Publikation

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

Wissenschaftlicher Artikel/Review - 09.08.2010

Bereiche
PubMed
DOI

Zitation
Martinelli G, Zucca E, Dietrich P, Lohri A, Vorobiof D, Heizmann M, Stahel R, Stupp R, Okkinga E, Bassi S, Hess U, Cerny T, Utiger U, Schmitz S, Ghielmini M. Long-term follow-up of patients with follicular lymphoma receiving single-agent rituximab at two different schedules in trial SAKK 35/98. J Clin Oncol 2010; 28:4480-4.
Art
Wissenschaftlicher Artikel/Review (Englisch)
Zeitschrift
J Clin Oncol 2010; 28
Veröffentlichungsdatum
09.08.2010
eISSN (Online)
1527-7755
Seiten
4480-4
Kurzbeschreibung/Zielsetzung

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.