2011
Randomized phase II study comparing efficacy and safety of combination-therapy trastuzumab and docetaxel vs. sequential therapy of trastuzumab followed by docetaxel alone at progression as first-line chemotherapy in patients with HER2+ metastatic breast cancer: Hertax trial
Publication
Publication
Clinical Breast Cancer , Volume 11 - Issue 2 p. 103- 113
Background: Because chemotherapy for metastatic breast cancer (MBC) is associated with relevant toxicity, sequential monotherapy trastuzumab followed by cytotoxic therapy at disease progression might be an attractive approach. Methods: In a multicenter phase II trial, 101 patients with overexpression of human epidermal growth factor receptor 2 (HER2+) MBC were randomized between combination-therapy trastuzumab (Herceptin) plus docetaxel (H + D) and sequential therapy of single-agent trastuzumab followed at disease progression by docetaxel alone (H→D) as first-line chemotherapy for metastatic disease. The primary endpoint was progression-free survival (PFS) after completed sequential or combination therapy. Results: For the H + D group the median PFS was 9.4 vs. 9.9 months for the H→D group and 1-year PFS rates were 44% vs. 35%, respectively. However the overall response rates (ORRs) were 79% vs. 53%, respectively (P =.016), and overall survival was 30.5 vs. 19.7 months, respectively (P =.11). In the H→D group, response rates to monotherapy trastuzumab and subsequent docetaxel were 34% and 39%, respectively, with a median PFS during single-agent trastuzumab of 3.9 months. The incidence and severity of neuropathy were significantly higher in the H + D group. Retrospective analysis of trastuzumab treatment beyond progression (applied in 46% of patients in the H + D group and 37% in the H→D group) showed a correlation with longer overall survival in both treatment arms (36.0 vs. 18.0 months and 30.3 vs. 18.6 months, respectively). Conclusion: First-line treatment in patients with MBC with H→D resulted in a similar PFS compared with H + D, but the response rate was lower and the overall survival nonsignificantly shorter.
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| doi.org/10.1016/j.clbc.2011.03.003, hdl.handle.net/1765/31168 | |
| Clinical Breast Cancer | |
| Organisation | Erasmus MC: University Medical Center Rotterdam |
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Hamberg, P., Bos, M., Braun, H., Stouthard, J., van Deijk, G., Erdkamp, F., … Klijn, J. (2011). Randomized phase II study comparing efficacy and safety of combination-therapy trastuzumab and docetaxel vs. sequential therapy of trastuzumab followed by docetaxel alone at progression as first-line chemotherapy in patients with HER2+ metastatic breast cancer: Hertax trial. Clinical Breast Cancer, 11(2), 103–113. doi:10.1016/j.clbc.2011.03.003 |
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