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On 18th January 2017, Laura Magnano from the Hospital Clínic de Barcelona, Barcelona, Spain, and colleagues published results of their 12 year follow up1 of a phase II GELCAB trial in the Annals of Hematology.
The phase II trial, previously reported in Haematologica in 2008 by Silvia Montoto et al., investigated fludarabine, mitoxantrone, and cyclophosphamide (FCM) to treat previously untreated FL patients with advanced stage disease.2 The current follow up report focuses on FCM’s effect on survival, relapse, and late toxicities.
Based on this long follow up data, the authors stated that FCM regimen allows high rates of overall response (93%) and demonstrates prolonged PFS. They also stated that the regimen had a high molecular response rate. Currently, there are concerns with using fludarabine containing regimens for treatment of lymphoma, mainly due to concerns relating to late toxicities. The authors of the follow up reported that the most common causes of death were disease progression (62%) and secondary malignancies (19%). This low, but not unimportant, incidence of secondary malignancies indicates that it is paramount that patients in prolonged remission stay in care and complete appropriate testing for secondary malignancies.
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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