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一项采用每周给药方案的马塞洛霉素I期试验。

A phase I trial of marcellomycin with a weekly dose schedule.

作者信息

Joss R A, Kaplan S, Goldhirsch A, Varini M, Brunner K W, Cavalli F

出版信息

Eur J Cancer Clin Oncol. 1983 Apr;19(4):455-9. doi: 10.1016/0277-5379(83)90106-2.

DOI:10.1016/0277-5379(83)90106-2
PMID:6683183
Abstract

Marcellomycin, a new anthracycline antibiotic, was administered intravenously on a weekly schedule to 22 patients with advanced malignant solid tumors. Patients were treated at 6 dosage levels ranging from 5 to 30 mg/m2 weekly for 4 weeks. Courses were repeated after a 3-week rest period. Hematologic toxicity was dose-limiting but unpredictable. Of 10 patients treated with weekly doses of 27.5 mg/m2, 3 patients exhibited myelosuppression and 2 died in agranulocytosis. Moderate to severe nausea and vomiting occurred in 19 of 22 evaluable patients. Other toxic effects were non-acute and consisted of mild stomatitis, diarrhea, phlebitis and moderate fatigue in 1-3 patients each. In 17 patients evaluable for antitumor activity no partial or complete responses occurred. One patient with advanced breast cancer showed a mixed response. Marcellomycin given on a weekly dose schedule has unpredictable and erratic hematologic toxicity. The maximally tolerated dose appears to be between 27.5 and 30 mg/m2 weekly. However, no firm recommendations can be given for a dose level that results in tolerable, predictable and reversible toxicity.

摘要

马塞洛霉素是一种新型蒽环类抗生素,以每周一次的给药方案静脉注射给22例晚期恶性实体瘤患者。患者接受6个剂量水平的治疗,每周剂量范围为5至30mg/m²,共4周。在3周的休息期后重复疗程。血液学毒性是剂量限制性的,但不可预测。在10例每周接受27.5mg/m²剂量治疗的患者中,3例出现骨髓抑制,2例死于粒细胞缺乏症。22例可评估患者中有19例出现中度至重度恶心和呕吐。其他毒性作用为非急性,分别有1 - 3例患者出现轻度口腔炎、腹泻、静脉炎和中度疲劳。在17例可评估抗肿瘤活性的患者中,未出现部分或完全缓解。1例晚期乳腺癌患者表现出混合反应。每周给药方案的马塞洛霉素具有不可预测且不稳定的血液学毒性。最大耐受剂量似乎在每周27.5至30mg/m²之间。然而,对于能产生可耐受、可预测且可逆毒性的剂量水平,无法给出确切建议。

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引用本文的文献

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Human pharmacokinetics of marcellomycin.马塞洛霉素的人体药代动力学。
Cancer Chemother Pharmacol. 1985;14(1):42-8. doi: 10.1007/BF00552724.
2
Comparative murine metabolism and disposition of class II anthracycline antibiotics.
Cancer Chemother Pharmacol. 1985;15(2):153-60. doi: 10.1007/BF00257527.
3
The mouse as a model for predicting the myelosuppressive effects of anticancer drugs.小鼠作为预测抗癌药物骨髓抑制作用的模型。
Cancer Chemother Pharmacol. 1986;16(3):243-6. doi: 10.1007/BF00293985.