clinicaltrials.gov Identifier: NCT02406781.

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Background: Despite neoadjuvant chemotherapy, few patients with colorectal cancer liver metastases (CRLM) are eligible for liver resection. The aim of the present study was to investigate the efficacy of intraoperative radiofrequency ablation (IRFA) in the treatment of unresectable CRLM. Methods: Patients with unresectable metastases confined to the liver were eligible for this prospective, multicentre phase II study conducted between 2003 and 2008. They received IRFA treatment either with or without parenchymal resection, and underwent clinical and pathological examinations. The primary endpoint was complete hepatic response at 3 months. Overall, event‐free and local progression‐free survival, morbidity and quality of life were also examined. Results: Fifty‐two patients were included, all of whom received neoadjuvant chemotherapy. They had a median of 5 (range 1–13) metastases, mostly bilateral or recurrent. A complete hepatic response was observed in 39 patients (75 (95 per cent confidence interval (c.i.) 61 to 86) per cent). Of ten patients with hepatic recurrence at 3 months, two relapses were at the site of ablation. Median follow‐up was 2·9 (95 per cent c.i. 2·5 to 3·6) years. The 1‐year local progression‐free survival rate was 46 (95 per cent c.i. 32 to 59) per cent, the 3‐year event‐free survival rate was 10 (95 per cent c.i. 4 to 21) per cent and the 5‐year overall survival rate was 43 (95 per cent c.i. 21 to 64) per cent. Twenty patients had postoperative complications, including one death. Quality of life increased over time for patients without disease progression. Conclusion: IRFA, either with or without resection, is a promising treatment option for patients with unresectable CRLM. Registration number: NTC00210106 (http://www.clinicaltrials.gov). Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

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Background. Preclinical studies demonstrated that nonnucleoside reverse transcriptase inhibitors used for the treatment of HIV could antagonize tumor development. This led us to assess the efficacy of efavirenz in patients with metastatic castration-resistant prostate cancer (mCRPC) in a multicenter phase II study. Methods. We used a Simon two-stage design and a 3-month prostate-specific antigen (PSA) nonprogression rate of 40% as a primary objective. Patients received 600 mg efavirenz daily with the possibility of a dose increase in case of PSA progression. Exploratory analyses included pharmacokinetics of efavirenz plasma concentrations and correlations with clinical outcomes. Results. Among 53 assessable patients, we observed 15 instances of PSA nonprogression at 3 months, corresponding to a nonprogressionrate of 28.3% (95% confidence interval: 16.8%-42.3%). The exploratory analysis revealed that for the 7 patients inwhomoptimalplasmaconcentrationofefavirenzwasachieved, PSA progression was observed in only 28.6% compared with 81.8% of patients with suboptimal plasma concentrations of efavirenz. Conclusion. Although 600 mg efavirenz did not statistically improve the PSA nonprogression rate, our exploratory analysis suggests that higher plasma concentrations of this drug (i.e., use of increased dosages) may be of potential benefit for the treatment of mCRPC.