Dokumentenart: | Artikel | ||||
---|---|---|---|---|---|
Titel eines Journals oder einer Zeitschrift: | Journal for ImmunoTherapy of Cancer | ||||
Verlag: | BMJ PUBLISHING GROUP | ||||
Ort der Veröffentlichung: | LONDON | ||||
Band: | 8 | ||||
Nummer des Zeitschriftenheftes oder des Kapitels: | 2 | ||||
Seitenbereich: | e001378 | ||||
Datum: | 2020 | ||||
Institutionen: | Medizin > Lehrstuhl für Strahlentherapie | ||||
Identifikationsnummer: |
| ||||
Stichwörter / 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 | ||||
Dewey-Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin | ||||
Status: | Veröffentlicht | ||||
Begutachtet: | Ja, diese Version wurde begutachtet | ||||
An der Universität Regensburg entstanden: | Ja | ||||
Dokumenten-ID: | 50455 |
Zusammenfassung
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 ...
Zusammenfassung
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.
Metadaten zuletzt geändert: 03 Feb 2022 10:35