A comparison of elderly patients with aggressive histology lymphoma who were entered or not entered on to a randomized phase II trial

The purpose of this study was to compare the baseline patient characteristi cs, treatments and outcomes of elderly patients with aggressive histology l ymphoma who were entered or not entered onto a randomized phase II trial. W e previously conducted a randomized phase II trial in patients greater than or equal to 65 years of age who had advanced stage intermediate grade lymp homa. A registry of all patients meeting the inclusion criteria for that tr ial was maintained. Many patients were not entered on to the randomized tri al because of the presence of at least one exclusion criterion, or because of patient or physician choice. We have compared the baseline characteristi cs, treatment, and survival of the randomized and non-randomized patients. Results show that 68 consecutive patients met inclusion criteria for the ra ndomized trial. Thirty-eight patients satisfied all eligibility criteria, c onsented, and were randomized; 30 patients (44%) were not entered. In compa rison with randomized patients, non-randomized patients were older (mean 75 .9 vs. 72.4 years; P=0.013), had a poorer performance status (P=0.0006), we re less likely to be given treatment with curative intent (60% vs. 100%; P< 0.001), and were less likely to complete 6 cycles of such treatment (27% vs . 89%; P<0.001). With a median follow-up of > 7 years, actuarial 5-year sur vival is superior in randomized patients (44.3% vs. 10%; P<0.00001). In con clusion, a substantial number of patients did not enter our randomized tria l phase II trial and had different characteristics, received different ther apy and had inferior outcomes in comparison with randomized patients. Rando mized trials of therapy for elderly lymphoma patients may include special s election criteria and results may not be generalizable to a substantial pro portion of other older patients.