Diapositiva 1 - Sociedad Española de Oncología Médica

Diapositiva 1 - Sociedad Española de Oncología Médica

Est indicado el tratamiento perioperatorio en cncer de recto? En contra Dr. Joan Maurel Oncologia Mdica Hospital Clnic Barcelona RDT Pre-op o post-op? Phase III (n=823) TME FU IC End Point 5y OS (10%) cT3-T4, Any N USE ST: Centro 50.4 Gy

5FU/LV TME FU IC 50.4 Gy Sauer et al, NEJM 2004 5FU/LV Mejora en preservacin de esfnter (39 vs 19%) Menor toxicidad aguda (27 vs 40%) y tarda (14 vs 24%) Reduccin de recurrencias locales (6 vs 13%) No diferencias en supervivencia (76 vs 74%) Sauer et al, NEJM 2004 Es necesaria la RDT con MSE? Phase III (n=1861) TME

1 End Point 2y LR 25 Gy T1-T3, Any N TME Kapiteijn et al, NEJM 2001 Author schedule LR DR Kapiteijn 25 Gy+MSE 2.4 vs 8.2 14.8 vs 16.8 (NEJ M,2001) vs MSE

Peters (Ann Surg, 2007) 25 Gy +MSE 5.6 vs 10.9 25.8 vs 28.3 vs MSE RDT pre-op o C-RDT post-op selectiva? Phase III (n=1350) TME End Point 2y LR (2.5%) T1-T4, Any N ST: Center ECOG Distance to anal verge 25 Gy

TME FU/LV 45 Gy * Slo si R1 Sebag-Montfiore et al, Lancet 2009 CHT-RDT pre-op selectiva? MRI prognostic factors Variable LR DR EMVI ?

++ Lymph node ?/+ +++ Radial margin +++ ?/+ > 5 mm ? ++ GEMCAD 08-02 (n=45)

1 end-point % PR T3 >5 cm anal verge, Any N by MRI >5 mm or EMVI and >2 mm fascia SD o PD capecitabine 45 Gy CAPOX TME PR o CR TME Cual es el impacto de la CHT peri-operatoria con MSE?

Phase III (n=1011) 45 Gy End Point 5 y OS (10%) T3-T4, Any N ST: Centro Sexo, T Distance to anal verge X 45 Gy 45 Gy+FU/LV 45 Gy+ FU/LV Bosset et al, NEJM 2009 TME

TME X Progression-free Survival According to Postoperative Treatment or No Postoperative Treatment. Compliance adjuvancy 70 60 50 40 CT-RT RT 30 20 10 0

Gerard Bosset Bosset (FD) GCR-3 Randomized phase II Trial; n=108 Operable rectal cancer High Risk defined by MRI and/or US Arm A Arm B CAPOX/RT Stratified by Center MSE CAPOX Fernandez-Martos, JCO 2009, in press CAPOX

CAPOX/RT MSE Baseline Characteristics Arm A n = 52 Arm B n= 56 62 60 Gender Male Female 34 (65%) 18 (35%) 39 (70%)

17(30%) ECOG 0 1 36 (69%) 16 (31%) 33 (59%) 23 (41%) Median Age Compliance to Adjuvant/Induction CT Maximum # cycles ArmA Adjuvant Arm B Induction Received per patient n= 49 n= 54 0 12 (24.5%)

0 2 10 (20.5%) 2 (3.5%) 3 2 (4%) 2 (4%) 4 25 (51%) 50(93%) Fisher's Exact Test <0.000 Pr <= P

1 Importancia de la CHT despus de CHT-RDT neoadyuvante Autor No Estad. local Estad. Sist. Ciruga CHT Ady. 5y DFS% Bosset

253* USE* CT MSE? (abierta) si 58 Sauer 397 USE CT MSE? (abierta)

si 68 Gerard 375 USE CT o MSE? ecografa (abierta) si 59 Pineda (SEOM 2009)

164 USE CT MSE por No* helicoidal LPS (selected) 74* Resultados (III) El subgrupo de pacientes con buen respuesta patolgica present mejores resultados oncolgicos a 5 aos, recibiendo adyuvancia slo en el 14.3% de los casos. N= 156 pT0-2 N0 N= 70 pT3-4 Nx pTx N1 N= 86

Recidiva local 7.1% (11) 0% (0) 12,8% (11) Recidiva a distancia 19.8%(31) 5.7% (4) 31.39% (27) 2 IQ - NEPE 3 IQ - NEPE SLE 5 aos

71.7% 92.5% 54.8% p<0.001 SG 5 aos 75.8% 97.1% 58.1% p<0.001 pT0-2 N0 pT3-4 Nx pTx N1 Problemas actuales en estudios de quimioterapia en recto

No conocemos que pacientes tienen riesgo de presentar metstasis en el seguimiento (2530%) No conocemos que pacientes son sensibles al tratamiento de quimioterapia o quimioradioterapia Pero sabemos que los pacientes con respuesta (ypT0-2N0) presentan un excelente pronstico (DFS>90% a 5 aos) Quien discrimina ypT0-2N0, el tratamiento o la biologa del tumor? Autor Esquema No ypT0N0 % ypT0-2N0 % Aschele

FU 379 16 43 X-FU 368 15 43 C 295 14 -

X-C 291 18 - Pineda FU 164 17 44 F-Martos X-C

52 14 - X-C* 56 13 - Gerard TLD As re c tu m (9 5 p ) 1 3 g e n e s ig n a t u r e XELOX S e le c t e d

m a rk e rs V a lid a t io n in 4 p r o s p e c t iv e t r ia ls n=185p C GR 45Gy 45Gy C TME XELOXx4 if ypN+? >90% DFS MRI; T3,4:Based on Selected markers C

45Gy TME XELOXx4 if ypN+? PR C+BEV 45Gy <60% DFS Conclusiones La quimioterapia adyuvante o neoadyuvante no puede ser considerada un tratamiento estandar en base a los estudios prospectivos aleatorizados publicados No podemos descartar que el beneficio de la QT-RDT neoadyuvante (10-40%) seleccione los pacientes sensibles La estrategia de tratamiento neoadyuvante debe ser explorada de forma prospectiva por su mejor compliance

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