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Clinical Trial
. 2023 Jan;34(1):101-110.
doi: 10.1016/j.annonc.2022.10.006. Epub 2022 Oct 28.

Pembrolizumab versus cetuximab concurrent with radiotherapy in patients with locally advanced squamous cell carcinoma of head and neck unfit for cisplatin (GORTEC 2015-01 PembroRad): a multicenter, randomized, phase II trial

Y Tao  1 , J Biau  2 , X S Sun  3 , C Sire  4 , L Martin  5 , M Alfonsi  6 , J B Prevost  7 , A Modesto  8 , C Lafond  9 , J M Tourani  10 , J Miroir  2 , M C Kaminsky  11 , A Coutte  12 , X Liem  13 , E Chautard  2 , E Vauleon  14 , F Drouet  15 , A Ruffier  16 , J F Ramee  17 , G Waksi  18 , A Péchery  18 , M Wanneveich  18 , J Guigay  19 , A Aupérin  20 , J Bourhis  21
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Free article
Clinical Trial

Pembrolizumab versus cetuximab concurrent with radiotherapy in patients with locally advanced squamous cell carcinoma of head and neck unfit for cisplatin (GORTEC 2015-01 PembroRad): a multicenter, randomized, phase II trial

Y Tao et al. Ann Oncol. 2023 Jan.
Free article

Abstract

Background: To evaluate potential synergistic effect of pembrolizumab with radiotherapy (RT) compared with a standard-of-care (SOC) cetuximab-RT in patients with locally advanced-squamous cell carcinoma of head and neck (LA-SCCHN).

Patients and methods: Patients with nonoperated stage III-IV SCC of oral cavity, oropharynx, hypopharynx, and larynx and unfit for receiving high-dose cisplatin were enrolled. Patients received once-daily RT up to 69.96 Gy in 33 fractions with weekly cetuximab (cetuximab-RT arm) or 200 mg Q3W pembrolizumab during RT (pembrolizumab-RT arm). The primary endpoint was locoregional control (LRC) rate 15 months after RT. To detect a difference between arms of 60%-80% in 15-month LRC, inclusion of 66 patients per arm was required to achieve a power of at least 0.85 at two-sided significance level of 0.20.

Results: Between May 2016 and October 2017, 133 patients were randomized to cetuximab-RT (n = 66) and pembrolizumab-RT (n = 67). Two patients (one in each arm) were not included in the analysis (a consent withdrawal and a progression before treatment start). The median age was 65 years (interquartile range 60-70 years), 92% were smokers, 60% were oropharynx (46% of oropharynx with p16+) and 75% were stage IV. Median follow-up was 25 months in both arms. The 15-month LRC rate was 59% with cetuximab-RT and 60% with pembrolizumab-RT ]odds ratio 1.05, 95% confidence interval (CI) 0.43-2.59; P = 0.91]. There was no significant difference between arms for progression-free survival (hazard ratio 0.85, 95% CI 0.55-1.32; P = 0.47) and for overall survival (hazard ratio 0.83, 95% CI 0.49-1.40; P = 0.49). Toxicity was lower in the pembrolizumab-RT arm than in the cetuximab-RT arm: 74% versus 92% patients with at least one grade ≥3 adverse events (P = 0.006), mainly due to mucositis, radiodermatitis, and rash.

Conclusion: Compared with the SOC cetuximab-RT, pembrolizumab concomitant with RT did not improve the tumor control and survival but appeared less toxic in unfit patients with LA-SCCHN.

Keywords: PD-1; concurrent radiotherapy; head and neck cancer; pembrolizumab.

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Conflict of interest statement

Disclosure YT has an advisory/consultancy role with and has received honoraria from Merck & Co. (Kenilworth, NJ); AM reports consulting or advisory role for Merck KGaA (Darmstadt, Germany), BMS, AstraZeneca, Merck & Co. (Kenilworth, NJ); research funding from AstraZeneca. AC has an advisory/consultancy role with or has received honoraria from Sanofi Aventis, Takeda, BMS, Merck & Co. (Kenilworth, NJ), Roche, Merck KGaA, Darmstadt, Germany, AstraZeneca, Janssen, Astellas, Ipsen. XL has an advisory/consultancy role with Aquilab and Nanobiotix. AR has an advisory/consultancy role with Lilly, Merck KGaA (Darmstadt, Germany), Seagen, BMS, Astellas, Ipsen. JG has an advisory/consultancy role with Merck KGaA, Nanobiotix, Roche; is an invited speaker for Merck & Co. (Kenilworth, NJ). JBo has an advisory/consultancy role with BMS, Merck & Co. (Kenilworth, NJ), Merck KGaA (Darmstadt, Germany), AstraZeneca, Debiopharm, Roche, and Nanobiotix. All other authors have declared no conflicts of interest.

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