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Title of Journal: Breast Cancer Res Treat

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Abbravation: Breast Cancer Research and Treatment

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Springer US

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DOI

10.1016/j.arcped.2012.09.001

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ISSN

1573-7217

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Effect of adding gefitinib to neoadjuvant chemothe

Authors: Mogens Bernsdorf Christian Ingvar Leif Jörgensen Malgorzata K Tuxen Erik H Jakobsen Anna Saetersdal Marie Louise KimperKarl Niels Kroman Eva Balslev Bent Ejlertsen
Publish Date: 2011/01/15
Volume: 126, Issue: 2, Pages: 463-470
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Abstract

Gefitinib an epidermal growth factor receptor tyrosine kinase inhibitor has shown both antiproliferative and antitumoral activity in breast cancer This study was designed to determine the effect of adding gefitinib to neoadjuvant epirubicin and cyclophosphamide EC on tumor response rates Women with unilateral primary operable estrogen receptor negative invasive breast cancer ≥ 2 cm were eligible for inclusion Randomized patients were to receive four cycles of neoadjuvant EC plus 12 weeks of either gefitinib 250 mg daily or placebo Primary endpoint was pathologic complete response pCR and secondary endpoints were complete response CR and overall objective response OR 181 patients were randomized A pCR was observed in 17 12/71 of patients treated with gefitinib and in 12 9/73 of patients treated with placebo 457 difference 95 CI −719 to 633 P = 044 CR was observed in 10 of patients in both the gefitinib 7/71 and the placebo group 7/73 027 difference 95 CI −96 to 102 P = 096 There was no significant difference in OR 596 95 CI −99 to 219 P = 045 between the two groups Post hoc subgroup analysis showed a significant difference in pCR between triple negative breast cancer TNBC and nonTNBC tumors P = 003 More patients in the gefitinib arm had hematological toxicity P = 015 and discontinued treatment 9/94 vs 2/86 because of adverse events AE Tumor response rates were similar in the two groups A significantly higher pCR rate was observed post hoc in TNBC versus nonTNBC independent of treatment More patients in the gefitinib group discontinued treatment because of AEThe study was sponsored by Astra Zeneca We would like to thank the following centers for provision of study material Sweden Malmö Hospital and Lund University Hospital Norway Trondheim Hospital and RikshospitaletRadiumhospitalet Oslo Denmark Herlev Hospital Aarhus University Hospital Odense University Hospital Vejle Hospital Roskilde Hospital Naestved Hospital and Ringsted Hospital Contribution of Charlotte Levin Tykjaer Jörgensen is gratefully acknowledged

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  6. Biopsy sampling of breast lesions: comparison of core needle- and vacuum-assisted breast biopsies
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  13. Comprehensive analysis of oncogenic effects of PIK3CA mutations in human mammary epithelial cells
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