Curiethérapie des cancers du sein 2 2nd traitement conservateur pour rechute locale homolatérale Cours nationaux de DES de Radiothérapie Oncologique Nancy – 2 au 4 février 2012 Pr. Jean-Michel Hannoun-Levi Centre Antoine Lacassagne – Université Nice-Sophia, NICE 1

Mastectomie de rattrapage pour récidive locale Auteurs N Suivi après RL (mois) RL après TT initial (%) MT de rattrapage MT SG à 5 ans après MT Kurtz 1593 - 12 69 Fourquet 518 11 80 73 Salvadori 2544 8,2 70 4 Fowble 1030 6 5 84 Dalberg 759 72 76 17 Abner 39 10 74 79

Mastectomie de rattrapage pour récidive locale Auteurs N Suivi après RL (mois) RL après TT initial (%) MT de rattrapage MT SG à 5 ans après MT Kurtz 1593 - 12 69 Fourquet 518 11 80 73 Salvadori 2544 8,2 70 4 Fowble 1030 6 5 84 Dalberg 759 72 76 17 Abner 39 10 74 79  10%

2nd TTT conservateur : chirurgie exclusive Hannoun-Levi JM et al. IJROBP 2004

2nd TTT conservateur : chirurgie exclusive  30% Hannoun-Levi JM et al. IJROBP 2004

2nd TTT conservateur : chirurgie + irradiation Hannoun-Levi JM et al. Brachytherapy 2010

2nd TTT conservateur : chirurgie + irradiation  15% Kauer-Dorner D, et al. Radiother Oncol. 2012;102:96-101 Hannoun-Levi JM et al. Brachytherapy 2010

2nd TTT IPAS Conserv. Indications Choix pte TTTs primo-tumeur CTV =, V150 & V200 , dose peau  Information +++

2nd TTT IPAS Conserv. Indications Choix pte TTTs primo-tumeur CTV =, V150 & V200 , dose peau  Information +++

2nd TTT conservateur avec curiethérapie à haut débit de dose De juin 2005 à juillet 2009 37 patientes 34 Gy en 10 fractions sur 5 jours Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Consultation à 1 mois puis tous les 6 mois Satisfaction des patientes : Echelle visuelle analogique (EVA), allant de 0 à 10 Résultat cosmétique Possibilité de garder son sein une deuxième fois Hannoun-Levi JM et al. Brachytherapy 2011;10:171-7

2nd TTT conservateur avec curiethérapie à haut débit de dose Suivi médian : 24 mois [2.3-50] Age médian à la réc. : 65 ans [31-85] Délai médian 1er cancer/réc. : 11 ans [2-35] Taille médiane réc. : 12 mm [2-30] Site de la réc. : dans lit tumoral initial = 19 ptes (51%) proche lit tumoral initial = 13 ptes (35%) non connu = 5 ptes (14%) Hannoun-Levi JM et al. Brachytherapy 2011;10:171-7

2nd TTT conservateur avec curiethérapie à haut débit de dose Taux de 2nd contrôle local : 97% 22 ptes (60%) ont présenté des complications : G1 = 14 ptes (38%) G2 = 7 ptes (19%) G3 = 1 pte ( 3%) Fibrose cutanée et sous cutanée : 72 % Douleur/dysesthésie : 28% Télangiectasies : 21% Fractures de côtes : 2% Hannoun-Levi JM et al. Brachytherapy 2011;10:171-7

conservation mammaire Résultats EVA 7/10 [4-9] 10/10 [8-10] Résultat esthétique Satisfaction de 2nde conservation mammaire

conservation mammaire Résultats EVA 7/10 [4-9] 10/10 [8-10] Résultat esthétique Satisfaction de 2nde conservation mammaire

World Congress of Brachytherapy Barcelona May 2012 Second conservative treatment for ipsilateral breast cancer recurrence: GEC-ESTRO Breast WG study Hannoun-Levi JM, Kauer-Dorner D, Strnad V, Niehoff P, Loessl K, Kovács G, Van Limbergen E, Polgar C

What type of study design for clinical research ?

What type of study design for clinical research ? Advantages Disadvantages Phase III randomized trial (non-inferiority) - Conclusion based on statistical results - Scientific impact (no previously reported study) - Clinical and statistical impact - Multicentric - Huge number of enrolled patient - Cost - Duration of the study - Uncertainty of the final results at the end of the study Phase 2 randomized trial (According to a Fleming one step statistical design) - Reasonable # of enrolled pt - Possible switch to phase III - No statistical comparison Retrospective study based on a matched-pair analysis - Duration: immediate results - Statistical comparison - Can be perform concomitantly with a prospective study - Retrospective analysis - No consistent conclusion in terms of clinical research Observatory study - No calculation of a needed number of enrolled patient - Quick conclusion - Non rigorous study - Low scientific impact - No consistent conclusion

What type of study design for clinical research ? Advantages Disadvantages Phase III randomized trial (non-inferiority) - Conclusion based on statistical results - Scientific impact (no previously reported study) - Clinical and statistical impact - Multicentric - Huge number of enrolled patient - Cost - Duration of the study - Uncertainty of the final results at the end of the study Phase 2 randomized trial (According to a Fleming one step statistical design) - Reasonable # of enrolled pt - Possible switch to phase III - No statistical comparison Retrospective study based on a matched-pair analysis - Duration: immediate results - Statistical comparison - Can be perform concomitantly with a prospective study - Retrospective analysis - No consistent conclusion in terms of clinical research Observatory study - No calculation of a needed number of enrolled patient - Quick conclusion - Non rigorous study - Low scientific impact - No consistent conclusion

What type of study design for clinical research ? Advantages Disadvantages Phase III randomized trial (non-inferiority) - Conclusion based on statistical results - Scientific impact (no previously reported study) - Clinical and statistical impact - Multicentric - Huge number of enrolled patient - Cost - Duration of the study - Uncertainty of the final results at the end of the study Phase 2 randomized trial (According to a Fleming one step statistical design) - Reasonable # of enrolled pt - Possible switch to phase III - No statistical comparison Retrospective study based on a matched-pair analysis - Duration: immediate results - Statistical comparison - Can be perform concomitantly with a prospective study - Retrospective analysis - No consistent conclusion in terms of clinical research Observatory study - No calculation of a needed number of enrolled patient - Quick conclusion - Non rigorous study - Low scientific impact - No consistent conclusion

What type of study design for clinical research ? Advantages Disadvantages Phase III randomized trial (non-inferiority) - Conclusion based on statistical results - Scientific impact (no previously reported study) - Clinical and statistical impact - Multicentric - Huge number of enrolled patient - Cost - Duration of the study - Uncertainty of the final results at the end of the study Phase 2 randomized trial (According to a Fleming one step statistical design) - Reasonable # of enrolled pt - Possible switch to phase III - No statistical comparison Retrospective study based on a matched-pair analysis - Duration: immediate results - Statistical comparison - Can be perform concomitantly with a prospective study - Retrospective analysis - No consistent conclusion in terms of clinical research Observatory study - No calculation of a needed number of enrolled patient - Quick conclusion - Non rigorous study - Low scientific impact - No consistent conclusion

Discussion / conclusions Indication du 2nd TTT conservateur Modalité du 2nd TTT conservateur Evidence Based Medicine Risque systémique…

Discussion / conclusions Indication du 2nd TTT conservateur Modalité du 2nd TTT conservateur Evidence Based Medicine Risque systémique…

Discussion / conclusions Indication du 2nd TTT conservateur Modalité du 2nd TTT conservateur Evidence Based Medicine Risque systémique…

Discussion / conclusions Indication du 2nd TTT conservateur Modalité du 2nd TTT conservateur Evidence Based Medicine Risque systémique…

Discussion / conclusions Indication du 2nd TTT conservateur Modalité du 2nd TTT conservateur Evidence Based Medicine Risque systémique…

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