330TiP - ASTER 70s UNICANCER phase III trial : Adjuvant treatment for women over 70 with luminal breast cancer

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Cytotoxic agents
Geriatric Oncology
Breast Cancer
Therapy
Biological therapy
Presenter Coraline Dubot
Citation Annals of Oncology (2014) 25 (suppl_4): iv85-iv109. 10.1093/annonc/mdu327
Authors C. Dubot1, Y. Tazi2, E. Bourbouloux3, S. Kirscher4, O. Rigal5, S. Abadie-Lacourtoisie6, J. Ferrero7, H. Curé8, E. Blot9, D. Allouache10, G. Romieu11, P.H. Cottu12, E. Malaurie13, C. Terret14, M. Triki Lacroix15, F. Rollot16, H. Peyro Saint Paul17, C. Orsini18, F. Bonnetain19, E. Brain1
  • 1Medical Oncology, Institut Curie, FR-92210 - St Cloud/FR
  • 2Medical Oncology, Institut de Cancérologie Gustave Roussy, Villejuif/FR
  • 3Medical Oncology, Centre René Gauducheau, Nantes/FR
  • 4Medical Oncology, Institut Ste Catherine, AVIGNON/FR
  • 5Medical Oncology, Centre Henri Becquerel, Rouen/FR
  • 6Medical Oncology, Institut de Cancérologie de la Loire, Angers/FR
  • 7Medical Oncology, Centre Antoine Lacassagne, 06189 - Nice/FR
  • 8Medical Oncology, Institut Jean Godinot, 51000 - Reims/FR
  • 9Medical Oncology, Hopitaux de Vannes, FR-56000 - Vannes/FR
  • 10Medical Oncology, Centre Francois Baclesse, 14000 - CAEN/FR
  • 11Medical Oncology, Institut régional du Cancer Montpellier Val d’Aurelle, MONTPELLIER/FR
  • 12Oncology, Institut Curie, FR-75248 - Paris CEDEX/FR
  • 13Oncologie - Radiothérapie, Centre Hospitalier Intercommunal de Créteil, 94010 - CRETEIL/FR
  • 14Medical Oncology, Centre Léon Bérard, 69008 - Lyon CEDEX/FR
  • 15Département D’anatomie Et Cytologie Pathologiques, Institut Universitaire du Cancer Toulouse - Oncopole, 31059 - TOULOUSE/FR
  • 16-, Institut Curie, Paris/FR
  • 17-, Ipsogen, Marseille/FR
  • 18R&d Unicancer, UNICANCER, 75013 - Paris/FR
  • 19Methodological And Quality Of Life In Oncology Unit, Ea 3181, University Hospital of Besançon, 25030 - Besançon/FR

Abstract

Background

Benefit of the additional adjuvant chemotherapy (CT) compared with hormonal therapy alone (HT) remains debated for women >70 with ER+ HER2- breast cancer (BC) and aggressive characteristics. This trial compares the impact of both strategies on overall survival (OS).

Trial design

Following surgery, ∼2,000 patients (Pts) will have a Genomic Grade (GG) performed centrally on FFPE specimens by RT-PCR. Those with a high risk defined as high or equivocal GG will be randomized to HT alone vs CT + HT. Pts with a low GG will be followed as an observational cohort. OS (all deaths) is the primary endpoint. Secondary objectives include competing events, cost-effectiveness and Q-TWiST analysis, geriatric dimension, willingness and health-related quality of life including specific ELD15. Translational research will focus on prognostic biomarkers and pharmacogenetics. Sample size based on an expected 4-year OS benefit (87.5 vs 80%; HR 0.60), with bilateral test α = 0.05 and a statistical power of 80%. It will require to observe 129 events and to randomize 700 Pts over a planned duration of 4 years. As of March 2014, 65 centres in France and Belgium have included 890 Pts aged 70-92. Only 30 GG evaluations were not performed (consent withdrawal, 7; tumour blocks not available, 14; central pathology review discordance, 6; treatment choice, 3). In the main participating site, the study was not proposed to 20% of pre-screened Pts mostly because of team choice (50%) and inclusion criteria (25%). Amongst those informed, 66% accepted to participate.). Overall, of 860 cases with GG report, 346 (41%), 167 (19%) and 338 (39%) were low, equivocal and high GG respectively; 9 tests (1%) failed for technical reasons. The proportion of high risk tumours (high + equivocal GG, 59%) is similar to those observed in general BC populations (40% to 60%) and only 19 of high-risk cases were not randomized (consent withdrawal, 6, distant metastases, 3, treatment choice, 5, tumour phenotype not confirmed, 3, or laboratory values, 2). With 69% of target recruitment at mid-term of the planned inclusion period, we confirm the feasibility of such a multicentre program investigating the role of an innovative prognostic signature to better select adjuvant strategy in the elderly BC population.

Disclosure

H. Peyro Saint Paul: employee and stock holder QIAGEN. All other authors have declared no conflicts of interest.