美国《临床肿瘤学杂志》：派姆单抗可治愈这种类型的癌症病人

美国《临床肿瘤学杂志》2017年12月28日在线先发

http://ascopubs.org/doi/full/10.1200/JCO.2017.75.6270

目的

派姆单抗（pembrolizumab）可使转移性黑色素瘤患者获得持续性的抗肿瘤疗效，大约有15%的患者会完全缓解，但对完全缓解的预测因素以及获得完全缓解中断派姆单抗治疗后患者转归的预测因素如何，这些数据资料有限。为此，我们对KEYNOTE-001研究（ClinicalTrials.gov identifier: NCT01295827）用派姆单抗治疗后完全缓解的患者进行了基线特征和长期随访的研究。

患者与方法

晚期/转移性黑色素瘤患者不论是否进行过伊匹单抗（ipilimumab）治疗，接受了3种剂量派姆单抗治疗方案中的一种，接受派姆单抗≥6个月、且确定完全缓解后至少做了两次派姆单抗治疗为符合条件的患者，就可以中断治疗。按照“实体瘤疗效评价标准1.1版”每12周集中评价一次缓解情况。对于本次分析，按照研究者评估和免疫相关性缓解标准确定是否完全缓解，采用单因素和多因素分析对完全缓解的潜在预测因素进行评价。

结果

655名治疗过的患者中，中位随访43个月后，105名（16.0%）获得了完全缓解。在数据截止日，自首次完全缓解到中位随访30个月，有92名（87.6%）患者完全缓解。14名（13.3%）患者继续接受了中位值≥40个月的治疗。91名患者中断了派姆单抗治疗，包括67名（63.8%）进入观察组而没有其它抗癌治疗。自完全缓解开始，所有完全缓解的105名患者，24个月的无病生存率为90.9%，完全缓解后中断派姆单抗治疗而进行观察的67名患者，24个月的无病生存率为89.9%。通过单因素分析发现，在入组因素中，肿瘤大小和程序性死亡配体1（PD-L1）表达情况与完全缓解独立相关。

结论

转移性黑色素瘤患者中断派姆单抗治疗能够获得持续的完全缓解，大约自派姆单抗中断治疗后2年的中位随访期后，复发的发生率低，这为有些患者的治愈带来了希望。持续完全缓解的机制需要进一步研究。

《壹篇》南南和北北

Purpose

Pembrolizumab provides durable antitumor activity in metastatic melanoma, including complete response (CR) in about 15% of patients. Data are limited on potential predictors of CR and patient disposition after pembrolizumab discontinuation after CR. We describe baseline characteristics and long-term follow-up in patients who experienced CR with pembrolizumab in the KEYNOTE-001 study (ClinicalTrials.gov identifier: NCT01295827).

Patients and Methods

Patients with ipilimumab-naive or -treated advanced/metastatic melanoma received one of three dose regimens of pembrolizumab. Eligible patients who received pembrolizumab for ≥ 6 months and at least two treatments beyond confirmed CR could discontinue therapy. Response was assessed every 12 weeks by central Response Evaluation Criteria in Solid Tumors version 1.1. For this analysis, CR was defined per investigator assessment, immune-related response criteria, and potential predictors of CR were evaluated using univariate and multivariate analyses.

Results

Of 655 treated patients, 105 (16.0%) achieved CR after median follow-up of 43 months. At data cutoff, 92 patients (87.6%) had CR, with median follow-up of 30 months from first CR. Fourteen (13.3%) patients continued to receive treatment for a median of ≥ 40 months. Pembrolizumab was discontinued by 91 patients (86.7%), including 67 (63.8%) who proceeded to observation without additional anticancer therapy. The 24-month disease-free survival rate from time of CR was 90.9% in all 105 patients with CR and 89.9% in the 67 patients who discontinued pembrolizumab after CR for observation. Tumor size and programmed death-ligand 1 status were among the baseline factors independently associated with CR by univariate analysis.

Conclusion

Patients with metastatic melanoma can have durable complete remission after discontinuation of pembrolizumab, and the low incidence of relapse after median follow-up of approximately 2 years from discontinuation provides hope for a cure for some patients. The mechanisms underlying durable CR require further investigation.

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