A phase Ⅰ dose-escalating trial of pegylated liposomal doxorubicin in combination with cyclophosphamide, vincristine and prednisone for aggressive non-Hodgkin lymphoma

• Published in: Zhōnghuá xuèyèxué zázhì 2016-12, Vol.37 (12), p.1044-1048
• Main Authors: Shen, W N, Ji, D M, Xue, K, Zhang, Q L, Lyu, F F, Hong, X N, Cao, J N, Guo, Y
• Format: Article
• Language: Chinese
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cyclophosphamide - administration & dosage; Doxorubicin - administration & dosage; Doxorubicin - analogs & derivatives; Female; Humans; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Male; Middle Aged; Neutropenia; Polyethylene Glycols - administration & dosage; Prednisolone - administration & dosage; Prednisone; Treatment Outcome; Vincristine - administration & dosage
• ISSN: 0253-2727
• DOI: 10.3760/cma.j.issn.0253-2727.2016.12.007

To explore the maximum tolerated dose of pegylated liposomal doxorubicin (PLD) in combination with cyclophosphamide, vincristine and prednisone as a modified CHOP regimen for aggressive non-Hodgkin lymphoma. Patients with newly diagnosed aggressive non-Hodgkin lymphoma were eligible for this trial. PLD was administered in cycle 1 and categorized into 4 dose level (30 mg/m , 35 mg/m , 40 mg/m , 45 mg/m D1) according to a 3 + 3 approach for dose-escalation. Doxorubin was used in cycles 2-6. In this combination regimen, the doses of cyclophosphamide (750 mg/m D1), vincristine (1.4 mg/m D1, maximum dose of 2 mg) and prednisone (100 mg D1-5) were fixed. Toxicities of cycle 1 were documented. Totally, 21 patients were enrolled in this trial. Among them, 15 patients had T-cell lymphoma and 6 had B-cell lymphoma. When the dose of PLD was escalated to the level of 45 mg/m , 2 of 3 patients developed grade 3 mucositis, which met the criteria of dose-limiting toxicity. Therefore, the dose was de-escalated for one level.