Continued excellent outcomes in previously untreated patients with follicular lymphoma after treatment with CHOP plus rituximab or CHOP plus 131I-tositumomab: Long-term follow-up of phase III randomized study SWOG-S0016
Journal of Clinical Oncology Jan 26, 2018
Shadman M, et al. - This study reports long-term follow-up outcomes of SWOG S0016, which was a phase III randomized study that compared the safety and efficacy of R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) with CHOP-RIT (CHOP followed by consolidation with iodine-133–tositumomab radioimmunotherapy) for previously untreated patients with follicular lymphoma. Given the outstanding outcomes, immunochemotherapy was recommended to be continued as the standard induction approach for patients with high-risk FL until long-term follow-up of alternative approaches demonstrates superiority.
Methods- Between 2001 and 2008, random assigning of a total of 531 previously untreated patients with FL to receive either 6 cycles of R-CHOP or 6 cycles of CHOP-RIT was done.
- Eligibility criteria included having advanced-stage disease (bulky stage II, III, or IV) of any pathologic grade (1, 2, or 3).
- Data showed that 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.
- Significantly better 10-year progression-free survival was observed in patients in the CHOP-RIT arm as 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).
- Researchers observed no significant difference between the CHOP-RIT and R-CHOP arms in terms of 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).
- In addition, no difference was observed in the estimated 10-year cumulative incidences of death resulting from second malignancies (7.1% v 3.2%; P=.16), but in the CHOP-RIT arm, the reported cumulative incidence of death resulting from myelodysplastic syndrome or acute myeloid leukemia was higher as compared with the R-CHOP arm (4% v 0.9%; P=.02).
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