Corrigendum to Six versus 12 months of adjuvant trastuzumab in combination with dose-dense chemotherapy for women with HER2-positive breast cancer: a multicenter randomized study by the Hellenic Oncology Research Group (HORG)

Abstract

The authors regret that while Figure 2B correctly depicts the Kaplan-Meier estimates for overall survival, the Hazard Ratio has been erroneously calculated: the given HR>1 favors in reality 6-month treatment. For reasons of consistency with Figure 2A (so, HR>1 favoring 12-month treatment), the correct value would be HR¼0.69 (95% CI: 0.27e1.76, p¼0.441).The first sentence from the Results section should now read: Between June 2004 and May 2012, 493 patients were randomized to receive either 12-months or 6-monhts trastuzumab treatment. However, five patients withdrew their consent after randomization and seven were found to be HER2 negative on local retesting. Thus, 481 (98%) were eligible for the study, 241 and 240 in the 12-months and 6-months, respectively (Figure 1; CONSORT diagram of the study).This change is depicted in the new CONSORT diagram, below. The authors would like to apologise for any inconvenience caused.

6 months versus 12 months of adjuvant trastuzumab in early breast cancer (PHARE): final analysis of a multicentre, open-label, phase 3 randomised trial

“…However, a few studies have assessed a shorter duration of adjuvant trastuzumab, and the one year standard of care has not changed (9) (10) (11) (12) (13). In 2012, the first analysis of the PHARE ('Protocol for Herceptin® as Adjuvant therapy with Reduced Exposure') trial failed to show that 6 months of adjuvant trastuzumab was noninferior to 12 months (9).…”

Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis

“…Non-inferiority margins varied across the included studies. PHARE had the most stringent non-inferiority margin HR 1.15 or absolute increase of 2% at 2 years for DFS while HORG had the largest non-inferiority margin HR 1.53 or absolute increase of 8% at 3 years for DFS [ 12 , 27 , 28 ]. PERSEPHONE, PHARE, and HORG used 6 months of trastuzumab, while Short-HER and SOLD used 9 weeks, to compare with the standard one year duration [ [10] , [11] , [12] , 27 , 29 ].…”

“…All five trials included OS outcomes, using the corrected OS results from HORG [ 28 ]. Applying the same predefined non-inferiority margin calculated using DFS, non-inferiority is inconclusive for OS (HR 1.14, 95%CI 1.00–1.30, I 2 0%) as the upper bound of 95%CI (1.30) was above our non-inferiority margin of HR 1.29 ( Fig.…”

Gene expression trend changes in breast cancer populations over two decades: insights from The Cancer Genome Atlas database

“…Targeted molecular therapies and immunotherapies are rapidly moving toward an era of bespoke, precision medicine. Endocrine therapy for ER-positive patients in the 1980s [ 32 , 33 ] and trastuzumab treatment for HER2-positive patients at the start of this century [ 34 , 35 ] inaugurated targeted therapies for solid tumors. Surgery, radiotherapy, endocrine therapy, chemotherapy, and/or targeted therapies based on molecular subtyping have also paved the way for “precision medicine” for breast cancer.…”