TY - JOUR
T1 - Effect of Adjuvant Trastuzumab for a Duration of 9 Weeks vs 1 Year With Concomitant Chemotherapy for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The SOLD Randomized Clinical Trial.
AU - Joensuu, Heikki
AU - Fraser, Judith
AU - Wildiers, Hans
AU - Huovinen, Riikka
AU - Auvinen, Päivi
AU - Utriainen, Meri
AU - Nyandoto, Paul
AU - Villman, Kenneth K
AU - Halonen, Päivi
AU - Granstam-Björneklett, Helena
AU - Lundgren, Lotta
AU - Sailas, Liisa
AU - Turpeenniemi-Hujanen, Taina
AU - Tanner, Minna
AU - Yachnin, Jeffrey
AU - Ritchie, Diana
AU - Johansson, Oskar
AU - Huttunen, Teppo
AU - Neven, Patrick
AU - Canney, Peter
AU - Harvey, Vernon J
AU - Kellokumpu-Lehtinen, Pirkko-Liisa
AU - Lindman, Henrik
PY - 2018/9/1
Y1 - 2018/9/1
N2 - Trastuzumab plus chemotherapy is the standard adjuvant treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. While the standard duration of trastuzumab treatment is 12 months, the benefits and harms of trastuzumab continued beyond the chemotherapy are unclear. To evaluate the efficacy and safety of adjuvant trastuzumab continued beyond chemotherapy in women treated with up-front chemotherapy containing a taxane and trastuzumab. Open-label, randomized (1:1) clinical trial including women with HER2-positive breast cancer. Chemotherapy was identical in the 2 groups, consisting of 3 cycles of 3-weekly docetaxel (either 80 or 100 mg/m2) plus trastuzumab for 9 weeks, followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide. Thereafter, no trastuzumab was administered in the 9-week group, whereas controls received trastuzumab to complete 1 year of administration. Disease-free survival (DFS) was compared between the groups using a Cox model and the noninferiority approach. The estimated sample size was 2168 patients (1-sided testing, with a relative noninferiority margin of 1.3). From January 3, 2008, to December 16, 2014, 2176 patients were accrued from 7 countries. Docetaxel plus trastuzumab for 9 weeks, followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide in both groups. Controls continued trastuzumab to 1 year.
AB - Trastuzumab plus chemotherapy is the standard adjuvant treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. While the standard duration of trastuzumab treatment is 12 months, the benefits and harms of trastuzumab continued beyond the chemotherapy are unclear. To evaluate the efficacy and safety of adjuvant trastuzumab continued beyond chemotherapy in women treated with up-front chemotherapy containing a taxane and trastuzumab. Open-label, randomized (1:1) clinical trial including women with HER2-positive breast cancer. Chemotherapy was identical in the 2 groups, consisting of 3 cycles of 3-weekly docetaxel (either 80 or 100 mg/m2) plus trastuzumab for 9 weeks, followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide. Thereafter, no trastuzumab was administered in the 9-week group, whereas controls received trastuzumab to complete 1 year of administration. Disease-free survival (DFS) was compared between the groups using a Cox model and the noninferiority approach. The estimated sample size was 2168 patients (1-sided testing, with a relative noninferiority margin of 1.3). From January 3, 2008, to December 16, 2014, 2176 patients were accrued from 7 countries. Docetaxel plus trastuzumab for 9 weeks, followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide in both groups. Controls continued trastuzumab to 1 year.
KW - Brjóstakrabbamein
KW - Lyfjameðferð
KW - Trastuzumab
KW - Breast Neoplasms
KW - Drug Therapy, Combination
KW - Drug Therapy
KW - Brjóstakrabbamein
KW - Lyfjameðferð
KW - Trastuzumab
KW - Breast Neoplasms
KW - Drug Therapy, Combination
KW - Drug Therapy
U2 - 10.1001/jamaoncol.2018.1380
DO - 10.1001/jamaoncol.2018.1380
M3 - Article
C2 - 29852043
SN - 2374-2445
JO - JAMA Oncology
JF - JAMA Oncology
ER -