THE NEUTROPENIA PROPHYLAXIS EVALUATION PROGRAM IN PATIENTS RECEIVING MYELOSUPPRESSIVE CHEMOTHERAPY WITH MODERATE OR HIGH RISK OF FEBRILE NETROPENIA – AN INTERIM ANALYSIS OF THE DIEPP STUDY

Background

Pegfilgrastim is a pegylated granulocyte colony stimulating factor (G-CSF) indicated for the prophylaxis of febrile neutropenia (FN) in patients (pts) treated with myelosuppressive chemotherapy (CT). The DIEPP study was designed to evaluate FN incidence and risk assessment in pts at high overall risk of FN receiving myelosuppressive CT with pegfilgrastim prophylaxis.

Methods

This prospective observational study collected data from pts within Central and Eastern Europe and Austria having the following malignancies: early stage breast cancer (stages I-III), diffuse large B-cell lymphoma, lung, gastric or ovarian cancer. To be eligible, pts had an investigator-assessed overall risk of FN ≥20% (CT plus patient risk factors), and were planned to receive pegfilgrastim according to the SmPC and to receive CT for ≥4 cycles. The primary objective was to estimate FN incidence and secondary objectives included assessment of which risk factors (RF) from the ASCO/EORTC guidelines most often contributed to the decision to use pegfilgrastim primary (PP) or secondary (SP) prophylaxis. The final planned sample size is 1,200 pts; this interim analysis includes data collected from the Czech Republic, Poland, Hungary, Romania, and Austria between 08/2011 and 01/2012.

Results

At the interim cut off time 268 enrolled pts (mean age 58 ± 12 years, 25% male) received 1343 CT cycles; 237 pts (88%) received PP, 10 pts (4%) SP, and 21 pts (8%) delayed or other pegfilgrastim administration. Overall 9 pts (4%; 95% CI [2%, 6%]) reported FN in a total of 10 (1%; 95% CI [0.4%, 1%]) cycles. Five pts (2%; 95% CI [1%, 4%]) reported FN in the first CT cycle. The high FN risk of planned CT was the most common reason reported by physicians for pegfilgrastim use: 80% pts [95% CI [74%, 84%]. The three most common pt-related RFs were: female gender, 54%, 95% CI [48, 60]; advanced disease stage, 41%, 95% CI [35%, 47%]; and age ≥65, 21% 95% CI [17%, 27%]. No SADR and 2 ADR cases (neutropenia and bone pain) were registered.

Conclusion

Based on data from the CEE and Austria, rates of FN were low with pegfilgrastim prophylaxis in pts receiving CT with an overall FN risk of ≥20%.

Disclosure

T. Csoszi: corporate-sponsored study - VECTIS, DIEPP, D-CARE( Amgen20060359, APPRIORI,Amgen 20080259,

M. Safanda: corporate-sponsored study - DIEPP (Amgen),

G. Mazur: corporate-sponsored study - DIEPP (Amgen)

G. Mihaylov: corporate-sponsored study - DIEPP (Amgen),

J. Benkovicová: corporate-sponsored study - DIEPP (Amgen),

E. Tóth: Amgen contract worker.

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