Original Article

Bone Marrow Transplantation (2006) 38, 217–222. doi:10.1038/sj.bmt.1705414; published online 12 June 2006

Autografting

A phase II trial of rituximab as adjuvant to intensive sequential chemotherapy in patients under 60 years with untreated poor-prognosis diffuse large B-cell lymphoma

D Coso1, C Sebban2, O Boulat3, P Biron2, J Rey1, T Aurran1, C Chabannon1, L Xerri1, B Chetaille1, B Esterni1, V Ivanov1, A M Stoppa1, J M Schiano de Collela1, J A Gastaut1, D Maraninchi1 and R Bouabdallah1

  1. 1Department of Hematology, Cancer Center Institut J Paoli - I Calmettes, Marseille Cedex, France
  2. 2Department of Medicine, Cancer Center Léon Bérard, Lyon, France
  3. 3Department of Medicine, Hopital La Durance, Avignon, France

Correspondence: Dr R Bouabdallah, Department of Hematology, Cancer Center Institut J Paoli – I Calmettes, 232, Boulevard Sainte-Marguerite, BP 156, 13273 Marseille Cedex 09, France. E-mail: bouabdr@marseille.fnclcc.fr

Received 23 November 2005; Revised 19 April 2006; Accepted 2 May 2006; Published online 12 June 2006.

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Abstract

The potential benefit of rituximab as adjuvant to high-dose therapy (HDT) has been investigated in patients under 60 years with poor-risk (age-adjusted international prognostic index at 2–3) CD20+ diffuse large B-cell lymphoma (DLBCL). The treatment consisted of four cycles of high-dose CEOP (cyclophosphamide, epirubicin, vincristine, prednisone), plus etoposide and cisplatin during the two last cycles. Peripheral blood stem cells were collected after cycle 1, and reinfused after cycles 3 and 4. Four weekly rituximab infusions were subsequently delivered. Among the 36 patients included, 30 could complete chemotherapy schedule, and 24/36 received rituximab. A complete response occured in 26/36 patients (72%). With a median follow-up of 30 months, the estimated 5-year overall survival (OS) and event-free survival (EFS) rates (meanplusminuss.d.) were 65plusminus16 and 63plusminus15%, respectively. For the 24 patients who received both chemotherapy and rituximab, the estimated 5-year OS and EFS rates were 86plusminus14 and 82plusminus15%. These data suggest that rituximab after HDT is feasible. Both complete remission rate and survival curves compare favorably with the poor outcome usually observed in high-risk DLBCL patients managed with HDT without rituximab.

Keywords:

aggressive lymphoma, high-dose chemotherapy, rituximab, survival

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