Results of a phase II study of vorinostat in combination with intravenous fludarabine, mitoxantrone, and dexamethasone in patients with relapsed or refractory mantle cell lymphoma: an interim analysis
- Authors
- Shin, Dong-Yeop; Kim, Seok Jin; Yoon, Dok Hyun; Park, Yong; Kong, Jee Hyun; Kim, Jeong-A; Kim, Byung-Su; Kim, Hyo Jung; Won, Jong-Ho; Park, Sung-Kyu; Kim, Won Seog
- Issue Date
- Apr-2016
- Publisher
- SPRINGER
- Keywords
- Mantle cell lymphoma; Phase II; Relapsed lymphoma; Vorinostat
- Citation
- CANCER CHEMOTHERAPY AND PHARMACOLOGY, v.77, no.4, pp 865 - 873
- Pages
- 9
- Indexed
- SCI
SCIE
SCOPUS
- Journal Title
- CANCER CHEMOTHERAPY AND PHARMACOLOGY
- Volume
- 77
- Number
- 4
- Start Page
- 865
- End Page
- 873
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/29726
- DOI
- 10.1007/s00280-016-3005-y
- ISSN
- 0344-5704
1432-0843
- Abstract
- Mantle cell lymphoma (MCL) is a disease that frequently relapses and primarily affects elderly people. We performed an open-label, multi-center, phase II study to investigate the effect and quality of life (QoL) of treatment with vorinostat in combination with fludarabine, mitoxantrone and dexamethasone (V-FND) for relapsed or refractory MCL. The treatment schedule was composed of four cycles of induction treatment with V-FND and subsequent consolidation therapy involving autologous hematopoietic stem cell transplantation or six cycles of vorinostat maintenance. QoL was assessed using EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) every 2 cycles. Data from a total of 20 patients were collected for an interim analysis. The median age was 67 years (range 49-75), and 14 or the patients (70 %) were male. The full course of V-FND induction treatment was completed in 11 patients, but only three completed all six cycles of maintenance therapy. Response to V-FND was not available in two patients. Among the other 18 patients, the objective response rate was 77.8 % (complete response in five patients + partial response in nine patients). Median progression-free survival was 9.3 months [95 % confidence interval (CI) 4.0-12.3]. Fifteen patients (75 %) experienced grade 3/4 toxicities. Analysis of QoL demonstrated significant deterioration of social functioning (p = 0.01), and significant aggravation of fatigue and nausea/vomiting (p = 0.04 and 0.01, respectively) after two cycles of V-FND induction. V-FND is effective in patients with relapsed or refractory MCL. However, significant toxicities were hurdles to sustained V-FND therapy.
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Collections - 2. Clinical Science > Department of Medical Oncology and Hematology > 1. Journal Articles
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