Therasse P, Le Cesne A, Van Glabbeke M, Verweij J, Judson I
EORTC Data Center, Brussels, Belgium.
Eur J Cancer. 2005 Jul;41(10):1426-30. doi: 10.1016/j.ejca.2005.04.005.
The present study was set up just after the publication of the response evaluation criteria in solid tumors (RECIST) as a prospective validation exercise in soft tissue sarcoma. Forty-nine patients were entered into a phase II clinical trial aiming at determining the activity and safety of ET-743 (Ecteinascidin) in second line advanced soft tissue sarcoma. Response to treatment and progression were monitored following the WHO criteria and RECIST. Discordances between WHO and RECIST criteria for the best response were reported for two cases: one no-change (WHO) reported as partial response (RECIST) and one progression (WHO) reported as no-change (RECIST). In terms of date of progression, 3 patients progressed on WHO criteria while they were still stable with RECIST. Overall the results of the study would not have changed if RECIST had been used instead of WHO criteria. In conclusion, response criteria as defined by RECIST are adequate to measure response and progression in non-GIST soft tissue sarcoma and can be used instead of the modified WHO criteria.
本研究是在实体瘤疗效评价标准（RECIST）发布后立即开展的，作为软组织肉瘤的一项前瞻性验证试验。49例患者进入一项II期临床试验，旨在确定ET-743（埃博霉素）在二线晚期软组织肉瘤中的活性和安全性。按照世界卫生组织（WHO）标准和RECIST标准监测治疗反应和疾病进展情况。报告了2例WHO标准与RECIST标准在最佳反应方面存在不一致的情况：1例WHO标准判定为病情无变化的患者，RECIST标准判定为部分缓解；1例WHO标准判定为病情进展的患者，RECIST标准判定为病情无变化。在疾病进展日期方面，3例患者按WHO标准已出现疾病进展，但按RECIST标准仍处于稳定状态。总体而言，如果使用RECIST标准而非WHO标准，该研究结果不会改变。总之，RECIST标准所定义的反应标准足以衡量非胃肠道间质瘤（GIST）软组织肉瘤的反应和疾病进展情况，可替代修改后的WHO标准使用。
