Familial Cancer

, Volume 11, Issue 1, pp 77–84 | Cite as

Uptake of a randomized breast cancer prevention trial comparing letrozole to placebo in BRCA1/2 mutations carriers: the LIBER trial

  • Pascal Pujol
  • Christine Lasset
  • Pascaline Berthet
  • Catherine Dugast
  • Suzette Delaloge
  • Jean-Pierre Fricker
  • Isabelle Tennevet
  • Nathalie Chabbert-Buffet
  • Pascale This
  • Karen Baudry
  • Jerome Lemonnier
  • Lise Roca
  • Sylvie Mijonnet
  • Paul Gesta
  • Jean Chiesa
  • Helene Dreyfus
  • Philippe Vennin
  • Capucine Delnatte
  • Yves Jean Bignon
  • Alain Lortholary
  • Fabienne Prieur
  • Laurence Gladieff
  • Anne Lesur
  • Krishna B. Clough
  • Catherine Nogues
  • Anne-Laure Martin
  • On behalf the French Federation of Cancer Centres (FNCLCC)
Original Article

Abstract

Women with germline BRCA1 or BRCA2 (BRCA1/2) mutations are considered as an extreme risk population for developing breast cancer. Prophylactic mastectomy provides a valid option to reduce such risk, impacting however, the quality of life. Medical prevention by aromatase inhibitor that has also recently shown to have preventive effect may thus be considered as an alternative. LIBER is an ongoing double-blind, randomized phase III trial to evaluate the efficacy of 5-year letrozole versus placebo to decrease breast cancer incidence in post-menopausal BRCA1/2 mutation carriers (NCT00673335). We present data on the uptake of this trial. We compared characteristics of women in the LIBER trial (n = 113) to those of women enrolled in the prospective ongoing national GENEPSO cohort (n = 1,505). Uptake was evaluated through a survey sent to all active centres, with responses obtained from 17 to the 20 (85%) centres. According to the characteristics of the women enrolled in the GENEPSO cohort and the survey, approximately one-third of BRCA1/2 mutation carriers were eligible for the trial. Five hundred and thirty-four women eligible from chart review have been informed by mail about the prevention trial and were invited to an oral information by participating centres. Forty-four percentage of them came to the dedicated medical visit. Uptake of drug prevention trial was 32% among women informed orally and 15% of all the eligible women. The main reasons of refusal were: potential side effects, probability to receive the placebo and lack of support from their physicians. Additionally, we noticed that prior prophylactic oophorectomy and previous unilateral breast cancer were more frequent in women enrolled in the LIBER trial than in the French cohort (93% vs. 60% and 50% vs. 39%, respectively). Based on an overall 15% uptake among all eligible subjects, greater and wider information of the trial should be offered to women with BRCA1/2 mutation to improve recruitment. Women with previous unilateral breast cancer or prior prophylactic oophorectomy are more likely to enter a medical prevention trial.

Keywords

Letrozole Chemoprevention Uptake Breast cancer BRCA1 BRCA2 

Notes

Acknowledgments

Supported by Unicancer the French national cancer institute, the ligue nationale centre le cancer and Novartis.

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Copyright information

© Springer Science+Business Media B.V. 2011

Authors and Affiliations

  • Pascal Pujol
    • 1
    • 2
  • Christine Lasset
    • 3
  • Pascaline Berthet
    • 4
  • Catherine Dugast
    • 5
  • Suzette Delaloge
    • 6
  • Jean-Pierre Fricker
    • 7
  • Isabelle Tennevet
    • 8
  • Nathalie Chabbert-Buffet
    • 9
  • Pascale This
    • 10
  • Karen Baudry
    • 1
  • Jerome Lemonnier
    • 11
  • Lise Roca
    • 2
  • Sylvie Mijonnet
    • 11
  • Paul Gesta
    • 12
  • Jean Chiesa
    • 13
  • Helene Dreyfus
    • 14
  • Philippe Vennin
    • 15
  • Capucine Delnatte
    • 16
  • Yves Jean Bignon
    • 17
  • Alain Lortholary
    • 18
  • Fabienne Prieur
    • 19
  • Laurence Gladieff
    • 20
  • Anne Lesur
    • 21
  • Krishna B. Clough
    • 22
  • Catherine Nogues
    • 10
  • Anne-Laure Martin
    • 11
  • On behalf the French Federation of Cancer Centres (FNCLCC)
  1. 1.Genetics and CancerUniversity Hospital CHU Arnaud de VilleneuveMontpellier Cedex 5France
  2. 2.INSERM 896 Val d’AurelleMontpellierFrance
  3. 3.CNRS 5558Centre Léon Bérard, Lyon and Université de Lyon 1LyonFrance
  4. 4.Centre Francois BaclesseCaenFrance
  5. 5.Centre Eugene MarquisRennesFrance
  6. 6.Institut Gustave RoussyVillejuifFrance
  7. 7.Centre Paul StraussStrasbourgFrance
  8. 8.Centre Henri BecquerelRouenFrance
  9. 9.AP HP Hôpital Tenon and university CurieParisFrance
  10. 10.Institut CurieSaint CloudFrance
  11. 11.UnicancerParisFrance
  12. 12.Centre Hospitalier de NiortNiortFrance
  13. 13.CHU de NimesNimesFrance
  14. 14.Clinique Sainte CatherineAvignonFrance
  15. 15.Centre Oscar LambretLilleFrance
  16. 16.Centre GauducheauNantesFrance
  17. 17.Centre Jean PerrinClermont FerrandFrance
  18. 18.Clinique Catherine de SienneNantesFrance
  19. 19.CHU de Saint EtienneSaint EtienneFrance
  20. 20.Institut Claudius RegaudToulouseFrance
  21. 21.Centre Alexis VautrinStrasbourgFrance
  22. 22.Institut du SeinParisFrance

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