Abstract

Background: Surgery is standard of gallbladder cancer (GBC) care. Chemotherapy (chemo) is indicated only in locally advanced and metastatic disease. Aim : Ameliorate 03 years disease free survival (DFS) of GBC after R0 surgery and adjuvant chemo. Methods: It’s a prospective randomised study. From January 2010 to March 2013, 83 patients were curativelly resected for GBC. 80 patients were included, 41 patients in surgery groupe and 39 patients surgery and adjuvant chemo. Surgical resection was cholecystectomy bisegmentectomy IVb-V and lymphadenectomy. Chemo regimen consisted in gemcitabin (1250 mg/m2 d1/d8) and cisplatin (70 mg/m2 d1) all 21 d (06 cycles). Results: There were 64 women and 16 males (sex ratio : 0,25), median age was 57. median follow up is 53 months (m). median recurrence delay is 25,8 m. Surgery was R0 in all patients, median lymph nodes number is 12.5. Post operative mortality is 3,61% (03 patients), the morbidity is 40% (32 patients) ; 10.2% major complications (Clavien III- IV). Chemo toxicity concerned 57% in adjuvant chemo group (39 patients). DFS at 3 and 5 y is 67,7% et 63,8 % respectivelly. DFS at 03 and 05 y in chemo is 58,6% and 52,9% versus 73,2% and 67,5% in surgery alone group respectivelly (p=0,125). Multivariate analysis ; age up to 65y, BMI up to 25, number of positive lymph nodes and main bile duct infiltration were recurrence predictive factors. Conclusion: Adjuvant chemo did not improve GBC prognosis. R0 resection is the standard of care and should be reserved for experienced teams.

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