Single agent activity of rhizoxin in non-small-cell lung cancer: a phase II trial of the EORTC Early Clinical Trials Group.
Single agent activity of rhizoxin in non-small-cell lung cancer: a phase II trial of the EORTC Early Clinical Trials Group.
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根蛋白毒素在非小细胞肺癌中的单药活性：EORTC早期临床试验组的II期试验。
DOI：
10.1038/bjc.1996.70
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发表时间：
1996-02
影响因子：
8.8
通讯作者：
Verweij, J
中科院分区：
文献类型：
--
作者：
Kaplan, S;Hanauske, A R;Pavlidis, N;Bruntsch, U;te Velde, A;Wanders, J;Heinrich, B;Verweij, J
在EORTC-早期临床试验组（ECTG）的一项多中心试验中，我们用一种新型微管蛋白结合剂rhizoxin治疗了31例未经化疗的晚期非小细胞肺癌（NSCLC）患者。该药物在门诊患者中以2 mg m-2静脉推注给药，每3周一次。未常规给予预防性止吐药。在29名符合条件的患者中，9名接受了手术治疗，3名接受了放射治疗。观察到的主要毒性反应为口腔炎（34%的周期）和中性粒细胞减少症（41%的周期）。中性粒细胞减少性发热罕见（3%的周期）。27例患者可评价缓解。有4名患者（15%）部分缓解，13名患者（48%）病情稳定。反应的中位持续时间为7个月（范围6.0-10.7个月），从根霉素治疗开始的中位生存期为6个月（范围2-14.7个月）。Rhizoxin作为单药在晚期NSCLC患者中显示出活性。
In a multicentre trial of the EORTC-Early Clinical Trials Group (ECTG) we treated 31 chemotherapy-naive patients with advanced non-small-cell lung cancer (NSCLC) with rhizoxin, a novel tubulin-binding agent. The drug was given as an i.v. bolus injection at 2 mg m-2 once every 3 weeks in an outpatient setting. Prophylactic antiemetics were not routinely given. Of the 29 eligible patients, nine had been treated surgically and three had received radiotherapy. The main toxic effects observed were stomatitis (34% of cycles) and neutropenia (41% of cycles). Neutropenic fever was rare (3% of cycles). Twenty-seven patients were evaluable for response. There were four partial responses (15%), while 13 patients (48%) showed stabilisation of their disease. The median duration of response was 7 months (range 6.0-10.7 months) and median survival from the start of rhizoxin treatment was 6 months (range 2-14.7 months). Rhizoxin as single agent shows activity in patients with advanced NSCLC.