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2014 ; 9
(3
): 169-74
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gab.com Text
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English Wikipedia
Sorafenib in the Treatment of Early Breast Cancer: Results of the Neoadjuvant
Phase II Study - SOFIA
#MMPMID25177258
Loibl S
; Rokitta D
; Conrad B
; Harbeck N
; Wüllner M
; Warm M
; Schwedler K
; Gerber B
; Schrader I
; Eidtmann H
; Mehta K
; Fuhr U
; von Minckwitz G
Breast Care (Basel)
2014[Jul]; 9
(3
): 169-74
PMID25177258
show ga
BACKGROUND: Sorafenib was tested for neoadjuvant treatment with an
anthracycline/taxane-based chemotherapy in the open-label, multicentre,
single-arm phase II study, 'SOFIA'. PATIENTS AND METHODS: INCLUSION CRITERIA
WERE: HER2 negative, cT3, cT4 or cT2 cN+, M0 primary breast cancer. Patients
received 4 × epirubicin 90 mg/m(2) and cyclophosphamide 600 mg/m(2) (EC)
intravenously (i.v.) in 3-weekly cycles followed or preceded by 12 weeks of
paclitaxel (Pw) 80 mg/m(2). In cohort 1, sorafenib started at 800 mg daily with
chemotherapy. An initial daily sorafenib dose of 200 mg was escalated, based on
individual toxicities, every 3 weeks in cohort 2 (starting with EC) and every 2
weeks in cohort 3 (starting with Pw). The primary objective was to identify the
most feasible regimen; secondary objectives were safety, pathological complete
response (pCR) at surgery and pharmacokinetics. RESULTS: Of the 36 recruited
patients, 7/12 patients completed the study in cohort 1 and 24/24 patients in
cohorts 2 and 3. The median cumulative sorafenib dose per patient was 37%, 65%
and 46% in cohorts 1, 2 and 3, respectively. The main grade 3-4 toxicities were
neutropenia and hand-foot syndrome. The pCR (ypT0/is) rate was 27.7%. No
pharmacokinetic interaction was observed between sorafenib and epirubicin.
CONCLUSION: Sorafenib EC-Pw is feasible if the starting dose is 200 mg, escalated
every 3 weeks based on the patients' individual toxicities.
free
free
free
