Nastoupil Loretta J, McLaughlin Peter, Feng Lei, Neelapu Sattva S, Samaniego Felipe, Hagemeister Fredrick B, Ayala Ana, Romaguera Jorge E, Goy Andre H, Neal Eleanor, Wang Michael, Fayad Luis, Fanale Michelle A, Oki Yasuhiro, Westin Jason R, Rodriguez Maria A, Cabanillas Fernando, Fowler Nathan H
Department of Lymphoma and Myeloma, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.
Department of Biostatistics, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.
Br J Haematol. 2017 Apr;177(2):263-270. doi: 10.1111/bjh.14541. Epub 2017 Mar 24.
We report a single-centre, randomized study evaluating the efficacy and safety of concurrent fludarabine, mitoxantrone, dexamethasone (FND) and rituximab versus sequential FND followed by rituximab in 158 patients with advanced stage, previously untreated indolent lymphoma, enrolled between 1997 and 2002. Patients were randomized to 6-8 cycles of FND followed by 6 monthly doses of rituximab or 6 doses of rituximab given concurrently with FND. All patients who achieved at least a partial response received 12 months of interferon (IFN) maintenance. Median ages were 54 and 55 years. The two groups were comparable with the exception of a higher percentage of females (65% vs. 43%) and baseline anaemia (23% vs. 11%) in the FND followed by rituximab group. Complete response/unconfirmed complete response rates were 89% and 93%. The most frequent grade ≥ 3 toxicity was neutropenia (86% vs. 96%). Neutropenic fever occurred in 21% and 16%. Late toxicity included myelodysplastic syndrome (n = 3) and acute myeloid leukaemia (n = 5). With 12·5 years of follow-up, no significant differences based on treatment schedule were observed. 10-year overall survival estimates were 76% and 73%. 10-year progression-free survival estimates were 52% and 51%. FND with concurrent or sequential rituximab, and IFN maintenance in indolent lymphoma demonstrated high response rates and robust survival.
我们报告了一项单中心随机研究，该研究评估了氟达拉滨、米托蒽醌、地塞米松（FND）与利妥昔单抗联合使用，对比序贯使用FND后再使用利妥昔单抗，对158例晚期、既往未接受治疗的惰性淋巴瘤患者的疗效和安全性。这些患者于1997年至2002年入组。患者被随机分为接受6 - 8个周期的FND治疗，随后每月接受6次利妥昔单抗治疗，或6次利妥昔单抗与FND同时给药。所有至少达到部分缓解的患者接受12个月的干扰素（IFN）维持治疗。中位年龄分别为54岁和55岁。两组具有可比性，只是在序贯使用FND后再使用利妥昔单抗的组中，女性比例更高（65%对43%），且基线贫血发生率更高（23%对11%）。完全缓解/未确认的完全缓解率分别为89%和93%。最常见的≥3级毒性是中性粒细胞减少（86%对96%）。中性粒细胞减少性发热发生率分别为21%和16%。晚期毒性包括骨髓增生异常综合征（n = 3）和急性髓系白血病（n = 5）。经过12.5年的随访，未观察到基于治疗方案的显著差异。10年总生存估计分别为76%和73%。10年无进展生存估计分别为52%和51%。FND联合或序贯使用利妥昔单抗，并使用IFN维持治疗惰性淋巴瘤显示出高缓解率和良好的生存率。
