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Purpose: No standard adjuvant treatment currently is recommended in localized biliary tract cancer (BTC) after surgical resection. We aimed to assess whether gemcitabine and oxaliplatin chemotherapy (GEMOX) would increase relapse-free survival (RFS) while maintaining health-related quality of life (HRQOL) in patients who undergo resection., Patients and Methods: We performed a multicenter, open-label, randomized phase III trial in 33 centers. Patients were randomly assigned (1:1) within 3 months after R0 or R1 resection of a localized BTC to receive either GEMOX (gemcitabine 1,000 mg/m 2 on day 1 and oxaliplatin 85 mg/m 2 infused on day 2 of a 2-week cycle) for 12 cycles (experimental arm A) or surveillance (standard arm B). Primary end points were RFS and HRQOL., Results: Between July 2009 and February 2014, 196 patients were included. Baseline characteristics were balanced between the two arms. After a median follow-up of 46.5 months (95% CI, 42.6 to 49.3 months), 126 RFS events and 82 deaths were recorded. There was no significant difference in RFS between the two arms (median, 30.4 months in arm A v 18.5 months in arm B; hazard ratio [HR], 0.88; 95% CI, 0.62 to 1.25; P = .48). There was no difference in time to definitive deterioration of global HRQOL (median, 31.8 months in arm A v 32.1 months in arm B; HR, 1.28; 95% CI, 0.73 to 2.26; log-rank P = .39). Overall survival was not different (median, 75.8 months in arm A v 50.8 months in arm B; HR, 1.08; 95% CI, 0.70 to 1.66; log-rank P = .74). Maximal adverse events were grade 3 in 62% (arm A) versus 18% (arm B) and grade 4 in 11% versus 3% ( P < .001)., Conclusion: There was no benefit of adjuvant GEMOX in resected BTC despite adequate tolerance and delivery of the regimen.

Unlabelled: Percutaneous ablation using acetic acid is an attractive method because of its low morbidity and low number of sessions required to induce complete tumor necrosis. Moreover, the real-time fluoroscopy CT scan could improve the technique by improving distribution of the necrotizing agent within the tumor., Aim: To determine the feasibility and the long-term results of the acetic acid percutaneous injection under CT fluoroscopy guidance in a series of cirrhotic patients with small hepatocellular carcinoma in a single French center., Methods: One hundred and two patients with hepatocellular carcinoma were evaluated for treatment between 1999 and 2000. The selection criteria for fluoroscopy CT scan-directed percutaneous acetic acid ablation were: 1) one to three nodules<5 centimeters; 2) Child-Pugh class<13; 3) prothrombin index > 40% and platelet count > 50000 per mm(3) and 4) contraindication to both resection and liver transplantation. Post treatment follow-up included ultrasonography, magnetic resonance and alphafetoprotein levels every 3 months. Recurrence and survival rates were estimated using the Kaplan-Meier method., Results: Forty-nine patients (48%) could benefit from a curative treatment, most of them (37/49) being eligible for fluoroscopy CT scan-directed percutaneous acetic acid. The mean follow up was 24.4 +/- 2.7 months. Complete tumor necrosis was achieved in 28 patients (76%) after a mean of 1.6 sessions. In these 28 patients, the recurrence rates were 34% and 48% and survival rates were 76% and 70%, at 24 and 36 months, respectively. No serious complications occurred during or after the treatment., Conclusions: Percutaneous ablation using acetic acid using CT fluoroscopy guidance may be considered as a short term efficient, low risk treatment and can be applied even in patients with ascites or severe hemostatic abnormalities. However, the high rate of recurrence and the early occurrence of multifocal hepatocellular carcinoma underline the limits of this method as well as of all other percutaneous strategies.