Prognostic significance of CA-125 re-elevation after interval debulking surgery in patients with advanced-stage ovarian cancer undergoing neoadjuvant chemotherapy

2019 ◽  
Vol 45 (4) ◽  
pp. 644-649
Author(s):  
Yong Jae Lee ◽  
Young Shin Chung ◽  
Jung-Yun Lee ◽  
Eun Ji Nam ◽  
Sang Wun Kim ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Prognostic Significance ◽  
Ca 125 ◽  
Advanced Stage ◽  
Debulking Surgery ◽  
Interval Debulking Surgery

scholarly journals Rethinking Radical Surgery in Interval Debulking Surgery for Advanced-Stage Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy

2020 ◽  
Vol 9 (4) ◽  
pp. 1235 ◽  
Author(s):  
Yong Jae Lee ◽  
Jung-Yun Lee ◽  
Eun Ji Nam ◽  
Sang Wun Kim ◽  
Sunghoon Kim ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Cancer Patients ◽  
Disease Burden ◽  
Residual Disease ◽  
Advanced Stage ◽  
Debulking Surgery ◽  
Cox Regression Analysis ◽  
Interval Debulking Surgery ◽  
Surgical Complexity

The aim of this study is to evaluate the effects on survival outcomes of the disease burden before interval debulking surgery (IDS), surgical complexity, and residual disease after IDS in advanced-stage ovarian cancer treated with neoadjuvant chemotherapy (NAC). We reviewed the data of 268 epithelial ovarian cancer patients who had received three or four cycles of NAC and undergone optimal resections through IDS. The Kaplan–Meier method and Cox regression analysis were used to assess the effects of disease burden (peritoneal cancer index (PCI)), degree of complexity of surgery (surgical complexity score/s (SCS)), and extent of residual disease. In no residual disease (R0) patients, those with intermediate/high SCS had shorter progression-free survival (PFS; p = 0.001) and overall survival (OS; p = 0.001) than patients with low SCS. An analysis of a subset of patients with R0 and low PCIs showed those with intermediate/high SCS had worse PFS and OS than patients with low SCS (p = 0.049) and OS (p = 0.037). In multivariate analysis, patients with R0 as a result of intermediate/high SCS fared worse than patients whose R0 was achieved by low SCS (PFS hazard ratio (HR) 1.80, 95% CI 1.05–3.10; OS HR 5.59, 95% CI 1.70–18.39). High PCIs at the time of IDS, high SCS, and residual disease signal poor prognoses for patients treated with NAC.

scholarly journals Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE)

2020 ◽  
Vol 30 (9) ◽  
pp. 1450-1454 ◽  
Author(s):  
Roni Nitecki ◽  
Jose Alejandro Rauh-Hain ◽  
Alexander Melamed ◽  
Giovanni Scambia ◽  
Rene Pareja ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Partial Response ◽  
Minimally Invasive ◽  
Epithelial Ovarian Cancer ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Ca 125 ◽  
Debulking Surgery ◽  
Interval Debulking Surgery

BackgroundObservational studies have supported the practice of offering minimally invasive interval debulking surgery after neoadjuvant chemotherapy for well-selected patients with advanced epithelial ovarian cancer. However, there are no prospective randomized data comparing the oncologic efficacy of minimally invasive and open interval debulking surgery in epithelial ovarian cancer.Primary objectiveThe primary objective of this study is to examine whether minimally invasive surgery is non-inferior to laparotomy in terms of disease-free survival in women with advanced stage epithelial ovarian cancer that responded to three or four cycles of neoadjuvant chemotherapy.Study hypothesisWe hypothesize that in patients who had a complete or partial response to neoadjuvant chemotherapy, minimally invasive interval debulking surgery is not inferior to laparotomy.Trial designThe Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE) trial is an international, prospective, randomized, multicenter, non-inferiority phase III trial to compare minimally invasive surgery vs laparotomy in women with advanced stage high-grade epithelial ovarian cancer that had a complete or partial response to three or four cycles of neoadjuvant chemotherapy and normalization of CA-125. The first 100 participants will be enrolled into a pilot lead-in to determine feasibility. The study will be considered feasible and will continue to Phase III under the following conditions: the accrual rate reaches at least 80% of the target rate after all pilot sites are open; the crossover rate in the minimally invasive group is less than 25%; and the difference of complete gross resection between the minimally invasive and open group is less than 20%. If the study is determined to be feasible, all remaining participants will be enrolled into the Phase III stage.Major inclusion/exclusion criteriaPatients with stage IIIC or IV high-grade epithelial ovarian, primary peritoneal or fallopian tube carcinoma who had a complete or partial response to three or four cycles of neoadjuvant chemotherapy based on imaging and normalization of CA-125 will be enrolled. Patients with evidence of tumor not amenable to minimally invasive resection on pre-operative imaging will be excluded.Primary endpointThe primary endpoint is non-inferiority of disease-free survival in minimally invasive vs laparotomic interval debulking surgery.Sample sizeTo demonstrate non-inferiority with a margin of 33% in the hazard ratio (HR=1.33), 549 patients will be randomized.

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