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Background In response to the critical shortage of liposomal doxorubicin (Doxil®) in the United States, the Food and Drug Administration (FDA) approved temporary importation of doxorubicin hydrochloride liposome (Lipodox®). The objective was to compare toxicity and clinical activity of Lipodox® with Doxil®. Methods Recurrent ovarian cancer patients who received Lipodox® were compared 3:1 to matched control Doxil® patients who had received Doxil®. Patients were matched based on age, stage, dose, platinum sensitivity, and prior treatments from an existing de-identified database. Patients receiving combination regimens were excluded. Results The data from 40 Lipodox® patients was compared to 120 matched control Doxil® patients. In this study, 17 (42.5%) of the Lipodox® patients were switched to Doxil®. The overall response rate Lipodox® was 4.3% (1/23) compared to 18% (20/111) in matched control Doxil® patients. In the platinum-sensitive patients, 100% progressed in the Lipodox® group compared to 78.4% in matched control Doxil® patients. The mean time to progression was 4.1 ± 2.8 months for Lipodox® and 6.2 ± 7.2 months in control Doxil®s (p = 0·25). Toxicity was similar in the Lipodox® group and control Doxil® group. Conclusion Lipodox® for treatment of recurrent ovarian cancer did not appear to have equivalent efficacy compared to Doxil®. A prospective clinical study is warranted before Lipodox® can be deemed equivalent substitution for Doxil®. [ABSTRACT FROM AUTHOR]

Background: Collaborative relationships between academic oncology and industry (pharmaceutical, biotechnology, "omic," and medical device companies) are essential for therapeutic development in oncology; however, limited research on engagement in and perceptions of these relationships has been done., Methods: Survey questions were developed to evaluate relationships between academic oncology and industry. An electronic survey was delivered to 1000 randomly selected members of the American Society of Clinical Oncology, a professional organization for oncologists, eliciting respondents' views around oncology-industry collaborations. The responses were analyzed according to prespecified plans., Results: There were 225 survey respondents. Most were from the United States (70.0%), worked at an academic institution (60.1%), worked in medical oncology (81.2%), and had an active relationship with industry (85.8%). One quarter (26.7%) of respondents reported difficulty establishing a relationship with industry collaborators, and most respondents (75%) did not report having had mentorship in developing these relationships. The majority (85.3%) of respondents considered these collaborations important to their careers. Respondents generally thought that scientific integrity was preserved (92%), and most respondents (95%) had little concern over the quality of the collaborative product. Many (60%) shared concerns over potential conflict of interest if an individual with a compensated relationship promoted an industry product for clinical care/research, yet most respondents (67%) stated these relationships did not shape their interactions with patients., Conclusions: This study provides novel data characterizing the nature of collaborative relationships between clinicians, researchers, and industry in oncology. Although respondents considered these collaborations an important part of clinical and academic oncology, formal education or mentorship around these relationships was rare. Conflicting findings around conflict of interest highlight the importance of more dedicated research in this area., Plain Language Summary: Business enterprises in health care play a central role in cancer research and care, driving the development of new medical testing, drugs, and devices. Effective working relationships among clinicians, researchers, and these industry partners can promote innovative research and enhance patient care. Study of these collaborations has been limited to date. Through distribution of a questionnaire to cancer clinicians and researchers, we found that most participants consider these relationships valuable, though they find establishing such relationships challenging partly because of gaps in educational programs in this area. Our findings also highlight the need for further policy around the potential bias these relationships can introduce., (© 2023 American Cancer Society.)

Context: A daily nine-item "Handbook for Self-Care at Work" was created to increase the well-being and satisfaction of the staff at the department of palliative care of a tertiary oncological center in the United States. Objectives: To evaluate the perceived usefulness of and adherence to the Handbook. Design, Setting and Participants: An anonymous survey was conducted among the palliative care staff asking for the frequency of utilization and the perception of usefulness of the Handbook. Additional data collected included demographics, satisfaction with professional life, frequency of burnout, and frequency of callousness toward people. We also compared the use and perception of the Handbook before and during the COVID-19 pandemic. Results: Of 52 palliative care clinicians, 39 (75%) completed the survey. Most participants were women and were <49 years. Most respondents (59%) found the Handbook useful or very useful. Offer help , ask for help , and hydration were perceived as the most useful items. The items most frequently achieved were movement , hydration , and eat light . The least useful perceived item was nap time , which was rarely achieved. During the COVID-19 pandemic, 32 (82%) respondents found the Handbook to be as/somewhat more/much more useful, and 29 (75%) were able to adhere to the items as/somewhat more/much more often than before. Conclusion: Most respondents found the Handbook useful and were able to accomplish the items most of the days. During the COVID-19 pandemic, the staff felt that the Handbook was more useful.

Background: Accurate identification of sentinel lymph nodes in patients with cancer improves detection of metastatic disease and decreases surgical morbidity. We sought to establish whether indocyanine green fluorescent dye is non-inferior to isosulfan blue dye in detecting sentinel lymph nodes in women with cervical and uterine cancers., Methods: In this non-inferiority, within-patient comparison study, patients aged 18 years or older with clinical stage I endometrial or cervical cancer undergoing curative surgery were randomly assigned 1:1 to lymphatic mapping with isosulfan blue dye (visualised by white light) followed by indocyanine green (visualised by near-infrared imaging), or indocyanine green followed by isosulfan blue dye. Permuted block randomisation with stratification by study site was done with a computerised random number generator. All participants were masked to their randomisation assignment until after the procedure; however, investigators were not masked to the procedure used. Laparoscopic surgery with the PINPOINT near-infrared fluorescence imaging system (Stryker, Kalamazoo, MI, USA) was used in all cases. The primary outcome was efficacy of intraoperative indocyanine green with near-infrared fluorescence imaging versus that of isosulfan blue dye in the identification of lymph nodes, defined as the number of lymph nodes identified by indocyanine green and isosulfan blue dye, respectively (and confirmed as lymphoid tissue by histology), divided by the number of lymph nodes identified intraoperatively and excised. The study had a 5% non-inferiority margin needed to show non-inferiority of the frequency of lymph node detection with indocyanine green to that with isosulfan blue dye with 80% power at a 5% two-sided significance level. Analyses were done in both per-protocol and modified intention-to-treat populations. The trial was registered with ClinicalTrials.gov, number NCT02209532, and is completed and closed., Findings: Between Dec 21, 2015, and June 19, 2017, 180 patients were enrolled and randomly assigned to the two groups (90 to each group); 176 patients received the intervention and were evaluable (modified intention-to-treat population). 13 patients with major protocol violations were subsequently excluded from the per-protocol population. 517 sentinel nodes were identified in the per-protocol population (n=163), of which 478 (92%) were confirmed to be lymph nodes on pathological processing: 219 (92%) of 238 nodes that were both blue and green, all seven nodes that were blue only, and 252 (95%) of 265 nodes that were green only (p=0·33). Seven sentinel lymph nodes were neither blue nor green but were removed for appearing suspicious or enlarged on visual examination. In total, 471 (97%) of 485 lymph nodes were identified with the green dye and 226 (47%) with the blue dye (difference 50%, 95% CI 39-62; p<0·0001). In the modified intention-to-treat population (n=176), 545 nodes were identified, of which 513 (94%) were confirmed to be lymph nodes on pathological processing: 229 (92%) of 248 nodes that were both blue and green, all nine nodes that were blue only, and 266 (95%) of 279 nodes that were green only (p=0·30). Nine sentinal lymph nodes were neither blue nor green but were removed for appearing suspicious or enlarged on visual examination. 495 (96%) of 513 nodes were identified with the green dye and 238 (46%) with the blue dye (50%, 39-61; p<0·0001)., Interpretation: Indocyanine green dye with near-infrared fluorescence imaging identified more sentinel nodes than isosulfan blue dye in women with cervical and uterine cancers, with no difference in the pathological confirmation of nodal tissue between the two mapping substances., Funding: Novadaq., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Objective: Advanced cancer patients often develop severe physical and psychological symptom clusters (SCs), but limited data exist on their consistency or severity after an outpatient interdisciplinary team consultation led by palliative care specialists. The primary aim of the study was to determine the consistency and severity of SCs in advanced cancer patients in this setting., Method: A total of 1373 patients with advanced cancer who were referred to The University of Texas MD Anderson Cancer Center's Outpatient Supportive Care Center between January 2003 and October 2008 with a complete Edmonton Symptom Assessment Scale (ESAS; 0-10 scale) occurred at initial and first follow-up visit were reviewed (median 14 days, range 1-4 weeks). We used a Wilcoxon signed-rank test to determine whether symptoms changed over time, and a principal components factor analysis with varimax rotation to determine SCs at baseline and at first follow-up. The number of factors calculated was determined based upon the number of eigenvalues., Results: The patients' ratings of the following symptoms (mean, SD) at the initial and follow-up visits, respectively, were: fatigue 6.2 (2.3) and 5.7 (2.5, p < 0.0001), pain 5.4 (2.9) and 4.6 (3, p < 0.0001), nausea 2.2 (2.8) and 2.0 (2.6, p < 0.0001), depression 3.0 (2.9) and 2.5 (2.7, p < 0.0001), anxiety 3.4 (3.0) and 2.8 (2.8, p < 0.0001), drowsiness 4.8 (3.1) and 4.4 (3.1, p < 0.0001), dyspnea 3.0 (2.9) and 2.7 (2.8), p < 0.0001), loss of appetite 4.2 (2.7) and 3.9 (2.7, p < 0.0001), sleep disturbances 4.2 (2.6) and 3.8 (2.6, P < 0.0001), and well-being 4.3 (2.5) and 3.9 (2.3, p < 0.0001). Cluster composition differentiated into physical (fatigue, pain, nausea, drowsiness, dyspnea, and loss of appetite) and psychological (anxiety and depression) components at the initial visit, and these two SCs were consistent upon follow-up., Significance of Results: We conclude that SCs remain constant between baseline and near-term follow-up but that the severity of those symptoms lessened during that interval. This knowledge may allow palliative care teams to provide more targeted and higher-quality care, but further studies are needed.

Background: A retrospective cohort study utilizing prospectively collected data was conducted from August 2003 until March 2008 at M.D. Anderson Cancer Center. It is unknown whether cardiovascular comorbidity and chronic stress impact ovarian cancer outcome, which remains poor despite advances in therapy. The purpose of this study was to determine whether cardiovascular disease and markers that may be associated with stress are also associated with survival in patients with ovarian cancer., Methods: Participants with newly diagnosed epithelial ovarian cancer were followed until time of death or truncation of study period (median follow-up = 4.2 years; n = 271). Tumor characteristics (stage, tumor grade, histology, debulking status), demographic variables, and cardiovascular comorbidity were documented and compared to overall survival., Results: Of the nine cardiovascular events tracked during follow-up, venous thromboembolism [VTE; HR, 3.2; 95% confidence interval (CI), 1.8-5.5] and pulmonary hypertension (HR, 8.5; 95% CI, 3.9-18.7) were associated with shorter survival in multivariate analysis. In addition, high tumor grade, suboptimal cytoreduction, and baseline heart rate (HR, 1.02; 95% CI, 1.01-1.04) were related to decreased survival., Conclusion: Careful management of certain cardiovascular comorbidities may extend survival in patients with ovarian cancer. Our findings suggest that increased baseline heart rate and the development of VTE and pulmonary hypertension after cancer diagnosis may be significant predictors of survival in women with ovarian cancer., Impact: Our study emphasizes the importance of identifying and optimally treating tachycardia, VTE, and pulmonary hypertension in conjunction with cancer therapy., (©2013 AACR.)

Background: Few recent studies have demonstrated similar quality of care for hospitalized black and white patients with heart failure (HF). However, systematic evaluation of racial differences in both the quality of care and outcomes is needed in the outpatient setting, where most patients with HF are treated and where care may be more fragmented., Methods: We examined racial differences in quality-of-care measures and outcomes of 1-year mortality and hospitalization in a national cohort of 18,611 ambulatory patients with HF treated at Veterans Affairs medical centers between October 2000 and September 2002., Results: Black patients were more likely to have left ventricular ejection fraction assessment than whites (risk-adjusted OR 1.29, 95% CI 1.11-1.49). In patients with left ventricular ejection fraction <40%, blacks were as likely as whites to be on treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (risk-adjusted OR 1.06, 95% CI 0.85-1.33) and beta-blockers (risk-adjusted OR 0.92, 95% CI 0.79-1.07). However, black patients more frequently had uncontrolled hypertension and were more likely to be hospitalized for any cause (OR 1.20, 95% CI 1.08-1.33) or for HF (OR 1.43, 95% CI 1.23-1.66), although 1-year mortality did not differ by race (OR 1.03, 95% CI 0.89-1.20)., Conclusions: In a financially "equal access" health care system, the quality of outpatient HF care assessed by select quality measures and 1-year mortality was similar in black compared to white patients. However, blacks were more likely to be hospitalized, especially with HF. Identifying and targeting potentially modifiable factors such as uncontrolled hypertension in black patients may narrow the racial gap in hospitalizations.

Objectives: Percutaneous endoscopic gastrostomy (PEG) tube placement is a widely used method for long-term enteral feeding of demented patients unable to take sufficient food by mouth. National time trends in PEG tube use over the last decade have not been previously reported. The objective of this study was to determine whether use of PEG tubes for patients with dementia has changed over time and by race., Design: Retrospective cohort study., Setting: All Veterans Affairs hospitals., Participants: Using an administrative database of the Veterans Health Administration, all veterans with dementia and all veterans who received a PEG tube were identified between fiscal years 1990-2001., Measurements: Proportion of PEG tube placement for dementia patients over time and by race., Results: Four hundred thirteen thousand six hundred twenty-seven dementia patients aged 60 and older were identified, of whom 6,464 (1.6%) received a PEG tube. Use of PEG tubes for dementia patients increased during the first half of the decade but subsequently decreased almost to baseline after peaking in 1996 (1990: 1.2%, 1996: 1.8%, 2001: 1.3%). Time trends in the use of PEG tube feeding for dementia patients varied by race. Specifically, the relative risk for PEG tube placement in African-American dementia patients increased from 1.65 (95% confidence interval (CI)=1.25-2.17, FY 1990) to 1.97 (95% CI=1.62-2.4, FY 2001)., Conclusion: Although the overall use of PEG tube feeding for dementia patients decreased over time, rates in use and changes in use over time varied significantly by race. Reasons for the differential use of this procedure should be explored.