Search

Background: Regional chemotherapy is used successfully in the treatment of both primary and secondary malignancies, in particular of the peritoneal surface and the liver, and is currently explored as an attractive approach for patients with locally advanced pancreatic ductal adenocarcinoma. To establish the feasibility and toxicity of regional intra-arterial gemcitabine delivered as a 24-h continuous infusion to the pancreas as a novel treatment option for patients with locally advanced PDAC a phase I clinical trial was conducted., Methods: Between April 2011 and September 2013 six patients with biopsy confirmed, borderline or unresectable pancreatic adenocarcinoma, and having received at least one line of systemic chemotherapy, underwent vascular redistribution of the inflow to the head of the pancreas by arterial coil embolization followed by perfusion catheter placement within the splenic artery. Patients were treated with increasing doses of gemcitabine administered by continuous splenic arterial infusion over 24 h with inter-patient and intra-patient dose escalation scheme. The primary endpoint was toxicity of the intra-arterial gemcitabine regimen and to establish the maximum tolerated dose., Results: Catheter placement and gemcitabine infusion was successful in all patients enrolled to date (n = 6). Four out of six patients experienced catheter tip migration requiring replacement or revision. Patients received a median of four doses of 24-h gemcitabine infusion. Two patients developed grade 3 and 4 duodenal ischemia and upper gastrointestinal bleeding. Median overall survival was 15.3 months and median time to progression was 3 months. Three patients (50 %, n = 3/6) progressed systemically. Two patients had stable disease >4 months following treatment and underwent pancreaticoduodenectomy., Conclusions: While technically feasible to treat locally advanced pancreatic ductal adenocarcinoma, prolonged regional pancreatic perfusion with gemcitabine following pancreatic arterial redistribution carries a high risk for gastrointestinal toxicity. Shorter infusion schedules with frequent on treatment evaluations should be considered for future clinical trials.

Purpose: To study the impact of race in an equal access care institution with a predominantly African-American (AA) population., Methods: We retrospectively reviewed data from 222 men with low risk (LR) or intermediate risk (IR) prostate cancer who underwent radical prostatectomy at the New York Harbor VA between 2003 and 2011. Biochemical relapse, distant control, and prostate cancer-specific survival were analyzed using the Kaplan-Meier method and compared using the log-rank test. Univariate and multivariate Cox regression modeling was performed to determine the impact of covariates on biochemical outcome., Results: Most patients (65.3 %) were AA. The median follow-up was 58 months, and 89.6 % of patients were followed for a minimum of 2 years after their surgery. Analyzing the whole cohort, the biochemical control was improved in Caucasian patients compared with AA (90.2 vs. 75.4 %, p = 0.008). On subgroup analysis, for IR disease, this difference was no longer significant, 80.5 % for Caucasians versus 69.8 % for AA (p = 0.36). However, for LR disease, the 5-year biochemical control remained significantly improved for Caucasians compared with AA, with a 5-year biochemical control of 97.6 versus 81.7 %, p = 0.006. On multivariate analysis, AA race was a significant predictor for biochemical recurrence (HR 2.69, 95 % CI 1.27-5.65, p = 0.009). There were no differences between the two groups regarding distant control (p = 0.14) or prostate cancer-specific survival (p = 0.29)., Conclusions: In this predominant AA population with equal access to medical care, AA race is an independent predictor of biochemical recurrence after prostatectomy in men with LR or IR prostate cancer.