Treatment of head and neck squamous cell carcinoma recurrences and distant metastases Highlights of the 2019 ASCO Meeting

Background 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. Materials and methods s and presentations from this year's ASCO Annual Meeting on R/M-HNSCC were screened and checked for clinical relevance. Results 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. Conclusion 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.