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Best abstracts

41O - Nine weeks vs 1 year adjuvant trastuzumab: long term outcomes of the ShortHER randomised trial.

Date

07 May 2021

Session

Best abstracts

Presenters

Pier Franco Conte

Citation

Annals of Oncology (2021) 32 (suppl_2): S37-S47. 10.1016/annonc/annonc504

Authors

P.F. Conte1, A. Frassoldati2, G. Bisagni3, A.A. Brandes4, M. Donadio5, O. Garrone6, F. Piacentini7, L. Cavanna8, F. Giotta9, M. Aieta10, V. Gebbia11, A. Musolino12, A. Ferro13, S. Danese14, C. Zamagni15, O. Nanni16, M.V. Dieci17, R. Vicini18, S. Balduzzi19, V. Guarneri20

Author affiliations

  • 1 University of Padova, 35128 - Padova/IT
  • 2 Azienda Ospedaliera di Ferrara St. Anna, 44100 - Ferrara/IT
  • 3 Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, 42100 - Reggio Emilia/IT
  • 4 Ospedale Bellaria, 40139 - Bologna/IT
  • 5 AOU Città della Salute e della Scienza Torino, 10128 - Torino/IT
  • 6 Azienda Ospedaliera St. Croce e Carle, 12100 - Cuneo/IT
  • 7 Azienda Ospedaliero - Universitaria Policlinico di Modena, 41125 - Modena/IT
  • 8 Area Ospedaliera di Piacenza - Ospedale Guglielmo da Saliceto - AUSL Piacenza, 29121 - Piacenza/IT
  • 9 Istituto Oncologico Bari, 70126 - Bari/IT
  • 10 Centro di Riferimento Oncologico Basilicata IRCCS, 85020 - Rionero in Vulture/IT
  • 11 Casa di Cura La Maddalena Dipartimento Oncologico di III livello, Palermo/IT
  • 12 Azienda Ospedaliera di Parma, 43126 - Parma/IT
  • 13 Ospedale Santa Chiara - APSS, 38122 - Trento/IT
  • 14 S Anna Hospital, 10127 - torino/IT
  • 15 AOU Policlinico S. Orsola-Malpighi, F.Addarii, 40138 - Bologna/IT
  • 16 Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 17 IOV - Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 18 azienda ospedaliero universitaria di modena, 41100 - modena/IT
  • 19 universita di modena e reggio emilia, 41126 - modena/IT
  • 20 Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
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Abstract 41O

Background

The ShortHER trial randomised 1254 patients with HER2+ early breast cancer to chemotherapy plus 9 weeks vs 1 year adjuvant trastuzumab. The study was designed as a non inferiority trial with a DFS hazard ratio (HR) < 1.29 as the non inferiority margin. At the event driven analysis, the HR for DFS was 1.13 (90% CI 0.89-1.42) therefore non inferiority could not be claimed (P Conte et al, Ann Oncol 29:2328-2333). Here we report the overall survival (co-primary end point of the study) and the updated DFS curves according to risk categories of long vs short treatment arms.

Methods

Study design, patient characteristics and event-driven DFS analysis have been previoulsy reported. This analysis reports the overall survival and the updated DFS curves according to HR status and three risk categories: low risk (pT< 2cm and pN0), intermediate risk (pT < 2cm and 1-3 pN+ or pT > 2cm and 0-3 pN+) and high risk (any pT and 4+ pN+).

Results

At a median follow up of 8.7 years, 237 DFS events have occurred: 121 in the short and 116 in the long arm respectively (HR 1.09; 90% CI 0.88-1.35). DFS according to post-hoc risk groups are: low risk (37.2% of the study population) HR 0.91 (90% CI 0.60-1.38); intermediate risk (46.7% of the study population) HR 0.88 (90% CI 0.63-1.21); high risk (15.2% of the study population) HR 2.06 (90% CI 1.36-3.13). DFS according to HR status are: HR+ HR 1.11 (90% CI 0.85-1.46); HR- HR 1.06 (90% CI 0.75-1.50). 109 deaths have been reported (58 in the short, 51 in the long arm). The 9 yrs OS is 90% in the short and 91% in the long arm (HR 1.18; 90% CI 0.86-1.62).

Conclusions

The updated DFS and OS analysis of the ShortHER trial confirm the favourable long-term results of 9 weeks adjuvant trastuzumab in the patients with low and intermediate risk factors. These patients represent 83.9 % of the ShortHER study population and the majority of the patients treated in daily practice. One-year trastuzumab remains standard. On the basis of these results however, a shorter trastuzumab administration could be an option in case of limited access to trastuzumab. Our data are reassuring for patients who have to discontinue trastuzumab due to a decline in LVEF.

Clinical trial identification

EUDRACT number: 2007-004326-25; NCI number: NCT00629278.

Legal entity responsible for the study

University of Padua, University of Modena and Reggio Emilia.

Funding

AIFA Agenzia Italiana del Farmaco (grant number FARM62MC97).

Disclosure

P.F. Conte: Honoraria (self), Speaker Bureau/Expert testimony, Research grant/Funding (institution): roche; Honoraria (self), Speaker Bureau/Expert testimony, Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Merck kga; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Speaker Bureau/Expert testimony: Lilly. A. Frassoldati: Advisory/Consultancy, Travel/Accommodation/Expenses: roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Daiichi; Advisory/Consultancy: astrazeneca; Travel/Accommodation/Expenses: Lilly; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer. O. Garrone: Advisory/Consultancy: Eisai; Advisory/Consultancy: Eli Lilly; Speaker Bureau/Expert testimony: Novartis. L. Cavanna: Speaker Bureau/Expert testimony: AstraZeneca; Travel/Accommodation/Expenses: Celgene; Travel/Accommodation/Expenses: MSD; Travel/Accommodation/Expenses: Ibsen; Speaker Bureau/Expert testimony: Pfizer. A. Musolino: Honoraria (self), Research grant/Funding (institution): Eisai; Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self): Macrogenics; Honoraria (self): Merck; Honoraria (self), Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Pfizer. A. Ferro: Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Eli Lilly. C. Zamagni: Advisory/Consultancy: Eisai; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: PharmaMar; Advisory/Consultancy: Amgen; Advisory/Consultancy, Travel/Accommodation/Expenses: Tesaro; Honoraria (self): Quintiles MS; Travel/Accommodation/Expenses: Pierre Fabre; Advisory/Consultancy: Gentili; Research grant/Funding (institution): Takeda; Research grant/Funding (institution): Teva; Research grant/Funding (institution): Medivation; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Array Biopharma; Research grant/Funding (institution): morphotek; Research grant/Funding (institution): synthon; Research grant/Funding (institution): Seattle Genetics; Advisory/Consultancy: Celgene. M.V. Dieci: Advisory/Consultancy: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eli Lilly; Advisory/Consultancy: Celgene; Advisory/Consultancy: Genomic Health. V. Guarneri: Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eli Lilly; Advisory/Consultancy: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis. All other authors have declared no conflicts of interest.

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