Acids - blood Hydroxamic Acids - pharmacokinetics Inhibitor drugs Male Maximum Tolerated Dose Medicine Medicine & Public Health Middle Aged Neoplasm Staging Oncology Original Article Surgical Oncology |
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Title | Evaluation of safety, pharmacokinetics, and efficacy of vorinostat, a histone deacetylase inhibitor, in the treatment of gastrointestinal (GI) cancer in a phase I clinical trial |
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