Garay G, Dupont J, Dragosky M, Nucifora E, Cacchione R, Schnidrig P, Fernández J, Riveros D, Noviello V, Bèguelin R, Campestri R, Albera C, Nicastro M, Triguboff E
CEMIC: Centro de Educación Médica e Investigación Clínica, Universidad Nacional de Buenos, Buenos Aires, Argentina.
Leuk Lymphoma. 1997 Aug;26(5-6):595-602. doi: 10.3109/10428199709050895.
In this study, 54 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were treated in a phase II, multicentric trial with ifosfamide-mesna 1500 mg/m2 IV days 1-3, idarubicin 12 mg/m2 IV day 1 and etoposide 100 mg/m2 IV day 1-3 (MIZE). Overall response was 72%; complete response (CR) and partial response (PR) were 46% and 26% respectively. In Stage I-II pts CR was 59% and in Stage III-IV pts CR was 40.5%. Patients who relapsed from an initial CR had a 64% CR rate when treated with MIZE, in contrast to refractory disease's patients who only had 19% CR (p = 0.004). The group of pts that had an objective response (CR + PR) to front line therapy had a 2 year survival rate of 55% compared with none for refractory disease (p = 0.029) after salvage therapy. Median survival for the entire group was 17.5 months. Better survival was seen in pts who were asymptomatic with low levels of LDH, previous CR, non high-grade histology, and limited disease stage at relapse. Toxicity was mainly hematologic: 91.5% had neutropenia, (56.5% grade III-IV), and 9.5% died from infectious complications. Other clinical toxicities including cardiac toxicity were negligible. MIZE chemotherapy was effective in patients with relapsed and refractory lymphoma and showed limited clinical and cardiac toxicity. Myelosupression was the most frequent single toxicity.
在本研究中,54例复发或难治性非霍奇金淋巴瘤(NHL)患者在一项II期多中心试验中接受了如下治疗:异环磷酰胺-美司钠1500mg/m²静脉滴注,第1 - 3天;伊达比星12mg/m²静脉滴注,第1天;依托泊苷100mg/m²静脉滴注,第1 - 3天(MIZE方案)。总缓解率为72%;完全缓解(CR)和部分缓解(PR)分别为46%和26%。I - II期患者的CR率为59%,III - IV期患者的CR率为40.5%。初始CR后复发的患者接受MIZE方案治疗时CR率为64%,而难治性疾病患者的CR率仅为19%(p = 0.004)。对一线治疗有客观缓解(CR + PR)的患者组在挽救治疗后的2年生存率为55%,而难治性疾病患者则无生存率(p = 0.029)。整个组的中位生存期为17.5个月。在无症状、乳酸脱氢酶水平低、既往CR、非高级别组织学且复发时疾病分期局限的患者中观察到更好的生存情况。毒性主要为血液学毒性:91.5%的患者有中性粒细胞减少(56.5%为III - IV级),9.5%的患者死于感染性并发症。包括心脏毒性在内的其他临床毒性可忽略不计。MIZE化疗对复发和难治性淋巴瘤患者有效,且临床和心脏毒性有限。骨髓抑制是最常见的单一毒性。