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Effect of adding gefitinib to neoadjuvant chemotherapy in estrogen receptor negative early breast cancer in a randomized phase II trial

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  1. Cumulative incidence of cardiovascular events under tamoxifen and letrozole alone and in sequence: a report from the BIG 1-98 trial

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  2. Breast cancer mortality and overdiagnosis after implementation of population-based screening in Denmark

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  3. Induction of PIK3CA alterations during neoadjuvant letrozole may improve outcome in postmenopausal breast cancer patients

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  4. Patterns in detection of recurrence among patients treated for breast cancer

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  5. Prognostic value of histopathological DCIS features in a large-scale international interrater reliability study

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  1. Road and railway noise and risk for breast cancer: A nationwide study covering Denmark

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  2. Cumulative incidence of cardiovascular events under tamoxifen and letrozole alone and in sequence: a report from the BIG 1-98 trial

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  3. Clinical implications of intrinsic molecular subtypes of breast cancer for sentinel node status

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Gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, has shown both anti-proliferative and anti-tumoral 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 (4.57% difference, 95% CI -7.19 to 6.33; P = 0.44). CR was observed in 10% of patients in both the gefitinib (7/71) and the placebo group (7/73) (0.27% difference, 95% CI -9.6 to 10.2; P = 0.96). There was no significant difference in OR (5.96%; 95% CI -9.9 to 21.9; P = 0.45) between the two groups. Post hoc subgroup analysis showed a significant difference in pCR between triple negative breast cancer (TNBC) and non-TNBC tumors (P = 0.03). More patients in the gefitinib arm had hematological toxicity (P = 0.15) 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 non-TNBC independent of treatment. More patients in the gefitinib group discontinued treatment because of AE.
Original languageEnglish
JournalBreast Cancer Research and Treatment
Volume126
Issue number2
Pages (from-to)463-70
Number of pages8
ISSN0167-6806
DOIs
Publication statusPublished - 2011

    Research areas

  • Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular, Cyclophosphamide, Double-Blind Method, Epirubicin, Female, Fever, Humans, Leukopenia, Middle Aged, Neoadjuvant Therapy, Neutropenia, Quinazolines, Receptors, Estrogen, Research Design, Treatment Outcome, Tumor Burden

ID: 33154419