Carbon-ion radiotherapy with concurrent gemcitabine for patients with locally advanced pancreatic cancer
Menée sur 76 patients atteints d'un carcinome canalaire invasif du pancréas sans métastase et non résécable, cette étude évalue les doses maximales tolérées de gemcitabine et de rayonnements par ions carbone délivrés de manière concomitante, puis évalue l'efficacité du traitement du point de vue du taux de survie globale à deux ans
Purpose : The aim of this study was to determine the maximum tolerated dose of carbon-ion radiotherapy (C-ion RT) and gemcitabine dose delivered concurrently and to estimate local effect and survival. Methods and Materials : Eligibility included pathological confirmation of pancreatic invasive ductal carcinomas and radiographically unresectable disease without metastasis. Concurrent gemcitabine was administered on days 1, 8, and 15, and the dose levels were escalated from 400 to 1000 mg/m2 under the starting dose level (43.2 GyE) of C-ion RT. The dose levels of C-ion RT were escalated from 43.2 to 55.2 GyE at 12 fractions under the fixed recommended gemcitabine dose determined. Results : Seventy-six patients were enrolled. Among the 72 treated patients, dose-limiting toxicity was observed in three patients: grade 3 infection in one patient and grade 4 neutropenia in two patients. Only one patient experienced a late grade 3 gastric ulcer and bleeding 10 months after C-ion RT. The recommended dose of gemcitabine with C-ion RT was found to be 1000 mg/m2. The dose of C-ion RT with the full dose of gemcitabine (1000 mg/m2) was safely increased to 55.2 GyE. The freedom from local progression rate was 83% at 2 yrs using the RECIST criteria. The 2-year overall survival rates in all patients and in the high-dose group with stage III (≥ 45.6 GyE) were 35% and 48%, respectively. Conclusions : C-ion RT with concurrent full-dose gemcitabine was well tolerated and effective in patients with unresectable locally advanced pancreatic cancer.