Fludarabine, mitoxantrone, and dexamethasone: An effective new regimen for indolent lymphoma
Fludarabine, mitoxantrone, and dexamethasone: An effective new regimen for indolent lymphoma
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DOI：
10.1200/jco.1996.14.4.1262
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发表时间：
1996-04-01
影响因子：
45.3
通讯作者：
Cabanillas, F
中科院分区：
文献类型：
--
作者：
McLaughlin, P;Hagemeister, FB;Cabanillas, F
目的：虽然大多数惰性淋巴瘤患者对初始治疗有反应，但几乎所有患者都会复发。二次治疗通常是有益的，但反应很少是持久的。我们进行了这项II期试验，以评估氟达拉滨、米托蒽醌和地塞米松（FND）对复发性惰性淋巴瘤患者的治疗效果和毒性。患者和方法：51例复发性或难治性无痛淋巴瘤患者接受氟达拉滨25mg /m(2)/d静脉滴注（IV）治疗，第1 ~ 3天；米托蒽醌10mg /m(2) IV治疗，第1 ~ 5天；地塞米松20mg /d IV或口服治疗。治疗每4周重复一次，最多8个疗程。在试验后期，甲氧苄啶-磺胺甲恶唑（TMP-SMX）被纳入卡氏肺囊虫（PCP）预防。结果：完全缓解（CR） 24例（47%），部分缓解（PR） 24例（47%）。CR患者的中位无衰竭生存期为21个月，PR患者的中位无衰竭生存期为9个月。FND的显著活性甚至见于老年人、血清乳酸脱氢酶（LDH）或β(2)-微球蛋白水平较高的患者，以及既往接受过多种治疗方案的患者。主要毒性作用为骨髓抑制和感染；其他毒性作用不大。12%的疗程发生感染。几乎一半的感染被证实或怀疑是机会性感染，包括6例皮肤疱疹试验和2例经证实的PCP肺炎。结论：FND联合治疗在复发或复发的无痛性淋巴瘤患者中高度活跃，导致高比例的cr。由于存在机会性感染的风险，我们目前建议使用TMP-SMX进行预防，并建议对发生机会性感染的患者停用皮质类固醇。(C)美国临床肿瘤学会1996。
Purpose: Although most patients with indolent lymphomas respond to initial therapy, virtually all experience relapse. Secondary therapy is often beneficial, but responses are rarely, if ever, durable. We conducted this phase II trial to evaluate the therapeutic efficacy and toxicity of fludarabine, mitoxantrone, and dexamethasone (FND) in patients with relapsed indolent lymphoma.Patients and Methods: Fifty-one patients with recurrent or refractory indolent lymphoma were treated with a regimen of fludarabine 25 mg/m(2)/d intravenously (IV) on days 1 to 3, mitoxantrone 10 mg/m(2) IV on day 1, and dexamethasone 20 mg/d IV or orally on days 1 to 5. Treatment was repeated at 4-week intervals for a maximum of eight courses. Late in the course of this trial, trimethoprim-sulfamethoxazole (TMP-SMX) was incorporated for Pneumocystis carinii (PCP) prophylaxis.Results: Responses were complete (CR) in 24 patients (47%) and partial (PR) in 24 (47%). The median failure-free survival time was 21 months for CR patients and 9 months for PR patients. Notable activity of FND was seen even in the elderly, in those with high serum lactate dehydrogenase (LDH) or beta(2)-microglobulin levels, and in those with multiple prior treatment regimens. The predominant toxic effects were myelosuppression and infections; other toxic effects were modest. Infections occurred in 12% of courses. Almost half of the infections were proven or suspected opportunistic infections, including six cases of dermatomal herpes tester and two cases of proven PCP pneumonia.Conclusion: The FND combination is highly active in patients recurrent or relapsed indolent lymphoma and results in a high percentage of CRs. Because of the risk of opportunistic infections, we currently recommend prophylaxis with TMP-SMX and advise deletion of corticosteroids for patients who develop opportunistic infections. (C) 1996 by American Society of Clinical Oncology.