Patients with Non-Hodgkin’s Lymphoma Receiving Myelosuppressive Chemotherapy with First and Subsequent Cycle Pegfilgrastim Support Experience Low Rates of Neutropenic Complications: Preliminary Results of FIRST, a Prospective Community-Based Study.

Introduction: Myelosuppressive chemotherapy (CT) is associated with many neutropenic complications (eg, hospitalizations and CT dose reductions and delays), which often occur in the first cycle and may compromise clinical outcomes. In a recent nationwide survey, Lyman found 40% of 4522 patients (pts) treated with CHOP-like regimens for diffuse, aggressive NHL in community practice experienced CT dose reductions, and 24% of pts experienced CT dose delays. Additionally, the incidence of neutropenia increases for patients with risk factors for neutropenia; Morrison determined 41% of diffuse large B-cell NHL pts ≥ 60 years receiving anthracycline-based chemotherapy experienced febrile neutropenia events, with 20% of pts experiencing events in cycle 1. The ability of pegfilgrastim to reduce complications of CT-induced neutropenia has now been established in clinical trials for pts receiving moderately myelosuppressive CT, (Vogel 2005) in addition to highly myelosuppressive CT (Holmes 2002). This study evaluates the effectiveness of pegfilgrastim to support pts with NHL receiving CT in community practice.

Methods: This open-label, single-arm study enrolled 2249 pts at 319 sites (including 331 pts with NHL) who were ≥ 18 yrs with malignancies other than leukemia or MDS, including pts with major comorbid illnesses not generally eligible for clinical trials. Pts receiving weekly CT or concurrent radiotherapy were not eligible. Pts received pegfilgrastim 6 mg ~24 hours post-CT in each cycle. Endpoints included neutropenic complications and physician-reported CT dose reductions and delays. Point estimates and 95% confidence limits (CL) are provided for this planned, interim analysis.

Results: First cycle and second cycle data are available for 111 pts with NHL. The median (range) age was 65 years (24, 87), 50% were men, 67% had advanced-stage (III-IV) disease, and 31% had major comorbidities (e.g., myocardial infarction, peripheral vascular disease). Most pts (76 of 111) received CHOP±R (cyclophosphamide, doxorubicin, vincristine, and prednisone with or without rituximab). Few pts experienced neutropenic complications (table). Serious adverse events were consistent with those expected in NHL pts receiving CT.

Conclusions: The NHL pts in our study are older (≥50% pf pts were 65 years or older) and represent ‘real-world’ pts as the only major entry criterion is confirmed diagnosis of malignancy. Despite this, many pts received CHOP±R with virtually no neutropenia-related alterations in CT dose and schedule early in the course of therapy indicating the effectiveness of pegfilgrastim in this setting. Final data for all NHL pts (n=331) to be presented.