ABSTRACT
PURPOSE: To determine the recommended dose and antitumor activity of single-agent elisidepsin as a 24-h intravenous (i.v.) infusion fortnightly [biweekly, d1 and 15 every 4 weeks (q4wk); Arm A, dose-intensity strategy] or as a 3-h i.v. infusion weekly (d1, 8, 15 and 22 q4wk; Arm B, dose-density strategy) in adult patients with unresectable, locally advanced or metastatic pretreated esophageal, gastroesophageal junction and gastric cancer. METHODS: Patients were randomized to one of two elisidepsin dosing schedules. Phase Ib starting doses were 8.0 mg flat dose (FD) in Arm A and 3.0 mg FD in Arm B. Phase II subsequently explored antitumor activity of both dosing schedules at the respective recommended doses. RESULTS: Forty-four patients received elisidepsin: 12 in stage Ib and 32 in stage II. The recommended doses were defined as 10 mg FD (Arm A) and 3.75 mg FD (Arm B). Both schedules were well tolerated. Most adverse events were mild or moderate, reversible and predictable with no meaningful differences between schedules. The pharmacokinetic profiles of both schedules were similar to those reported previously in patients with solid tumors treated with a comparable dose. An interim analysis found tumor control in one patient receiving elisidepsin fortnightly, and in none given elisidepsin weekly; patient accrual was therefore discontinued due to lack of efficacy. CONCLUSIONS: Both schedules at the recommended doses presented an acceptable safety profile, but lack of response means that we do not recommend further evaluation of single-agent elisidepsin as chemotherapy for unresectable, locally advanced or metastatic gastroesophageal cancer.
Subject(s)
Antineoplastic Agents/therapeutic use , Depsipeptides/therapeutic use , Esophageal Neoplasms/drug therapy , Esophagogastric Junction , Stomach Neoplasms/drug therapy , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/adverse effects , Antineoplastic Agents/pharmacokinetics , Depsipeptides/adverse effects , Depsipeptides/pharmacokinetics , Female , Humans , Male , Middle Aged , Neoplasm MetastasisABSTRACT
La automatización de la información médica es una meta que representa enormes ventajas para losprofesionales de la salud, los pacientes, y el Estado. La transformación de las historias clínicas de lospacientes de su formato tradicional, en copia de papel, a uno electrónico, constituye un eslabón fundamental dentro de esta tarea; sin embargo, la implementación de dichas historias es aún unaquimera. La mayor parte de las instituciones de salud en el mundo alcanzan un Nivel 1, acorde a losconceptos establecidos por el Instituto de Medicina de los Estados Unidos, mundialmente aceptados, y solo unas pocas instituciones con gran desarrollo, logran alcanzar un Nivel 3.Este trabajo propone una vía para lograr un sistema de historias clínicas electrónicas en nuestro país. Sebrindan las distintas etapas para alcanzar su aplicación de una forma gradual, económica y eficiente,dentro del Sistema Nacional de Salud, lo que le permitiría colocarse en un nivel intermedio deautomatización de las historias clínicas, con todas las facilidades que implicaría(AU)
