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PRESENTATOR: MD VƯƠNG NHẤT PHƯƠNG. HO CHI MINH CITY ONCOLOGY HOSPITAL
INITIAL FINDINGS OF NEO-ADJUVANT CHEMORADIOTHERAPY COMBINED WITH SURGERY IN TREATMENT OF STAGE II – III RECTAL CANCER PRESENTATOR: MD VƯƠNG NHẤT PHƯƠNG. HO CHI MINH CITY ONCOLOGY HOSPITAL
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INTRODUCTION Rectal cancer – 5th most popular cancer in Vietnam.
TME - reducing local recurrent rate. In 1990, NCI (National Cancer Institute): Multi modality treatment - a new standard of rectal cancer treatment. CAO/ARO/AIO-94 trial: Preoperative chemo radiotherapy on local recurrent rate of stage II, III rectal cancer (6% vs 13%).
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The necessity of research
Bachmai Hospital and Hanoi K Institute - MD Phạm Cẩm Phương’s Clinical Trial Ho Chi Minh City Oncology Hospital - Multi modality treatment (surgery combined with postoperative chemoradiotherapy) since 1990.
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Research question Pre-operative chemoradiotherapy vs Post-operative chemoradiotherapy in treatment of local advanced rectal cancer, combined with surgery.
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General Objectives 2-year DFS and OS Radical resection rate
Sphincter preservation rate
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Specific targets Findings: * 2-year DFS and OS * Radical resection
* Sphincter preservation Comparing Operative difficulty levels: * Operation time * Blood loss * Complication
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Research recruitment Middle and low third local advanced rectal cancer
Adenocarcinoma Department II of Ho Chi Minh city Oncology Hospital From June 2014 to December 2015 Patients, Pathology, Admitted
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Clinical trial >< Historical control.
Research method Clinical trial >< Historical control. Sample Size: 101 cases +
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Criteria Recruitment vs. Elimination
Research Recruitment Patients’ consent Not adenocarcinoma Emergency problems: bowel obstruction, peritonitis Metastasis after neo-adjuvent chemoRT (carcinomatosis)
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Preparation before treatment
Tattooing tumor location Pelvic MRI
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Patient positioning - Radiation
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Radiotherapy simulation
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Evaluation of neo-adjuvent chemoRT responsiveness
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Patient positioning - Operation
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Pelvic cavity Low anterior resection
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Operative specimen APR PELVECTOMY LOW ANTRIOR RESECTION
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FOLLOW-UP 1ST - Adjuvant chemotherapy = Capecitabine / XELOX; 2ND - Colonoscopy. 3-month periodical examination. Yearly schedule of Pelvic MRI & Colonoscopy.
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Results Study group = 119 cases Historical control group =104 cases
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Age Gender
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Tumor location Tumor mobilization
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Stage
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Clinical Responsiveness
Pathological responsiveness
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Operation P = 0.000* Fisher’s exact test
Operation type Study group n = 119 cases His. Control n = 104 cases Unresectable 20 = 19,2% Low anterior resection 75 = 63% 58 = 55,8% Ultra low anterior resection 13 = 10,9% Hartmann procedure 2 = 1,7% 5 = 4,8% Miles procedure 27 = 22,7% 21 = 20,2% Pelvectomy
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Operation - Tumor ≤ 5cm from anus verge P = 0.000* Fisher’s exact test
Operation type Study group n = 65 cases His. control n =47 cases Unresectable 11 = 23,4% Low anterior resection 26 = 40% 14 = 29,8% Ultra low anterior resection 11 = 16,9% Hartmann procedure 3 = 6,4% Miles procedure 27 = 41,5% 19 = 40.4% Pelvectomy 1 = 1,6%
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Operation P = 0.000* Fisher’s exact test
Operation type Study group n = 119 His. Control n = 104 Open surgery 91= 76,5% 100 = 96,2% Laparoscopic surgery 28 = 23,5% 4 = 3,8% Cutting merging Study group n=119 His. control n=104 Unresectable 20 = 19,3% R0 115 = 96,8% 81 = 77,9% R1 3 = 2,4% 2 = 1,9% R2 1 = 0,8% 1 = 0,9 %
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Operation Time & Blood Loss
Study group His. group P (unequal variance) Average operation time 120 115 Low anterior resection 120 ± 41,8 n=75 109,6 ± 27,8 n=53 0,067 Miles procedure 133 ± 27,9 n=27 122 ± 28.1 n=21 0,204 Hartmann procedure 117,5 ± 24,7 n=2 109 ± 15,9n=5 0,542 Blood loss (ml) Study group His. control P (unequal variance) Low anterior resection 70 ( ) 70 ( ) 0,572 Miles procedure 100( ) 120 ( ) 0,374 Hartmann procedure 125 ± 35,3 90 ± 14.1 0,093
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Complication and mortality
Description Study group His. group Anastomosis leaked 2cases = 2,2% 2cases = 3,4% Bowel obstruction 3cases = 2,4% 3cases = 2,7% Necrosis colostomy 1cases = 0,8% Recto-vaginal fistule 1cases = 1,7% Intestineperineal fistule Mortality
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Conclusion Increase in radical resection and sphincter preservation
No negative impact on operation safety FOLLOWED UP 2-YEAR DFS & OS SUGGESTION: Standard Multi-Modality Regimen for Middle and Low third Local advanced Rectal Cancer.
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Thank you.
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