PMID- 24668580 OWN - NLM STAT- MEDLINE DCOM- 20140930 LR - 20240322 IS - 1097-0142 (Electronic) IS - 0008-543X (Print) IS - 0008-543X (Linking) VI - 120 IP - 12 DP - 2014 Jun 15 TI - The use and effectiveness of rituximab maintenance in patients with follicular lymphoma diagnosed between 2004 and 2007 in the United States. PG - 1830-7 LID - 10.1002/cncr.28659 [doi] AB - BACKGROUND: The authors examined the "real-world" effectiveness of rituximab (R) maintenance therapy (R-maintenance) compared with observation after R-based induction therapy in patients with previously untreated follicular lymphoma (FL) in the United States. METHODS: The National LymphoCare Study is a prospective, multicenter, observational study that enrolled > 2700 untreated patients with FL diagnosed from 2004 to 2007 at 265 sites in the United States. Among these, patients who achieved at least stable disease after R-based induction therapy were eligible for the current analysis. Patients who initiated R-maintenance within 215 days of completing induction therapy were categorized as the R-maintenance group, and those who did not initiate therapy during this period were categorized as the observation group. The objective of the current study was to determine the effect of R-maintenance on progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS). RESULTS: A total of 1439 patients completed R-based induction therapy, 1186 of whom met all inclusion criteria (541 patients received R-maintenance and 645 patients were observed). Characteristics that were found to be predictive of receiving R-maintenance were histology grade (1/2), Ann Arbor stage of disease (III/IV), geographic region (region other than the West), and practice setting (community practice). With a median follow-up of 5.7 years, R-maintenance was associated with superior PFS (hazards ratio [HR], 0.68; 95% confidence interval [95% CI], 0.56-0.84 [P = .0003]) and TTNT (HR, 0.66; 95% CI, 0.52-0.84 [P = .0007]). No significant difference in OS was observed (HR, 0.81; 95% CI, 0.58-1.14 [P = .23]). CONCLUSIONS: R-maintenance in patients with FL and at least stable disease after R-based induction therapy provided significantly longer PFS and TTNT in comparison with observation, but no significant difference in OS was observed with 5-years of follow-up. This comparative effectiveness study aligns with the results of randomized trials suggesting that similar outcomes occur with R-maintenance in FL with the treatment variations observed in clinical practice. CI - (c) 2014 The Authors.Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. FAU - Nastoupil, Loretta J AU - Nastoupil LJ AD - Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Sinha, Rajni AU - Sinha R FAU - Byrtek, Michelle AU - Byrtek M FAU - Zhou, Xiaolei AU - Zhou X FAU - Taylor, Michael D AU - Taylor MD FAU - Friedberg, Jonathan W AU - Friedberg JW FAU - Link, Brian K AU - Link BK FAU - Cerhan, James R AU - Cerhan JR FAU - Dawson, Keith AU - Dawson K FAU - Flowers, Christopher R AU - Flowers CR LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20140325 PL - United States TA - Cancer JT - Cancer JID - 0374236 RN - 0 (Antibodies, Monoclonal, Murine-Derived) RN - 4F4X42SYQ6 (Rituximab) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal, Murine-Derived/adverse effects/*therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Disease-Free Survival MH - Female MH - Humans MH - Induction Chemotherapy MH - Lymphoma, Follicular/*drug therapy/epidemiology/pathology/therapy MH - Maintenance Chemotherapy MH - Male MH - Middle Aged MH - Prospective Studies MH - Randomized Controlled Trials as Topic MH - Rituximab MH - Survival Analysis MH - Treatment Outcome MH - United States/epidemiology MH - Young Adult PMC - PMC4265986 OTO - NOTNLM OT - follicular lymphoma OT - frontline therapy OT - non-Hodgkin lymphoma OT - outcomes OT - rituximab maintenance EDAT- 2014/03/29 06:00 MHDA- 2014/10/01 06:00 CRDT- 2014/03/27 06:00 PHST- 2013/10/31 00:00 [received] PHST- 2013/12/20 00:00 [revised] PHST- 2014/01/23 00:00 [accepted] PHST- 2014/03/27 06:00 [entrez] PHST- 2014/03/29 06:00 [pubmed] PHST- 2014/10/01 06:00 [medline] AID - 10.1002/cncr.28659 [doi] PST - ppublish SO - Cancer. 2014 Jun 15;120(12):1830-7. doi: 10.1002/cncr.28659. Epub 2014 Mar 25.