• Nicolas Girard, Françoise Mornex, Nadine Bossard, Marc Ychou, Bruno Chauffert, and Virginie Wautot.
• Department of Radiotherapy-Oncology, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Lyon, France.
• Int. J. Radiat. Oncol. Biol. Phys. 2010 Aug 1; 77 (5): 1426-32.

PurposeTo accurately determine the maximal tolerated dose, feasibility, and antitumor activity of concurrent chemoradiotherapy including twice-weekly gemcitabine in patients with unresectable pancreatic adenocarcinoma.Methods And MaterialsEligible patients with histologically proven adenocarcinoma of the pancreas were included in this Phase I trial. Radiotherapy was delivered to a total dose of 50 Gy. Concurrent chemotherapy with twice-weekly gemcitabine was administered during the 5 weeks of radiotherapy, from an initial dose of 30 mg/m(2). The gemcitabine doses were escalated in 10-mg/m(2) increments in a three-plus-three design, until dose-limiting toxicities were observed.ResultsA total of 35 patients were included in the trial. The feasibility of chemoradiotherapy was high, because all the patients received the planned total radiation dose, and 26 patients (74%) received > or = 70% of the planned chemotherapy dose. The mean total delivered dose of gemcitabine was 417 mg/m(2) (i.e., 77% of the prescribed dose). The maximal tolerated dose of twice-weekly gemcitabine was 70 mg/m(2). Of the 35 patients, 13 had a partial response (37%) and 21 had stable disease (60%). Overall, the median survival and the 6-, 12-, and 18-month survival rates were 10.6 months and 82%, 31%, and 11%, respectively. Survival was significantly longer in patients with an initial performance status of 0 or 1 (p = .004).ConclusionOur mature data have indicated that gemcitabine doses can be increased < or = 70 mg/m(2), when delivered twice-weekly with concurrent radiotherapy. This combination shows promises to achieve better recurrence-free and overall survival. These results will serve as a basis for further implementation of the multimodal treatment of locally advanced pancreatic carcinoma.Copyright 2010 Elsevier Inc. All rights reserved.

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