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- Title
Prospective phase II study of rituximab with alternating cycles of hyper- CVAD and high-dose methotrexate with cytarabine for young patients with high-risk diffuse large B-cell lymphoma.
- Authors
Oki, Yasuhiro; Westin, Jason R.; Vega, Francisco; Chuang, Hubert; Fowler, Nathan; Neelapu, Sattva; Hagemeister, Fredrick B.; McLaughlin, Peter; Kwak, Larry W.; Romaguera, Jorge E.; Fanale, Michelle; Younes, Anas; Rodriguez, Maria Alma; Orlowski, Robert Z.; Wang, Michael; Ouzounian, Souzanne T.; Samaniego, Felipe; Fayad, Luis
- Abstract
We conducted a prospective randomized phase II study to evaluate two chemotherapy regimens: (i) rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin and dexamethasone ( R- HCVAD) alternating with rituximab, high-dose methotrexate, and cytarabine ( R- MA) and (ii) rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone ( R- CHOP) in diffuse large B-cell lymphoma ( DLBCL). This study randomized patients aged ≤60 years with DLBCL and an age-adjusted international prognostic index ≥2 to R- HCVAD/ R- MA or R- CHOP based on a Bayesian adaptive algorithm. Interim analysis of the first 26 eligible patients showed that the complete response rate ( CRR) was higher with R- HCVAD/ R- MA than R- CHOP ( P = 0·03); thus, R- CHOP arm was closed. In the final analysis, 49 and 10 eligible patients were treated in R- HCVAD/ R- MA and R- CHOP arms respectively; CRR were 82% and 60% respectively ( P = 0·13); 3-year progression-free survival ( PFS) rates were 75·7% and 77·8% respectively ( P = 0·53). In the R- HCVAD/ R- MA arm, 3-year PFS rates in patients aged 46-60 years and ≤45 years were 70·3% and 87·1% respectively ( P = 0·13), and the treatment-associated early mortality rate in patients >45 years was 12%. In conclusion, R- HCVAD/ R- MA is associated with excellent outcome in patients ≤45 years old. However, in patients >45 years old, R- HCVAD/ R- MA is associated with unacceptable mortality rates.
- Subjects
LYMPHOMA treatment; B cell lymphoma; CLINICAL trials; RITUXIMAB; DOXORUBICIN; DEXAMETHASONE; CANCER chemotherapy; CYTARABINE; METHOTREXATE; TUMOR treatment
- Publication
British Journal of Haematology, 2013, Vol 163, Issue 5, p611
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/bjh.12585