bluuebunny/crossref_metadata_2025_split huggingface dataset:
Associations between patient knowledge of others' experiences and treatment choice in men with localized prostate cancer.
Authors: Katz Aaron J. , Cao Ying , Shen Xinglei , Usinger Deborah , Walden Sarah , Chen Ronald C. 
Published: June 2021

6578 Background: Men with localized prostate cancer must select from multiple treatment options, without one clear best choice. Consequently, personal factors, such as knowing other prostate cancer patients who have undergone treatment, may influence patient decision-making. However, associations between knowledge about others’ experiences and treatment decision-making among localized prostate cancer patients has not been well characterized. We used data from a population-based cohort of localized prostate cancer patients to examine whether patient-reported knowledge of others’ experiences is associated with treatment choice. Methods: The North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) is a population-based cohort of localized prostate cancer patients enrolled from 2011-2013 throughout the state of North Carolina in collaboration with the North Carolina Central Cancer Registry. All patients were enrolled prior to treatment and followed prospectively. Patient decision-making factors including knowledge of others’ experiences with prostate cancer treatment options were collected through patient report. Patient treatment choice was determined through medical record abstraction and cancer registry data. Results: Among 1,202 patients, 17% reported knowing someone who pursued active surveillance (AS) while 28%, 46%, and 59% reported knowing someone who received brachytherapy, external beam radiation (EBRT), or radical prostatectomy (RP), respectively; 26% underwent AS, 9% brachytherapy, 21% EBRT, and 39% RP as their initial treatment. In unadjusted analyses, patients with knowledge of others’ experiences with brachytherapy, EBRT or RP had more than twice the odds of receiving that treatment compared to patients who did not. Knowledge of others’ experience with AS was not associated with choice to undergo AS. Multivariable analysis adjusting for age, race, risk group, and patient-reported goals of care showed knowledge of others’ experiences with brachytherapy (OR 4.60, 95% confidence interval [CI] 2.76 to 7.68), EBRT (OR 2.38, 95% CI 1.69 to 3.34), or RP (OR 4.02, 95% CI 2.84 to 5.70) was significantly associated with odds of receiving that treatment. The odds of receiving a particular treatment option were further increased among patients who reported knowing someone who had a “good” experience with the treatment in question. Conclusions: This is the first population-based study to directly demonstrate the impact of a patient’s knowledge of others’ experiences on treatment choice in prostate cancer. These data provide a new consideration to clinicians in their counseling of patients with newly diagnosed prostate cancer, and also impacts research into the informed decision-making process for this disease.
Provision of subspecialized expert oncology (SEO) opinions using Navya Cancer Data Model (NCDM), a technology-based platform: Prospective study to facilitate access to care.
Authors: Traina Tiffany A. , Kantoff Philip W. , Matasar Matthew J. , Dunn Lara , Friedman Claire Frances , Voss Martin H , Seidman Andrew David , Cahlon Oren , Zauderer Marjorie Glass , Manship Cole , Kauff Emily , Srivastava Gitika , Ramarajan Naresh , Abou-Alfa Ghassan K. 
Published: June 2021

6580 Background: Outcomes for patients (pts) with cancer may vary widely based on accessibility and quality of care. Subspecialized expert care is associated with improved outcomes yet access to this scarce resource is limited. Providing SEO opinions in legacy ways is time-consuming and difficult to scale. We hypothesized that summarizing comprehensive pt records could enhance efficiency of a remote opinion process. In this prospective pilot, oncologists (MDs) at Memorial Sloan Kettering (MSK) tested the NCDM, a clinically-validated, semi-automated system which abstracts pertinent data elements from medical records into a structured summary to support SEO decision making for remote opinions. Methods: From July to December 2020, 12 MSK MDs provided remote opinions to consecutive pts from an international second opinion service who were specifically seeking MSK expertise. NCDM summaries, with relevant DICOM imaging, were provided to MDs via web and mobile app. MDs answered a brief survey about their experience after each opinion. Time spent to read and respond to an NCDM summary was tracked electronically. Pt feedback was collected by prospective phone follow up. Results: N = 101 remote opinions. Cancer type (N): breast (24), gastrointestinal (15), heme malignancy (14), prostate (12), renal (8), gynecologic (7), head & neck (11), lung (9) and skin (1). 92% MD response rate. Pt characteristics: median age (60 years, range 17-83); stage of disease (early stage 41%, advanced 59%); 86% of pts had received prior treatment. MDs survey responses: median time to complete record review and render opinion = 4.8 min (IQR 2.7 – 7.9 min); NCDM provided adequate information needed to make a decision in this case = 95.7% (89/93); Decision making was easy in this case with data presented in the NCDM format = 96.8% (90/93). Pt survey responses (71/88): 92% shared recommendation with local MD; 87% received the recommended treatment; 99% stated they would recommend a NCDM enabled remote opinion service to others. Conclusions: NCDM summaries enabled subspecialized MSK cancer experts to provide oncology remote opinions with ease. Patients reported high satisfaction with the experience. Technology assisted abstraction and case summary can facilitate access to subspecialized expert opinions at a global scale.
Assessment of vitamin D deficiency and COVID-19 diagnosis in patients with breast or prostate cancer using electronic medical records.
Authors: Galaznik Aaron , Rusli Emelly , Wing Vicki , Jain Rahul , Diamond Sheila , Fajgenbaum David 
Published: June 2021

6589 Background: While patients with cancer are known to be at increased risk of infection in part due to the immunocompromising nature of cancer treatments, recent data indicate a particularly high risk for COVID-19 infection and poor outcomes (Wang et al., 2020). A recent study (Meltzer et al., 2020) demonstrated Vitamin D deficiency may increase risk of COVID-19 infection, and a small randomized controlled trial in Spain reported significant improvement in mortality among hospitalized patients treated with calcifediol. Vitamin D deficiency has been reported in two leading causes of cancer deaths: breast and prostate. In this study, we performed a retrospective cohort analysis on nationally representative electronic medical records (EMR) to assess whether Vitamin D deficiency affects risk of COVID-19 among these patients. Methods: Patients with breast (female) or prostate (male) cancer were identified between 3/1/2018 and 3/1/2020 from EMR data provided pro-bono by the COVID-19 Research Database ( covid19researchdatabase.org ). Patients with an ICD-10 code for Vitamin D deficiency or < 20ng/mL 20(OH)D laboratory result within 12 months prior to 3/1/2020 were classified as Vitamin D deficient. COVID-19 diagnosis was defined using ICD-10 codes and laboratory results for COVID-19 at any time after 3/1/2020. Logistic regressions, adjusting for baseline demographic and clinical characteristics, were conducted to estimate the effect of Vitamin D deficiency on COVID-19 incidence in each cancer cohort. Results: A total of 16,287 breast cancer and 14,919 prostate cancer patients were included in the study. The average age was 68.9 years in the breast cancer cohort and 73.6 years in the prostate cancer cohort. The breast cancer cohort consisted of 85% Whites, 13% Black or African Americans, and less than 5% of other races. A similar race distribution was observed in the prostate cancer cohort. Unadjusted analysis showed the risk of COVID-19 was higher among Vitamin D deficient patients compared to non-deficient patients in both cohorts (breast: OR = 1.60 [95% C.I.: 1.15, 2.20]; prostate: OR = 1.59 [95% C.I.: 1.08, 2.33]). Similar findings were observed when assessed in subgroups of patients with newly diagnosed cancer in the dataset, as well as after adjusting for baseline characteristics. Conclusions: Our study suggests breast and prostate cancer patients may have an elevated risk of COVID-19 infection if Vitamin D deficient. These results support findings by Meltzer et al., 2020 demonstrating a relationship between Vitamin D deficiency and COVID-19 infection. While a randomized clinical trial is warranted to confirm the role for Vitamin D supplementation in preventing COVID-19, our study underscores the importance of monitoring Vitamin D levels across and within cancer populations, particularly in the midst of the global COVID-19 pandemic.
Comparative study of prevalence and costs of depression and anxiety among elderly cancer patients.
Authors: DaCosta Byfield Stacey , Tanudtanud Kae , Barrientos John Rich , Lasquite Kiesha Mae , Catlett Kierstin 
Published: June 2021

6595 Background: Depression and anxiety are common among cancer patients and can worsen outcomes. We studied the occurrence of depression and anxiety in three common cancers to investigate whether healthcare costs were greater for cancer patients with two mental health disorders (MHD), depression and anxiety, compared to patients without MHD. Methods: This retrospective analysis used deidentified medical and pharmacy claims from a large national U.S. health insurer. Patients were Medicare Advantage enrollees ≥65 years diagnosed with breast, colorectal, or prostate cancer and continuously enrolled from 1/2018–12/2019. We determined statistically whether the annual prevalence of the two MHDs varied by cancer types. Total costs and costs exclusive of MHD-related expenses in five sub-categories were compared: inpatient, emergency room, non-inpatient medical, professional, and pharmacy. Costs from 2019 claims were presented as per-patient per-month (PPPM). Direct depression- and anxiety-related costs were from claims with depression/anxiety diagnoses or drugs. The impact of MHDs on 2019 healthcare spending was examined using multiple linear regression, controlling for demographic and clinical characteristics. LASSO was used for variable selection. Mann-Whitney U tests compared differences in costs by service types between patients with and without MHDs. Results: Of 19,304 study patients, 8,916 (46%) had coexisting depression or anxiety: (i) 4% depression only; (ii) 27% anxiety only; (iii) 7% depression and anxiety; and (iv) 8% were on antidepressant without MHDs diagnoses. There were significant differences in the rates of MHDs between the three cancer groups, with the highest frequency in breast cancer ( breast vs colorectal. 56% vs 49%, p < 0.0005 ; breast vs prostate. 56% vs 38%, p < 0.0005; colorectal vs prostate. 49% vs 38%, p < 0.0005). After excluding the MHDs-related costs (PPPM mean = $44), the monthly spending was 54% higher for patients with MHDs ($2,184 MHDs vs. $1,406 non-MHDs). After adjusting for covariates, the PPPM costs were 23%–58% higher for the MHD-cohort vs. the non-MHD cohort for each cancer type ( non-MHD vs. with depression only, CI 13%–34%, p < 0.0001; non-MHD vs. with anxiety only, CI 40%-52%, p < 0.0001; non-MHD vs. with depression and anxiety, CI 48%-70%, p < 0.0001; non-MHD vs. with antidepressant only, CI 28%-45%, p < 0.0001). Higher costs in MHD-cohort were observed in all cost categories (p < 0.0001). Conclusions: We found high prevalence of MHDs in patients diagnosed with cancer. Analyses showed that total spending was significantly higher in individuals with cancer and MHD for all cost categories. Explanations for higher costs are unclear, as costs remain high even after adjusting for MHD-related care costs. Research on specific healthcare services driving higher costs and the risk factors for depression and anxiety is needed to address broader MHDs to improve cancer care.
Update of a phase II, multicenter study of high-dose chemotherapy with autologous stem cell transplant followed by maintenance romidepsin for T-cell lymphoma.
Authors: Khan Niloufer , Khimani Farhad , Shustov Andrei R. , Shadman Mazyar , Ruan Jia , Moskowitz Alison J. , Straus David J. , Kumar Anita , Sauter Craig Steven , Zelenetz Andrew David , Noy Ariela , Shah Gunjan L. , Matasar Matthew J. , Drullinsky Pamela , Hamilton Audrey M. , Drill Esther N. , Van Besien Koen , Giralt Sergio , Horwitz Steven M. , Dahi Parastoo 
Published: June 2021

7533 Background: Peripheral T-cell lymphomas (PTCL) have suboptimal outcomes with conventional chemotherapy. Autologous hematopoietic stem cell transplant (AHCT) is a therapeutic strategy for patients in first complete or partial remission (CR1 or PR1), with median progression-free survival (PFS) after AHCT of 36-48% by intent to treat (d’Amore et al JCO 2012, Reimer et al JCO 2009). Romidepsin (romi) is a histone deacetylase inhibitor approved for treatment of relapsed/refractory T-cell lymphoma. We present updated data of the first multicenter study to evaluate PFS of patients (pts) receiving maintenance therapy with romi after AHCT. Methods: This was a phase 2, open-label, investigator-initiated study (expected PFS 45%, desired PFS 70%; success achieved if 15 or more pts out of 25 were progression-free at 2 years post-AHCT). 26 pts transplanted in CR1 or PR1 were evaluable for the primary endpoint of 2-year PFS (Cohort 1, Table). An exploratory cohort (Cohort 2, n=7) enrolled pts either transplanted ≥ CR/PR2 (n=5) or with high risk histologies (n=2). Pts underwent AHCT with carmustine, etoposide, cytarabine and melphalan (BEAM) conditioning. Maintenance romi 14 mg/m2 started days 42-80 post AHCT; every other week through 6 mon, every 3 weeks through 1 year and every 4 weeks through 2 years post AHCT. PFS was estimated by Kaplan-Meier. Results: 47 pts consented; 13 did not receive romi (no AHCT, n=2; relapse before romi, n=3; cardiac comorbidity, n=3, patient declined, n=5). 1 consented pt did not have PTCL. 15 out of the first 25 pts in Cohort 1 were progression free after 2 years; median follow up of 31 mon (21 - 36 mon). Estimated 2-year PFS was 62% (45-83%, 95% CI); median PFS 30 mon (12.0- NA, 95% CI). In Cohort 2, estimated 2-year PFS was 43% (18 – 100, 95% CI); median follow up of 30 mon (range, 24 – 37 mon); median PFS 14 mon (5 – NA, 95% CI). Across cohorts, 5 pts required dose reduction. The most common toxicities (≥10% of pts, all grades) were fatigue (n=24, 73%), decreased platelets (n=16, 48%) and anemia (n=16, 48%). Conclusions: While the study did not meet its desired primary efficacy endpoint, maintenance romi was well-tolerated with an estimated 2-year PFS of 62%, greater than historical data. A larger, randomized study would be needed to determine the superiority of this approach. Clinical trial information: NCT01908777. [Table: see text]
Effects of weekly selinexor, bortezomib, dexamethasone (XVd) versus standard twice weekly bortezomib and dexamethasone (Vd) on RAS-mutated previously treated multiple myeloma (MM).
Authors: Walker Christopher James , Li Shirong , Chai Yi , Shah Jatin J. , Shacham Sharon , Lentzsch Suzanne , Landesman Yosef 
Published: June 2021

8027 Background: Activating mutations of the RAS genes NRAS, KRAS, and HRAS ( RASmut) occur in up to 50% of MM and portend poor survival and high recurrence rates. MM cells with RASmut are susceptible to inhibition of germinal center kinase (GCK), resulting in IKAROS degradation independent of cereblon (CRBN). Selinexor is a selective inhibitor of nuclear export (SINE) compound that can induce IKAROS degradation through CRBN-independent pathways to overcome immunomodulatory drug resistance. We explored the benefit of selinexor treatment for pts with RASmut MM. Methods: In the randomized BOSTON study, pts with MM after 1-3 therapies received weekly XVd or twice weekly Vd. In the single-arm STORM study pts with penta-treated, triple class refractory MM were treated with twice weekly Xd. Both treatment regimens are now FDA approved. Mutations were assessed post-hoc by exome sequencing of 119 and 52 pts from BOSTON and STORM, respectively. Pts were considered RASmut if their MM had NRAS, KRAS or HRAS mutations in codons 12, 13 or 61. Results: There were 54 pts (45%) with RASmut in BOSTON (XVd = 26, Vd = 28), and 17 (33%) in STORM. In BOSTON, pts with RASmut MM treated with XVd had significantly longer progression-free survival (PFS) than those treated with Vd (median [med] = 12.9 vs 6.7 months [mo], hazard ratio [HR] = 0.48 [95% CI 0.24-0.97], p = 0.039). For pts treated with Vd, those with RASmut had significantly shorter overall survival (OS) compared to RASwild-type (WT) (med = 16.8 mo vs not reached [NR], HR = 2.87 [95% CI 1.03-7.99], p = 0.035). PFS was not significantly different (med = 6.74 vs 9.82 mo, HR = 1.64 [95% CI 0.88-3.07], p = 0.122). Amongst pts on XVd, there was no difference in survival between RASmut and RASWT pts (PFS: med = 12.8 vs 12.9 mo, HR = 1.08 [95% CI 0.52-2.26], p = 0.83; OS: med = NR vs NR, HR = 0.94 [95% CI 0.36-2.45], p = 0.91). In STORM, pts with RASmut had shorter OS compared to RASwt pts (med = 6.1 vs NR, HR = 2.05 [95% CI 1.22-5.19], p = 0.010). Preliminary studies to explore the mechanisms of action related to RASmut MM sensitivity to XVd demonstrated that selinexor treatment in vitro leads to downregulation of GCK. Conclusions: Despite typically having the worst outcomes, pts with RASmut MM had a similar benefit from XVd as RASWT MM, showing that the XVd combination can overcome RASmut. Mechanistically, selinexor induced down regulation of GCK and enhanced killing of RASmut MM cells. With a manageable safety profile, the XVd regimen could provide a viable treatment option to improve survival of pts with MM with RAS mutations. Clinical trial information: NCT03110562. [Table: see text]
Isatuximab plus carfilzomib and dexamethasone in patients with relapsed multiple myeloma according to prior lines of treatment and refractory status: IKEMA subgroup analysis.
Authors: Hajek Roman , Moreau Philippe , Augustson Bradley , Castro Nelson , Pika Tomas , Delimpasi Sosana , de La Rubia Javier , Maiolino Angelo , Reiman Tony J. , Kryuchkova Irina , Martinez-Lopez Joaquin , Martin Thomas G. , Mikhael Joseph , Yong Kwee , Risse Marie-Laure , Asset Gaëlle , Marion Sylvia , Dimopoulos Meletios A. 
Published: June 2021

8034 Background: Patients (pts) with multiple myeloma (MM) often relapse and become refractory to successive lines of therapy, warranting better treatment options. The Phase 3 IKEMA study (NCT03275285) demonstrated that isatuximab (Isa) plus carfilzomib and dexamethasone (Kd) significantly improved progression-free survival (PFS) compared with Kd in pts with relapsed MM (RMM) (HR 0.53; 99% CI 0.32–0.89; P= 0.0007). We evaluated the efficacy and/or safety of Isa-Kd by number of prior lines of therapy (1 vs > 1) and refractoriness to lenalidomide (Len) or bortezomib (Bor). Methods: Pts were randomized (3:2) to Isa-Kd (n = 179) or Kd (n = 123). Isa (10 mg/kg IV) was given weekly for 4 weeks, then every 2 weeks. K (20 mg/m² days 1-2, then 56 mg/m²) was given twice-weekly 3 of 4 weeks, and d (20 mg) twice-weekly. The primary endpoint was PFS; key secondary endpoints were very good partial response or better (≥VGPR), minimal residual disease negativity (MRD-), and complete response (CR) rates. Results: Of the 302 randomized pts, 44.7% had 1 prior line, 55.3% had > 1 prior line, 32.8% were Len-refractory, and 30.1% were Bor-refractory. PFS was improved with Isa-Kd vs Kd in pts who received 1 prior line and > 1 prior line, as well as in pts refractory to Len, Len at last regimen, Bor, or Bor at last regimen (Table). The addition of Isa to Kd improved depth of response (≥VGPR, MRD-, and CR rates) in all subpopulations analyzed by prior treatment. Grade ≥3 treatment-emergent adverse events (TEAEs) were generally similar between the prior line subgroups (77.2% [Isa-Kd] vs 64.8% [Kd], 1 prior line; 76.5% [Isa-Kd] vs 69.1% [Kd], > 1 prior line) and the overall safety population (76.8% [Isa-Kd] vs 67.2% [Kd]). Serious AEs were 62.0% vs 48.1% in the 1 prior line subgroup, and 57.1% vs 64.7% in the > 1 prior line subgroup; TEAEs leading to discontinuations were 8.9% vs 11.1%, 1 prior line and 8.2% vs 16.2%, > 1 prior line. Conclusions: The addition of Isa to Kd improved PFS and depth of response, irrespective of prior lines of therapy or refractory status, consistent with the benefit observed in the overall IKEMA study population. Isa-Kd had a manageable safety profile regardless of number of prior lines. Isa-Kd is a potential new treatment option for pretreated pts with RMM. Clinical trial information: NCT03275285. [Table: see text]
Melflufen plus dexamethasone (dex) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) exposed/refractory to prior alkylators: A pooled analysis of the O-12-M1 and HORIZON studies.
Authors: Rodríguez-Otero Paula , Mateos Maria-Victoria , Oriol Albert , Larocca Alessandra , Blade Joan , Cavo Michele , Leleu Xavier , Nadeem Omar , Hiemenz John W. , Hassoun Hani , Touzeau Cyrille , Alegre Adrian , Paner Agne , Maisel Christopher , Mazumder Amitabha , Raptis Anastasios , Thuresson Marcus , Harmenberg Johan , Harlin Olof , Richardson Paul G. 
Published: June 2021

8048 Background: Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate (PDC) that leverages aminopeptidases and rapidly releases alkylating agents inside tumor cells. Melflufen has a mechanism of action distinct from other alkylating agents (Slipicevic et al. AACR 2020. Abs. 1843). In the O-12-M1 (NCT01897714) and HORIZON (OP-106; NCT02963493) studies, melflufen plus dex showed meaningful efficacy and a clinically manageable safety profile in pts with RRMM (Richardson et al. Lancet Haematol. 2020;7:5; Richardson et al. J Clin Oncol. 2020;Dec 9 [Epub]). This pooled analysis examines pts from these studies exposed to prior alkylators. Methods: Both the O-12-M1 and HORIZON studies included pts with RRMM who received ≥ 2 prior lines of therapy (LoTs) and had a primary endpoint of overall response rate (ORR). Secondary endpoints included progression-free survival (PFS) and safety. Data from the 2 studies were pooled and analyzed according to previous exposure and refractoriness to alkylators before study entry. Refractoriness to prior alkylator therapy was defined as disease that failed to achieve a minimal response or progressed while on therapy, or within 60 d of last therapy. Results: Of 202 pts (HORIZON: n = 157, cutoff January 14, 2020; O-12-M1: n = 45, cutoff October 29, 2019), 178 (88%) had been exposed to alkylators in ≥ 1 prior LoT (see Table for subgroups). Pts exposed and refractory to alkylators in ≥ 2 LoTs had the highest number of pts refractory to an alkylator in the last LoT (61%), and 82% were refractory to an alkylator within 12 mo of study entry. Meaningful response rates were seen in all subgroups, except for pts who were exposed and refractory to alkylators in ≥ 2 prior LoTs (see Table). PFS trended toward being shorter with higher exposure and refractoriness to prior alkylators. Results should be interpreted with caution due to limited pt numbers. Grade 3/4 adverse events (AEs) were similar between pts exposed to prior alkylators (O-12-M1: 85%; HORIZON: 89%) and the overall population (O-12-M1: 84%; HORIZON: 89%). The most common AEs were hematologic, but were mostly reversible and clinically manageable. Nonhematologic AEs were infrequent and primarily grade 1/2. Conclusions: Melflufen in combination with dex showed meaningful efficacy and a clinically manageable safety profile in pts with RRMM exposed/refractory to prior alkylators. Clinical trial information: NCT02963493 and NCT01897714. [Table: see text]