Abdominal and pelvic stop-flow (hypoxic, chemotherapeutic loco-regional treatment): Preliminary report of a phase I study

Stop Flow in abdominal and pelvic cancer relapses

“…A clear-cut pharmacokinetic advantage for perfused tissues was observed both for MMC and doxorubin (DOXO) or epirubicin (EPI) DOXO and MMC local concentrations resulted, respectively, 5-26 (10 and 15 for EPI) and 6-48 higher than those measured in peripheral plasma in spite of elevated interindividual variabilities. The drug percentage eliminated in the ultra filtrate was 7.7% (MMC) and 0.9% (DOXO) The plasmatic drug AUC0-24 were similar to those observed with iv bolus of equivalent drug doses (8,9,10,16).…”

“…Preliminary findings with regard to therapeutic response in the abdominal stop-flow group were of scant significance compared to those obtained in the pelvic stop-flow group, both on account of the limited number of patients treated and the less effective and less durable control of pain in the former. Furthermore, abdominal stop-flow was difficult to implement because it entailed anchoring the balloons in the subdiaphragmatic site, dangerously dose to the area of maximum heart ejection (8,9,10). It should also be kept in mind that with an increase in the number of patients studied, the heightened difficulty in positioning the balloon catheters could correspond to a greater risk of embolism.…”

“…It should also be kept in mind that with an increase in the number of patients studied, the heightened difficulty in positioning the balloon catheters could correspond to a greater risk of embolism. By contrast, the clinical responses obtained in colorectal and gynaecological pelvic recurrences seem promising (3,4,5,6,7,10). In particular, pelvic recurrences of colorectal disease, due to their frequency, may constitute a useful clinical target for assessing the capacity that this therapeutic procedure has in rendering recurrences resectable.…”

“…The initial responses extrapolated from the phase I study prompted us to consider pelvic relapses caused by colorectal and gynecological tumors. The latter became the object of a separate, ongoing study (8,9,10). Stop-flow treatment of pelvic recurrences of colorectal cancer was chosen as the primary target.…”

From Clinical Trials to the Front Line: Vinflunine for Treatment of Urothelial Cell Carcinoma at the National Cancer Institute of Naples

“…Transitional cell cancer of the urothelial tract, TCCU, is the sixth most common type of cancer in western countries (Siegel et al, 2013 ; Franco et al, 2014 ), in most cases it involves the bladder but may also origin from the ureter or the renal pelvis; the estimated number of deaths from bladder cancer in US in 2015 are 16.000 which means that the need of new therapeutic approaches is extremely urgent (Bladder cancer incidence and mortality National Cancer Institute 1 ; Leopardo et al, 2013 ). Advanced TCCU is considered a relatively chemosensitive tumor due to the high Response Rate, RR, observed in first line with platinum-based regimens, varying from 40 to 70% (Von der Maase et al, 2005 ; Roberts et al, 2006 ; Bellmunt et al, 2012 ; Ferro et al, 2012 ; Marra et al, 2013 ; Cavaliere et al, 2014 ), nevertheless the duration of response is limited and when progression after primary treatment occurs the outcome is generally poor (Iaffaioli et al, 1997 ; Strocchi et al, 2004 ). Several regimens have been tested in the recurrent setting, including both single agents (Albers et al, 2002 ; Vaughn et al, 2002 ; Franco et al, 2011 ) and combinations (Bellmunt et al, 2002 ; Iaffaioli et al, 2006 ; Lin et al, 2007 ; Marra et al, 2008 ) but they showed modest activity often associated with significant toxicity.…”