晚期卵巢癌的细胞减灭术（腹膜切除术）联合腹腔内热化疗（HIPEC）：意大利511例病例的回顾性多中心观察研究
Cytoreduction (Peritonectomy Procedures) Combined with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Advanced Ovarian Cancer: Retrospective Italian Multicenter Observational Study of 511 Cases.
作者信息
Di Giorgio Angelo, De Iaco Pierandrea, De Simone Michele, Garofalo Alfredo, Scambia Giovanni, Pinna Antonio Daniele, Verdecchia Giorgio Maria, Ansaloni Luca, Macrì Antonio, Cappellini Paolo, Ceriani Valerio, Giorda Giorgio, Biacchi Daniele, Vaira Marco, Valle Mario, Sammartino Paolo
机构信息
Department of Surgery 'P. Valdoni', Sapienza University of Rome, Rome, Italy.
General Surgery and Gynecologic Oncology Unit, Sant'Orsola Hospital, Bologna, Italy.
出版信息
Ann Surg Oncol. 2017 Apr;24(4):914-922. doi: 10.1245/s10434-016-5686-1. Epub 2016 Nov 28.
PURPOSE
The aim of this study was to help with the process of selecting patients with advanced ovarian cancer to undergo cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) by analyzing outcome data at distinct clinical time points reflecting the natural history of the disease.
METHODS
In a retrospective Italian multicenter study investigating patients with advanced ovarian cancer who underwent CRS plus HIPEC between 1998 and 2014, we analyzed data for consecutive patients at eight treatment time points: primary debulking surgery (PDS); interval debulking surgery after partial response, after no response, and after a pathologic complete response to neoadjuvant chemotherapy; first recurrence with a progression-free interval >12, <12 months, or >12 months in patients who underwent further chemotherapy before CRS and HIPEC; and patients who underwent two or more CRS procedures and chemotherapy lines before CRS and HIPEC.
RESULTS
The 511 enrolled patients underwent 3373 procedures; 72.6% achieved complete cytoreduction, with an overall major morbidity of 17.4%. At a median follow-up of 53.8 months, overall survival (OS) was 54.2 months (95% confidence interval [CI] 44-58.4) and progression-free (PFS) survival was 16.6 months (95% CI 14.7-19.1). Outcome analysis in patients in whom CRS plus HIPEC was used for primary advanced cancer or recurrent ovarian cancer showed significant differences in OS and PFS according to the time points analyzed. Multivariate analysis identified completeness of CRS, Peritoneal Cancer Index, and the times when patients underwent CRS plus HIPEC as independent prognostic factors.
CONCLUSIONS
This selective information on survival should help in interpreting the findings from ongoing randomized studies focusing on CRS plus HIPEC in patients with advanced ovarian cancer.
目的
本研究旨在通过分析反映疾病自然史的不同临床时间点的结局数据，辅助选择晚期卵巢癌患者接受细胞减灭术（CRS）联合热灌注化疗（HIPEC）。
方法
在一项意大利多中心回顾性研究中，调查了1998年至2014年间接受CRS联合HIPEC的晚期卵巢癌患者，我们分析了连续患者在八个治疗时间点的数据：初次肿瘤细胞减灭术（PDS）；新辅助化疗部分缓解、无缓解及病理完全缓解后的中间性肿瘤细胞减灭术；无进展生存期>12个月、<12个月或>12个月的首次复发，这些患者在CRS和HIPEC前接受了进一步化疗；以及在CRS和HIPEC前接受了两次或更多次CRS手术和化疗疗程的患者。
结果
511名入组患者共接受了3373次手术；72.6%实现了完全细胞减灭，总体严重并发症发生率为17.4%。中位随访53.8个月时，总生存期（OS）为54.2个月（95%置信区间[CI] 44 - 58.4），无进展生存期（PFS）为16.6个月（95% CI 14.7 - 19.1）。对将CRS联合HIPEC用于原发性晚期癌症或复发性卵巢癌患者的结局分析显示，根据所分析的时间点，OS和PFS存在显著差异。多变量分析确定CRS的完整性、腹膜癌指数以及患者接受CRS联合HIPEC的时间为独立预后因素。
结论
这些关于生存的选择性信息应有助于解读正在进行的针对晚期卵巢癌患者CRS联合HIPEC的随机研究结果。
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