Rituximab maintenance therapy of follicular lymphoma in clinical practice

Abstract

Standard of care for patients with symptomatic, advanced‐stage follicular lymphoma (FL) is rituximab‐containing chemoimmunotherapy followed by rituximab maintenance. This prospective, multicenter, noninterventional study analyzed how efficacy and safety data from randomized controlled trials translate into clinical practice in Germany. Both treatment‐naïve and relapsed/refractory patients with FL, who responded to rituximab‐containing induction and were scheduled for rituximab maintenance, were observed for 24 months. Effectiveness was measured by response and Kaplan‐Meier survival analysis. In addition, treatment patterns of induction and maintenance, as well as adverse events, were documented. The evaluable study population consisted of 310 first‐line patients and 173 relapsed/refractory patients, including 116 patients with initial Ann‐Arbor stage I/II and 20 patients with FL grade 3B. Regarding first‐line induction, a shift from R‐CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) to R‐bendamustine was observed over time, as well as a decline in radiotherapy. 2‐year progression‐free survival rates were 88.3% (95% confidence interval [CI] 84.0‐92.6) for first‐line patients and 76.0% (95% CI: 68.8‐83.3) for relapsed/refractory patients. Conversion from partial to complete remission (PR, CR) occurred in 53.4% of analyzed first‐line patients with PR, resulting in 69.4% CRs at study end (relapsed/refractory: conversion in 42.9%, final CRs 57.9%). Safety results were consistent with the known safety profile of rituximab in this setting. Both treatment‐naïve and relapsed/refractory patients with FL show favorable 2‐year PFS rates and improvements in the remission status with postinduction rituximab monotherapy as maintenance and consolidation therapy.

Subcutaneous rituximab in patients with diffuse large B cell lymphoma and follicular lymphoma: Final results of the non‐interventional study MabSCale

“…Furthermore, our data show an unexpected treatment pattern in FL patients with limited stage I/II disease accounting for about one quarter of the study cohort (Table 2). These patients may be cured with radio(immuno)therapy 29,30 but received chemoimmunotherapy with palliative intent, which is in line with findings from the NCLS study reported by Nastoupil et al 31 and the recently published RIM trial 32 . Interestingly, in our study, FL patients with limited disease were more prevalent in the private practice (30.8%) as compared to the hospital treatment setting (20.2%).…”

“…These patients may be cured with radio(immuno)therapy 29 , 30 but received chemoimmunotherapy with palliative intent, which is in line with findings from the NCLS study reported by Nastoupil et al 31 and the recently published RIM trial. 32 Interestingly, in our study, FL patients with limited disease were more prevalent in the private practice (30.8%) as compared to the hospital treatment setting (20.2%). Our real‐world results together with findings from the RIM trial may suggest a shift from radiotherapy as recommended in current guidelines to early systemic treatment in this patient subgroup.…”

Maintenance rituximab in Veterans with follicular lymphoma

“…40,[44][45][46] In a systematic review and meta-analysis of RCTs, MR was associated with improved OS, primarily in the relapsed or refractory setting. 47 Several reports have recently described real-world 1L practices and outcomes in FL in relation to the use of MR. [48][49][50][51] For instance, a German study reported improvement in complete response rates with maintenance therapy, 48 whereas Nordic 49 and Czech 50,51 studies reported improvement in OS with MR. In contrast, the largest-and, to date, only-nationwide study of real-world FL practices and outcomes in the United States, the NLCS, 27 did not reveal an association between MR and OS.…”

“…Several reports have recently described real‐world 1L practices and outcomes in FL in relation to the use of MR 48‐51 . For instance, a German study reported improvement in complete response rates with maintenance therapy, 48 whereas Nordic 49 and Czech 50,51 studies reported improvement in OS with MR.…”

Maintenance therapy in AML: The past, the present and the future

“…Maintenance therapy has become a standard part of treatment. It has contributed to long term durable remissions and cures in other hematological diseases, such as acute lymphoblastic leukemia and follicular lymphoma, but its role in AML is still controversial. With the exception of arsenic trioxide and retinoic acid in acute promyelocytic leukemia, no maintenance therapy has demonstrated sufficient efficacy to be considered standard in the treatment of AML.…”