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. 2024 Feb 8:14:1348045.
doi: 10.3389/fonc.2024.1348045. eCollection 2024.

Real-world use of first-line pembrolizumab + platinum + taxane combination regimens in recurrent / metastatic head and neck squamous cell carcinoma

Christopher M Black  1 , Dandan Zheng  1 , Gleicy M Hair  1 , Lei Ai  1 , Liya Wang  1 , Daisuke Goto  1 , Nati Lerman  2 , Behzad Bidadi  2 , Glenn J Hanna  3
Affiliations

Real-world use of first-line pembrolizumab + platinum + taxane combination regimens in recurrent / metastatic head and neck squamous cell carcinoma

Christopher M Black et al. Front Oncol. .

Abstract

Introduction: The programmed death-1 (PD-1) immune checkpoint inhibitor pembrolizumab is currently approved in the US for the first-line (1L) treatment of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), either alone or in combination with platinum and 5-fluorouracil (5-FU). However, the toxicity of 5-FU has motivated the study of alternate combinations that replace 5-FU with a taxane. The objective of the current study was to describe the baseline characteristics, treatment patterns and sequences, and real-world outcomes of individuals receiving pembrolizumab + platinum + taxane as 1L treatment for R/M HNSCC in the US.

Methods: This was a retrospective study of US adults ≥18 years of age receiving pembrolizumab + platinum + taxane as 1L treatment for R/M HNSCC, using electronic health record data from a nationwide de-identified database. Real-world overall survival (rwOS), time on treatment (rwToT), and time to next treatment (rwTTNT) outcomes were assessed using Kaplan-Meier analysis.

Results: The study population comprised 83 individuals (80.7% male) with a median age of 64 years. The most common tumor site was the oropharynx (48.2%); 70.0% of these tumors were HPV-positive. A total of 71.1% of the study population had an Eastern Cooperative Oncology Group performance status of 0-1 at index date, 71.8% had a combined positive score for programmed death ligand-1 (PD-L1) expression of ≥1, and 30.8% had a score of ≥20. The median (95% CI) rwOS was 14.9 (8.8-23.3) months, rwToT was 5.3 (4.0-8.2) months, and rwTTNT was 8.7 (6.8-12.3) months. Among the 24 individuals who received a subsequent therapy, the most common second-line therapies were cetuximab-based (n = 9) or pembrolizumab-containing (n = 8) regimens.

Conclusions: The rwOS and other real-world outcomes observed for this study population further support pembrolizumab + platinum + taxane combination therapy as a potential 1L treatment option for R/M HNSCC.

Keywords: Kaplan-Meier estimate; PD-1; antineoplastic agents; head and neck squamous cell carcinoma; patient outcomes; real-world observational study; taxanes; treatment patterns.

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Conflict of interest statement

Authors CB, DZ, GMH, LA, LW, NL, and BB were employed by the company Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and may be shareholders in Merck & Co., Inc., Rahway, NJ, USA. Author DG was employed by the company Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and a shareholder in Merck & Co., Inc., Rahway, NJ, USA at the time of the study. Author GJH has received consulting fees from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Figures

Figure 1
Figure 1
Real-world overall survival (A), real-world time on treatment (B), and real-world time to next treatment (C) outcomes among 83 individuals receiving 1L pembrolizumab + platinum + taxane combination therapy. CI, confidence interval. All values provided in months.
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