Abstract | 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 (< or =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> or =2), > or =2 extranodal sites and high beta2-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 > or =2 and high beta2-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.
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Authors | Silvia Montoto, Carol Moreno, Eva Domingo-Doménech, Cristina Estany, Albert Oriol, Albert Altés, Joan Besalduch, Carme Pedro, Santiago Gardella, Lourdes Escoda, Antoni Asensio, Pilar Vivancos, Pilar Galán, Alberto Fernández de Sevilla, Josep M Ribera, Javier Briones, Dolors Colomer, Elías Campo, Emili Montserrat, Armando López-Guillermo, Grup per l'Estudi dels Limfomes de Catalunya I Balears (GELCAB) Spain |
Journal | Haematologica
(Haematologica)
Vol. 93
Issue 2
Pg. 207-14
(Feb 2008)
ISSN: 1592-8721 [Electronic] Italy |
PMID | 18223288
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- beta 2-Microglobulin
- Cyclophosphamide
- Mitoxantrone
- Vidarabine
- fludarabine
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Topics |
- Adult
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects)
- Cyclophosphamide
(administration & dosage, adverse effects)
- Disease-Free Survival
- Female
- Follow-Up Studies
- Humans
- Lymphoma, Follicular
(drug therapy, metabolism, mortality)
- Male
- Middle Aged
- Mitoxantrone
(administration & dosage, adverse effects)
- Neoplasm Staging
- Recurrence
- Survival Rate
- Vidarabine
(administration & dosage, adverse effects, analogs & derivatives)
- beta 2-Microglobulin
(biosynthesis)
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