Developing and promoting evidence-based use of granulocyte colony stimulating factors (GCSF) in the palliative chemotherapy setting.

Abstract

172 Background: National guidelines help define the standard for institutional clinical and insurance coverage policies, butdo not cover all chemo regimens or clinical scenarios. Given high utilization rates of primary granulocyte colony stimulating factors (GCSF) use in metastatic prostate cancer (CaP) patients treated with second-line cabazitaxel chemotherapy, we assessed indications and clinical rationale with goal of developing guidelines for appropriate use of GCSF in this population. Methods: We analyzed existing National Comprehensive Cancer Network (NCCN) and ASCO Myeloid Growth Factors supportive care guidelines as applied to specific chemo regimens, patient and laboratory risk factors (RF). We subsequently examined phase III TROPIC trial data for incidence of neutropenic events in CaP patients treated with cabazitaxel. Additionally, the medical records of the 25 Dana-Farber CaP patients treated with cabazitaxel from 1/2012 through 9/2012 who received primary GCSF prophylaxis were characterized by neutropenia/complications and their RF profiles using existing guidelines. Findings were presented to the genitourinary oncology providers with discussion culminating in consensusrecommendations for GCSF use. Results: Existing guidelines recommend 7 un-weighted factors to consider for GCSF use, in addition to febrile neutropenia (FN) risk > 20% for any chemo regimen. Cabazitaxel is listed as intermediate FN risk (10-20%). Trial data report FN incidence as 7% without primary prophylaxis. The number of NCCN RF for evaluated Dana-Farber CaP patients is represented below. Conclusions: Group consensus considered any of the following to place patients at high risk of neutropenic events: ECOG ≥2; prior episode of FN with any-line chemo; prior neutropenia resulting in treatment delay; and previous radiation comprising >25% bone marrow exposure. Final clinical consensus regarding high risk patients was to consider standard dose cabazitaxel (25mg/m2) with GCSF support versus dose reduced cabazitaxel (20mg/m2) without GCSF. In cases where provider posits there is no compromise of benefit to patient, initial consideration will be for dose reduction. [Table: see text]