ESMO Supporter 2018

Found 1 Presentation For Request "191PD_PR"

Poster Discussion session - Breast cancer, early stage Poster Discussion session

191PD_PR - 9 weeks versus 1 year adjuvant trastuzumab for HER2+ early breast cancer: subgroup analysis of the ShortHER trial allows to identify patients for whom a shorter trastuzumab administration may have a favourable risk/benefit ratio

Presentation Number
191PD_PR
Lecture Time
15:50 - 15:50
Speakers
  • Pier Franco Conte (Padova, IT)
Location
Hall A1 - Room 15, ICM M√ľnchen, Munich, Germany
Date
20.10.2018
Time
15:00 - 16:15

Abstract

Background

In the ShortHER trial, 1254 HER2+ early breast cancer patients were randomized to 9 weeks versus 1 year trastuzumab. At 6 years median follow up, non inferiority could not be claimed according to the frequentistic approach (HR 1.13; 90% CI 0.89;1.42) with the upper limit of CI crossing the non inferiority margin set at 1.29. However, based on the pre-planned Bayesian analysis, the probability that the short arm is not inferior to the long one was 80%. Moreover, G >/= 2 cardiac events were 82 in the long and 27 in the short arm (RR 0.33, 95% CI 0.22 to 0.55). It is therefore of interest to identify subgroups of patients for whom, based on the risk/benefit ratio, a shorter treatment might be an option

Methods

At multivariate analysis, pathologic tumor size and nodal status were independent prognostic parameter for Disease-Free Survival (DFS) and three prognostic groups could be identified: low risk (pT </= 2cm and N0), intermediate risk (pT </= 2cm and any N category or pT > 2cm and N 0-3) and high risk (pT > 2cm and N 4+).

Results

The low, intermediate and high risk groups included 37.5%, 51.9% and 10.5% of the patient population, respectively. The 5 year DFS and G>/=2 cardiac events in the long and short arms according to the prognostic group are summarized below:

5 year DFS

Hazard Ratio(95% CI)
Long arm Short arm
Low risk 91% 92% 0.96 (0.56-1.66)
Intermediate risk 87% 86% 1.05 (0.71-1.54)
High risk 80% 60% 1.94 (1.07-3.53)
G>/=2 cardiac events Relative Risk (95% CI)
Low risk 14.6% 5.1% 2.85 (1.51-5.36)
Intermediate risk 11.6% 3.9% 2.9 (1.57-5.35)
High risk 14.1 3.3 4.22 (0.96-18.5)

Conclusions

Subgroups analysis of the ShortHER trial allows to identify patients at low and intermediate risk of relapse. This population includes 89% of the patients and the 5 year DFS is not different in the two treatment arms (89% long, 88% short; HR 1.02, 95% CI 0.78-1.33); on the contrary, the risk of cardiac events is significantly higher in the long arm (12.8% vs 4.5%; RR 2.88, 95% CI 1.85-4.47). These results may contribute to better define the risk/benefit ratio of 1 year adjuvant trastuzumab.

Clinical trial identification

EUDRACT number: 2007-004326-25

NCI ClinicalTrials.gov number: NCT00629278

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