Tangjitgamol Siriwan, Manusirivithaya Sumonmal, Laopaiboon Malinee, Lumbiganon Pisake
Department of Obstetrics and Gynaecology, Bangkok Metropolitan Administration Medical College and Vajira Hospital, 681 Samsen Road, Dusit District, Bangkok, Thailand, 10300.
Cochrane Database Syst Rev. 2009 Jan 21(1):CD006014. doi: 10.1002/14651858.CD006014.pub3.
Primary debulking surgery, a crucial step in the management of epithelial ovarian cancer, is not always an option in patients with advanced stage disease (stage III to IV). In some circumstances, surgery may not yield satisfactory results with residual tumour masses > 1 to 2 cm (so called suboptimal surgery). Induction or neoadjuvant chemotherapy followed by interval debulking surgery (IDS) may have an alternative role in this setting. However, the advantage of IDS compared to conventional methods is still a controversial issue.
To assess the effectiveness and complications of IDS for patients with advanced stage epithelial ovarian cancer.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), (The Cochrane Library, Issue 2, 2008), MEDLINE (January 1966 to June 2008), EMBASE (January 1966 to June 2008), and reference lists of included studies.
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. Meta-analysis of overall and progression free survival (PFS) was performed using fixed effects models.
Three RCTs, randomising 853 women of whom 781 were evaluated, met the inclusion criteria. Overall survival (OS) showed substantial heterogeneity between trials (I2 = 58%). Subgroup analysis for overall survival in two trials, wherein the primary surgery was not performed by gynecologic oncologists or was less extensive, showed a benefit of IDS: (relative risk) RR = 0.7 (95% confidence interval (CI): 0.5 to 0.9, I2 = 0%). Likewise, substantial heterogeneity between two trials for PFS evaluating 702 women was also shown (I(2) =75%). Rates of toxic reactions to chemotherapy were similar in both arms (RR = 1.3, 95%CI: 0.4 to 3.6), but little information is available for other adverse events. Only one trial reported quality of life (QOL), which was generally similar in both treatment arms.
AUTHORS' CONCLUSIONS: No conclusive evidence was found 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 the patients whose primary surgery was not performed by gynecologic oncologists or was less extensive. Data on QOL and adverse events were inconclusive.
初次肿瘤细胞减灭术是上皮性卵巢癌治疗中的关键步骤,但对于晚期疾病(III至IV期)患者而言,这并非总是可行的选择。在某些情况下,手术可能无法产生令人满意的结果,残余肿瘤肿块>1至2厘米(即所谓的次优手术)。诱导化疗或新辅助化疗后行中间型肿瘤细胞减灭术(IDS)在这种情况下可能具有替代作用。然而,与传统方法相比,IDS的优势仍是一个有争议的问题。
评估IDS对晚期上皮性卵巢癌患者的有效性和并发症。
我们检索了Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》,2008年第2期)、MEDLINE(1966年1月至2008年6月)、EMBASE(1966年1月至2008年6月)以及纳入研究的参考文献列表。
随机对照试验(RCT),比较初次手术后在化疗周期之间接受IDS的晚期上皮性卵巢癌女性患者与接受传统治疗(初次肿瘤细胞减灭术和辅助化疗)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。尝试从研究作者处获取更多信息。使用固定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RCT纳入了853名女性,其中781名女性接受评估,符合纳入标准。总生存期(OS)在各试验之间显示出很大的异质性(I² = 58%)。在两项试验中,对总生存期进行亚组分析,其中初次手术并非由妇科肿瘤学家进行或范围较小,结果显示IDS有获益:(相对危险度)RR = 0.7(95%置信区间(CI):0.5至0.9,I² = 0%)。同样,在两项评估702名女性的PFS试验之间也显示出很大的异质性(I² = 75%)。化疗的毒性反应发生率在两组中相似(RR = 1.3,95%CI:0.4至3.6),但关于其他不良事件的信息很少。只有一项试验报告了生活质量(QOL),两个治疗组的生活质量总体相似。
与初次手术加辅助化疗的传统治疗相比,没有确凿证据能确定化疗周期之间的IDS会提高还是降低晚期卵巢癌女性患者的生存率。IDS似乎仅在初次手术并非由妇科肿瘤学家进行或范围较小的患者中产生获益。关于生活质量和不良事件的数据尚无定论。