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

Martinelli, Giovanni
Schmitz, Shu-Fang Hsu
Utiger, Urs
Cerny, Thomas
Hess, Urs
Bassi, Simona
Okkinga, Emmie
Stupp, Roger
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Published in Journal of clinical oncology. 2010, vol. 28, no. 29, p. 4480-4484
Abstract 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.
Keywords Antibodies, Monoclonal/administration & dosage/*therapeutic useAntibodies, Monoclonal, Murine-DerivedAntineoplastic Agents/administration & dosage/therapeutic useDisease-Free SurvivalDrug Administration ScheduleFollow-Up StudiesHumansLymphoma, Follicular/*drug therapyMiddle AgedMultivariate AnalysisPrognosisProportional Hazards ModelsProspective StudiesRemission InductionTime FactorsTreatment Outcome
PMID: 20697092
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Other version: http://jco.ascopubs.org/content/28/29/4480.full.pdf
Research group Immunothérapie des cancers (42)
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MARTINELLI, Giovanni et al. Long-term follow-up of patients with follicular lymphoma receiving single-agent rituximab at two different schedules in trial SAKK 35/98. In: Journal of clinical oncology, 2010, vol. 28, n° 29, p. 4480-4484. doi: 10.1200/JCO.2010.28.4786 https://archive-ouverte.unige.ch/unige:21118

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Deposited on : 2012-05-23

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