A comparative analysis of prognostic factor models for follicular lymphoma based on a phase III trial of CHOP-rituximab versus CHOP + 131iodine--tositumomab
- PMID: 24130072
- PMCID: PMC3872052
- DOI: 10.1158/1078-0432.CCR-13-1120
A comparative analysis of prognostic factor models for follicular lymphoma based on a phase III trial of CHOP-rituximab versus CHOP + 131iodine--tositumomab
Abstract
Purpose: There is currently no consensus on optimal frontline therapy for patients with follicular lymphoma. We analyzed a phase III randomized intergroup trial comparing six cycles of CHOP-R (cyclophosphamide-Adriamycin-vincristine-prednisone (Oncovin)-rituximab) with six cycles of CHOP followed by iodine-131 tositumomab radioimmunotherapy (RIT) to assess whether any subsets benefited more from one treatment or the other, and to compare three prognostic models.
Experimental design: We conducted univariate and multivariate Cox regression analyses of 532 patients enrolled on this trial and compared the prognostic value of the FLIPI (follicular lymphoma international prognostic index), FLIPI2, and LDH + β2M (lactate dehydrogenase + β2-microglobulin) models.
Results: Outcomes were excellent, but not statistically different between the two study arms [5-year progression-free survival (PFS) of 60% with CHOP-R and 66% with CHOP-RIT (P = 0.11); 5-year overall survival (OS) of 92% with CHOP-R and 86% with CHOP-RIT (P = 0.08); overall response rate of 84% for both arms]. The only factor found to potentially predict the impact of treatment was serum β2M; among patients with normal β2M, CHOP-RIT patients had better PFS compared with CHOP-R patients, whereas among patients with high serum β2M, PFS by arm was similar (interaction P value = 0.02).
Conclusions: All three prognostic models (FLIPI, FLIPI2, and LDH + β2M) predicted both PFS and OS well, though the LDH + β2M model is easiest to apply and identified an especially poor risk subset. In an exploratory analysis using the latter model, there was a statistically significant trend suggesting that low-risk patients had superior observed PFS if treated with CHOP-RIT, whereas high-risk patients had a better PFS with CHOP-R.
©2013 AACR.
Conflict of interest statement
Oliver W. Press (Principal Investigator) – consultancy with Roche/Genentech and clinical trial research funding from Roche/Genentech to the Fred Hutchinson Cancer Research Center. Joseph M. Unger – no conflict of interest. Lisa M. Rimsza – no conflict of interest. Jonathan W. Friedberg – consultancy with Genentech. Michael LeBlanc – no conflict of interest. Myron S. Czuczman - consultancy with Genentech Pharmaceuticals and Spectrum Pharmaceuticals. Mark S. Kaminski – research funding from GlaxoSmithKline; royalties from patents on CD20 Radioimmunotherapy. Rita M. Braziel – no conflict of interest. Catherine M. Spier – no conflict of interest. Ajay K. Gopal – consultancy with Seattle Genetics; honoraria from Seattle Genetics and Millennium/Takeda; research funding from Seattle Genetics, GlaxoSmithKline, Spectrum, Lilly, SBio, Piramal, Abbott, and Emergent Biosolutions. David G. Maloney – honoraria from Genentech, Roche, and GlaxoSmithKline; research funding from Genentech. Bruce D. Cheson – consultancy with Roche-Genentech. Shaker Dakhil – no conflict of interest. Thomas P. Miller – no conflict of interest. Richard I. Fisher – consultancy with Roche.
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References
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