Phase II study of celecoxib and trastuzumab in metastatic breast cancer patients who have progressed after prior trastuzumab-based treatments Journal Article
| Authors: | Dang, C. T.; Dannenberg, A. J.; Subbaramaiah, K.; Dickler, M. N.; Moasser, M. M.; Seidman, A. D.; D'Andrea, G. M.; Theodoulou, M.; Panageas, K. S.; Norton, L.; Hudis, C. A. |
| Article Title: | Phase II study of celecoxib and trastuzumab in metastatic breast cancer patients who have progressed after prior trastuzumab-based treatments |
| Abstract: | Purpose: Preclinical studies demonstrate a link between overexpression of HER-2/neu and cyclooxygenase-2 (COX-2) activity. To explore the possibility that COX-2 is a therapeutic target, we conducted a phase II study of celecoxib, a selective COX-2 inhibitor, and trastuzumab in patients with HER-2/neu- overexpressing metastatic breast cancer that had progressed while receiving trastuzumab. Experimental Design: Eligible patients had bi-dimensionally measurable or evaluable HER-2/neu-overexpressing metastatic breast cancer. HER-2/neu overexpression, defined as 2+ or 3+ by the HercepTest, was required. Patients had to have progressed despite prior trastuzumab-based therapy. Treatment consisted of celecoxib (400 mg twice daily) and trastuzumab. Results: Twelve patients were enrolled (42% status post 1 regimen for metastatic disease 58% status Post > 2 prior regimens (range of 2-6). Eleven patients were evaluable. There were no responses. Median duration of treatment was 9 weeks. One patient had stable disease at 3 months but progressed at 6 months. A second patient stopped treatment at 3 months because of unresolved grade 2 rash, felt to be related to celecoxib. Toxicities were generally grade 1 or 2. One patient (8%) experienced grade 3 toxicity (abdominal pain). Conclusions: Celecoxib combined with trastuzumab is well tolerated. However, this combination in patients with HER2/neu-overexpressing, trastuzumab-refractory disease, was not active. |
| Keywords: | adult; clinical article; treatment outcome; aged; middle aged; clinical trial; fatigue; cancer growth; diarrhea; antineoplastic agents; in situ hybridization, fluorescence; gene overexpression; edema; metastasis; phase 2 clinical trial; breast cancer; mucosa inflammation; epidermal growth factor receptor 2; membrane proteins; bone pain; enzyme activity; breast neoplasms; time factors; abdominal pain; pruritus; rash; alanine aminotransferase; alkaline phosphatase; aspartate aminotransferase; insomnia; antibodies, monoclonal; celecoxib; cyclooxygenase 2 inhibitor; cyclooxygenase 2 inhibitors; pyrazoles; sulfonamides; cyclooxygenase 2; neoplasm metastasis; receptor, erbb-2; trastuzumab; dyspepsia; dry skin; isoenzymes; oncogene neu; prostaglandin-endoperoxide synthases; cyclooxygenase inhibitors; humans; human; female; priority journal; article |
| Journal Title: | Clinical Cancer Research |
| Volume: | 10 |
| Issue: | 12 Part 1 |
| ISSN: | 1078-0432 |
| Publisher: | American Association for Cancer Research |
| Date Published: | 2004-06-15 |
| Start Page: | 4062 |
| End Page: | 4067 |
| Language: | English |
| DOI: | 10.1158/1078-0432.ccr-03-0463 |
| PROVIDER: | scopus |
| PUBMED: | 15217939 |
| DOI/URL: | |
| Notes: | Clin. Cancer Res. -- Cited By (since 1996):38 -- Export Date: 16 June 2014 -- CODEN: CCREF -- Source: Scopus |
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