ORLANDOPresentations at the 43rd Annual Meeting of the American Society of Hematology (ASH) showed increased survival for patients with aggressive and indolent non-Hodgkin’s lymphoma (NHL) who received the anti-CD20 monoclonal antibody rituximab(Drug information on rituximab) (Rituxan) in addition to standard CHOP chemotherapy (cyclophosphamide, doxorubicin(Drug information on doxorubicin), vincristine, prednisone(Drug information on prednisone)).
At a median of 24 months follow-up, the Groupe d’Etude des Lymphomes de l’Adulte (GELA) phase III study showed a 23% relative increase in overall survival in patients with aggressive NHL treated with rituximab plus CHOP vs CHOP alone (abstract 3025). In a phase II indolent NHL study of rituximab plus CHOP, progression-free survival has not been reached at more than 5.4 years of follow-up (abstract 2519).
In the GELA study, 399 previously untreated patients age 60 and older with stage II to IV diffuse large B-cell lymphomas were randomized to receive either standard CHOP alone every 3 weeks for eight cycles or rituximab 375 mg/m0178 plus CHOP. Rituximab was administered on day 1 of each cycle.
Two-year event-free survival improved significantly from 37% in the CHOP alone arm to 57% in the combination arm, a relative increase of 54%. Event-free survival was defined as ongoing survival without events, including disease progression or relapse, death, or initiation of new alternative treatment.
Overall survival at 2 years was increased from 57% in the CHOP alone arm to 70% in the rituximab/CHOP arm, a relative increase of 23%. "This is the first new drug combination in more than 20 years to show an improvement in overall survival for patients with aggressive NHL," said principal investigator Bertrand Coiffier, MD, of the Hospices Civils de Lyon, France.At 18 months, complete response rate increased from 64% in the CHOP alone arm to 77% in the combination arm, a relative increase of 20% (P = .007).
Apart from grade 3-4 first-infusion events, experienced by approximately 10% of patients in the rituximab/CHOP arm, toxicity was not increased by the addition of rituximab to CHOP chemotherapy, Dr. Coiffier said.