Carcinoma del retto: Highlights

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1 Carcinoma del retto: Highlights Stefano Cordio Struttura Complessa di Oncologia Medica ARNAS Garibaldi Catania Roma 17 Febbraio 2018

2 Disclosures Advisory Committee, research funding and speakers bureau Amgen Inc, Bayer HealthCare, Roche, Merk Serono, Sanofi Genzyme

3 Dimension of rectal cancer The incidence in the UE is per year cases/ population per year Incidence is /year in USA Mortality is 4 10/ population per year Median age at diagnosis remain 70 years

4 13%

5 Which certainty?

6 Specialised and dedicated multidisciplinary team (MDT) of named radiologists, surgeons, radiation oncologists, medical oncologists and pathologists should attend regular meetings and discuss all relevant patients [III, A].

7

8

9 MRI nodal staging c N???

10 1 Poor surgery little mesorectum 2 Average surgery incomplete removal of mesorectum 3 Excellent surgery complete mesorectal excision In/on muscularis In mesorectum Fascial plane

11 Circumferential Resection Margin CRM

12

13

14

15 Risk profile

16 Consensus statements Early Rectal Cancer Local excision (TEM) If pt1 and no adverse features If adverse histopathology (sm2, G3, V1, L1), requires radical resection (TME) as standard

17

18

19 Consensus statements Rectal cancer ct1-ct2; ct3a/b if middle or high N0 MRF clear, no EMVI Surgery (TME) alone is standard. consider postoperative CRT/CT good

20 Consensus statements Rectal cancer ct3a/b very low, Levators and MRF clear ct3a/b in mid- or high rectum cn1-2 no EMVI TME alone is a standard only if good quality mesorectal resection assured Preoperative SCPRT or CRT followed by TME BRUTTO

21 Consensus statements Rectal Cancer ct3c/d or very low localization levators threatened MRF clear ct3c/d mid-rectum, cn1 N2(extranodal), EMVI posit Limited ct4an0 Preoperative SCPRT or CRT followed by TME, depending on need for regression Molto brutto

22 Consensus statements rectal cancer advanced ct3 with any MRF involved any ct4a/b lateral node positive Preoperative CRT followed by TME Preoperative SCPRT plus FOLFOX and delay to surgery Ugly cattivo

23 Which radiotherapy schedule? Short-course preoperative radiotherapy (SCPRT) with a 25 Gy total dose at 5 Gy/fraction during 1 week, followed by immediate surgery (< 10 days from the first radiation fraction)

24 Which radiotherapy schedule? CRT with a recommended dose of Gy in fractions with optional boost with a further 5.4 Gy in 3 fractions can be considered for preoperative RT if the CRM is threatened

25 Which chemotherapy? Continuous intravenous infusion of 5-Fluorouracil or oral Capecitabine during CRT are recommended rather than bolus 5-FU

26 Which chemotherapy plus 5-FU or Capecitabine? Oxaliplatin added to CRT may slightly increase pathological complete response (pcr) rates and DFS in selected patients, but also enhances acute toxicity Oxaliplatin as a radiosensitizer is not currently recommended to be routinely added to fluoropyrimidine-based CRT (contradictory results and lack of a clear long-term oncological benefit in the seven randomised trials testing this combination) Biological molecularly targeted agents have not been successfully integrated into CRT.

27 Randomized trials with OXA-based CT-RT Trial N Arm pcr TOX G3-4 ACCORD Cape Oxa + RT50 Cape + RT45 19% 14% 25% 11% STAR FUpvi Oxa + RT50 5FUpvi + RT50 16% 16% 24% 8% NSABP-R FP Oxa + RT50 FP + RT50 21% 19% 15% 7% CAO/ARO/AIO FUpvi Oxa + RT50 5FUic + RT50 17% 13% 23% 20% PETACC Cape Oxa + RT45 Cape + RT45 13% 11% NR NR p=0.04 p<0.001

28 Advantages of Pre-operative RT+CT pcr 15% Local recurrence 8% Sphincter preservation surgery 60% 5 year survival 65% Acute toxicity 16%

29

30

31

32 Locally Advanced Rectal Cancer

33 Locally Advanced Rectal Cancer We are impacting on LOCAL RECURRENCE 7-10% but NOT on DISTANT METASTASES 24-30%

34

35 Asco GI 2018 rectal cancer : topics Preoperative short course radiotherapy Selective use of Surgery: watch and wait Preoperative (neoadjuvant) chemotherapy Adjuvant chemotherapy after preoperative CRT

36 Asco GI 2018 rectal cancer : topics Preoperative short course radiotherapy Selective use of Surgery: watch and wait Preoperative (neoadjuvant) chemotherapy Adjuvant chemotherapy after preoperative CRT

37 PRO Short-Course RT vs Long-Course CT-RT similar results in LR and OS (if > 6 cm from anal verge) less acute toxicity less expensive more convenient CONTRA No down-staging (early surgery) No combination with CT Late Toxicity

38

39 What is the risk of delaying surgery? Presented By Cornelis Van De Velde at 2018 Gastrointestinal Cancers Symposium

40 5x5 with immediate vs delayed surgery Presented By Cornelis Van De Velde at 2018 Gastrointestinal Cancers Symposium

41

42 The RAPIDO Trial Presented By Cornelis Van De Velde at 2018 Gastrointestinal Cancers Symposium

43 Compliance neoadjuvant CAPOX Presented By Cornelis Van De Velde at 2018 Gastrointestinal Cancers Symposium

44 Rapido study Presented By Cornelis Van De Velde at 2018 Gastrointestinal Cancers Symposium

45

46 Asco GI 2018 rectal cancer : topics Preoperative short course radiotherapy Selective use of Surgery: watch and wait Preoperative (neoadjuvant) chemotherapy Adjuvant chemotherapy after preoperative CRT

47 SURGERY AFTER COMPLETE RESPONSE TO PRE-OP TREATMENT

48 Non operative management approach Pioneered by Habr-Gama suggests that patients with a clinical complete response to neoadjuvant chemoradiation many have preserved oncologic outcomes and may not derive additional benefit from surgery

49

50

51 Wait & See Local Excision for LARC Mainly retrospective data Heterogeneous trials (staging, patients, Tx, follow up) Short follow up Salvage treatments often unsatisfactory ccr pcr NO TME NO data on mesorectal status LARGE PROSPECTIVE TRIALS ARE NEEDED

52 Accidental organ preservation Presented By Cornelis Van De Velde at 2018 Gastrointestinal Cancers Symposium

53 IWWD Presented By Cornelis Van De Velde at 2018 Gastrointestinal Cancers Symposium

54 IWWD Presented By Cornelis Van De Velde at 2018 Gastrointestinal Cancers Symposium

55 Asco GI 2018 rectal cancer : topics Preoperative short course radiotherapy Selective use of Surgery: watch and wait Preoperative (neoadjuvant) chemotherapy Adjuvant chemotherapy after preoperative CRT

56 Colorectal Cancer Response to Chemotherapy Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

57 Rationale for Neoadjuvant Chemotherapy in Rectal Cancer Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

58

59 Slide 16 Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

60 Neoadjuvant Capecitabine and Oxaliplatin Followed by Synchronous <br />Chemoradiation and TME in MRI Defined Poor Risk Rectal Cancer Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

61 Phase II Randomized Study of chemoradiotherapy followed by surgery and adjuvant CapeOx compared with Induction CapeOx followed by chemort and Surgery in Locally Advanced Rectal Cancer : GCR3 Study Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

62 GCR3 Study Results Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

63 Total Neoadjuvant Therapy in Rectal Cancer: MSK Experience Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

64 Updated Retrospective Review of MSK Experience with Total Neoadjuvant Therapy Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

65 Slide 25 Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

66 Slide 26 Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

67 Slide 28 Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

68

69 Slide 30 Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

70 Asco GI 2018 rectal cancer : topics Preoperative short course radiotherapy Selective use of Surgery: watch and wait Preoperative (neoadjuvant) chemotherapy Adjuvant chemotherapy after preoperative CRT

71 EORTC R A N D O M RT RT+ CT S R A N D O M observation CT

72 EORTC The 5-year cumulative incidence rates for local recurrence were 8.7%, 9.6%, and 7.6% for groups that received chemotherapy preoperatively, postoperatively, or both, and 17.1% in those that did not receive any chemotherapy (p = 0.002) There was no effect on OS or disease-free survival(dfs) with the addition of postoperative chemotherapy compared to no adjuvant chemotherapy (p = 0.32 and 0.29, respectively).

73 437 eligible pts closed because of poor accrual there was no difference in OS, DFS, local recurrence, or distant metastases.

74 Adjuvant therapy in Rectal Cancer Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

75 Adjuvant treatment for rectal cancer Presented By Cornelis Van De Velde at 2018 Gastrointestinal Cancers Symposium

76 Meta-analysis of adjuvant chemotherapy in rectal cancer Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

77 Risk of distant metastasis Presented By Cornelis Van De Velde at 2018 Gastrointestinal Cancers Symposium

78 Adjuvant chemotherapy for rectal cancer Presented By Cornelis Van De Velde at 2018 Gastrointestinal Cancers Symposium

79 Adjuvant chemotherapy for rectal cancer: considerations Heterogeneity 5FU-based CT Timing Compliance after CT-RT TME Only 75% of pts starts adj-ct Only 50% of pts complete adj-ct

80 Adjuvant Chemotherapy Presented By Andrea Cercek at 2018 Gastrointestinal Cancers Symposium

81 Optimal chemotherapy regimen OXA Fp AIO/ARO/CAO pts 5-FU OXALIPLATIN vs 5-FU DFS HR 0,79 PETACC pts CAPE-OXALIPLATIN vs CAPE DFS HR 0,78 CHRONICLE 120 pts closed poor accrual CAPE-OXALIPLATIN vs OBS DFS HR 0,80 ADORE 321 pts FOLFOX vs 5FU LV DFS HR 0,65

82 Kim, Lancet Oncol 2014

83

84 Adjuvant chemotherapy in rectal cancer Although colon and rectal cancers are frequently grouped as a single disease entity, there are important differences in treatment approaches and patterns of recurrence between these malignancies The role of adjuvant therapy in colon cancers is well established, but available data do not support the routine use of adjuvant chemotherapy in patients with locally advanced rectal cancer receiving neoadjuvant therapy

85 Future Diagnostic tools to better select patients Molecular characteristics Decrease the high metastases rate Evaluation of the late toxicity and functional outcome

86 Grazie per l attenzione

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