Tomar Than Singh, Nair Rema Prabhakaran, Sambasivan Suchetha, Krishna K M Jagathnath, Mathew Aleyamma, Ahmed Iqbal M
Division of Surgical Oncology, Regional Cancer Centre, Trivandrum, Kerala, India.
Division of Cancer Epidemiology and Biostatistics, Regional Cancer Centre, Trivandrum, Kerala, India.
Indian J Cancer. 2017 Jul-Sep;54(3):550-555. doi: 10.4103/ijc.IJC_306_17.
The objective of this study was to evaluate the safety and efficacy of laparoscopy in detecting inoperable disease in patients undergoing interval cytoreduction (ICR) for advanced ovarian carcinoma (AOC). The primary outcome measured was the performance of laparoscopy-based predictive index value (PIV) score developed by Fagotti et al. The secondary outcomes measured were performance of individual parameters included in PIV score and optimal cytoreduction (OCR) rates in our population.
This is a single-arm, prospective validation trial. Patients undergoing ICR for AOC in our institution were evaluated prospectively with laparoscopy before planned attempt at debulking surgery. Seven laparoscopic parameters included in laparoscopic PIV score were evaluated. Laparoscopic findings were compared with the final outcomes of definitive surgery. OCR was defined as residual disease <1 cm. The efficiency of the individual laparoscopy score was analyzed using receiver operating characteristic (ROC) curves.
A total of 73 patients planned for ICR for AEOC were included in the study. Laparoscopic PIV score could successfully predict inoperability in 12 (16.4% of total study population) out of 14 inoperable patients in the total population and thus could avoid 85% of unsuccessful surgeries at a PIV score cutoff of ≥8. Performance of individual parameters included in PIV score was also evaluated. Two parameters out of seven, that is, mesenteric retraction and stomach infiltration had poor performance on ROC curve. Modified PIV score was calculated for each patient after excluding these two parameters. Modified PIV score had similar performance as Fagotti's PIV score at cutoff ≥6 (P = 0.728, for difference in area under the curve). No staging laparoscopy-related serious adverse events were noted in any of the patients.
Laparoscopy is a safe, effective, and accurate method for predicting inoperability in patients undergoing ICR for AEOC.
本研究旨在评估腹腔镜检查在晚期卵巢癌(AOC)间隔期肿瘤细胞减灭术(ICR)患者中检测不可切除疾病的安全性和有效性。测量的主要结局是法戈蒂等人制定的基于腹腔镜检查的预测指数值(PIV)评分的表现。测量的次要结局是PIV评分中包含的各个参数的表现以及我们研究人群中的最佳肿瘤细胞减灭术(OCR)率。
这是一项单臂前瞻性验证试验。在我们机构接受AOC的ICR的患者在计划进行减瘤手术之前接受了腹腔镜检查的前瞻性评估。评估了腹腔镜PIV评分中包含的七个腹腔镜参数。将腹腔镜检查结果与确定性手术的最终结果进行比较。OCR定义为残留病灶<1 cm。使用受试者工作特征(ROC)曲线分析各个腹腔镜检查评分的效率。
本研究共纳入73例计划接受AEOC的ICR的患者。腹腔镜PIV评分能够成功预测总体14例不可切除患者中的12例(占总研究人群的16.4%)不可切除,因此在PIV评分临界值≥8时可避免85%的手术失败。还评估了PIV评分中包含的各个参数的表现。七个参数中的两个,即肠系膜退缩和胃浸润,在ROC曲线上表现不佳。在排除这两个参数后为每位患者计算了改良PIV评分。在临界值≥6时,改良PIV评分与法戈蒂的PIV评分表现相似(曲线下面积差异的P = 0.728)。在任何患者中均未观察到与分期腹腔镜检查相关的严重不良事件。
腹腔镜检查是预测接受AEOC的ICR患者不可切除性的一种安全、有效且准确的方法。