Effectiveness of biosimilar filgrastim vs. original granulocyte colony-stimulating factors in febrile neutropenia prevention in breast cancer patients.

PURPOSE: The purpose of this study is to describe the effectiveness of biosimilar filgrastim and original granulocyte colony-stimulating factors (G-CSFs), lenograstim and pegfilgrastim, in febrile neutropenia (FN) prevention in breast cancer patients receiving docetaxel/doxorubicin/cyclophosphamide (TAC) as adjuvant/neoadjuvant treatment and to analyze their treatment patterns. METHODS: A pharmacoepidemiology cohort study was developed in a university hospital (with 23 healthcare centers) with retrospective data collection (2012-2014). Effectiveness of G-CSFs was assessed by the FN incidence. Other parameters analyzed were as follows: moderate and severe neutropenia incidence, neutropenia-related hospitalizations, dosage, and duration. Data was analyzed using each cycle as a unit of analysis. RESULTS: We identified 98 patients representing 518 chemotherapy cycles, 215 with original G-CSFs (35 lenograstim and 180 pegfilgrastim) and 303 with biosimilar filgrastim. The FN incidence was similar in both groups (3.7% original vs. 3.3% biosimilar; p = 0.79). No statistically significant differences were found in moderate and severe neutropenia incidence (4.7 vs. 6.3%; p = 0.43) or neutropenia-related hospitalizations (3.3 vs. 3.6%; p = 0.19). When the three drugs were evaluated separately, a higher FN incidence was observed with lenograstim than with pegfilgratim or biosimilar (p = 0.024). The dosage and duration of biosimilar were lower than lenograstim (4.9 vs. 5.7 µg/kg/day; 5 vs. 7 days; p < 0.001). CONCLUSION: An abbreviated 5-day course of biosimilar filgrastim provided optimal primary prophylaxis against FN post-chemotherapy TAC in patients with breast cancer. The clinical relevance of the highest FN incidence in the lenograstim cohort needs further attention.

Lifestyle factors associated with BMI in a Spanish graduate population: the SUN Study.

OBJECTIVE: To study the association between BMI and lifestyle factors such as alcohol consumption, smoking habits, education level and marital status in a Spanish graduate population. METHOD: Cross-sectional analysis of 8,706 participants (3,643 men and 5,063 women) from the Seguimiento Universidad de Navarra (SUN) Study, an ongoing dynamic cohort study in Spain. Data on body weight, height and sociodemographic characteristics, and lifestyle habits were collected with self-administered validated questionnaires. RESULTS: Among older participants (above sex-specific median age), educational level was a factor independently associated with BMI. University graduates with a lower educational level (3-year college degree or 5-year university degree) had a significantly higher BMI than those with doctorate which requires, at least, 8 years of university studies in Spain. Mean BMI was significantly higher among past smokers than among never smokers. Alcohol consumption, marital and smoking status were associated with BMI only among men. CONCLUSION: In a study whose members were all university graduates, several factors were independently associated with a higher BMI, such as less years of higher education, past smoking, marital status and higher alcohol consumption.