PEGYLATED LIPOSOMAL DOXORUBICIN COMBINED WITH CYCLOPHOSPHAMIDE, VINCRISTINE/VINDESINE, AND PREDNISONE IN PATIENTS WITH AGGRESSIVE T‐CELL LYMPHOMA: PRELIMINARY RESULTS OF APHASE II STUDY

Abstract

Introduction: Anthracycline-based chemotherapy is commonly used as the first line treatment for aggressive T-cell lymphoma. The aim of this study was to evaluate the efficacy and toxicity of pegylated liposomal doxorubicin (PLD) combined with cyclophosphamide, vincristine/vindesine, and prednisone in patients with aggressive T-cell lymphoma. Methods: Patients with newly diagnosed aggressive T-cell lymphoma except for NK/T-cell lymphoma were eligible and treated with 6 cycles of PLD (40 mg/m2 day 1), cyclophosphamide (750 mg/m2 day 1), vincristine (1.4 mg/m2 day 1) or vindesine (2 mg/m2 day 1) and prednisone (100 mg days 1–5). The primary endpoint was the overall response rate (ORR). Results: A total of 40 patients were enrolled, and 39 were evaluable for response assessment. The patient characteristics were shown in Table 1. The ORR was 84.6%, and 18 patients (46.2%) achieved the complete response (CR). The ORRs of patients with 3 major histology (PTCL nos, ALCL and AITL) were 72.2%, 90.9% and 100%, respectively. The common grade 3/4 toxicities included neutropenia (87.5%), anemia (17.5%), pneumonia (15%) and mucositis (7.5%). Although 7 patients (17.5%) developed hand-foot syndrome and only 1 was grade 3, no treatment-related mortality was observed. Conclusions: This PLD-containing regimen is effective and tolerable in patients with aggressive T-cell lymphoma. Longer follow-up time is needed for analyzing the survival results. Keywords: anthracycline; Chemotherapy; T-cell lymphoma (TCL).