Surgical cytoreduction for recurrent epithelial ovarian cancer.
Surgical cytoreduction for recurrent epithelial ovarian cancer.
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DOI：
10.1002/14651858.cd008765.pub3
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发表时间：
2013-02-28
期刊：
影响因子：
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通讯作者：
Galaal, Khadra
中科院分区：
文献类型：
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作者：
Al Rawahi, Thuria;Lopes, Alberto D;Galaal, Khadra
背景：原发性卵巢癌的标准治疗是最佳细胞减灭术，然后进行铂类化疗。大多数患有原发性卵巢癌的女性通过这种联合疗法获得缓解。对于完成初始治疗后获得临床缓解的女性来说，大多数（60%）患有晚期上皮性卵巢癌的女性最终将出现复发性疾病。然而，复发性卵巢癌女性的标准治疗仍然不明确。复发性卵巢癌的手术被认为与总体生存率的提高有关。目的：评估最佳二次肿瘤细胞减灭术对复发性上皮性卵巢癌女性的有效性和安全性。旨在评估 0 cm 至 2 cm 范围内的各种残留肿瘤大小对总生存率的影响。 检索方法：我们检索了截至 2012 年 12 月的 Cochrane 妇科癌症组试验注册库、MEDLINE、EMBASE 和 Cochrane 对照试验中央注册库 (CENTRAL)。我们还检索了临床试验注册库、科学会议摘要、纳入研究的参考文献清单并联系了该领域的专家。对于 MEDLINE 以外的数据库，搜索策略已进行相应调整。 选择标准：残留病灶的回顾性数据，或来自随机对照试验 (RCT) 或前瞻性/回顾性观察研究的数据，其中包括对 50 名或更多患有复发性上皮性卵巢癌的成年女性进行的多变量分析，这些女性接受了辅助化疗的二次细胞减灭术。我们仅纳入将最佳细胞减灭术定义为手术导致残留肿瘤最大直径达到任何阈值不超过2厘米的研究。数据收集和分析：两位综述作者（KG、TA）独立提取数据并评估偏倚风险。在可能的情况下，在荟萃分析中综合数据。 主要结果：没有随机对照试验；然而，我们发现了 9 项非随机研究，报告了 1194 名女性接受二次细胞减灭术后残留疾病的比较，使用符合我们纳入标准的多变量分析。这些回顾性和前瞻性研究评估了复发性上皮性卵巢癌女性二次细胞减灭术后的生存率。荟萃分析和单一研究分析表明，完全细胞减灭术对微观疾病的预后重要性，因为这些女性群体的总生存期显着延长（大多数研究表明，与微观疾病相比，所有残留疾病组的死亡风险在统计学上显着更高）。所有研究均未报告无复发生存率。所有研究均纳入了至少 50 名女性，并对重要的预后因素进行了统计调整。一项研究比较了次优（> 1 cm）与最佳（< 1 cm）细胞减灭术，并证明如果无法实现微观病变，实现细胞减灭术至小于 1 cm 是有益的（风险比 (HR) 3.51，95% CI 1.84 至 6.70）。同样，一项研究发现，与术后残留病灶大于 0.5 cm 的女性相比，肿瘤细胞减灭术小于 0.5 cm 的女性死亡风险较低（HR 未报告；P 值 < 0.001）。由于这些研究的非随机性，存在很高的偏倚风险，尽管对重要的预后因素进行了统计调整，但选择是基于细胞减灭术的回顾性可实现性，而不是治疗意图，因此一定程度的偏倚是不可避免的。任何研究均未报告不良事件、生活质量和成本效益。作者的结论：在患有铂敏感复发性卵巢癌的女性中，完成完全细胞减灭术（无可见残留病灶）的手术与总体生存率的显着改善相关。然而，在缺乏随机对照试验证据的情况下，尚不清楚这仅仅是由于手术效果还是由于肿瘤生物学。间接证据支持对选定的女性进行手术以实现完全细胞减灭术。需要根据具体情况仔细权衡大手术的风险与潜在益处。
BACKGROUND: The standard management of primary ovarian cancer is optimal cytoreductive surgery followed by platinum-based chemotherapy. Most women with primary ovarian cancer achieve remission on this combination therapy. For women achieving clinical remission after completion of initial treatment, most (60%) with advanced epithelial ovarian cancer will ultimately develop recurrent disease. However, the standard treatment of women with recurrent ovarian cancer remains poorly defined.Surgery for recurrent ovarian cancer has been suggested to be associated with increased overall survival.OBJECTIVES: To evaluate the effectiveness and safety of optimal secondary cytoreductive surgery for women with recurrent epithelial ovarian cancer. To assess the impact of various residual tumour sizes, over a range between 0 cm and 2 cm, on overall survival.SEARCH METHODS: We searched the Cochrane Gynaecological Cancer Group Trials Register, MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) up to December 2012. We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. For databases other than MEDLINE, the search strategy has been adapted accordingly.SELECTION CRITERIA: Retrospective data on residual disease, or data from randomised controlled trials (RCTs) or prospective/retrospective observational studies that included a multivariate analysis of 50 or more adult women with recurrent epithelial ovarian cancer, who underwent secondary cytoreductive surgery with adjuvant chemotherapy. We only included studies that defined optimal cytoreduction as surgery leading to residual tumours with a maximum diameter of any threshold up to 2 cm.DATA COLLECTION AND ANALYSIS: Two review authors (KG, TA) independently abstracted data and assessed risk of bias. Where possible the data were synthesised in a meta-analysis.MAIN RESULTS: There were no RCTs; however, we found nine non-randomised studies that reported on 1194 women with comparison of residual disease after secondary cytoreduction using a multivariate analysis that met our inclusion criteria. These retrospective and prospective studies assessed survival after secondary cytoreductive surgery in women with recurrent epithelial ovarian cancer.Meta- and single-study analyses show the prognostic importance of complete cytoreduction to microscopic disease, since overall survival was significantly prolonged in these groups of women (most studies showed a large statistically significant greater risk of death in all residual disease groups compared to microscopic disease).Recurrence-free survival was not reported in any of the studies. All of the studies included at least 50 women and used statistical adjustment for important prognostic factors. One study compared sub-optimal (> 1 cm) versus optimal (< 1 cm) cytoreduction and demonstrated benefit to achieving cytoreduction to less than 1 cm, if microscopic disease could not be achieved (hazard ratio (HR) 3.51, 95% CI 1.84 to 6.70). Similarly, one study found that women whose tumour had been cytoreduced to less than 0.5 cm had less risk of death compared to those with residual disease greater than 0.5 cm after surgery (HR not reported; P value < 0.001).There is high risk of bias due to the non-randomised nature of these studies, where, despite statistical adjustment for important prognostic factors, selection is based on retrospective achievability of cytoreduction, not an intention to treat, and so a degree of bias is inevitable.Adverse events, quality of life and cost-effectiveness were not reported in any of the studies.AUTHORS' CONCLUSIONS: In women with platinum-sensitive recurrent ovarian cancer, ability to achieve surgery with complete cytoreduction (no visible residual disease) is associated with significant improvement in overall survival. However, in the absence of RCT evidence, it is not clear whether this is solely due to surgical effect or due to tumour biology. Indirect evidence would support surgery to achieve complete cytoreduction in selected women. The risks of major surgery need to be carefully balanced against potential benefits on a case-by-case basis.