Combined PET and ctDNA response as a predictor of POD24 for follicular lymphoma after first-line induction treatment.

A representative cohort of 141 patients from the RELEVANCE phase 3 trial with both available serum samples for ctDNA testing and PET images at randomization and at EOI (week 24) was investigated.

研究了RELEVANCE第三阶段试验中具有可用血清样本进行ctDNA检测和随机化时以及EOI（第24周）时PET图像的141名代表性患者队列。

Twelve percent were POD24. ctDNA was analyzed using a customized 130-kilobase capture panel, with phased variant (PV) enriched regions representing 39% of the panel. ctDNA was detected in 140 patients (99.3%) at baseline.

12%的患者为POD24。使用定制的130千碱基捕获面板分析循环肿瘤DNA（ctDNA），其中相位变异（PV）富集区域占面板的39%。在基线时，140名患者（99.3%）检测到ctDNA。

To optimize specificity, only PVs, found in 124 patients (88%), were considered for ctDNA MRD assessment at EOI.

为了优化特异性，只有在124名患者（88%）中发现的PVs，才被考虑用于EOI时的ctDNA微小残留病（MRD）评估。

Median progression-free survival(PFS) from EOI was not reached (NR) for the 112 patients with undetected ctDNA at EOI vs 17.7 months (95% confidence interval[CI], 1.4 to NR) for patients with positive ctDNA (MRD+) (P = .0038).

从研究结束时起算的中位无进展生存期（PFS）对于112名研究结束时未检测到循环肿瘤DNA（ctDNA）的患者尚未达到（NR），而对于循环肿瘤微小残留病灶（MRD+）阳性患者为17.7个月（95%置信区间[CI]，1.4至未达到）（P = .0038）。

Similarly, median PFS was NR for the 104 patients with undetected disease on PET at EOI vs 28.3 months (95% CI, 2.9 to NR; P = .0002) for patients with PET positivity.

同样，对于研究结束时正电子发射断层扫描（PET）未检测到疾病的104名患者，中位PFS尚未达到（NR），而对于PET阳性患者为28.3个月（95% CI, 2.9至未达到；P = .0002）。

Both tests had a negative predictive value (NPV) of >90% for POD24.

两种检测对POD24的阴性预测值(NPV)均>90%。

The positive predictive value was 58.3% for ctDNA MRD and 45% for PET but increased to 85.7% when both parameters were combined, without alteration of NPV.

ctDNA MRD的阳性预测值为58.3%，PET为45%，但当两者结合时，阳性预测值提高到85.7%，而NPV保持不变。

These data show that the combination of PET response and ctDNA MRD at EOI allows an early prediction of POD24, which may lead to a preemptive treatment decision.

这些数据表明，在治疗结束时（EOI）结合PET反应和循环肿瘤DNA（ctDNA）微小残留病（MRD）的评估可以早期预测24个月无进展生存（POD24），这可能导致预先采取治疗决策。

This trial was registered at www.clinicaltrials.gov as #NCT01650701.

这项试验已在www.clinicaltrials.gov上注册，注册号为#NCT01650701。