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医学界肿瘤频道|PD-1可以是“神药” 但还不是“仙药”( 三 )

医学界肿瘤频道|PD-1可以是“神药” 但还不是“仙药”
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2020 ESMO大会公布的KEYNOTE-590研究在精选人群和整体人群的OS[23]在占据我国食管癌发病率95%的ESCC人群中 ， PD-L1 CPS≥10人群的中位OS较化疗对照组提高了5.1个月 ， 死亡风险降低43% ， 而ESCC整体人群的OS提高了2.8个月 ， 死亡风险降低28% 。 精准免疫治疗的“尴尬”目前 ， PD-L1表达水平评估是目前临床研究和验证最广泛 ， 认可度最高的PD-1/PD-L1抑制剂疗效预测标志物 ， 对其检测结果作为伴随诊断或补充诊断依据已在美国FDA批准的包括K药、O药在内的多个PD-1/PD-L1单抗的适应证中被要求或提及 。 但是 ， 目前在国内 ， 唯有PD-L1检测试剂盒（免疫组织化学法）PD-L1 IHC 22C3 pharmDx（DAKO 22C3）于2019年8月30日在国内获批并作为K药单药一线治疗PD-L1TPS≥50%的伴随诊断来指导K药单药治疗的临床实践 。 但是 ， 已在国内获批的国产PD-1或其它进口的PD-1/PD-L1都还没有获批的伴随诊断或补充诊断PD-L1检测试剂 。在如火如荼的“免疫+”的浪潮下 ， 国内PD-1单抗对于免疫单药治疗失去了兴趣 。 而且 ， 目前还存在一种认识误区 ， 即只要是“免疫+” ， 只要临床研究结果显示针对“全人群”能显示具有统计学意义的PFS或者OS差异 ， 就无需精选患者人群 ， 也就省去了检测的“麻烦” 。但是KEYNOTE研究系列的OS分析结果已经为我们带来了高级别的循证医学证据证明 ， 即使是在免疫联合化疗的方案 ， PD-L1表达与患者的长期生存成正相关的关联 。国内PD-1/PD-L1单抗在“泛肿瘤”治疗领域强势发力 ， 以扩大患者适用人群的同时 ， 也应该在精准免疫治疗的道路上奋起直追 ， 因为精准免疫治疗可以让“泛人群”活得久 ， 而这才是免疫治疗意义的真谛所在 。这也是让PD-1成为真正“仙药”的关键所在 。这也是让患者、社会和国家不浪费资源 ， 并真正“把钱用在刀刃上”的关键所在 。免疫治疗的”盛宴“丰富多样 ， 美不胜收 ， 但是每一位已经尝试 ， 或试图尝试免疫治疗的医生、患者应该首先意识到免疫治疗的真谛和精准免疫治疗的意义 。 参考文献
[1]www.keytruda.com[2]Reck M, et al., Updated Analysis of KEYNOTE-024: Pembrolizumab Versus Platinum-Based Chemotherapy for Advanced Non–Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score of 50% or Greater, Journal of Clinical Oncology, Volume 37, Issue 7, P537-546[3]Reck M ， et al.Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer[J].N Engl J Med, 2016, 375:1823-33[4]Brahmer JR ， et al.KEYNOTE-024 5-year OS update: First-line(1L) pembrolizumab (pembro) vs platinum-based chemotherapy (chemo）in patients(pts) with metastatic NSCLC and PD-L1 tumour proportion score (TPS) ≥50%[EB/OL].ESMO 2020 ， abstract LBA51[5]特瑞普利单抗注射液说明书[6] Xu JM et al., Sintilimab in patients with advanced esophageal squamous cell carcinoma refractory to previous chemotherapy: A randomized,open-label phase II trial (ORIENT-2). ASCO 2020, Abstract 4511[7]替雷利珠单抗注射液说明书[8]卡瑞利珠单抗注射液说明书[9]www.rohe.com[10] Wu YL et al., Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced Non-Small Cell Lung Cancer: CheckMate 078 Randomized Phase III Clinical Trial, JTO[12] www.keytruda.com[13] Garon E.B., Five-Year Overall Survival for Patients With Advanced Non-Small-Cell Llung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study. JCO.com, June 2nd, 2019[14] Ghandi L et al., Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer, N Engl J Med 2018; 378: 2078-92[15] Paz-Ares L, Luft A, Vicente D, et al. Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer. N Engl J Med 2018;379:2040-2051.[16] Zhou C, et al., A RANDOMIZED PHASE 3 STUDY OF CAMRELIZUMAB PLUS CHEMOTHERAPY AS 1ST LINE THERAPY FOR ADVANCED/METASTATIC NON- SQUAMOUS NON-SMALL CELL LUNG CANCER, 2019 WCLC, OA04.03[17] Zhang L, et al., ORIENT-11: sintilimab + pemetrexed + platinum as first-line therapy for locally advanced or metastatic non-squamous NSCLC, 2020 WCLC, Oral Presentation[18] Zhou C, et al., ORIENT-12: Sintilimab plus gemcitabine and platinum (GP) as first-line (1L) treatment for locally advanced or metastatic squamous non-small-cell lung cancer (sqNSCLC), 2020 ESMO Mini-Oral Presentation, Annals of Oncology (2020) 31 (suppl_4): S1142-S1215[19] Wang J, et al., Phase III study of tislelizumab plus chemotherapy vs chemotherapy alone as first-line (1L) treatment for advanced squamous non-small cell lung cancer (sqNSCLC).2020 ASCO, Abstract 9554[20] Lu S, et al, Tislelizumab + chemotherapy vs chemotherapy alone as first-line treatment for locally advanced/metastatic nonsquamous NSCLC, 2020 ESMO, Poster, Annals of Oncology (2020) 31 (suppl_4): S754-S840[21] Burtness B, Harrington KJ, Greil R,et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Oct 31: S0140-6736(19)32591-7[22] Greil Richard, et al., Long-Term Outcomes From KEYNOTE-048: Pembrolizumab Alone or With Chemotherapy Versus EXTREME as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, ESMO 2020, Oral Presentation[23] Ken Kato et al., Pembrolizumab Plus Chemotherapy Versus Chemotherapy as First-Line Therapy in Patients with Advanced Esophageal Cancer: The Phase 3 KEYNOTE-590 Study, ESMO 2020, LBA 8


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