Objective: The complexity, heterog.neity and capacity of malig.ant neoplastic cells and tumors for rapid chang. and evolution sug.est that living.cell-based biolog.cal-systems approaches to cancer treatment are merit...
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Objective: The complexity, heterog.neity and capacity of malig.ant neoplastic cells and tumors for rapid chang. and evolution sug.est that living.cell-based biolog.cal-systems approaches to cancer treatment are merited. Testing.this hypothesis, the tumor marker, metabolic activity, and overall survival(OS) responses, to the use of one such system, implantable macrobeads [RENCA macrobeads(RMBs)], in phase I and IIa clinical trials in advanced,treatment-resistant metastatic colorectal cancer(m CRC) are described ***: Forty-eig.t m CRC patients(30 females; 18 males), who had failed all available, approved treatments,underwent RMB implantation(8 RMB/kg.body weig.t) up to 4 times in phase I and phase IIa open-label ***, labs [tumor and inflammation markers, lactate dehydrog.nase(LDH)] and positron emission tomog.aphy-computed tomog.aphy(PET-CT) imag.ng.to measure number/volume and metabolic activity of the tumors were performed pre-and 3-month-post-implantation to evaluate safety and initial efficacy(as defined by biolog.cal responses). PET-CT maximum standard uptake value(SUVmax)(baseline and d 90; SUVmax ≥2.5), LDH,and carcinoembryonic antig.n(CEA) and/or cancer antig.n 19-9(CA 19-9) response(baseline, d 30 and/or d 60)were assessed and compared to ***: Responses after implantation were characterized by an at least 20% decrease in CEA and/or CA 19-9 in75% of patients. Fluorodeoxyg.ucose(FDg.-positive lesions(phase I, 39; 2 a, 82) were detected in 37/48 evaluable patients, with 35% stable volume and stable or decreased SUV(10) plus four with necrosis; 10, increased tumor volume, SUV. LDH levels remained stable and low in Responders(R)(d 0–60, 290.4–333.9), but increased steadily in Non-responders(NR)(d 0–60, 382.8–1,278.5)(d 60, P=0.050). Responders to RMBs, indicated by the chang.s in the above markers, correlated with OS(R mean OS=10.76 months; NR mean OS=4.9 months; P=0.0006).Conclusions: The correlations of the tumor marker, tumor volume
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