German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.
Department of Nuclear Medicine, University of Cologne, Cologne, Germany.
Leukemia. 2024 Jan;38(1):160-167. doi: 10.1038/s41375-023-02064-y. Epub 2023 Oct 16.
The primary analysis of the GHSG HD16 trial indicated a significant loss of tumor control with PET-guided omission of radiotherapy (RT) in patients with early-stage favorable Hodgkin lymphoma (HL). This analysis reports long-term outcomes. Overall, 1150 patients aged 18-75 years with newly diagnosed early-stage favorable HL were randomized between standard combined-modality treatment (CMT) (2x ABVD followed by PET/CT [PET-2] and 20 Gy involved-field RT) and PET-2-guided treatment omitting RT in case of PET-2 negativity (Deauville score [DS] < 3). The study aimed at excluding inferiority of PET-2-guided treatment and assessing the prognostic impact of PET-2 in patients receiving CMT. At a median follow-up of 64 months, PET-2-negative patients had a 5-year progression-free survival (PFS) of 94.2% after CMT (n = 328) and 86.7% after ABVD alone (n = 300; HR = 2.05 [1.20-3.51]; p = 0.0072). 5-year OS was 98.3% and 98.8%, respectively (p = 0.14); 4/12 documented deaths were caused by second primary malignancies and only one by HL. Among patients assigned to CMT, 5-year PFS was better in PET-2-negative (n = 353; 94.0%) than in PET-2-positive patients (n = 340; 90.3%; p = 0.012). The difference was more pronounced when using DS4 as cut-off (DS 1-3: n = 571; 94.0% vs. DS ≥ 4: n = 122; 83.6%; p < 0.0001). Taken together, CMT should be considered standard treatment for early-stage favorable HL irrespective of the PET-2-result.
GHSG HD16 试验的主要分析表明，在早期预后良好的霍奇金淋巴瘤（HL）患者中，PET 引导下放疗（RT）的省略显著降低了肿瘤控制率。本分析报告了长期结果。总体而言，1150 名年龄在 18-75 岁之间的新诊断为早期预后良好的 HL 患者被随机分为标准联合治疗（CMT）（2xABVD 后行 PET/CT[PET-2]和 20Gy 受累野 RT）和 PET-2 引导治疗（如果 PET-2 为阴性，则省略 RT）。研究目的是排除 PET-2 引导治疗的劣势，并评估在接受 CMT 的患者中 PET-2 的预后影响。在中位随访 64 个月时，CMT 后 PET-2 阴性患者的 5 年无进展生存率（PFS）为 94.2%（n=328），ABVD 单独治疗后为 86.7%（n=300；HR=2.05[1.20-3.51]；p=0.0072）。5 年 OS 分别为 98.3%和 98.8%（p=0.14）；4/12 例记录的死亡是由第二原发恶性肿瘤引起的，只有 1 例是由 HL 引起的。在接受 CMT 治疗的患者中，PET-2 阴性（n=353）的 5 年 PFS 优于 PET-2 阳性（n=340）（p=0.012）。当使用 DS4 作为截止值时，差异更为明显（DS1-3：n=571；94.0%比 DS≥4：n=122；83.6%；p<0.0001）。总之，CMT 应被视为早期预后良好的 HL 的标准治疗方法，而与 PET-2 结果无关。
