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; Stahel, Rolf; Heizmann, Marc; Vorobiof, Daniel; Lohri, Andreas; Dietrich, Pierre-Yves; Zucca, Emanuele; Ghielmini, Michele

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Title		Long-term follow-up of patients with follicular lymphoma receiving single-agent rituximab at two different schedules in trial SAKK 35/98
Authors		Martinelli, Giovanni Schmitz, Shu-Fang Hsu Utiger, Urs Cerny, Thomas Hess, Urs Bassi, Simona Okkinga, Emmie Stupp, Roger Stahel, Rolf Heizmann, Marc Vorobiof, Daniel Lohri, Andreas Dietrich, Pierre-Yves Zucca, Emanuele Ghielmini, Michele show all authors [1 - 15]
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 use — Antibodies, Monoclonal, Murine-Derived — Antineoplastic Agents/administration & dosage/therapeutic use — Disease-Free Survival — Drug Administration Schedule — Follow-Up Studies — Humans — Lymphoma, Follicular/drug therapy — Middle Aged — Multivariate Analysis — Prognosis — Proportional Hazards Models — Prospective Studies — Remission Induction — Time Factors — Treatment Outcome
Identifiers		DOI: 10.1200/JCO.2010.28.4786 PMID: 20697092
Full text		Article - Limited access to UNIGE Other version: http://jco.ascopubs.org/content/28/29/4480.full.pdf
Structures		Faculté de médecine / Section de médecine clinique / Département de médecine interne des spécialités
Research group		Immunothérapie des cancers (42)
Citation (ISO format)		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. https://archive-ouverte.unige.ch/unige:21118