bluuebunny/crossref_metadata_2025_split huggingface dataset:
How far do laypersons believe in the cure of cancer? Results of the EDIFICE6 survey.
Authors: De La Motte Rouge Thibault , Couraud Sebastien , Roupret Morgan , Touboul Chantal , Lhomel Christine , Viguier Jerome , Eisinger Francois , Greillier Laurent , Morere Jean F. 
Published: March 2020

11616 Background: Advances in therapy and early detection, by population-based screening in particular, have significantly increased the number of patients cured from cancer. However, cancer patients’ chances of being cured varies strongly from one cancer to another. We studied the understanding of the concept of cure in the lay population and the factors associated with believing that cancer can be cured. Methods: The French nationwide observational survey, EDIFICE 6, was conducted online (June 26-July 28, 2017) on a core sample of 12 046 individuals (age, 18-69y). Representativeness was ensured by quota sampling on age, sex, profession, and stratification by geographical area/type of urban district. This analysis focused on understanding of the meaning of cure in breast (BC), cervical (CC), colorectal (CRC), lung (LC) and bladder (BLC) cancer for individuals with no history of cancer. Results: The majority of respondents believed that cure exists (BC 95%; CC 91%; CRC 89%; BLC 87%, LC 71%). Some agreed with the definition that cure is the disappearance of the disease (BC 42%; CC 38%; CRC 35%; BLC 33%, LC 25%), while others preferred the definition that cure is several years without disease (BC, CC 53%; CRC, BLS 54%; LC 46%). More men than women (P < 0.05) believed that cure exists for CRC, BLC and LC. Socially non-vulnerable individuals were more likely to believe in cure than their vulnerable counterparts (P < 0.05), as were individuals aged 50-69y (P < 0.05) versus those of 18-50y, and for all cancer types except LC. In multivariate analysis, the variable “clinical research enables progress” was correlated with believing that cure exists (BC, OR = 2.93; CC, OR = 1.86; CRC, OR = 2.22; LC, OR = 1.57, BLC, OR = 2.06), as was “progress is rapid” (BC, OR = 1.61; CC, OR = 1.66; CRC, OR = 1.7; LC, OR = 1.84; BLC OR = 1.68), and also social non-vulnerability. However, the variables “prevention”, respectively screening/treatments, “are important for cancer control” had a low impact on the belief in cure (OR~1). Conclusions: The lay population is relatively optimistic about the cure for cancer. Confidence in the existence of cure relies on medical progress. However, factors related to individual behavior, e.g., prevention and screening, did not affect the perception of cure.
After cancer, what’s more important? The survivorship care plan or the survivorship care visit?
Authors: Saiganesh Harish , Duffy Christine M. , Higel-Mcgovern Camille , Lopresti Mary Lorraine , Fenton Mary Anne , Strenger Rochelle , Korber Susan F. , Szymanski Tara , Dizon Don S. 
Published: March 2020

11618 Background: The Commission on Cancer has made the provision of survivorship care plans (SCPs) a prerequisite for accreditation of cancer programs. However, whether all patients desire or derive benefits from an SCP is not established. This study sought to characterize the provision of survivorship care at the Lifespan Cancer Institute (LCI) to (1) determine clinical and distress characteristics at first visit to the LCI among patients treated with curative intent for a solid tumor diagnosis; (2) characterize which factors are associated with receipt of an SCP with or without a survivorship care visit (SCV); and (3) determine referral patterns and outcomes among patients with an SCP with or without an SCV. Methods: We have retrospectively reviewed 650 patients at Lifespan Cancer Institute so far, all of whom were initially seen between the years 2014-2017. As part of routine practice, all new patients are screened with the NCCN Distress Thermometer (DT). Data related to demographics, treatment variables, and presenting distress score were gathered using our electronic medical records. Categorical data were analyzed using Fisher’s Exact Test or Chi-Square. Multinomial logistic regression was performed for multivariate analysis. All analyses were performed in STATA 15.0. Results: The median age was 63 (range 29 to 90), 74.8% were female, and 39.5% were married or partnered. The major cancers represented included breast (52.2%), lung (16.6%), and prostate (6%) cancers. Severe distress (DT≥4) was reported in 49.5% of patients at their first visit with top concerns being worry (54.3%), nervousness (46.6%) and fatigue (37.3%). An SCP was documented in 461 patients (71.1%) and of these, 267 (57.9%) were seen in an SCV as well. On multivariate analysis, gender, marital status, and stage were significantly associated with the receipt of an SCP. However, only disease site was significantly associated with being seen in an SCV. Compared to those with an SCP but not seen in an SCV, those who attended an SCV were significantly more likely (p < 0.005) to be referred for post-treatment evaluation, including psychological counseling (15.7 vs 6.7%), physical therapy (56.9 vs 22.7%), and nutrition (26.6 vs 8.2%). The majority of patients followed up with referrals, though it was significantly higher among those with an SCV (95.4 vs 87%, p = 0.015). Conclusions: Survivorship care varies by cancer type, with highest rates of visits for patients with gynecologic and GI cancers. Referral to other resources is significantly higher among those seen in visits, and those who are referred will follow up.
Depression and anxiety symptoms in bereaved caregivers of patients with advanced cancer.
Authors: Vanbenschoten Olivia , Greer Joseph , Jackson Vicki , Kamdar Mihir , Gallagher Emily R. , Anand Maya V. , Temel Jennifer S. , El-Jawahri Areej 
Published: March 2020

11623 Background: Caregivers of patients with advanced cancer experience substantial caregiving burden and psychological distress during the illness course. However, data on depression and anxiety symptoms in bereaved caregivers and factors associated with their psychological distress are lacking. Methods: We conducted a secondary analysis of 168 caregivers enrolled in a randomized trial of early palliative care integrated with oncology care versus oncology care alone for patients newly-diagnosed with incurable lung and non-colorectal gastrointestinal cancers and their caregivers who completed bereavement assessments at 3 months after their loved one’s death. We used the Hospital Anxiety and Depression Scale (HADS) to assess patients’ and caregivers’ depression and anxiety symptoms at baseline within 8 weeks of diagnosis, and at 3-4 months after the patient’s death (for caregivers). We asked caregivers to rate patient’s physical and psychological distress in the last week of life on a 10-point scale. We used linear regression adjusting for randomization and cancer type to explore associations between patient and caregiver factors and bereaved caregivers’ depression and anxiety. Results: 30.4% (51/168) and 43.4% (73/168) of bereaved caregivers reported clinically significant depression and anxiety symptoms, respectively. Younger patient age (B = -0.06, P = 0.041), higher patient baseline anxiety (B = 0.28, P = 0.002), and caregiver rating of worse physical (B = 0.28, P = 0.035) and psychological (B = 0.41, P < 0.001) distress experienced by the patient at the end of life (EOL) were associated with worse depression symptoms in bereaved caregivers. Only caregiver factors, including age (B = -0.07, P = 0.004), female sex (B = 1.60, P = 0.024), and rating of worse psychological distress experienced by the patient at the EOL (B = 0.42, P < 0.001) were associated with worse bereaved caregivers’ anxiety symptoms. Conclusions: Bereaved caregivers of patients with advanced cancer experience substantial psychological distress which is associated with their perceptions of their loved one’s distress at the EOL. Interventions to optimize EOL care for patients and reduce bereaved caregivers’ psychological distress are needed.
The importance of altruism to biomarker development for pancreatic cancer.
Authors: Heo Danny HJ , DeCicco Corinne , Singer Tori , Vemulapalli Vijetha , Yee Christopher , Kiebish Michael A. , Grund Eric M. , Akmaev Viatcheslav R , Narain Niven R. , Kennedy Kevin F. , Moser A. James 
Published: March 2020

11626 Background: Longitudinal donation of tissue and health information by patients with pancreatic ductal adenocarcinoma (PDAC) is critical to validating algorithms for precision treatment. Unlike therapeutic trials offering potential survival benefit, factors motivating long-term participation in biomarker studies are poorly understood. We hypothesized that long-term participation (PART) depends on identifiable factors motivating study volunteers in non-therapeutic biomarker studies. Methods: A prospective, single-institution biomarker study was screened to identify participants with, or at elevated risk for, PDAC and periampullary cancer (Jul 2015-Dec 2018). Study consent precluded individual receipt of value or research benefit. Detailed biospecimen and clinical data (n = 294) were analyzed using multivariable modeling and Bayesian AI (bAIcis) to characterize motivators of PART. Results: Of 294 participants, 185 had PDAC (63%); 89 had premalignant lesions (30%) or tumors (20; 7%) mimicking PDAC. Mean age was 68 years, 54% male, 26% with prior cancers, and 18% family PDAC history. Treatment was not indicated (37% no cancer), potentially curative (27%), non-curative (35%); or refused (1.4%). Bayesian AI showed PDAC diagnosis to be the leading predictor of PART. Using multivariable modeling and adjusting for the competing risk of death, none of the following domains predicted PART: demographics, perceived personal/family cancer risk, health insurance type, median income, housing price, travel time/distance or charitable expense, or primary institution providing clinical treatment. The following motivators were significant predictors of PART: worsening symptoms (McGill Brisbane > 9; HR 0.54; p = 0.045), non-curative treatment (HR 0.55; p = 0.042); and shorter AJCC predicted survival (HR 0.77, p = 0.042). Conclusions: Volunteers with symptomatic PDAC and shorter predicted survival who received non-curative treatment were more motivated to participate in biomarker discovery. Volunteers were undeterred by apparent self-interests such as travel time, insurance type, income, charitable expense, and personal life expectancy. We attribute these findings to altruistic behaviors among patients most likely to die of PDAC.
ENESTop 192-week results: Treatment-free remission (TFR) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after stopping second-line (2L) nilotinib (NIL).
Authors: Hughes Timothy P. , Boquimpani Carla , Takahashi Naoto , Benyamini Noam , Clementino Nelma Cristina D. , Shuvaev Vasily , Lipton Jeffrey Howard , Turkina Anna G. , De Paz Arias Raquel , Moiraghi Beatriz , Nicolini Franck E. , Dengler Jolanta , Sacha Tomasz , Kim Dong-Wook , Fellague-Chebra Rafik , Acharya Sandip , Bouard Catherine , Mahon Francois-Xavier 
Published: March 2020

7005 Background: In the ENESTop study (NCT01698905) of TFR in pts with CML-CP who achieved a sustained deep molecular response (MR) with 2L NIL, 57.9% remained in TFR 48 wks after stopping NIL (primary endpoint). Analyses at 144 wks showed durability of TFR. Data from longer follow-up (192 wks) evaluating the maintenance of TFR are reported. Methods: Pts treated with ≥2 y NIL after > 4 wks imatinib (≥3 y total) and achieving MR4.5 ( BCR-ABL1IS ≤0.0032%) on NIL were eligible. After a 1 y consolidation, pts with no confirmed loss of MR4.5 could attempt TFR. NIL was resumed upon loss of major MR ( BCR-ABL1IS ≤0.1%) or confirmed loss of MR4 ( BCR-ABL1IS ≤0.01%). At the data cut-off (Sep 24 2018), all pts had completed ≥192 wks of TFR, resumed NIL, or discontinued the study. Results: By the data cut-off, of 126 pts entering TFR, 56 were ongoing, 59 had resumed NIL, and 11 had discontinued. TFR rate at 192 wks was 46.0% (58/126; 95% CI, 37.1–55.1%); all but 1 of the 58 pts were in MR4.5. Only 1/61 pts in TFR at 144 wks lost response by 192 wks (confirmed loss of MR4); another 2 pts discontinued due to serious AE (polycythemia vera) and pt/guardian decision, respectively. Of 59 pts who resumed NIL, 56 (94.9%) and 55 (93.2%) regained MR4 and MR4.5, respectively. 40/56 pts (71.4%) who regained MR4 had stable MR4 at 96 wks (12 discontinued < 96 wks, and 4 remained on study with < 96 wks, after regaining MR4); 37/55 pts (67.3%) who regained MR4.5 had stable MR4.5 at 96 wks (12 discontinued < 96 wks, and 6 remained on study with < 96 wks, after regaining MR4.5). There were no disease progressions, deaths due to CML, or new deaths since the 144-wk analysis. The 192 wk treatment-free survival rate was 50.3% (95% CI, 41.2–58.7%). Of 62 pts who remained in TFR for > 144 wks, 11.3%, 53.2%, 21.0%, 14.5% and 3.2% had musculoskeletal pain AEs during consolidation and each subsequent 48 wk period of TFR. Among 59 pts who resumed NIL, most common AEs were hypertension (20.3%) and arthralgia (13.6%); the majority of AEs were grade 1/2. Conclusions: Results demonstrate long-term durability and safety of TFR following 2L NIL, with no disease progressions or CML-related deaths, and musculoskeletal pain AEs were transient. Clinical trial information: NCT01698905.
Post-transplant cyclophosphamide in matched and haploidentical transplant recipients receiving myeloablative timed sequential busulfan conditioning regimen: Results of a phase II study.
Authors: Popat Uday R. , Mehta Rohtesh S. , Bassett Roland , Olson Amanda Leigh , Alousi Amin Majid , Anderlini Paolo , Alatrash Gheath , Bashir Qaiser , Ciurea Stefan O. , Hosing Chitra , Kebriaei Partow , Khouri Issa F. , Marin David , Nieto Yago , Oran Betul , Rezvani Katayoun , Qazilbash Muzaffar H. , Shpall Elizabeth J. , Champlin Richard E. , Andersson Borje 
Published: March 2020

7007 Background: Myeloablative stem cell transplants have a lower rate of relapse than reduced intensity regimens. Timed sequential busulfan (TSB) with fludarabine (Flu) is a promising myeloablative regimen for patients undergoing matched sibling (MSD) or unrelated (MUD) donor transplantation (HCT) with low non-relapse mortality (NRM) (Popat et al Lancet Haematology 2018), but was not tested in haploidentical (haplo). Also, whether this approach can be used with post-transplant cyclophosphamide (PTCy) in MSD, MUD and haplo HCT is unknown. To address these issues, we conducted a prospective phase II study. Methods: Patients with hematological malignancies with MSD, MUD or haplo donor were eligible. They received fixed doses of Busulfan(BU) 80mg/m2 either on day -13 and -12 (n=45) or on -20 and -13 (n=10). Then, Flu 40mg/m2 was given on day -6 to -2 followed by Bu dosed to achieve target area under the curve (AUC) of 20,000 umol/min for the whole course based on pharmacokinetic studies. Thiotepa 5mg/kg was given on day -7 to haplo group. GVHD prophylaxis was PTCy 50mg/kg on day 3 and 4 and tacrolimus. Haplo and later MUD recipients also received mycophenolate mofetil. Results: 55 patients with a median age of 47 (15-65) years were enrolled. 30 patients had AML or MDS, 9 CML or MPD, 5 lymphoma, 5 myeloma and 6 ALL. About half had haplo 26 (47%); others had MUD 18 (33%) or MSD 11(20%). Disease risk index was high in 18 (32%), intermediate in 32 (58%), and low in 5 (9%) patients. Comorbidity score was ≥3 in 22 (40%) patients. With a median follow up of 17 months (5-28), 1-year OS, PFS, NRM and relapse rates were 71% (60-84%), 63% (51-77%), 20% (9-31%), and 17% (7-27%), respectively [Table]. There were no graft failures. Day 100 grade II-IV and III-IV acute GVHD rates were 38% (25-51%) and 9% (95% CI 1-17%), respectively; 1-year chronic GVHD and extensive chronic GVHD rates were 10% (2-28%) and 8% (0-15%), respectively. 1-year OS in MSD, MUD and haplo groups were 91% (75-100%), 72% (54-96%), and 62% (45-83%) respectively (P=0.11). Conclusions: Myeloablative TSB with PTCy is feasible in MSD, MUD and haplo HCT. It lowers the incidence of severe acute and chronic GVHD without apparent increase in relapse. Clinical trial information: NCT02861417. [Table: see text]
The first-in-class anti-CD47 antibody Hu5F9-G4 is active and well tolerated alone or with azacitidine in AML and MDS patients: Initial phase 1b results.
Authors: Sallman David Andrew , Donnellan William Bruce , Asch Adam Steven , Lee Daniel Junseung , Al Malki Monzr , Marcucci Guido , Pollyea Daniel Aaron , Kambhampati Suman , Komrokji Rami S. , Van Elk Joanna , Lin Ming , Agoram Balaji , Chen James Y , Volkmer Jens-Peter , Takimoto Chris H.M. , Chao Mark , Vyas Paresh 
Published: March 2020

7009 Background: Hu5F9-G4 (5F9) is an antibody targeting CD47, a macrophage immune checkpoint and “don’t eat me” signal on cancers. CD47 blockade induces tumor phagocytosis and eliminates leukemia stem cells (LSC) in AML models. Azacitidine (AZA) synergizes with 5F9 by inducing “eat me” signals on AML, enhancing phagocytosis. This trial explored the safety/efficacy of 5F9 alone or with AZA in AML/MDS patients (pts). Methods: This Phase 1b treated: r/r AML/MDS pts with 5F9; and untreated AML (induction chemo ineligible) and higher risk MDS pts with 5F9+AZA. A 5F9 priming/intrapatient dose escalation regimen (1-30 mg/kg weekly) was used to mitigate on target anemia. Results: 10 (6 AML, 4 MDS) r/r pts received 5F9 (median 2 prior therapies (range 1-6). 24 untreated pts (15 AML, 9 MDS) received 5F9+AZA. In total, median age was 73, 62% of AML pts were intermediate or poor cytogenetic risk (38% unknown), all MDS pts were intermediate or high risk by IPSS-R. 5F9 alone or with AZA was well-tolerated with no MTD reached. 5F9 did not potentiate AZA toxicities. Treatment-related AEs ( > 10% of pts) for 5F9+AZA were anemia (25%), thrombocytopenia (20%), and infusion reactions (15%). In 25 efficacy evaluable pts, 8/15 (53%) untreated AML/MDS pts had a CR/CRi to 5F9+AZA (5/10 (50%) in AML, 3/5 (60%) in MDS). 1/10 (10%) r/r AML/MDS pts had a response (MLFS) to 5F9 alone. LSC frequency was reduced/eliminated in most 5F9+aza responders; 50% of responders were MRD negative by flow cytometry. 4/10 (40%) AML pts became RBC transfusion independent and 4/5 (80%) MDS pts had hematologic improvement. Time to response was more rapid (median 1.9 mos) than expected for AZA alone. As of Jan 2019, no responder has relapsed (median follow-up of 3.4 mos (range 1.1 – 6.8 mos). 2 pts had successful allogeneic transplant. Conclusions: 5F9+AZA is a novel immunotherapy blocking a key macrophage checkpoint. It has been well tolerated with robust activity in AML/MDS pts with rapid CRs and MRD negativity. Adding 5F9 to cytotoxic agents may be a promising treatment strategy. An expansion cohort is ongoing. Funded by Forty Seven and the California Institute for Regenerative Medicine. Clinical trial information: NCT03248479.
Low-dose cytarabine with or without glasdegib in newly diagnosed patients with acute myeloid leukemia: Long-term analysis of a phase 2 randomized trial.
Authors: Smith B. Douglas , Papayannidis Cristina , Heuser Michael , Montesinos Pau , Sekeres Mikkael A. , Oriol Albert , Schiller Gary J. , Candoni Anna , Jamieson Catriona HM , Hoang Caroline J. , Ma Wendy , Zeremski Mirjana , O'Connell Ashleigh , Chan Geoffrey , Cortes Jorge E. 
Published: March 2020

7010 Background: Glasdegib is a potent, selective, oral inhibitor of the Hedgehog signaling pathway, approved in the US – in combination with low-dose cytarabine (LDAC) – for treatment of newly diagnosed acute myeloid leukemia (AML) in patients (pts) unable to receive intensive chemotherapy due to comorbidities or age (≥75 y). Methods: In this follow-up analysis from the phase 2 BRIGHT AML trial (NCT01546038), newly diagnosed pts with AML ineligible for intensive chemotherapy were randomized 2:1 to glasdegib + LDAC or LDAC alone (study design: Cortes et al., Leukemia 2018). This long-term analysis evaluated efficacy and safety after ~20 mo of additional follow-up. Results: As of Oct 11, 2018, 116 pts were assigned to treatment with glasdegib + LDAC (n = 78) or LDAC alone (n = 38) (median follow-up: 43.4 and 42.0 mo, respectively). Median overall survival (OS) was higher with glasdegib + LDAC vs LDAC alone (Table). Improvement in OS was consistent across the prespecified subgroups. The main cause of death in both arms was disease progression (both during study and follow-up). The incidence of adverse events (AEs) and serious AEs on glasdegib was generally lower long term (after 90 days) than short term (during the first 90 days) (83.7% and 51.2% vs 98.7% and 65.3%, respectively). Clinical trial information: NCT01546038. Conclusions: Addition of glasdegib to LDAC vs LDAC alone continued to demonstrate improved OS in pts with AML in this analysis; improvement was consistent across groups stratified by cytogenic risk. Long-term follow-up confirmed treatment with glasdegib was associated with an acceptable safety profile.[Table: see text]
Pooled safety summary for patients treated with the CD22-directed cytotoxin moxetumomab pasudotox-tdfk.
Authors: Kreitman Robert J. , Coutre Steven , Elesinmogun Cynthia , Kuptsova-Clarkson Nataliya , Li Xia , Pastan Ira , Gladstone Douglas Edward 
Published: March 2020

7014 Background: Moxetumomab pasudotox-tdfk was FDA-approved in 2018 for the treatment of adults with relapsed/refractory hairy cell leukemia (HCL) who have received ≥2 prior therapies, including a purine nucleoside analog. Methods: The pooled integrated safety summary included all adult patients (N=165) treated with ≥1 dose of moxetumomab across 5 open-label, single-arm clinical trials. Two trials included patients with HCL (N=129, with N=80 in the pivotal phase 3 trial) and 3 trials included patients with non-Hodgkin lymphoma (N=15) or chronic lymphocytic leukemia/small lymphocytic lymphoma (N=21). Overall, 81% were male, median age was 60 years (range 34–84) and 94% had an ECOG ≤1. Results: The most common adverse events (AEs) with moxetumomab were peripheral edema (41%), hypoalbuminemia (35%), and nausea (35%). Serious AEs occurred in 47 (28.5%) patients and were considered treatment-related in 21 (12.7%) patients. Treatment-related AEs were mainly grade 1/2; the most common were peripheral edema (32%), hypoalbuminemia (32%), increased ALT (29%), increased AST (28%), nausea (26%), headache (24%), pyrexia (23%), fatigue (22%), and myalgia (20%). In total, 19 deaths (11.5% of patients) occurred (including 3 in the pivotal trial), with most (13) due to underlying disease and 6 due to AEs (none were assessed as treatment-related by the investigators, however, 1 fatal AE in a non-HCL patient was re-assessed by the Sponsor as possibly related to moxetumomab). In 16 patients (9.7%), a treatment-related AE led to treatment discontinuation, with hemolytic uremic syndrome HUS; 3.6%) and capillary leak syndrome (CLS; 2.4%) the most common. Treatment-related AEs resulted in dose delay, omission or treatment interruption in 11 patients (6.7%). Conclusions: Moxetumomab had an acceptable safety profile based on pooled data from 165 adult patients with hematologic malignancies, with few treatment-related discontinuations. Proactive monitoring of patients is important to manage AEs. These results are consistent with results from the pivotal phase 3 trial in patients with HCL. Clinical trial information: NCT01829711, NCT00586924, NCT00587457, NCT00587015, NCT01030536.