Camrelizumab Plus Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin in Relapsed/Refractory Primary Mediastinal B-Cell Lymphoma: A Single-Arm, Open-Label, Phase II Trial

Autor: Meixia Chen, John E.J. Rasko, Qingming Yang, Liang Dong, Wenying Zhang, Jing Nie, Huitao Wu, Yang Liu, Weidong Han, Qian Mei, Xiang Li, Lu Shi, Yan Zhang, Jiejie Liu
Rok vydání: 2020
Předmět:
Adult
Male
0301 basic medicine
Cancer Research
medicine.medical_specialty
Lymphoma
B-Cell
Adolescent
medicine.medical_treatment
Population
Phases of clinical research
Context (language use)
Antibodies
Monoclonal
Humanized
Vinorelbine
Mediastinal Neoplasms
Gastroenterology
Polyethylene Glycols
Interferon-gamma
Young Adult
03 medical and health sciences
0302 clinical medicine
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Biomarkers
Tumor
medicine
Humans
fas Receptor
education
Chemotherapy
education.field_of_study
business.industry
Middle Aged
Prognosis
medicine.disease
Progression-Free Survival
Gemcitabine
Interleukin-10
Regimen
030104 developmental biology
Oncology
Doxorubicin
Drug Resistance
Neoplasm
030220 oncology & carcinogenesis
Female
Primary mediastinal B-cell lymphoma
Neoplasm Recurrence
Local
business
medicine.drug
Zdroj: Clinical Cancer Research. 26:4521-4530
ISSN: 1557-3265
1078-0432
Popis: Purpose: Patients with relapsed/refractory primary mediastinal B-cell lymphoma (rrPMBCL) represent a particularly challenging population to treat, with few life-saving treatment options in the context of a dismal prognosis. Patients and Methods: In this open-label, single-arm, phase II study, the safety and efficacy of combined regimen of chemotherapy consisting of gemcitabine, vinorelbine, and pegylated liposomal doxorubicin (GVD) plus anti-PD-1 antibody camrelizumab was assessed in rrPMBCL. Patients received chemo-immunotherapy every 3 weeks until the second confirmed complete response (CR) or up to 12 cycles, followed by camrelizumab monotherapy for up to 1 year. The primary endpoints were objective response rate (ORR) and safety. Results: Twenty-seven response evaluable patients were enrolled, who received a median of three first-line therapies, 59% with bulky disease. The ORR was 74%, including 56% with a CR. A median time of 1.7 months to response was observed, with 78% exhibiting tumor shrinkage at the first evaluation. After 24.8 months median follow-up, the median duration of response was not reached, with a 65% 2-year estimated response rate. Thirteen responders remained in sustained complete remission. Estimated 24-month progression-free survival and overall survival rates were 48.2% and 81.5%, respectively. Any grade and grade 3 treatment-related adverse events (AE) occurred in 93% and 33% of patients, respectively; with no grade 4 or 5 AEs. Baseline levels of IL10, IFNγ, and soluble Fas were associated with objective response. Conclusions: Camrelizumab plus GVD chemotherapy offers a potent option as life-saving chemo-immunotherapy with promising efficacy and a manageable safety profile for patients with rrPMBCL, especially with bulky aggressive disease.
Databáze: OpenAIRE
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