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| 评价莫特沙芬治疗进展性或症状性转移性甲状腺髓样癌晚期患者的安全性与疗效的II期试验 |
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| Phase II Study of Safety and Efficacy of Motesanib in Patients With Progressive or Symptomatic, Advanced of Metastatic Medullary Thyroid Cancer |
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| Schlumberger MJ, Elisei R, Bastholt L 2010/5/24 16:42:14 |
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| J Clin Oncol, 2009, |
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| View at Publisher |
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Purpose:
This phase II study investigated the efficacy and tolerability of motesanib, an investigational, highly selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3; platelet-derived growth factor receptor; and Kit in advanced medullary thyroid cancer (MTC).
Patients and Methods:
Patients with locally advanced or metastatic, progressive or symptomatic MTC received motesanib 125mg/d orally for up to 48 weeks or until unacceptable toxicity or disease progression. The primary end point was objective response by independent review. Other end points included duration of response, progression-free survival, safety, pharmacokinetics, and changes in tumor markers.
Results:
Of 91 enrolled patients who received motesanib, two (2%) achieved objective response (95% CI, 0.3% to 7.7%); their duration of response was 32 weeks (censored) and 21 weeks (disease progressed). Eighty-one percent of patients had stable disease (48% had durable stable disease ≥ 24 weeks), 8% had disease progression as best response, and 9% were not evaluated; 76% experienced a decrease from baseline in target lesion measurement. Median progression-free survival was 48 weeks (95% CI, 43 to 56 weeks). Among patients with tumor marker analysis, 69 (83%) of 83 and 63 (75%) of 84 had decreased serum calcitonin and carcinoembryonic antigen during treatment, respectively, compared with baseline. The most common treatment-related adverse events were diarrhea (41%), fatigue (41%), hypothyroidism (29%), hypertension (27%), and anorexia (27%). In pharmacokinetic analyses, motesanib trough concentrations were lower compared with differentiated thyroid cancer patients from the same study.
Conclusion:
Although the objective response rate was low, a significant proportion of MTC patients (81%) achieved stable disease while receiving motesanib. |
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 疾病资源中心
病例分析 [栏目介绍]
摘自：《西氏内科学》，第23版
患者男性，36岁，幼年有吸入性肺损伤史，因呼吸急促和精神状态改变来我院就诊。患者睡眠和运动时，吸氧流量基值为2 L/min，每天均进行肺功能康复训练。患者居住在美国中西部，入院5天前曾离家乘船来这里看望其兄弟。入院前一天，患者呼吸急促加剧，自觉发热并注意到其慢性咳嗽稍加重，但痰液无变化。当天晚上，家人注意到患者更加急躁并有点偏执。由于症状加重，患者于次日送我院就诊。
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