346P - Characteristics of patients with HER2-positive metastatic (mBC) or locally advanced breast cancer (aBC), treated with trastuzumab (T) as 1st line-th...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Biomarkers
Breast Cancer, Metastatic
Presenter Olivier Tredan
Authors O. Tredan1, B. You2, P. Beuzeboc3, D. Coeffic4, A. Lortholary5, M. Fellous6, T. De La Motte Rouge7, F. André8, L. Arnould9, J. Ferrero10
  • 1Lyon Bérard Centre, 69008 - Lyon/FR
  • 2Medical Oncology, Lyon-Sud Hospital, Lyon/FR
  • 3Medical Oncology Unit, Curie Institute, 75005 - Paris/FR
  • 4Medical Oncology, Clinique Hartmann, Neuilly-sur-Seine/FR
  • 5Medical Oncology, Catherine de Sienne Institute, Nantes/FR
  • 6Medical, Roche France, 92650 - Boulogne Billancourt/FR
  • 7Medical Oncology, Salpétrière Hospital, Paris/FR
  • 8Department Of Medical Oncology, Institut Gustave Roussy, 94805 - Villejuif CEDEX/FR
  • 9Biology & Pathology Of The Tumor, Centre GF LECLERC, Dijon/FR
  • 10Centre Antoine Lacassagne, FR-06189 - Nice CEDEX 2/FR

Abstract

Background

For more than ten years, treatment of HER2-positive mBC patients (Pts) is based on T plus taxane in 1st line therapy. So far, in numerous studies, we have observed few subsets of Pts (long-term responders) who have not experienced disease progression for several years after T-based regimen in 1st line treatment. This study aims to characterise these Pts in the daily practice from a clinical and biological perspective.

Material and methods

This is an ambispective French multicentre non-interventional study. Eligible Pts were women aged ≥18 years with HER2-positive mBC or aBC treated with T as 1st line and who were progression-free for at least 3 years after starting T. The primary objective was to describe the clinical and tumor characteristics of these Pts. Progression Free Survival (PFS), Overall Survival (OS), data on treatment administration and safety were also collected. An exploratory biomarkers analysis is planned on tumor tissue samples. Here we present some preliminary results based on the interim analysis performed at the end of inclusions.

Results

159 Pts were enrolled in 2011 and 110 Pts were eligible for data analysis. Median age was 59 years [34-95]. Tumor characteristics were: invasive ductal carcinoma for 96 Pts (88%), positive hormonal receptors in 63 Pts (58%). At initial diagnosis, presenting stages were I-II for 52 Pts (50%). 36 Pts (33%) had a mBC de novo or an aBC. The main metastatic localisations were bone, liver and lung in 51 (47%), 35 (32%) and 22 (20%) Pts respectively. Median T treatment duration was 4.1 years [0.8 - 11.0] in 1st line. T was associated with a taxane-based chemotherapy in 86 Pts (78%). Median PFS was 6.4 years [4.9; - ]. Median OS was not reached. 13 retrospective adverse events related to T (cardiac or leading to discontinuation) were reported. None of these was serious.

Conclusions

In this long PFS population treated with a T-based treatment in first line for aBC or mBC Pts, no specific profile in terms of clinical or histological characteristics have been observed. Thus, the exploratory biomarkers analysis will be useful to identify such a profile.

Disclosure

O. Tredan: Roche consultant.

P. Beuzeboc: Roche consultant.

D. Coeffic: Roche consultant.

M. Fellous: Roche employee.

L. Arnould: Roche Consultant.

All other authors have declared no conflicts of interest.