Universität zu Köln

Loibl, Sibylle, Rokitta, Dennis, Conrad, Bettina, Harbeck, Nadia, Wuellner, Michaela, Warm, Mathias, Schwedler, Kathrin, Gerber, Bernd, Schrader, Iris, Eidtmann, Holger, Mehta, Keyur, Fuhr, Uwe and von Minckwitz, Gunter (2014). Sorafenib in the Treatment of Early Breast Cancer: Results of the Neoadjuvant Phase II Study - SOFIA. Breast Care, 9 (3). S. 169 - 175. BASEL: KARGER. ISSN 1661-3805

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Abstract

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 x 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Loibl, Sibylle UNSPECIFIED UNSPECIFIED UNSPECIFIED Rokitta, Dennis UNSPECIFIED UNSPECIFIED UNSPECIFIED Conrad, Bettina UNSPECIFIED UNSPECIFIED UNSPECIFIED Harbeck, Nadia UNSPECIFIED UNSPECIFIED UNSPECIFIED Wuellner, Michaela UNSPECIFIED UNSPECIFIED UNSPECIFIED Warm, Mathias UNSPECIFIED UNSPECIFIED UNSPECIFIED Schwedler, Kathrin UNSPECIFIED UNSPECIFIED UNSPECIFIED Gerber, Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED Schrader, Iris UNSPECIFIED UNSPECIFIED UNSPECIFIED Eidtmann, Holger UNSPECIFIED UNSPECIFIED UNSPECIFIED Mehta, Keyur UNSPECIFIED UNSPECIFIED UNSPECIFIED Fuhr, Uwe UNSPECIFIED UNSPECIFIED UNSPECIFIED von Minckwitz, Gunter UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-449955
DOI:	10.1159/000363430
Journal or Publication Title:	Breast Care
Volume:	9
Number:	3
Page Range:	S. 169 - 175
Date:	2014
Publisher:	KARGER
Place of Publication:	BASEL
ISSN:	1661-3805
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language REFRACTORY SOLID TUMORS; 1ST-LINE TREATMENT; COMBINATION; BEVACIZUMAB; PACLITAXEL; TRIAL; THERAPY; CHEMOTHERAPY; SUNITINIB; PHARMACOKINETICS Multiple languages Oncology; Obstetrics & Gynecology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/44995