Fred Hutchinson Cancer Research Center / Mazyar Shadman*
SWOG S0016 was a phase III randomized study that compared the safety and efficacy of R-CHOP (rituximab pluscyclophosphamide, doxorubicin, vincristine, and prednisone) with CHOP-RIT (CHOP followed by consolidation with iodine-133-tositumomab radioimmunotherapy) for previously untreated patients with follicular lymphoma. Understanding the long-term outcome of patients provides a benchmark for novel treatment regimens for FL.
Patients and Methods
Between 2001 and 2008, 531 previously untreated patients with FL were randomly assigned to receive either six cycles of R-CHOP or six cycles of CHOP-RIT. Patients with advanced-stage disease (bulky stage II, III, or IV) of any pathologic grade (1, 2, or 3) were eligible.
After a median follow-up of 10.3 years, 10-year estimates of progression-free and overall survival were 49% and 78% among all patients, respectively. Patients in the CHOP-RIT arm had significantly better 10-year progression-free survival compared with patients in the R-CHOP arm (56% v 42%; P = .01), but 10-year overall survival was not different between the two arms (75% v 81%; P = .13). There was no significant difference between the CHOP-RIT and R-CHOP arms in regard to incidence of second malignancies (15.1% v 16.1%; P = .81) or myelodysplastic syndrome or acute myeloid leukemia (4.9% v 1.8%; P = .058). The estimated 10-year cumulative incidences of death resulting from second malignancies were not different (7.1% v 3.2%; P = .16), but cumulative incidence of death resulting from myelodysplastic syndrome or acute myeloid leukemia was higher in the CHOP-RIT arm compared with the R-CHOP arm (4% v 0.9%; P = .02).
Conclusion Given these outstanding outcomes, immunochemotherapy should remain the standard induction approach for patients with high-risk FL until long-term follow-up of alternative approaches demonstrates superiority.
Shadman M1, Li H1, Rimsza L1, Leonard JP1, Kaminski MS1, Braziel RM1, Spier CM1, Gopal AK1, Maloney DG1, Cheson BD1, Dakhil S1, LeBlanc M1, Smith SM1, Fisher RI1, Friedberg JW1, Press OW1.
1 Mazyar Shadman, Ajay K. Gopal, David G. Maloney, and Oliver W. Press, University of Washington and Fred Hutchinson Cancer Research Center; Hongli Li and Michael LeBlanc, SWOG Statistical Center, Seattle, WA; Lisa Rimsza, Mayo Clinic Arizona, Scottsdale; Catherine M. Spier, University of Arizona, Tucson, AZ; John P. Leonard, Weill Cornell Medical College, New York; Jonathan W. Friedberg, Wilmot Cancer Institute, University of Rochester, Rochester, NY; Mark S. Kaminski, University of Michigan Health System, Ann Arbor, MI; Rita M. Braziel, Oregon Health & Science University, Portland, OR; Bruce D. Cheson, Lombardi Comprehensive Cancer Center, Georgetown University Hospital, Washington, DC; Shaker Dakhil, University of Kansas School of Medicine-Wichita, Wichita, KS; Sonali M. Smith, University of Chicago Medicine, Chicago, IL; and Richard I. Fisher, Fox Chase Cancer Center and Temple University School of Medicine, Philadelphia, PA.