Long-term follow-up of patients with follicular lymphoma receiving single-agent rituximab at two different schedules in trial SAKK 35/98.


Autoria(s): Martinelli G.; Schmitz S.F.; Utiger U.; Cerny T.; Hess U.; Bassi S.; Okkinga E.; Stupp R.; Stahel R.; Heizmann M.; Vorobiof D.; Lohri A.; Dietrich P.Y.; Zucca E.; Ghielmini M.
Data(s)

2010

Resumo

PURPOSE: We report the long-term results of a randomized clinical trial comparing induction therapy with once per week for 4 weeks single-agent rituximab alone versus induction followed by 4 cycles of maintenance therapy every 2 months in patients with follicular lymphoma. PATIENTS AND METHODS: Patients (prior chemotherapy 138; chemotherapy-naive 64) received single-agent rituximab and if nonprogressive, were randomly assigned to no further treatment (observation) or four additional doses of rituximab given at 2-month intervals (prolonged exposure). RESULTS: At a median follow-up of 9.5 years and with all living patients having been observed for at least 5 years, the median event-free survival (EFS) was 13 months for the observation and 24 months for the prolonged exposure arm (P < .001). In the observation arm, patients without events at 8 years were 5%, while in the prolonged exposure arm they were 27%. Of previously untreated patients receiving prolonged treatment after responding to rituximab induction, at 8 years 45% were still without event. The only favorable prognostic factor for EFS in a multivariate Cox regression was the prolonged rituximab schedule (hazard ratio, 0.59; 95% CI, 0.39 to 0.88; P = .009), whereas being chemotherapy naive, presenting with stage lower than IV, and showing a VV phenotype at position 158 of the Fc-gamma RIIIA receptor were not of independent prognostic value. No long-term toxicity potentially due to rituximab was observed. CONCLUSION: An important proportion of patients experienced long-term remission after prolonged exposure to rituximab, particularly if they had no prior treatment and responded to rituximab induction.

Identificador

http://serval.unil.ch/?id=serval:BIB_2B7C3E6161FB

isbn:1527-7755[electronic], 0732-183X[linking]

pmid:20697092

doi:10.1200/JCO.2010.28.4786

isiid:000282643600037

Idioma(s)

en

Fonte

Journal of Clinical Oncology, vol. 28, no. 29, pp. 4480-4484

Palavras-Chave #non-hodgkins-lymphoma; stem-cell transplantation; randomized phase-ii; event-free survival; maintenance therapy; indolent lymphoma; chemotherapy; fludarabine; interferon; cancer
Tipo

info:eu-repo/semantics/article

article