Phase I-II trial of concurrent capecitabine and oxaliplatin with preoperative intensity-modulated radiotherapy in patients with locally advanced rectal cancer.
Aristu JJ, Arbea L, Rodriguez J, Hernández-Lizoain JL, Sola JJ, Moreno M, Azcona JD, Díaz-González JA, García-Foncillas JM, Martínez-Monge R.
Service of Radiation Oncology, Department of Oncology, Clínica Universitaria, University of Navarre, Pamplona, Spain
Revista: International Journal of Radiation Oncology
Fecha: 01-jul-2008Oncología Médica Anatomía Patológica Oncología Radioterápica Cirugía General y Digestiva Área de Tumores de Tubo Digestivo
To identify the maximal tolerated dose level of preoperative intensity-modulated radiotherapy combined with capecitabine and oxaliplatin and to evaluate the efficacy.
PATIENTS AND METHODS
Patients with rectal T3-T4 and/or N0-N+ rectal cancer received capecitabine 825 mg/m(2) twice daily Monday through Friday and oxaliplatin 60 mg/m(2) intravenously on Days 1, 8, and 15, concurrently with intensity-modulated radiotherapy. The radiation dose was increased in 5.0-Gy steps in cohorts of 3 patients starting from 37.5 Gy in 15 fractions (dose level [DL] 1). DL2 and DL3 were designed to reach 42.5 Gy in 17 fractions and 47.5 Gy in 19 fractions, respectively.
No dose-limiting toxicity was observed at DL1 or DL2. Of the 3 patients treated at DL3, 1 presented with Grade 3 diarrhea, which was considered a dose-limiting toxicity, and 3 additional patients were added. Of the 6 patients treated at DL3, no new dose-limiting toxicities were observed, and DL3 was identified as the recommended dose in this study. Eight additional patients were treated at 47.5 Gy. Grade 2 proctitis was the most frequent adverse event (40%); Grade 3 diarrhea occurred in 2 patients (10%). All patients underwent surgery, and 17 patients (85%) underwent R0 resection. Four patients (20%) presented with a histologic response of Grade 4, 11 (55%) with Grade 3+, 2 (15%) with Grade 3, and 2 patients (10%) with Grade 2.
The maximal tolerated dose in this study was 47.5 Gy. The high rates of pathologic response of Grade 3+ and 4 must be confirmed through the accrual of new patients in the Phase II study.
CITA DEL ARTÍCULO Int J Radiat Oncol Biol Phys. 2008 Jul 1;71(3):748-55
tal vezLE INTERESE
La Clínica es el hospital privado con mayor dotación tecnológica de España, todo en un único centro.
Los profesionales de la Clínica realizan una labor continuada de investigación y formación, siempre en beneficio del paciente.
Conozca por qué somos diferentes a otros centros sanitarios. Calidad, rapidez, comodidad y resultados.