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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.

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Authors
Joensuu, Heikki
Fraser, Judith
Wildiers, Hans
Huovinen, Riikka
Auvinen, Päivi
Utriainen, Meri
Nyandoto, Paul
Villman, Kenneth K
Halonen, Päivi
Granstam-Björneklett, Helena
Lundgren, Lotta
Sailas, Liisa
Turpeenniemi-Hujanen, Taina
Tanner, Minna
Yachnin, Jeffrey
Ritchie, Diana
Johansson, Oskar
Huttunen, Teppo
Neven, Patrick
Canney, Peter
Harvey, Vernon J
Kellokumpu-Lehtinen, Pirkko-Liisa
Lindman, Henrik
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Issue Date
2018-09-01

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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. 2018, 4(9):1199-1206 JAMA Oncology
Abstract
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.
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https://jamanetwork.com/journals/jamaoncology/fullarticle/2682589
ae974a485f413a2113503eed53cd6c53
10.1001/jamaoncol.2018.1380
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