RT Journal Article T1 Safety and efficacy of pembrolizumab-carboplatin-paclitaxel in cisplatin-unfit and/or fluoropyrimidine-ineligilible patients with pdl1- positive recurrent/metastatic head and neck cancer. A1 Cabezas Camarero, Santiago A1 Merino Menéndez, Salome A1 Cabrera Martín, María Nieves A1 Sotelo, Miguel J. A1 Plaza Hernández, José Carlos A1 Falahat Noushzady, Farzin A1 Iglesias Moreno, María Cruz A1 Pérez Segura, Pedro 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. PB Spandidos Publication SN 1792-1074 YR 2023 FD 2023-12-07 LK https://hdl.handle.net/20.500.14352/131413 UL https://hdl.handle.net/20.500.14352/131413 LA eng NO Cabezas-Camarero S, Merino-Menéndez S, Cabrera-Martín MN, Sotelo MJ, Plaza-Hernández JC, Falahat F, Iglesias-Moreno MC, Pérez-Segura P. Safety and preliminary activity of pembrolizumab-carboplatin-paclitaxel in heavily pretreated and/or fragile patients with PDL1-positive recurrent/metastatic head and neck cancer. Oncol Lett. 2022 Dec 7;25(1):37. doi: 10.3892/ol.2022.13623. PMID: 36589672; PMCID: PMC9773311 DS Docta Complutense RD 15 abr 2026