Impact of Sodium Thiosulfate on Prevention of Nephrotoxicities in HIPEC: An Ancillary Evaluation of Cisplatin-Induced Toxicities in Ovarian Cancer.

PURPOSE: Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin confers a survival benefit in epithelial ovarian cancer (EOC) but is associated with renal toxicity. Sodium thiosulfate (ST) is used for nephroprotection for HIPEC with cisplatin, but standard HIPEC practices vary. METHODS: A prospective, nonrandomized, clinical trial evaluated safety outcomes of HIPEC with cisplatin 75 mg/m2 during cytoreductive surgery (CRS) in patients with EOC (n = 34) and endometrial cancer (n = 6). Twenty-one patients received no ST (nST), and 19 received ST. Adverse events (AEs) were reported according to CTCAE v.5.0. Serum creatinine (Cr) was collected preoperatively and postoperatively (Days 5-8). Progression-free survival (PFS) was followed. Normal peritoneum was biopsied before and after HIPEC for whole transcriptomic sequencing to identify RNAseq signatures correlating with AEs. RESULTS: Forty patients had HIPEC at the time of interval or secondary CRS. Renal toxicities in the nST group were 33% any grade AE and 9% grade 3 AEs. The ST group demonstrated no renal AEs. Median postoperative Cr in the nST group was 1.1 mg/dL and 0.5 mg/dL in the ST group (p = 0.0001). Median change in Cr from preoperative to postoperative levels were + 53% (nST) compared with - 9.6% (ST) (p = 0.003). PFS did not differ between the ST and nST groups in primary or recurrent EOC patients. Renal AEs were associated with downregulation of metabolic pathways and upregulation of immune pathways. CONCLUSIONS: ST significantly reduces acute renal toxicity associated with HIPEC with cisplatin in ovarian cancer patients. As nephrotoxicity is high in HIPEC with cisplatin, nephroprotective agents should be considered.

Leveraging an Informatics Approach to Identify an Unmet Clinical Need for BRCA1/2 Testing Among Patients With Ovarian Cancer.

PURPOSE: Although BRCA1/2 testing in ovarian cancer improves outcomes, it is vastly underutilized. Scalable approaches are urgently needed to improve genomically guided care. METHODS: We developed a Natural Language Processing (NLP) pipeline to extract electronic medical record information to identify recipients of BRCA testing. We applied the NLP pipeline to assess testing status in 308 patients with ovarian cancer receiving care at a National Cancer Institute Comprehensive Cancer Center (main campus [MC] and five affiliated clinical network sites [CNS]) from 2017 to 2019. We compared characteristics between (1) patients who had/had not received testing and (2) testing utilization by site. RESULTS: We found high uptake of BRCA testing (approximately 78%) from 2017 to 2019 with no significant differences between the MC and CNS. We observed an increase in testing over time (67%-85%), higher uptake of testing among younger patients (mean age tested = 61 years v untested = 65 years, P = .01), and higher testing among Hispanic (84%) compared with White, Non-Hispanic (78%), and Asian (75%) patients (P = .006). Documentation of referral for an internal genetics consultation for BRCA pathogenic variant carriers was higher at the MC compared with the CNS (94% v 31%). CONCLUSION: We were able to successfully use a novel NLP pipeline to assess use of BRCA testing among patients with ovarian cancer. Despite relatively high levels of BRCA testing at our institution, 22% of patients had no documentation of genetic testing and documentation of referral to genetics among BRCA carriers in the CNS was low. Given success of the NLP pipeline, such an informatics-based approach holds promise as a scalable solution to identify gaps in genetic testing to ensure optimal treatment interventions in a timely manner.

Recall of Genomic Testing Results Among Patients with Cancer.

BACKGROUND: Genomic testing of somatic and germline DNA has transformed cancer care. However, low genetic knowledge among patients may compromise care and health outcomes. Given the rise in genomic testing, we sought to understand patients' knowledge of their genetic test results. MATERIALS AND METHODS: We conducted a survey-based study with 85 patients at a comprehensive cancer center. We compared self-reported recall of (a) having had somatic/germline testing and (b) their specific somatic/germline results to the genomic test results documented in the medical record. RESULTS: Approximately 30% of patients did not recall having had testing. Of those who recalled having testing, 44% of patients with pathogenic/likely pathogenic germline mutations and 57% of patients with reported somatic alterations did not accurately recall their specific gene or variant-level results. CONCLUSION: Given significant knowledge gaps in patients' recall of genomic testing, there is a critical need to improve patient-directed education and return-of-results strategies.

Interdisciplinary Palliative Care for Patients With Lung Cancer.

CONTEXT: Palliative care, including symptom management and attention to quality of life (QOL) concerns, should be addressed throughout the trajectory of a serious illness such as lung cancer. OBJECTIVES: This study tested the effectiveness of an interdisciplinary palliative care intervention for patients with Stage I-IV non-small cell lung cancer (NSCLC). METHODS: Patients undergoing treatments for NSCLC were enrolled in a prospective, quasi-experimental study whereby the usual care group was accrued first followed by the intervention group. Patients in the intervention group were presented at interdisciplinary care meetings, and appropriate supportive care referrals were made. They also received four educational sessions. In both groups, QOL, symptoms, and psychological distress were assessed at baseline and 12 weeks using surveys which included the Functional Assessment of Cancer Therapy-Lung and the Lung Cancer Subscale, the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being, and the Distress Thermometer. RESULTS: A total of 491 patients were included in the primary analysis. Patients who received the intervention had significantly better scores for QOL (109.1 vs. 101.4; P < 0.001), symptoms (25.8 vs. 23.9; P < 0.001) spiritual well-being (38.1 vs. 36.2; P = 0.001), and lower psychological distress (2.2 vs. 3.3; P < 0.001) at 12 weeks, after controlling for baseline scores, compared to patients in the usual care group. Patients in the intervention group also had significantly higher numbers of completed advance care directives (44% vs. 9%; P < 0.001), and overall supportive care referrals (61% vs. 28%; P < 0.001). The benefits were seen primarily in the earlier stage patients vs. those with Stage IV disease. CONCLUSION: Interdisciplinary palliative care in the ambulatory care setting resulted in significant improvements in QOL, symptoms, and distress for NSCLC patients.

Use and Effectiveness of Intraperitoneal Chemotherapy for Treatment of Ovarian Cancer.

PURPOSE: A 2006 randomized trial demonstrated a 16-month survival benefit with intraperitoneal and intravenous (IP/IV) chemotherapy administered to patients who had ovarian cancer, compared with IV chemotherapy alone, but more treatment-related toxicities. The objective of this study was to examine the use and effectiveness of IP/IV chemotherapy in clinical practice. PATIENTS AND METHODS: Prospective cohort study of 823 women with stage III, optimally cytoreduced ovarian cancer diagnosed at six National Comprehensive Cancer Network institutions. We examined IP/IV chemotherapy use in all patients diagnosed between 2003 and 2012 (N = 823), and overall survival and treatment-related toxicities with Cox regression and logistic regression, respectively, in a propensity score-matched sample (n = 402) of patients diagnosed from 2006 to 2012, excluding trial participants, to minimize selection bias. RESULTS: Use of IP/IV chemotherapy increased from 0% to 33% between 2003 and 2006, increased to 50% from 2007 to 2008, and plateaued thereafter. Between 2006 and 2012, adoption of IP/IV chemotherapy varied by institution from 4% to 67% (P < .001) and 43% of patients received modified IP/IV regimens at treatment initiation. In the propensity score-matched sample, IP/IV chemotherapy was associated with significantly improved overall survival (3-year overall survival, 81% v 71%; hazard ratio, 0.68; 95% CI, 0.47 to 0.99), compared with IV chemotherapy, but also more frequent alterations in chemotherapy delivery route (adjusted rates discontinuation or change, 20.4% v 10.0%; adjusted odds ratio, 2.83; 95% CI, 1.47 to 5.47). CONCLUSION: Although the use of IP/IV chemotherapy increased significantly at National Comprehensive Cancer Network centers between 2003 and 2012, fewer than 50% of eligible patients received it. Increasing IP/IV chemotherapy use in clinical practice may be an important and underused strategy to improve ovarian cancer outcomes.

Longitudinal changes in function, symptom burden, and quality of life in patients with early-stage lung cancer.

BACKGROUND: Emerging evidence supports the integration of palliative care concurrently with disease-focused care in patients with serious illnesses, such as lung cancer. This paper describes how longitudinal changes in physical function, symptom burden, and QOL of patients with early-stage non-small cell lung cancer (NSCLC) informed the development of an interdisciplinary, tailored palliative care intervention. METHODS: Patients with early stage (I-IIIB) NSCLC were accrued into the usual care phase (Phase 1) of an NCI-funded Program Project Grant. Baseline and longitudinal (up to 52 weeks post-accrual) physical function, symptoms, and QOL were assessed in the thoracic ambulatory clinics of one NCI-designated Comprehensive Cancer Center. Outcome measures included geriatric assessments, psychological distress, symptoms, and QOL. The association between disease stage (I-II vs. III) and longitudinal changes in these domains was evaluated. RESULTS: A total of 103 patients were accrued. Stage I-II patients were significantly more likely to complete the study (p = 0.005). The stages (I-II vs. III) were equivalent at baseline on all demographic variables, clinical, and functional status. Physical function fluctuated longitudinally and was higher at 6 and 24 weeks than at baseline and 12 weeks. There was a longitudinal decrease in total number of symptoms (p < 0.001). Physical and social/family QOL fluctuated longitudinally (p < 0.001 and p = 0.016, respectively). CONCLUSIONS: Patients with early-stage NSCLC report a significant longitudinal decrease in physical QOL, and fluctuations in objective and subjective measures of physical function over time were observed regardless of disease stage category. An interdisciplinary palliative care intervention is currently being tested to decrease symptom burden and improve QOL.

Quality of life and barriers to symptom management in colon cancer.

PURPOSE OF THE RESEARCH: Pain and fatigue are recognized as critical symptoms that impact QOL for patients with colon cancer. Barriers to optimum pain and fatigue relief include patient-related beliefs and attitudes about the treatment of cancer-related symptoms. The overall objective of this paper was to describe quality of life (QOL) and barriers to pain and fatigue management in patients with colon cancer. METHODS AND SAMPLE: This longitudinal, descriptive study included was conducted in the ambulatory clinic of one NCI-designated comprehensive cancer center. A cohort of 56 patients with colon cancer and a pain and/or fatigue of ≥4 (moderate to severe) was recruited. Subjects completed questionnaires to assess subjective ratings of overall QOL, fatigue, barriers to pain and fatigue, and pain and fatigue knowledge. KEY RESULTS: The majority of subjects (58%) reported having moderate to severe (4-6) fatigue at the time of accrual. Overall QOL score was moderate (M = 5.20, SD = 1.43), and the social well-being subscale had the lowest score (M = 4.57, SD = 1.82). Patient barriers to pain and fatigue existed in attitudes and beliefs regarding addiction, tolerance, and that fatigue is an inevitable part of cancer and its treatments. Patient knowledge of pain and fatigue was high (77%-88% correct), but lack of knowledge persisted in areas such as addiction to pain medications and utilizing physical activity to manage fatigue. CONCLUSIONS: Several patient-related attitudes and beliefs may hinder optimum relief of symptoms such as pain and fatigue. Social well-being may be a major determinant of overall QOL for patients with colon cancer.

An interdisciplinary care approach for integration of palliative care in lung cancer.

PURPOSE: Quality of Life (QOL) and symptom concerns are common in lung cancer. This article presents findings from 2 separate pilot studies that utilize an educational model to reduce barriers to pain and fatigue management ("barriers study") and an interdisciplinary palliative care approach to manage QOL concerns for patients with lung cancer ("QOL pilot"). PATIENTS AND METHODS: In the barriers study, a total of 46 patients with lung cancer with a self-reported pain and/or fatigue rating of >or=4 were accrued, with 18 patients in the usual care group and 28 in the experimental group, using a quasi-experimental design. This study involved a 4-part educational intervention delivered by a nurse to address pain and fatigue. In the QOL study, the pilot intervention included 10 patients with lung cancer. This pilot included use of QOL assessment completed by a nurse followed by an interdisciplinary case conference intended to initiate supportive care to address QOL and symptom concerns. Patient-reported outcomes such as barriers to pain and fatigue management, fatigue intensity, other symptoms, and overall QOL were analyzed through tabulation of standard summary statistics and multivariate analysis methods. All eligible patients were recruited from the ambulatory clinic of one National Cancer Institute-designated Comprehensive Cancer Center. RESULTS: For the barriers study, patients with lung cancer in the experimental group had a statistically significant decrease in patient-related barriers for both pain and fatigue. Findings from the QOL pilot revealed that patients with lung cancer have multiple QOL concerns and that an interdisciplinary palliative care approach was feasible to address these complex, multidimensional patient needs. CONCLUSION: Attention to barriers of symptom management, early referral to supportive care services, and coordination of interdisciplinary care are essential to supporting the QOL of patients with lung cancer. The next phase of this research will test QOL/symptom interventions for patients with lung cancer.