Therapy of advanced head and neck cancer with double checkpoint blockade followed by radioimmunotherapy – results of the CheckRad-CD8 study.

Antoniu-Oreste Gostian; Markus Eckstein; Sandra Rutzner; Jens von der Grün; Thomas Illmer; Matthias G. Hautmann; Thomas B. Brunner; Simon Laban; Gunther Klautke; Balint Tamaskovics; Benjamin Frey; Arndt Hartmann; Wilfried Budach; Udo Gaipl; Heinrich Iro; Rainer Fietkau; Markus Hecht

doi:10.1055/s-0042-1746637

Laryngo-Rhino-Otologie, Table of Contents

CC BY-NC-ND 4.0 · Laryngorhinootologie 2022; 101(S 02): S202
DOI: 10.1055/s-0042-1746637

Abstracts | DGHNOKHC

Head-Neck-Oncology: Clinical studies

Therapy of advanced head and neck cancer with double checkpoint blockade followed by radioimmunotherapy – results of the CheckRad-CD8 study.

Authors

Antoniu-Oreste Gostian

¹Universitätsklinikum Erlangen, HNO, Kopf- und Halschirurgie Erlangen
Markus Eckstein

²Universitätsklinikum Erlangen, Pathologisches Institut Erlangen
Sandra Rutzner

³Universitätsklinikum Erlangen, Klinik für Strahlentherapie Erlangen
Jens von der Grün

⁴Universitätsklinikum Frankfurt, Zentrum der Radiologie – Klinik für Strahlen- therapie und Onkologie Frankfurt/Main
Thomas Illmer

⁵Gemeinschaftspraxis Hämatologie – Onkologie, Freiberg- Richter- Jacobasch – Illmer – Wolf Dresden
Matthias G. Hautmann

⁶Universitätsklinikum Regensburg, Klinik und Poliklinik für StrahlentherapieRegensburg
Thomas B. Brunner

⁷Universitätsklinikum Magdeburg, Universitätsklinik für Strahlentherapie Magdeburg
Simon Laban

⁸Universitätsklinikum Ulm, Hals- Nasen- und Ohrenheilkunde Ulm
Gunther Klautke

⁹Klinikum Chemnitz, Klinik für Radioonkologie Chemnitz
Balint Tamaskovics

¹⁰Universitätsklinikum Düsseldorf, Klinik für Strahlentherapie und Radioonkologie Düsseldorf
Benjamin Frey

³Universitätsklinikum Erlangen, Klinik für Strahlentherapie Erlangen
Arndt Hartmann

²Universitätsklinikum Erlangen, Pathologisches Institut Erlangen
Wilfried Budach

¹⁰Universitätsklinikum Düsseldorf, Klinik für Strahlentherapie und Radioonkologie Düsseldorf
Udo Gaipl

³Universitätsklinikum Erlangen, Klinik für Strahlentherapie Erlangen
Heinrich Iro

¹Universitätsklinikum Erlangen, HNO, Kopf- und Halschirurgie Erlangen
Rainer Fietkau

³Universitätsklinikum Erlangen, Klinik für Strahlentherapie Erlangen
Markus Hecht

³Universitätsklinikum Erlangen, Klinik für Strahlentherapie Erlangen

Abstract

Full Text

Introduction The CheckRad-CD8 study investigates the feasibility and efficacy of chemo-immune induction therapy followed by radioimmunotherapy with double immune checkpoint blockade after prior patient selection based on intratumoral CD8 cells.

Patients and Methods This multicenter phase II study treated patients with stage III-IVB head and neck tumors with a single cycle of cisplatin, docetaxel, durvalumab, and tremelimumab. Patients with increased CD8+ immune cell density or pathologic complete response (pCR) received radioimmunotherapy and another three cycles of durvalumab/tremelimumab followed by eight cycles of durvalumab mono.

Results Between September 2018 and May 2020, 80 patients were enrolled. The median follow-up time is 17.2 months. After induction chemoimmunotherapy, 41 patients had pCR, and another 31 had an increase in CD8+ cells. Radioimmunotherapy achieved a feasibility rate of 82%: of 60 patients, 10 experienced dose-limiting toxicity, and 4 others discontinued treatment. The cohort of patients after radioimmunotherapy had progression-free survival rates of 78% (CI(95% confidence interval) 69-90%) and 72% (CI 61-85%) at one and two years, respectively, and overall survival rates of 90% (CI 83-98%) and 84% (CI 74-94%). Grade 3-4 toxicities included predominantly dysphagia (53%), leukopenia (52%), and infection (32%). CONCLUSION: The study met its primary endpoint of feasibility of radioimmunotherapy. Induction chemoimmunotherapy followed by chemotherapy-free radioimmunotherapy after intratumoral CD8+ immune cell-based patient selection achieved a promising oncologic outcome.