Pralatrexate Alone or in Combination With Bexarotene: Long-Term Tolerability in Relapsed/Refractory Mycosis Fungoides
Autor: | Pamela Gangar, Andrew Thompson, Rakhshandra Talpur, Madeleine Duvic |
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Rok vydání: | 2014 |
Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Tetrahydronaphthalenes Combination therapy Refractory Mycosis Fungoides Neutropenia Gastroenterology Mycosis Fungoides Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Mucositis Humans Aged Retrospective Studies Aged 80 and over Bexarotene Mycosis fungoides business.industry Pralatrexate Hematology Middle Aged medicine.disease Dermatology Aminopterin Treatment Outcome Oncology Tolerability Female Neoplasm Recurrence Local business medicine.drug |
Zdroj: | Clinical Lymphoma Myeloma and Leukemia. 14:297-304 |
ISSN: | 2152-2650 |
DOI: | 10.1016/j.clml.2014.01.010 |
Popis: | Background This study aimed to assess the long-term tolerability of pralatrexate alone or in combination with oral bexarotene for relapsed or refractory mycosis fungoides (MF). Patients and Methods Patients with MF in this report were participants in 1 of 2 multicenter trials. During the dose-ranging phase I/II study, participants were treated with pralatrexate alone for 3 of 4 weeks. During a second phase I/II dose-ranging combination trial, participants were treated with pralatrexate at 15 mg/m 2 /wk for 3 of 4 weeks combined with 150 to 300 mg/m 2 of daily oral bexarotene. Results Twenty-six patients were enrolled at our center, including 12 receiving pralatrexate and 14 receiving pralatrexate plus bexarotene. Four of 12 patients (33%) treated with pralatrexate alone responded. Of 14 patients treated with bexarotene plus pralatrexate, 7 (50%) responded. Ten participants, with a median age of 71 years (range, 41-82 years), received more than 9 cycles of pralatrexate, including 3 receiving pralatrexate and 7 receiving combination therapy. Median time to response was 15.75 weeks (range, 4-24 weeks), and the median duration of response was 26.75 weeks (range, 8.5-49.5 weeks). The most common adverse event (AE) was mucositis in 8 (80%) patients. Other AEs of any grade included arthralgias (n = 1), headache (n = 1), neutropenia (n = 5), and skin necrosis (n = 2). Two patients initially had lower leg tumors that responded to therapy, leaving residual chronic leg ulcers. Conclusion Pralatrexate alone or in combination with low-dose oral bexarotene is well tolerated and capable of providing long-term responses in patients of advanced age with advanced-stage MF. |
Databáze: | OpenAIRE |
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