Johns Hopkins Medical Institutions, Baltimore, Maryland; the Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, New York; the University of California San Francisco, Comprehensive Cancer Center, San Francisco, and the University of California, Irvine Medical Center, Orange, California; the University of Arizona, Tucson, Arizona; and the University of Texas, MD Anderson Cancer Center, Houston, Texas.
Obstet Gynecol. 2013 Aug;122(2 Pt 1):225-232. doi: 10.1097/AOG.0b013e31829ce7ec.
To examine clinicopathologic variables associated with survival among women with low-grade (grade 1) serous ovarian carcinoma enrolled in a phase III study.
This was an ancillary data analysis of Gynecologic Oncology Group protocol 182, a phase III study of women with stage III-IV epithelial ovarian carcinoma treated with carboplatin and paclitaxel compared with triplet or sequential doublet regimens. Women with grade 1 serous carcinoma (a surrogate for low-grade serous disease) were included in the analysis.
Among the 3,686 enrolled participants, 189 had grade 1 disease. The median age was 56.5 years and 87.3% had stage III disease. The median follow-up time was 47.1 months. Stratification according to residual disease after primary surgery was microscopic residual in 24.9%, 0.1-1.0 cm of residual in 51.3%, and more than 1.0 cm of residual in 23.8%. On multivariate analysis, only residual disease status (P=.006) was significantly associated with survival. Patients with microscopic residual had a significantly longer median progression-free (33.2 months) and overall survival (96.9 months) compared with those with residual 0.1-1.0 cm (14.7 months and 44.5 months, respectively) and more than 1.0 cm of residual disease (14.1 months and 42.0 months, respectively; progression-free and overall survival, P<.001). After adjustment for other variables, patients with low-grade serous carcinoma with measurable residual disease had a similar adjusted hazard ratio for death (2.12; P=.002) as their high-grade serous carcinoma counterparts with measurable disease (2.31; P<.001).
Surgical cytoreduction to microscopic residual was associated with improved progression-free and overall survival in women with advanced-stage low-grade serous ovarian carcinoma.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00011986.
II.
研究纳入 III 期研究的低级别(1 级)浆液性卵巢癌女性患者的临床病理变量与生存的关系。
这是妇科肿瘤组方案 182 的辅助数据分析,该方案为 III 期研究,比较卡铂和紫杉醇与三联或序贯二联方案治疗 III-IV 期上皮性卵巢癌的疗效。在分析中纳入了 1 级浆液性癌(低级别浆液性疾病的替代指标)的女性患者。
在纳入的 3686 名参与者中,189 名患有 1 级疾病。中位年龄为 56.5 岁,87.3%为 III 期疾病。中位随访时间为 47.1 个月。根据初次手术后残留疾病进行分层,显微镜下残留为 24.9%,0.1-1.0cm 残留为 51.3%,>1.0cm 残留为 23.8%。多变量分析显示,只有残留疾病状态(P=.006)与生存显著相关。显微镜下残留患者的中位无进展生存期(33.2 个月)和总生存期(96.9 个月)明显长于残留 0.1-1.0cm(分别为 14.7 个月和 44.5 个月)和>1.0cm 残留疾病(分别为 14.1 个月和 42.0 个月;无进展生存期和总生存期,P<.001)。在调整其他变量后,有可测量残留疾病的低级别浆液性癌患者的死亡调整后危险比与有可测量疾病的高级别浆液性癌患者相似(2.12;P=.002)。
在晚期低级别浆液性卵巢癌女性中,手术减瘤至显微镜下残留与无进展生存期和总生存期的改善相关。
ClinicalTrials.gov,www.clinicaltrials.gov,NCT00011986。
II 级。