Phase II study of 9-nitro-camptothecin in patients with advanced chordoma or soft tissue sarcoma
Phase II study of 9-nitro-camptothecin in patients with advanced chordoma or soft tissue sarcoma
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DOI：
10.1200/jco.2005.02.170
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发表时间：
2005-05-20
影响因子：
45.3
通讯作者：
Baker, LH
中科院分区：
文献类型：
--
作者：
Chugh, R;Dunn, R;Baker, LH
本试验的目的是评估9-硝基喜树碱（9-NC）治疗晚期脊索瘤、软组织肉瘤（STS）和胃肠道间质瘤（GIST）患者的客观临床反应、毒性和进展时间。患者和方法局部晚期和/或转移性脊索瘤、STS或GIST患者接受9-NC 1.25 mg/m(2)口服，连续5天，然后休息2天。患者继续接受治疗，直到疾病进展、无法控制的毒性或撤回同意。结果2000年1月至2003年5月共纳入51例（脊索瘤5例，STS 23例，GIST 13例）。1例脊索瘤患者（7%）和1例STS患者（4%）有客观反应。脊索瘤、STS和GIST患者的中位进展时间分别为9.9、8.0和8.3周。脊索瘤患者的3个月和6个月无进展生存率分别为47%和33%，STS患者为26%和22%，GIST患者为31%和23%。常见的不良事件包括贫血（42例，7例为3/4级毒性）、毒性。白细胞减少（33例，9例3/4级毒性），疲劳（30例，3例3/4级毒性），恶心（34例，6例3/4级毒性），腹泻（28例，5例3/4级毒性）。结论9-NC对不可切除或转移性脊索瘤有一定的延缓进展作用。9-NC与中度毒性相关，在晚期STS和GIST患者中几乎没有益处。(c) 2005年由美国临床肿瘤学会出版。
Purpose The purpose of this trial was to assess the objective clinical response, toxicity, and time to progression of treatment with 9-Nitro-Camptothecin (9-NC) in patients with advanced chordoma, soft tissue sarcoma (STS), and gastrointestinal stromal tumor (GIST).Patients and Methods Patients with locally advanced and/or metastatic chordoma, STS, or GIST received 9-NC 1.25 mg/m(2) orally for 5 consecutive days followed by 2 days of rest. Patients continued on therapy until disease progression, uncontrollable toxicity, or withdrawal of consent.Results From January 2000 to May 2003, 51 patients 0 5 chordoma, 23 STS, 13 GIST patients) enrolled. One patient (7%) with chordoma and one patient (4%) with STS had an objective response. Median time to progression was 9.9, 8.0, and 8.3 weeks for chordoma, STS, and GIST patients, respectively. Three- and 6-month progression-free survival rates were 47% and 33% for chordoma patients, 26% and 22% for STS patients, and 31% and 23% for GIST patients, respectively. Ten patients (10%) stopped study drug before disease progression secondary to Common adverse events included anemia (42 patients, seven with grade 3/4 toxicity), toxicity. leukopenia (33 patients, nine with grade 3/4 toxicity), fatigue (30 patients, three with grade 3/4 toxicity), nausea (34 patients, six with grade 3/4 toxicity), and diarrhea (28 patients, five with grade 3/4 toxicity).Conclusion 9-NC has modest activity in delaying progression in patients with unresectable or metastatic chordoma. 9-NC is associated with moderate toxicity and shows little benefit in patients with advanced STS and GIST. (c) 2005 by American Society of Clinical Oncology.