Watchful Waiting in Low–Tumor Burden Follicular Lymphoma in the Rituximab Era: Results of an F2-Study Database

• Published in: Journal of clinical oncology Vol. 30; no. 31; pp. 3848 - 3853
• Main Authors: SOLAL-CELIGNY, Philippe, BELLEI, Monica, DECONINCK, Eric, MILPIED, Noel, GORDON, Leo I, FEDERICO, Massimo, MARCHESELLI, Luigi, PESCE, Emanuela Anna, PILERI, Stefano, MCLAUGHLIN, Peter, LUMINARI, Stefano, PRO, Barbara, MONTOTO, Silvia, FERRERI, Andrés J. M
• Format: Journal Article
• Language: English
• Published: Alexandria, VA American Society of Clinical Oncology 01-11-2012
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Murine-Derived - administration & dosage; Antibodies, Monoclonal, Murine-Derived - adverse effects; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Cohort Studies; Female; Hematologic and hematopoietic diseases; Humans; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Lymphoma, Follicular - diagnosis; Lymphoma, Follicular - drug therapy; Lymphoma, Follicular - pathology; Male; Medical sciences; Middle Aged; Rituximab; Treatment Outcome; Tumor Burden; Tumors; Watchful Waiting; Antineoplastic agent; Rituximab; B cell neoplasm; Malignant hemopathy; Monoclonal antibody; Lymphoid neoplasm; Non Hodgkin lymphoma; Watchful waiting; Cancerology; Treatment; Lymphoproliferative syndrome; Immunotherapy; Database; Follicular lymphoma; Tumor; Cancer
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2010.33.4474

Patients with follicular lymphoma (FL) registered in the F2-study and initially managed without treatment were analyzed to describe the presentation and outcome of a watch and wait (W&W) strategy in the rituximab era, to identify parameters for initiating treatment, and to evaluate whether initial W&W could have deleterious effects on treatment efficacy after progression or relapse.
Between 2003 and 2005, 120 patients selected from the 1,093 treatment-naive patients with FL in the F2-study cohort were initially managed expectantly (W&W), and 107 patients were assessed. Most of these patients (80%) had disseminated disease with a low tumor burden according to Groupe d'Etudes des Lymphomes Folliculaires criteria.
After a median follow-up of 64 months, treatment was initiated in 54 patients (50%), with a median delay of 55 months for the entire cohort. In a univariate analysis, involvement of more than four nodal areas (hazard ratio [HR], 2.26) and serum albumin less than 3.5 g/dL (HR, 3.51) were predictive of a shorter time to lymphoma treatment initiation. In a multivariate analysis, only involvement of more than four nodal areas remained significant (HR, 2.32). The 4-year freedom from treatment failure (FFTF) rate of W&W patients (79%; 95% CI, 69% to 85%) was not inferior to that of a subgroup of 242 patients from the F2-study cohort with good prognosis characteristics who were initially treated with a rituximab-based regimen (69%; 95% CI, 61% to 76%; P = .103).
In the rituximab era, patients with FL in a selected prognostically favorable group can still be managed with W&W. W&W does not seem to have detrimental effects on FFTF and overall survival rates after treatment.