Primary G-CSF prophylaxis for adjuvant TC or FEC-D chemotherapy outside of clinical trial settings: a systematic review and meta-analysis
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- Younis, T., Rayson, D. & Thompson, K. Support Care Cancer (2012) 20: 2523. doi:10.1007/s00520-011-1375-6
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Variable febrile neutropenia (FN) rates reported with adjuvant TC (taxotere®, cyclophosphamide) and FEC-D (5-flurouracil, epirubicin, cyclophosphamide, docetaxel) outside of clinical trials have precluded definitive recommendations for primary G-CSF (granulocyte colony-stimulating factor) prophylaxis in most jurisdictions. A systematic review and meta-analysis was conducted to assess: (a) FN rates associated with TC and FEC-D without primary G-CSF prophylaxis outside of clinical trial settings, and (b) the potential impact of G-CSF prophylaxis on FN prevention.
A MEDLINE search was conducted and major conference abstracts were reviewed up to June 15th 2011 to identify all relevant English-language studies. Random- and fixed-effects meta-analysis models were performed.
Nine hundred two patients treated with TC and 1342 with FEC-D from 13 to 9 studies, respectively, were included. The pooled random-effects meta-analysis estimates of FN rates for TC and FEC-D without G-CSF were 29% (95% CI 24–35%) and 31% (95% CI 27–35%), with a 76% (RR = 0.24, 95% CI 0.14–0.41) and 63% (RR = 0.37, 95% CI 0.11–1.24) relative risk reduction with G-CSF, respectively.
In routine clinical practice, TC and FEC-D without G-CSF are associated with FN rates exceeding the 20% threshold for which primary G-CSF prophylaxis is commonly recommended, and are considerably higher than those reported in pivotal clinical trials.