Regional Therapy for Management of Peritoneal Carcinomatosis from Gastrointestinal Malignancies
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1 Regional Therapy for Management of Peritoneal Carcinomatosis from Gastrointestinal Malignancies Byrne Lee, MD FACS Chief, Mixed Tumor Surgery Service City of Hope Division of Surgical Oncology September 22, 2018
2 Nothing to disclose DISCLOSURE
3 Peritoneal Carcinomatosis: Incidence 10-15% of GI cancers have peritoneal implants at diagnosis Serosal Involvement Bowel Perforation Adnexal Metastases 25-35% - Peritoneum is the primary site of failure
4 Colorectal Cancer Carcinomatosis Poor prognosis Median survival 6 months - Chua et al, Cancer 1989 N=100 7 months - Jayne et al, Br J Surg 2002 N= months EVOCAPE, Cancer 2000 N= Franko et al, JCO 2012 N=2095
5 Survival with Modern Chemotherapy - FOLFOX Franko, et al., JCO 2012
6 Survival with Modern Chemotherapy - FOLFIRI Franko, et al., JCO 2012
7 Survival with Modern Chemotherapy - IROX Franko, et al., JCO 2012
8 Peritoneal Surface Malignancies Pseudomyxoma peritonei Mesothelioma Primary peritoneal carcinoma Carcinomatosis Colorectal Gastric Appendiceal Ovarian/GYN Sarcomatosis
9 History Cancer Treat Rep, 1978
10 History Cancer Research, 1980
11 The 1 st HIPEC Cancer Research, 1980
12 The Sugarbaker Ann Surg 1995
13 The Sugarbaker 181 consecutive patients 51 CRC 130 Appendiceal cancer 24 month mean F/U
14 The Sugarbaker
15 The Sugarbaker
16 The Sugarbaker 3 deaths Fistula rate of 26% (19/72) in high risk patients Previous obstruction, chemotherapy, radiation Fistula rate of 1.8% (2/109) in low risk patients Anastomotic leak in 5.5%
17 Patient Selection Patients must be medically fit to undergo the rigors of cytoreductive surgery and HIPEC There must be no: extra-abdominal disease parenchymal hepatic metastases gross nodal metastases bulky retroperitoneal disease Peritoneal disease must be resectable to minimal surface disease
18 Peritoneal Carcinomatosis Index (PCI) Sugarbaker. The Cancer Journal 2009
19 Completeness of Cytoreduction Completeness of cytoreduction score CC-0 or CC-1 considered complete or optimal cytoreduction CC-2 or CC-3 considered incomplete cytoreduction Sugarbaker. The Cancer Journal 2009
20 Stripping of the Parietal Peritoneum All involved parietal peritoneum is removed Visceral peritoneum: Electro-evaporation of small tumors Bowel resection for large tumors Liver: Resection of Glisson capsule
21 Reconstruction Anastomoses: After HIPEC Ostomies Chest tubes
22 HIPEC Closed vs. Colisseum
23 Evidence?
24 Phase III Trial for CRC (5 withdrew) (2 progressed) (1 withdrew) (4 progressed) (5FU + Leucovorin) (Irinotecan) Verwaal, et al., J Clin Ocol, 2003
25 Phase III Trial for CRC 8% mortality 19% bone marrow toxicity 15% fistula rate Survival affected by extent of debulking Median survival HIPEC 22.4 mos Standard 12.6 mos Predicted 5 yr OS for treatment arm - 20% Verwaal, et al., J Clin Ocol, 2003
26 Verwaal, et al., J Clin Ocol, 2003 Median Survival HIPEC 22.4 mos Standard 12.6 mos
27 Verwaal, et al., Ann Surg Oncol, 2008
28 Verwaal, et al., Ann Surg Oncol, 2008
29 Is it possible to obtain definitive cure with CRS + HIPEC? Prospective study of patients treated between January 1995 and December 2005 (n=93). Learning curve = worst results Cure = no recurrence at 5 years Median follow-up: 99 months Median Survival : 34 months Overall 5-year survival : 32% Goéré, et al. Ann Surg 2013
30 Is it possible to obtain definitive cure with CRS + HIPEC? At risk Overall Survival Disease-free Survival Months NED at 5 years = 16%
31 At 10 years: 102/612 pts =16.7% JCO, 2007
32 Is it possible to obtain definitive cure with CRS + HIPEC? 5-year overall survival 38.5% for Liver Mets group 36.5% for Peritoneal Mets group 26.4% for LM+PM group Elias et al. Ann Surg Oncol. 2014
33 Is it possible to obtain definitive cure with CRS + HIPEC? Hepatectomy for LM or HIPEC for PM overall survival and definitive cure rates are similar Peritoneum should be considered as an organ Metastastectomy works
34 Is it the CRS or the HIPEC?
35 Surgery versus No Surgery Is there a trial comparing? Similar patients Surgery No Surgery
36 Complete resection alone of PC? N Selection Median OS 5-Y Survival Mulsow PCI<10 25 months 22% (Erlangen) Cashin SPIC* 25 months 18% (Uppsala) Evrard PCI<10 30 months 25% (Bordeaux) *SPIC = Sequential postop. intraperitoneal chemo.
37 Survival Comparing CRS + HIPEC to Modern Chemotherapy Janko, et al. Cancer 2014
38 PRODIGE 7 Complete Cytoreductive Surgery HIPEC Oxali, 30 min, 43 C +5-FU and Leuco IV No HIPEC Chemotherapy
39 Background Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
40 Background Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
41 Unicancer Prodige 7 trial design Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
42 Baseline Characteristics Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
43 Peritoneal Carcinomatosis Characteristics Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
44 Safety: Mortality Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
45 Safety: Morbidity at 30 days Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
46 Morbidity at 30 days: Intra-abdominal complications Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
47 Morbidity at 60 days Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
48 Overall survival (ITT) Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
49 Relapse-free survival (ITT) Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
50 Forest Plot for Overall Survival Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
51 Overall survival and PCI Presented By Fran?Ois Quenet at 2018 ASCO Annual Meeting
52 Gastric Cancer Yang, et al, Ann Surg Oncol 2011
53 Diffuse Malignant Peritoneal Mesothelioma Yan et al., J Clin Oncol, 2009
54 Diffuse Malignant Peritoneal Mesothelioma Helm, et al., Ann Surg Oncol, 2015
55 What s Next?
56 PIPAC
57 PIPAC Pressurized Intraperitoneal Aerosolized Chemotherapy Performed during laparoscopy CRS is not performed at the time of treatment Outpatient surgery Adjunct to systemic chemotherapy Can be repeated
58 PIPAC Laparoscopic access can be difficult Should not be performed in symptomatic patients Bowel obstruction? Escape of chemotherapy
59 PIPAC
60 PIPAC
61
62 Future Directions Non-chemotherapy based perfusion Imaging needs to get better Use of fluorescence in the OR to assess CRS Molecular profiling of peritoneal metastasis
63 Conclusions The treatment of Peritoneal Surface malignancies has dramatically changed during the last 30 years. CURE is possible in some PSM Complete CRS is critical HIPEC with Oxaliplatinum does not improve the outcomes of CRS
64 Conclusions Clinical trials needed Better imaging will help with patient selection Research into new perfusion agents and techniques on the way
65 Questions?
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