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Poster display session

4548 - Composite index of risk shows that benefit from adjuvant dose dense chemotherapy is not confined to triple negative breast cancer


11 Sep 2017


Poster display session


Fabio Puglisi


Annals of Oncology (2017) 28 (suppl_5): v43-v67. 10.1093/annonc/mdx362


F. Puglisi1, M. Ceppi2, L. Gerratana1, F. Cognetti3, S. De Placido4, P. Bruzzi2, M. De Laurentiis5, G. Bisagni6, G. Cavazzini7, A. Durando8, A. Turletti9, E. Valle10, F. Montemurro11, S. Barni12, A. Ardizzoni13, G. Colantuoni14, T. Gamucci15, L. Del Mastro16

Author affiliations

  • 1 Department Of Medicine, University Of Udine, School of Medical Oncology, 33100 - Udine/IT
  • 2 Clinical Epidemiology, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, 16132 - Genova/IT
  • 3 Medical Oncology Unit, IFO Regina Elena, 00144 - Roma/IT
  • 4 Medical Oncology Unit, Federico II Hospital, Napoli/IT
  • 5 Medical Oncology, IRCCS Fondazione Pascale, Napoli/IT
  • 6 Medical Oncology, Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, 42100 - Reggio Emilia/IT
  • 7 Medical Oncology, Azienda Ospedaliera Ospedale Carlo Poma, Mantova/IT
  • 8 Breast Unit, Azienda Ospedaliera Universitaria Città della Salute e delle Scienze, Torino/IT
  • 9 Medical Oncology, AOU S. Giovanni Battista - Molinette, Torino/IT
  • 10 Medical Oncology, Ospedale Oncologico A. Businco, Cagliari/IT
  • 11 Medical Oncology, IRCCS Istituto di Candiolo, 10060 - Candiolo/IT
  • 12 Medical Oncology, Azienda Ospedaliera Treviglio-Caravaggio, 24047 - Treviglio/IT
  • 13 Medical Oncology Unit, University Hospital Sant'Orsola, Bologna/IT
  • 14 Breast Unit, A.O.R.N. San Giuseppe Moscati, Avellino/IT
  • 15 Medical Oncology, Ospedale SS Trinità, 03039 - Sora/IT
  • 16 Medical Oncology, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, 16132 - Genova/IT


Abstract 4548


Compared with the standard interval adjuvant chemotherapy, dose-dense schedule is proved to increase disease-free survival (DFS) in node-positive early breast cancer (EBC) patients (pts). To date, GIM2 is the only trial supporting the role of dose-dense chemotherapy in pts with hormone receptor-negative (HR-) or hormone receptor-positive tumours (HR+) (Del Mastro et al. Lancet 2015). To further refine the evidence of treatment effect in the HR+ subgroup, a composite index of risk was developed including clinico-pathological features.


The randomized phase III GIM2 trial enrolled 2091 pts with node-positive EBC (primary endpoint: DFS). A continuous, composite measure of treatment benefit was determined from a Cox model incorporating potential predictive factors (age: 25-40/41-55/56-71; histological grade: 1 + 2/3; HR status: positive/negative; ki-67 levels: ≤20%/>20%). Subpopulation treatment effect pattern plot methodology was used to reveal differential treatment effects on DFS according to composite index. The study analyzed the cohort of pts with HER2- (N = 1127) disease with a special focus on HR+ disease (N = 980).


On average, the magnitude of benefit with dose dense chemotherapy versus standard chemotherapy widely varied according to composite measure of specific features. In the HER2- subgroup, the highest benefit was observed in pts with G3, HR-, >10 positive nodes, age 20% (hazard ratio for DFS 0.57, 95% CI 0.35-0.94). Notably, among pts with HR+ disease, the following clinic-pathological characteristics conferred the highest benefit: G3, ≥4 positive nodes, age ≥56 yrs, ki-67 > 20% (hazard ratio for DFS 0.66, 95% CI 0.38-1.15).


Composite risk evaluation and corresponding subpopulation treatment effect pattern plot methodology suggest that benefit of dose dense adjuvant chemotherapy is not confined to triple negative EBC.

Clinical trial identification

Legal entity responsible for the study

Gruppo Italiano Mammella




All authors have declared no conflicts of interest.

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