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
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%).
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.
Research question Pre-operative chemoradiotherapy vs Post-operative chemoradiotherapy in treatment of local advanced rectal cancer, combined with surgery.
General Objectives 2-year DFS and OS Radical resection rate Sphincter preservation rate
Specific targets Findings: * 2-year DFS and OS * Radical resection * Sphincter preservation Comparing Operative difficulty levels: * Operation time * Blood loss * Complication
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
Clinical trial >< Historical control. Research method Clinical trial >< Historical control. Sample Size: 101 cases +
Criteria Recruitment vs. Elimination Research Recruitment Patients’ consent Not adenocarcinoma Emergency problems: bowel obstruction, peritonitis Metastasis after neo-adjuvent chemoRT (carcinomatosis)
Preparation before treatment Tattooing tumor location Pelvic MRI
Patient positioning - Radiation
Radiotherapy simulation
Evaluation of neo-adjuvent chemoRT responsiveness
Patient positioning - Operation
Pelvic cavity Low anterior resection
Operative specimen APR PELVECTOMY LOW ANTRIOR RESECTION
FOLLOW-UP 1ST - Adjuvant chemotherapy = Capecitabine / XELOX; 2ND - Colonoscopy. 3-month periodical examination. Yearly schedule of Pelvic MRI & Colonoscopy.
Results Study group = 119 cases Historical control group =104 cases
Age Gender
Tumor location Tumor mobilization
Stage
Clinical Responsiveness Pathological responsiveness
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
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%
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 %
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 (10 - 300) 70 (20 - 200) 0,572 Miles procedure 100(15 - 300) 120 (40 - 500) 0,374 Hartmann procedure 125 ± 35,3 90 ± 14.1 0,093
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
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.
Thank you.