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Pembrolizumab versus cetuximab, concomitant with radiotherapy (RT) in locally advanced head and neck squamous cell carcinoma (LA-HNSCC): Results of the GORTEC 2015-01 “PembroRad” randomized trial

Date

19 Sep 2020

Session

Proffered Paper - Head & Neck cancer

Presenters

Yungan Tao

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

Y. Tao1, X. Sun2, C. Sire3, L. Martin4, M. Alfonsi5, J.B. Prevost6, M. Rives7, C. Lafond8, J.M. Tourani9, J. Biau10, L. Geoffrois11, A. Coutte12, X. Liem13, E. Vauleon14, F. Drouet15, A. Pechery16, J. Guigay17, M. Wanneveich16, A. Aupérin1, J. Bourhis18

Author affiliations

  • 1 Radiation Oncology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 2 Belfort, Hôpital Nord Franche-Comté - HNFC, 90015 - Belfort/FR
  • 3 Lorient, CHU Bretagne Sud, 56322 - Lorient/FR
  • 4 Le Havre, Clinique des Ormeaux, 76600 - Le Havre/FR
  • 5 Avignon, Institut Sainte Catherine, 84918 - Avignon/FR
  • 6 Beuvry, Centre Pierre Curie, 62660 - Beuvry/FR
  • 7 Toulouse, Institut Claudius Regaud, 31000 - Toulouse/FR
  • 8 Le Mans, Clinique Victor Hugo, 72015 - Le Mans/FR
  • 9 Poitiers, CHU Poitiers, Jean Bernard Hôpital, 86021 - Poitiers/FR
  • 10 Clermont Ferrand, Centre de Lutte contre le Cancer J. Perrin, 63000 - Clermont Ferrand/FR
  • 11 Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
  • 12 Radiation Oncology, CHU Amiens-Picardie - Site Sud, 80054 - Amiens/FR
  • 13 Radiotherapy, Centre Oscar Lambret, 59000 - Lille/FR
  • 14 Rennes, Centre Eugene - Marquis, 35042 - Rennes/FR
  • 15 Saint-nazaire, Clinique Mutualiste de l'Estuaire, 44600 - Saint-Nazaire/FR
  • 16 Gortec, GORTEC-CHU Bretonneau, 37044 - Tours cedex/FR
  • 17 Medical Oncology Department, Centre Anticancer Antoine Lacassagne, 06189 - Nice/FR
  • 18 Radiation Oncology, CHUV - Centre Hospitalier Universitaire Vaudois, 1011 - Lausanne/CH
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Resources

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Abstract LBA38

Background

Based on the hypothesis of a potential synergistic effect of the anti-PD1 pembrolizumab when combined with RT, this new combination was tested in a randomized trial against the well-established standard of care (SOC) cetuximab-RT in LA-HNSCC.

Methods

In this phase II randomized trial, patients with non operated stage III-IVa-b SCC of oral cavity, oropharynx, hypopharynx and larynx and unfit for receiving high dose of cisplatin were enrolled. Patients received once-daily IMRT up to 69,96 Gy concomitant with cetuximab (Cetux-RT arm: 400 mg/m2 loading dose and 250 mg/m2 weekly) or pembrolizumab (Pembro-RT arm: 200 mg Q3W during RT). The primary endpoint was 15-month Loco-Regional Control (LRC) rate and secondary endpoints included Progression-free survival (PFS), Overall Survival (OS) and tolerance. To detect a difference between arms of 60% to 80% in 15-month LRC, inclusion of 66 patients per arm was required to achieve a power of at least 0.85 at 2-sided significance level of 0.20.

Results

Between May 2016 and October 2017, 131 patients were randomized and treated by 27 centers: 65 patients in Cetux-RT arm and 66 patients in Pembro-RT arm. The median age was 65 years, 92% were smokers, 60% of oropharynx (46% p16+), 41% of N2c-N3 with 25%, 56% and 19% of stage III, IVa and IVb respectively. Median follow-up was 25 months in both arms. Acute toxicity was lower in Pembro-RT arm than Cetux-RT arm: 74% vs 92% patients with at least one grade ≥ 3 acute adverse events (p=0.006), mainly due to dermatitis in radiation field, mucositis and cutaneous rash. LRC at 15 months were 59% in Cetux-RT arm and 60% in Pembro-RT arm, not significantly different: OR=1.05 (95%CI: 0.43-2.59, p=0.91). 2-year PFS rate was 40% in the Cetux-RT arm vs 42% in the Pembro-RT arm. There was no significant difference between arms for PFS: HR=0.83 (95%CI 0.53-1.29, p=0.41). 2-year OS rate was 55% in the Cetux-RT arm vs 62% in the Pembro-RT arm. OS was not significantly different between arms: HR=0.83 (95%CI: 0.49-1.40, p=0.49).

Conclusions

Compared to the SOC cetuximab-RT, the anti-PD1 pembrolizumab concomitant with RT did not improve carcinologic outcomes but appeared less toxic.

Clinical trial identification

NCT 02707588.

Editorial acknowledgement

Legal entity responsible for the study

GORTEC.

Funding

GORTEC.

Disclosure

J. Bourhis: Advisory/Consultancy: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Merck. All other authors have declared no conflicts of interest.

Resources from the same session

Q&A and live discussion

Presenter: Anthony T.C. Chan

Session: Proffered Paper - Head & Neck cancer

Resources:

Webcast

Q&A and live discussion

Presenter: Anthony T.C. Chan

Session: Proffered Paper - Head & Neck cancer

Resources:

Webcast

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