BACKGROUND: This study sought to determine the feasibility and recommended phase 2 dose (RP2D) of the combination of cetuximab with chemoradiotherapy based on 5-fluorouracil (5-FU) and cisplatin (CP) in locally advanced anal canal carcinoma. METHODS: Cetuximab was administered on days 1,8,15, 29, 36, 43, and 50 (400 mg/m 2 initial dose, then 250 mg/m 2 /week) concurrent with total dose radiation of 55 to 59 Gy, both starting on day 1. Escalating doses of 5-FU (96-hour infusion) and CP (2-hour infusion), both on days 1 and 29, were administered according to the following design: starting dose level (0) 5-FU/CP 5 800/60 mg/m 2 /day and up to dose level (12) 5-FU/CP 5 1000/80 mg/m 2 /day. RESULTS: Dose-limiting toxicity (DLT) events (uncontrolled diarrhea or febrile neutropenia) occurred in 3 of 14 assessable patients receiving escalated dose of 5-FU/CP, with 1 in dose level (0) and 2 in dose level (12). The RP2D was 5-FU/CP 5 800/80 mg/m 2 /day. Because of unexpected non-DLT treatment-related grade 3 (G3) adverse events (AEs) such as thrombosis/embolism, syncope, and infection occurring in 20% of patients, a safety expansion cohort with an additional 9 patients was investigated with the RP2D. The most frequent G3/G4 AEs evaluated in 23 patients were radiation dermatitis (12 patients), diarrhea (10 patients), thrombosis/embolism (6 patients), and infection (5 patients). The study was closed due to these severe AEs, although no G5 AEs occurred. Twenty of 21 patients (95%) achieved pathological complete response at primary tumor. With a median follow-up of 43.4 months, the 3-year locoregional control rate was 64.2%. CONCLUSIONS: Cetuximab could not be integrated with chemoradiotherapy-cisplatin-based therapy due to the high toxicity rate. However, efficacy is encouraging and further investigation of an epidermal growth factor receptor-targeted agent (other than cetuximab) concurrent with chemoradiation should be pursued. Cancer 2013;119:2973-80.
OBJETIVO: Descrever os achados tomográficos do tumor estromal gastrintestinal de origem gástrica. MATERIAIS E MÉTODOS: No período de janeiro de 1999 a dezembro de 2006, foram selecionados 14 pacientes com diagnóstico histopatológico e imuno-histoquímico de tumor estromal gastrintestinal gástrico que apresentavam tomografia computadorizada realizada anteriormente ao tratamento. As variáveis tomográficas analisadas foram: topografia da lesão, dimensões, homogeneidade, contornos, limites, morfologia, padrão e intensidade do realce pelo meio de contraste venoso, padrão de crescimento, invasão de órgãos adjacentes, presença de ulceração, fístula, calcificações, infiltração da gordura mesentérica, linfonodomegalias e metástases a distância. RESULTADOS: Os tumores foram localizados no corpo (57,1%) ou fundo gástrico (42,9%), com dimensões variando entre 6,0 e 23,0 cm (média de 11,5 cm). O crescimento foi predominantemente extraluminal (57,1%) ou intra/extraluminal (35,7%). O realce pelo contraste venoso foi discreto em 50% dos casos, moderado em 50% e heterogêneo em 64,3%. Foram ainda observadas hipodensidade central em 64,3% dos casos, invasão de órgãos adjacentes em 42,9% e metástases hepáticas em 7,2%. CONCLUSÃO: No presente estudo, a maioria dos tumores localizava-se no corpo gástrico, com tamanho médio de 11,5 cm, apresentando área hipodensa central, realce heterogêneo pelo meio de contraste e crescimento predominantemente extraluminal.
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