Camrelizumab Plus Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin in Relapsed/Refractory Primary Mediastinal B-Cell Lymphoma: A Single-Arm, Open-Label, Phase II Trial.
Full text not available from this repository.Item Type: | Article |
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Official URL: | https://doi.org/10.1158/1078-0432.CCR-20-0514 |
Journal or Publication Title: | Clinical Cancer Research |
Volume: | 26 |
Number: | 17 |
Page Range: | pp. 4521-4530 |
Date: | 2020 |
Divisions: | Gene and Stem Cell Therapy |
Depositing User: | General Admin |
Identification Number: | 10.1158/1078-0432.CCR-20-0514 |
ISSN: | 1078-0432 |
Date Deposited: | 04 Jan 2021 01:20 |
Abstract: | 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. |
Creators: | Creators Email Mei, Qian UNSPECIFIED Zhang, Wenying UNSPECIFIED Liu, Yang UNSPECIFIED Yang, Qingming UNSPECIFIED Rasko, John E.J. UNSPECIFIED Nie, Jing UNSPECIFIED Liu, Jiejie UNSPECIFIED Li, Xiang UNSPECIFIED Dong, Liang UNSPECIFIED Chen, Meixia UNSPECIFIED Zhang, Yan UNSPECIFIED Shi, Lu UNSPECIFIED Wu, Huitao UNSPECIFIED Han, Weidong UNSPECIFIED |
Last Modified: | 04 Jan 2021 01:20 |
URI: | https://eprints.centenary.org.au/id/eprint/787 |
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