Presentation on theme: "RAPIDO Rectal cancer And Preoperative Induction therapy followed by Dedicated Operation Lars Påhlman Dept. Surgery, Colorectal unit, University Hospital,"— Presentation transcript:
RAPIDO Rectal cancer And Preoperative Induction therapy followed by Dedicated Operation Lars Påhlman Dept. Surgery, Colorectal unit, University Hospital, Uppsala, Sweden
Rectal cancer treatment MRI staging Stage Irradiation Good; No Bad; 5 x 5 Gy Ugly;Chemo-rad or 5 x 5 ?
Advanced Rectal Cancer Problems ! Local recurrences solved ! Occult metastases the problem ! Survival not improved Chemo-rad. standard of care Chemotherapy too weak !
Advanced Rectal Cancer Standard of care Chemorad. 5 weeks Time to surgery 8 weeks Recovery after surgery; 4 weeks In total > 4 months until patients receive decent chemotherapy !!
Neoadjuvant; Rectal cancer The RAPIDO trial Standard of care arm: Chemorad. Surgery Chemo 4 m Experimental arm: 5x5 Gy Chemo 5 m Surgery
The RAPIDO trial Inclusion criteria Biopsy proven rectal cancer Staging 5 weeks prior treatment No contra indication to chemotherapy ECOG performance < 1 Written informed consent 18 years Adequate for follow up
The RAPIDO trial Inclusion criteria Good quality MRI (T 3 c/d), T4 a/b EMVI + N2 N+ (outside the fascia plane) MRF +
The RAPIDO trial At leased one of the criteria's T4 overgrowth to adjacent organs T4b peritoneal involvement EMVI + vascular invasion N2 > 4 nodes which looks abnormal N+ lateral nodes > 1 cm MRF + threatened mesorectal fascia
The RAPIDO trial Endpoints DFS at 3 years (Main endpoint) 880 patients (DFS %) Toxicity + postop. complications pCR OS, Local recurrence rate QoL
The RAPIDO trial Experimental arm previous experience Dutch M 1 Study 50 patients M1 (75% T3/4N+) 5x5 Gy + XELOX + Bevacizumab (6 cycles) + surgery 83% received all chemo (90% >4 cycles) Low/acceptable toxicity pCR in 26% of specimens No progression was seen on chemotherapy van Dijk et al. JCO 2009: p. ASCO GI Abstract 427
The RAPIDO trial Experimental arm What are we treating ? Local tumourSystemic growthdisease Surgery Radioth. Chemoth.
The RAPIDO trial Possible concerns Surgery difficult after > 20 weeks Progressive disease during the delay