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晚期卵巢癌患者在随机临床试验中接受治疗后的长期随访

Long-term follow-up of patients with advanced ovarian cancer treated in randomised clinical trials.

作者信息

Warwick J, Kehoe S, Earl H, Luesley D, Redman C, Chan K K

机构信息

CRC Trials Unit, CRC Institute for Cancer Studies, University of Birmingham, Queen Elizabeth Hospital, UK.

出版信息

Br J Cancer. 1995 Dec;72(6):1513-7. doi: 10.1038/bjc.1995.539.

DOI:10.1038/bjc.1995.539
PMID:8519669
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2034090/
Abstract

The data from two prospective randomised phase III trials that were initiated by the West Midlands Ovarian Cancer Study Group (WMOCSG) in 1981 and 1986, recruiting 167 and 195 patients respectively, have been pooled and the survival patterns of the 362 patients treated for advanced epithelial ovarian cancer within clinical trials in the West Midlands over the 10 year period (1981-91) have been explored. All patients had histologically proven epithelial ovarian cancer and all had residual disease after primary surgery, with the majority having stage III/IV disease. The primary treatment for all patients was debulking surgery followed by platinum-based chemotherapy. Eligible patients were further randomised to undergo a second debulking operation. The main end point, survival, was assessed using Kaplan-Meier curves and the log-rank test. A Cox proportional hazards model identified performance status (P = 0.002), residual disease (P = 0.005) and albumin level (P = 0.04) as independent prognostic factors. A multivariate model to predict survival curves for patients with the best and worst prognoses was developed with predicted 5 year survival of 30% and 3% for those in the best and worst prognostic groups respectively. The identification of clinical interventions to improve outcome is an urgent matter since the prognosis for patients with advanced ovarian cancer remains poor.

摘要

西米德兰兹卵巢癌研究小组(WMOCSG)于1981年和1986年发起了两项前瞻性随机III期试验,分别招募了167名和195名患者,现已将这些数据汇总,并对1981年至1991年这10年间在西米德兰兹地区临床试验中接受晚期上皮性卵巢癌治疗的362名患者的生存模式进行了探索。所有患者均经组织学证实为上皮性卵巢癌,且在初次手术后均有残留病灶,大多数患者为III/IV期疾病。所有患者的主要治疗方法是肿瘤细胞减灭术,随后进行铂类化疗。符合条件的患者被进一步随机分组接受第二次肿瘤细胞减灭术。主要终点指标生存率采用Kaplan-Meier曲线和对数秩检验进行评估。Cox比例风险模型确定了体能状态(P = 0.002)、残留病灶(P = 0.005)和白蛋白水平(P = 0.04)为独立的预后因素。建立了一个多变量模型来预测预后最佳和最差患者的生存曲线,预测结果显示,预后最佳组和最差组患者的5年生存率分别为30%和3%。由于晚期卵巢癌患者的预后仍然很差,确定改善预后的临床干预措施是当务之急。

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