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- Title
Phase 2 study of pegylated liposomal doxorubicin plus cyclophosphamide, vincristine/vindesine, and prednisone in newly diagnosed PTCL: 8-year results.
- Authors
Xia, Zu-Guang; Lv, Fang-Fang; Zhang, Qun-Ling; Liu, Yi-Zhen; Zhang, Sheng-Jian; Liu, Chang; Li, Xiao-Qiu; Wen, Yu; Wu, Zhen-Yu; Hong, Xiao-Nan; Guo, Ye; Cao, Jun-Ning
- Abstract
Background Pegylated liposomal doxorubicin (PLD) is a liposome-encapsulated form of doxorubicin with equivalent efficacy and less cardiotoxicity. This phase 2 study evaluated the efficacy and safety of the PLD-containing CHOP regimen in newly diagnosed patients with aggressive peripheral T-cell lymphomas (PTCL). Methods Patients received PLD, cyclophosphamide, vincristine/vindesine, plus prednisone every 3 weeks for up to 6 cycles. The primary endpoint was the objective response rate at the end of treatment (EOT). Results From September 2015 to January 2017, 40 patients were treated. At the EOT, objective response was achieved by 82.5% of patients, with 62.5% complete response. As of the cutoff date (September 26, 2023), median progression-free survival (mPFS) and overall survival (mOS) were not reached (NR). The 2-year, 5-year, and 8-year PFS rates were 55.1%, 52.0%, and 52.0%. OS rate was 80.0% at 2 years, 62.5% at 5 years, and 54.3% at 8 years. Patients with progression of disease within 24 months (POD24) had worse prognosis than those without POD24, regarding mOS (41.2 months vs NR), 5-year OS (33.3% vs 94.4%), and 8-year OS (13.3% vs 94.4%). Common grade 3-4 adverse events were neutropenia (87.5%), leukopenia (80.0%), anemia (17.5%), and pneumonitis (17.5%). Conclusion This combination had long-term benefits and manageable tolerability, particularly with less cardiotoxicity, for aggressive PTCL, which might provide a favorable benefit-risk balance. ClinicalTrials.gov Identifier Chinese Clinical Trial Registry, ChiCTR2100054588; IRB Approved: Ethics committee of Fudan University Shanghai Cancer Center (Date 2015.8.31/No. 1508151-13.
- Subjects
THERAPEUTIC use of antineoplastic agents; THERAPEUTIC use of alkaloids; T-cell lymphoma; LEUCOPENIA; ANEMIA; PNEUMONIA; CANCER invasiveness; PATIENT safety; CLINICAL trials; PREDNISONE; CANCER patients; DESCRIPTIVE statistics; VINCRISTINE; KAPLAN-Meier estimator; LOG-rank test; DOXORUBICIN; DRUG efficacy; PROGRESSION-free survival; COMPARATIVE studies; DATA analysis software; CYCLOPHOSPHAMIDE; OVERALL survival; DISEASE progression; NEUTROPENIA; EVALUATION
- Publication
Oncologist, 2024, Vol 29, Issue 9, p819
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1093/oncolo/oyae108