Department of Oncology, University of Torino, Torino, Italy.
Clinical Epidemiology, Città della Salute e della Scienza and Centro di Prevenzione Oncologica (CPO) Piemonte, Torino, Italy.
Blood Adv. 2021 Nov 9;5(21):4504-4514. doi: 10.1182/bloodadvances.2021005150.
The role of consolidation radiotherapy (RT) for bulky lesions is controversial in patients with advanced-stage Hodgkin lymphoma who achieve complete metabolic response (CMR) after doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD)-based chemotherapy. We present the final results of the Fondazione Italiana Linfomi HD0801 trial, which investigated the potential benefit of RT in that setting. In this phase 3 randomized study, patients with a bulky lesion at baseline (a mass with largest diameter ≥5 cm) who have CMR after 2 and 6 ABVD cycles were randomly assigned 1:1 to RT vs observation (OBS) with a primary endpoint of event-free survival (EFS) at 2 years. The sample size was calculated estimating an EFS improvement for RT of 20% (from 60% to 80%). The secondary end point was progression-free survival (PFS). One hundred sixteen patients met the inclusion criteria and were randomly assigned to RT or OBS. Intention-to-treat (ITT) analysis showed a 2-year EFS of 87.8% vs 85.8% for RT vs OBS (hazard ratio [HR], 1.5; 95% confidence interval [CI], 0.6-3.5; P = .34). At 2 years, ITT-PFS was 91.3% vs 85.8% (HR, 1.2; 95% CI, 0.5-3; P = .7). Patients in CMR randomly assigned to OBS had a good outcome, and the primary end point of a 20% benefit in EFS for RT was not met. However, the sample size was underpowered to detect a benefit of 10% or less, keeping open the question of a potential, more limited role of RT in this setting. This trial was registered at www.clinicaltrials.gov as #NCT00784537.
对于接受多柔比星、博来霉素、长春碱、达卡巴嗪（ABVD）为基础的化疗后达到完全代谢缓解（CMR）的晚期霍奇金淋巴瘤患者，巩固性放疗（RT）在大肿块病变中的作用存在争议。我们报告了意大利淋巴瘤基金会 HD0801 试验的最终结果，该试验研究了在这种情况下 RT 的潜在益处。在这项 3 期随机研究中，基线时有大肿块病变（最大直径≥5cm 的肿块）且在 2 和 6 个 ABVD 周期后达到 CMR 的患者，以 1:1 的比例随机分配至 RT 或观察（OBS）组，主要终点为 2 年时的无事件生存（EFS）。根据 RT 改善 EFS 的 20%（从 60%到 80%）来计算样本量。次要终点为无进展生存（PFS）。116 名患者符合纳入标准，并随机分配至 RT 或 OBS 组。意向治疗（ITT）分析显示，RT 组和 OBS 组的 2 年 EFS 分别为 87.8%和 85.8%（危险比[HR]，1.5；95%置信区间[CI]，0.6-3.5；P=.34）。在 2 年时，ITT-PFS 分别为 91.3%和 85.8%（HR，1.2；95% CI，0.5-3；P=.7）。随机分配至 OBS 的 CMR 患者结局良好，且 RT 的 EFS 获益 20%的主要终点未达到。然而，该样本量不足以检测到 10%或更低的获益，因此 RT 在这种情况下的潜在、更有限作用的问题仍然存在。该试验在 www.clinicaltrials.gov 上注册，编号为 #NCT00784537。
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