Abstract:
BACKGROUND:Irinotecan has a 20% to 25% response rate (RR) in patients with previously treated metastatic breast cancer (MBC). Epidermal growth factor receptor (EGFR) is overexpressed in some MBC, especially in triple-negative breast cancer (TNBC). Cetuximab is a monoclonal antibody against EGFR with additive preclinical activity with irinotecan. PATIENTS AND METHODS:We report a 1-stage phase II study on MBC, measurable disease, and previous anthracycline and/or taxane therapy. Patients received cetuximab 400 mg/m(2) on day 1 cycle 1 then 250 mg/m(2) weekly thereafter and irinotecan 80 mg/m(2) on days 1 and 8 of each 21-day cycle. The primary end point was overall RR (ORR) according to Response Evaluation Criteria in Solid Tumors criteria (version 1.1). RESULTS:Of 19 eligible patients enrolled from February to September 2006, 14 patients (74%) had visceral disease, seven patients (37%) were hormone receptor-positive, two patients (11%) HER2-positive, and 11 patients (58%) were triple-negative. Patients received a median of 2 cycles (range, 1-37). Confirmed ORR was 11% (95% confidence interval [CI], 1%-33%), with 1 partial response and 1 complete response. One patient had stable disease for 8 months. RR for TNBC versus non-TNBC was 18% versus 0% (P = .49). Median time to progression was 1.4 months (95% CI, 1.0-2.2) and median overall survival was 9.4 months (95% CI, 2.8-16.1). Twelve patients had disease progression within 2 cycles during therapy. Because of a low RR and rapid disease progression, the study leadership decided to close the trial early. CONCLUSION:The tolerability of the combination of cetuximab and irinotecan is acceptable but demonstrated low overall activity. Potentially promising results were noted in patients with TNBC and further studies of these patients might be considered.
journal_name
Clin Breast Cancerjournal_title
Clinical breast cancerauthors
Crozier JA,Advani PP,LaPlant B,Hobday T,Jaslowski AJ,Moreno-Aspitia A,Perez EAdoi
10.1016/j.clbc.2015.08.002subject
Has Abstractpub_date
2016-02-01 00:00:00pages
23-30issue
1eissn
1526-8209issn
1938-0666pii
S1526-8209(15)00169-Xjournal_volume
16pub_type
杂志文章abstract:BACKGROUND:Two large randomized trials, CALGB 9343 and PRIME II, support omission of radiotherapy after breast conserving surgery (BCS) in elderly women with favorable-risk early stage breast cancer intending to take endocrine therapy. However, patients with grade 3 histology were underrepresented on these trials. We h...
journal_title:Clinical breast cancer
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journal_title:Clinical breast cancer
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pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Clinical breast cancer
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journal_title:Clinical breast cancer
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journal_title:Clinical breast cancer
pub_type: 杂志文章
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journal_title:Clinical breast cancer
pub_type: 杂志文章
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pub_type: 杂志文章,评审
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doi:10.1016/j.clbc.2018.12.002
更新日期:2019-04-01 00:00:00
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pub_type: 杂志文章,meta分析
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pub_type: 杂志文章,评审
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pub_type: 杂志文章
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doi:10.1016/j.clbc.2011.03.017
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journal_title:Clinical breast cancer
pub_type: 杂志文章
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