Primary Debulking Surgery Group Research Articles

The effectiveness of CA125 and HE4 as clinical prognostic markers in epithelial ovarian cancer patients with BRCA mutation.

To investigate the efficacy of cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) in predicting survival outcomes based on breast cancer gene (BRCA) mutational status in epithelial ovarian cancer. Medical records of 448 patients diagnosed with epithelial ovarian cancer at a single tertiary institution in Korea were retrospectively analyzed. Area under the curve, sensitivity, specificity, and accuracy were assessed using the CA125 and HE4 values after surgery and 3 cycles of chemotherapy to predict 1-year survival based on the BRCA mutational status. Kaplan-Meier analysis was used to obtain progression-free and overall survival to evaluate CA125 and HE4 effectiveness in predicting survival outcomes. A total of 423 patients were analyzed, including 180 (42.6%) who underwent interval debulking surgery (IDS) and 243 (57.4%) who underwent primary debulking surgery (PDS). BRCA mutations were observed in 37 (15.2%) and 44 (22.4%) patients in the PDS and IDS groups, respectively. CA125 and HE4 normalization demonstrated the highest specificity in patients with or without BRCA mutations, with specificities of 97.1% and 99.1% in the PDS group and 78.6% and 86.2% in the IDS group, respectively. Normalizing HE4 alone may be an effective prognostic marker, with an area under the curve of 0.774 and specificity of 75.0%, in patients with BRCA mutations. Normalizing both biomarkers emerged as the most effective predictive marker for the 1-year recurrence rate, regardless of BRCA mutational status. A negative HE4 value can be a useful predictor for 1-year recurrence-free survival in patients with BRCA mutations.

"Things Have Changed"-Laparoscopic Cytoreduction for Advanced and Recurrent Ovarian Cancer: The Experience of a Referral Center on 108 Patients.

To report the feasibility of laparoscopic cytoreduction surgery for primary and recurrent ovarian cancer in a select group of patients. A retrospective analysis was conducted on a cohort of patients with FIGO stage IIIA-IV advanced ovarian cancer who underwent laparoscopic primary debulking surgery (PDS), interval debulking surgery (IDS), or secondary debulking surgery (SDS) between June 2008 and January 2020. The primary endpoint was achieving optimal cytoreduction, defined as residual tumor less than 1 cm. Secondary endpoints included evaluating surgical complications and long-term survival, assessed at three-month intervals during the initial two years and then every six months. This study included a total of 108 patients, among whom, 40 underwent PDS, 44 underwent IDS, and 24 underwent SDS. Optimal cytoreduction rates were found to be 95.0%, 97.7%, and 95.8% for the PDS, ISD, and SDS groups, respectively. Early postoperative complications (<30 days from surgery) occurred in 19.2% of cases, with 7.4% of these cases requiring reintervention. One patient died following postoperative respiratory failure. Late postoperative complications (<30 days from surgery) occurred in 9.3% of cases, and they required surgical reintervention only in one case. After laparoscopic optimal cytoreduction with a median follow-up time of 25 months, the overall recurrence rates were 45.7%, 38.5%, and 39.3% for PDS, ISD, and SDS, respectively. The three-year overall survival rates were 84%, 66%, and 63%, respectively, while the three-year disease-free survival rates were 48%, 51%, and 71%, respectively. Laparoscopic cytoreduction surgery is feasible for advanced ovarian cancer in carefully selected patients, resulting in high rates of optimal cytoreduction, satisfactory peri-operative morbidity, and encouraging survival outcomes. Future studies should focus on establishing standardized selection criteria and conducting well-designed investigations to further refine patient selection and evaluate long-term outcomes.

Advanced ovarian yolk sac tumor: upfront surgery or neoadjuvant chemotherapy followed by interval debulking?

ObjectiveTo compare surgery and survival outcomes between neoadjuvant chemotherapy and primary debulking surgery in patients with advanced ovarian yolk sac tumor.MethodsIn this retrospective cohort analysis, patients with stage III to...

Prognostic Role of Neutrophil, Monocyte and Platelet to Lymphocyte Ratios in Advanced Ovarian Cancer According to the Time of Debulking Surgery.

Despite a multimodal radical treatment, mortality of advanced epithelial ovarian cancer (AEOC) remains high. Host-related factors, such as systemic inflammatory response and its interplay with the immune system, remain underexplored. We hypothesized that the prognostic impact of this response could vary between patients undergoing primary debulking surgery (PDS) and those undergoing interval debulking surgery (IDS). Therefore, we evaluated the outcomes of two surgical groups of newly diagnosed AEOC patients according to the neutrophil, monocyte and platelet to lymphocyte ratios (NLR, MLR, PLR), taking median ratio values as cutoffs. In the PDS group (n = 61), low NLR and PLR subgroups showed significantly better overall survival (not reached (NR) vs. 72.7 months, 95% confidence interval [CI]: 40.9-95.2, p = 0.019; and NR vs. 56.1 months, 95% CI: 40.9-95.2, p = 0.004, respectively) than those with high values. Similar results were observed in progression free survival. NLR and PLR-high values resulted in negative prognostic factors, adjusting for residual disease, BRCA1/2 status and stage (HR 2.48, 95% CI: 1.03-5.99, p = 0.043, and HR 2.91, 95% CI: 1.11-7.64, p = 0.03, respectively). In the IDS group (n = 85), ratios were not significant prognostic factors. We conclude that NLR and PLR may have prognostic value in the PDS setting, but none in IDS, suggesting that time of surgery can modulate the prognostic impact of baseline complete blood count (CBC).

Quality of life in patients with advanced ovarian cancer after primary debulking surgery versus neoadjuvant chemotherapy: results from the randomised SCORPION trial (NCT01461850).

To investigate the effect of treatment with neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS), versus primary debulking surgery (PDS), on quality of life (QoL) in patients with advanced epithelial ovarian cancer (EOC). Randomised trial conducted in a single institution. Division of Gynaecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. Patients with stage-IIIC/IV EOC and high tumour load. Patients were randomised (1:1) to undergo either PDS (PDS group) or NACT followed by IDS (NACT/IDS group). Quality-of-life (QoL) data, assessed using the European Organization for Research and Treatment of Cancer core QoL questionnaire (QLQ-C30) and ovarian cancer module (OV28); co-primary outcomes were the QLQ-C30 global health score at 12 months (cross-sectional analysis) and the difference in mean QLQ-C30 global health score over time between treatment groups (longitudinal analysis). From October 2011 to May 2016, 171 patients were enrolled (PDS = 84; NACT/IDS = 87). We observed no clinical or statistically significant difference between treatment groups in any of the QoL functioning scales at 12 months, including QLQ-C30 global health score (NACT/IDS group vs PDS group, mean difference 4.7, 95% CI -4.99 to 14.4, p = 0.340). Over time, we found lower global health scores for those undergoing PDS than for those receiving NACT (difference in mean score 6.27, 95% CI 0.440-12.11, p = 0.035), albeit this was not clinically relevant. We found no difference in global QoL related to treatment approach at 12 months, even though patients in the NACT/IDS group reported better global health scores across the 12-month period compared with the PDS group; these findings further confirm that NACT/IDS might be a feasible option for patients unsuitable for PDS.

Uptake and Outcomes of Neoadjuvant Chemotherapy Among US Patients With Less Common Epithelial Ovarian Carcinomas

ImportanceRandomized clinical trials examining the effectiveness of neoadjuvant chemotherapy (NACT) for advanced ovarian cancer predominantly included patients with high-grade serous carcinomas. The use and outcomes of NACT in less common epithelial carcinomas are understudied.ObjectiveTo investigate the uptake and survival outcomes in treatment with NACT for less common histologic subtypes of epithelial ovarian cancer.Design, Setting, and ParticipantsA retrospective cohort study and systematic literature review with meta-analysis was conducted using the National Cancer Database from 2006 to 2017 and the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program from 2006 to 2019. Data analysis was performed from July 2022 to April 2023. The evaluation included patients with stage III to IV ovarian cancer with clear cell, mucinous, or low-grade serous histologic subtypes who received multimodal treatment with surgery and chemotherapy.ExposuresExposure assignment per the sequence of treatment: primary debulking surgery (PDS) followed by chemotherapy (PDS group) or NACT followed by interval surgery (NACT group).Main Outcomes and MeasuresTemporal trends and characteristics of NACT use were assessed using multivariable analysis, and overall survival (OS) was assessed with the inverse probability of treatment weighting propensity score.ResultsA total of 3880 patients were examined in the National Cancer Database including 1829 women (median age, 56 [IQR, 49-63] years) with clear cell, 1156 women (median age, 53 [IQR, 42-64] years) with low-grade serous, and 895 women (median age, 57 [IQR, 48-66] years) with mucinous carcinomas. NACT use increased in patients with clear cell (from 10.2% to 16.2%, 58.8% relative increase; P &amp;amp;lt; .001 for trend) or low-grade serous (from 7.7% to 14.2%, 84.4% relative increase; P = .007 for trend) carcinoma during the study period. This association remained consistent in multivariable analysis. NACT use also increased, but nonsignificantly, in mucinous carcinomas (from 8.6% to 13.9%, 61.6% relative increase; P = .07 for trend). Across the 3 histologic subtypes, older age and stage IV disease were independently associated with NACT use. In a propensity score–weighted model, the NACT and PDS groups had comparable OS for clear cell (4-year rates, 31.4% vs 37.7%; hazard ratio [HR], 1.12; 95% CI, 0.95-1.33) and mucinous (27.0% vs 26.7%; HR, 0.90; 95% CI, 0.68-1.19) carcinomas. For patients with low-grade serous carcinoma, NACT was associated with decreased OS compared with PDS (4-year rates, 56.4% vs 81.0%; HR, 2.12; 95% CI, 1.55-2.90). Increasing NACT use and histologic subtype–specific survival association were also found in the Surveillance, Epidemiology, and End Results Program cohort (n = 1447). A meta-analysis of 4 studies, including the current study, observed similar OS associations for clear cell (HR, 1.13; 95% CI, 0.96-1.34; 2 studies), mucinous (HR, 0.93; 95% CI, 0.71-1.21; 2 studies), and low-grade serous (HR, 2.11; 95% CI, 1.63-2.74; 3 studies) carcinomas.Conclusions and RelevanceDespite the lack of data on outcomes of NACT among patients with less common carcinomas, this study noted that NACT use for advanced disease has gradually increased in the US. Primary chemotherapy for advanced-stage, low-grade serous ovarian cancer may be associated with worse survival compared with PDS.

Concordance of Radiological, Laparoscopic and Laparotomic Scoring to Predict Complete Cytoreduction in Women with Advanced Ovarian Cancer.

To identify the best method among the radiologic, laparoscopic and laparotomic scoring assessment to predict the outcomes of cytoreductive surgery in patients with advanced ovarian cancer (AOC). Patients with AOC who underwent pre-operative computed tomography (CT) scan, laparoscopic evaluation, and cytoreductive surgery between August 2016 and February 2021 were retrospectively reviewed. Predictive Index (PI) score and Peritoneal Cancer Index (PCI) scores were used to estimate the tumor load and predict the residual disease in the primary debulking surgery (PDS) and interval debulking surgery (IDS) after neoadjuvant chemotherapy (NACT) groups. Concordance percentages were calculated between the two scores. Among 100 eligible patients, 69 underwent PDS, and 31 underwent NACT and IDS. Complete cytoreduction was achieved in 72.5% of patients in the PDS group and 77.4% in the IDS. In patients undergoing PDS, the laparoscopic PI and the laparotomic PCI had the best accuracies for complete cytoreduction (R0) [area under the curve (AUC) = 0.78 and AUC = 0.83, respectively]. In the IDS group, the laparotomic PI (AUC = 0.75) and the laparoscopic PCI (AUC= 0.87) were associated with the best accuracy in R0 prediction. Furthermore, radiological assessment, through PI and PCI, was associated with the worst accuracy in either PDS or IDS group (PI in PDS: AUC = 0.64; PCI in PDS: AUC = 0.64; PI in IDS: AUC = 0.46; PCI in IDS: AUC = 0.47). The laparoscopic score assessment had high accuracy for optimal cytoreduction in AOC patients undergoing PDS or IDS. Integrating diagnostic laparoscopy in the decision-making algorithm to accurately triage AOC patients to different treatment strategies seems necessary.

Role of diagnostic laparoscopy in deciding primary treatment in advanced-stage ovarian cancer.

We evaluated the usefulness of preoperative diagnostic laparoscopy for treatment planning in patients with advanced-stage ovarian cancer. We retrospectively analyzed 614 patients diagnosed with advanced-stage ovarian cancer between January 2010 and May 2018. Primary debulking surgery (PDS) or neoadjuvant chemotherapy (NAC) followed by interval debulking surgery were selected based on preoperative laparoscopic (Group 1, n=192) and computed tomography findings (Group 2, n=422). The primary outcomes in the PDS and NAC groups were suboptimal cytoreduction (residual disease >1 cm) rate and non-high-grade serous carcinoma (non-HGSC) rate, respectively. The patients who underwent PDS in group 1 and group 2 were 49 (25.5%) and 279 (66.1%), respectively. The suboptimal cytoreduction rate after PDS was lower in Group 1 than in Group 2 (2.0% vs 11.1%, p=0.023). Moreover, Group 1 showed a tendency toward a lower proportion of non-HGSC patients who underwent NAC than that in Group 2 (9.1% vs. 15.4%, p=0.069). Further, Group 1 showed lower rates of postoperative morbidity than Group 2 (5.2% vs. 10.4%, p=0.033). However, Kaplan-Meier analysis showed no significant differences in survival outcomes between the 2 groups. Diagnostic laparoscopy reduced the suboptimal cytoreduction rate in the PDS group and the implementation rate of NAC in non-HGSC patients. Moreover, it reduced postoperative morbidity without affecting survival in both groups. Thus, diagnostic laparoscopy is a valuable diagnostic tool for determining the primary treatment.

Outcomes and long-term follow-up by treatment type for patients with advanced-stage ovarian cancer managed at a tertiary cancer center: A Memorial Sloan Kettering Cancer Center Team Ovary study

ObjectiveTo assess long-term outcomes of patients with advanced-stage ovarian cancer by treatment type. MethodsPatients with newly diagnosed stage III-IV ovarian cancer who underwent primary treatment at our tertiary cancer center from 01/01/2015–12/31/2015 were included. We reviewed electronic medical records for clinicopathological, treatment, and survival characteristics. ResultsOf 153 patients, 88 (58%) had stage III and 65 (42%) stage IV disease. Median follow-up was 65.8 months (range, 3.6–75.3). Eighty-nine patients (58%) underwent primary debulking surgery (PDS), 50 (33%) received neoadjuvant chemotherapy followed by interval debulking surgery (IDS), and 14 (9%) received chemotherapy alone, without surgery (NSx). Median PFS to first recurrence was 26.2 months (range, 20.1–36.2), 13.5 months (range, 12–15.1), and 4.2 months (range, 1.1–5.8) in the PDS, IDS, and NSx groups, respectively (P < .001). At first recurrence/progression, 80 patients (72.7%) were treated with chemotherapy, 28 (25.5%) underwent secondary cytoreductive surgery (CRS) followed by chemotherapy, and 2 (1.8%) received no treatment. Seven patients (4.6%) underwent palliative surgery for malignant bowel obstruction. Overall, 62.7% received 1–3 lines of chemotherapy. The 5-year OS rates were 53.2% (95% CI: 44.7%–61%) for the entire cohort, 71.5% (95% CI: 60.2%–80%) for the PDS group, 35.2% (95% CI: 22.2–48.5%) for the IDS group, and 7.9% (95% CI: 0.5%–29.9%) for the NSx group. ConclusionThe longitudinal treatment modalities and outcomes of patients with advanced ovarian cancer described here can be useful for patient counseling, long-term planning, and future comparison studies.

Preoperative PET/CT score can predict incomplete resection after debulking surgery for advanced serous ovarian cancer better than CT score, MTV, tumor markers and hematological markers.

Complete resection after debulking surgery is strongly associated with prolonged survival for advanced serous ovarian cancer (ASOC). Though positron emission tomography/computed tomography (PET/CT) is more advantageous than computed tomorgraphy (CT) for detecting metastases, studies on the PET/CT prediction model for incomplete resection for ovarian cancer are insufficient. We analyzed and compared the predictive value of preoperative PET/CT score, CT score, metabolic parameters, tumor markers and hematological markers for incomplete resection after debulking surgery for ASOC. A total of 62 ASOC patients who underwent preoperative [18 F]FDG PET/CT and debulking surgery were retrospectively analyzed. PET/CT and CT scores were based on the Suidan model. The predictive value of PET/CT score, CT score, the maximum standardized uptake value (SUVmax), metabolic tumor volume (MTV), human epididymis protein 4 (HE4), cancer antigen 125 (CA125), lymphocyte-to-monocyte ratio (LMR), platelet-to-lymphocyte ratio (PLR) and neutrophil-to-lymphocyte ratio (NLR) for incomplete resection were analyzed and compared. Preoperative PET/CT score had the highest predictive value for incomplete resection in primary debulking surgery group (sensitivity: 65.0%, specificity: 88.9%, area under the ROC curve (AUC): 0.847, p < 0.001), however, in secondary debulking surgery group, preoperative PET/CT score and CT score had the same and highest predictive value for incomplete resection (sensitivity: 80.0%, specificity: 94.7%, AUC: 0.853, p=0.017), compared with preoperative metabolic parameters SUVmax and MTV, tumor markers HE4 and CA125, and hematological markers LMR, PLR and NLR. Preoperative PET/CT score ≥ 3 (Suidan model) and preoperative PET/CT score ≥ 2 predicted a high risk of incomplete resection after primary and secondary debulking surgeries, respectively. There was no statistical difference between primary and secondary debulking surgery groups in predictive value of PET/CT score for incomplete resection (p=0.971). There were significant differences between PET/CT scores and CT scores in primary debulking surgery group and no significant differences in secondary debulking surgery group. A high PET/CT score predicted a high risk of incomplete resection. The preoperative PET/CT score had an identical predictive value in primary and secondary debulking surgery groups. PET/CT score was more accurate in the detection of metastases than CT score was.

The prognostic effect of residual tumor for advanced epithelial ovarian cancer treated with neoadjuvant chemotherapy or primary debulking surgery.

PurposeThe role of neoadjuvant chemotherapy (NACT) and primary debulking surgery (PDS) in advanced epithelial ovarian cancer (EOC) remains controversial. This study aimed to investigate the prognosis between NACT and PDS in advanced EOC. We also investigated the prognostic effect of the residual tumor (RT) after NACT and PDS.MethodsPatients with stage III‐IV EOC diagnosed between 2010 and 2017 were included from the Surveillance, Epidemiology, and End Results (SEER) database. Chi‐square test, multivariate logistic regression analysis, Kaplan–Meier curves, and Cox proportional hazards model were used for statistical analyses.ResultsA total of 5522 women patients were identified, 2017 (36.5%) and 3505 (63.5%) patients received NACT and PDS, respectively. There were 2971 (53.8%), 1637 (29.6%), and 914 (16.6%) patients who had no residual tumor, RT ≤1 cm, and RT >1 cm, respectively. There were 25.5% of patients receiving NACT in 2010 and 48.4% in 2017 (p < 0.001). Women treated with NACT were not related to a higher chance of complete resection than the PDS group (p = 0.098). Patients receiving PDS had significantly better cancer‐specific survival (CSS) than those receiving NACT (p < 0.001). The 5‐year CSS was 35.3% and 51.1% in those receiving NACT and PDS, respectively. In patients receiving NACT, those who had no residual tumor had significantly better CSS compared to those who had RT ≤1 cm (p < 0.001), while comparable CSS was found between those who had RT ≤1 cm and RT >1 cm (p = 0.442). In those receiving PDS, the CSS was decreased with a RT increase (p < 0.001).ConclusionsOur study suggests that PDS may be the optimal procedure for the majority of advanced EOC patients. Complete resection of all residual diseases should be the goal with the increased utilization of NACT.

Incidence of gastrointestinal perforation associated with bevacizumab in combination with neoadjuvant chemotherapy as first-line treatment of advanced ovarian, fallopian tube, or peritoneal cancer: analysis of a Japanese healthcare claims database.

To assess the incidence of bevacizumab-associated gastrointestinal (GI) perforation during first-line treatment of patients with ovarian, fallopian tube, or peritoneal cancer receiving neoadjuvant chemotherapy (NAC) in Japanese real-world clinical practice. A retrospective study was conducted using a healthcare claims database owned by Medical Data Vision Co., Ltd. (study period, 2008-2020). Patients who initiated first-line treatment of ovarian, fallopian tube, or peritoneal cancer were identified and divided into NAC and primary debulking surgery (PDS) groups. The incidence of bevacizumab-associated GI perforation was compared within the NAC group and between the groups. Paclitaxel + carboplatin (TC) was most commonly used as first-line treatment (39.5% and 59.6% in the NAC and PDS groups, respectively). TC + bevacizumab was used in 9.3% and 11.6% of patients in the NAC and PDS groups, respectively. In the NAC group receiving TC, the proportion of patients with risk factors for GI perforation was lower among patients with versus without concomitant bevacizumab. The incidence of GI perforation in the NAC group was 0.38% (1/266 patients) in patients receiving TC + bevacizumab and 0.18% (2/1,131 patients) in patients receiving TC without bevacizumab (risk ratio=2.13; 95% confidence interval [CI]=0.19 to 23.36; risk difference=0.20; 95% CI=-0.58 to 0.97). None of the 319 patients in the PDS group receiving TC + bevacizumab had GI perforation. No notable increase was observed in GI perforation associated with NAC containing bevacizumab. We conclude that bevacizumab is prescribed with sufficient care in Japan to avoid GI perforation.

A New Paradigm in Managing Advanced Ovarian Cancer: Differentiating Patients Requiring Neoadjuvant Treatment from Primary Cytoreduction.

Simple SummaryThis study evaluates the comparability of patients treated with primary cytoreduction and patients undergoing neoadjuvant chemotherapy for advanced stages high grade serous ovarian carcinoma by comparing the preoperative and postoperative characteristics after a propensity score matching analysis during ten years in a tertiary cancer center.Our study aims to evaluate the comparability of primary debulking surgery (PDS) and neoadjuvant chemotherapy (NACT) patients. This single-center retrospective study includes all patients treated for advanced stages high-grade serous ovarian carcinomas (HGSOC) between 2007 and 2017. Preoperative characteristics and postoperative outcomes were compared after a propensity score matching analysis. Of the 221 patients included, 38% underwent PDS, and 62% received NACT. There was no age difference at diagnosis; however, CA125 levels, PCI score levels, and rates of stage IV were higher in the NACT group. There were no differences concerning the rate and the severity of complications (p = 0.29). The propensity score distribution showed a broad distinction between PDS patients and NACT patients with no significant overlap. Survival analyses demonstrate, after a median follow-up of 66.5 months, an overall survival (OS) of 105.9 and progression-free survival (PFS) of 29.2 months in the PDS group, compared to OS of 52.8 and PFS of 18.9 months in the NACT group. Advanced HGSOC is a heterogeneous population, in which inoperable patients should be differentiated from PDS patients based on many factors, primarily tumor burden.

Preoperative serum CA-125 level as a predictor for the extent of cytoreduction in patients with advanced stage epithelial ovarian cancer.

BackgroundOvarian cancer is the seventh most common cancer in women worldwide and the eighth most common cause of cancer death. Due to the lack of effective early detection strategies and the unspecific onset of symptoms, it is diagnosed at an advanced stage in 75% of cases. The cancer antigen (CA) 125 is used as a prognostic marker and its level is elevated in more than 85% of women with advanced stages of epithelial ovarian cancer (EOC). The standard treatment is primary debulking surgery (PDS) followed by adjuvant chemotherapy (ACT), but the later approach is neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). Several studies have been conducted to find out whether preoperative CA-125 serum levels influence treatment choice, surgical resection and survival outcome. The aim of our study was to analyse experience of single institution as Cancer comprehensive center with preoperative usefulness of CA-125.Patients and methodsAt the Institute of Oncology Ljubljana a retrospective analysis of 253 women with stage FIGO IIIC and IV ovarian cancer was conducted. Women were divided into two groups based on their primary treatment. The first group was the NACT group (215 women) and the second the PDS group (38 women). The differences in patient characteristics were compared using the Chi-square test and ANOVA and the Kaplan-Meier method was used for calculating progression-free survival (PFS) and overall survival (OS).ResultsThe median serum CA-125 level was higher in the NACT group than in the PDS group, 972 IU/ml and 499 IU/ ml, respectively. The PFS in the NACT group was 8 months (95% CI 6.4–9.5) and 18 months (95% CI 12.5–23.4) in the PDS group. The median OS was lower in the NACT group than in the PDS group, 25 months (95% CI 20.6–29.5) and 46 months (95% CI 32.9–62.1), respectively.ConclusionsPreoperative CA-125 cut off value of 500 IU/ml is a promising threshold to predict a successful PDS.

Management of Advanced Staged Ovarian Cancer in a National Cancer Center: Comparison of the Efficacy of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy

Background: In most cases, ovarian cancer is diagnosed at an advanced stage. The aim of this study was to determine if Primary Debulking Surgery (PDS) for women with advanced epithelial ovarian cancer is an equivalent treatment approach to neoadjuvant chemotherapy (NACT). Methods: A retrospective analysis of 214 women with stage FIGO IIIC and IV ovarian cancer was performed at the Institute of Oncology Ljubljana, Slovenia. Women were divided into two groups based on their primary treatment. The first group was the NACT group (184 women) and the second the PDS group (30 women). The selection of the women for PDS or NACT was based on the expertise of the gynecological-oncological surgeon and the image exam results. We used the Kaplan-Meier method for calculating Overall Survival (OS) and Progression-Free Survival (PFS). The statistical analysis was performed with IBM SPSS. Results: The median OS was lower in the NACT group than in the PDS group, 25 months (95% CI 20.6-29.5) and 46 months (95% CI 32.9-62.1), respectively. The PFS in the NACT group was 8 months (95% CI 6.4-9.5) and 18 months (95% CI 12.5-23.4) in the PDS group. For women treated with PDS the 5-year survival rate was 36.7% and 20.1% in the NACT group. Conclusion: In this study, the best survival results were observed in women treated with PDS, followed by adjuvant chemotherapy. If a woman is not suitable for surgery, NACT doubles the chance of a complete gross resection. Despite higher rates of complete gross resection after NACT, women treated with PDS (complete gross resection or optimal surgery) had higher OS.

Neoadjuvant chemotherapy before surgery versus surgery followed by chemotherapy for initial treatment in advanced ovarian epithelial cancer.

Epithelial ovarian cancer presents at an advanced stage in the majority of women. These women require a combination of surgery and chemotherapy for optimal treatment. Conventional treatment has been to perform surgery first and then give chemotherapy. However, there may be advantages to using chemotherapy before surgery. To assess whether there is an advantage to treating women with advanced epithelial ovarian cancer with chemotherapy before debulking surgery (neoadjuvant chemotherapy (NACT)) compared with conventional treatment where chemotherapy follows debulking surgery (primary debulking surgery (PDS)). We searched the following databases up to 9 October 2020: the Cochrane Central Register of Controlled Trials (CENTRAL), Embase via Ovid, MEDLINE (Silver Platter/Ovid), PDQ and MetaRegister. We also checked the reference lists of relevant papers that were identified to search for further studies. The main investigators of relevant trials were contacted for further information. Randomised controlled trials (RCTs) of women with advanced epithelial ovarian cancer (Federation of International Gynaecologists and Obstetricians (FIGO) stage III/IV) who were randomly allocated to treatment groups that compared platinum-based chemotherapy before cytoreductive surgery with platinum-based chemotherapy following cytoreductive surgery. Two review authors independently extracted data and assessed risk of bias in each included trial. We extracted data of overall (OS) and progression-free survival (PFS), adverse events, surgically-related mortality and morbidity and quality of life outcomes. We used GRADE methods to determine the certainty of evidence. We identified 2227 titles and abstracts through our searches, of which five RCTs of varying quality and size met the inclusion criteria. These studies assessed a total of 1774 women with stage IIIc/IV ovarian cancer randomised to NACT followed by interval debulking surgery (IDS) or PDS followed by chemotherapy. We pooled results of the four studies where data were available and found little or no difference with regard to overall survival (OS) (Hazard Ratio (HR) 0.96, 95% CI 0.86 to 1.08; participants = 1692; studies = 4; high-certainty evidence) or progression-free survival in four trials where we were able to pool data (Hazard Ratio 0.98, 95% CI 0.88 to 1.08; participants = 1692; studies = 4; moderate-certainty evidence). Adverse events, surgical morbidity and quality of life (QoL) outcomes were variably and incompletely reported across studies. There are probably clinically meaningful differences in favour of NACT compared to PDS with regard to overall postoperative serious adverse effects (SAE grade 3+): 6% in NACT group, versus 29% in PDS group, (risk ratio (RR) 0.22, 95% CI 0.13 to 0.38; participants = 435; studies = 2; heterogeneity index (I2) = 0%; moderate-certainty evidence). NACT probably results in a large reduction in the need for stoma formation: 5.9% in NACT group, versus 20.4% in PDS group, (RR 0.29, 95% CI 0.12 to 0.74; participants = 632; studies = 2; I2 = 70%; moderate-certainty evidence), and probably reduces the risk of needing bowel resection at the time of surgery: 13.0% in NACT group versus 26.6% in PDS group (RR 0.49, 95% CI 0.30 to 0.79; participants = 1565; studies = 4; I2 = 79%; moderate-certainty evidence). NACT reduces postoperative mortality: 0.6% in NACT group, versus 3.6% in PDS group, (RR 0.16, 95% CI 0.06 to 0.46; participants = 1623; studies = 5; I2 = 0%; high-certainty evidence). QoL on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scale produced inconsistent and imprecise results in three studies (MD -0.29, 95% CI -2.77 to 2.20; participants = 524; studies = 3; I2 = 81%; very low-certainty evidence) but the evidence is very uncertain and should be interpreted with caution. The available high to moderate-certainty evidence suggests there is little or no difference in primary survival outcomes between PDS and NACT. NACT probably reduces the risk of serious adverse events, especially those around the time of surgery, and reduces the risk of postoperative mortality and the need for stoma formation. These data will inform women and clinicians (involving specialist gynaecological multidisciplinary teams) and allow treatment to be tailored to the person, taking into account surgical resectability, age, histology, stage and performance status. Data from an unpublished study and ongoing studies are awaited.

Analysis of factors related to the prognostic benefit of neoadjuvant chemotherapy followed by interval debulking surgery in patients with advanced ovarian cancer

Objective: To explore the prognostic factors of patients with advanced epithelial ovarian cancer (EOC) who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). Methods: The clinical and pathological data of patients with stage Ⅲc-Ⅳ EOC underwent surgical treatment in Sichuan Cancer Center from January 1st, 2014 to December 31th, 2018 were retrospectively analyzed, and the prognosis was followed up. Results: (1) A total of 216 EOC patients were included in the study, whose age was (52.1±8.7) years old, the median follow-up time was 44.6 months (17.2-80.1 months), the median progression free survival (PFS) was 11.1 months (8.5-13.8 months), and the median overall survival (OS) was 40.0 months (32.7-47.3 months). (2) Among 216 patients with advanced EOC, there were 75 cases in the primary debulking surgery (PDS) group and 141 cases in the NACT+IDS group. Compared with the PDS group, the serum CA125 level before treatment (median: 859.4 vs 1 371.0 kU/L), proportion of stage Ⅳ patients [5.3% (4/75) vs 23.4% (33/144)] and no visible residual disease (R0) cytoreduction rate in the NACT+IDS group were significantly higher [(41.3% (31/75) vs 61.7% (87/144); all P<0.05]. The median PFS in the NACT+IDS group was significantly shorter than that of the PDS group (9.1 vs 15.2 months; χ2=7.014, P=0.008), but there was no significant difference in the median OS between the two groups (42.6 vs 38.0 months; χ2=1.325, P=0.250). (3) Univariate analysis showed that body mass index (BMI), preoperative serum CA125 level, surgical-pathological stage, NACT effect, postoperative residual tumor size, time to initiation of postoperative chemotherapy and chemotherapy regimen were significantly correlated with PFS in the NACT+IDS group (all P<0.05); preoperative serum CA125 level, surgical-pathological stage, NACT effect, postoperative residual tumor size, postoperative chemotherapy regimen were significantly related with OS in the NACT+IDS group (all P<0.05). Multivariate analysis showed that BMI, postoperative residual tumor size, time to initiation of postoperative chemotherapy were independent factors of PFS in the NACT+IDS group (all P<0.05); preoperative serum CA125 level, surgical-pathological stage, postoperative residual tumor size were independent factors of OS in the NACT+IDS group (all P<0.05). The results showed that the PFS of patients with normal preoperative serum CA125 level and (or) chemotherapy ≤7 days after IDS was longer, while no significant difference comparable with those in the PDS group (P>0.05), and OS was also showing an prolonged trend, but the difference was also not statistically significant (P>0.05). Conclusions: Normal CA125 before IDS and time received chemotherapy no longer than 7 days after IDS are two related factors of prognosis benefit in advance EOC patients treated with NACT+IDS. Therefore, timely adjustment of the dose and regimen of NACT to reduce CA125 level to normal range in about three cycles before IDS, and strengthen IDS perioperative management to promote postoperative recovery and perform chemotherapy as soon as possible might help to improve the prognosis of patients.

Postoperative outcomes of primary and interval cytoreductive surgery for advanced ovarian cancer registered in the Dutch Gynecological Oncology Audit (DGOA)

ObjectivesThe challenge when performing cytoreductive surgery (CRS) is to balance the benefits and risks. The aim of this study was to report short term postoperative morbidity and mortality in relation to surgical outcome in patients undergoing primary debulking surgery (PDS) or interval debulking (IDS) surgery in the Netherlands. MethodsThe Dutch Gynecological Oncology Audit (DGOA) was used for retrospective analysis. Patients undergoing PDS or IDS between January 1st, 2015 - December 31st, 2018 were included. Outcome was frequency of postoperative complications. Median time to adjuvant chemotherapy and severity of complications were related to outcome of CRS. Complications with Clavien-Dindo ≥3 were analyzed per region and case mix corrected. Statistical analysis was performed with R.Studio. Results1027 patients with PDS and 1355 patients with IDS were included. Complications with re-invention were significantly higher in PDS compared to IDS (5.7% vs. 3.6%, p = 0.048). Complete cytoreduction was 69.7% in PDS and 62.1% IDS, p < 0.001. Time to adjuvant chemotherapy was 49 days in patients with complete CRS and a complication with re-intervention. Regional variation for severe complications showed one region outside confidence intervals. ConclusionsHigher complete cytoreduction rate in the PDS group indicates that the correct patients have been selected, but is associated with a higher percentage of complication with re-intervention. As result, time to start adjuvant chemotherapy is longer in this group. Maintaining a balance in aggressiveness of surgery and outcome of the surgical procedure with respect to severe complications is underlined. Bench marked data should be discussed nationally to improve this balance.

Comparison of Survival Between Primary Debulking Surgery Versus Neoadjuvant Chemotherapy for Ovarian Cancers in a Personalized Treatment Cohort

ObjectiveTo compare survival between primary debulking surgery (PDS) and neoadjuvant chemotherapy (NACT) for the treatment of ovarian cancer patients per our selective protocol.MethodsBetween Sep 1st, 2015, and Aug 31st, 2017, 161 patients were enrolled in our prospective cohort. All of the patients received preoperative clinic-radiological assessments, according to the Suidan criteria for R0 resection. Patients with a score of 0–2 received PDS. Patients with a score of ≥3 were counseled on the choices of PDS, NACT, or an optional staging laparoscopy, according to the Fagotti criteria. Clinic-pathological data were prospectively collected until May 1st, 2020, and the impacts of different treatment strategies on progression-free survival (PFS) and overall survival (OS) were analyzed.Results110 patients underwent PDS, and 51 patients received NACT with consequent interval debulking surgery. The R0 resection rate was 57.8%. All but one of the patients received platinum-based chemotherapy, and 105 (65.2%) patients were platinum-sensitive. Based on the univariate analysis, the PDS group exhibited prolonged PFS compared with the NACT group (P=0.029). The subgroup analysis showed that patients receiving NACT with residual disease (RD) exhibited the worst PFS (P=0.001). Based on the multivariate analysis, NACT with RD was still an independent impaired factor for PFS (P=0.04). However, NACT did not affect OS in the univariate or multivariate analyses.ConclusionIn our prospective cohort, NACT ovarian patients exhibited inferior PFS and noninferior OS compared with PDS patients. Given our selective protocol, NACT cannot be arbitrarily denied while appropriate PDS is still a priority.

Neoadjuvant Chemotherapy Followed by Surgery versus Primary Surgery in Advanced Epithelial Ovarian Cancer: A Review of Outcomes at National Institute of Cancer Research Hospital in Bangladesh

Introduction: This study evaluated the difference in operative and clinical outcomes for patients with advanced ovarian cancer after primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) in Bangladesh. Methods: Sixty patients with advanced epithelial ovarian cancer presenting to the department of Gynaecological Oncology at the National Institute of Cancer Research and Hospital were prospectively enrolled. Thirty patients underwent primary debulking surgery and thirty patients received NACT followed by IDS. Results: In the PDS and IDS groups respectively, 56.7% and 50% of patients presented with stage IIIC and 67.7% and 56.7% respectively had serious papillary type histopathology. Duration of surgery, amount of blood loss and total hospital stay were significantly lower (p in the PDS group. There was a statistically significant difference in postoperative tumor residuals between IDS and PDS patients. Complete tumor resection (R0) was obtained in 24 (80%) of IDS patients versus 13 (43.3%) PDS patients. In fifteen months of follow-up, 21 (70%) in the PDS group and 5 (16.7%) in the IDS group recurred (p = 0.021). Median progression free survival in PDS patients was twelve months while that of the IDS group was seventeen months. There was one death at 45 days in the PDS group. No other deaths were documented at fifteen months of follow-up. Conclusion: Interval debulking surgery has a more favorable outcome than primary debulking surgery on progression free survival in advanced ovarian cancer patients and permits a less aggressive surgery to be performed in Bangladesh.