Long-term results of the GELA study comparing R-CHOP and CHOP chemotherapy in older patients with diffuse large B-cell lymphoma show good survival in poor-risk patients

Abstract

8009 Background: The prospective randomized study LNH-98.5 was first reported in the N Engl J Med and J Clin Oncol with a median follow-up of 2 and 5 years. Here, we present the 7-year follow-up of the 399 patients included in the study. Methods: Patients had untreated diffuse large B-cell lymphoma and were 60 to 80 years old with a median age at diagnosis of 69 years. 60% had a poor risk lymphoma as defined by the aaIPI risk score of 2 or 3. 197 patients were randomized in CHOP arm and 202 in R-CHOP arm. Treatment consisted of 8 cycles of CHOP every 3 weeks with rituximab the same day in R-CHOP. Results: With a median follow-up of 7.1 years, 76% of the patients had an event in CHOP compared to 58% in R-CHOP, p=0.0002 ( Table ). 65% of patients died in CHOP arm compared to 47% in R-CHOP arm: 80% and 71% of them from lymphoma or treatment toxicity, 5% and 5% from another cancer, and 15% and 22% in CR from other causes, respectively. Survival curves show the same difference as reported before with a large difference in favour of R-CHOP ( Table ). Patients not expressing bcl-2 protein treated with R-CHOP have a statistically longer PFS but only a trend for OS because they responded better to salvage treatment. No statistically significant difference was observed for patients <70, 70–74, or ≥75 years old. Patients treated with R-CHOP have good survival even with poor risk parameters: 43% are alive for age ≥75 years, 38% for PS=2, 54% for B symptoms, 47% for stage IV, 45% for high LDH level, 54% for Hb ≤10 g/dl, and 42% for high aaIPI score. Death in CR was associated with high risk aaIPI score and presence of other diseases before lymphoma diagnosis. Conclusions: This analysis confirms the long term benefit associated with the combination of rituximab and CHOP and shows that older patients must be treated as younger patients even in presence of high risk characteristics or concomitant diseases. [Table: see text] [Table: see text]