Capecitabine in combination with preoperative radiation therapy in locally advanced, resectable, rectal cancer: a multicentric phase II study.

De Paoli, A; Chiara, S; Luppi, G; Friso, M L; Beretta, G D; Del Prete, S; Pasetto, L; Santantonio, M; Sarti, E; Mantello, G; Innocente, R; Frustaci, S; Corvò, R; Rosso, R

De Paoli, A; Chiara, S; Luppi, G; Friso, M L; Beretta, G D; Del Prete, S; Pasetto, L; Santantonio, M; Sarti, E; Mantello, G; Innocente, R; Frustaci, S; Corvò, R; Rosso, R.

Afiliación

De Paoli A; Department of Radiation Oncology, C.R.O. - National Cancer Institute, Aviano, Italy. adepaoli@cro.it

Ann Oncol ; 17(2): 246-51, 2006 Feb.

Article en En | MEDLINE | ID: mdl-16282246

RESUMEN

BACKGROUND: The aim of the study was to evaluate tolerance and efficacy of preoperative treatment with capecitabine in combination with radiation therapy (RT) in patients with locally advanced, resectable, rectal cancer. PATIENTS AND METHODS: Fifty-three patients with potentially resectable T3, N0-2 (87%) and T4, N0-2 (13%) rectal cancer were treated with capecitabine (825 mg/m2, twice daily for 7 days/week) and concomitant RT (50.4 Gy/28 fractions). Patients underwent surgery after 6-8 weeks followed, upon physician's indications, by 4-months adjuvant capecitabine. The primary end point was to determine the rate of pathologic complete response. Secondary end points were to assess the rate of clinical response and the safety profile. RESULTS: All patients but two completed the RT programme and 47 (89%) received 81%-100% of the capecitabine dose (100% of dose in 72% patients, 81%-95% in 17% patients and 48%-74% in 11% of patients). No patient had grade 4 toxicity. Grade 3 toxicity occurred in six patients (11%) and consisted mainly of leucopenia (4%) and hand-foot syndrome (4%). Mild or moderate toxicity was common and included leucopenia (72%), diarrhea (40%), proctitis (34%) and skin toxicity (20%). The overall clinical response rate was 58% and the downstaging rate was 57%, with a pathologic complete response rate of 24%. Among 34 patients with low-lying tumors (

Asunto(s)

Antimetabolitos Antineoplásicos/uso terapéutico; Desoxicitidina/análogos & derivados; Fluorouracilo/análogos & derivados; Neoplasias del Recto/tratamiento farmacológico; Administración Oral; Adulto; Anciano; Anciano de 80 o más Años; Antimetabolitos Antineoplásicos/administración & dosificación; Capecitabina; Terapia Combinada; Desoxicitidina/administración & dosificación; Desoxicitidina/uso terapéutico; Femenino; Fluorouracilo/administración & dosificación; Fluorouracilo/uso terapéutico; Humanos; Masculino; Persona de Mediana Edad; Cooperación del Paciente; Cuidados Preoperatorios; Neoplasias del Recto/radioterapia; Neoplasias del Recto/cirugía

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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias del Recto / Desoxicitidina / Fluorouracilo / Antimetabolitos Antineoplásicos Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2006 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Reino Unido

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