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Trastuzumab duration effects within patient prognostic subgroups in the PHARE trial.
Kramar, A; Bachelot, T; Madrange, N; Pierga, J-Y; Kerbrat, P; Espié, M; Fumoleau, P; Pauporté, I; Khayat, D; Romieu, G; Pivot, X.
Affiliation
  • Kramar A; Methdology and Biostatistics Unit, Centre Oscar Lambret, Lille.
  • Bachelot T; Department of Medical Oncology, Centre Léon Bérard, Lyon.
  • Madrange N; Department of Medical Oncology, Institut Bergonié, Bordeaux.
  • Pierga JY; Department of Medical Oncology, Institut Curie, Paris.
  • Kerbrat P; Department of Medical Oncology, Centre Eugene Marquis, Rennes.
  • Espié M; Department of Medical Oncology, University Hospital Saint-Louis, Paris.
  • Fumoleau P; Department of Medical Oncology, Centre Georges François Leclerc, Dijon.
  • Pauporté I; French National Cancer Institut, Boulogne-Billancourt.
  • Khayat D; Department of Medical Oncology, University Hospital Pitié Salpetrière, Paris.
  • Romieu G; Department of Medical Oncology, Val d'Aurelle Institut Régional du Cancer, Montpellier.
  • Pivot X; Department of Medical Oncology, University Hospital Besancon, Besancon, France xavier.pivot@univ-fcomte.fr.
Ann Oncol ; 25(8): 1563-70, 2014 Aug.
Article in En | MEDLINE | ID: mdl-24827132
ABSTRACT

BACKGROUND:

At 42.5 months of median follow-up, PHARE failed to show that 6 was non-inferior to 12 months of adjuvant trastuzumab. From the results of PHARE, questions remain regarding whether the magnitude of benefit derived from 1 year is sufficient to justify its systematic use for different patient subgroups.

METHODS:

Treatment effects were evaluated according to various tumour characteristics, and the multivariate Cox proportional hazards regression models were carried out on metastases-free survival (MFS) in the 12 months control arm. A prognostic score was defined providing the identification of patient categories with similar risks. The 6-month arm was used as a validation set in order to test for heterogeneity. This study is registered at clinicaltrials.gov, number NCT00381901.

RESULTS:

A total of 261 metastatic events were observed and four prognostic groups were defined very low, low, intermediate and high risk in the 12-month arm. The corresponding 3-year MFS rates were 98.3%, 95.8%, 90.4% and 78.4% in the four prognostic groups, respectively. In the 6-month arm, the 3-year MFS rates were 98.3%, 94.2%, 85.7% and 74.8% in the four prognostic groups, respectively.

CONCLUSION:

In the very low-risk group, the potential absolute benefit of standard duration of trastuzumab was small enough to indicate that optimal standard treatment might be clinically questionable. On the other hand, the 3-year metastasis occurrence rates strongly support the need for a search of a more efficient treatment in the low-, intermediate- and high-risk groups.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Breast Neoplasms / Antibodies, Monoclonal, Humanized Type of study: Clinical_trials / Prognostic_studies Limits: Adult / Aged / Female / Humans / Middle aged Country/Region as subject: Europa Language: En Journal: Ann Oncol Journal subject: NEOPLASIAS Year: 2014 Type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Breast Neoplasms / Antibodies, Monoclonal, Humanized Type of study: Clinical_trials / Prognostic_studies Limits: Adult / Aged / Female / Humans / Middle aged Country/Region as subject: Europa Language: En Journal: Ann Oncol Journal subject: NEOPLASIAS Year: 2014 Type: Article