Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas
Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas
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DOI：
10.1016/s0959-8049(01)00398-7
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发表时间：
2002-03-01
影响因子：
8.4
通讯作者：
Nielsen, OS
中科院分区：
文献类型：
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作者：
Van Glabbeke, M;Verweij, J;Nielsen, OS
我们从我们的临床试验数据库中估计了不同组软组织肉瘤患者的无进展率（PFR），为以PFR为主要终点的II期研究提供参考价值。在146名接受活性药物预处理的患者中，在3个月和6个月时的PFR估计分别为39%和14%，而在非活性方案（234名患者）中，这些估计分别为21%和8%。在1154例未经预处理的患者中，PFR估计在3个月时从77%（滑膜肉瘤）到57%（恶性纤维组织细胞瘤（MFH））不等，在6个月时从56%（滑膜肉瘤）到38% （MFH）不等。胃肠源性平滑肌肉瘤61例，相应比例分别为44%和30%。因此，对于一线治疗，6个月PFR大于或等于30-56%（取决于组织学）可被视为建议药物活性的参考值；对于二线治疗，3个月的PFR大于或等于40%表明药物有活性，小于或等于20%表明无活性。(C) 2002 Elsevier Science Ltd.版权所有。
We have estimated progression-free rates (PFR) for various groups of soft-tissue sarcoma patients from our clinical trials database, to provide reference values for conducting phase II studies with PFR as the principal end-point. In 146 pretreated patients receiving an active agent, the PFR estimates were 39 and 14% at 3 and 6 months, with inactive regimens (234 patients), those estimates were 21 and 8% respectively. In 1154-non-pretreated patients, PFR estimates varied from 77% (synovial sarcoma) to 57% (malignant fibrous histiocytoma (MFH)) at 3 months, and from 56% (synovial sarcoma) to 38% (MFH ) at 6 months. In 61 leiomyosarcomas from gastrointestinal origin, the corresponding figures were 44 and 30%, respectively. Consequently, for first-line therapy, a 6-month PFR of greater than or equal to 30-56% (depending on histology) can be considered as a reference value to suggest drug activity; for second-line therapy, a 3-month PFR of greater than or equal to 40% would suggest a drug activity, and less than or equal to 20% would suggest inactivity. (C) 2002 Elsevier Science Ltd. All rights reserved.