Pegfilgrastim primary prophylaxis in patients with non-Hodgkin lymphoma: results from an integrated analysis.

Severe neutropenia and febrile neutropenia (FN) are serious, dose-limiting side effects of chemotherapy for aggressive non-Hodgkin lymphoma (NHL). Observational data suggest that with current practice neutropenia management up to 23% of patients receiving CHOP-like regimens experience FN, and around half of patients do not receive the planned relative dose intensity (RDI). In this integrated analysis we assessed the efficacy of pegfilgrastim for preventing FN and related outcomes in patients with NHL. A literature search was used to identify chemotherapy regimens with an FN risk ≥15% that are used to treat lymphoma. Search results were then used to identify clinical trials in which these regimens were administered with pegfilgrastim primary prophylaxis. Individual patient data were available for three trials meeting the inclusion criteria, and these were combined in an integrated analysis. The primary outcome measure was the incidence of FN in any cycle. A total of 282 patients were included in the analysis [mean age 65 years (SD ± 12.5 years); 172 (61%) aged ≥ 65 years]. All patients had NHL and 244 (87%) received RCHOP-21. The incidence of FN in any cycle was 16% (95% CI 12-20%) (13% in patients aged <65 years; 18% in patients aged ≥65 years). Chemotherapy dose delays >3 days occurred in 26% (95% CI 20-31%) of patients, and was relatively consistent across age groups. Chemotherapy dose reductions ≥10% were seen in 43% (95% CI 37-49%) of patients and were more frequent in the elderly. Overall, 83% (95% CI 78-87%) of patients received ≥90% RDI (89% of patients aged <65 years; 78% of patients aged ≥65 years). In this integrated analysis of NHL patients at higher risk of FN receiving pegfilgrastim primary prophylaxis, the overall incidence of FN was 16% and a high proportion of both younger and elderly patients achieved RDI ≥90%.