Phase II study of the histone deacetylase inhibitor vorinostat (Suberoylanilide Hydroxamic Acid; SAHA) in recurrent or metastatic transitional cell carcinoma ... View Full Text


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Article Info

DATE

2021-01-06

AUTHORS

David I. Quinn, Denice D. Tsao-Wei, Przemyslaw Twardowski, Ana M. Aparicio, Paul Frankel, Gurkamal Chatta, John J. Wright, Susan G. Groshen, Stella Khoo, Heinz-Josef Lenz, Primo N. Lara, David R. Gandara, Edward Newman

ABSTRACT

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. More... »

PAGES

812-820

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10637-020-01038-6

DOI

http://dx.doi.org/10.1007/s10637-020-01038-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1134394539

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/33409898


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29 schema:description 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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36 California Cancer Consortium Trial
37 Caucasians
38 Consortium Trial
39 HDACi vorinostat
40 II study
41 Karnofsky performance status
42 NCI-CTEP
43 Pt
44 RECIST response rate
45 accruals
46 activity
47 advanced disease
48 advent
49 age 66
50 anti-cancer activity
51 apoptosis
52 bladder cancer cell lines
53 bleeding
54 cancer
55 cancer cell lines
56 carcinoma
57 cell carcinoma
58 cell lines
59 cycle
60 deacetylase inhibitors
61 design
62 disease
63 disease-free survival
64 efficacy
65 end point
66 first stage
67 first-line platinum-based therapy
68 good response
69 grade 3 toxicity
70 grade 4
71 grade 5 toxicity
72 histone deacetylase inhibitor vorinostat
73 histone deacetylase inhibitors
74 imaging
75 inhibitor vorinostat
76 inhibitors
77 lines
78 males
79 median age 66
80 median disease-free survival
81 median number
82 metastatic transitional cell carcinoma
83 metastatic urothelial cancer
84 model
85 modulation
86 modulation of apoptosis
87 months
88 neoadjuvant setting
89 number
90 overall survival time
91 patients
92 performance status
93 phase II study
94 platinum-based therapy
95 point
96 primary end point
97 progression
98 rate
99 ratio
100 recurrent
101 response
102 response rate
103 risk
104 scan imaging
105 second-line therapy
106 setting
107 significant toxicity
108 stable disease
109 stage
110 standard second-line therapy
111 status
112 study
113 subjects
114 survival
115 survival time
116 therapy
117 thrombocytopenic bleeding
118 time
119 total
120 toxicity
121 transitional cell carcinoma
122 treatment
123 trials
124 tumor model
125 unacceptable toxicity
126 unfavorable risk
127 urothelial cancer
128 urothelium
129 variety
130 vorinostat
131 weeks
132 years
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