Nevin Manimala

J Clin Oncol. 2024 Jul 1:JCO2302261. doi: 10.1200/JCO.23.02261. Online ahead of print.

ABSTRACT

PURPOSE: To assess whether the integration of PD-1 inhibitor with total neoadjuvant therapy (iTNT) can lead to an improvement in complete responses (CRs) and favors a watch-and-wait (WW) strategy in patients with proficient mismatch repair or microsatellite stable (pMMR/MSS) locally advanced rectal cancer (LARC).

PATIENTS AND METHODS: We conducted a prospective, multicenter, randomized, open-label, phase II trial using a pick-the-winner design. Eligible patients with clinical T3-4 and/or N+ rectal adenocarcinoma were randomly assigned to group A for short-course radiotherapy (SCRT) followed by six cycles of consolidation immunochemotherapy with capecitabine and oxaliplatin and toripalimab or to group B for two cycles of induction immunochemotherapy followed by SCRT and the rest four doses. Either total mesorectal excision or WW was applied on the basis of tumor response. The primary end point was CR which included pathological CR (pCR) after surgery and clinical CR (cCR) if WW was applicable, with hypothesis of an increased CR of 40% after iTNT compared with historical data of 25% after conventional TNT.

RESULTS: Of the 130 patients enrolled, 121 pMMR/MSS patients were evaluable (62 in group A and 59 in group B). At a median follow-up of 19 months, CR was achieved at 56.5% in group A and 54.2% in group B. Both groups fulfilled the predefined statistical hypothesis (P < .001). Both groups reported a pCR rate of 50%. Respectively, 15 patients in each group underwent WW and remained disease free. The most frequent grade 3 to 4 toxicities were thrombocytopenia and neutropenia. Patients in group A had higher rate of cCR (43.5% v 35.6%) at restaging and lower rate of grade 3 to 4 thrombocytopenia (24.2% v 33.9%) during neoadjuvant treatment.

CONCLUSION: The iTNT regimens remarkably improved CR rates in pMMR/MSS LARC compared with historical benchmark with acceptable toxicity. Up-front SCRT followed by immunochemotherapy was selected for future definitive study.

PMID:38950321 | DOI:10.1200/JCO.23.02261

JCO Oncol Pract. 2024 Jul 1:OP2400164. doi: 10.1200/OP.24.00164. Online ahead of print.

ABSTRACT

PURPOSE: Cancer center clinical trial offices (CCTOs) support trial development, activation, conduct, regulatory adherence, data integrity, and compliance. In 2018, the Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) Steering Committee conducted and published survey results to benchmark North American CCTOs, including trial volume, accrual, full time equivalents (FTEs), and budget. The survey was readministered in 2023 to assess contemporary CCTO performance and capacity with results presented here.

METHODS: The 28 question 2023 survey was sent to directors of AACI’s clinical member cancer centers. Survey participation was voluntary, no compensation was provided, and data requested covered operations during 2022. Definitions were consistent with National Cancer Institute (NCI) CCTO reporting requirements and AACI staff anonymously compiled results for descriptive statistical reporting.

RESULTS: The survey response rate was 61% (60/99). The median annual CCTO budget was $11.5 million (M) US dollars (USD) versus $8.2M USD in 2018. These budgets support a median of 150 FTEs versus 104 previously, and a median total of 384 versus 280 interventional treatment trials and a median of 479 versus 531 interventional treatment accruals. Sources of support for CCTO annual budgets were primarily from industry revenue (45.3%) or institutional support (31.7%). Nearly 60% of centers reported activating NCI-sponsored studies within 90 days but only 9% reported meeting a 90-day activation timeline for industry sponsored studies.

CONCLUSION: Contemporary benchmarks for CCTO operations through this survey demonstrate larger staff sizes, larger budgets, more trials supported, but fewer patients enrolled to interventional treatment trials in comparison with 2018. These data shine a critical light on the increasing complexity of cancer clinical trials, the importance of external funding sources, and necessary operational efficiency upgrades to provide cutting-edge cancer research and care.

PMID:38950320 | DOI:10.1200/OP.24.00164

JCO Clin Cancer Inform. 2024 Jun;8:e2400054. doi: 10.1200/CCI.24.00054.

ABSTRACT

There has been growing interest in the use of real-world data (RWD) to address clinically and policy-relevant (research) questions that cannot be answered with data from randomized controlled trials (RCTs) alone. This is, for example, the case in rare malignancies such as sarcomas as limited patient numbers pose challenges in conducting RCTs within feasible timeliness, a manageable number of collaborators, and statistical power. This narrative review explores the potential of RWD to generate real-world evidence (RWE) in sarcoma research, elucidating its application across different phases of the patient journey, from prediagnosis to the follow-up/survivorship phase. For instance, examining electronic health records (EHRs) from general practitioners (GPs) enables the exploration of consultation frequency and presenting symptoms in primary care before a sarcoma diagnosis. In addition, alternative study designs that integrate RWD with well-designed observational RCTs may offer relevant information on the effectiveness of clinical treatments. As, especially in cases of ultrarare sarcomas, it can be an extreme challenge to perform well-powered randomized prospective studies. Therefore, it is crucial to support the adaptation of novel study designs. Regarding the follow-up/survivorship phase, examining EHR from primary and secondary care can provide valuable insights into identifying the short- and long-term effects of treatment over an extended follow-up period. The utilization of RWD also comes with several challenges, including issues related to data quality and privacy, as described in this study. Notwithstanding these challenges, this study underscores the potential of RWD to bridge, at least partially, gaps between evidence and practice and holds promise in contributing to the improvement of sarcoma care.

PMID:38950319 | DOI:10.1200/CCI.24.00054

Health Aff (Millwood). 2024 Jul;43(7):994-1002. doi: 10.1377/hlthaff.2023.00928.

ABSTRACT

US health care use declined during the initial phase of the COVID-19 pandemic in 2020. Although utilization is known to have recovered in 2021 and 2022, it is unknown how revenue in 2020-22 varied by physician specialty and practice setting. This study linked medical claims from a large national federation of commercial health plans to physician and practice data to estimate pandemic-associated impacts on physician revenue (defined as payments to eligible physicians) by specialty and practice characteristics. Surgical specialties, emergency medicine, and medical subspecialties each experienced a greater than 9 percent adjusted gross revenue decline in 2020 relative to prepandemic baselines. By 2022, pathology and psychiatry revenue experienced robust recovery, whereas surgical and oncology revenue remained at or below baseline. Revenue recovery in 2022 was greater for physicians practicing in hospital-owned practices and in practices participating in accountable care organizations. Pandemic-associated revenue recovery in 2021 and 2022 varied by specialty and practice type. Given that physician financial instability is associated with health care consolidation and leaving practice, policy makers should closely monitor revenue trends among physicians in specialties or practice settings with sustained gross revenue reductions during the pandemic.

PMID:38950307 | DOI:10.1377/hlthaff.2023.00928

Health Aff (Millwood). 2024 Jul;43(7):1011-1020. doi: 10.1377/hlthaff.2023.01649.

ABSTRACT

Percutaneous coronary intervention (PCI) is a procedure that opens blocked arteries and restores blood flow to the heart. Timely access to hospitals offering PCI services can be a matter of life or death for patients experiencing a heart attack; however, hospitals’ adoption of PCI services may vary between communities, posing potential barriers to critical care. Our cohort study of US general acute hospitals during the period 2000-20 examined PCI service adoption across communities stratified by race, ethnicity, income, and rurality and further classified as segregated or integrated. Of 5,260 hospitals, 1,621 offered PCI services in 2020 or before, 630 added PCI services between 2001 and 2010, and 225 added PCI services between 2011 and 2020. Hospitals serving Black, racially segregated communities were 48 percent less likely to adopt PCI services compared with hospitals serving non-Black, racially segregated communities, and hospitals serving Hispanic, ethnically segregated communities were 41 percent less likely to do so than those serving non-Hispanic, ethnically segregated communities. Hospitals in high-income, economically integrated communities were 1.8 times more likely to adopt PCI services than those in high-income, economically segregated communities, and rural hospitals were less likely to do so than urban hospitals. Understanding where services are expanding in relation to community need may aid in successful policy interventions.

PMID:38950302 | DOI:10.1377/hlthaff.2023.01649

Health Aff (Millwood). 2024 Jul;43(7):979-984. doi: 10.1377/hlthaff.2023.00977.

ABSTRACT

The COVID-19 Uninsured Program, administered by the Health Resources and Services Administration (HRSA), reimbursed providers for administering COVID-19 vaccines to uninsured US adults from December 11, 2020, through April 5, 2022. Using HRSA claims data covering forty-two states, we estimated that the program funded about 38.9 million COVID-19 vaccine doses, accounting for 5.7 percent of total doses distributed and 10.9 percent of doses administered to adults ages 19-64.

PMID:38950301 | DOI:10.1377/hlthaff.2023.00977

Health Aff (Millwood). 2024 Jul;43(7):1032-1037. doi: 10.1377/hlthaff.2023.00840.

ABSTRACT

As people lose Medicaid because of the end of the COVID-19 public health emergency, many states will route former Medicaid managed care enrollees into Affordable Care Act Marketplace coverage with the same carrier. In 2021, 52.1 percent of Medicaid managed care enrollees were enrolled by a carrier that also had a plan on the Marketplace in the same county.

PMID:38950299 | DOI:10.1377/hlthaff.2023.00840

Health Aff (Millwood). 2024 Jul;43(7):1021-1031. doi: 10.1377/hlthaff.2023.00661.

ABSTRACT

Health care payment reforms in the US have aimed to encourage the use of high-value care while discouraging the use of low-value care. However, little is known about whether the use of high- and low-value care differs by income level. Using data from the 2010-19 Medical Expenditure Panel Survey, we examined the use of specified types of high- and low-value care by income level. We found that high-income adults were significantly more likely than low-income adults to use nearly all types of high-value care. Findings were consistent across age categories, although differences by income level in the use of high-value care were smaller among the elderly. Our analysis of differences in the use of low-value care had mixed results. Among nonelderly adults, significant differences between those with high and low incomes were found for five of nine low-value services, and among elderly adults, significant differences by income level were found for three of twelve low-value services. Understanding the mechanisms underlying these disparities is crucial to developing effective policies and interventions to ensure equitable access to high-value care and discourage low-value services for all patients, regardless of income.

PMID:38950294 | DOI:10.1377/hlthaff.2023.00661

Health Aff (Millwood). 2024 Jul;43(7):970-978. doi: 10.1377/hlthaff.2023.01153.

ABSTRACT

Although emergency department (ED) and hospital overcrowding were reported during the later parts of the COVID-19 pandemic, the true extent and potential causes of this overcrowding remain unclear. Using data on the traditional fee-for-service Medicare population, we examined patterns in ED and hospital use during the period 2019-22. We evaluated trends in ED visits, rates of admission from the ED, and thirty-day mortality, as well as measures suggestive of hospital capacity, including hospital Medicare census, length-of-stay, and discharge destination. We found that ED visits remained below baseline throughout the study period, with the standardized number of visits at the end of the study period being approximately 25 percent lower than baseline. Longer length-of-stay persisted through 2022, whereas hospital census was considerably above baseline until stabilizing just above baseline in 2022. Rates of discharge to postacute facilities initially declined and then leveled off at 2 percent below baseline in 2022. These results suggest that widespread reports of overcrowding were not driven by a resurgence in ED visits. Nonetheless, length-of-stay remains higher, presumably related to increased acuity and reduced available bed capacity in the postacute care system.

PMID:38950291 | DOI:10.1377/hlthaff.2023.01153

Med Educ Online. 2024 Dec 31;29(1):2373523. doi: 10.1080/10872981.2024.2373523. Epub 2024 Jul 1.

ABSTRACT

Depression amongst medical students is a crucial matter. Grit, which is a potentially modifiable psychological factor, has been inversely linked to depressive symptoms. However, it remains unclear how grit is associated with depression. This study aims to examine the relationship between grit and depressive symptoms and to further investigate the potential effect modification by academic performance on the association between grit and depression among medical students. We focus on the total grit score and its subscales, namely perseverance of effort and consistency of interest. A cross-sectional study was conducted using data from second-year medical students at Tokyo Medical and Dental University in Japan from 2020 to 2023. The participants responded to questionnaire surveys comprising the Center for Epidemiologic Studies Depression Scale and the Short Grit Scale. Linear regression analysis was performed to assess the association between grit and depressive symptoms. We also tested for effect modification by first-year Grade Point Average (GPA) on the association between grit and depression. The total grit score and its subscales, perseverance of effort and consistency of interest, were all inversely associated with depressive symptoms (b = -4.7 [95%CI – 6.7 to – 2.6], b = -3.7 [95%CI – 5.3 to – 2.1], b = -1.8 [95%CI – 3.5 to – 0.2], respectively). While the interaction term for the total grit score and GPA was not significant, the interaction term for perseverance of effort and GPA was significant, indicating that the association between perseverance of effort and depression was stronger among the higher-achieving students. The interaction term for consistency of interest and GPA was also significant, indicating that the association was stronger among the lower-achieving students. We reveal a novel aspect of the association between grit and depressive symptoms in light of academic performance. The findings will contribute to future research on depression amongst medical students.

PMID:38950191 | DOI:10.1080/10872981.2024.2373523