Patterns of initial ovarian cancer recurrence on niraparib maintenance monotherapy in patients with no baseline evidence of disease after first-line chemotherapy: An ad hoc subgroup analysis of PRIMA/ENGOT-OV26/GOG-3012.

OBJECTIVES: Patterns of disease recurrence on poly(ADP-ribose) polymerase inhibitor maintenance therapy are unclear and may affect subsequent treatment. This ad hoc subgroup analysis of the phase 3 PRIMA/ENGOT-OV26/GOG-3012 study evaluated patterns of initial recurrence in patients with advanced ovarian cancer (AOC). METHODS: PRIMA included participants at high risk for disease progression. This ad hoc analysis only evaluated participants randomized to niraparib maintenance without evidence of disease at baseline. The number and site(s) of initial recurrent lesions at investigator-assessed progressive disease (PD) were evaluated. RESULTS: Of the 314 niraparib-treated patients analyzed, 190 developed ≥1 new lesion (median number of new lesions, 1.0; interquartile range, 1-2). In total, 93.2% (177/190) of patients developed 1-3 lesions at first disease progression. The most common sites of recurrence were the peritoneum (30.0% [57/190]), lymph nodes (26.3% [50/190]), and liver (20.5% [39/190]). Similar results were observed when patients with PD were stratified by biomarker status, disease stage at diagnosis, and type of debulking surgery. Patients with homologous recombination-proficient tumors, stage III disease, or a history of primary debulking developed a median of 2.0 new lesions at first progression; patients with homologous recombination-deficient tumors, stage IV disease, or a history of interval debulking developed a median of 1.0 new lesion. CONCLUSIONS: Many patients with AOC without lesions at first-line maintenance treatment initiation develop oligometastatic disease at first recurrence. Prospective evaluation is required to determine whether these patients have improved outcomes when local therapies are combined with continuous, systemic, targeted maintenance therapy.

Textbook oncologic outcome is an easy-to-use composite quality measure that is strongly associated with survival in advanced-stage ovarian cancer.

OBJECTIVE: Textbook oncologic outcome (TOO) has been validated in surgical oncology as a composite quality measure correlated with oncologic outcomes. We aimed to assess the association between TOO and overall survival (OS) in patients undergoing primary treatment for advanced epithelial tubo-ovarian cancer (AEOC). METHODS: Patients undergoing surgery for AEOC between 2008 and 2019 were identified in the National Cancer Database (NCDB). Primary debulking surgery (PDS) and interval debulking surgery (IDS) cohorts were analyzed separately. TOO was defined as achieving complete debulking, length of hospital stay <10 days, no 30-day readmission, no death within 90 days, and initiation of adjuvant chemotherapy within 42 days. The Kaplan-Meier method was used to estimate 5-year OS by TOO status and Cox regression to evaluate the relationship between TOO and death within 5 years. RESULTS: A total of 21,657 patients were included: 51.4% in the PDS cohort and 48.6% in the IDS cohort. TOO was achieved (TOO+) in 20.5% of the PDS cohort and 39.2% of the IDS cohort. For the PDS cohort, achieving TOO was associated with improved 5-year OS: 59.0% TOO+ vs. 39.5% TOO- (HR 0.53, 95% CI 0.49-0.57). For the IDS cohort, a similar benefit was seen for 5-year OS: 43.9% TOO+ vs. 31.2% TOO- (HR 0.67, 95% CI 0.63-0.70). Multivariable analysis demonstrated that patients achieving TOO were at lower risk of death within 5 years in both the PDS cohort (HR 0.58, 95% CI 0.54-0.62) and the IDS cohort (HR 0.69, 95% CI 0.65-0.73). CONCLUSIONS: The TOO composite measure is associated with improved long-term survival and could be a useful quality assessment tool for patients undergoing primary treatment for AEOC, irrespective of surgical timing. This tool reflects the ability to deliver risk-based individualized decision-making using a multidisciplinary approach.

The impact of perioperative transfusions on the oncologic outcomes of patients with ovarian cancer: A population-based study.

Perioperative blood transfusion in ovarian cancer patients was associated with a 28% increase in all-cause mortality. The negative impact of perioperative blood transfusion extends beyond the immediate postoperative period. OBJECTIVES: The effect of perioperative blood transfusions on long-term oncologic outcomes of patients with advanced ovarian cancer undergoing cytoreductive surgery remains uncertain. Our study aims to determine the association between perioperative blood transfusion and all-cause mortality in this population. METHODS: Using province-wide administrative databases, patients with advanced ovarian cancer who underwent surgery between 2007 and 2021 as part of first-line treatment were identified. Perioperative transfusion was defined as any transfusion from date of surgery to discharge from hospital. Multivariable Cox proportional hazards regression models were used to determine if there was an independent association of transfusion with all-cause mortality, accounting significant confounders. RESULTS: A total of 5891 patients had cytoreductive surgery for advanced ovarian cancer between 2007 and 2021, of which 2898 (49.2%) had interval cytoreductive surgery (ICS) and 2993 (50.8%) had primary cytoreductive surgery (PCS). Perioperative blood transfusion was given to 37.3% of patients (40.5% ICS and 34.2% PCS). On multivariable analysis, there was an increased hazard of all-cause mortality for patients receiving perioperative transfusion compared to those who did not (hazard ratio: 1.28; 95% CI: 1.20-1.37). The association of increased all-cause mortality was observed starting 1 year after surgery, was sustained thereafter, and seen in both ICS and PCS groups. CONCLUSION: Perioperative blood transfusion after cytoreductive surgery for ovarian cancer is common in Ontario, Canada and was significantly associated with an increase in all-cause mortality. Blood transfusion is a poor prognostic factor, and the negative impact of blood transfusion persists beyond the immediate postoperative period.

Diagnosis, treatment and burden in advanced ovarian cancer: a UK real-world survey of healthcare professionals and patients.

Aim: Little is known regarding uptake of epithelial ovarian cancer (EOC) treatments or patient burden in UK real-world practice.Methods: Cross-sectional surveys of patients with advanced EOC and healthcare professionals (HCPs).Results: 101 HCPs and 142 patients participated. Time from initial primary care consultation to diagnosis was ∼7 weeks. 83% patients were offered hereditary genetic testing, with 89% uptake. 53% HCPs reported surgery was performed ≤1 month in non-neoadjuvant setting. Surgery delay negatively impacted patient quality of life (61%), mental health (89%), and surgical outcomes (63%). 56% patients received active first-line maintenance treatment; patients on active surveillance had greater emotional/psychological distress.Conclusion: Treatment delays and low uptake of active first-line treatment should be addressed. Emotional support must be readily accessible throughout treatment.

What is this article about? New treatments for ovarian cancer mean that patients could be treated and live with the disease for many years. However, not much is known about the treatments that are actually received by patients with ovarian cancer in real-life. These surveys were done to learn more about the treatment and experience of patients with ovarian cancer in the UK.What were the results? 101 healthcare professionals (HCPs) and 142 patients took the surveys. The surveys found that patients usually waited about 7 weeks from their first GP visit to diagnosis of ovarian cancer. Half of HCPs reported that patients had surgery within 1 month of the decision that surgery was needed. HCPs reported that delays in surgery had a negative impact on patient quality of life, mental health, and the success of the surgery. After finishing their first line of chemotherapy, about half of patients had a maintenance treatment to control their ovarian cancer and give them as long as possible between recurrences. The remaining patients were not given treatment but were watched for further signs of cancer. Patients on maintenance treatment experienced less emotional/psychological distress than those managed by watchful waiting.What do the results of the study mean? This survey shows that more needs to be done to make sure that patients with ovarian cancer in the UK are diagnosed and treated quickly and offered the right treatment. Emotional support should be available to patients during their treatment.

Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial.

BACKGROUND: In the PAOLA-1/ENGOT-ov25 primary analysis, maintenance olaparib plus bevacizumab demonstrated a significant progression-free survival (PFS) benefit in newly diagnosed advanced ovarian cancer patients in clinical response after first-line platinum-based chemotherapy plus bevacizumab, irrespective of surgical status. Prespecified, exploratory analyses by molecular biomarker status showed substantial benefit in patients with a BRCA1/BRCA2 mutation (BRCAm) or homologous recombination deficiency (HRD; BRCAm and/or genomic instability). We report the prespecified final overall survival (OS) analysis, including analyses by HRD status. PATIENTS AND METHODS: Patients were randomized 2 : 1 to olaparib (300 mg twice daily; up to 24 months) plus bevacizumab (15 mg/kg every 3 weeks; 15 months total) or placebo plus bevacizumab. Analysis of OS, a key secondary endpoint in hierarchical testing, was planned for ∼60% maturity or 3 years after the primary analysis. RESULTS: After median follow-up of 61.7 and 61.9 months in the olaparib and placebo arms, respectively, median OS was 56.5 versus 51.6 months in the intention-to-treat population [hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.76-1.12; P = 0.4118]. Subsequent poly(ADP-ribose) polymerase inhibitor therapy was received by 105 (19.6%) olaparib patients versus 123 (45.7%) placebo patients. In the HRD-positive population, OS was longer with olaparib plus bevacizumab (HR 0.62, 95% CI 0.45-0.85; 5-year OS rate, 65.5% versus 48.4%); at 5 years, updated PFS also showed a higher proportion of olaparib plus bevacizumab patients without relapse (HR 0.41, 95% CI 0.32-0.54; 5-year PFS rate, 46.1% versus 19.2%). Myelodysplastic syndrome, acute myeloid leukemia, aplastic anemia, and new primary malignancy incidence remained low and balanced between arms. CONCLUSIONS: Olaparib plus bevacizumab provided clinically meaningful OS improvement for first-line patients with HRD-positive ovarian cancer. These prespecified exploratory analyses demonstrated improvement despite a high proportion of patients in the placebo arm receiving poly(ADP-ribose) polymerase inhibitors after progression, confirming the combination as one of the standards of care in this setting with the potential to enhance cure.

The 2022 PSOGI International Consensus on HIPEC Regimens for Peritoneal Malignancies: Epithelial Ovarian Cancer.

BACKGROUND AND AIM: We report the results of an international consensus on hyperthermic intraperitoneal chemotherapy (HIPEC) regimens for epithelial ovarian cancer (EOC) performed with the following goals: To define the indications for HIPEC To identify the most suitable HIPEC regimens for each indication in EOC To identify areas of future research on HIPEC To provide recommendations for some aspects of perioperative care for HIPEC METHODS: The Delphi technique was used with two rounds of voting. There were three categories of questions: evidence-based recommendations [using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system with the patient, intervention, comparator, and outcome (PICO) method], an opinion survey, and research recommendations. RESULTS: Seventy-three (67.5%) of 108 invited experts responded in round I, and 68 (62.9%) in round II. Consensus was achieved for 34/38 (94.7%) questions. However, a strong positive consensus that would lead to inclusion in routine care was reached for only 6/38 (15.7%) questions. HIPEC in addition to interval cytoreductive surgery (CRS) received a strong positive recommendation that merits inclusion in routine care. Single-agent cisplatin was the only drug recommended for routine care, and OVHIPEC-1 was the most preferred regimen. The panel recommended performing HIPEC for a minimum of 60 min with a recommended minimum intraabdominal temperature of 41°C. Nephroprotection with sodium thiosulfate should be used for cisplatin HIPEC. CONCLUSIONS: The results of this consensus should guide clinical decisions on indications of HIPEC and the choice and various parameters of HIPEC regimens and could fill current knowledge gaps. These outcomes should be the basis for designing future clinical trials on HIPEC in EOC.

Consensus statements and treatment algorithm to guide clinicians in the selection of maintenance therapy for patients with newly diagnosed, advanced ovarian carcinoma: Results of a Delphi study.

INTRODUCTION: Standard treatment of newly diagnosed, advanced ovarian carcinoma (OC) consists of cytoreductive surgery followed by platinum-based chemotherapy with or without bevacizumab. Maintenance therapy with PARP inhibitors and olaparib-bevacizumab has recently shown to significantly improve progression-free survival in the first-line setting. Some practical aspects of maintenance therapy, however, are still poorly defined. AIM OF THE STUDY: To provide guidance to clinicians in the selection of maintenance therapy for newly diagnosed, advanced ovarian carcinoma. METHODS: A board of six gynecologic oncologists with expertise in the treatment of OC in Italy convened to address issues related to the new options for maintenance treatment. Based on scientific evidences, the board produced practice-oriented statements. Consensus was reached via a modified Delphi study that involved a panel of 22 experts from across Italy. RESULTS: Twenty-seven evidence- and consensus-based statements are presented, covering the following areas of interest: use of biomarkers (BRCA mutations and presence of homologous recombination deficiency); timing and outcomes of surgery; selection of patients eligible for bevacizumab; definition of response to treatment; toxicity and contraindications; evidence of synergy of bevacizumab plus PARP inhibitor. Two treatment algorithms are also included, for selecting maintenance therapy based on timing and outcomes of surgery, response to platinum-based chemotherapy and biomarker status. A score for the assessment of response to chemotherapy is proposed, but its validation is ongoing. CONCLUSIONS: We provide here consensus statements and treatment algorithms to guide clinicians in the selection of appropriate and personalized maintenance therapy in the first-line setting of advanced OC management.

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

OBJECTIVE: 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). DESIGN: Randomised trial conducted in a single institution. SETTING: Division of Gynaecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. SAMPLE: Patients with stage-IIIC/IV EOC and high tumour load. METHODS: Patients were randomised (1:1) to undergo either PDS (PDS group) or NACT followed by IDS (NACT/IDS group). MAIN OUTCOME MEASURES: 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). RESULTS: 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. CONCLUSIONS: 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.

NIRVANA-1: maintenance therapy with niraparib versus niraparib-bevacizumab in patients with advanced ovarian cancer.

Following the results of the PRIMA and PAOLA-1 trials, the most effective maintenance strategy for International Federation of Gynecology and Obstetrics stage III patients is still debated, raising the question which of those two maintenance strategies is the most effective: PARP inhibitors alone or PARP inhibitors in combination with bevacizumab. The ongoing NIRVANA-1 study will try to answer this question by assessing the efficacy and safety of niraparib + bevacizumab in comparison with niraparib alone after adjuvant chemotherapy for completely resected stage III patients. Stratification factors include tumor BRCA status, International Federation of Gynecology and Obstetrics stage (IIIA vs IIIB/IIIC) and the use of hyperthermic intraperitoneal chemotherapy during surgery - within the OVHIPEC-2 trial. The primary end point will be progression-free survival rate at 24 months. Safety, median progression-free survival and overall survival will also be studied.

In many patients with ovarian cancer who are treated with platinum-based chemotherapy after surgery, the tumor comes back several months later. In order to minimize this risk, one treatment approach that has shown promising results is PARP inhibitors. This treatment works by inhibiting cancer cells' ability to repair themselves after DNA damage. One of the PARP inhibitors approved by medical authorities is niraparib, used as a solo therapy after surgery and chemotherapy. Nevertheless, the most effective maintenance strategy for patients in this setting is still debated. In a worldwide clinical trial called NIRVANA-1, researchers are investigating how niraparib would work if combined with another treatment called bevacizumab, which stops the growth of new blood vessels in tumors. Patients who participate in this trial will be randomly assigned to one of two treatment groups: the combination of niraparib + bevacizumab or niraparib by itself. The main purpose of NIRVANA-1 is to understand whether the combination of niraparib and bevacizumab prevents the cancer from returning in patients with completely resected stage III ovarian cancer. The trial will also assess the safety of this combination compared with niraparib alone. At the time of this writing, NIRVANA-1 is open for new patients to join. Sponsored by ARCAGY-GINECO, the NIRVANA-1 trial is currently recruiting patients from France, Spain, Italy, Belgium, Japan and Korea. The duration of the inclusion period is estimated to be around 36 months. The study is registered on ClinicalTrial.gov with registration number NCT05183984.

Comparison of advanced ovarian cancer patients treated with or without bevacizumab in the US Community Oncology Clinics.

Aim: Real-world data on treatment patterns and outcomes of advanced ovarian cancer (OC) patients since bevacizumab approval in first-line (1L) OC treatment were assessed. Materials & methods: In this descriptive retrospective study using the ConcertAI Oncology Dataset, patient characteristics, treatment patterns and real-world progression-free survival (rwPFS) from start of 1L were evaluated among patients diagnosed with advanced OC between 2011-2020. Treatment data from structured sources were confirmed and/or supplemented by human review of unstructured data. Results: Median rwPFS for bevacizumab and non bevacizumab cohorts was 17.3 months (95% CI: 14.9, 20.4) and 15.7 months (95% CI: 12.3, 29.1), respectively. Patients with ≥10 doses during 1L had higher median rwPFS compared with patients receiving 3-9 doses. Conclusion: This real-world study suggests benefits of bevacizumab treatment in advanced OC were primarily experienced by patients who received ≥10 doses in 1L.

What is this article about? Bevacizumab (Avastin) is a medicine that treats cancer. It makes it harder for the cancer to get nutrients from blood. At first, you could only use it after other cancer medicine did not work. From 2018, bevacizumab could be used with cancer medicine as the first treatment. Experts said it should continue for a year after cancer medicine stopped. This would make it harder for the cancer to come back. What did we do? We checked if more patients got bevacizumab as their first medicine after 2018 approval. We also saw how long it took for the cancer to come back. We did this by looking at electronic medical records between January 2011 and August 2020. We looked for women who had cancer that was staring to spread or had spread. We compared women who got bevacizumab to women who only got other cancer medicines. What were the results? After 2018, more women got bevacizumab early. We saw that the cancer did not take longer to come back. We noticed that half the women took bevacizumab less than ten-times out of up to 22-times. The cancer took longer to come back for women who took bevacizumab ten or more times. What do the result mean? We do not know why so many women stopped treatment early. Other studies in different countries also showed better results for women who got more bevacizumab. This study can help doctors and patients decide how much bevacizumab to give when they might be thinking of stopping treatment.

Incidence of and survival after surgical intervention for bowel obstruction in women with advanced ovarian cancer.

INTRODUCTION: Women with advanced ovarian cancer commonly present with peritoneal disease both at primary diagnosis and relapse, with risk of subsequent bowel obstruction. The aims of this study were to assess the cumulative incidence of and survival after intervention for bowel obstruction in women with advanced ovarian cancer, to identify factors predictive of survival and the extent to which the intended outcome of the intervention was achieved. MATERIAL AND METHODS: Women diagnosed with advanced ovarian cancer stages III and IV in 2009-2011 and 2014-2016 in the Stockholm-Gotland Region in Sweden were identified in the Swedish Quality Registry for Gynecologic Cancer. Through hospital records, types of intended and executed interventions for bowel obstruction were assessed, and as well as when in the course of oncologic treatment, the intervention was performed. Time from first intervention to death was analyzed with survival methodology and proportional hazard regression was used. RESULTS: Of 751 identified women, 108 had an intervention for bowel obstruction. Laparotomy was the most prevalent intervention and was used in 87% (94/108) of all women, with a success rate of 87% (82/94). An intervention for bowel obstruction was performed before or during first line treatment in 32% (35/108) with a cumulative incidence in the whole cohort of 14% (108/751, 95% confidence interval [CI] 11-16). Median survival after intervention for bowel obstruction was 4 months (95% CI 3-6). The hazard of death increased when the intervention was performed after completion of primary treatment (HR 4.46, 95% CI 1.61-12.29, P < 0.01), with a median survival of 3 months. In women subjected to radical surgery during primary treatment, the hazard of death after intervention for bowel obstruction decreased (hazard ratio [HR] 0.54, 95% CI 0.32-0.91, P = 0.02). CONCLUSIONS: Women with advanced ovarian cancer undergoing intervention for bowel obstruction have a dismal prognosis, regardless of which line of oncologic treatment the intervention was performed. In the majority of women an intervention for bowel obstruction was performed in a relapse situation with an even worse survival. Our findings emphasize the importance of a holistic approach in the decision-making before an intervention for bowel obstruction in women with advanced ovarian cancer.

A retrospective, real-life analysis of metronomic oral single-agent cyclophosphamide for the treatment of platinum-pretreated advanced ovarian carcinoma in Italy.

INTRODUCTION: Metronomic oral cyclophosphamide (MOC) presents many potential advantages, such as significantly less severe side effects than standard regimens, ease of administration, and the delivery of a dose-dense but not necessarily dose-intense treatment. These observations prompted us to evaluate in a retrospective, multicenter study the efficacy and toxicity of MOC in a real-life series of pretreated cancer patients. METHODS: The study is a multicenter, retrospective analysis of the activity of single-agent MOC in patients with recurrent or residual epithelial ovarian, fallopian tube, or primary. Eligible patients were continuously treated with MOC at 50 mg/day until progression, toxicity, or death. Overall response rate (ORR), stable disease (SD), and disease control rate (DCR) were reported. RESULTS: The study included 62 patients. Three patients reached a complete response rate (5%), 11 had a partial response rate (18), and 15 had stabilization of disease (24) for an ORR of 23% and a DCR of 47%. Patients with low-grade indolent tumors showed an ORR and an SD rate higher than that observed in non-indolent ones (33% vs. 18% and 28% vs. 14%, respectively). Overall, progression-free survival was 3.5 months (range 1-9 months). CONCLUSION: Single-agent MOC is active and very well tolerated in a significant fraction of patients with refractory, recurrent, or residual epithelial ovarian, fallopian tube, or primary peritoneal cancer. In the vision of a practical approach, single-agent MOC may be a useful palliative treatment option for patients with poor tolerance to high-dose regimens or widely pretreated. Further studies are needed better to characterize the role of such an approach in clinical practice.

Significance of cholecystectomy in cytoreductive surgery for advanced ovarian cancer.

BACKGROUND: There have been no studies concerning the complications or benefits of cholecystectomy in ovarian cancer. In this study, we aimed to evaluate the outcomes of cholecystectomy performed during various time periods of the disease course and suggest a management strategy for cholecystectomy in ovarian cancer. METHODS: We retrospectively reviewed the medical records of patients with advanced ovarian cancer who underwent cholecystectomy during the cytoreductive surgery from 2009 to 2020. Cholecystectomy was primarily indicated when the gallbladder and surrounding structures were considered to have metastatic tumor invasion. If the final pathologic results showed free of malignant tumor, patients were placed into the no-infiltration group. Clinical outcomes including the recurrence rate and complications were analyzed. RESULTS: A total of 62 patients underwent cholecystectomy, 48 of whom (77.4%) underwent cholecystectomy during primary or interval debulking surgery, whereas 14 (22.6%) underwent cholecystectomy during the follow-up period (five with benign disease and 9 with disease recurrence). Among the patients, 32 (51.6%) patients were included in the no-infiltration group in the final pathology. There were no complications observed in the no-infiltration group (n = 32). Seven (78%) of the nine patients who received cholecystectomy for disease recurrence had metastatic disease in the porta-hepatis or lesser sac at the time of primary surgery. However, no recurrent lesions were observed around the porta-hepatis in patients who received cholecystectomy during primary treatment. CONCLUSION: Considering the safety of the procedure, as well as the risk of disease recurrence or cholecystitis, a cholecystectomy can be offered to patients with ovarian cancer who have metastatic lesions around the gallbladder and porta-hepatis at the time of primary surgery.

Rectosigmoid resection morbidity in ovarian cancer cytoreductive surgery.

This case series evaluated morbidity following rectosigmoid resection during cytoreductive surgery for advanced ovarian cancer at the Shaukat Khanum Memorial Cancer Hospital, Lahore. The data of 20 female patients with complications corresponding to the Clavien-Dindo classification was included; the patients received treatment between January 2016 and January 2021. The mean age was 45.05± 13.11 years. Complications were observed in 3 (15.0%) cases, i.e., urinary complications in 2 (66.7%), and intra-abdominal abscess in 1 (33.3%) case. Clavien-Dindo classification grade II was noted in 2 (66.7%), while grade III-B in 1 (33.3%) case. Surgical risk factors were noted as appendectomy in 6 (66.7%) cases, bowel resection in 1 (11.1%), left colectomy in 1 (11.1%), sigmoid colectomy in 1 (11.1%), and stoma formation in 11 (55.0%) cases. In this reported case series, significant complications were observed in women undergoing rectosigmoid resection as cytoreductive surgery for advanced ovarian cancer.

What proportion of patients with stage 3 ovarian cancer are potentially cured following intraperitoneal chemotherapy? Analysis of the long term (≥10 years) survivors in NRG/GOG randomized clinical trials of intraperitoneal and intravenous chemotherapy in stage III ovarian cancer.

OBJECTIVE: Patients with advanced epithelial ovarian cancer (EOC) alive without progression at a landmark time-point of 10 years from diagnosis are likely cured. We report the proportion of patients with Stage III EOC who were long-term disease-free survivors (LTDFS≥10 years) following either intraperitoneal (IP) or intravenous (IV) chemotherapy as well as the predictors of LTDFS. METHODS: Data from 3 mature NRG/GOG trials (104, 114, 172) were analyzed and included demographics, clinicopathologic details, route of administration, and survival outcomes of patients living ≥10 years assessed according to the Kaplan-Meier method. Cox regression survival analysis was performed to evaluate independent prognostic predictors of LTDFS. RESULTS: Of 1174 patients randomized, 10-year overall survival (OS) was 26% (95% CI, 23-28%) and LTDFS ≥10 years was 18% (95% CI, 16-20%). Patients with LTDFS ≥10 years had a median age of 54.6 years (p < 0.001). Younger age (p < 0.001) was the only independent prognostic factor for LTDFS≥10 years on multivariate Cox analysis. CONCLUSIONS: Approximately 18% of patients were LTDFS ≥10 years. They form the tail end of the survival curve and are likely cured. Our results provide a comparative benchmark to evaluate the impact of PARP inhibitors in 1st line maintenance trials on survival outcomes.

HIPEC after neoadjuvant chemotherapy is associated with acceptable toxicity and favorable quality of life in newly diagnosed advanced ovarian cancer patients.

OBJECTIVE: To evaluate toxicity, quality of life and PFS in patients with advanced ovarian cancer who underwent neoadjuvant chemotherapy (NAC) followed by CRS and HIPEC with carboplatin. METHODS: Patients with stage IIIC or IVA epithelial ovarian cancer, who were not candidates for primary CRS, were enrolled in this phase two trial. Patients received 3-6 cycles of NAC with an IV carboplatin doublet followed by CRS with HIPEC (carboplatin 800 mg/m2 for 90 min). They were followed for at least 12 months to assess for adverse events, quality of life (QOL) and disease progression. QOL was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaires prior to CRS and post-operatively at 6 weeks, 3 months, and 6 months after CRS. RESULTS: Twenty patients were enrolled. HIPEC was completed successfully in all twenty patients, and there was no peri-operative mortality. Twelve (70.6%) patients experienced a grade 3 or 4 toxicity; most commonly anemia (59%), thrombocytopenia (29%), and hypokalemia (24%). There was no significant change between the pre-operative and postoperative 6 weeks, 3 month, and 6 month FACT-O, NTX, and AD scores. Nine (45%) patients have experienced disease recurrence to date. The median progression free survival in this cohort is 11.2 months (2.5-23.7 months). CONCLUSION: The addition of HIPEC with carboplatin to interval CRS was well tolerated in patient population. Myelosuppression was the most common adverse event. CRS with HIPEC did not adversely impact these patients' QOL indices. The efficacy of this regimen should be further evaluated in a larger clinical trial.

Impact of no residual disease on postoperative computed tomography on survival in patients with optimally debulked advanced high-grade serous ovarian cancer during upfront surgery.

OBJECTIVE: We sought to investigate the impact of size of residual tumors as determined by postoperative computed tomography (CT) on survival of patients with advanced, high-grade serous ovarian carcinoma (HGSC) who achieved residual disease less than 1 cm after primary debulking surgery (PDS). METHODS: We collected data of patients with stage III HGSC who had residual tumor less than 1 cm after PDS between 2013 and 2018. Surgeon-assessed residual disease during surgery was defined as sR0 (no gross residual) or sR1 (gross residual <1 cm), and radiologist-assessed residual disease on postoperative CT was defined as rR0 (no evidence of disease) or rRany (existing residual disease). All patients were classified into the following groups: sR0/rR0, sR1/rR0, sR0/rRany, and sR1/rRany. RESULTS: A total of 436 patients was placed into the sR0/rR0 (n = 187, 42.9%), sR1/rR0 (n = 59, 13.5%), sR0/rRany (n = 79, 18.1%), or sR1/rRany group (n = 111, 25.5%). Discrepancies between surgical and radiological assessments were recorded for 176 patients (40.4%) including 38 cases of sR1/rRany group with discordant residual tumor location indicated between two methods. During multivariate analysis, patients with ascites on preoperative CT, sR0/rRany group inclusion, and sR1/rRany group inclusion showed unfavorable progression-free and overall survival. CONCLUSIONS: The incorporation of surgical and radiological evaluations for determining the size of residual tumors was more accurate than surgical evaluation only for predicting survival among patients with advanced ovarian cancer who underwent PDS to residual disease less than 1 cm.

Usability and acceptability of the electronic self-assessment and care (eSAC) program in advanced ovarian cancer: A mixed methods study.

OBJECTIVE: To determine usability and acceptability of the electronic self-assessment and care (eSAC) web-based, patient reported outcome (PRO) program for people with advanced ovarian cancer. METHODS: Patient participants recruited from a single ambulatory site were prompted by email to answer symptom/quality of life items prior to each clinic visit. Patient participant acceptability was measured with the Acceptability E-Scale Score (AES). Usability was measured among a subset of patient participants using semi-structured interviews. Clinician participant acceptability and usability were measured via survey and semi-structured interviews. Quantitative data were analyzed with descriptive statistics. Qualitative data were analyzed using thematic content analysis. A mixed methods analysis was performed. RESULTS: Of 163 eligible patients approached, 143 (87.7%) provided written consent. Patient participants (n = 71) who created an eSAC report prior to at least 3 clinic visits, rated eSAC as acceptable with a mean AES score of 26.19 ± 3.36 (out of 30). Interview data from patient participants (n = 33) revealed that eSAC was easy to use and important to the clinic visit conversation. Data from clinician surveys (n = 8) and focus groups (n = 3) revealed that the eSAC program was acceptable and useful for clinicians. Qualitative analysis suggested process improvements from patients and clinicians for effectiveness in the advanced ovarian cancer setting. Mixed methods analysis demonstrated no major discrepancies between quantitative and qualitative findings, with the qualitative data broadening understanding of quantitative ratings. CONCLUSION: eSAC was useful and acceptable in this setting. This PRO is a promising strategy for enhancing patient-centered care for people with advanced ovarian cancer.

Laparoscopic En Bloc Pelvic Resection with Rectosigmoid Resection and Anastomosis for Stage IIB Ovarian Cancer: Hudson's Procedure Revisited.

STUDY OBJECTIVE: To demonstrate a systematic approach to the laparoscopic en bloc pelvic resection with rectosigmoid resection and anastomosis as part of ovarian cancer treatment in a tertiary gynecologic surgery referral center. DESIGN: This video illustrates an en bloc pelvic resection performed par laparoscopy in 10 steps. SETTING: A 56-year-old patient with an advanced high-grade serous ovarian cancer extending into the rectum was amenable to primary debulking surgery in accordance with the French guidelines [1]. In diagnostic laparoscopy, a bilateral adnexectomy was performed, and the pelvic carcinomatosis was considered primarily resectable. Histopathology of the subsequent en bloc resection was consistent with stage IIB high-grade serous ovarian cancer with an indication for adjuvant chemotherapy. INTERVENTION: The Hudson's procedure revisited consists of a radical monobloc excision by way of a completely extraperitoneal dissection and total mobilization of the rectum. In this case, owing to rectal invasion, we achieved a laparoscopic radical resection including rectosigmoidectomy and primary anastomosis without the need for a defunctioning stoma [2]. CONCLUSION: Traditionally, an en bloc pelvic resection with rectosigmoid resection and anastomosis was performed by laparotomy. The feasibility of performing laparoscopic optimal cytoreductive surgery in selected patients with advanced ovarian cancer was recently demonstrated without compromising survival in case of low residual disease. The prognosis depends rather on the resectability than on the operative access. However, the radicality and completeness of the cytoreduction, as well as the potential risk of tumor seeding, remain controversially discussed. Here, we demonstrate the minimally invasive approach following the same operative strategy as in open surgery. In this way, the radicality of the "en bloc resection" entailing avoidance of tumor rupture, less bleeding, and less urethral injury is combined with the benefits of a minimally invasive access. In expert hands, this procedure can be performed laparoscopically for other pelvic malignancies with peritoneal carcinomatosis.

Management of advanced ovarian cancer in Leicester: The benefits of a paradigm shift in surgical approach.

AIM: Surgery for advanced ovarian cancer (AOC) has evolved over the past decade to ingeminate the need to offer maximum effort surgery (MES). The aim of this study is to analyze the implementation of a paradigm shift in the surgical management of women with AOC at the University Hospitals of Leicester NHS Trust (UHL) in 2015, until 2020, compared to 2011-2014. METHODS: Retrospective cohort study of women with AOC who underwent cytoreductive surgery (CRS) in the UHL. The two groups were: 153 women from January 2011 to December 2014 (group 1), 136 women from January 2015 to January 2020 (group 2). RESULTS: In group 1, the 1, 3, and 5 years overall survival rates (OS) were, 90.4%, 33.7%, and 19.3%, compared to 90.2%, 55.4%, and 29.7%, respectively, in group 2 (p = 0.012). Significantly more women had CRS in group 2: 45-Primary debulking surgery (PDS) and 57-interval debulking surgery (IDS) versus 17-PDS & 67-IDS in group 1 (p < 0.001). Surgical complexity score (modified Aletti score) was higher in group 2 compared to group 1 (p = <0.001). No significant difference was noted in the postoperative complications, in group 2, in women who underwent PDS versus IDS, yet PDS was associated with higher OS. CONCLUSIONS: MES/CRS in women with AOC significantly improves OS. Our data highlights the importance of a dedicated team to implement this change in cancer centers. Where possible, suitable women with AOC likely to have complete cytoreduction based on preoperative assessment, should be offered PDS.