Carlo Visco1, Silvia Finotto1, Renato Zambello1,2, Rossella Paolini1,3, Andrea Menin1, Roberta Zanotti1,4, Francesco Zaja1,2, Gianpietro Semenzato1, Giovanni Pizzolo1,4, Emanuele S.G. dʼAmore1, Francesco Rodeghiero1,2
1Carlo Visco, Silvia Finotto, Andrea Menin, Emanuele S.G. D'Amore, and Francesco Rodeghiero, San Bortolo Hospital, Vicenza; Renato Zambello and Gianpietro Semenzato, Padua University School of Medicine, Padova; Rossella Paolini, Santa Maria della Misericordia Hospital, Rovigo; Roberta Zanotti and Giovanni Pizzolo, University of Verona, Verona; and Francesco Zaja, Azienda Ospedaliera Universitaria Santa Maria Misericordia, Udine, Italy.
2San Bortolo Hospital, Vicenza;
3della Misericordia Hospital, Rovigo;
4University of Verona, Verona
Tóm tắt
Purpose The combination of bendamustine (B) and rituximab (R) is efficacious, with favorable toxicity in mantle-cell lymphoma (MCL). In this phase II study, we combined cytarabine with R and B (R-BAC) in patients with MCL age ≥ 65 years who were previously untreated or relapsed or refractory (R/R) after one prior immunochemotherapy treatment. Patients and Methods In stage one, we established the maximum-tolerated dose (MTD) of cytarabine in R-BAC. In stage two, patients received R (375 mg/m2 intravenously [IV] on day 1), B (70 mg/m2 IV on days 2 and 3), and cytarabine (MTD IV on days 2 to 4) every 28 days for four to six cycles. The primary end point (overall response rate [ORR]) was evaluated by positron emission tomography. Secondary end points included safety, progression-free survival (PFS), response duration, and overall survival. Results Forty patients (median age, 70 years; 20 previously untreated patients) were enrolled; 93% had Ann Arbor stage III/IV disease; 49% had high Mantle Cell International Prognostic Index scores, with 15% blastoid histology. All R/R patients (35% refractory) had previously received R-containing regimens. The cytarabine MTD used in stage two was 800 mg/m2, and R-BAC was well tolerated, with an 85% treatment completion rate. The major toxicity was transient grades 3 to 4 thrombocytopenia (87% of patients); febrile neutropenia occurred in 12%. The ORR was 100% (95% complete response [CR]) for previously untreated and 80% (70% CR) for R/R patients. The 2-year PFS rate (± standard deviation) was 95% ± 5% for untreated and 70% ± 10% for R/R patients. Conclusion R-BAC is well tolerated and active against MCL.
