期刊
ANNALS OF ONCOLOGY
卷 19, 期 9, 页码 1592-1599出版社
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mdn281
关键词
chemoradiotherapy; 5-fluorouracil; cisplatin; gemcitabine; maintenance; overall survival; pancreatic cancer; randomized phase III trial
类别
Background: The role of chemoradiation with systemic chemotherapy compared with chemotherapy alone in locally advanced pancreatic cancer (LAPC) is uncertain. Patients and methods: One hundred and nineteen patients with LAPC, World Health Organization performance status of zero to two were randomly assigned to either the induction CHRT group (60 Gy, 2 Gy/fraction; concomitant 5-fluorouracil infusion, 300 mg/m(2)/day, days 1-5 for 6 weeks; cisplatin, 20 mg/m(2)/day, days 1-5 during weeks 1 and 5) or the induction gemcitabine group (GEM: 1000 mg/ m(2) weekly for 7 weeks). Maintenance gemcitabine (1000 mg/ m(2) weekly, 3/4 weeks) was given in both arms until disease progression or toxicity. Results: Overall survival was shorter in the CHRT than in GEM arm [median survival 8.6 (99% confidence interval 7.1-11.4) and 13 months (8.7-18.1), P = 0.03]. One-year survival was, respectively, 32% and 53%. These results were confirmed in a per-protocol analysis for patients who received 75% or more of the planned dose of radiotherapy. More overall grades 3-4 toxic effects were recorded in the CHRT arm, both during induction (36 versus 22%) and maintenance (32 versus 18%). Conclusion: This intensive induction schedule of CHRT was more toxic and less effective than gemcitabine alone.
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