Rituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-label randomised phase 3 trial

Summary Background Patients with advanced-stage, low-tumour-burden follicular lymphoma have conventionally undergone watchful waiting until disease progression. We assessed whether rituximab use could delay the need for chemotherapy or radiotherapy compared with watchful waiting and the effect of th...

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Bibliographic Details
Published in:The lancet oncology 2014-04, Vol.15 (4), p.424-435
Main Authors: Ardeshna, Kirit M, Dr, Qian, Wendi, PhD, Smith, Paul, MSc, Braganca, Nivette, MSc, Lowry, Lisa, FRCPath, Patrick, Pip, PhD, Warden, June, MSc, Stevens, Lindsey, Pocock, Christopher F E, PhD, Miall, Fiona, MD, Cunningham, David, Prof, Davies, John, FRCP, Jack, Andrew, FRCP, Stephens, Richard, MA, Walewski, Jan, MD, Ferhanoglu, Burhan, Prof, Bradstock, Ken, Prof, Linch, David C, Prof
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Murine-Derived - administration & dosage
Antibodies, Monoclonal, Murine-Derived - adverse effects
Antibodies, Monoclonal, Murine-Derived - therapeutic use
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Asymptomatic Diseases
Australia
Biopsy
Cancer
Cancer therapies
Disease Progression
Disease-Free Survival
Drug Administration Schedule
Europe
Female
Hematology, Oncology and Palliative Medicine
Humans
Illnesses
Intention to Treat Analysis
Kaplan-Meier Estimate
Lymphoma
Lymphoma, Follicular - drug therapy
Lymphoma, Follicular - mortality
Lymphoma, Follicular - pathology
Male
Medical imaging
Medical research
Medical treatment
Middle Aged
Neoplasm Grading
Neoplasm Staging
New Zealand
Patient Selection
Proportional Hazards Models
Quality of Life
Radiation therapy
Risk Factors
Rituximab
Time Factors
Treatment Outcome
Watchful Waiting
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Summary:Summary Background Patients with advanced-stage, low-tumour-burden follicular lymphoma have conventionally undergone watchful waiting until disease progression. We assessed whether rituximab use could delay the need for chemotherapy or radiotherapy compared with watchful waiting and the effect of this strategy on quality of life (QoL). Methods Asymptomatic patients (aged ≥18 years) with low-tumour-burden follicular lymphoma (grades 1, 2, and 3a) were randomly assigned centrally (1:1:1), by the minimisation approach stratified by institution, grade, stage, and age, to watchful waiting, rituximab 375 mg/m2 weekly for 4 weeks (rituximab induction), or rituximab induction followed by a maintenance schedule of 12 further infusions given at 2-monthly intervals for 2 years (maintenance rituximab). On Sept 30, 2007, recruitment into the rituximab induction group was closed and the study was amended to a two-arm study. The primary endpoints were time to start of new treatment and QoL at month 7 (ie, 6 months after completion of rituximab induction). All randomly assigned patients were included in the analysis of time to start of new treatment on an intention-to-treat basis. The main study is now completed and is in long-term follow-up. The study is registered with ClinicalTrials.gov , NCT00112931. Findings Between Oct 15, 2004, and March 25, 2009, 379 patients from 118 centres in the UK, Australia, New Zealand, Turkey, and Poland were randomly assigned to watchful waiting or maintenance rituximab. 84 patients were recruited to the rituximab induction group before it was closed early. There was a significant difference in the time to start of new treatment, with 46% (95% CI 39–53) of patients in the watchful waiting group not needing treatment at 3 years compared with 88% (83–92) in the maintenance rituximab group (hazard ratio [HR] 0·21, 95% CI 0·14–0·31; p
ISSN:1470-2045
1474-5488
DOI:10.1016/S1470-2045(14)70027-0