Van de Putte Gregg, Oben Jolien, Prenen Leen, Schobbens Jean Christophe, Vlasselaer Jos, Van Holsbeke Caroline, Debrock Guy, Van Eycken Peter, de Jonge Eric
*Department of Gynecology, Ziekenhuis Oost-Limburg, Genk, Belgium; †Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Universiteit Hasselt, Diepenbeek, Belgium; and Departments of ‡Oncology and §Pathology, Ziekenhuis Oost Limburg, Genk, Belgium.
Int J Gynecol Cancer. 2015 Jul;25(6):993-9. doi: 10.1097/IGC.0000000000000461.
The standard treatment of ovarian cancer is the combination of debulking surgery and chemotherapy. There is an ongoing discussion on which treatment is best: primary debulking surgery (PDS) or neoadjuvant chemotherapy with interval debulking (NACT-IDS). Even a large randomized trial has not settled this issue. We examined whether comparing a specified treatment protocol would not be a more logical approach to answer this type of discussions.
A retrospective study of 142 consecutively treated patients according to a fixed protocol between 2000 and 2012 was conducted. Disease-free survival and overall survival were calculated by univariate and multivariate analyses for the whole group and for advanced stages separately. Specific differences between PDS and NACT-IDS were studied. Comparison of results from large databases was made.
Disease-free survival and overall 5-year survival for the whole group were 35% and 50%. For the advanced stages, disease-free survival and overall 5-year survival were 14% and 36%, with a median disease-free and overall survival of 16 and 44 months. Of the 98 women with advanced ovarian carcinoma, 54% of operable patients underwent PDS and 44% underwent NACT-IDS. More patients in the PDS group were optimally (<1 cm) debulked: 80% vs 71%. There was no significant difference in survival between PDS or NACT-IDS. Optimally debulked patients had a significant better overall survival in multivariate analysis with a hazard ratio of 2.1.
Outcome of treatment according to a fixed protocol with a mixture of PDS and NACT-IDS was similar to results from large databases. We hypothesize that comparison of a specific strategy may yield more useful results than awaiting the perfect randomized trial.
卵巢癌的标准治疗方法是减瘤手术与化疗相结合。关于哪种治疗方法最佳存在持续的讨论：初次减瘤手术（PDS）还是新辅助化疗联合间隔减瘤手术（NACT-IDS）。即使是一项大型随机试验也未能解决这个问题。我们研究了比较特定的治疗方案是否不是回答这类讨论的更合理方法。
对2000年至2012年间按照固定方案连续治疗的142例患者进行回顾性研究。通过单因素和多因素分析计算全组以及晚期患者的无病生存期和总生存期。研究PDS和NACT-IDS之间的具体差异。对大型数据库的结果进行比较。
全组的无病生存期和5年总生存率分别为35%和50%。对于晚期患者，无病生存期和5年总生存率分别为14%和3%，无病生存期和总生存期的中位数分别为16个月和44个月。在98例晚期卵巢癌女性患者中，54%的可手术患者接受了PDS，44%接受了NACT-IDS。PDS组中更多患者实现了最佳（<1 cm）减瘤：80%对71%。PDS或NACT-IDS之间的生存率无显著差异。在多因素分析中，实现最佳减瘤的患者总生存率显著更好，风险比为2.1。
按照包含PDS和NACT-IDS的固定方案进行治疗的结果与大型数据库的结果相似。我们推测，比较特定策略可能比等待完美的随机试验产生更有用的结果。
