Zech H B, Laban S, Schafhausen P, Bussmann L, Betz C, Busch C-J
Klinik und Poliklinik für Hals‑, Nasen‑, Ohrenheilkunde, Kopf-Hals-Chirurgie und -Onkologie, Universitätsklinikum Hamburg Eppendorf, Martinistraße 52, 20246, Hamburg, Deutschland.
Kopf-Hals-Tumorzentrum des Universitätsklinikums Ulm, Klinik für Hals‑, Nasen‑, Ohrenheilkunde und Kopf-Hals-Chirurgie, Universitätsklinikum Ulm, Frauensteige 12, 87070, Ulm, Deutschland.
HNO. 2019 Dec;67(12):898-904. doi: 10.1007/s00106-019-00773-4.
The contributions presented at this year's ASCO conference on treatment of recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC) focused on systemic therapies, as in recent years. Two phase III studies-TPExtreme and Keynote-048-are expected to change clinical practice in first-line treatment of R/M-HNSCC.
Abstracts and presentations from this year's ASCO Annual Meeting on R/M-HNSCC were screened and checked for clinical relevance.
TPExtreme, a randomized phase III trial, could show less toxicity and similar overall survival in patients treated with docetaxel, cisplatin, and cetuximab (TPEx regimen) compared to standard first-line therapy with the Extreme regimen (cisplatin, 5‑fluorouracil [5-FU], cetuximab), albeit failing its endpoint of significantly improved survival. The randomized phase III Keynote-048 study could show a significant survival benefit in all patients treated with pembrolizumab, 5‑FU, and cis-/carboplatin compared to Extreme. When selected patients (PD-L1 CPS ≥1 and ≥20) were treated with pembrolizumab monotherapy, they showed increased overall response rates in contrast to patients treated with Extreme.
Based on the results of Keynote-048, pembrolizumab ± chemotherapy gained FDA approval as first-line treatment for R/M-HNSCC in the USA. Approval in Europe is expected soon and will probably have a strong impact on clinical routine.
与近年来一样，在今年美国临床肿瘤学会（ASCO）会议上发表的关于复发性或转移性头颈部鳞状细胞癌（R/M-HNSCC）治疗的报告主要集中在全身治疗方面。两项III期研究——TPExtreme和Keynote-048——有望改变R/M-HNSCC一线治疗的临床实践。
对今年ASCO年会上关于R/M-HNSCC的摘要和报告进行筛选，并检查其临床相关性。
TPExtreme是一项随机III期试验，与采用Extreme方案（顺铂、5-氟尿嘧啶[5-FU]、西妥昔单抗）的标准一线治疗相比，采用多西他赛、顺铂和西妥昔单抗（TPEx方案）治疗的患者毒性较小，总生存期相似，尽管未达到显著改善生存的终点。随机III期Keynote-048研究表明，与Extreme方案相比，接受帕博利珠单抗、5-FU和顺铂/卡铂治疗的所有患者均有显著的生存获益。当选择的患者（PD-L1综合阳性评分≥1和≥20）接受帕博利珠单抗单药治疗时，与接受Extreme方案治疗的患者相比，他们的总缓解率有所提高。
基于Keynote-048的结果，帕博利珠单抗±化疗已获得美国食品药品监督管理局（FDA）批准，作为R/M-HNSCC的一线治疗方案。预计欧洲很快也会批准，这可能会对临床常规治疗产生重大影响。
