ABSTRACT
JCOG1113 is a randomized phase III trial in patients with advanced biliary tract cancers (BTCs) (UMIN000001685), and gemcitabine plus S-1 (GS) was not inferior to gemcitabine plus cisplatin (GC). However, poor renal function often results in high toxicity of S-1. Therefore, we examined whether GS can be recommended for patients with low creatinine clearance (CCr). Renal function was classified by CCr as calculated by the Cockcroft-Gault formula: high CCr (CCr ≥ 80 ml/min) and low CCr (80 > CCr ≥ 50 ml/min). Of 354 patients, 87 patients on GC and 91 on GS were included in the low CCr group, while there were 88 patients on GC and 88 patients on GS in the high CCr group. The HR of overall survival for GS compared with GC was 0.687 (95% CI 0.504-0.937) in the low CCr group. Although the total number of incidences of all Grade 3-4 non-haematological adverse reactions was higher (36.0% vs. 11.8%, p = 0.0002), the number of patients who discontinued treatment was not different (14.1% vs. 16.9%, p = 0.679) for GS compared with GC in the low CCr group. This study suggests that GS should be selected for the treatment of advanced BTC patients with reduced renal function.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Biliary Tract Neoplasms/drug therapy , Biliary Tract Neoplasms/pathology , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Biliary Tract Neoplasms/complications , Biomarkers , Deoxycytidine/administration & dosage , Deoxycytidine/analogs & derivatives , Disease Management , Female , Humans , Kaplan-Meier Estimate , Kidney Diseases/diagnosis , Kidney Diseases/etiology , Kidney Function Tests , Male , Neoplasm Metastasis , Neoplasm Staging , Prognosis , Treatment Outcome , GemcitabineABSTRACT
A woman in her 70s was admitted to our hospital because of epigastric pain and anorexia. Laboratory evaluations revealed elevated levels of liver transaminases, biliary enzymes, and amylase. CT and MRCP showed dilatation of the bile and pancreatic ducts and a large juxtapapillary diverticulum filled with contents. There were no gallstones or tumors present. Our differential diagnosis included obstruction of the papilla of Vater, so we performed an urgent ERCP. Endoscopic examination showed the juxtapapillary diverticulum filled with food residue;however, we were unable to locate the papilla of Vater. We rinsed out and removed food residue from the diverticulum using a retrieval balloon catheter used for gallstones. After the endoscopic removal of the food residue, the patient's epigastric pain immediately subsided and her cholangitis and pancreatitis improved gradually.
Subject(s)
Cholangitis , Diverticulum , Duodenal Diseases , Gallstones , Cholangiopancreatography, Endoscopic Retrograde , Female , Humans , Pancreatic DuctsABSTRACT
In order to quickly confirm a potentially hazardous psychoactive designer drug (a compound in which part of the molecular structure of a stimulant or narcotic has been modified), we created a psychoactive drugs data library by performing analysis using liquid chromatography with photodiode array spectrophotometry (LC/PDA) and gas chromatography-mass spectrometry (GC/MS). The data in this library consist of the LC capacity factor (k') ratios in relation to the internal standard, the ultraviolet (UV) spectra and the MS spectra of 104 compounds. By performing a comparative study of the data in this report with the analytical data for commercial and illegal drug products, it is possible to quickly identify the psychoactive designer drugs in 205 purchased products by using the library. Further, it is possible to analogize the structure of drugs for which there is no matching data in the library using similar data. Furthermore, when structural isomers of controlled substances have detected from the presented library, similarity of their biological effects on human will be predicted, thus leading to regulate their public circulation. Examples of these types of isomers include, for instance, the narcotic 3,4,5-trimethoxyamphetamine (TMA) and its positional isomers 2,4,5-trimethoxyamphetamine (TMA-2) and 2,4,6-trimethoxyamphetamine (TMA-6), or the narcotic 1-(3-chlorophenyl)piperazine (3CPP) and its isomers 1-(o-chlorophenyl)piperazine (2CPP) and 1-(p-chlorophenyl)piperazine (4CPP). Differentiation of these compounds is necessary in regulating them, and we report here the results of a study of a method to confirm these compounds using the present library.
