Eltabbakh G H, Piver M S, Hempling R E, Recio F O, Lele S B, Marchetti D L, Baker T R, Blumenson L E
Department of Gynecologic Oncology, Roswell Park Cancer Institute, Buffalo, New York, USA.
Gynecol Oncol. 1998 Sep;70(3):392-7. doi: 10.1006/gyno.1998.5109.
The extreme drug resistance (EDR) assay has been correlated with failure of response to chemotherapy in greater than 99% of patients. The goal of this study is to correlate the results of the EDR assay to response to first-line paclitaxel/cisplatin among patients with epithelial ovarian cancer.
Seventy-five of 100 patients with epithelial ovarian cancer for whom EDR assay was performed were treated with weekly induction cisplatin (1 mg/kg body wt) x 4, followed by monthly paclitaxel (135 mg/m2) and cisplatin (75 mg/m2) x 6 and were evaluable for correlation of response to chemotherapy and EDR assay. Specimens for EDR assay were obtained at primary surgery and the EDR assay was performed by Oncotech, Inc. Response to chemotherapy was correlated to EDR assay results regarding paclitaxel and cisplatin.
Among 75 evaluable patients, the prevalence of EDR to paclitaxel was 20.0% (n = 15) and to cisplatin it was 2.7% (n = 2). Only 1 patient (1.3%) exhibited EDR to both paclitaxel and cisplatin. Surgical assessment of response was performed in 42 patients; 33 patients were clinically evaluable. The overall response rate was 85.3%. The overall response rate for patients whose tumors demonstrated no EDR to either paclitaxel or cisplatin did not differ significantly from that for patients whose tumors demonstrated EDR to at least one of these two drugs (86.4% versus 81.3%, respectively, P = 0.692). Similarly, the complete surgical response rate for both groups did not differ significantly (25.4% versus 12.5%, respectively, P = 0. 34). A single patient whose tumor exhibited EDR to both paclitaxel and cisplatin had tumor progression. The sensitivity, specificity, positive predictive value, and negative predictive value of the EDR assay were 79.6, 27.0, 86.0, and 19.0%, respectively.
EDR to paclitaxel does not preclude response to the combination of paclitaxel and cisplatin as primary therapy for patients with epithelial ovarian cancer. The role of the EDR assay in the primary management of patients with epithelial ovarian cancer remains to be determined.
超耐药（EDR）检测已被证实与超过99%的患者化疗反应失败相关。本研究的目的是将EDR检测结果与上皮性卵巢癌患者一线紫杉醇/顺铂治疗反应相关联。
100例接受EDR检测的上皮性卵巢癌患者中，75例接受每周一次顺铂诱导治疗（1mg/kg体重）×4周，随后每月接受紫杉醇（135mg/m²）和顺铂（75mg/m²）治疗×6个周期，并可评估化疗反应与EDR检测的相关性。EDR检测样本在初次手术时获取，由Oncotech公司进行EDR检测。化疗反应与紫杉醇和顺铂的EDR检测结果相关联。
在75例可评估患者中，对紫杉醇的EDR发生率为20.0%（n = 15），对顺铂的EDR发生率为2.7%（n = 2）。仅1例患者（1.3%）对紫杉醇和顺铂均表现出EDR。42例患者进行了手术反应评估；33例患者可进行临床评估。总体反应率为85.3%。肿瘤对紫杉醇或顺铂均未表现出EDR的患者的总体反应率与肿瘤对这两种药物中至少一种表现出EDR的患者的总体反应率无显著差异（分别为86.4%和81.3%，P = 0.692）。同样，两组的完全手术反应率也无显著差异（分别为25.4%和12.5%，P = 0.34）。1例肿瘤对紫杉醇和顺铂均表现出EDR的患者出现肿瘤进展。EDR检测的敏感性、特异性、阳性预测值和阴性预测值分别为79.6%、27.0%、86.0%和19.0%。
对紫杉醇的EDR并不排除上皮性卵巢癌患者对紫杉醇和顺铂联合作为一线治疗的反应。EDR检测在上皮性卵巢癌患者的初始治疗中的作用仍有待确定。
