DEFINING A NEW ERA IN DIGESTIVE DISEASE INTERVENTIONS
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1 DEFINING A NEW ERA IN DIGESTIVE DISEASE INTERVENTIONS
2 JEAN-CLAUDE HORIOT MD RADIO-ONCOLOGIST CLINIQUE DE GENOLIER, GSMN JACQUES BERNIER MD, PD RADIO-ONCOLOGIST CLINIQUE DE GENOLIER, GSMN
3 THE ROLE OF INTRACAVITARY RADIOTHERAPY FOR CURATIVE MANAGEMENT AND ANAL PRESERVATION OF LOW RECTAL CANCERS
4 Intracavitary rectal radiotherapy A brief history H.Chaoul (Berlin) 1936 PL. Lamarque and Ch. M. Gros (Montpellier) 1947 Jean Papillon (CLB Lyon) Les disciples de Jean Papillon: JC Horiot 1965, JP Gérard 1970, puis RB Turnbull, B Sischy (1974), etc : Death of Jean Papillon ( ) : An endangered species? Specific equipment (Philips 50 Kv) discontinued : The Ariane thread: The Papillon 50! The renaissance: France, UK, DK, Sweden, Switzerland!
5 Intracavitary radiotherapy: Rationale Intrarectal delivery of contact radiotherapy 50 kv. X-rays. Low penetration (50 % at 7 mm.) High output (15-20 Gy per minute) Tumor destruction «layer per layer» at each fraction. Total dose Gy in 3-4 fractions with days intervals Treatment is ambulatory No severe early or late side effects
6 Contact x-ray 50 KV Jean PAPILLON Lyon 1975 Philips RT 50 ut1n0 : Day 1 (35 Gy) Day 7 (30 Gy) 2009 Day 21 (20 Gy)
7 Transanal Endoscopic Brachytherapy RT Contact X 50 Kv 30Gy 2 min. CXB unique RT = high precision with eye guided into Small Volume (5cm 3 ) : HIGH DOSE / Fraction
8 RADIOTHERAPY ALONE FOR CURE RECTAL CANCER Lyon T1 (T2 selected) N0 - Inst. N Loc.control 5 yr survival Papillon % 75% Lyon Sud % 83% J.P. GERARD IJROBP 1996;34:775 Lancet Oncology 2003; 4:158
9 Low rectal adenocarcinomas T1 N0 year N0 pts Loc Control Papillon (F) % Horiot (F) % Sischy (USA) % Myerson(USA) % Gérard (F) % Bey (F) % Sun Myint (UK) % Gerard, Romestaing Lancet Oncol 2003; 4 :
10 CONTACT X-RAY T1(+ selected T2) N0 RECTAL CANCER Country No pts Local control 5 yr-survival HORIOT F % 67% HULL USA % 91% DE GARAC Canada 55 84% 87% MYERSON USA % 86% MENDENHALL USA 34 85% 90% SCHILD USA 20 90% 76%
11 Ct 50Kv post transanal resection of low to mid rectal tumors W.D. Adeno-carcinomas T1 Incidental adeno-carcinoma discovery on a biopsy/resection of adenoma/polyp. Insufficient margins on microscopic exam. Questionnable conservative surgery and/or functional rectum/anus Elderly/frail Patients
12 Rectal cancer - T1 N0 Local excision + contact + EBRT Lyon Nice : 50 pts pt1 = 46 pt2 = 4 - CXRT alone = 40 CXRT + EBRT = 10 N pts Loc control 5 y survival 50 (47) 94% 85% GCB 2000;24:430 - IJROBP 2008;72:665
13 Rectal cancer - T1 N0 Local excision + Postop radiotherapy Inst n Loc control 5 y survival USA % 70-80% UK % 70-80% (TEM SG) T1 SM1 = 96% R0 = 97% N.You Ann Surg 2007;245:726
14 Adjuvant contact Day 1 50 Gy 3 fractions 3 weeks Applicator : Day 21 3 cm diameter
15 wider indications for intra-rectal RT : Small low rectal AdenoCa: LC 90 % with excellent sphincter preservation and function Since 1980: in addition to transanal excisions : in selected T2-T3 or medically inoperable in combination with external beam RT. LC 60 % and above Since 2000: IRRT + radio-chimio préopératoire to increase the rate of CR and sterilisation of T specimens Now: Evaluation of Watch and wait in patients with CR
16 RT vs RT + contact Rx : Lyon Phase III R96-02 T2-3a < 1/2 circumf 6 cm Anal Verge R RXT (39 Gy/4w) " ( " ) + contact x ray (90 Gy/3) End Point : sphincter preservation : 40% 70 % : 88 pts randomized Gérard : J Clin Oncol 2004; 22 : 2404
17 LYON R J Clin Oncol 2004 ; 22 : 2404 RXT (43) RXT + contact (45) age (y) distance (cm) 4 4 T3 29 (70%) 33 (77%) clin. complete resp. 2% (1) 29% (13) < 0.05 yp T0N0 4 (10%) 16 (35%) < 0.05 Sph. preserv. 44% (19) 76% (34*) < 0.05 * Transanal Local Excis.= 3 RX alone = 7 : Rectal preserv: 10
18 Lyon R96.02 RXT dose escalation: 10 years Low rectum EBRT (43) EBRT + contact (45) T3 (<50% circ) Clinical CR 2% (1) 29% (13) y colst. free 29% 61%.001 Rectal preserv y Loc. Rec. 16% (5) 11% (4) 10y ov. surv. 55% 55% Ortholan-Gérard IJROBP 2012
19 Considerations techniques «modernes» - Imagerie - Radiothérapie externe - Radiothérapie endocavitaire: Papillon 50
20 1985 to 2009: In search of a tool! : failure of all attempts (including Intrabeam) Since 2004, Ariane Medical Systems UK develops the «Papillon 50». First commercial machine delivered in So far 9 worldwide, including ours! Enhanced radiation protection rules made it difficult to efficiently mimic what we were doing with the Philips 50!
21
22 Applicators with insertion tool
23 - TPS monte Carlo code M C 2 PLAN TM 3 cm : 5 cc 2.5 : 3 cc 3 cm : 50% : 7 mm 3 cm 7 mm
24 Applicator docked with Micronode
25 Patient Treatment Position
26 Mr Boe 84 y ADK T3 N0 Card, IR. Inop.. low R. /2009 March 2009 : CBX (100 Gy) 50 Cap Jan : NED
27 CBX 50 Kv + Scheme used at Genolier T2-T3 (ut4), Nx,(N1) EBRT + simultaneous contact RT 50,4 /28 fr + 60/90 Gy 2/3 fr 6-7wks PR: 9-12 wks: Surgery CR: Watch & Wait
28 Clatterbridge - Liverpool Pr A. Sun Myint The Papillon Clinic Papillon Clinic
29 Clatterbridge Liverpool A. Sun Mynt combined ncrt + CXB Papillon : 700 pts - - T2 : 89 T3 : 87 P50 TM : 450 (2009) (P50 TM ) - Cap 45 Gy (EBRT alone) + CXB 90 Gy/3F - Median Fol-up : 3 years - CCR : T2 : 84% - T3 : 72% - Loc. Rec. after ccr : 10 % /2009
30 The OPERA TRIAL A CRT 45 (5w) weeks Clinical evaluation (w13) Surgery Watch and wait Radical TME Visit 2 months Loc Exc. : (organ preservation) Visit m 24 m B CRT 45 (5w) Radical TME Visit Visit D1 D7 D21 Surgery 2 months m 24 m 2 weeks Clinical 3 weeks CBX CBX CBX evaluation Watch and wait Loc Exc. : (organ preservation) (w13) - Adenocarcinoma of the rectum classified ct2, ct3a, ct3b (penetration in the mesorectal fat from 1 to 5 mm), < 5 cm. largest diameter and < ½ circumference (MRI staging), N0-N1(any node<8mm diameter), M0 - Operable patient - Tumour accessible to endocavitary contact X-Ray -Distance from the lower tumour border to the anal verge 10 cm
31 Intracavitary RT indications: A summary T1N0: RT alone Gy 3-4 fr, 6-8 wks. Post transanal resections: Gy, 2-3 fr In addition to pre-op radiochemotherapy (45-50 Gy in 5 wks) Gy 2-3 fr after completion of EBRT. Surgery 6-12 wks later GY 2-3 fr during EBRT. Surgery 6-12 wks later operablet2-t3 (T4) s : Watch & wait (RTE id + CT Gy) Inoperable: same EBRT scheme Gy 3-4 fractions Haemostatic and/or occlusive threat (mid and upper 1/3 included) Gy/fraction x 2 ou 3 during EBRT (+/-Chemo)
32 Innovative, Targeted, Image (eye) guided and adaptive.. Why Adaptive? At each fraction: The radiation-oncologist decides of The selection of the target, The evaluation of response The applicator size and dose to deliver. In summary: totally tumor/patient customised
33
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