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

Autor: Emanuele Zucca, Roger Stupp, Shu Fang Hsu Schmitz, Urs Utiger, Simona Bassi, Rolf A. Stahel, Emmie Okkinga, Pierre-Yves Dietrich, Marc Heizmann, Daniel A. Vorobiof, Michele Ghielmini, Urs Hess, Giovanni Martinelli, Thomas Cerny, Andreas Lohri
Přispěvatelé: University of Zurich, Ghielmini, M
Jazyk: angličtina
Rok vydání: 2010
Předmět:
Cancer Research
medicine.medical_specialty
Time Factors
medicine.medical_treatment
Follicular lymphoma
Antineoplastic Agents
610 Medicine & health
Lymphoma
Follicular/*drug therapy
Disease-Free Survival
Drug Administration Schedule
law.invention
Antibodies
Monoclonal
Murine-Derived
Randomized controlled trial
Maintenance therapy
law
medicine
Humans
1306 Cancer Research
Antibodies
Monoclonal/administration & dosage/*therapeutic use
Prospective Studies
Prospective cohort study
Lymphoma
Follicular
Proportional Hazards Models
ddc:616
Chemotherapy
business.industry
Remission Induction
Antibodies
Monoclonal
Middle Aged
Prognosis
medicine.disease
Surgery
Lymphoma
Clinical trial
Treatment Outcome
Oncology
Multivariate Analysis
10032 Clinic for Oncology and Hematology
Rituximab
2730 Oncology
Antineoplastic Agents/administration & dosage/therapeutic use
business
Follow-Up Studies
medicine.drug
Zdroj: Journal of Clinical Oncology, Vol. 28, No 29 (2010) pp. 4480-4484
ISSN: 0732-183X
DOI: 10.5167/uzh-53278
Popis: 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.
Databáze: OpenAIRE
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