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RAPIDO Rectal cancer And Preoperative Induction therapy followed by Dedicated Operation Lars Påhlman Dept. Surgery, Colorectal unit, University Hospital,

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Presentation on theme: "RAPIDO Rectal cancer And Preoperative Induction therapy followed by Dedicated Operation Lars Påhlman Dept. Surgery, Colorectal unit, University Hospital,"— Presentation transcript:

1 RAPIDO Rectal cancer And Preoperative Induction therapy followed by Dedicated Operation Lars Påhlman Dept. Surgery, Colorectal unit, University Hospital, Uppsala, Sweden

2 Rectal cancer treatment MRI staging Stage Irradiation Good; No Bad; 5 x 5 Gy Ugly;Chemo-rad or 5 x 5 ?

3 Advanced Rectal Cancer Problems ! Local recurrences solved ! Occult metastases the problem ! Survival not improved Chemo-rad. standard of care Chemotherapy too weak !

4 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 !!

5 Neoadjuvant; Rectal cancer The RAPIDO trial Standard of care arm: Chemorad. Surgery Chemo 4 m Experimental arm: 5x5 Gy Chemo 5 m Surgery

6 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

7 The RAPIDO trial Inclusion criteria Good quality MRI (T 3 c/d), T4 a/b EMVI + N2 N+ (outside the fascia plane) MRF +

8 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

9 The RAPIDO trial Endpoints DFS at 3 years (Main endpoint) 880 patients (DFS %) Toxicity + postop. complications pCR OS, Local recurrence rate QoL

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12 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

13 The RAPIDO trial Experimental arm What are we treating ? Local tumourSystemic growthdisease Surgery Radioth. Chemoth.

14 The RAPIDO trial Possible concerns Surgery difficult after > 20 weeks Progressive disease during the delay

15 Local recurrence rate Trial / level Local recurrence RT -RT +p value SRCT < 5 cm27 % 10 % TME < 5 cm11 %12 % 0.53 CRO 7 < 5 cm11 % 5 %< SRCT cm26 % 9 %< TME cm15 % 4 %< CRO cm10 % 5 %< SRCT > 10 cm12 % 8 % 0.3 TME > 10 cm 6 % 4 % 0.15 CRO 7 > 10 cm 6 % 1 %< 0.001

16 Swedish Rectal Cancer Registry

17 Dutch TME - trial Overall survival; eligible patients (n=1809) 64.2% vs 63.4% p = 0.87 TME alone RT + TME

18 CRO7 - Overall survival All patients Years Preop. RT Postop. RT p = 0.07 %

19 Polish trial Trial design Preop. chemorad. 25 x 2 Gy Preop. radiotherapy 5 x 5 Gy RandomisationRandomisation LocalRecurrLocalRecurr SurvivalSurvival SphincterpreservSphincterpreserv

20 Polish Trial Local Recurrences Years Chemo-radiation 5 x 5 Gy p = % 11%

21 Polish Trial - Overall Survival eligible patients (n=312) p = 0.82

22 Short - course radiotherapy Still an important option Better than chemo-rad. ? Polish trial ! Australian trial ? Stockholm III !!!!

23 Stockholm III Trial Ongoing trial in Sweden 3-armed trial 25 Gy / 1 weekimmediate surgery 25 Gy / 1 weekdelayed surgery 50 Gy / 5 weeksdelayed surgery

24 Non-resectable rectal cancer

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26 Advanced Rectal Cancer Conclusion with 5x5 Gy Delayed surgery is feasible Delayed surgery gives down – sizing / staging ! Delayed surgery will not increase complication rates


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