Weekly gemcitabine (100 mg/m2) was given as a 24-hour infusion during the course of three-dimensional radiotherapy (50.4 Gy to the tumor, 39.6 Gy to the nodes). After CT-RT, pts received five cycles of sequential chemotherapy with gemcitabine (1000 mg/m2; 1, 8, q21). Response rate was assessed according to World Health Organization criteria 6 weeks after the end of CT-RT. Local control (LC), time to progression (TTP), metastases-free survival (MFS), and overall survival (OS) were analyzed by the Kaplan Meier method.
Forty pts (male/female 22/18; median age 62 years, range, 36–76) were treated from 2000 to 2005. The majority had T4 tumour (n = 34, 85 % ), six pts (15 % ) had T3 tumour. Sixteen pts (40 % ) were node positive at diagnosis. Grade 3–4 acute toxicity was observed in 21 pts (52.5 % ). Thirty pts (75 % ) completed the treatment schedule. A clinical response was achieved in 12 pts (30 % ). With a median follow-up of 76 months (range, 32–98), 2-year LC was 39.6 % (median, 12 months), 2-year TTP was 18.4 % (median, 10 months), and 2-year MFS was 29.7 % (median, 10 months). Two-year OS (25 % ; median, 15.5 months) compared with our previous study on 5-fluorouracil-based CT-RT (2.8 % ) was significantly improved (p <0.001).
Gemcitabine CT-RT seems correlated with improved outcomes. Healthier patients who are likely to complete the treatment schedule may benefit most from this therapy.