Fenretinide (4‐HPR) in chemoprevention of oral leukoplakia
Fenretinide (4‐HPR) in chemoprevention of oral leukoplakia
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DOI：
10.1002/jcb.240531038
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发表时间：
1993
影响因子：
4
通讯作者：
F. Chiesa;N. Tradati;M. Marazza;N. Rossi;P. Boracchi;L. Mariani;F. Formelli;R. Giardini;Alberto Costa;G. D. de Palo;U. Veronesi
中科院分区：
文献类型：
--
作者：
F. Chiesa;N. Tradati;M. Marazza;N. Rossi;P. Boracchi;L. Mariani;F. Formelli;R. Giardini;Alberto Costa;G. D. de Palo;U. Veronesi
自1988年以来，米兰的Istituto Nazionale Tumori（INT）一直在进行对照临床试验。该试验的目的是评估芬维A胺（4-HPR）在预防口腔白斑手术治疗的良性术后诊断患者复发，新定位和癌症方面的有效性。本文介绍了这项研究的设计和初步结果。迄今为止，137例患者在口腔白斑手术切除后随机接受200 mg 4‐HPR每日一次治疗52周或不进行干预。到目前为止，对照组发生了20例局部复发或新的局部化，4-HPR组发生了9例。7名患者因毒性而中断干预。未观察到暗适应受损。我们的结论是，4-HPR耐受性良好，似乎在治疗期间有效预防复发和新的局部化。
A controlled clinical trial has been underway at the Istituto Nazionale Tumori (INT) of Milan since 1988. The goal of the trial is to evaluate the effectiveness of fenretinide (4‐HPR) in preventing relapses, new localizations, and carcinomas in patients with benign postoperative diagnoses who have been surgically treated for oral leukoplakias. This paper presents the design and the preliminary results of this study. To date, 137 patients have been randomized, following surgical excision of oral leukoplakia, to receive either 200 mg 4‐HPR daily for 52 weeks or no intervention. Twenty local relapses or new localizations have occurred so far in the control group and 9 in the 4‐HPR group. Seven patients have interrupted the intervention because of toxicity. No impaired dark adaptation has been observed. We conclude that 4‐HPR is well‐tolerated and appears to be effective in preventing relapses and new localizations during the treatment period.