Health state utility and health-related quality of life measures in patients with advanced ovarian cancer.

Purpose: Measuring health-related quality of life (HRQoL) in ovarian cancer patients is critical to understand the impact of disease and treatment. Preference-based HRQoL measures, called health state utilities, are used specifically in health economic evaluations. Real-world patient-reported data on HRQoL and health state utilities over the long-term course of ovarian cancer are limited. This study aims to determine HRQoL and health state utilities in different health states of ovarian cancer. Methods: This cross-sectional, multicenter study included patients with stage III-IV ovarian cancer in six health states: at diagnosis, during chemotherapy, after cytoreductive surgery (CRS), after chemotherapy, in remission, and at first recurrence. HRQoL was measured using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30, and the ovarian cancer-specific module OV28. Health state utilities were assessed using the EuroQol five-dimension five-level (EQ-5D-5L) questionnaire. Descriptive analyses were performed for each health state. Results: Two hundred thirty-two patients participated, resulting in 319 questionnaires. Median age was 66 years. The lowest HRQoL was observed during chemotherapy and shortly after CRS. Physical and role functioning were most affected and the highest symptom prevalence was observed in the fatigue, nausea, pain, dyspnea, gastrointestinal, neuropathy, attitude, and sexuality domains. Patients in remission had the best HRQoL. Mean utility values ranged from 0.709 (±0.253) at diagnosis to 0.804 (±0.185) after chemotherapy. Conclusions: This study provides clinicians with a valuable resource to aid in patient counseling and clinical decision-making. The utilities, in particular, are crucial for researchers conducting economic analyses to inform policy decisions.

Is routine admission to a critical care setting following hyperthermic intraperitoneal chemotherapy for ovarian cancer necessary?

INTRODUCTION: Hyperthermic intraperitoneal chemotherapy (HIPEC) is increasingly being used in patients with stage III ovarian cancer undergoing interval cytoreductive surgery (CRS). It is uncertain whether routine postoperative admission to a critical care setting after CRS-HIPEC is necessary. This study aims to estimate the incidence of patients requiring critical care, and to create a prediction model to identify patients who may forego admission to a critical care setting. METHODS: We analyzed 154 patients with primary ovarian cancer undergoing interval CRS-HIPEC at two Dutch centers between 2007 and 2021. Patients were routinely admitted to a critical care setting for 12-24 h. Patients that received critical support as defined by pre-specified definitions were retrospectively identified. Logistic regression analysis with backward selection was used to predict the need for critical care and the model was validated using bootstrapping. RESULTS: Thirty-eight percent of patients received postoperative critical care, consisting mainly of hemodynamic interventions. Independent predictors of critical care were blood loss, norepinephrine dose during surgery, and age (bootstrapped AUC = 0.76). Using a probability cut-off of 20%, one-third of patients are defined as low-risk for requiring critical care, with a negative predictive value of 0.88. CONCLUSIONS: The majority of patients,primarily undergoing low to intermediate complexity surgeries, did not receive critical care interventions after CRS-HIPEC. Selective admission to a critical care setting may be warranted and its feasibility and safety needs to be evaluated prospectively. Our prediction model can help identify patients in whom admission to a critical care setting may be omitted. Hospital costs and burden on critical care units will benefit from patient selection.

Evaluation of external validity of the OVHIPEC-1 trial in a real-world population.

OBJECTIVE: The OVHIPEC-1 trial (Phase III randomised clinical trial for stage III ovarian carcinoma randomising between interval cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy) showed improved survival when interval cytoreductive surgery (CRS) was combined with hyperthermic intraperitoneal chemotherapy in patients with stage III epithelial ovarian cancer (EOC). The authors compared the control arm of the trial with a real-world population treated in the Netherlands during the same period to explore generalizability of the trial results. METHODS: For this nationwide comparative cohort study, all patients with EOC undergoing interval CRS between 2007 and 2016 were identified from the Netherlands Cancer Registry if they fulfilled the eligibility criteria of OVHIPEC-1 (n = 1376). Patient and treatment characteristics, and overall survival (OS) were compared between trial and real-world populations. RESULTS: Age, comorbidity, BRCA status, histologic subtype, and residual disease were similar in trial and real-world patients. Trial patients had a better performance status, higher socioeconomic status, and underwent bowel surgery more often. In a real-world setting, patients more often received more than six cycles. The difference in OS between the trial and the real-world populations was not statistically significant (unadjusted hazard ratio, 1.09 [95% confidence interval, 0.87-1.37]; P = 0.44). CONCLUSION: Despite differences in patient characteristics, OS of patients treated in the control arm of OVHIPEC-1 was similar to patients treated outside the trial. The trial population accurately represents real-world patients with stage III EOC undergoing interval CRS in terms of outcome.

Standardizing HIPEC and perioperative care for patients with ovarian cancer in the Netherlands using a Delphi-based consensus.

OBJECTIVE: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is standard of care in the Netherlands in patients with stage III epithelial ovarian cancer following interval cytoreductive surgery (CRS). Differences in patient selection, technical aspects, and perioperative management exist between centers performing HIPEC. Standardization aims to reduce unwanted variation in clinical practice. As part of an implementation process, we aimed to standardize perioperative care for patients treated with CRS and HIPEC using a Delphi-based consensus approach. METHODS: We performed a two-phase modified Delphi method involving a multidisciplinary panel of 40 experts who completed a survey on CRS and HIPEC. During a consensus meeting, survey outcomes and available scientific evidence was discussed. Items without consensus (<75% agreement) were adjusted and evaluated in a second survey. RESULTS: Consensus was reached in the first round on 51% of items. After two rounds, consensus was reached on the majority of items (82%) including patient selection, preoperative workup, technical aspects of CRS and HIPEC, and postoperative care. No consensus was reached on the role of HIPEC in rare ovarian cancer types, preoperative bowel preparation, timing to create bowel anastomoses, and manipulation of the perfusate. CONCLUSIONS: Dutch experts reached consensus on most items regarding interval CRS and HIPEC for ovarian cancer. This consensus study may help to align treatment protocols and to minimize practice variation. Topics without consensus may be put on the research agenda of HIPEC for ovarian cancer.

Hyperthermic Intraperitoneal Chemotherapy for Ovarian and Colorectal Cancer: A Review.

IMPORTANCE: The peritoneal surface is a common site of disease in ovarian and colorectal cancer. Peritoneal metastases carry a poor prognosis, despite maximal therapeutic efforts, including surgical removal of tumor deposits and intravenous chemotherapy. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a single intraoperative procedure that delivers chemotherapy directly into the abdominal cavity, leading to high intracellular drug concentration at the peritoneal surface. This review describes the current knowledge regarding the mechanism of action, safety, and efficacy of HIPEC in the treatment of peritoneal metastases from epithelial ovarian and colorectal cancers and explores current knowledge gaps. OBSERVATIONS: Toxic effects of HIPEC are limited. Evidence from a randomized trial shows improved recurrence-free and overall survival after HIPEC in patients with ovarian cancer who are ineligible for primary cytoreductive surgery (CRS). The effect of HIPEC for patients with ovarian cancer undergoing primary CRS or CRS for recurrent disease has not yet been determined, and results of ongoing trials must be awaited. A recent study in patients with peritoneal metastases from colorectal cancer did not show a benefit of HIPEC when added to perioperative chemotherapy. CONCLUSIONS AND RELEVANCE: Based on available evidence, various international guidelines include the option to add HIPEC to interval CRS for patients with stage III ovarian cancer. The role of HIPEC in colorectal cancer is less well defined. Future studies will need to tailor patient selection, timing, and optimal regimens of HIPEC to improve the effectiveness of this specialized treatment in ovarian, colorectal, and other tumor types.

Effects of Sampling Conditions and Environmental Factors on Fecal Volatile Organic Compound Analysis by an Electronic Nose Device.

Prior to implementation of volatile organic compound (VOC) analysis in clinical practice, substantial challenges, including methodological, biological and analytical difficulties are faced. The aim of this study was to evaluate the influence of several sampling conditions and environmental factors on fecal VOC profiles, analyzed by an electronic nose (eNose). Effects of fecal sample mass, water content, duration of storage at room temperature, fecal sample temperature, number of freeze-thaw cycles and effect of sampling method (rectal swabs vs. fecal samples) on VOC profiles were assessed by analysis of totally 725 fecal samples by means of an eNose (Cyranose320®). Furthermore, fecal VOC profiles of totally 1285 fecal samples from 71 infants born at three different hospitals were compared to assess the influence of center of origin on VOC outcome. We observed that all analyzed variables significantly influenced fecal VOC composition. It was feasible to capture a VOC profile using rectal swabs, although this differed significantly from fecal VOC profiles of similar subjects. In addition, 1285 fecal VOC-profiles could significantly be discriminated based on center of birth. In conclusion, standardization of methodology is necessary before fecal VOC analysis can live up to its potential as diagnostic tool in clinical practice.