PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer

Autor: Israel Lowy, N. Alice Yama-Dang, Jingjin Li, June Y. Hou, Suk Young Yoo, Kyriakos P. Papadopoulos, Danny Rischin, Joaquina Baranda, Antonio González-Martín, M. Feng, Daniel Cho, Melissa Mathias, Silvia C. Formenti, Marta Gil-Martin, Wen Fury, Gerald Steven Falchook, Kathleen N. Moore, Salma K. Jabbour, Aung Naing, Irene Brana, Matthew G. Fury, Elizabeth Stankevich
Přispěvatelé: Institut Català de la Salut, [Rischin D] Department of Medical Oncology, Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Australia. [Gil-Martin M] Institut Català d'Oncologia-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain. [González-Martin A] Clinica Universidad de Navarra, Madrid, Spain. [Braña I] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Hou JY] Division of Gynecologic Oncology, Columbia University Medical Center, New York, NY, USA. [Cho D] Perlmutter Cancer Center at NYU Langone Medical Center, New York, NY, USA, Vall d'Hebron Barcelona Hospital Campus
Rok vydání: 2020
Předmět:
Adult
0301 basic medicine
Oncology
medicine.medical_specialty
medicine.medical_treatment
Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores]
Uterine Cervical Neoplasms
Adenocarcinoma
Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms
Female::Uterine Neoplasms::Uterine Cervical Neoplasms [DISEASES]
Other subheadings::Other subheadings::/drug therapy [Other subheadings]
Antibodies
Monoclonal
Humanized
B7-H1 Antigen
Coll uterí - Càncer - Tractament
03 medical and health sciences
Antineoplastic Agents
Immunological
0302 clinical medicine
Internal medicine
Biomarkers
Tumor
medicine
Carcinoma
Neoplasms::Neoplasms by Histologic Type::Neoplasms
Glandular and Epithelial::Carcinoma::Carcinoma
Squamous Cell [DISEASES]
Humans
neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::carcinoma de células escamosas [ENFERMEDADES]
Aged
Cervical cancer
Chemotherapy
business.industry
Obstetrics and Gynecology
Histology
Middle Aged
medicine.disease
030104 developmental biology
Tolerability
030220 oncology & carcinogenesis
Cohort
Carcinoma
Squamous Cell
Biomarker (medicine)
Administration
Intravenous
Female
business
neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales femeninos::neoplasias uterinas::neoplasias del cuello uterino [ENFERMEDADES]
Zdroj: Scientia
ISSN: 0090-8258
Popis: Cemiplimab; Càncer de coll uterí metastàtic; Càncer de coll uterí recurrent Cemiplimab; Cáncer de cuello uterino metastásico; Cáncer de cuello uterino recurrente Cemiplimab; Metastatic cervical cancer; Recurrent cervical cancer Objectives To characterize the safety, tolerability, and anti-tumor activity of cemiplimab as monotherapy or in combination with hypofractionated radiation therapy (hfRT) in patients with recurrent or metastatic cervical cancer. To determine the association between histology and programmed death-ligand 1 (PD-L1) expression. Methods In non-randomized phase I expansion cohorts, patients (squamous or non-squamous histology) received cemiplimab 3 mg/kg intravenously every 2 weeks for 48 weeks, either alone (monotherapy cohort) or with hfRT during week 2 (combination cohort). Due to insufficient tissue material, PD-L1 protein expression was evaluated in commercially purchased samples and mRNA expression levels were analyzed from The Cancer Genome Atlas (TCGA). Results Twenty patients enrolled in both cohorts in total; 10 had squamous histology. The most common adverse events of any grade were diarrhea, fatigue, and hypokalemia, occurring in 35%, 25%, and 25%, respectively. Objective response rate was 10% in each cohort; responders had squamous histology. Duration of response was 11.2 months and 6.4 months for the responder in the monotherapy and combination cohort, respectively. Irradiated lesions were not included in the response assessments. In separate archived specimens ( N = 155), PD-L1 protein expression in tumor and immune cells was negative (
Databáze: OpenAIRE
Externí odkaz: