PMID- 36589672 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230103 IS - 1792-1082 (Electronic) IS - 1792-1074 (Print) IS - 1792-1074 (Linking) VI - 25 IP - 1 DP - 2023 Jan TI - Safety and preliminary activity of pembrolizumab-carboplatin-paclitaxel in heavily pretreated and/or fragile patients with PDL1-positive recurrent/metastatic head and neck cancer. PG - 37 LID - 10.3892/ol.2022.13623 [doi] LID - 37 AB - Novel chemo-immunotherapy (chemo-IO) combinations should be evaluated, which may be suitable for cisplatin-unfit or fluoropyrimide-ineligible patients with recurrent or metastatic squamous cell carcinoma of head and neck (R/M SCCHN) to guarantee higher and deeper responses than IO alone. The aim of the present study was to review our experience using pembrolizumab-carboplatin-paclitaxel (pembro + CP) in patients with R/M SCCHN. This was a retrospective study of patients with R/M SCCHN who received pembro + CP in any-line via a compassionate-use program. The present study evaluated safety using Common Terminology Criteria for Adverse Events v4.0, compliance, overall response rate (ORR) and disease control rate (DCR) using Response Evaluation Criteria in Solid Tumors 1.1, duration of treatment, progression-free survival (PFS) and overall survival (OS). Between March 2020 and August 2021, 10 patients were identified (median age, 64 years; female, 60%; Eastern Cooperative Oncology Group 2, 80%). A total of 8 patients received pembro + 3-weekly carboplatin-paclitaxel (3wkCP). A total of 2 patients received pembro + weekly carboplatin-paclitaxel (wkCP). Patients received a median of 3 lines (range, 0-6) of systemic therapy prior to pembro + CP and 80% received IO in previous lines. Grade 1-2 adverse events (AEs) occurred in 100% of patients. Grade 3-5 AEs occurred in 30% of patients [all grade 3 (anemia, neutropenia, thrombopenia, hypertension)]. The mean numbers of pembro + wkCP and pembro + 3wkCP cycles were 2.5 and 6. The ORR (n=7) was 14% (1/7) with one complete response. The DCR was 43% (3/7). The median PFS (n=7) and OS (n=10) times since pembro + CP were 5 months (95% CI, 1-9) and 6 months (95% CI, 0.5-14), respectively. In this small retrospective series of heavily pretreated patients, pembro + CP was well tolerated, and compliance was high. Studies should be conducted to prospectively evaluate the safety and efficacy of this combination in patients with R/M SCCHN. CI - Copyright: (c) Cabezas-Camarero et al. FAU - Cabezas-Camarero, Santiago AU - Cabezas-Camarero S AD - Head and Neck Cancer, Neuro-Oncology and Genetic Counseling Unit, Medical Oncology Department, Instituto de Investigacion Sanitaria San Carlos, Madrid 28040, Spain. FAU - Merino-Menendez, Salome AU - Merino-Menendez S AD - Radiology Department, Clinico San Carlos University Hospital, Madrid 28040, Spain. FAU - Cabrera-Martin, Maria Nieves AU - Cabrera-Martin MN AD - Nuclear Medicine Department, Clinico San Carlos University Hospital, Madrid 28040, Spain. FAU - Sotelo, Miguel J AU - Sotelo MJ AD - Medical Oncology Department, Aliada Cancer Center, San Isidro 15036, Peru. AD - Medical Oncology Department, San Felipe Hospital, Jesus Maria 15072, Peru. AD - Medical Oncology Department, Maria Auxiliadora Hospital, San Juan de Miraflores 15801, Peru. FAU - Plaza-Hernandez, Jose Carlos AU - Plaza-Hernandez JC AD - Pathology Department, Clinico San Carlos University Hospital, Madrid 28040, Spain. FAU - Falahat, Farzin AU - Falahat F AD - Department of Craniomaxilofacial Surgery, Clinico San Carlos University Hospital, Madrid 28040, Spain. FAU - Iglesias-Moreno, Maria Cruz AU - Iglesias-Moreno MC AD - Department of Otolaryngology-Head and Neck Surgery, Clinico San Carlos University Hospital, Madrid 28040, Spain. FAU - Perez-Segura, Pedro AU - Perez-Segura P AD - Head and Neck Cancer, Neuro-Oncology and Genetic Counseling Unit, Medical Oncology Department, Instituto de Investigacion Sanitaria San Carlos, Madrid 28040, Spain. LA - eng PT - Journal Article DEP - 20221207 PL - Greece TA - Oncol Lett JT - Oncology letters JID - 101531236 PMC - PMC9773311 OTO - NOTNLM OT - anti-programmed cell death protein 1 OT - carboplatin OT - chemoimmunotherapy OT - head and neck cancer OT - paclitaxel OT - pembrolizumab COIS- SCC has worked as a consultant and as a Speaker's Bureau representative for Bristol-Myers Squibb, Merck and MSD, and has received grant/research support from clinical trials with AstraZeneca, MSD and Merck. PPS has also worked as a consultant and as a Speaker's Bureau representative for Bristol-Myers Squibb, Merck and MSD, and received grant/research support from clinical trials with Bristol-Myers Squibb, AstraZeneca and MSD. The remainder of the authors declare that they have no competing interests. EDAT- 2023/01/03 06:00 MHDA- 2023/01/03 06:01 PMCR- 2022/12/07 CRDT- 2023/01/02 04:03 PHST- 2022/09/29 00:00 [received] PHST- 2022/11/02 00:00 [accepted] PHST- 2023/01/02 04:03 [entrez] PHST- 2023/01/03 06:00 [pubmed] PHST- 2023/01/03 06:01 [medline] PHST- 2022/12/07 00:00 [pmc-release] AID - OL-25-01-13623 [pii] AID - 10.3892/ol.2022.13623 [doi] PST - epublish SO - Oncol Lett. 2022 Dec 7;25(1):37. doi: 10.3892/ol.2022.13623. eCollection 2023 Jan.