1077: Concomitant Administration of Weekly Oxaliplatin, 5FU Continuous Infusion and Radiotherapy in Locally Advanced Pancreatic Cancer (LAPC): A Gercor Phase II Study

Abstract

According to previous GERCOR studies in LAPC, concomitant chemoradiation therapy (CCRT) is indicated for non-progressive patients (pts) after systemic chemotherapy (CT). In order to improve the results of a classical 5FU-based CCRT, this study was designed to assess the efficacy and toxicity of weekly oxaliplatin (Ox), 5FU continuous infusion (c.i.) and radiation therapy (RT) in LAPC pts. Eligibility criteria included non resectable pathologically-proven LAPC, age > 18 yrs, PS < 2, and no prior CT or RT. All patients were first treated with 4 cycles of GEMOX (gemcitabine 1000 mg/m2, 100 min IV, d1; Ox 100 mg/m2, 2h IV, d2, every 2 wk). One month after cycle 4, non-progressive pts with PS < 2 received 45 Gy (25 fractions, 5 d/wk) + 10 Gy (concomitant boost in macroscopic tumor during wks 4 & 5, six hours apart large volume irradiation), combined with 250 mg/m2/d 5FU c.i. and weekly Ox. Initial 50 mg/m2 Ox dose was increased to 60 mg/m2 in absence of unacceptable toxicity after the 3 first included pts. 60 pts were included (29 F/ 31 M, age 65.8 ± 9.6 yrs, range 37 - 80). 50 pts (83%) received CCRT, while 10 did not for the following reasons: metastatic progression (7 pts), OMS>2 (1), and CT toxicity (2). 44 pts (73 %) received the full planned CCRT dose-intensity. NCI-CTC grade 3-4 toxicities during CCRT and the following month (% of pts) were : neutropenia (14%), thrombocytopenia (10%), nausea-vomiting (20%), diarrhea (12%) and neuropathy (2%). 2 toxic deaths occurred during CCRT. With a median follow up of 15 mo, median progression-free survival (PFS) and overall survival (OS) of the whole population were 7.6 mo and 13.8 mo, respectively. For pts who received CCRT, median PFS and OS were 9.4 and 13.9 mo, respectively (2.6 and 9.9 mo, respectively, for pts who did not received CCRT). Chemotherapy before CCRT can identify pts who might potentially benefit of CCRT. Concomitant administration of weekly Ox, continuous IV FU and RT in LAPC is feasible with an acceptable toxicity. The results in terms of PFS and OS compare favourably with a classical 5FU-based CCRT.