Abstract P3-09-05: Febrile neutropenia in FEC-D regimen for early stage breast cancer, is there a place for G-CSF primary prophylaxis?
Authors: I Miguel, P Wincler, M Sousa, C Cardoso, A Moreira, M Brito
Journal: Cancer Research (2013)

Abstract Background: Febrile neutropenia (FN) is a major toxicity of anthracycline-taxane based chemotherapy, which is actually the most active cytotoxic combination for breast cancer treatment. The standard and widely adopted FEC-D regimen reported initially a favorable toxicity profile, with a global and Docetaxel FN rate of 11.2% and 7.4% respectively. FEC-D has not been commonly considered by guidelines (ASCO, ESMO, EORTC and NCCN) a high risk FN regimen (FN risk ≥20%), and G-CSF primary prophylaxis is therefore not systematically recommended. We aimed to analyze the incidence and severity of FN in FEC-D in our Center. Methods: Retrospective study to evaluate the incidence and severity of FN events in a cohort of women with breast cancer consecutively treated in our Center with adjuvant or neoadjuvant FEC-D regimen (5-FU 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2 - 3 cycles followed by Docetaxel 100 mg/m2 - 3 cycles). Patients (pts) on concomitant trastuzumab were excluded. FN was defined as axillary temperature ≥38°C and absolute neutrophil count (ANC) &amp;lt; 500/mm3. Data is described as median and interquartile range (IQR) / range and association between variables was calculated using relative risk (RR). Results: Our cohort consisted of 189 pts treated with FEC-D, 56% adjuvant and 44% in the neoadjuvant setting. Median age was 61 years (IQR: 52-66). In 5% the stage was I, 50% II and in 45% III. Hormonal receptors and HER 2/neu were positive in 80% and 19% pts respectively. Fifty-one pts (27%) developed at least one episode of FN, 7% (n = 13) during FEC and 21% (n = 40) during docetaxel administration. There were a total of 61 FN episodes in the 1100 cycles of FEC-D administered (5.6%). The majority (n = 47; 77%) occurred during C4-C6 (Docetaxel cycles), with a predominance of FN events in C4 (46%). Median day of FN presentation was 11 for FEC and 8 for Docetaxel. In 33 episodes (54.1%) FN resulted in hospital admission for a median duration of 5 days (range: 2-13). There were no deaths related to FN. Ten pts delayed the subsequent cycle of chemotherapy, nine needed dose intensity reduction and five pts changed chemotherapy regimen, all due to Docetaxel related NF. The risk of developing a FN episode was globally equal in pts &amp;lt; and ≥ 65 years (RR = 1). Discussion: In contrast with the initial results reported for FEC-D, we found a substantial higher than expected rate of FN (&amp;gt; 20%) during FEC-D Docetaxel cycles. Our Docetaxel FN rate is already in line with some other authors experience in out-of-trial patients. FN had a significant impact on patients care and on healthcare system with hospital admittance and chemotherapy dose or regimen modification needed in approximately half of FN episodes. Our results were practice-changing in our Center. We now recommend the use of G-CSF primary prophylaxis in all FEC-D pts from cycle 4 to 6. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-09-05.