Use of primary and secondary pegfilgrastim prophylaxis for reducing incidence of neutropenia: Findings from a large study in German clinical practice (PROTECT)

Background: The EORTC guidelines recommend primary prophylaxis with G-CSF when the overall risk of febrile neutropenia (FN) is ≥ 20% (high risk [HR]) or if the chemotherapy FN risk is 10–20% (medium risk [MR]) with additional patient (pt)-related risk factors. This study assessed the acceptance of these guidelines in German routine practice. Methods: Non-interventional study of pegfilgrastim use in pts receiving Ctx for solid tumors or lymphomas (2007–2014 in 123 German centers). Pts were >18 yrs, had breast, ovarian, gastric, prostate or lung cancer, or aggressive lymphoma, EORTC-defined FN risk ≥10%, and prophylactic pegfilgrastim use. Primary endpoint: proportion of pts receiving pegfilgrastim as primary (prior to neutropenia) or secondary (following neutropenia occurrence) prophylaxis. Results: Data were available from 1914/2069 pts (average age 58 yrs, 79% female, 60% had breast cancer, 69% had prior tumor-related therapy and 20% prior Ctx). Of those receiving prior Ctx, 39% needed neutropenia treatment. Of the 1914 pts, pegfilgrastim was used as primary and secondary prophylaxis in 78% and 22%, respectively (primary endpoint). Primary prophylaxis was more frequent than secondary in the HR (87 vs 13% of 936 pts) and MR (73 vs 27% of 835 pts) groups. At a pt level, overall FN rate was 8% and varied across tumors: gastric 12%, breast 9%, lung 7%, lymphoma 8% and ovarian 3%. Across these tumors, the number of cycles with FN were 1.9%, 3.2%, 1.9%, 1.9%, 2.1% and 0.6%, respectively. Overall, 2% had a dose reduction or therapy switch due to FN. In breast cancer, dose reductions or therapy switches occurred in 1% of pts receiving primary prophylaxis and 3% receiving secondary prophylaxis. Conclusions: In this study of pts receiving pegfilgrastim prophylaxis in routine German practice, the majority of HR pts with overall FN risk of > 20% were treated with primary pegfilgrastim prophylaxis in concordance with the EORTC guidelines. Primary prophylaxis with pegfilgrastim was associated with a low FN incidence and a low rate of dose reductions and treatment delays. Clinical trial identification: NCT02178475. Legal entity responsible for the study: Amgen. Funding: Amgen GmBH. Disclosure: C.M. Kurbacher: Honoraria and travel expenses, advisory role: Amgen. M. Schmidt: Honoraria: Pierre-Fabre, Roche, Pfizer, Novartis, AstraZeneca, Eisai, Amgen, Celgene; Research grants: Pierre-Fabre; Non-financial support: Roche, Pfizer, Amgen, Celgene. H. Eschenburg: Honoraria: Roche AG; Other financial support: Bristol-Myers Squibb. P. Ramdohr: Employee and holds stock: Amgen. All other authors have declared no conflicts of interest.