tbuckley/cabot-search huggingface dataset:
A prospective double-blind clinical study: Effect of probiotics and thalidomide on radiation enteritis in patients with pelvic cancer undergoing concurrent chemoradiotherapy.
Authors: Chunling Jiang, Xiaoyan Xu, Xin Wang, An Yi, Bin Li, Jingao Li, Huaiwen Zhang
Journal: Journal of Clinical Oncology (2024)

e23013 Background: Radiation induced diarrhea (RID) is one of the commonest and most distressing side effects during and after radiotherapy predominantly in patients whose irradiation region is pelvis. Thalidomide reduces severity as well as the frequency indicated in RID but mechanism of action is not elucidated. Probiotics are beneficial microorganisms that may regulate flora of intestines to increase immunity and have a protective effect on RID. This pilot study was designed to ascertain effects of thalidomide and probiotics on RID in patients being subjected to pelvic irradiation. Methods: A double-blind, single-center, randomized pilot study was conducted. Patients were classified into two groups as thalidomide plus probiotics (Lactobacillus rhamnosus + Probio-M9, ) group (TP group) or plus placebo group (P group).Incidence of grade 3/4 diarrhea, was a primary endpoint of the study. Other secondary endpoints analyzed were rates and severity of diarrhea, antibiotics use, body weight, albumin, and lymphocyte changes. 31 patients undergoing pelvic radiotherapy with or without concurrent chemotherapy were randomly selected from government tertiary general hospital. Results: The incidence of grade 3/4 diarrhea was 9.5% (95% CI: 0 to 24.5%) in TP, which was significantly different from historical data of 30% to 60%. The incidence of grade 3/4 diarrhea in group P was 19.8% (95% CI: 0~41.3%). The frequency and severity of diarrhea in group TP were little less than in group P. There is no significant difference between them. Basically, the time for antibiotic use in groups P and TP was the same, with a slightly longer time from first antibiotic exposure in group TP as compared to group P. The moment of first antibiotics have been prescribed in our study patients, this was better than that of a clinical routine treatment experience and other research data according to the literature. The changes in body weight, albumin level, and lymphocyte at different stages before and after radiotherapy in group TP were not statistically significant, and the level of body weight and albumin in group P was slightly reduced compared with before radiotherapy but increased compared with group TP after radiotherapy. Furthermore, there were no severe adverse effects regarding thalidomide as well as probiotics reported among patients who participated in this study. Conclusions: The combined treatment with thalidomide and probiotics is beneficial to ameliorate RID in patients receiving pelvic radiotherapy, yet this study can't represent whole conclusion due to small size of patients. We will also need larger, multicenter double-blind placebo-controlled trials to confirm exact efficacy and safety of this combined treatment. Clinical trial information: NCT05059613 .
Psilocybin, peyote, mescaline, and lysergic acid diethylamide (LSD) use in a nationally representative population by cancer history.
Authors: Amrit Baral, Yue Pan, Alberto J. Caban Martinez, Paulo S. Pinheiro, WayWay M. Hlaing, Denise Christina Vidot
Journal: Journal of Clinical Oncology (2024)

e22518 Background: Classic psychedelics (Peyote, Psilocybin, Mescaline, and LSD) are re-emerging in the oncology toolbox. Peyote is the oldest known psychedelic, yet underexplored in clinical research. Preclinical studies suggest its extract stimulates lymphocyte proliferation, kills tumor cells, and may regulate sleep. This study aims to estimate the prevalence of classic psychedelic use among a US-representative sample of adults with and without a history of cancer. Methods: Data ( N= 208,220, weighted N: 239,589,661) from adults &gt;18y in the 2015 - 2019 National Surveys on Drug Use and Health (52.8% female, 68.4% non-Hispanic White, 45.6% aged ≥50y) were analyzed to estimate lifetime classic psychedelic use among those with no cancer history, past history (diagnosed &gt; 1y ago), or recently (≤1y ago) diagnosed. Weighted prevalence of psychedelic use, 95% confidence intervals, and adjusted (sex, race, income, education) odds ratio were calculated using logistic regression analysis in SAS. Results: Overall, 6.2% had a cancer history and 14.0% reported lifetime classic psychedelics use. LSD was the most prevalent in the sample (10.6%, 95% CI:10.4-10.8) compared to Psilocybin (9.6%, 95% CI: 9.4-9.9), Mescaline (3.1%, 95% CI:3.0-3.2), and Peyote (2.3%, 95% CI:2.2-2.4). Psychedelic use was lowest in adults with past cancer diagnosis (12.3%, 95% CI:11.4-13.1) vs recently diagnosed [14.0% (95% CI:12.0-16.0] and cancer naive (14.1%, 95% CI:13.8-14.4). Each classic psychedelic was used more often among recent cancer diagnosed adults than past diagnosed (p &lt; 0.05). Specifically, LSD (11.1%, 95% CI:9.3-12.9 vs 9.3%, 95% CI:8.5-10.0), Psilocybin (8.3%, 95% CI:6.6-10.0 vs 7.3%, 95% CI: 6.7-8.0), Mescaline (5.4%, 95% CI:4.0-6.8 vs 4.6%, 95% CI: 3.9-5.2), and Peyote (3.7%, 95% CI: 2.5-5.0 vs 2.9%, 95% CI: 2.5-3.4) use was higher in recently diagnosed cancer patients than past diagnosed. There were no significant differences in age, except among Peyote. Among 18-to-34-year-olds, recent cancer patients had 3-fold greater odds (aOR:3.55, 95%CI: 1.11-11.31) of using peyote vs cancer naïve. In ≥50-year-olds, those with past cancer diagnosis had 21% lower odds (aOR:0.79, 95% CI:0.63-0.97) of using peyote vs cancer naïve. Conclusions: Results suggest differential psychedelic use by cancer history and age. These findings, while limited by temporality of diagnosis and initiation of psychedelic use, underscore the need to investigate reasons and long-term impact of specific psychedelic use with more rigor among adults with a cancer history.
Early integrated rehabilitation and vocational rehabilitation in 435 patients with breast cancer: A comparison between the intervention group and control group in a prospective study.
Authors: Nikola Besic, Mateja Kurir Borovcic, Zlatka Mavric, Anamarija Mozetic, Tina Zagar, Vesna Homar, Nena Kopcavar Gucek, Andreja Cirila Skufca Smrdel, Nada Rotovnik Kozjek, Vedran Hadzic, Natasa Kos, Bojan Pelhan, Marko Sremec, Tina Rozman, Simona Borstnar
Journal: Journal of Clinical Oncology (2024)

11007 Background: Return to work is beneficial both for breast cancer (BC) patients and for society. This study explored the impact of early integrated and vocational rehabilitation on sick leave and disability one year after the start of cancer treatment in BC patients. Methods: The subjects of our prospective study were 435 employed female BC patients (26-65 (mean 52) years of age), who participated in the pilot study on the individualized integrated rehabilitation in 2019-2022 and were followed for at least one year. There were 211 patients in the control group and 224 in the intervention group. The patients completed three questionnaires (EORTC QLQ - C30, B23, and NCCN): before, half and one year after the start of cancer treatment. The control group received the standard rehabilitation programme, offered to all BC patients before the start of the study. The multidisciplinary rehabilitation team reviewed the documentation of the patients from the intervention group before, half and one year after the start of treatment and recommended appropriate interventions according to the patient's needs in compliance with the institute’s new clinical pathway (psychologist, general practitioner, nutritional treatment, physical rehabilitation, kinesiologist-guided online exercises, gynaecologist, analgesia, vocational rehabilitation). Data on the patients’ demographics and needs reported in questionnaires, the extent of the disease and cancer treatment were collected. These data and the frequency of sick leave and disability retirement one year after the start of treatment in both groups of patients were analysed using the chi-square and ANOVA test. Results: The patients from the intervention group had 50 calendar days shorter sick leave compared to the control group (p = 0.002). Patients without metastatic disease from the intervention group had 52 calendar days shorter sick leave compared to the control group (p = 0.002). The intervention group treated with chemotherapy had 43 calendar days shorter sick leave compared to the control group (p = 0.029). The difference in sick leave of the group of patients who did not receive chemotherapy was statistically borderline significant (50 calendar days, p = 0.053). The patients in the intervention group had a better work ability (p &lt; 0.001) and less disability (p &lt; 0.001) than the patients in the control group one year after the start of treatment. Conclusions: One year after the beginning of cancer treatment, patients from the intervention group had shorter sick leave, better work ability, and a lower proportion of disability compared to the control group.
Real-world outcomes and molecular correlates of incorporating immunotherapy (IO) and bevacizumab (Bev) in treating patients with peritoneal mesothelioma (PeM): A comparative analysis with pleural mesothelioma (PM).
Authors: Ryan W. Huey, Nishant Gandhi, Beth A. Helmink, Michael J. Overman, Anais Malpica, Jeannelyn Estrella, Melissa Taggart, Joelle Allam, Christopher Scally, Paul F. Mansfield, Aurelio Matamoros, Andrew Elliott, Ari VanderWalde, Patrick C. Ma, Balazs Halmos, Stephen V Liu, Keith F. Fournier, Kanwal Pratap Singh Raghav
Journal: Journal of Clinical Oncology (2024)

e23300 Background: Nivolumab/Ipilimumab (IO) and Bev/Chemo are now considered standards of care for patients (pts) with advanced PM, based on randomized (CheckMate743 and MAPS) trials. By extrapolation, they are also endorsed by guidelines and used clinically in pts with PeM. Due to lack of any prospective data, we evaluated real-world effectiveness of these agents in PeM (vs PM) and investigated molecular correlates underlying their therapeutic impact. Methods: The study cohort was composed of mesothelioma pts (N = 723) who underwent DNA (592-gene panel or whole exome)/RNA (whole transcriptome) [PeM (221/224) and PM (493/499)] sequencing at Caris Life Sciences (Phoenix, AZ). Treatment and real-world survival (OS) were obtained from insurance claims and calculated from time of tissue collection to last contact. Hazard ratio (HR) was calculated using Cox proportional hazards model. Tumor microenvironment (TME) estimates were calculated from bulk RNA sequencing using QuanTIseq method. Significance was determined using Chi-square, Mann Whitney U and log-rank tests and corrected for multiple comparisons (q-value &lt; 0.05) when applicable. Results: PeM (vs PM) had a higher proportion of females (46% vs 29%) and younger age (62 vs 73 years; both p &lt; 0.001). 20% and 22% of PeM were treated with IO or Bev/Chemo, with similar utilization rates in PM of 22% and 24%, respectively. OS estimates and comparisons are shown in Table. Prevalence of mutations in key mesothelioma associated genes ( BAP1, NF2, TP53 and SETD2) was not significantly different between PeM and PM. NF2 (10.1 vs 51.3 m for wild type; p &lt; 0.001) and TP53 (10.4 vs 46.6 m for wild type; p &lt; 0.006) mutations were associated with worse OS in PeM but not in PM. Prevalence of high tumor mutation burden (≥10 mut/Mb: 1.0% vs 3.4%; q = 0.37) and PD-L1+ (18.7% vs 28.8%; q = 0.07) tumors was slightly lower in PeM than PM. Macrophage fractions, M2 were higher (1.5-fold) and M1 were lower (0.8-fold) in PeM (both q &lt; 0.05) compared to PM. Conclusions: In this large real-world analysis, use of IO appears to be associated with improved outcomes in PeM, despite a potentially immunosuppressive TME. Notably, addition of Bev did not appear to improve outcomes in PeM, in contrast to PM. These results highlight variances in clinical utility/value of these therapies. Molecular mechanisms underlying these outcome differences warrant further investigation. [Table: see text]
Pilot study to evaluate automated laboratory data transfer into Medidata Rave for NCI-supported pediatric cooperative group trials in the Pediatric Early Phase Clinical Trials Network (PEP-CTN) and Pediatric Brain Tumor Consortium (PBTC).
Authors: Tamara P. Miller, Richard Aplenc, Charles G. Minard, Yu Wang, Shelly Lensing, Prasanna Velamuru, Jennie Haunani Foster, Milena Silverman, Cheryl Sung, Karina Wong, Thalia Angelica Beeles, Brenda Weigel, Arzu Onar-Thomas, Elizabeth Fox
Journal: Journal of Clinical Oncology (2024)

e23017 Background: Electronic data capture (EDC) has the potential to improve data accuracy and efficiency. As an initial step toward improvement in the accuracy and completeness of data acquisition for clinical trials, PEP-CTN and PBTC conducted a pilot project to assess the feasibility of automated transfer of laboratory data from participating institutions’ electronic health records to the NCI Medidata Rave EDC that is housed within each consortium’s Uniform Resource Locator (URL). The pilot aimed to assess feasibility of automated laboratory data extraction and transfer and to evaluate discrepancies between laboratory data obtained retrospectively through automated extraction and data manually ascertained during the original conduct of the study. Methods: Data from patients treated on 7 completed PEP-CTN or PBTC trials at 7 sites were included. Each consortium created a Rave EDC study to receive data. Sites used the ExtractEHR R package or local methods to map and extract laboratory data for designated patients. Post-extraction data were uploaded via a file transfer protocol (FTP) periodically polled by the Rave Batch Uploader (BU) that uploaded data into Rave EDC. After successful upload, extracted data (EHR) were compared to laboratory data that had been manually reported when patients were enrolled on the trials (MANUAL) and discrepancies were identified. Discrepancy types were categorized and 2 sites reviewed discrepancies at their sites to identify reasons. Results: Preparation and support for automated extraction and upload required significant central operations and local site effort. All sites successfully extracted specified laboratory data and had at least one complete upload via BU to Rave EDC. There were more laboratory data in the EHR datasets than MANUAL datasets across most sites. These results were due to multiple EHR results on a given day or from additional days in the study window than specified in MANUAL. Sites verified that laboratory data in MANUAL and not EHR were stored in un-extractable formats (e.g. PDFs) or outside laboratories. Most discrepant results in both EHR and MANUAL were mismatched values or units. Conclusions: This pilot demonstrated the feasibility of implementing automated laboratory data extraction and transfer in the cooperative group setting. Automated data transfer requires significant central operational support as well as detailed protocols, data specifications, and case report forms and engagement of site technical teams to be successful, but also permits collection of more comprehensive data with reduced manual data entry. Clinical trial information: NCT05020951 .
Patterns and trends in incidence, survival, and treatment among patients with early-onset lung cancer in the U.S.: A population-based study.
Authors: Wang-Zhong Li, Hengrui Liang, Jun Liu, Wei Wang, Ying Huang, Shen Lao, Miao He, Wenhua Liang, Jianxing He
Journal: Journal of Clinical Oncology (2024)

e22517 Background: Lung cancer is the second leading cause of cancer-related deaths among young adults. An in-depth investigation into the demographic distribution and temporal trends in early-onset lung cancer (EOLC) incidence and survival, as well as treatment patterns, could help monitor the cancer burden, identify high-risk populations, and develop effective screening and prevention strategies. Methods: This serial cross-sectional study used data from the U.S. Cancer Statistics (USCS) and the Surveillance, Epidemiology, and End Results (SEER) program. EOLC refers to lung cancer diagnosed in individuals aged 20-49 years. USCS database (2001-2019) was used for demographic description and incidence estimation. SEER-17 registries database (2000-2019) was used for survival estimation and treatment patterns examination. Age-adjusted incidence rate per 100,000 population and cancer-specific survival were reported. Changes in rates were assessed with average annual percentage change (AAPC) using Joinpoint regression. Results: There were 4,086,435 lung cancer cases recorded between 2001 and 2019 in the U.S. (USCS: 53.3% male; median age of 70 years). EOLC accounted for 4.1% (169,132) of all lung cancer cases and was more common among females, non-Whites, with higher adenocarcinoma and advanced-stage diagnoses. During this period, the incidence of EOLC decreased from 9.0 to 4.5 per 100,000 population (APC, -4.2; P &lt; 0.001). EOLC incidence continued to decrease across all demographic groups, except for young people aged 20-29. The rate of decline was faster among men than women, blacks than whites, squamous carcinoma than adenocarcinoma, and distant disease than localized disease. The historical higher incidence among young men vs. young women and among blacks vs. whites have been reversed in recent years. A consistent increase in survival rates of EOLC across all demographic groups from 2001 to 2017 (SEER-17) was observed. Despite the increases were more pronounced among men than women and among black individuals than white individuals, gender and racial disparities persisted. EOLC patients received more intensive treatment than late-onset patients. Still, 12.1% of EOLC cases were not treated, and this was most common among black individuals and those with distant disease. Treatment patterns for EOLC have not undergone significant changes in recent decades. Of note, the proportion of untreated patients has not decreased during the study period. Conclusions: EOLC was an uncommon type of disease with distinctive clinical features in the U.S. Substantial decreases in incidence and improves in survival were observed, whereas major treatment pattern remained relatively stable.
Impact of social determinants of health on health-related quality of life in cancer survivors.
Authors: Josephine Peitz, Sally Nneoma Adebamowo
Journal: Journal of Clinical Oncology (2024)

11183 Background: Social determinants of health (SDoH) encompass the various environmental conditions that influence health, well-being, outcomes, and potential risks. Adverse SDoH can exacerbate health disparities and result in a reduced health-related quality of life (HRQoL). We conducted an investigation into the impact of SDoH on the HRQoL of cancer survivors. Methods: The study population was a nationally representative cohort of individuals aged 20-80 years who took part in the United States National Health and Nutrition Examination Survey (NHANES) 2001 to 2018 cycles. We evaluated HRQoL by measuring the number of physically unhealthy days, mentally unhealthy days, inactive days, as well as assessing social support and emotional well-being. We used logistic regression models to investigate the impact of each SDoH on the HRQoL of cancer survivors. Results: We included 4,780 participants in our analyses, comprising 2,533 women and 2,247 men. The participants mean age was 66 (±14) years at the time of enrollment, and 55 (±17) years at the time of cancer diagnosis. Among the total study population, non-melanoma skin cancer (16%) was the most prevalent cancer type. After adjusting for age, age at cancer diagnosis and gender, people who had the lowest self-reported health were more likely to have completed fewer years of education (OR 0.380 [95% CI: 0.32 - 0.45], p &lt; 0.0001), be unemployed (OR 2.30 [1.91 - 2.77], p &lt; 0.0001), have lower family income (OR 0.36 [0.28 - 0.45], p &lt; 0.0001), be food insecure (OR 3.90 [2.80 - 5.44], p &lt; 0.0001), not have private health insurance (OR 1.68 [1.37 - 2.07], p &lt; 0.0001), and have been hospitalized overnight in the last year (OR 5.23 [3.49 - 7.83], p &lt; 0.001) compared to those with the highest self-reported health. SDoH including employment status, family income, food security status, health insurance type, and overnight hospital patient status, were significantly associated with physical and mental health, and physically active days. Level of education and food security were significantly associated with social support and emotional well-being. Conclusions: Adverse SDoH were associated with the reduced HRQoL of cancer survivors in the United States. These findings underscore the importance of addressing and mitigating these social determinants in order to alleviate health disparities and improve the overall well-being and quality of life for cancer survivors.
Enrollment of older adults in clinical trials for oncology indications, 2010-2020: An evaluation by the FDA.
Authors: Felice Yang, Catherine C. Lerro, Zhou Feng, Oladimeji Akinboro, Richard Curley, Asma Ali Dilawari, Mallorie Fiero, Yue Huang, Gwynn Ison, Bindu Kanapuru, Ruby Leong, Wei Liu, Timil Patel, Daniel L. Suzman, Paul Gustav Kluetz, Harpreet Singh, Donna Rivera
Journal: Journal of Clinical Oncology (2024)

e23029 Background: Underrepresentation of older adults (≥65 years) in clinical trials may limit important evidence for regulatory and clinical decision-making. Prior FDA analysis 1 demonstrated underrepresentation of older adults in oncology clinical trials. With recent efforts to encourage inclusion of older adults, we evaluated representation in clinical trials using updated data. Methods: This analysis used patient-level data from pivotal trials supporting approvals of new drugs and biologics, and expanded indications from 2010-2020 for cancers with high incidence in the U.S. population and older adults: breast (BC), colorectal (CRC), non-small cell lung (NSCLC), prostate (PC), chronic myeloid leukemia (CML), and multiple myeloma (MM). Age distribution of trial participants compared to incident cases from the NCI SEER Program was analyzed using the Enrollment to Incidence Ratio (EIR). For each cancer-age group, EIR is the percentage of trial participants divided by percentage of incident cases. Previously established EIR categories of &lt; 0.8, 0.80-1.20, and &gt; 1.2 indicate under-, adequate, and over-representation, respectively. Results: The analysis included 86000 participants in 152 trials. Adults &gt;65 yrs were underrepresented in BC trials. Adults &gt;75 yrs were underrepresented in BC, CRC, NSCLC, CML, and MM trials (Table 1). Conclusions: Despite slight variation across cancers, adults &gt;75 yrs appeared to be underrepresented in clinical trials, excepting PC. Given heterogeneity in the natural history by cancer site, incidence may not best represent age distribution of the intended use population for all trials. Further evaluation using prevalence as a comparator may provide additional insights. Additionally, results may be affected by clinical factors such as stage; however, comparison is limited by SEER data element availability. Planned sensitivity analyses such as stratification by drug class and line of therapy may further elucidate enrollment patterns. References: Singh H, Kanapuru B, Smith C, et al: FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: A 10-year experience by the U.S. Food and Drug Administration. Journal of Clinical Oncology 35:10009-10009, 2017. [Table: see text]