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S. Rule et al.
A
B
Figure 4. Survival outcomes from enrollment to end of Maintenance I, according to induction chemotherapy. Kaplan-Meier analysis of progression-free (A) and over- all survival (B) from enrollment to end of Maintenance I, according to induction chemotherapy received (bendamustine vs. CHOP and CVP). aIntent to treat population for Induction. Time to event calculated from first induction therapy up to the earliest date of event until randomization; data censored after randomization. CHOP: cyclophosphamide, doxorubicin, vincristine and prednisone; CVP: cyclophosphamide, vincristine and prednisone.
reached) or CVP (95% CI: 46.82–not reached). The median OSreg was 58.84 months (95% CI: 42.22-not reached) in patients receiving CHOP induction. Three-year OS esti- mates for patients receiving bendamustine, CHOP, and CVP were 0.83 (95% CI: 0.78–0.87), 0.70 (95% CI: 0.53– 0.82), and 0.82 (95% CI: 0.59–0.93), respectively. PFSreg and OSreg by NHL subtype are available in Online Supplementary Table S6. Unfortunately, due to the low numbers no con- clusion can be drawn from these data.
Response rates at the end of Induction by both chemotherapy regimen and patients remaining at the start of each subsequent study phase showed that 56.9% of patients (157/276) who responded and who ultimately entered Maintenance II had received bendamustine as
induction therapy (Online Supplementary Table S7).
There were 18 deaths (OSrand events) in total, ten in the rit- uximab arm and eight in the observation arm (not includ- ing the patient with a retrospective record of death). The
median OSrand was not reached (Figure 3B).
Discussion
The benefit of 2 years of maintenance therapy with rit- uximab after response to frontline induction in patients with indolent NHL is well established in terms of signifi- cantly improved PFS. Early trials of rituximab mainte- nance in patients with R/R indolent NHL indicated effica-
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haematologica | 2022; 107(2)