LYON, FranceA year after he presented interim data indicating that R-CHOP produced better results than CHOP alone against aggressive B-cell lymphomas in the elderly, Bertrand Coiffier, MD, reported that the benefits of the combination of rituximab(Drug information on rituximab) (Rituxan) plus CHOP (cyclophosphamide [Cytoxan, Neosar], doxorubicin(Drug information on doxorubicin) HCl, vincristine [Oncovin], prednisone(Drug information on prednisone)) increased over time.
"We observed a better outcome for every parameter," Dr. Coiffier said at the 43rd Annual Meeting of the American Society of Hematology (ASH). "CHOP plus rituximab increased response rate, decreased relapse, increased event-free survival and overall survival, and produced no more toxicity than classical CHOP."
Interim Results of ‘Landmark Study’
The phase III Groupe d’Etude des Lymphoma de l’Adulte (GELA) study was heralded as a "landmark study" at last year’s ASH meeting. Interim results at 12-months follow-up allowed Dr. Coiffier to predict then that R-CHOP "may be the new standard for treatment of aggressive B-cell lymphomas in elderly patients." Two-year results presented by Dr. Coiffier this year confirmed R-CHOP’s benefit for elderly patients. Dr. Coiffier also indicated that R-CHOP might be useful for younger patients, but that supporting data are needed.
The GELA study randomized patients to two different armseither standard CHOP every 3 weeks for eight cycles or standard CHOP plus rituximab at 375 mg/m² on day 1 of each cycle. In order to be eligible for the study, patients had to be 60 to 80 years old and have diffuse large B-cell lymphoma (DLCL). "Only 40% of the patients had a good prognosis according to the International Prognostic Index," Dr. Coiffier reported, with the remaining 60% considered poor risk.
The interim analysis included 328 patients with a median follow-up of 12 months. An update at a median follow-up of 18 months included age-adjusted data on 399 patients, and Dr. Coiffier presented results at a median of 2 years follow-up.
Response and Toxicity Data