A phase I trial of topical topitriol (calcitriol, 1,25-dihydroxyvitamin D3) to prevent chemotherapy-induced alopecia
A phase I trial of topical topitriol (calcitriol, 1,25-dihydroxyvitamin D3) to prevent chemotherapy-induced alopecia
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DOI：
10.1097/00001813-199904000-00007
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发表时间：
1999-04-01
影响因子：
2.3
通讯作者：
Von Hoff, DD
中科院分区：
文献类型：
--
作者：
Hidalgo, M;Rinaldi, D;Von Hoff, DD
本研究评估了局部托吡醇（骨化三醇，1，25-二羟基维生素D-3）预防化疗诱导的脱发（CIA）的毒性和疗效。计划接受FAC化疗（5-氟尿嘧啶、阿霉素和环磷酰胺）的乳腺癌患者有资格参加本研究。最初，前六名患者以双盲方式随机接受托吡醇或安慰剂，所有随后的患者用托吡醇治疗，每天两次局部施用托吡醇乳膏（0.0025或0.005%; 25和50 μ g/g浓度）。评价了三种不同的给药剂量和时间表，包括：化疗前7天每天500和1000 μ g，化疗前5天和化疗后5天每天2000 μ g。14名患者接受了三种不同剂量水平的治疗（12名使用托吡醇，2名使用安慰剂）。所有患者在化疗后第20天至第30天发生2级脱发，表明在该给药方案下局部托吡醇缺乏预防CIA的功效。8例暴露于托吡醇的患者在暴露于药物的区域发生毒性斑丘疹性皮炎。总之，在本试验中评价的剂量和时间表的局部托吡醇对预防CIA无效，并在暴露于药物的区域诱导局部皮炎。[(C)1999 Lippincott威廉姆斯& Wilkins.]。
This study evaluated the toxicity and efficacy of topical topitriol (calcitriol, 1,25-dihydroxyvitamin D-3) to prevent chemotherapy-induced alopecia (CIA). Patients with breast cancer scheduled to receive FAC chemotherapy (5-fluorouracil, adriamycin and cyclophosphamide) were eligible for the study. Initially, the first six patients were randomized in a double-blind fashion to have received topitriol or placebo with all subsequent patients being treated with topitriol, Topitriol cream (0.0025 or 0.005%; 25 and 50 mu g/g concentration) was administered topically twice a day. Three different doses and schedules of administration were evaluated including: 500 and 1000 mu g daily for 7 days prior to chemotherapy, and 2000 mu g daily for 5 days prior and 5 days post-chemotherapy. Fourteen patients were treated (12 with topitriol and two with placebo) at three different dose levels. All patients developed grade 2 alopecia between day 20 and 30 after chemotherapy, demonstrating the lack of efficacy of topical topitriol on this schedule of administration to prevent CIA. Eight patients exposed to topitriol developed a toxic maculopapular dermatitis in areas exposed to the drug. In conclusion, topical topitriol at the doses and schedules evaluated in this trial was ineffective to prevent CIA and induced a local dermatitis in areas exposed to the drug. [(C) 1999 Lippincott Williams & Wilkins.].