cours nationaux de des de radiothérapie oncologique nancy – 2 au 4 février 2012 pr. jean-michel...
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Cours nationaux de DES de Radiothérapie OncologiqueNancy – 2 au 4 février 2012
Pr. Jean-Michel Hannoun-LeviCentre Antoine Lacassagne – Université Nice-Sophia, NICE
Curiethérapie des cancers du sein
2nd traitement conservateur pour rechute locale homolatérale2
Auteurs
N
Suiviaprès RL
(mois)
RL aprèsTT initial
(%)
MT derattrapage
(%)
RL aprèsMT(%)
SG à 5 ansaprès MT
(%)
Kurtz 1593 - 12 - 12 69
Fourquet 518 - 11 80 - 73
Salvadori 2544 73 8,2 70 4 70
Fowble 1030 - 6 80 5 84
Dalberg 759 72 11 76 17 -
Abner 1593 39 10 74 - 79
Mastectomie de rattrapagepour récidive locale
Auteurs
N
Suiviaprès RL
(mois)
RL aprèsTT initial
(%)
MT derattrapage
(%)
RL aprèsMT(%)
SG à 5 ansaprès MT
(%)
Kurtz 1593 - 12 - 12 69
Fourquet 518 - 11 80 - 73
Salvadori 2544 73 8,2 70 4 70
Fowble 1030 - 6 80 5 84
Dalberg 759 72 11 76 17 -
Abner 1593 39 10 74 - 79
10%
Mastectomie de rattrapagepour récidive locale
2nd TTT conservateur : chirurgie exclusive
Hannoun-Levi JM et al. IJROBP 2004
2nd TTT conservateur : chirurgie exclusive
Hannoun-Levi JM et al. IJROBP 2004
30%
2nd TTT conservateur : chirurgie + irradiation
Hannoun-Levi JM et al. Brachytherapy 2010
2nd TTT conservateur : chirurgie + irradiation
Hannoun-Levi JM et al. Brachytherapy 2010
15%Kauer-Dorner D, et al. Radiother Oncol. 2012;102:96-101
IPAS 2nd TTTConserv.Indications
TTTs primo-tumeur
Choix pte
Information +++
CTV =, V150 & V200 , dose peau
IPAS 2nd TTTConserv.Indications
TTTs primo-tumeur
Choix pte
Information +++
CTV =, V150 & V200 , dose peau
Hannoun-Levi JM et al. Brachytherapy 2011;10:171-7
2nd TTT conservateur aveccuriethérapie 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
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%)
2nd TTT conservateur aveccuriethérapie à haut débit de dose
Hannoun-Levi JM et al. Brachytherapy 2011;10:171-7
2nd TTT conservateur aveccuriethérapie 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
Résultats EVA
5
6
7
8
9
10
11
Est SatRésultat esthétique Satisfaction de 2nde
conservation mammaire
7/10[4-9]
10/10[8-10]
Résultats EVA
5
6
7
8
9
10
11
Est SatRésultat esthétique Satisfaction de 2nde
conservation mammaire
7/10[4-9]
10/10[8-10]
World Congress of BrachytherapyBarcelona 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 ?
Study design 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- 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
What type of study design for clinical research ?
Study design 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- 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
What type of study design for clinical research ?
Study design 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- 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
What type of study design for clinical research ?
Study design 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- 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
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…