Hecht, Markus and Gostian, Antoniu Oreste and Eckstein, Markus and Rutzner, Sandra and von der Gruen, Jens and Illmer, Thomas and Hautmann, Matthias G. and Klautke, Gunther and Laban, Simon and Brunner, Thomas and Hinke, Axel and Becker, Ina and Frey, Benjamin and Semrau, Sabine and Geppert, Carol and Hartmann, Arndt and Balermpas, Panagiotis and Budach, Wilfried and Gaipl, Udo S. and Iro, Heinrich and Fietkau, Rainer (2020) Safety and efficacy of single cycle induction treatment with cisplatin/docetaxel/durvalumab/tremelimumab in locally advanced HNSCC: first results of CheckRad-CD8. JOURNAL FOR IMMUNOTHERAPY OF CANCER, 8 (2): e001378. ISSN , 2051-1426
Full text not available from this repository. (Request a copy)Abstract
Background To determine safety and efficacy of single cycle induction treatment with cisplatin/docetaxel and durvalumab/tremelimumab in stage III-IVB head and neck cancer. Methods Patients received a single cycle of cisplatin 30 mg/m(2) on days 1-3 and docetaxel 75 mg/m(2) on day 1 combined with durvalumab 1500 mg fix dose on day 5 and tremelimumab 75 mg fix dose on day 5. Patients with pathologic complete response (pCR) in the rebiopsy after induction treatment or at least 20% increase of intratumoral CD8+ cell density in the rebiopsy compared with baseline entered radioimmunotherapy with concomitant durvalumab/tremelimumab. The objective of this interim analysis was to analyze safety and efficacy of the chemoimmunotherapy-induction treatment before radioimmunotherapy. Results A total of 57 patients were enrolled, 56 were treated. Median pretreatment intratumoral CD8+ cell density was 342 cells/mm(2). After induction treatment, 27 patients (48%) had a pCR in the rebiopsy and further 25 patients (45%) had a relevant increase of intratumoral CD8+ cells (median increase by a factor of 3.0). Adverse event (AE) grade 3-4 appeared in 38 patients (68%) and mainly consisted of leukopenia (43%) and infections (29%). Six patients (11%) developed grade 3-4 immune-related AE. Univariate analysis computed p16 positivity, programmed death ligand 1 immune cell area and intratumoral CD8+ cell density as predictors of pCR. On multivariable analysis, intratumoral CD8+ cell density predicted pCR independently (OR 1.0012 per cell/mm(2), 95% CI 1.0001 to 1.0022, p=0.016). In peripheral blood CD8+ cells, the coexpression of programmed death protein 1 significantly increased especially in patients with pCR. Conclusions Single cycle induction treatment with cisplatin/docetaxel and durvalumab/tremelimumab is feasible and achieves a high biopsy-proven pCR rate.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | SQUAMOUS-CELL CARCINOMA; HUMAN-PAPILLOMAVIRUS; ADVANCED HEAD; OROPHARYNX CANCER; OPEN-LABEL; PHASE-III; CHEMOTHERAPY; CISPLATIN; FLUOROURACIL; DOCETAXEL; radioimmunotherapy; head and neck neoplasms; CD8-Positive T-lymphocytes; clinical trials; Phase II as topic; combined modality therapy |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Strahlentherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 06 Apr 2021 10:52 |
| Last Modified: | 06 Apr 2021 10:52 |
| URI: | https://pred.uni-regensburg.de/id/eprint/45412 |
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