University of Iowa Hospitals and Clinics, Iowa City, IA, USA.
J Clin Oncol. 2010 Jun 20;28(18):3035-41. doi: 10.1200/JCO.2009.27.8325. Epub 2010 May 10.
The efficacy and safety of cyclophosphamide, vincristine, and prednisone (CVP) followed by tositumomab and iodine-131 ((131)I) -tositumomab therapy were evaluated in a multicenter phase II study in patients with untreated low-grade follicular lymphoma.
Patients received six cycles of CVP followed by one cycle of tositumomab and (131)I-tositumomab (one dosimetric dose and one therapeutic dose). The treatment was evaluated for efficacy and safety.
All 30 patients enrolled completed CVP as well as tositumomab and (131)I-tositumomab therapy. The overall response rate after completion of therapy was 100%, with 28 patients (93%) achieving a complete response (CR) and two patients achieving a partial response. Of the 17 patients with bone marrow involvement at enrollment, 15 achieved a confirmed CR. Fourteen of 15 patients with bulky disease (> or = 5 cm) had a CR after treatment completion. After a median follow-up of 8.4 years, the median response duration had not been reached (range, 3 to 111+ months). Five-year progression-free and overall survival rates were 56% and 83%, respectively. The most common grade > or = 3 hematologic adverse events were neutropenia (87%) and thrombocytopenia (37%). Nineteen patients received growth factor support, and three required blood product transfusions. No patients developed human antimurine antibodies. Two patients developed myelodysplastic syndrome/acute myeloid leukemia.
These mature data demonstrate that sequential therapy with a non-anthracycline-containing regimen comprising CVP followed by one cycle of tositumomab and (131)I-tositumomab produced high response rates with adequate safety and durable remissions and that this regimen represents a highly active treatment for first-line therapy of follicular non-Hodgkin's lymphoma.
在一项多中心 II 期研究中，评估了环磷酰胺、长春新碱和泼尼松（CVP）序贯替西莫单抗和碘-131（131I）-替西莫单抗治疗未经治疗的低级别滤泡性淋巴瘤患者的疗效和安全性。
患者接受了六个周期的 CVP 治疗，随后接受了一个周期的替西莫单抗和 131I-替西莫单抗（一个剂量测定剂量和一个治疗剂量）治疗。评估了治疗的疗效和安全性。
所有 30 名入组患者均完成了 CVP 以及替西莫单抗和 131I-替西莫单抗治疗。完成治疗后的总缓解率为 100%，28 名患者（93%）达到完全缓解（CR），2 名患者达到部分缓解。在入组时有骨髓受累的 17 名患者中，15 名患者获得了确认的 CR。在 15 名有大块疾病（>或=5cm）的患者中，有 14 名患者在治疗完成后获得了 CR。在中位随访 8.4 年后，中位缓解持续时间未达到（范围，3 至 111+个月）。5 年无进展生存和总生存率分别为 56%和 83%。最常见的>或=3 级血液学不良事件是中性粒细胞减少症（87%）和血小板减少症（37%）。19 名患者接受了生长因子支持，3 名患者需要输血。没有患者产生人抗鼠抗体。两名患者发生骨髓增生异常综合征/急性髓系白血病。
这些成熟的数据表明，非蒽环类药物包含的 CVP 序贯治疗方案，随后是一个周期的替西莫单抗和 131I-替西莫单抗，产生了高缓解率，安全性良好，缓解持久，并且该方案代表了滤泡性非霍奇金淋巴瘤一线治疗的一种高度活跃的治疗方法。
