Pralatrexate Alone or in Combination With Bexarotene: Long-Term Tolerability in Relapsed/Refractory Mycosis Fungoides
Pralatrexate Alone or in Combination With Bexarotene: Long-Term Tolerability in Relapsed/Refractory Mycosis Fungoides
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DOI：
10.1016/j.clml.2014.01.010
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发表时间：
2014-08-01
影响因子：
2.7
通讯作者：
Duvic, Madeleine
中科院分区：
文献类型：
--
作者：
Talpur, Raldishandra;Thompson, Andrew;Duvic, Madeleine
本研究评估了普拉曲沙单药或与口服贝沙罗汀联合治疗10例晚期复发性或难治性蕈样肉芽肿（MF）患者的长期耐受性。中位缓解持续时间为26.75周。该研究表明，普拉曲沙单药或与口服贝沙罗汀联合给药耐受性良好，能够产生长期反应。背景资料：本研究旨在评估普拉曲沙单药或与口服贝沙罗汀联合治疗复发性或难治性蕈样肉芽肿（MF）的长期耐受性。患者和方法：本报告中的MF患者参与了2项多中心试验中的1项。在剂量范围探索I/II期研究期间，受试者单独接受普拉曲沙治疗3/4周。在第二个I/II期剂量范围组合试验中，受试者接受普拉曲沙15 mg/m2/wk治疗3/4周，同时每日口服150 - 300 mg/m2的贝沙罗汀。结果：26例患者入组本中心，其中12例接受普拉曲沙治疗，14例接受普拉曲沙+贝沙罗汀治疗。12例接受普拉曲沙单药治疗的患者中有4例（33%）有应答。在14例接受贝沙罗汀联合普拉曲沙治疗的患者中，7例（50%）有反应。10例受试者的中位年龄为71岁（范围：41-82岁），接受了超过9个周期的普拉曲沙治疗，其中3例接受普拉曲沙治疗，7例接受联合治疗。中位至缓解时间为15.75周（范围：4-24周），中位缓解持续时间为26.75周（范围：8.5-49.5周）。最常见的不良事件（AE）为8例（80%）患者的粘膜炎。任何级别的其他AE包括关节痛（n = 1）、头痛（n = 1）、中性粒细胞减少症（n = 5）和皮肤坏死（n = 2）。两名患者最初患有对治疗有反应的小腿肿瘤，留下残留的慢性腿部溃疡。结论：普拉曲沙单药或与低剂量口服贝沙罗汀联合给药耐受性良好，能够为高龄晚期MF患者提供长期缓解。
The current study assessed the long-term tolerability of pralatrexate alone or in combination with oral bexarotene in the treatment of 10 responding individuals with advanced-stage relapsed or refractory mycosis fungoides (MF). The median duration of response was 26.75 weeks. The study demonstrated that pralatrexate alone or in combination with oral bexarotene is well tolerated and capable of producing long-term responses. 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.