Presentation on theme: "Dept. Surgery, Colorectal unit, University Hospital, Uppsala, Sweden"— Presentation transcript:
1 Dept. Surgery, Colorectal unit, University Hospital, Uppsala, Sweden RAPIDORectal cancer And Preoperative Induction therapy followed by Dedicated OperationLars PåhlmanDept. Surgery, Colorectal unit,University Hospital, Uppsala, Sweden
2 Rectal cancer treatment MRI stagingStage IrradiationGood; NoBad; x 5 GyUgly; Chemo-rador 5 x 5 ?
3 Advanced Rectal Cancer Problems !Local recurrences solved !Occult metastases the problem !Survival not improvedChemo-rad. standard of careChemotherapy too weak !
4 Advanced Rectal Cancer Standard of careChemorad. 5 weeksTime to surgery 8 weeksRecovery after surgery; 4 weeksIn total > 4 months until patients receive decent chemotherapy !!
5 Neoadjuvant; Rectal cancer The RAPIDO trialStandard of care arm:Chemorad. Surgery Chemo 4 mExperimental arm:5x5 Gy Chemo 5 m Surgery
6 The RAPIDO trial Inclusion criteria Biopsy proven rectal cancer Staging 5 weeks prior treatmentNo contra indication to chemotherapyECOG performance < 1Written informed consent18 yearsAdequate for follow up
7 The RAPIDO trial Inclusion criteria Good quality MRI (T 3 c/d), T4 a/b EMVI +N2N+ (outside the fascia plane)MRF +
8 At leased one of the criteria's The RAPIDO trialAt leased one of the criteria'sT4 overgrowth to adjacent organsT4b peritoneal involvementEMVI + vascular invasionN2 > 4 nodes which looks abnormalN+ lateral nodes > 1 cmMRF + threatened mesorectal fascia
9 The RAPIDO trial Endpoints DFS at 3 years (Main endpoint) 880 patients (DFS %)Toxicity + postop. complicationspCROS, Local recurrence rateQoL
12 Experimental arm previous experience The RAPIDO trialExperimental arm previous experienceDutch M 1 Study50 patients M1 (75% T3/4N+) 5x5 Gy + XELOX + Bevacizumab (6 cycles) + surgery83% received all chemo (90% >4 cycles) Low/acceptable toxicitypCR in 26% of specimens ‘No progression was seen on chemotherapy’van Dijk et al. JCO 2009: p. ASCO GI Abstract 427
13 The RAPIDO trial Experimental arm What are we treating ? Local tumour Systemicgrowth diseaseSurgery Radioth. Chemoth.
14 Possible concerns The RAPIDO trial Surgery difficult after > 20 weeksProgressive disease during the delay
15 Local recurrence rate Trial / level Local recurrence RT - RT + p value SRCT < 5 cm 27 % %TME < 5 cm 11 % 12 %CRO 7 < 5 cm 11 % 5 % < 0.001SRCT cm 26 % 9 % < 0.001TME cm 15 % 4 % < 0.001CRO cm 10 % 5 % < 0.001SRCT > 10 cm 12 % 8 %TME > 10 cm 6 % 4 %CRO 7 > 10 cm 6 % 1 % < 0.001