IN FIRST-LINE FOLLICULAR LYMPHOMA PATIENTS WHO RESPONDED TO R-CHEMO

PRIMA: A PROVEN MAINTENANCE STRATEGY FOR FIRST-LINE FOLLICULAR LYMPHOMA

PRIMA TRIAL DESIGN 1,2*

*To ensure that all patients received an equal number of courses of RITUXAN prior to maintenance randomization, an additional 2 courses of RITUXAN were given to R-CHOP– and R-FCM–treated patients. For the R-CHOP patients, the 2 additional courses were given on Day 1 of Cycles 7 and 8; for the R-FCM patients, the 2 additional courses were given on Day 15 of Cycles 1 and 4. 2

CRu defined as the following: a) disappearance of all detectable evidence of disease as well as disease-related symptoms and normalization of NHL-related biochemical abnormalities, b) reduction in size of enlarged organs palpable on physical examination in addition to the following features: i) regression of lymph node (greater than 1.5 cm in its greatest transverse diameter) by more than 75% in sum of the products of the greatest diameters and/or ii) indeterminate bone marrow. 2

The PRIMA Dosing Schedule Was Chosen Based In Part On Its Potential To Maintain A Target Serum Level Of RITUXAN. This Level Was Derived From Pharmacokinetic Data In The Pivotal McLaughlin Trial In Relapsed Or Refractory Low-Grade Or Follicular Lymphoma. 2-4
  • At 3 months post-RITUXAN treatment, median serum levels in responding and non-responding patients were 25.4 μg/mL and 5.9 μg/mL, respectively (P<0.001) 2
  • Based on these pharmacokinetic data, a once-every-2-months PRIMA dosing regimen was developed to help increase the likelihood of patients maintaining a serum concentration of 25 μg/mL 2

SELECT IMPORTANT SAFETY INFORMATION

SINGLE-AGENT RITUXAN AS MAINTENANCE FOR FOLLICULAR NHL AFTER FIRST-LINE RITUXAN-BASED CHEMOTHERAPY

  • Detailed safety data collection was limited to Grade ≥2 infections, Grade ≥3 adverse reactions, and serious adverse reactions
  • The most common Grade 3-4 adverse reactions occurring at a higher incidence (≥2%) in the RITUXAN arm than in the observation arm were infections (4% vs. 1%) and neutropenia (4% vs. <1%)
  • The most frequently reported adverse reaction was infections. In patients receiving RITUXAN as single-agent maintenance therapy following RITUXAN plus chemotherapy, infections were reported more frequently compared with the observation arm (37% vs. 22%)

PRIMA=Primary RItuximab and MAintenance; ECOG=Eastern Cooperative Oncology Group; FLIPI=Follicular Lymphoma International Prognostic Index; R=RITUXAN; CHOP=cyclophosphamide, doxorubicin, vincristine, and prednisone; CVP=cyclophosphamide, vincristine, and prednisone; FCM=fludarabine, cyclophosphamide, and mitoxantrone; PR=partial response; CR=complete response; CRu=complete response, unconfirmed; PFS=progression-free survival; NHL=non-Hodgkin’s lymphoma.

NEXT: Safety and Efficacy >

CONTACT YOUR REPRESENTATIVE

Interested in more information about RITUXAN clinical data?