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Cours nationaux de DES de Radiothérapie Oncologique Nancy – 2 au 4 février 2012 Pr. Jean-Michel Hannoun-Levi Centre Antoine Lacassagne – Université Nice-Sophia,

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Présentation au sujet: "Cours nationaux de DES de Radiothérapie Oncologique Nancy – 2 au 4 février 2012 Pr. Jean-Michel Hannoun-Levi Centre Antoine Lacassagne – Université Nice-Sophia,"— Transcription de la présentation:

1 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 Curiethérapie des cancers du sein 2 nd traitement conservateur pour rechute locale homolatérale 2

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3 Auteurs N Suivi apr è s RL (mois) RL apr è s TT initial (%) MT de rattrapage (%) RL apr è s MT (%) SG à 5 ans apr è s MT (%) Kurtz Fourquet Salvadori ,270 4 Fowble Dalberg Abner Mastectomie de rattrapage pour récidive locale

4 Auteurs N Suivi apr è s RL (mois) RL apr è s TT initial (%) MT de rattrapage (%) RL apr è s MT (%) SG à 5 ans apr è s MT (%) Kurtz Fourquet Salvadori ,270 4 Fowble Dalberg Abner % Mastectomie de rattrapage pour récidive locale

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6 2 nd TTT conservateur : chirurgie exclusive Hannoun-Levi JM et al. IJROBP 2004

7 2 nd TTT conservateur : chirurgie exclusive Hannoun-Levi JM et al. IJROBP %

8 2 nd TTT conservateur : chirurgie + irradiation Hannoun-Levi JM et al. Brachytherapy 2010

9 2 nd TTT conservateur : chirurgie + irradiation Hannoun-Levi JM et al. Brachytherapy % Kauer-Dorner D, et al. Radiother Oncol. 2012;102:96-101

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

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

14 Hannoun-Levi JM et al. Brachytherapy 2011;10: nd TTT conservateur avec curiethérapie à haut débit de dose De juin 2005 à juillet 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

15 Suivi médian :24 mois [2.3-50] Age médian à la réc. :65 ans [31-85] Délai médian 1 er 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%) 2nd TTT conservateur avec curiethérapie à haut débit de dose Hannoun-Levi JM et al. Brachytherapy 2011;10:171-7

16 2nd TTT conservateur avec curiethérapie à haut débit de dose Taux de 2 nd 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

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

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

19 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

20 What type of study design for clinical research ?

21 Study designAdvantagesDisadvantages 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 - Cost - Possible switch to phase III - Multicentric - No statistical comparison - Duration of the study - Uncertainty of the final results at the end of the study Retrospective study based on a matched- pair analysis - Duration: immediate results - Multicentric - 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 - Multicentric - Non rigorous study - Low scientific impact - No consistent conclusion

22 What type of study design for clinical research ? Study designAdvantagesDisadvantages 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 - Cost - Possible switch to phase III - Multicentric - No statistical comparison - Duration of the study - Uncertainty of the final results at the end of the study Retrospective study based on a matched- pair analysis - Duration: immediate results - Multicentric - 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 - Multicentric - Non rigorous study - Low scientific impact - No consistent conclusion

23 What type of study design for clinical research ? Study designAdvantagesDisadvantages 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 - Cost - Possible switch to phase III - Multicentric - No statistical comparison - Duration of the study - Uncertainty of the final results at the end of the study Retrospective study based on a matched- pair analysis - Duration: immediate results - Multicentric - 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 - Multicentric - Non rigorous study - Low scientific impact - No consistent conclusion

24 What type of study design for clinical research ? Study designAdvantagesDisadvantages 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 - Cost - Possible switch to phase III - Multicentric - No statistical comparison - Duration of the study - Uncertainty of the final results at the end of the study Retrospective study based on a matched- pair analysis - Duration: immediate results - Multicentric - 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 - Multicentric - Non rigorous study - Low scientific impact - No consistent conclusion

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

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

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

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

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

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