RANDOMIZED PHASE-II COMPARISON OF STANDARD CHOP WITH WEEKLY CHOP IN ELDERLY PATIENTS WITH NON-HODGKINS-LYMPHOMA

Purpose: To determine whether modifying the standard-regimen of cyclop hosphamide, doxorubicin, vincristine, and prednisone (CHOP) from full doses given every 3 weeks to one-third doses given weekly (chop) incre ases the received chemotherapy dose-intensity in elderly patients with advanced-stage intermediate-grade lymphoma. Patients and Methods: Con senting patients, age greater than or equal to 65 years who had accept able cardiac, renal, and liver function and an Eastern Cooperative Onc ology Group (ECOG) performance status less than 4, were stratified by bone marrow and performance status and randomized to receive standard CHOP or weekly chop. Drug doses were attenuated or escalated according to a defined dose-modification schedule. The primary outcome was aver age relative received dose-intensity. Secondary outcomes included resp onse, progression-free and overall survival, toxicity, and performance status. Results: Nineteen patients were allocated to each group;No di fference in received dose-intensity wets seen. When dose-intensity was calculated for the first six cycles of therapy, average relative rece ived dose-intensity was .92 with CHOP versus .89 with weekly chop (P = .5); when calculated for the first 18 weeks of therapy, values were . 88 with CHOP versus .89 with weekly chop (P = .8). The complete respon se rate was 68% with CHOP versus 74% with weekly chop (P = .9). At 2 y ears, the progression-free survival rate was 57% with CHOP versus 46% with weekly chop (P = .16) and the survival rate was 74% with CHOP ver sus 51% with weekly chop (P = .05). More myelotoxicity was seen with C HOP. Conclusion: We conclude that CHOP can be given in sufficient dose s to elderly patients and that weekly chop does not increase received dose-intensity. Progression-free and overall survival are unlikely to be superior with weekly chop, and may be worse. CHOP should remain the standard against which new therapies for elderly patients with interm ediate-grade lymphoma are compared. (C) 1995 by American Society of Cl inical Oncology.