Up to 8 cycles of RITUXAN+CVP significantly improved PFS in previously untreated patients with follicular NHL
MARCUS TRIAL DESIGN: R-CVP ×8 VS CVP ×81
- CVP=cyclophosphamide 750 mg/m2 on Day 1; vincristine 1.4 mg/m2 on Day 1; prednisolone 40 mg/m2 on Days 1–5. R=RITUXAN 375 mg/m2, given on the first day of each CVP cycle. Patients were randomized to receive either 8 cycles of CVP or 8 cycles of R-CVP every 21 days.1
- PFS=progression-free survival; NHL=non-Hodgkin’s lymphoma; IWF=International Working Formulation; SD=stable disease; PD=progressive disease; CR=complete response; PR=partial response.
MARCUS TRIAL: PREVIOUSLY UNTREATED, ADVANCED-STAGE PATIENTS2
|Baseline patient characteristics||
|Age range (years)||27-79||29-80|
|Elevated LDH (>1×ULN)||26%||26%|
|Ann Arbor Stage||I/II III/IV||
|ECOG performance status||0-1 2||
|Bulky disease (>7cm)||39%||46%|
|Number of nodal sites||<5 ≥5||
|FLIPI index||0-2 3-5||
- LDH=lactate dehydrogenase; ULN=upper limit of normal; ECOG=Eastern Cooperative Oncology Group; FLIPI=Follicular Lymphoma International Prognostic Index.
MARCUS (M39021) TRIAL: PFS AT 1.5-YEAR FOLLOW-UP2
- *One patient assigned to the CVP group did not receive any trial medication because this patient withdrew consent.1
- Median PFS was improved by 71% (2.4 years vs 1.4 years, p<0.0001) at 1.5-year follow-up3
- At 2.5-year follow-up, median PFS was improved by 113% with R-CVP vs CVP (2.67 years vs 1.25 years, p<0.001)1
RITUXAN in combination with CVP for previously untreated follicular NHL
- Patients in the R-CVP arm had higher incidences of infusional toxicity and neutropenia compared with those in the CVP arm. The following adverse reactions occurred more frequently (≥5%) in patients receiving R-CVP compared with CVP alone: rash (17% vs. 5%), cough (15% vs. 6%), flushing (14% vs. 3%), rigors (10% vs. 2%), pruritus (10% vs. 1%), neutropenia (8% vs. 3%), and chest tightness (7% vs. 1%)
- Marcus R, Imrie K, Belch A, et al. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood. 2005;105:1417-1423.
- Data on file, Genentech, Inc.
- RITUXAN® (Rituximab) full prescribing information, Genentech, Inc., 2013.