Kumar Anita, Casulo Carla, Yahalom Joachim, Schöder Heiko, Barr Paul M, Caron Philip, Chiu April, Constine Louis S, Drullinsky Pamela, Friedberg Jonathan W, Gerecitano John F, Hamilton Audrey, Hamlin Paul A, Horwitz Steven M, Jacob Alexandra G, Matasar Matthew J, McArthur Gianna N, McCall Susan J, Moskowitz Alison J, Noy Ariela, Palomba Maria L, Portlock Carol S, Straus David J, VanderEls Nicholas, Verwys Stephanie L, Yang Joanna, Younes Anas, Zelenetz Andrew D, Zhang Zhigang, Moskowitz Craig H
Memorial Sloan Kettering Cancer Center, New York, NY; and.
Wilmot Cancer Institute, University of Rochester, Rochester, NY.
Blood. 2016 Sep 15;128(11):1458-64. doi: 10.1182/blood-2016-03-703470. Epub 2016 Jul 25.
This multicenter pilot study assessed the safety and efficacy of brentuximab vedotin (BV) and AVD (adriamycin, vinblastine, and dacarbazine) followed by 30 Gy involved site radiation therapy (ISRT). Patients with newly diagnosed, early stage classical Hodgkin lymphoma (HL) with unfavorable-risk features were treated with 4 cycles of BV and AVD. Patients who achieved a negative positron emission tomography (PET) scan (Deauville score of 1-3) received 30 Gy ISRT. Thirty patients received treatment and were assessable for toxicity. Twenty-nine patients completed 4 cycles of BV + AVD, and 25 patients BV + AVD + 30 Gy ISRT. No clinically significant noninfectious pneumonitis was observed. Serious adverse events (≥grade 3) were reported in 4 patients, including febrile neutropenia, peripheral neuropathy, and hypertension. After 2 and 4 cycles of BV + AVD, 90% (26 of 29) and 93% (27 or 29) of patients achieved a negative PET scan, respectively. Two patients with biopsy-proven primary refractory HL were treated off-study. All 25 patients who completed BV + AVD + ISRT achieved a complete response. With a median follow-up of 18.8 months, by intent to treat, the 1-year progression-free survival is 93.3% (95% confidence interval, 84-102). Overall, the treatment was well-tolerated with no evidence of significant pulmonary toxicity. The majority of patients (≥90%) achieved negative interim PET scans after 2 and 4 cycles of BV + AVD. Excluding the 2 primary refractory patients, all patients are disease free, suggesting that this is a highly active treatment program even in patients with substantial disease bulk. This trial was registered at www.clinicaltrials.gov as #NCT01868451.
这项多中心前瞻性研究评估了本妥昔单抗（BV）和AVD（阿霉素、长春花碱和达卡巴嗪）联合30 Gy受累部位放射治疗（ISRT）的安全性和有效性。新诊断的、具有不良风险特征的早期经典型霍奇金淋巴瘤（HL）患者接受4个周期的BV和AVD治疗。正电子发射断层扫描（PET）扫描结果为阴性（迪厄多内评分1 - 3分）的患者接受30 Gy的ISRT。30例患者接受了治疗并可评估毒性。29例患者完成了4个周期的BV + AVD治疗，25例患者完成了BV + AVD + 30 Gy ISRT治疗。未观察到具有临床意义的非感染性肺炎。4例患者报告了严重不良事件（≥3级），包括发热性中性粒细胞减少、周围神经病变和高血压。在BV + AVD治疗2个周期和4个周期后，分别有90%（29例中的26例）和93%（29例中的27例）的患者PET扫描结果为阴性。2例经活检证实为原发性难治性HL的患者未按研究方案接受治疗。所有25例完成BV + AVD + ISRT治疗的患者均获得完全缓解。中位随访时间为18.8个月，按意向性治疗分析，1年无进展生存率为93.3%（95%置信区间，84 - 102）。总体而言，该治疗耐受性良好，无明显肺部毒性证据。大多数患者（≥90%）在BV + AVD治疗2个周期和4个周期后中期PET扫描结果为阴性。排除2例原发性难治性患者后，所有患者均无疾病，这表明即使对于疾病负荷较大的患者，该治疗方案也具有很高的活性。该试验已在www.clinicaltrials.gov上注册，注册号为#NCT01868451。
