Background: Pirarubicin (THP) is an anthracycline which was introduced to the Japanese market due to less cardiotoxicity compared to doxorubicin. The efficacy of THP-COP regimen (THP, cyclophosphamide (CPM), vincristine (VCR) and prednisolone (PSL)) was compared with CHOP in elderly patients with non- Hodgkin’s lymphoma in the previous Japanese randomized trial [Int J Hematol 81, 246–254, 2005]. The subset analysis showed peripheral T cell lymphoma (PTCL) had significantly better complete response (CR) rate with THP-COP than that of CHOP, whereas no such difference was observed in patients with B cell lymphoma.

Methods: We underwent a multicenter phase II study to investigate the efficacy of THP-COP as a first line treatment for PTCL and adult T cell leukemia/lymphoma (ATLL). THP 50 mg/m2, CPM 750 mg/m2, and VCR 1.4 mg/m2 were given intravenously on day 1. PSL 60 mg/m2 was administered orally on days 1–5. The treatment was repeated at a 21-day interval, and its efficacy and toxicity were investigated.

Results: Fifty-three patients aged from 38 to 83 (median 66) were entered into this study. Twenty-six patients were male and 27 female. Seventeen patients had PTCL including PTCL-U and AILT, and 36 ATLL. Stage IV disease was seen in 33, stage III in 15, and stage II in 5 patients. Thirty-four (64%) patients responded to THP-COP, including 17 (32%) CR and 17 (32%) partial response (PR). The median time to progression and overall survival were 9.5 and 17.5 months, respectively. Grade 3 to 4 neutropenia, anemia and thrombocytopenia occurred in 38 (72%), 18 (34%) and 31 (58%) patients, respectively. Twenty-seven (51%) patients developed febrile neutropenia, while grade 3 of nausea, anorexia, fatigue, arrhythmia, cardiac ischemia, sensory neuropathy, hypoalbuminemia, hyperbilirubinemia, and elevated serum AST/ALT were observed in 1 to 6 (2–11%) patients. No other adverse events greater than grade 3 were encountered.

Conclusion: THP-COP is an effective and well-tolerated treatment regimen in patients with PTCL and ATLL as a first-line therapy.

Disclosures: No relevant conflicts of interest to declare.

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