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卡铂每日给药5天的I期临床和药理学试验。

Phase I clinical and pharmacologic trial of carboplatin daily for 5 days.

作者信息

Van Echo D A, Egorin M J, Whitacre M Y, Olman E A, Aisner J

出版信息

Cancer Treat Rep. 1984 Sep;68(9):1103-14.

PMID:6383605
Abstract

Twenty-two patients with refractory tumors received 64 courses of iv bolus carboplatin every day X 5, every 4-5 weeks. All patients are evaluable for toxicity and 18 are evaluable for response. For solid tumor phase II studies, a dose of 77 mg/m2/day X 5 is recommended for patients who have received prior chemotherapy. Patients with no prior chemotherapy experience should receive 99 mg/m2/day X 5. The major dose-limiting side effect is dose-related thrombocytopenia. Courses of carboplatin on this schedule should be repeated every 5 weeks to avoid cumulative wbc count toxicity, since leukopenia frequently did not occur until Day 28. Other toxic effects observed were nausea and vomiting and lower-extremity myalgias and arthralgias. There was no evidence of hearing loss, mucosal damage, or changes in liver or renal function tests of any patient while in this study. Therapeutic responses were seen in four patients: one partial response in renal cancer of 9+ months' duration; one partial response in head and neck cancer of 7+ months' duration; and objective responses in melanoma and colorectal carcinoma of 6 months' duration.

摘要

22例难治性肿瘤患者接受了64个疗程的静脉推注卡铂治疗,每天一次,每次剂量为X 5,每4 - 5周重复一次。所有患者均可评估毒性,18例可评估疗效。对于实体瘤II期研究,对于既往接受过化疗的患者,推荐剂量为77 mg/m²/天×5天;无既往化疗经验的患者应接受99 mg/m²/天×5天。主要的剂量限制性副作用是与剂量相关的血小板减少。按照此方案的卡铂疗程应每5周重复一次,以避免白细胞计数累积毒性,因为白细胞减少通常直到第28天才会出现。观察到的其他毒性反应有恶心、呕吐以及下肢肌痛和关节痛。在本研究中,没有任何患者出现听力丧失、黏膜损伤或肝肾功能检查异常的证据。4例患者出现治疗反应:1例肾癌部分缓解,持续9个多月;1例头颈癌部分缓解,持续7个多月;1例黑色素瘤和1例结直肠癌出现客观缓解,持续6个月。

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