tbuckley/cabot-search huggingface dataset:
Change in facility-level share of Medicaid patients with cancer following implementation of the affordable care act.
Authors: Matthew Buck, Patrick C Demkowicz, James Nie, Victoria A. Marks, Michelle C. Salazar, Patrick Aloysius Kenney, Daniel J. Boffa, Michael S. Leapman
Journal: Journal of Clinical Oncology (2021)

e18543 Background: Although Medicaid expansions associated with the Affordable Care Act (ACA) significantly increased insurance coverage for Americans with cancer, there is evidence that some facilities limit the number of Medicaid patients they treat due to lower reimbursement. We aimed to assess facility-level changes in the proportion of patients with Medicaid who were diagnosed with cancer in relation to Medicaid expansions associated with the ACA. Methods: We identified adult patients with the 19 most commonly diagnosed cancers using the National Cancer Database who were diagnosed with cancer from 2010 through 2017. We clustered Commission on Cancer (CoC) accredited institutions and included those diagnosing at least 10 patients in each year. The primary study endpoint was the change in the proportion of Medicaid-insured individuals relative to the implementation of the ACA (pre- and post-Jan 1, 2014). We used adjusted difference-in-differences (DID) estimation and multivariable logistic regression to examine patient and facility-level factors associated with changes in the proportion of Medicaid insured individuals. Results: We identified 1,064 eligible facilities in the study period. There were considerable changes in the share of Medicaid insured patients at the facility-level (range -20.0% to +44.7%, IQR -0.64% to +5.63%). There were significantly larger changes in facilities located in Medicaid expansion states (11.5 to 16.5% percentage points) versus non-expansion states (9.2 to 8.9% percentage points) with adjusted DID +5.79% (p &lt; 0.001). Despite overall increases, 14.6% of facilities in expansion states experienced reductions in their share of Medicaid insured patients. Facility factors associated with decreasing share of Medicaid patients were non-expansion status (OR: 6.25, 95% CI 3.89 – 9.98, p &lt; 0.001) and higher baseline Medicaid population (OR: 2.93, 95% CI 2.00 – 4.35, p &lt; 0.001). There was also significant regional variation with larger decreases in the West South Central (OR: 5.86, 95% CI 2.30 – 15.74, p &lt; 0.001) and West North Central (OR: 2.46, 95% CI 1.07 – 5.87, p = 0.037) regions. Conclusions: Although state expansions associated with the ACA led to increases in the share of Medicaid-insured patients diagnosed with cancer at CoC facilities, there was considerable variation in changes at the facility-level. These findings highlight that improved insurance coverage may not be sufficient to improve access to care, and facility-level policies may remain a source of access disparity.
Serum Metabolite Profiles Are Strongly Correlated with Membrane Lipid Alterations in Beta Thalassemia Patients
Authors: Alexandros Makis, Dimitra Papagiannaki, Theodoros Palianopoulos, Eleftheria Hatzimichael, Eleni Kapsali, Nikolaos Chaliasos, Vasilios Sakkas, Evangelos Gikas
Journal: Blood (2017)
U.S. budget impact (BI) model for selinexor, bortezomib, and dexamethasone (XVd) for the treatment of patients with previously treated multiple myeloma (MM).
Authors: Mike Dolph, Gabriel Tremblay, Hoyee Leong
Journal: Journal of Clinical Oncology (2021)

e18839 Background: Despite advances in the treatment of MM, prognosis remains poor for most patients due to its refractory nature. In a phase 3 study, a once-per-week regimen of XVd showed a novel, effective, and convenient option for patients with previously treated MM. This study was conducted to estimate the projected budget impact (BI) of XVd in patients with previously treated MM from the perspective of a third-party payer and Medicare in the US. Methods: The introduction of XVd as a treatment option for patients with previously treated MM compared to the status quo (i.e. without the introduction of XVd) was considered from a private third-party US payer and a Medicare perspective in one-year increments for the first 3 years. The model assumed market uptake of 5.9%, 7.2%, and 7.7% at years 1, 2 and 3, respectively. Total annual treatment costs (2020 US dollars [USD]) were calculated as the sum of drug costs, the costs of treating serious treatment emergent adverse events (grade ≥3), ongoing best supportive care costs, and mortality costs. Results: In the base-case analysis for a private third-party payer plan (1,000,000 members), 3 to 4 patients were projected to receive XVd out of 47 to 49 eligible patients each year. The absolute BI (Millions, USD) of including XVd from a private third-party payer plan perspective was $0.06, $0.07, $0.08 and $0.22 for years 1, 2, 3, and overall, respectively. The relative BI of including XVd was 0.33%, 0.40%, 0.43%, and 0.38% for years 1, 2, 3, and overall, respectively. This translated to a per member per month (PMPM) budget impact of $0.005, $0.006, $0.007, and $0.006 (USD), for years 1, 2, 3, and overall, respectively. In the base-case analysis from the Medicare perspective (59,499,015 members), 1,361 to 1,808 patients were projected to receive XVd out of 22,892 to 23,425 eligible patients each year. From a Medicare perspective, the absolute BI (Millions, USD) of including XVd was $29.68, $36.62, $39.42 and $105.72 for years 1, 2, 3, and overall, respectively. The relative BI of including XVd was 0.33%, 0.40%, 0.43%, and 0.38% percent for years 1, 2, 3, and overall, respectively. This translated to a PMPM budget impact of $0.041, $0.051, $0.054, and $0.049 (USD), for years 1, 2, 3, and overall, respectively. One-way sensitivity analyses showed general consistency with the base-case findings. Conclusions: Understanding the potential BI of new therapies in MM is vital for decision makers to manage spending and assess the value of treatments. The introduction of XVd presents a small and manageable BI for a third-party US payer and Medicare.
Gemcitabine (Gem) and nab-paclitaxel (NP) ± nivolumab (nivo) ± CD40 agonistic monoclonal antibody APX005M (sotigalimab), in patients (Pts) with untreated metastatic pancreatic adenocarcinoma (mPDAC): Phase (Ph) 2 final results.
Authors: Mark H. O'Hara, Eileen Mary O'Reilly, Robert A. Wolff, Zev A. Wainberg, Andrew H. Ko, Osama E. Rahma, George A. Fisher, Jaclyn Paige Lyman, Christopher R. Cabanski, Joyson Joseph Karakunnel, Pier Federico Gherardini, Lacey J. Kitch, Samantha Bucktrout, Elizabeth Christopher, Rosemarie Mick, Richard Chen, Ovidiu C. Trifan, Lisa Salvador, Jill O'Donnell-Tormey, Robert H. Vonderheide
Journal: Journal of Clinical Oncology (2021)

4019 Background: Results from a ph1b trial evaluating gem/NP with CD40 agonistic monoclonal antibody APX005M ± nivo demonstrated promising clinical activity in pts with untreated mPDAC (O’Hara 2021). Herein, we report results from the follow-on, randomized (rand) ph2 trial evaluating gem/NP ± nivo ± APX005M. Methods: Pts with untreated mPDAC were rand to 1 of 3 open-label arms: gem/NP/nivo (A), gem/NP/APX005M (B), gem/NP/nivo/APX005M (C). All pts were treated with 1000 mg/m 2 gem and 125 mg/m 2 NP. Patients received 240 mg nivo in arms A and C and 0.3 mg/kg APX005M (RP2D) IV in arms B and C. Ph1b pts were included in ph2 analyses. 1° endpoint: 1-year OS rate of each arm, compared to a 35% historical OS rate for gem/NP (Von Hoff 2013). Key 2° endpoints: ORR, DCR, DOR, PFS and safety. Tumor and blood were collected for biomarker analysis. Planned enrollment of 35 pts/arm provided 81% power for testing the alternative of 58% OS rate vs 35%, using a 1-sided, 1-sample Z test with 5% type I error. Trial was not powered for cross-arm comparison. Results: 93 pts were rand in ph2 (N = 34, 30, 29 to A, B, C); when ph1b pts included, a total of 105 pts (34, 36, 35) were analyzed for efficacy and 108 pts (36, 37, 35) for safety. Min follow-up was 14 months (mos). Baseline characteristics were balanced across arms, inclusive of tumor burden, presence of liver metastases and stage at initial diagnosis (stage 1-3 vs 4). 1-year OS rate was 57% (1-sided p = 0.007 vs 35% historical rate, 95% lower CI bound = 41%) for A, 51% (p = 0.029, 95% bound = 36%) for B and 41% (p = 0.236, 95% bound = 27%) for C. Median OS and secondary endpoints are listed in Table. TRAE rates were similar across arms and to ph1b. 8 (7%) pts experienced an AE leading to tx discontinuation (6, 1, 1 in A, B, C), 40 (37%) pts experienced a serious TRAE (14, 15, 11 in A, B, C) and 2 pts died due to TRAEs; 1 each in B (acute hepatic failure) and C (intracranial hemorrhage). Conclusions: In this ongoing, seamless ph1b/2 trial of gem/NP ± nivo ± APX005M in pts with mPDAC, antitumor activity was observed in all arms. 1° endpoint of 1-year OS &gt; 35% was met when combining gem/NP with either nivo or APX005M; however, not the combination. Safety was manageable; consistent with ph1b. Detailed multiomic immune and tumor biomarker analyses are underway to elucidate mechanisms of action and inform pt subsets that benefit most from these combinations. Clinical trial information: NCT03214250. [Table: see text]
Real-world prognostic model for malignant pleural mesothelioma.
Authors: Abdullah Nasser, Andrew Baird, Mathieu D. Saint-Pierre, Scott A. Laurie, Paul Wheatley-Price
Journal: Journal of Clinical Oncology (2021)

e20562 Background: Two mesothelioma prognostic models have been suggested: European Organisation for Research and Treatment of Cancer (EORTC) and Cancer and Leukaemia Group B (CALGB) models. Both were based on clinical trial patients enrolled in the mid-1980s to early-1990s. Several changes to mesothelioma management have been adopted since publication of these models, including improved surgical and palliative interventions and changes to systemic therapy. Methods: With ethics approval, we collected and analyzed the health data of malignant pleural mesothelioma (MPM) patients with histologically confirmed diagnosis treated at our institution between January 1991 and March 2019. The primary endpoint was overall survival (OS). Univariate analysis was used to identify significant predictors of survival, which were then used to construct a multivariate survival tree with complete case-analysis and bootstrapping. Patients were then stratified into three prognostic groups based on their median OS. Results: 337 patients were included in the study; 309 (91.7%) were dead at last follow-up. The median OS was 9.4 (8.1-11.5) months for the entire population. Eastern Cooperative Oncology Group (ECOG) performance status (PS), histology, white blood count, platelets, International Mesothelioma Interest Group stage, age and hemoglobin were independent predictors of survival. The final pruned survival tree was based on 285 patients and incorporated the first five predictors. Good, intermediate and poor prognostic groups had median OS of &gt; 12 months, 6-12 months, and &lt; 6 months, respectively. Factors associated with the prognostic groups were: good prognosis: ECOG 0-1, normal platelets, stage 1, 2 and epithelioid histology; intermediate prognosis: ECOG 0-1 with either stage 3, 4 and/or sarcomatoid or biphasic histology; poor prognosis: ECOG 2-4 regardless of other factors. Conclusions: In contrast to EORTC/CALGB, real world evidence generates these prognostic groups with face validity but will need independent validation. Our data does not account for recent advances including immunotherapy, and thus patients with non-epithelioid histology may have better survival than predicted.[Table: see text]
Impact of a metastatic site on circulating tumor DNA (ctDNA) analysis in patients (pts) with metastatic colorectal cancer (mCRC).
Authors: Hideaki Bando, Yoshiaki Nakamura, Hiroya Taniguchi, Manabu Shiozawa, Hisateru Yasui, Taito Esaki, Takashi Ohta, Tadamichi Denda, Taroh Satoh, Kentaro Yamazaki, Yu Sunakawa, Takeshi Kato, Masahiro Goto, Satoshi Yuki, Tomohiro Nishina, Eiji Oki, Eiji Shinozaki, Nobuhisa Matsuhashi, Masayuki Hata, Takayuki Yoshino
Journal: Journal of Clinical Oncology (2021)

3554 Background: ctDNA genotyping has been used as an alternative to tissue genotyping for precision oncology. In mCRC, although low plasma RAS variant allelic frequencies (VAFs) and low concordance with tissue RAS tests have been reported in pts with lung-only metastasis (mets) (Kagawa Y. et al., Clin Cancer Res 2021), the association of ctDNA identified using the next-generation sequencing method with metastatic sites is still unknown. Methods: We investigated the association between metastatic site and ctDNA detection by using the Guardant360 (G360), a ctDNA assay which detects 74 gene alterations including mutations with the 95% of limit of detection of 0.2%, in mCRC pts with single organ mets in pts who had not received anti-EGFR therapy in the SCRUM-Japan GOZILA study. We also evaluated the correlations between the size/number of mets by CT and detected VAFs. Results: Of 1187 mCRC pts enrolled in GOZILA, 138 pts (49 with liver-only, 15 with lymph node-only, 27 with peritoneum-only, and 47 with lung-only mets) were eligible for this study. The concordance of RAS/ BRAF status between G360 and tissue in-vitro diagnostic tests were 93.9% in liver-only, 80.0% in lymph node-only, 56.0% in peritoneum-only, and 65.9% in lung-only mets. The median maximum VAF (maxVAF) corresponding to the highest ctDNA fraction and the median numbers of detected variants were 23.1% and 5 in liver-only, 6.0% and 5 in lymph node-only, 0.4% and 3 in peritoneum-only, and 0.4% and 3 in lung-only (all P&lt;0.001, Kruskal-Wallis test). A few pts with liver-only (2.0%) and lymph node-only mets (13.3%) had a maxVAF of &lt;0.2%, but maxVAF was more frequently &lt;0.2% in pts with lung-only (27.7%) or peritoneum-only mets (29.6%), especially in those with lung-only mets &lt;20 mm as the longest diameter and &lt;20 lesions (69.2%) or with peritoneum-only mets &lt;20 mm as the longest diameter (87.5%). Conclusions: Lung-only and peritoneum-only mets had significantly lower maxVAF and lower numbers of detected variants, suggesting lower detections of subclonal variants. To ensure the sufficient clinical performance in G360 assay, inclusion of pts with lung-only mets ≥20 mm of longest diameter and/or ≥20 lesions, and ≥20 mm of the longest diameter in pts with peritoneum-only mets may be required.[Table: see text]
Paroxysmal Atrioventricular Block
Authors: Matthew C. Hyman, Muralidhar Papireddy, David S. Frankel
Journal: JAMA Internal Medicine (2021)

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Associations of pre-existing cardiovascular disease (CVD) with treatment patterns and survival outcomes in patients with metastatic prostate cancer: A real-world, population-based study.
Authors: Atul Batra, Shiying Kong, Winson Y. Cheung
Journal: Journal of Clinical Oncology (2021)

e17056 Background: Prior cardio-oncology research has focused on examining the future risk of CVD as a result of cancer treatments. The impact of pre-existing CVD on cancer treatments is less clear. This study aimed to identify the associations of baseline CVD on treatment patterns and survival outcomes in metastatic prostate cancer where older age and exposure to androgen deprivation therapy can potentiate cardiac risks. Methods: We identified all patients diagnosed with metastatic prostate cancer in a large Canadian province from 2004 to 2017 using the population-based cancer registry. Administrative claims were linked to ascertain any diagnoses of pre-existing CVD, defined as any of arrythmias [AR], cerebrovascular accidents [CVAs], myocardial infarctions [MIs], or congestive heart failure [CHF] that preceded the diagnosis of metastatic prostate cancer. Logistic and Cox regression models were constructed to determine the associations of baseline CVD with receipt of cancer treatments (such as radiation, or systemic therapy) and overall survival (OS). Results: A total of 3,257 patients were included. The median age was 66 years (interquartile range, 46-95 years). At diagnosis of advanced prostate cancer, 993 (30.5%) had pre-existing CVD: 10.0% AR, 4.3% CVAs, 3.0% MIs, 2.8% CHF and 10.4% multiple CVDs. The Charlson comorbidity index (CCI) was 0, 1 and &gt;1 in 53.4%, 27.3% and 19.3%, respectively. Overall, 2078 (63.8%) patients received chemotherapy, while 747 (22.9%) received radiotherapy. After adjusting for age and CCI, pre-existing CVD was associated with a lower likelihood of chemotherapy (odds ratio [OR], 0.67; 95% confidence interval [CI], 0.61-0.75; P=0.001) and radiotherapy (OR, 0.87; 95% CI, 0.85-0.91; P&lt;0.001). Likewise, CVD was associated with worse OS, after adjusting for measured confounding variables (see table). Conclusions: One-third of patients with metastatic prostate cancer had pre-existing CVD, which was associated with a lower likelihood of chemotherapy and worse OS. In the context of an aging general population, early cardio-oncology consultations to optimize CVD management may lead to safer and broader uptake of appropriate prostate cancer treatments.[Table: see text]
Significance of scores generated by a cancer therapy matching engine for patient outcomes.
Authors: Eden Romm, Emiliya Davtyan, Kevin Bush, Ramsay Sutton, Itamar Patek, Parisa Imanirad, Jason K. Sicklick, Shumei Kato, Razelle Kurzrock, Ally Perlina
Journal: Journal of Clinical Oncology (2021)

e15099 Background: Oncologists need effective precision medicine tools to navigate the myriad of therapeutic options to best address each patient’s unique tumor profile. Described here is a digital solution, which analyzes tumor data (NGS, other), scores and ranks known and novel matching combinations of cancer drugs with molecular-level precision for decision support. Methods: All data was acquired through the published supplement of the I-PREDICT study (NCT 02534675). Patients with available progression-free survival (PFS) and sequencing data who received &lt;3 matched non-experimental cancer drugs in combination were evaluated (n=77). To determine each patient’s score (represented as %), the system used expert-curated content integrated within an artificial intelligence (AI) reasoning framework that computed how well the therapy each patient received matched their tumor’s genomic profile. The dataset was binarized at 36 possible thresholds, which split the data into higher vs. lower score bins. Relationship with PFS and the degree of separation between bins were evaluated with Kaplan-Meier plots and assessed in terms of p-value, hazard ratios and related confidence intervals (Table). To prevent sampling bias at high and low thresholding extremes of this dataset, a limit was imposed of &gt;25 patients per bin. Results: Significant separation between high and low scoring bins was observed in &gt;73% of evaluable thresholds. The mean p-value was 0.044 (range, 0.011-0.13). The hazard ratio was consistently ̃2 (mean, 1.81, range, 1.50-2.08). A similar level of statistical significance was observed for all thresholds up to and including bracketing of 60% (Table). Despite the small size of this dataset and the disparity between sample counts per bin seen at the end of the range, significant p-values of &lt;0.05 were achieved. Ex., a 68-year-old female with an ampullary adenocarcinoma harboring ERBB2, CDK6 and other alterations, received a combination of pertuzumab and trastuzumab scoring 56%. The PFS was 745+ days. However, had palbociclib, ribociclib, or abemaciclib been added to this combination, the resulting 3-drug options would have scored even higher due to also targeting CDK6. Conclusions: Our study indicates that therapies with higher scores were predictive of better PFS, while lower scores were predictive of worse PFS. The results will be validated on larger datasets but are already demonstrative of the utility of this system in providing digital guidance to oncologists in selecting the most suitable treatment. [Table: see text]
The sequence of chemotherapy and anti-PD-1 antibody influence the efficacy of neoadjuvant immunochemotherapy in locally advanced esophageal squamous cell cancer: A phase II study.
Authors: Lingdi Zhao, Wenqun Xing, Yonghao Yang, Yong Zhang, Baozhen Ma, Xiaomin Fu, Guanghui Liang, Yiman Shang, Zibing WANG, Hongwei Lin, Quanli Gao
Journal: Journal of Clinical Oncology (2021)

4051 Background: PD-1 blockade may result in expansion of tumor-specific T cells. However, traditional immunochemotherapy regimens usually designed to use chemotherapy drugs and anti-PD-1 antibody on the same day, which may make chemotherapy drugs kill activated T cells. The purpose of this study was to investigate the rate of pCR of chemotherapy plus anti-PD-1 therapy and the influence of sequence of chemotherapy and anti-PD-1 therapy on pCR in patients with locally advanced esophageal squamous cell cancer. Methods: Thirty esophageal squamous cell cancer patients with T3, T4, or lymph node positive were assigned into experiment group (anti-PD-1 antibody was administrated two days after chemotherapy) and control group ( anti-PD-1 antibody and chemotherapy were administrated on the same day) according to the order of enrollment. There were fifteen patients in each group. The chemotherapeutic regimen was paclitaxel and cisplatin, paclitaxel was given at the dose of 150-175mg/m 2 on day 1 and cisplatin was given at the dose of 70-75mg/m 2 on day 1. The anti-PD-1 antibody was toripalimab at the fixed dose of 240mg on day 3 or day 1. Operation was performed four to six weeks after the second cycle of chemotherapy combined with toripalimab. Results: From July 2019 to September 2020, a total of 30 patients completed at least one cycle of immunochemotherapy. 11 in the experimental group received operation after two cycles of neoadjuvant chemotherapy plus toripalimab. Thirteen in control groupreceived operation aftertwo cycles of neoadjuvant chemotherapy plus toripalimab. Four patients in experimental group and one in control group got pCR, the rates of pCR in experimental group and control group were 36.4% and 7.7% individually. Although the difference was not significant in statistics, the experimental group had the trend of higher pCR rate(c 2 = 3.092, p = 0.079). PD-L1 CPS examination before treatment was performed in fourteen patients, it was found that except one patient with PD-L1 CPS was 10, the left thirteen with PD-L1 CPS were all below one. The patient with PD-L1 CPS 10 was in control group and pCR was got in this patient. Except one patient in the experimental group had grade 3 immune-related enteritis, one patient in the control group died from immune-related myocarditis after operation, there were no more immune-related events more than grade 3. Conclusions: Toripalimab was delayed on day 3 when toripalimab plus chemotherapy was taken as neoadjuvant therapy regimen in locally advanced esophageal squamous cell carcinoma might achieve a higher pathological complete response than toripalimab and chemotherapy used on the same day. Clinical trial information: NCT 03985670.