In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 606-606
Abstract:
606 Background: A is an oral, irreversible, ErbB Family Blocker. This Phase II study investigated A, L and T monotherapy in pts with locally advanced HER2 (ErbB2)-positive BC in a 6-wk preoperative treatment window. Methods: This international, multi-institutional, open-label, randomized, Phase II study included pts with HER2-positive locally advanced disease Stage IIIa–c and inflammatory BC with no evidence of distant metastatic disease, at least one tumor lesion ≥5 cm in diameter, and an ECOG score 0–1. Pts agreed to fresh tumor biopsies for biomarker analyses at trial entry, and at 3 and 6 wks of treatment. Pts received 50 mg A once daily, 1500 mg L once daily, or T 2 mg/kg weekly after a loading dose of 4 mg/kg for 6 wks. Results: 73 pts were screened and 29 pts randomized and treated* (10 pts A, 8 pts L, 11 pts T). All pts were female, median age 49 (range 25–88) yrs, 28/29 pts had Stage III disease, 3/29 pts had inflammatory BC, median tumour size was 6.4 cm, and median time to treatment was 1.4 months (range 0–3.4). After 6 wks of treatment, OR was assessed using RECIST 1.0 (Table). Best objective response during treatment was 80%, 75%, and 36.4% in the pts treated with A, L, and T, respectively. Drug-related AEs assessed by CTCAE v.3.0 occurred in all pts treated with A, 75% of pts treated with L, and 45.5% of patients treated with T (largely GI and skin-related AEs for A and L, and GI and musculoskeletal AEs for T). Three pts treated with A and one pt with L had drug-related AEs of CTCAE Grade 3. Conclusions: Afatinib showed a high OR rate in this Phase II trial of a 6-wk preoperative treatment window and compared favorably to two approved agents in HER2-positive BC, albeit at a slightly higher rate of AEs. Further trials will be needed to identify the potential role of A as a single agent or in combination with other agents in HER2-positive BC. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.15_suppl.606
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
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