Prospective cohort study of febrile neutropenia in breast cancer patients administered with neoadjuvant and adjuvant chemotherapies: CSPOR-BC FN study

Background As Asians are more vulnerable to febrile neutropenia (FN) than Caucasians, evaluations of FN incidence and risk factors in Asians are important for the appropriate use of primary pegfilgrastim (PEG-G). Patients and methods Japanese breast cancer patients receiving standard adjuvant chemotherapies were prospectively enrolled in multicenter institutions from August 2015 to July 2017. FN was evaluated from 2 treatment policies: true FN (T-FN): ≥37.5 °C, grade 4 neutropenia, mandatory hospital visit (visiting); surrogate FN (S-FN): ≥37.5 °C, oral antibiotic, no mandatory visit (non-visiting). PEG-G was used at the physicians’ discretion. The primary endpoint was FN incidence during all cycles. Multivariate logistic regression analysis was performed to identify T-FN risk factors. Results Of 1005 enrolled patients, 980 women treated with FEC, E(A)C, and TC were analyzed. The FN incidence proportions in all patients were 22.5%, 27.5%, and 33.9% for FEC, E(A)C, and TC, respectively. Those of T-FN were 27.7%, 22.4%, and 36.6%; those of S-FN were 17.3%, 32.4%, and 31.5% with more frequent primary PEG-G usage. The relative dose intensity (RDI) of the 3 regimens was ≥0.85 in both groups. In the analysis of risk factors, TC (odds ratio = 2.67), age ≥ 65 years (2.24), and pretreatment absolute neutrophil count (ANC)/1000 μl (0.8) remained significant. Conclusions FN incidences were above 20% in the 3 regimens, with TC showing the highest. RDI was maintained at a high level in both visiting and non-visiting groups. Patient-related risk factors were age and pretreatment ANC

The Impact on Quality of Life of Highly Effective Antiemetic Therapy among Breast Cancer Patients Receiving Anthracycline Plus Cyclophosphamide-based Regimen

Treatment for chemotherapy-induced nausea and vomiting （CINV） has improved significantly with the development of antiemetic drugs. We conducted a prospective observational study to clarify the quality of life （QOL） impact of antiemetic therapy recommended by the Japanese Cancer Therapy Association （JSCO） guidelines for Japanese breast cancer patients receiving an anthracycline plus cyclophosphamide regimen （ACR）. This was an open, single-center, prospective observational study conducted in Yokohama City University Medical Center. Antiemetic therapy recommended by the JSCO guidelines was implemented for all cases treated therein （i.e., aprepitant, dexamethasone, and palonosetron）. The primary endpoint was no impact on daily living （NIDL） rate during a 120-hour period following chemotherapy （i.e., overall phase）. We use the Japanese version of the Functional Living Index?Emesis （FLIE） to evaluate the impact of CINV on QOL. There were 118 analyzable cases. The NIDL rate during the overall phase was 44.9％, and was significantly lower than the complete response （CR） rate of 58.5％ （i.e., no emetic responses and no rescue medication; P＝0.037）. Age＜55 years （P＝0.008） and a history of morning sickness （P＝0.005） were identified as independent risk factors of NIDL （P＜0.05）. Among Japanese breast cancer patients receiving ACR and a combination of aprepitant, dexamethasone, and palonosetron, the NIDL rate was relatively low at approximately 45％. A more effective antiemetic therapy should therefore be developed for patients’ QOL that takes NIDL risk factors into account. In addition, our results suggested that the CR rate is insufficient for evaluating the effect of antiemetic therapy on a patient’s QOL