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.

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

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish
JournalJAMA Oncology
DOIs
Publication statusPublished - 1 Sept 2018

Other keywords

  • Brjóstakrabbamein
  • Lyfjameðferð
  • Trastuzumab
  • Breast Neoplasms
  • Drug Therapy, Combination
  • Drug Therapy

Fingerprint

Dive into the research topics of '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.'. Together they form a unique fingerprint.

Cite this