Phase I trial of escalating-dose cisplatin with 5-fluorouracil and concurrent radiotherapy in Chinese patients with esophageal cancer

Qiang Lin, Xian Shu Gao, Xue Ying Qiao, Zhi Guo Zhou, Ping Zhang, Kun Chen, Yan Nan Zhao, Junichi Asaumi

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15 Citations (Scopus)

Abstract

We defined the maximum-tolerated dose (MTD) of chemoradiotherapy (cisplatin (CDDP) with 5-fluorouracil (5-FU) and concurrent chemoradiotherapy) for Chinese patients with esophageal cancer. Twenty-one previously untreated patients with primary esophageal cancer were entered into this study. Escalating doses of CDDP with 5-FU were administered in a modified Fibonacci sequence, with concurrent conventional fractionation radiotherapy (CFR) of 60 Gy or 50 Gy. The starting doses were CDDP 37.5 mg/m2 on day 1, and 5-FU 500 mg/m2 on days 1-5, respectively. The regimen was repeated 4 times every 28 days. If no dose-limiting toxicity (DLT) was observed, the next dose level was applied. The procedures were repeated until DLT appeared. The MTD was declared to be 1 dose level below the level at which DLT appeared. DLT was grade 3 radiation-induced esophagitis at a dose level of CDDP 60 mg/m2 with 5-FU 700 mg/m 2 and concurrent 60 Gy CFR. MTD was defined as CDDP 52.5 mg/m 2 with 5-FU 700 mg/m2 and concurrent 50 Gy CFR. The MTD of CDDP with 5-FU and in concurrent chemoradiotherapy for Chinese patients with esophageal cancer is CDDP 52.5 mg/m2 on day 1 and 5FU 700 mg/m 2 on days 1-5, repeated 4 times every 28 days, and concurrent 50 Gy CFR. Further evaluation of this regimen in a prospective phase II trial is ongoing. Copyright

Original languageEnglish
Pages (from-to)37-44
Number of pages8
JournalActa medica Okayama
Volume62
Issue number1
Publication statusPublished - Feb 1 2008

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Keywords

  • 5-fluorouracil
  • Cisplatin
  • Concurrent chemoradiotherapy
  • Dose escalation
  • Esophageal neoplasm

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

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