Tangjitgamol Siriwan, Manusirivithaya Sumonmal, Laopaiboon Malinee, Lumbiganon Pisake, Bryant Andrew
Department of Obstetrics and Gynaecology, Faculty of Medicine Vajira Hospital, Bangkok, Thailand.
Cochrane Database Syst Rev. 2013 Apr 30;4(4):CD006014. doi: 10.1002/14651858.CD006014.pub6.
Interval debulking surgery (IDS), following induction or neoadjuvant chemotherapy, may have a role in treating advanced epithelial ovarian cancer (stage III to IV) where primary debulking surgery is not an option.
To assess the effectiveness and complications of IDS for women with advanced stage epithelial ovarian cancer.
We searched the Cochrane Gynaecological Cancer Group's Specialised Register to June 2012, the Cochrane Central Register of Controlled Trials (CENTRAL) 2012, Issue 6, MEDLINE to June 2012 and EMBASE to June 2012.
Randomised controlled trials (RCTs) comparing survival of women with advanced epithelial ovarian cancer, who had IDS performed between cycles of chemotherapy after primary surgery with survival of women who had conventional treatment (primary debulking surgery and adjuvant chemotherapy).
Two review authors independently assessed trial quality and extracted data. Searches for additional information from study authors were attempted. We performed meta-analysis of overall and progression-free survival (PFS), using random-effects models.
Three RCTs randomising 853 women, of whom 781 were evaluated, met the inclusion criteria. Meta-analysis of three trials for overall survival (OS) found no statistically significant difference between IDS and chemotherapy alone (hazard ratio (HR) = 0.80, 95% confidence interval (CI) 0.61 to 1.06, I² = 58%). Subgroup analysis for OS in two trials, where the primary surgery was not performed by gynaecologic oncologists or was less extensive, showed a benefit of IDS (HR = 0.68, 95% CI 0.53 to 0.87, I² = 0%). Meta-analysis of two trials for PFS found no statistically significant difference between IDS and chemotherapy alone (HR = 0.88, 95% CI 0.57 to 1.33, I² = 83%). Rates of toxic reactions to chemotherapy were similar in both arms (risk ratio = 1.19, 95% CI 0.53 to 2.66, I² = 0%), but little information was available for other adverse events or quality or life (QoL).
AUTHORS' CONCLUSIONS: We found no conclusive evidence to determine whether IDS between cycles of chemotherapy would improve or decrease the survival rates of women with advanced ovarian cancer, compared with conventional treatment of primary surgery followed by adjuvant chemotherapy. IDS appeared to yield benefit only in women whose primary surgery was not performed by gynaecologic oncologists or was less extensive. Data on QoL and adverse events were inconclusive.
间隔减瘤手术(IDS)在诱导化疗或新辅助化疗之后,对于无法进行初次减瘤手术的晚期上皮性卵巢癌(Ⅲ至Ⅳ期)患者可能具有治疗作用。
评估间隔减瘤手术治疗晚期上皮性卵巢癌女性患者的有效性及并发症。
我们检索了截至2012年6月的Cochrane妇科癌症小组专业注册库、2012年第6期的Cochrane对照试验中心注册库(CENTRAL)、截至2012年6月的MEDLINE以及截至2012年6月的EMBASE。
随机对照试验(RCT),比较初次手术后在化疗周期之间接受间隔减瘤手术的晚期上皮性卵巢癌女性患者与接受传统治疗(初次减瘤手术及辅助化疗)的女性患者的生存率。
两位综述作者独立评估试验质量并提取数据。尝试向研究作者查询更多信息。我们采用随机效应模型对总生存期和无进展生存期(PFS)进行荟萃分析。
三项随机分配853名女性患者(其中781名接受评估)的RCT符合纳入标准。三项试验总生存期(OS)的荟萃分析发现,间隔减瘤手术与单纯化疗之间无统计学显著差异(风险比(HR)=0.80,95%置信区间(CI)0.61至1.06,I² = 58%)。两项试验中初次手术并非由妇科肿瘤学家实施或范围较小的患者亚组的总生存期分析显示,间隔减瘤手术具有益处(HR = 0.68,95% CI 0.53至0.87,I² = 0%)。两项试验无进展生存期的荟萃分析发现,间隔减瘤手术与单纯化疗之间无统计学显著差异(HR = 0.88,95% CI 0.57至1.33,I² = 83%)。两组化疗的毒副反应发生率相似(风险比 = 1.19,95% CI 0.53至2.66,I² = 0%),但关于其他不良事件或生活质量(QoL)的信息较少。
我们没有确凿证据来确定与初次手术加辅助化疗的传统治疗相比,化疗周期之间的间隔减瘤手术是否会提高或降低晚期卵巢癌女性患者的生存率。间隔减瘤手术似乎仅对初次手术并非由妇科肿瘤学家实施或范围较小的女性患者有益。关于生活质量和不良事件的数据尚无定论。