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Long-term safety and outcome of fludarabine, cyclophosphamide and mitoxantrone (FCM) regimen in previously untreated patients with advanced follicular lymphoma: 12 years follow-up of a phase 2 trial

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Abstract

Fludarabine combinations are very affective in follicular lymphoma (FL) with high rates of complete response and prolonged survival. However, late toxicities could be a concern. The aim of the present study was to analyze the long-term impact on survival, relapse and late toxicities of a trial of treatment with fludarabine, mitoxantrone and cyclophosphamide (FCM regimen) for untreated patients with advanced stage FL. One hundred and twenty patients enrolled in a phase 2 trial of treatment with FCM regimen between 2000 and 2003 were evaluated. After a median follow-up of 12 years, 52 patients eventually relapsed/progressed with 10 year progression-free survival (PFS) of 46 %. Ten patients showed histological transformation to aggressive lymphoma with a risk of transformation of 2 and 9 % at 5 and 10 years, respectively. Three patients developed therapy-related myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML) and seven solid neoplasms with an overall risk of 3 and 8 % at 5 and 10 years, respectively. Twenty-six patients eventually died during the follow-up. Overall survival at 10 years was 83 %. In conclusion, FCM regimen allows excellent long-lasting response in previously untreated patients with FL. The incidence of late events including histological transformation and secondary neoplasia is low but not negligible.

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Authors and Affiliations

  1. Department of Hematology, Hospital Clinic, IDIBAPS, CIBERONC, Villarroel, 170, 08036, Barcelona, Spain

    Laura Magnano & Armando López-Guillermo

  2. Department of Hematology, Barts Cancer Institute, QMUL, London, UK

    Silvia Montoto

  3. Department of Hematology, Hospital Duran y Reynals, Hospitalet de Llobregat, Spain

    Eva González-Barca, Eva Domingo-Domenech & Alberto Fernández de Sevilla

  4. Department of Hematology, Hospital de Sant Pau, Barcelona, Spain

    Javier Briones, Carol Moreno & Albert Altés

  5. Department of Hematology, ICO-Hospital Germans Trias y Pujol, Badalona, Spain

    Juan Manuel Sancho, Albert Oriol & Josep María Ribera

  6. Department of Hematology, Mutua de Terrasa, Terrasa, Spain

    Ana Muntañola & Cristina Estany

  7. Department of Hematology, Hospital del Mar, Barcelona, Spain

    Antonio Salar & Carmen Pedro

  8. Department of Hematology, Hospital Son Espases, Palma de Mallorca, Spain

    Joan Besalduch

  9. Department of Hematology, Hospital Joan XXIII, Tarragona, Spain

    Lourdes Escoda

  10. Department of Hematology, Hospital Doctor Josep Trueta, Girona, Spain

    Santiago Gardella

  11. Department of Hematology, Hospital Sant Camil, Sant Pere de Ribas, Spain

    Antoni Asensio

  12. Department of Hematology, Centro Médico Teknon, Barcelona, Spain

    Pilar Vivancos

  13. Hematopathology Unit, Hospital Clínic, IDIBAPS, CIBERONC, Barcelona, Spain

    Dolors Colomer & Elias Campo

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  1. Laura Magnano
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Correspondence to Armando López-Guillermo.

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Magnano, L., Montoto, S., González-Barca, E. et al. Long-term safety and outcome of fludarabine, cyclophosphamide and mitoxantrone (FCM) regimen in previously untreated patients with advanced follicular lymphoma: 12 years follow-up of a phase 2 trial. Ann Hematol 96, 639–646 (2017). https://doi.org/10.1007/s00277-017-2920-2

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