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…