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 Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Early Stage
Geriatric Oncology
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.