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A European Organisation for Research and Treatment of Cancer randomized, double-blind, placebo-controlled, multicentre phase II trial of anastrozole in combination with gefitinib or placebo in hormone receptor-positive advanced breast cancer (NCT00066378).Tryfonidis, Konstantinos ...Preclinical data suggest that epidermal growth factor receptor (EGFR) inhibitors (e.g. gefitinib) can delay endocrine resistance in breast cancer. A double-blind, placebo-controlled, phase II trial ... investigated whether adding gefitinib (G) to anastrozole (A) would improve outcome in advanced breast cancer (ABC). METHODS: Postmenopausal pre-treated hormone receptor-positive ABC patients (locally recurrent or metastatic) were 1:1 randomized to A (1 mg/d) plus G 250 mg/d or plus placebo (P). Patients who had prior treatment with an aromatase inhibitor in metastatic setting or with trastuzumab, anti-EGFR or anti-VEGF agents were excluded. Treatment was given until disease progression, unacceptable toxicity or patient withdrawal. Progression-free survival (PFS) rate at 1 year was assessed according to Response Evaluation Criteria in Solid Tumours, version 1.0. RESULTS: Of 108 planned patients, 71 were recruited (36 in A/G and 35 in A/P). The trial closed prematurely due to slow recruitment; 31 patients had prior chemotherapy and 53 prior endocrine therapy (all except one received tamoxifen); 60% in adjuvant and 16% in metastatic setting received tamoxifen; 59 patients had visceral disease. Median follow-up was 18 months. PFS rate at 1 year was 35% for A/G and 32% for A/P arm. Objective responses were six (22%) in the A/G and nine (28%) in the A/P arm. Median duration of response was 13.8 and 18.6 months in the A/G and A/P arms, respectively. Fatigue (35%), diarrhoea (31%), rash (32%), dry skin (27%), and arthralgia/myalgia (27%) were the commonest adverse events in the A/G arm. CONCLUSIONS: This phase II study, although prematurely closed, did not show a signal that adding G to A improves PFS at 1 year and its use is not supported. Gastrointestinal and skin toxicities were more pronounced with G resulting in premature therapy interruption in almost 1 in 3 patients (ClinicalTrials.gov number, NCT00066378).Source: European Journal of Cancer. - ISSN 0959-8049 (Vol. 53, no. 1, Jan. 2016, str. 144-154)Type of material - article, component partPublish date - 2016Language - englishCOBISS.SI-ID - 2217595
Author
Tryfonidis, Konstantinos |
Basaran, Gul |
Bogaerts, Jan |
Debled, Marc |
Dirix, Luc Yves |
Thery, Jean-Christophe |
Tjan-Heijnen, Vivianne C. G. |
Van den Weyngaert, Danielle |
Čufer, Tanja, 1955- |
Piccart, Martine |
Cameron, David A.
Topics
anastrozol |
gefitinib |
metastaziran rak dojke |
rak dojke |
endokrina odpornost |
anastrozole |
gefitinib |
metastatic breast cancer |
endocrinic resistence
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Database name | Field | Year |
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Tryfonidis, Konstantinos | |
Basaran, Gul | |
Bogaerts, Jan | |
Debled, Marc | |
Dirix, Luc Yves | |
Thery, Jean-Christophe | |
Tjan-Heijnen, Vivianne C. G. | |
Van den Weyngaert, Danielle | |
Čufer, Tanja, 1955- | 12179 |
Piccart, Martine | |
Cameron, David A. |
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