Phase II study of the histone deacetylase inhibitor vorinostat (Suberoylanilide Hydroxamic Acid; SAHA) in recurrent or metastatic transitional cell carcinoma of the urothelium – an NCI-CTEP sponsored: California Cancer Consortium trial, NCI 6879
Summary Background: Until the advent of T cell check point inhibitors standard second-line therapy for patients with metastatic urothelial cancer (mUC) was undefined. Histone deacetylase inhibitors (HDACi) have anti-cancer activity in a variety of tumor models including modulation of apoptosis in bl...
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| Published in | Investigational new drugs Vol. 39; no. 3; pp. 812 - 820 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York
Springer US
01.06.2021
Springer Nature B.V |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Summary
Background:
Until the advent of T cell check point inhibitors standard second-line therapy for patients with metastatic urothelial cancer (mUC) was undefined. Histone deacetylase inhibitors (HDACi) have anti-cancer activity in a variety of tumor models including modulation of apoptosis in bladder cancer cell lines. We evaluated the efficacy and toxicity of the HDACi vorinostat in patients with mUC failing first-line platinum-based therapy either in the adjuvant/neoadjuvant setting or for recurrent/advanced disease.
Methods:
Vorinostat was given orally 200 mg twice daily continuously until progression or unacceptable toxicity. The primary end point was RECIST response rate (RR); a RR > 20% was deemed interesting in a 2-stage design requiring one response in the first 12 patients to proceed to 2nd stage for a total of 37 subjects. CT or MRI scan imaging occurred every 6 weeks.
Results:
Fourteen patients were accrued characterized by: median age 66 years (43–84); Caucasian (79%); males (86%); and Karnofsky performance status ≥90 (50%). Accrual was terminated in the first stage as no responses were observed. Best response was stable disease (3 patients). Progression was observed in 8 patients. Two patients came off therapy prior to re-imaging and a 3rd patient died while on treatment and was not assessed for response. Median number of cycles was 2 (range 1–11). Median disease-free survival and overall survival times were 1.1 (0.8, 2.1) & 3.2 (2.1, 14.5) months, respectively. Toxicities were predominantly cytopenias and thrombocytopenic bleeding. Two pts. had grade 5 toxicity unlikely related to treatment. Two pts. had grade 4 and 6 had grade 3 toxicities observed. Two patients with stable disease remained on therapy for 6+ cycles.
Conclusions:
Vorinostat on this dose-schedule had limited efficacy and significant toxicity resulting in a unfavorable risk:benefit ratio in patients with mUC. NCT00363883. |
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| AbstractList | SummaryBackground: Until the advent of T cell check point inhibitors standard second-line therapy for patients with metastatic urothelial cancer (mUC) was undefined. Histone deacetylase inhibitors (HDACi) have anti-cancer activity in a variety of tumor models including modulation of apoptosis in bladder cancer cell lines. We evaluated the efficacy and toxicity of the HDACi vorinostat in patients with mUC failing first-line platinum-based therapy either in the adjuvant/neoadjuvant setting or for recurrent/advanced disease. Methods: Vorinostat was given orally 200 mg twice daily continuously until progression or unacceptable toxicity. The primary end point was RECIST response rate (RR); a RR > 20% was deemed interesting in a 2-stage design requiring one response in the first 12 patients to proceed to 2nd stage for a total of 37 subjects. CT or MRI scan imaging occurred every 6 weeks. Results: Fourteen patients were accrued characterized by: median age 66 years (43–84); Caucasian (79%); males (86%); and Karnofsky performance status ≥90 (50%). Accrual was terminated in the first stage as no responses were observed. Best response was stable disease (3 patients). Progression was observed in 8 patients. Two patients came off therapy prior to re-imaging and a 3rd patient died while on treatment and was not assessed for response. Median number of cycles was 2 (range 1–11). Median disease-free survival and overall survival times were 1.1 (0.8, 2.1) & 3.2 (2.1, 14.5) months, respectively. Toxicities were predominantly cytopenias and thrombocytopenic bleeding. Two pts. had grade 5 toxicity unlikely related to treatment. Two pts. had grade 4 and 6 had grade 3 toxicities observed. Two patients with stable disease remained on therapy for 6+ cycles. Conclusions: Vorinostat on this dose-schedule had limited efficacy and significant toxicity resulting in a unfavorable risk:benefit ratio in patients with mUC. NCT00363883. Until the advent of T cell check point inhibitors standard second-line therapy for patients with metastatic urothelial cancer (mUC) was undefined. Histone deacetylase inhibitors (HDACi) have anti-cancer activity in a variety of tumor models including modulation of apoptosis in bladder cancer cell lines. We evaluated the efficacy and toxicity of the HDACi vorinostat in patients with mUC failing first-line platinum-based therapy either in the adjuvant/neoadjuvant setting or for recurrent/advanced disease.BACKGROUNDUntil the advent of T cell check point inhibitors standard second-line therapy for patients with metastatic urothelial cancer (mUC) was undefined. Histone deacetylase inhibitors (HDACi) have anti-cancer activity in a variety of tumor models including modulation of apoptosis in bladder cancer cell lines. We evaluated the efficacy and toxicity of the HDACi vorinostat in patients with mUC failing first-line platinum-based therapy either in the adjuvant/neoadjuvant setting or for recurrent/advanced disease.Vorinostat was given orally 200 mg twice daily continuously until progression or unacceptable toxicity. The primary end point was RECIST response rate (RR); a RR > 20% was deemed interesting in a 2-stage design requiring one response in the first 12 patients to proceed to 2nd stage for a total of 37 subjects. CT or MRI scan imaging occurred every 6 weeks.METHODSVorinostat was given orally 200 mg twice daily continuously until progression or unacceptable toxicity. The primary end point was RECIST response rate (RR); a RR > 20% was deemed interesting in a 2-stage design requiring one response in the first 12 patients to proceed to 2nd stage for a total of 37 subjects. CT or MRI scan imaging occurred every 6 weeks.Fourteen patients were accrued characterized by: median age 66 years (43-84); Caucasian (79%); males (86%); and Karnofsky performance status ≥90 (50%). Accrual was terminated in the first stage as no responses were observed. Best response was stable disease (3 patients). Progression was observed in 8 patients. Two patients came off therapy prior to re-imaging and a 3rd patient died while on treatment and was not assessed for response. Median number of cycles was 2 (range 1-11). Median disease-free survival and overall survival times were 1.1 (0.8, 2.1) & 3.2 (2.1, 14.5) months, respectively. Toxicities were predominantly cytopenias and thrombocytopenic bleeding. Two pts. had grade 5 toxicity unlikely related to treatment. Two pts. had grade 4 and 6 had grade 3 toxicities observed. Two patients with stable disease remained on therapy for 6+ cycles.RESULTSFourteen patients were accrued characterized by: median age 66 years (43-84); Caucasian (79%); males (86%); and Karnofsky performance status ≥90 (50%). Accrual was terminated in the first stage as no responses were observed. Best response was stable disease (3 patients). Progression was observed in 8 patients. Two patients came off therapy prior to re-imaging and a 3rd patient died while on treatment and was not assessed for response. Median number of cycles was 2 (range 1-11). Median disease-free survival and overall survival times were 1.1 (0.8, 2.1) & 3.2 (2.1, 14.5) months, respectively. Toxicities were predominantly cytopenias and thrombocytopenic bleeding. Two pts. had grade 5 toxicity unlikely related to treatment. Two pts. had grade 4 and 6 had grade 3 toxicities observed. Two patients with stable disease remained on therapy for 6+ cycles.Vorinostat on this dose-schedule had limited efficacy and significant toxicity resulting in a unfavorable risk:benefit ratio in patients with mUC. NCT00363883.CONCLUSIONSVorinostat on this dose-schedule had limited efficacy and significant toxicity resulting in a unfavorable risk:benefit ratio in patients with mUC. NCT00363883. Until the advent of T cell check point inhibitors standard second-line therapy for patients with metastatic urothelial cancer (mUC) was undefined. Histone deacetylase inhibitors (HDACi) have anti-cancer activity in a variety of tumor models including modulation of apoptosis in bladder cancer cell lines. We evaluated the efficacy and toxicity of the HDACi vorinostat in patients with mUC failing first-line platinum-based therapy either in the adjuvant/neoadjuvant setting or for recurrent/advanced disease. Vorinostat was given orally 200 mg twice daily continuously until progression or unacceptable toxicity. The primary end point was RECIST response rate (RR); a RR > 20% was deemed interesting in a 2-stage design requiring one response in the first 12 patients to proceed to 2nd stage for a total of 37 subjects. CT or MRI scan imaging occurred every 6 weeks. Fourteen patients were accrued characterized by: median age 66 years (43-84); Caucasian (79%); males (86%); and Karnofsky performance status ≥90 (50%). Accrual was terminated in the first stage as no responses were observed. Best response was stable disease (3 patients). Progression was observed in 8 patients. Two patients came off therapy prior to re-imaging and a 3rd patient died while on treatment and was not assessed for response. Median number of cycles was 2 (range 1-11). Median disease-free survival and overall survival times were 1.1 (0.8, 2.1) & 3.2 (2.1, 14.5) months, respectively. Toxicities were predominantly cytopenias and thrombocytopenic bleeding. Two pts. had grade 5 toxicity unlikely related to treatment. Two pts. had grade 4 and 6 had grade 3 toxicities observed. Two patients with stable disease remained on therapy for 6+ cycles. Vorinostat on this dose-schedule had limited efficacy and significant toxicity resulting in a unfavorable risk:benefit ratio in patients with mUC. NCT00363883. Summary Background: Until the advent of T cell check point inhibitors standard second-line therapy for patients with metastatic urothelial cancer (mUC) was undefined. Histone deacetylase inhibitors (HDACi) have anti-cancer activity in a variety of tumor models including modulation of apoptosis in bladder cancer cell lines. We evaluated the efficacy and toxicity of the HDACi vorinostat in patients with mUC failing first-line platinum-based therapy either in the adjuvant/neoadjuvant setting or for recurrent/advanced disease. Methods: Vorinostat was given orally 200 mg twice daily continuously until progression or unacceptable toxicity. The primary end point was RECIST response rate (RR); a RR > 20% was deemed interesting in a 2-stage design requiring one response in the first 12 patients to proceed to 2nd stage for a total of 37 subjects. CT or MRI scan imaging occurred every 6 weeks. Results: Fourteen patients were accrued characterized by: median age 66 years (43–84); Caucasian (79%); males (86%); and Karnofsky performance status ≥90 (50%). Accrual was terminated in the first stage as no responses were observed. Best response was stable disease (3 patients). Progression was observed in 8 patients. Two patients came off therapy prior to re-imaging and a 3rd patient died while on treatment and was not assessed for response. Median number of cycles was 2 (range 1–11). Median disease-free survival and overall survival times were 1.1 (0.8, 2.1) & 3.2 (2.1, 14.5) months, respectively. Toxicities were predominantly cytopenias and thrombocytopenic bleeding. Two pts. had grade 5 toxicity unlikely related to treatment. Two pts. had grade 4 and 6 had grade 3 toxicities observed. Two patients with stable disease remained on therapy for 6+ cycles. Conclusions: Vorinostat on this dose-schedule had limited efficacy and significant toxicity resulting in a unfavorable risk:benefit ratio in patients with mUC. NCT00363883. |
| Author | Frankel, Paul Chatta, Gurkamal Twardowski, Przemyslaw Aparicio, Ana M. Groshen, Susan G. Quinn, David I. Wright, John J. Khoo, Stella Newman, Edward Tsao-Wei, Denice D. Lenz, Heinz-Josef Gandara, David R. Lara, Primo N. |
| AuthorAffiliation | 2 City of Hope Comprehensive Cancer Center, Duarte, CA 3 University of Pittsburgh, Pittsburgh, PA 5 University of California Davis Cancer Center, Sacramento, CA 4 Clinical Treatment Evaluation Program, National Cancer Institute, Bethesda, MD 1 University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA |
| AuthorAffiliation_xml | – name: 3 University of Pittsburgh, Pittsburgh, PA – name: 4 Clinical Treatment Evaluation Program, National Cancer Institute, Bethesda, MD – name: 2 City of Hope Comprehensive Cancer Center, Duarte, CA – name: 1 University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA – name: 5 University of California Davis Cancer Center, Sacramento, CA |
| Author_xml | – sequence: 1 givenname: David I. orcidid: 0000-0002-1411-0417 surname: Quinn fullname: Quinn, David I. email: diquinn@usc.edu organization: Division of Oncology, University of Southern California Norris Comprehensive Cancer Center – sequence: 2 givenname: Denice D. surname: Tsao-Wei fullname: Tsao-Wei, Denice D. organization: Biostatistics Core, University of Southern California Norris Comprehensive Cancer Center – sequence: 3 givenname: Przemyslaw surname: Twardowski fullname: Twardowski, Przemyslaw organization: City of Hope Comprehensive Cancer Center, John Wayne Cancer Institute – sequence: 4 givenname: Ana M. surname: Aparicio fullname: Aparicio, Ana M. organization: Division of Oncology, University of Southern California Norris Comprehensive Cancer Center, University of Texas MD Anderson Cancer Center – sequence: 5 givenname: Paul surname: Frankel fullname: Frankel, Paul organization: City of Hope Comprehensive Cancer Center – sequence: 6 givenname: Gurkamal surname: Chatta fullname: Chatta, Gurkamal organization: University of Pittsburgh, Roswell Park Comprehensive Cancer Center – sequence: 7 givenname: John J. surname: Wright fullname: Wright, John J. organization: Clinical Treatment Evaluation Program, National Cancer Institute – sequence: 8 givenname: Susan G. surname: Groshen fullname: Groshen, Susan G. organization: Biostatistics Core, University of Southern California Norris Comprehensive Cancer Center – sequence: 9 givenname: Stella surname: Khoo fullname: Khoo, Stella organization: City of Hope Comprehensive Cancer Center – sequence: 10 givenname: Heinz-Josef surname: Lenz fullname: Lenz, Heinz-Josef organization: Division of Oncology, University of Southern California Norris Comprehensive Cancer Center – sequence: 11 givenname: Primo N. surname: Lara fullname: Lara, Primo N. organization: University of California Davis Cancer Center – sequence: 12 givenname: David R. surname: Gandara fullname: Gandara, David R. organization: University of California Davis Cancer Center – sequence: 13 givenname: Edward surname: Newman fullname: Newman, Edward organization: City of Hope Comprehensive Cancer Center |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33409898$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
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| DOI | 10.1007/s10637-020-01038-6 |
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| Keywords | Urothelial cancer Clinical trial Histone deacetylase inhibitor Bladder cancer |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Feature-1 content type line 23 Conception and design: DIQ, AMA, PF, JJW, SGG, SK, HJL, PNL, DRG, EN. Provision of study materials or patients: DIQ, PT, GK, PNL, DRG Current address: John Wayne Cancer Institute, Santa Monica, CA Data analysis and interpretation: DIQ, DDTW, PT, AMA, GK, PF, SGG, SK, HJL, PNL, EN Manuscript writing: All authors University of Texas MD Anderson Cancer Center, Houston, TX Roswell Park Comprehensive Cancer Center, Buffalo, NY. Final approval of manuscript: All authors Collection and assembly of data: All authors Author Contributions |
| ORCID | 0000-0002-1411-0417 |
| OpenAccessLink | https://www.ncbi.nlm.nih.gov/pmc/articles/11981684 |
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| PublicationDate | 2021-06-01 |
| PublicationDateYYYYMMDD | 2021-06-01 |
| PublicationDate_xml | – month: 06 year: 2021 text: 2021-06-01 day: 01 |
| PublicationDecade | 2020 |
| PublicationPlace | New York |
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| PublicationSubtitle | Novel Anti-Cancer Therapeutics and Therapies |
| PublicationTitle | Investigational new drugs |
| PublicationTitleAbbrev | Invest New Drugs |
| PublicationTitleAlternate | Invest New Drugs |
| PublicationYear | 2021 |
| Publisher | Springer US Springer Nature B.V |
| Publisher_xml | – name: Springer US – name: Springer Nature B.V |
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| Snippet | Summary
Background:
Until the advent of T cell check point inhibitors standard second-line therapy for patients with metastatic urothelial cancer (mUC) was... Until the advent of T cell check point inhibitors standard second-line therapy for patients with metastatic urothelial cancer (mUC) was undefined. Histone... SummaryBackground: Until the advent of T cell check point inhibitors standard second-line therapy for patients with metastatic urothelial cancer (mUC) was... |
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| SubjectTerms | Adult Aged Aged, 80 and over Anticancer properties Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antitumor activity Apoptosis Bladder Bladder cancer Cancer Carcinoma, Transitional Cell - drug therapy Carcinoma, Transitional Cell - mortality Carcinoma, Transitional Cell - pathology Computed tomography Consortia Cytopenia Dosage Female Histone deacetylase Histone Deacetylase Inhibitors - administration & dosage Histone Deacetylase Inhibitors - adverse effects Histones Humans Hydroxamic acid Inhibitors Kaplan-Meier Estimate Lymphocytes Lymphocytes T Magnetic resonance imaging Male Medical imaging Medicine Medicine & Public Health Metastases Metastasis Middle Aged Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - mortality Neoplasm Recurrence, Local - pathology Oncology Pharmacology/Toxicology Phase II Studies Platinum Schedules Survival Therapy Toxicity Transitional cell carcinoma Treatment Outcome Tumor cell lines Urologic Neoplasms - drug therapy Urologic Neoplasms - mortality Urologic Neoplasms - pathology Urothelial cancer Urothelium Urothelium - pathology Vorinostat - administration & dosage Vorinostat - adverse effects |
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| Title | Phase II study of the histone deacetylase inhibitor vorinostat (Suberoylanilide Hydroxamic Acid; SAHA) in recurrent or metastatic transitional cell carcinoma of the urothelium – an NCI-CTEP sponsored: California Cancer Consortium trial, NCI 6879 |
| URI | https://link.springer.com/article/10.1007/s10637-020-01038-6 https://www.ncbi.nlm.nih.gov/pubmed/33409898 https://www.proquest.com/docview/2517674467 https://www.proquest.com/docview/2476126220 https://pubmed.ncbi.nlm.nih.gov/PMC11981684 |
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