Impact of colony-stimulating factors to reduce febrile neutropenic events in breast cancer patients receiving docetaxel plus cyclophosphamide chemotherapy.

BACKGROUND: Data from US Oncology Adjuvant Trial 9735 has shown that four cycles of docetaxel plus cyclophosphamide (TC) improved disease-free and overall survival when compared against doxorubicin and cyclophosphamide (AC) in early-stage breast cancer. The febrile neutropenia (FN) rate was 4% in this study without primary granulocyte colony-stimulating factors (G-CSF) prophylaxis. However, the incidence of docetaxel-induced myelosuppression is recognized to be higher among Asian population. Hence, this study was designed to evaluate the impact of G-CSF to reduce FN-related events in Asian cancer patients treated with TC. METHOD: This retrospective cohort study was conducted on Asian breast cancer patients who have received intravenous docetaxel 75 mg/m(2) and cyclophosphamide 600 mg/m(2) between 2006 to 2008. Patients did not receive oral antibiotic prophylaxis, and prophylactic G-CSF after chemotherapy was prescribed under the discretion of the primary oncologist. RESULTS: During cycle 1 of chemotherapy, 6.3% patients received G-CSF manifested FN, while 25% patients who did not receive G-CSF manifested FN (RR = 0.252, 95% CI 0.102 to 0.622). Introduction of G-CSF as primary prophylaxis provided an absolute risk reduction of FN events by 18.7%. Chemotherapy doses were maintained throughout all cycles. Patients with pretreatment white blood cell counts (WBC) below 6.0 × 10(3)/mm(3) and absolute neutrophil counts (ANC) below 3.1 × 10(3)/mm(3) were associated with higher rates of FN during Cycle 1 (p = 0.009, p = 0.007). CONCLUSIONS: Our findings indicate that TC was associated with higher rates of FN than reported in the clinical trial. The 25% incidence fulfills the requirement of primary prophylaxis with G-CSF. Routine administration of G-CSF is highly recommended to reduce the rates of FN in breast cancer patients receiving TC.

Comparing two regimens of intravaginal misoprostol with intravaginal gemeprost for second-trimester pregnancy termination: a randomised controlled trial.

AIM: To compare the efficacy and safety of intravaginal misoprostol 200 µg, 400 µg and gemeprost regimens for second-trimester termination of pregnancy (TOP). METHODS: A three- armed randomi sed controlled trial (Clinical Trial Certificate 1100015) where 116 women undergoing second-trimester TOP were given intravaginal misoprostol 200 µ g (n=37), misoprostol 400 µg (n=40) or gemeprost 1 mg (n=39) at 4- hour intervals until abortion occurred with a maximum of five doses. RESULTS: The misoprostol 400 µg group had the highest incidence of successful abortions (92.5%) compared to the misoprostol 200 µg (70.3%; p=0.017) and gemeprost 1 mg (74.4%; p=0.037) within 48 hours. There was no significant difference in abortion rate between misoprostol 200 µg and gemeprost. The misoprostol 400 µg group had the highest incidence of fever (70.0%) compared to misoprostol 200 µg (24.3%; p<0.001) and gemeprost 1 mg (46.2%; p=0.041). The gemeprost group had the highest incidence of diarrhoea (38.5%) compared to misoprostol 400 µg (10.0%; p=0.004) and misoprostol 200 µg (8.1%; p=0.003) groups. CONCLUSIONS: Intravaginal misoprostol 400 µ g at 4- hour intervals was the most effective regimen but was associated with a high incidence of fever. Misoprostol 200 µg demonstrated similar effectiveness as gemeprost and had lower incidence of diarrhoea. Gemeprost should not be first line for medical therapy given the cost, storage requirements and lower efficacy.