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Phase 2 study of pegylated liposomal doxorubicin plus cyclophosphamide, vincristine/vindesine, and prednisone in newly diagnosed PTCL: 8-year results.
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.
Afiliación
  • Xia ZG; Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
  • Lv FF; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.
  • Zhang QL; Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
  • Liu YZ; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.
  • Zhang SJ; Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
  • Liu C; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.
  • Li XQ; Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
  • Wen Y; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.
  • Wu ZY; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.
  • Hong XN; Department of Radiology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
  • Guo Y; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.
  • Cao JN; Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Oncologist ; 29(9): 819-e1223, 2024 Sep 06.
Article en En | MEDLINE | ID: mdl-38821519
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Polietilenglicoles / Vincristina / Prednisona / Protocolos de Quimioterapia Combinada Antineoplásica / Doxorrubicina / Linfoma de Células T Periférico / Ciclofosfamida Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Oncologist Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Polietilenglicoles / Vincristina / Prednisona / Protocolos de Quimioterapia Combinada Antineoplásica / Doxorrubicina / Linfoma de Células T Periférico / Ciclofosfamida Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Oncologist Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido