Phase I Trial of Escalating-dose Cisplatin with 5-fluorouracil and Concurrent Radiotherapy in Chinese Patients with Esophageal Cancer
| Autor: | Qiang, Lin, Xian-Shu, Gao, Xue-Ying, Qiao, Zhi-Guo, Zhou, Ping, Zhang, Kun, Chen, Yan-Nan, Zhao, Junichi, Asaumi |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2008 |
| Předmět: |
Adult
Male Antimetabolites Antineoplastic Dose-Response Relationship Drug Esophageal Neoplasms cisplatin Antineoplastic Agents Middle Aged Combined Modality Therapy esophageal neoplasm concurrent chemoradiotherapy Asian People Antineoplastic Combined Chemotherapy Protocols dose escalation Carcinoma Squamous Cell Humans Female 5-fluorouracil Fluorouracil neoplasms Aged |
| Zdroj: | Acta Medica Okayama. 62(1):37-44 |
| ISSN: | 0386-300X |
| Popis: | 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/m2 and concurrent 60 Gy CFR. MTD was defined as CDDP 52.5 mg/m2 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/m2 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. |
| Databáze: | OpenAIRE |
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