Hyperthermic Intraperitoneal Chemotherapy (HIPEC) as Part of an Integrative Treatment Plan for Colorectal Peritoneal Carcinomatosis

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1 Hyperthermic Intraperitoneal Chemotherapy (HIPEC) as Part of an Integrative Treatment Plan for Colorectal Peritoneal Carcinomatosis T. Christopher Windham, M.D., F.A.C.S. Medical Director, Florida Hospital Memorial Medical Center Cancer Care Institute, Daytona Beach, Florida Associate Clinical Professor of Surgery Florida State University College of Medicine

2 Background Traditional 5-FU regimens for PC colorectal patients associated with 5.2-7mth survival Modern treatment regimens with Oxaliplatin, bevazizumab, irinotecan etc. are reporting median survival rages of 15-23mths Jayne,et al., Br J Surg, 2002 Minsky, et al., J Clin Oncol, 1988 Chua, et al., Ann Surg Oncol 2011

3 Background Synchronous PC at initial Sx found in 7-15% of colorectal cases PC develops in 4-19% during follow-up Pts with synchronous PC, 58% had no systemic disease Those who develop subsequent PC, 3-4% have isolated disease to the peritoneum Jayne,et al., Br J Surg, 2002 Koppe, et al., Ann Surg, 2006 Minsky, et al., J Clin Oncol, 1988

4 Background Suggests a third route of spread, rather than hematogenous or lymphatic Spread from tumor dissemination from invasion of the bowel wall through the serosal surface Webber, et al., Clin Colorectal Can, 2012.

5 Carcinomatosis

6 Scope of Problem Major problem in cancer management Hard to detect by imaging Difficult to manage Marked deterioration in quality of life Short survival

7 Natural History of Carcinomatosis Crampy abdominal pain Anorexia/ weight loss Bowel obstruction Ascites Infection

8 Scope of Problem Combined- Gastric, Pancreatic, Small bowel, 20,000 Gall Bladder Colorectal Cancer 23,000 Ovarian Cancer 22,000 Appendiceal Cancer 1,200 Mesothelioma 500 Of these approximately 25,000 are candidates for cytoreduction/ HIPEC. In 2009 only 5% received this treatment

9 Current Treatment Options Systemic Chemotherapy Radiation - Poor penetration to peritoneum Surgical Treatment Surgery with or without systemic chemotherapy has shown to be inadequate for the treatment of patients with PC.

10 Rationale for Cytoreduction and HIPEC Cytoreduction reduces tumor to minimal disease increasing the effect of chemotherapy Hyperthermia has direct tumoricidal effects Hyperthermia can act synergistically with chemotherapy

11 Definitions Carcinomatosis Cancer cells that have spread within the abdominal cavity Considered Stage IV disease Initially these cells grow into nodules of tumor on the of the lining of the abdomen (peritoneum) or on the surface of abdominal organs There may be associate ascites (fluid or mucous) within the abdominal cavity

12 Definitions Cytoreduction The surgical removal of disease identified in the abdominal cavity- Completeness of Cytoreduction (CCR) CCR0- No residual macroscopic disease CCR1- Residual tumor implants max diam <5mm CCR2- Residual tumor implants max diam >5mm

13 Definitions Hyperthermic Intraperitoneal Chemotherapy HIPEC The treatment of peritoneal surface malignancies with the instillation of a heated chemotherapy agent directly in the peritoneal cavity This can be done through catheters left in the abdomen following surgery (dwell) technique (EPIC)

14 Rationale for Cytoreduction and HIPEC We can achieve more than 20 fold higher doses of chemotherapy within the peritoneal cavity Higher doses with limited systemic side effects as seen with IV chemotherapy Direct contact of both heat and chemotherapeutic agents with malignant cells

15 Rationale for Cytoreduction and HIPEC Hyperthermia Directly toxic to malignant cells Disrupts microtubule system and induces apoptosis Potentiates the cytotoxic effects of chemotherapy Improves tissue absorption of chemotherapy Has a selective lethal effect on cancer cells (41 0 C-43 0 C)

16 Rationale for Cytoreduction and HIPEC Peritoneal Cavity Subperitoneal Layer Peritoneal Nodule Capillaries Peritoneum Adapted from: Zoctmulder J. Surg Onc., 2002

17 Cytoreduction/HIPEC Procedure Heat Chemotherapy

18 EPIC Technique

19 Rationale for Cytoreduction and HIPEC Performed at the time of surgery -Eliminating pain and discomfort for patient -Improves distribution of heat and chemotherapy -At the time of lowest tumor burden

20 Candidates Disease confined to the peritoneal cavity Excellent performance status Disease from gastrointestinal, ovarian, primary peritoneal or mesothelioma origins

21 Cytoreduction/HIPEC Procedure Pre-operative Evaluation/preparation- History/physical examination Laboratory/Imaging Studies Review at Cancer Multidisciplinary Conference Surgery- Emphasis on pain control Cytoreduction/HIPEC Post-operative- ICU-2-3 days In hospital days

22 Cytoreduction/HIPEC Procedure Recovery- At least 4-8 weeks Gastrointestinal discomfort Poor appetite Need for IV nutrition support

23 Cytoreduction/HIPEC Procedure Surgery may be extensive and require multiple organs be resected Splenectomy, Omentectomy, Bowel resection, and Hysterectomy/Oophorectomy are often required Some patients may require an ostomy

24 Cytoreduction/HIPEC Procedure Meticulous removal of implants from the peritoneal surface Then catheters are placed in the abdominal cavity with temperature probes

25 Cytoreduction/HIPEC Procedure

26

27 Cytoreduction/HIPEC Procedure

28 Does it Work?

29 Median Survival (mths) 105 pts CRC Carcinomatosis Standard Systemic Chemo +/-palliative Sx 12.6 P=0.032 Cytoreduct/HIPEC Systemic Chemo % mortality 19% Bone marrow toxicity 15% Fistula rate Survival affected by extent of debulking Verwaal, J Clin Onc., 2003

30 Results/Outcomes Verwaal, J Clin Onc., 2003

31 Results/Outcomes Verwaal, J Clin Onc., 2003

32 Complete Cytoreductive Surgery Plus Intraperitoneal Chemohyperthermia With Oxaliplatin for Peritoneal Carcinomatosis of Colorectal Origin By: Elias, D., et. al -Comparison of complete resection/hipec (n=48) with retrospectively analyzed matched patients treated with best systemic therapy alone -Those not treated with cytoreduction /HIPEC- due to travel and unable to accommodate schedule

33 Median Survival 23.9mths vs 62.7 mths 5yr OS 13% vs 51% Elias, D., J. Clin Oncol., 2009

34 Results/Outcomes Weber, et al., Clin Colorectal Canc

35 Problems/Future Directions Lack of standardization -Drugs Mitomycin Oxaliplatin Carboplatin -Temperature C EPIC normothermic -Time Intraoperative-HIPEC Early Post-operative- EPIC

36 Problems/Future Directions Lack of standardization -Technique Open Coliseum Closed -Duration 30-90min

37 Conclusions Cytoreductive surgery with HIPEC offers the chance for long-term survival in selected patients with CRC with PC This approach is complementary to systemic chemotherapy not a replacement Careful patient selection and complete cytoreduction are important to maximize benefits

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