Validation of the newly introduced Deauville score 5a for patients treated for advanced-stage classic Hodgkin lymphoma.

We investigated whether this improves prognostic discrimination at interim positron emission tomography (PET) after 2 cycles (PET-2) in patients with advanced-stage classical Hodgkin lymphoma (AS-cHL) treated in recent German Hodgkin Study Group randomized phase 3 trials.

我们研究了这是否能在最近的德国霍奇金研究组随机III期试验中，对接受治疗的晚期经典霍奇金淋巴瘤（AS-cHL）患者，在两个周期后的中期正电子发射断层扫描（PET-2）时改善预后鉴别。

The primary analysis cohort was HD18 postamendment standard arms (uniform treatment with 6 cycles of escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone [eBEACOPP]); sensitivity cohorts were HD18 intention-to-treatand HD21 eBEACOPP and brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone arms.

主要分析队列是HD18修正后的标准治疗组（统一治疗方案为6个周期的增加剂量的博莱霉素、依托泊苷、阿霉素、环磷酰胺、长春新碱、丙卡巴肼和泼尼松[eBEACOPP]）；敏感性队列包括HD18意向治疗组和HD21的eBEACOPP和布雷替尼单抗、依托泊苷、环磷酰胺、阿霉素、达卡巴嗪和地塞米松治疗组。

Progression-free survival(PFS) was analyzed by landmark Cox models starting at PET-2.

从PET-2开始，通过里程碑式的Cox模型分析无进展生存期（PFS）。

DS5a was infrequent (4%-6% across cohorts; 39/639, 67/1745, 33/568, and 29/560).

DS5a的发生率较低（各队列中为4%-6%；639例中有39例，1745例中有67例，568例中有33例，560例中有29例）。

In the primary cohort, DS5 was associated with inferior PFS vs DS1 to DS3 (hazard ratio[HR], 3.00; 95% confidence interval[CI], 1.25-7.23) and vs DS1 to DS4 (HR, 2.35; 95% CI, 1.01-5.50).

在主要队列中，DS5与DS1至DS3（风险比[HR]，3.00；95%置信区间[CI]，1.25-7.23）和DS1至DS4（HR，2.35；95% CI，1.01-5.50）相比，无进展生存期（PFS）较差。

Across sensitivity cohorts, DS5a remained adverse compared with DS1 to DS4 (HR range, 2.57-5.47), whereas DS4 according to the new definition did not consistently separate from DS1 to DS3, which is likely a result of PET-adapted treatment.

在敏感性队列中，DS5a与DS1至DS4相比仍然不利（HR范围，2.57-5.47），而根据新定义的DS4与DS1至DS3相比并没有一致地区分开来，这可能是由于PET适应性治疗的结果。

Overall survivaltrends were concordant, but interpretation is limited by few events.

总体生存趋势是一致的，但由于事件较少，解释受到限制。

To our knowledge, this is the first prognostic validation of the refined DS in prospectively randomized trial populations.

据我们所知，这是首次在前瞻性随机试验人群中对细化的DS进行预后验证。

The newly introduced DS5a isolates a small high-risk AS-cHL, which further supports risk assessment and adaptation using quantitative biomarkers from PET.

新引入的DS5a分离出一小部分高风险的AS-cHL，这进一步支持了使用PET定量生物标志物进行风险评估和适应。

The HD18 and HD21 trials were registered at www.clinicaltrials.gov as NCT00515554 and NCT02661503, respectively.

HD18和HD21试验已在www.clinicaltrials.gov上注册，注册号分别为NCT00515554和NCT02661503。