BACKGROUND: We aimed to determine duration of response in patients with CTCL treated using DD who experienced partial response, complete clinical response, or complete response. PATIENTS AND METHODS: Data from 3 phase III studies were pooled. Patients received up to 8 courses of 9 or 18 μg/kg intravenous DD daily for 5 days every 21 days, or placebo. Data on DD-treated patients were analyzed by dose and CD25 status. Kaplan-Meier product limit estimates and 95% confidence intervals were calculated for duration of response and time to response. RESULTS: The pooled population comprised 263 DD-treated and 44 placebo-treated patients, and 100 and 7, respectively, had at least a partial response. Median duration of response using DD was 277 days vs. 81 days using placebo. Overall response vs. placebo (n = 7; 16%) as (n = 25; 31%) for DD 9 μg/kg (P = .05), (n = 56; 47%) for DD 18 μg/kg (P = .004), (n = 8; 28%) for re-treated patients (DD 18 μg/kg; P = .21), and (n = 11; 31%) for CD25 low-expression patients (DD 18 μg/kg; P = .14). Overall response rates were similar between patients who did (n = 95; 36%) and did not (n = 105; 40%) develop capillary leak syndrome (CLS); median duration of response was longer in patients who developed CLS, but was not significant (619 vs. 267 days, respectively; P = .28). Adverse events occurred in 98% of DD-treated patients; most frequent were nausea, pyrexia, fatigue, CLS, and rigors. CONCLUSION: These data indicate a durable response with DD in CTCL, even in heavily pretreated patients and those with CD25 low-expression disease.
RCT Entities:
BACKGROUND: We aimed to determine duration of response in patients with CTCL treated using DD who experienced partial response, complete clinical response, or complete response. PATIENTS AND METHODS: Data from 3 phase III studies were pooled. Patients received up to 8 courses of 9 or 18 μg/kg intravenous DD daily for 5 days every 21 days, or placebo. Data on DD-treated patients were analyzed by dose and CD25 status. Kaplan-Meier product limit estimates and 95% confidence intervals were calculated for duration of response and time to response. RESULTS: The pooled population comprised 263 DD-treated and 44 placebo-treated patients, and 100 and 7, respectively, had at least a partial response. Median duration of response using DD was 277 days vs. 81 days using placebo. Overall response vs. placebo (n = 7; 16%) as (n = 25; 31%) for DD 9 μg/kg (P = .05), (n = 56; 47%) for DD 18 μg/kg (P = .004), (n = 8; 28%) for re-treated patients (DD 18 μg/kg; P = .21), and (n = 11; 31%) for CD25 low-expression patients (DD 18 μg/kg; P = .14). Overall response rates were similar between patients who did (n = 95; 36%) and did not (n = 105; 40%) develop capillary leak syndrome (CLS); median duration of response was longer in patients who developed CLS, but was not significant (619 vs. 267 days, respectively; P = .28). Adverse events occurred in 98% of DD-treated patients; most frequent were nausea, pyrexia, fatigue, CLS, and rigors. CONCLUSION: These data indicate a durable response with DD in CTCL, even in heavily pretreated patients and those with CD25 low-expression disease.
Authors: Larisa J Geskin; Oleg E Akilov; Soonyou Kwon; Michael Schowalter; Simon Watkins; Theresa L Whiteside; Lisa H Butterfield; Louis D Falo Journal: Cancer Immunol Immunother Date: 2017-12-04 Impact factor: 6.968
Authors: Arthur E Frankel; Jung H Woo; Chul Ahn; Francine M Foss; Madeleine Duvic; Paul H Neville; David M Neville Journal: Haematologica Date: 2015-03-20 Impact factor: 9.941
Authors: Lise M Lindahl; Simon Fredholm; Claudine Joseph; Boye Schnack Nielsen; Lars Jønson; Andreas Willerslev-Olsen; Maria Gluud; Edda Blümel; David L Petersen; Nina Sibbesen; Tengpeng Hu; Claudia Nastasi; Thorbjørn Krejsgaard; Ditte Jæhger; Jenny L Persson; Nigel Mongan; Mariusz A Wasik; Ivan V Litvinov; Denis Sasseville; Sergei B Koralov; Charlotte M Bonefeld; Carsten Geisler; Anders Woetmann; Elisabeth Ralfkiaer; Lars Iversen; Niels Odum Journal: Oncotarget Date: 2016-07-19