The addition of rituximab to front-line therapy with CHOP (R-CHOP) results in a higher response rate and longer time to treatment failure in patients with lymphoplasmacytic lymphoma: results of a randomized trial of the German Low-Grade Lymphoma Study Group (GLSG)

Abstract

Lymphoplasmacytic lymphoma (LPL) is an indolent lymphoma with moderate sensitivity to conventional chemotherapy. This study investigated whether the addition of rituximab to standard chemotherapy improves treatment outcome in LPL and the subgroup of LPL patients fulfilling the criteria of Waldenstroem's macroglobulinemia (WM). A total of 69 patients with previously untreated LPL were enrolled into the trial; 64 patients were evaluable for treatment outcome. In all, 48 of the 64 LPL patients fulfilled the criteria of WM. Patients were randomly assigned to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, n ¼ 34) or CHOP (n ¼ 30). R-CHOP resulted in significantly higher overall response (OR) rate (94 vs 67%, P ¼ 0.0085) in the LPL patients and in the WM subgroup (91 vs 60%, P ¼ 0.0188). With a median observation time of 42 months, R-CHOP induced a significantly longer time to treatment failure (TTF) with a median of 63 months for R-CHOP vs 22 months in the CHOP arm in the LPL patients (P ¼ 0.0033) and in the WM subgroup (P ¼ 0.0241). There was no major difference of treatment-associated toxicity between both treatment groups. These data indicate that the addition of rituximab to front-line chemotherapy improves treatment outcome in patients with LPL or WM.

BDR in newly diagnosed patients with WM: final analysis of a phase 2 study after a minimum follow-up of 6 years

“…Bendamustine with rituximab have also shown a PFS of 69 months, but the numbers were small. 18 Ibrutinib was recently approved for treatment-naïve and relapsed/refractory WM patients; however, available data are based only on previously treated patients and long-term follow up is still missing. Furthermore, ibrutinib requires continuous treatment.…”

Cost-effectiveness analysis of ibrutinib in patients with Waldenström macroglobulinemia in Italy

“…Clinical input data (efficacy and safety), treatment dosing schedules, overall population mortality were used to populate the model and derived respectively from global trials (2007)(2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015) as well as published literature [1,16,[18][19][20][21][22][23][24]. Comparative efficacy for ibrutinib vs. CTP was derived from a multivariate Cox proportional hazard model performed to estimate the hazard ratio (HR) of the PFS for ibrutinib vs. CTP [1,16,[18][19][20][21][22][23][24].…”

“…The aim of this study is to estimate, from the Italian National Health System (NHS) perspective, the incremental cost-effectiveness ratio (ICER) of ibrutinib in relapsing/ refractory (R/R) WM, compared with the current therapeutic pathways (CTP) applied to WM: fludarabine + cyclophosphamide + rituximab (FCR), bortezomib + rituximab (BOR), rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone (RCHOP), bortezomib + dexamethasone + rituximab (BDR), dexamethasone + rituximab + cyclophosphamide (DRC), and bendamustine/rituximab (BR) [1,[18][19][20][21][22][23].…”

Unresolved issues in the comparison of therapies and determination of responses in Waldenström macroglobulinemia

“…The one recently published, large randomized trial in WM does provide some guidance in the choice of therapies for WM [22]. This trial showed major clinical benefit in response rate, PFS, and OS from the addition of rituximab to conventional chemotherapy (CHOP; cyclophosphamide, doxorubicin, vincristine, prednisone).…”