Avtor/Urednik		Slamon, Denis; Eiermann, Wolfgang; Robert, Nicholas; Pienkowski, Tadeusz; Martin, Miguel; Press, Michael; Mackey, John; Matos, Erika; Čufer, Tanja; Takač, Iztok
Naslov		Adjuvant trastuzumab in HER2-positive breast cancer
Tip		članek
Vir		N Engl J Med
Vol. in št.		Letnik 365, št. 14
Leto izdaje		2011
Obseg		str. 1273-83
Jezik		eng
Abstrakt		Background: Trastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer, although combined therapy with anthracycline-based regimens has been associated with cardiac toxicity. We wanted to evaluate the efficacy and safety of a new nonanthracycline regimen with trastuzumab. Methods: We randomly assigned 3222 women with HER2-positive early-stage breast cancer to receive doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks (AC-T), the same regimen plus 52 weeks of trastuzumab (AC-T plus trastuzumab), or docetaxel and carboplatin plus 52 weeks of trastuzumab (TCH). The primary study end point was disease-free survival. Secondary end points were overall survival and safety. Results: At a median follow-up of 65 months, 656 events triggered this protocol-specified analysis. The estimated disease-free survival rates at 5 years were 75% among patients receiving AC-T, 84% among those receiving AC-T plus trastuzumab, and 81% among those receiving TCH. Estimated rates of overall survival were 87%, 92%, and 91%, respectively. No significant differences in efficacy (disease-free or overall survival) were found between the two trastuzumab regimens, whereas both were superior to AC-T. The rates of congestive heart failure and cardiac dysfunction were significantly higher in the group receiving AC-T plus trastuzumab than in the TCH group (P<0.001). Eight cases of acute leukemia were reported: seven in the groups receiving the anthracycline-based regimens and one in the TCH group subsequent to receiving an anthracycline outside the study. Conclusions: The addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer. (Abstract truncated at 2000 characters)
Deskriptorji		BREAST NEOPLASMS ANTIBODIES, MONOCLONAL PROTO-ONCOGENE PROTEINS C-ERBB-2 ANTHRACYCLINES STROKE VOLUME HEART FAILURE, CONGESTIVE DISEASE-FREE SURVIVAL SURVIVAL ANALYSIS FOLLOW-UP STUDIES