TAXOL - A UNIQUE ANTINEOPLASTIC AGENT WITH SIGNIFICANT ACTIVITY IN ADVANCED OVARIAN EPITHELIAL NEOPLASMS
TAXOL - A UNIQUE ANTINEOPLASTIC AGENT WITH SIGNIFICANT ACTIVITY IN ADVANCED OVARIAN EPITHELIAL NEOPLASMS
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DOI：
10.7326/0003-4819-111-4-273
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发表时间：
1989-08-15
影响因子：
39.2
通讯作者：
DONEHOWER, RC
中科院分区：
文献类型：
--
作者：
MCGUIRE, WP;ROWINSKY, EK;DONEHOWER, RC
研究目的：评估紫杉醇在晚期、进展性和难治性卵巢癌患者中的活性，并更清楚地描述紫杉醇在这类患者群体中的毒性。设计：非随机、前瞻性II期试验。患者：47例药物难治性上皮性卵巢癌患者，有一个或多个垂直直径可测量的病变。在这些患者中，45例可评估毒性，40例可评估反应。干预措施：患者每22天接受不同剂量的紫杉醇（110至250mg /m2体表）24小时输注，并根据不良反应进行后续剂量治疗。采用药物前治疗方案以避免急性过敏反应。测量和主要结果：12例患者（30%；CI， 16%至44%）对紫杉醇有反应，持续时间为3至15个月。剂量限制性毒性是骨髓抑制，与血小板或网织细胞相比，白细胞受到的影响更为严重和普遍。白细胞减少通常持续时间短，但有3例与败血症相关（2例死亡）。其他不良反应包括肌痛、关节痛、脱发、腹泻、恶心、呕吐、粘膜炎和周围神经病变。罕见的心脏和中枢神经毒性病例也被注意到。结论：紫杉醇是一种治疗难治性卵巢癌的活性药物，值得进一步研究紫杉醇与其他活性药物联合治疗未治疗的晚期卵巢癌。
Study Objective: To assess the activity of taxol in patients with advanced, progressive, and drug-refractory ovarian cancer and to delineate more clearly the toxicity of taxol in this patient population. Design: Nonrandomized, prospective phase II trial. Patients: Forty-seven patients with drug-refractory epithelial ovarian cancer who had one or more lesions measurable in perpendicular diameters. Of these patients, 45 were evaluable for toxicity and 40 were evaluable for response. Interventions: Patients were treated every 22 days with varying doses of taxol (110 to 250 mg/m2 body surface) given as a 24-hour infusion with subsequent doses based on adverse effects. A premedication regimen was used to avoid acute hypersensitivity reactions. Measurements and Main Results: Twelve patients (30%; CI, 16% to 44%) responded to taxol for periods lasting from 3 to 15 months. The dose-limiting toxicity was myelosuppression with leukocytes affected more severely and commonly than thrombocytes or reticulocytes. Leukopenia was usually brief in duration but was associated with sepsis in 3 cases (2 fatal). Other adverse effects included myalgias, arthralgias, alopecia, diarrhea, nausea, vomiting, mucositis, and peripheral neuropathy. Rare cases of cardiac and central neurotoxicity were also noted. Conclusions: Taxol is an activ eagent in drug-refractory ovarian cancer and deserves further study in combination with other active drugs in previously untreated patients with advanced ovarian cancer.