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A randomized phase II study of cisplatin/5-FU concurrent chemoradiotherapy for esophageal cancer: Short-term infusion vs protracted infusion chemotherapy (KROSG0101/JROSG021)
Radiotherapy and Oncology, 08/06/09
Nishimura Y et al. - In a trial to compare the toxicity and efficacy of combining short-term chemotherapy (CT) or protracted CT with radiotherapy (RT) for esophageal cancer, it was concluded that protracted infusion CT with RT provides no advantage over standard short-term infusion CT with RT for esophageal cancer.
Methods- Eligible pts were <75 yrs and with performance status (PS) of 0–2, and had stages II–IVA esophageal cancer.
- 2 cycles of cisplatin 70 mg/m2 for 1 day and 5-FU 700 mg/m2 for 5 days (arm A) or cisplatin 7 mg/m2 for 10 days and 5-FU 250 mg/m2 for 14 days (arm B) were given with RT of 60 Gy/30 fractions/7 wks (1-wk split).
- Of 91 pts enrolled, 46 were randomized to arm A and 45 to arm B.
- 2 cycles of CT were given concurrently with RT for 89% in arm A and for 71% in arm B with significant difference.
- 2- and 5-yr overall survival rates for arm A were 46% and 35%, while those for arm B were 44% and 24%, respectively, without significant difference.
- 2- and 5-yr progression-free survival rates for arm A were 30% and 30%, while those for arm B were 29% and 12%, respectively.
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