GELA LNH 98-5 Trial
Up to 8 cycles of RITUXAN+CHOP significantly improved OS for elderly DLBCL patients
GELA TRIAL DESIGN: R-CHOP ×8 VS CHOP ×81,2
- CHOP=cyclophosphamide 750 mg/m2 on Day 1, doxorubicin 50 mg/m2 on Day 1, vincristine 1.4 mg/m2 on Day 1; prednisone 40 mg/m2/day on Days 1 through 5. R=RITUXAN 375 mg/m2, given on the first day of each CHOP cycle. Randomization was stratified by the IPI score. Tumor response was assessed after the eighth cycle of treatment or at the end of treatment.2
- GELA=Groupe d’Etude des Lymphomes de l’Adulte; OS=overall survival; DLBCL=diffuse large B-cell lymphoma.
GELA TRIAL: ELDERLY DLBCL PATIENTS2
|Baseline patient characteristics||
|Age range (years)||59-80||60-80|
|Elevated LDH (>1×ULN)||65%||67%|
|Ann Arbor Stage||I/II III/IV||
|ECOG performance status||0-1 2-3||
|Bulky disease (>10 cm)||30%||33%|
|Extranodal involvement (≥2)||52%||52%|
|IPI score*||<2 ≥2||
- *In the GELA trial, the age-adjusted IPI score, which ranged from 0 to 3, was derived by assigning 1 point for each of the following risk factors: Ann Arbor Stage III or IV, ECOG performance status ≥2, and elevated LDH.
- LDH=lactate dehydrogenase; ULN=upper limit of normal; ECOG=Eastern Cooperative Oncology Group; IPI=International Prognostic Index.
GELA TRIAL: OVERALL SURVIVAL AT 5-YEAR MEDIAN FOLLOW-UP (N=399)2,3
- OS, with a median follow-up of 5 years, was 58% for 8 cycles of R-CHOP vs 46% for CHOP alone1
- 164% improvement in the primary endpoint of event-free survival at 2-year follow-up (2.9 years vs 1.1 years, p<0.05)1
RITUXAN in combination with CHOP chemotherapy for DLBCL
- Detailed safety data collection was primarily limited to Grade 3 and 4 adverse reactions and serious reactions. In studies of elderly patients with DLBCL, the following adverse reactions, regardless of severity, were reported more frequently (≥5%) in patients ≥60 years of age receiving R-CHOP as compared with CHOP alone: pyrexia (56% vs. 46%), lung disorder (31% vs. 24%), cardiac disorder (29% vs. 21%), and chills (13% vs. 4%)
- A review of cardiac toxicity determined that supraventricular arrhythmias or tachycardia accounted for most of the difference in cardiac disorders (4.5% for R-CHOP vs. 1.0% for CHOP)
- The following Grade 3 or 4 adverse reactions occurred more frequently among patients in the R-CHOP arm compared with those in the CHOP arm: thrombocytopenia (9% vs. 7%) and lung disorder (6% vs. 3%). Other Grade 3 or 4 adverse reactions reported more frequently among patients receiving R-CHOP were viral infection, neutropenia, and anemia
- RITUXAN® (Rituximab) full prescribing information, Genentech, Inc., 2013.
- Coiffier B, Lepage E, Brière J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002;346:235-242.
- Feugier P, Van Hoof A, Sebban C, et al. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d’Etude des Lymphomes de l’Adulte. J Clin Oncol. 2005;23:4117-4126.