Association of age and performance status with adverse events in older adults with diffuse large B-cell lymphoma receiving frontline R-CHOP therapy: Alliance 151930, a secondary analysis of the phase III trial CALGB 50303.

INTRODUCTION

Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) therapy is the standard of care for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). However, detailed delineation of toxicity data is limited and has not been examined by age. We sought to examine adverse event data in patients receiving R-CHOP from the Cancer and Leukemia Group B (CALGB) 50303 trial to determine if there were differences in grade 3+ toxicities by age cohort or ECOG performance status (PS), and if outcome was impacted by age cohort or toxicity occurrence.

MATERIALS AND METHODS

CALGB 50303 was an intergroup phase III study for previously untreated patients with DLBCL that included R-CHOP as one of the trial arms. In the subset of 235 evaluable, seemingly fit patients receiving R-CHOP on this trial, data regarding the occurrence of grade 3+ hematologic and non-hematologic toxicities by treatment arm, as well as completion of protocol therapy, overall response rate (ORR), and survival outcome parameters were collected and analyzed for Alliance A151930.

RESULTS

Data were available for further analysis from 235 of 243 patients evaluable for safety, i.e., those who received R-CHOP therapy on this trial, with 165 being <65 years of age, and 70 ≥ 65 years of age. There was an increased rate of grade 3+ non-hematologic (but not hematologic) toxicities in the older age cohorts, after controlling for disease stage and performance status (p < 0.001). One-year and three-year overall survival (OS) were inferior in patients ≥65 years of age, compared to those <65 years of age; there was no difference in one-year or in three-year progression-free survival (PFS) between the age cohorts.

DISCUSSION

Standard frontline therapy with R-CHOP can be effectively administered to an older age cohort. We found more grade 3+ non-hematologic, but not hematologic, toxicities in older patients. These data can be used in clinical trial and real-world settings to identify at-risk DLBCL subgroups for which pro-active measures can be utilized to ensure completion of therapy and optimization of clinical outcomes.

CLINICALTRIALS

gov Identifier: NCT00118209 (CALGB 50303).