Published online 26 January 2008
Haematologica, Vol 93, Issue 2, 207-214 doi:10.3324/haematol.11671
Copyright © 2008 by Ferrata Storti Foundation
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Malignant Lymphomas

High clinical and molecular response rates with fludarabine, cyclophosphamide and mitoxantrone in previously untreated patients with advanced stage follicular lymphoma

Silvia Montoto1, Carol Moreno2, Eva Domingo-Doménech3, Cristina Estany4, Albert Oriol5, Albert Altés6, Joan Besalduch7, Carme Pedro8, Santiago Gardella9, Lourdes Escoda10, Antoni Asensio11, Pilar Vivancos12, Pilar Galán, Alberto Fernández de Sevilla3, Josep M. Ribera5, Javier Briones6, Dolors Colomer2, Elías Campo2, Emili Montserrat1, Armando López-Guillermo1, for the Grup per l’Estudi dels Limfomes de Catalunya I Balears (GELCAB) Spain

1 Department of Hematology, Hospital Clínic, IDIBAPS, Barcelona;
2 Hematopathology Unit, Hospital Clínic, IDIBAPS, Barcelona;
3 Department of Hematology, Hospital Duran i Reynals, Hospitalet de Llobregat;
4 Department of Hematology, Mútua de Terrassa, Terrassa;
5 Department of Hematology, Hospital Germans Trias i Pujol, Badalona;
6 Department of Hematology, Hospital de Sant Pau, Barcelona;
7 Department of Hematology, Hospital Son Dureta, Palma de Mallorca;
8 Department of Hematology, Hospital del Mar, Barcelona;
9 Department of Hematology, Hospital Dr. Trueta, Girona;
10 Department of Hematology, Hospital Joan XXIII, Tarragona;
11 Department of Hematology, Hospital Sant Camil, Sant Pere de Ribas and
12 Department of Hematology, Clínica Teknon, Barcelona, Spain

Correspondence: Armando López-Guillermo, MD, Department of Hematology, Hospital Clínic, Villarroel 170, 08036-Barcelona, Spain. E-mail: alopezg{at}clinic.ub.es

Background: Purine analogs have demonstrated significant activity in patients with follicular lymphoma. The aim of this study was to analyze the efficacy and toxicity of a fludarabine combination as first-line treatment in patients with advanced-stage disease.

Design and Methods: This is a phase II trial including 120 patients (≤65 years) treated with 6 cycles of fludarabine, cyclophosphamide and mitoxantrone (FCM). Molecular response was assessed by q-PCR in peripheral blood.

Results: Of 119 patients with an assessable response, complete response was achieved in 99 (83%) partial response in 13 (11%) and 7 (6%) did not respond. After treatment, 37 out of 46 (81%) patients achieved molecular response. After a median follow-up of 3.9 years, 32 patients have relapsed. The 5-year progression-free survival was 58% (95% confidence interval: 47–69). Variables associated with a shorter progression-free survival were a poor performance status (ECOG≥2), ≥2 extranodal sites and high β2-microglobulin. Sixteen episodes of grade 3–4 infections were observed. Two patients died during therapy (of progressive multifocal leukoencephalopathy and bronchoaspiration respectively). No late toxicity has been observed. Twelve patients died during follow-up (9 after relapse, 2 during chemotherapy, 1 in complete remission after surgery for meningioma). The overall survival at 5 years was 89%. ECOG ≥2 and high β2-microglobulin were associated with a shorter survival.

Conclusions: FCM results in high complete and molecular response rates, with prolonged response duration in younger patients with advanced-stage follicular lymphoma. The combination of FCM with rituximab as front-line treatment warrants further investigation.

Key words: follicular lymphoma, treatment, molecular response, outcome.


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