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260 citation(s) found for "Csóka, Monika".

The state of neuro-oncology during the COVID-19 pandemic: a worldwide assessment
Mrugała, Maciej M. , Pressley, Shelley M., Taylor, Jennie , Thomas, Alissa A. , Wefel, Jeffrey S. , Acquaye, Alvina , Haynes, Chas, Agnihotri, Sameer , Lim, Michael , Peters, Katherine B. , Sulman, Erik P. , Salcido, Joanne, Butowski, Nicholas , Hervey‐Jumper, Shawn L. , Mansouri, Alireza , Oliver, Kathy , Porter, Alyx B. , Nassiri, Farshad , Schiff, David , Dunbar, Erin, Hegi, Monika E. , Bent, Martin J. van den , Chang, Susan M. , Zadeh, Gelareh , Chheda, Milan G. , Wefel, Jeffrey S , Peters, Katherine B , Mansouri, Alireza , Armstrong, Terri S , van den Bent, Martin J , Zadeh, Gelareh , Chheda, Milan G , Sulman, Erik P , Ostrom, Quinn T. , Coven, Scott L. , Armstrong, Terri S. , Chang, Susan Marina

Neuro-Oncology Advances | February 21, 2021 | Volume: 3 | Issue: 1 | Pages: No page available

10.1093/noajnl/vdab035 | PMID 34007966 Get It

AbstractBackgroundIt remains unknown how the COVID-19 pandemic has changed neuro-oncology clinical practice, training, and research efforts.MethodsWe performed an international survey of practitioners, scientists, and trainees from 21 neuro-oncology organizations across 6 continents, April 24–May 17, 2020. We assessed clinical practice and research environments, institutional preparedness and support, and perceived impact on patients.ResultsOf 582 respondents, 258 (45%) were US-based and 314 (55%) international. Ninety-four percent of participants reported changes in their clinical practice. Ninety-five percent of respondents converted at least some practice to telemedicine. Ten percent of practitioners felt the need to see patients in person, specifically because of billing concerns and pressure from their institutions. Sixty-seven percent of practitioners suspended enrollment for at least one clinical trial, including 62% suspending phase III trial enrollments. More than 50% believed neuro-oncology patients were at increased risk for COVID-19. Seventy-one percent of clinicians feared for their own personal safety or that of their families, specifically because of their clinical duties; 20% had inadequate personal protective equipment. While 69% reported increased stress, 44% received no psychosocial support from their institutions. Thirty-seven percent had salary reductions and 63% of researchers temporarily closed their laboratories. However, the pandemic created positive changes in perceived patient satisfaction, communication quality, and technology use to deliver care and mediate interactions with other practitioners.ConclusionsThe pandemic has changed treatment schedules and limited investigational treatment options. Institutional lack of support created clinician and researcher anxiety. Communication with patients was satisfactory. We make recommendations to guide clinical and scientific infrastructure moving forward and address the personal challenges of providers and researchers.
Brentuximab Vedotin with Chemotherapy for Patients with Previously Untreated, Stage III/IV Classical Hodgkin Lymphoma: 5-Year Update of the ECHELON-1 Study
Straus, David J. , Picardi, Marco, Feldman, Tatyana , Ramchandren, Radhakrishnan , Hutchings, Martin , Kim, Won Seog , Ansell, Stephen M. , Younes, Anas , Gallamini, Andrea , Little, Meredith, Fenton, Keenan , Fanale, Michelle A. , Długosz‐Danecka, Monika , Connors, Joseph M. , Illés, Árpád , Lech‐Marańda, Ewa , Smolewski, Piotr , Savage, Kerry J. , Bartlett, Nancy L. , Walewski, Jan , Zinzani, Pier Luigi , Muñoz, Javier , Advani, Ranjana H. , Liu, Rachael , Radford, John

Blood | February 8, 2021 | Volume: 136 | Issue: Supplement 1 | Pages: 26-28

10.1182/blood-2020-137089 Get It

Introduction Historically, nearly all relapses in classical Hodgkin lymphoma (cHL) occur within the first 5 years (Radford et al, BMJ 1997). In the phase 3 ECHELON-1 study (NCT01712490), treatment with brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine (A+AVD) significantly improved modified progression-free survival (PFS) in patients (pts) with newly-diagnosed Stage III/IV cHL compared with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) (Connors et al, NEJM 2018). 3- and 4-year follow-up (Straus et al, Blood 2020; Bartlett et al, Blood 2019) reported durable PFS benefit with A+AVD vs ABVD in the intent-to-treat (ITT) population that was consistent across most key pt subgroups, irrespective of interim positron emission tomography (PET) scan status, disease stage, and baseline disease risk factor score. We report updated efficacy and safety results for pts in the ECHELON-1 study after a median follow-up of 55.6 months. Methods In this evaluation of longer follow-up, an exploratory analysis of PFS (time from randomization to relapse, progression, or death from any cause) per investigator (INV) was conducted, with a cutoff date of May 18, 2020. Pts with previously untreated Stage III or IV cHL were randomized 1:1 to receive up to six cycles of A+AVD (n=664) or ABVD (n=670) intravenously on days 1 and 15 of a 28-day cycle. An interim PET scan after cycle 2 (PET2) was required. Resolution and improvement (defined as improvement by ≥1 grade from worst grade as of the latest assessment) of peripheral neuropathy (PN) in pts with ongoing symptoms at the end of treatment (EoT) were monitored during the extended follow-up period. The rate of secondary malignancies, and the incidence and outcomes of pregnancies among pts and their partners were also assessed. Results With extended follow-up (median 55.6 months; 95% CI 55.2-56.7) estimated 5-year PFS rates were 82.0% (95% CI 78.7-84.8) for A+AVD and 75.2% (95% CI 71.5-78.4) for ABVD. Overall, PFS per INV favored A+AVD over ABVD (HR 0.691; 95% CI 0.543-0.880; p=0.003) (Table). Exploratory subgroup analyses by PET2 status and age demonstrated PFS benefits regardless of PET2 status (Table); estimated 5-year PFS per INV with A+AVD vs ABVD in the ITT population was 84.7% vs 78.8% in PET2-negative pts (HR 0.676; 95% CI 0.512-0.892; p=0.005), and 60.6% vs 45.9% in PET2-positive pts (HR 0.703; 95% CI 0.393-1.256; p=0.230). PFS benefit with A+AVD over ABVD was also independent of the number of International Prognostic Factors Project (IPFP) risk factors (Figure). After a median follow-up of almost 5-years, 84% (370/442) and 86% (245/286) of pts with treatment-emergent PN reported complete resolution or improvement of symptoms in the A+AVD and ABVD arms, respectively. Median time to complete resolution of PN events that were ongoing at EoT was 30 weeks (range 0-262) in the A+AVD arm and 16 weeks (range 0-267) in the ABVD arm; median time to improvement was 49 weeks (range 8-270) and 12 weeks (range 2-70) , respectively. Of the 132 (30%) pts with ongoing PN in the A+AVD arm, 77 (17%), 39 (9%), 15 (3%) and 1 (<1%) experienced a maximum severity of grade 1, 2, 3 or 4, respectively. In the ABVD arm, PN was ongoing in 61 pts (21%); maximum severity was grade 1, 2, 3 or 4 in 40 (14%), 17 (6%), 4 (1%) and 0 pts, respectively. A total of 124 pregnancies were reported among pts and their partners (40 female and 30 male pts in the A+AVD arm; 26 female and 28 male pts in the ABVD arm). The proportion of live births was similar between arms for female pts (26/40 in the A+AVD arm and 17/26 in the ABVD arm, 65% in each arm) and for male pts' partners (19/30 [63%] in the A+AVD arm and 20/28 [71%] in the ABVD arm). No stillbirths were recorded. Additional follow-up at an estimated median of ~5 years and secondary malignancy data will be presented. Conclusions After a median follow-up of 55.6 months, A+AVD continues to demonstrate a robust and durable treatment benefit independent of disease stage, risk factor score, and PET2 status. In addition, compared with ABVD, treatment adaptation by interim PET2 status is not required and bleomycin exposure is avoided. The sustained PFS benefit with A+AVD is coupled with a manageable safety profile with symptoms of PN improving or resolving over time and similar pregnancy rates in both treatment arms. The benefits observed with A+AVD at this important milestone suggest that A+AVD is an attractive treatment option for all pts with previously untreated Stage III or IV cHL. Disclosures Straus: Karyopharm Therapeutics: Membership on an entity's Board of Directors or advisory committees; Imedex, Inc.: Speakers Bureau; Targeted Oncology: Consultancy, Speakers Bureau; NY Lymphoma Rounds: Consultancy; Takeda Pharmaceuticals: Research Funding, Speakers Bureau; OncLive: Speakers Bureau; Elsevier: Membership on an entity's Board of Directors or advisory committees, Other: CME writer; ASH: Other: Conference in December 2019 on HL to other physicians during ASH; Seattle Genetics: Consultancy, Membership on an entity's Board of Directors or advisory committees. Connors:Seattle Genetics: Other: Sponsorship to educational presentations; Takeda: Other: Sponsorship to educational presentations. Illés:Takeda, Seattle Genetics: Research Funding; Novartis, Janssen, Pfizer, Roche;: Other: Travel, Accommodations, Expenses; Janssen, Celgene, Takeda, Novartis Pharma SAS, Pfizer Pharmaceuticals Israel, Roche;: Consultancy, Honoraria; Celgene, Janssen, Novartis,Roche, Takeda: Consultancy. Lech-Marańda:Roche, Novartis, Takeda, Janssen-Cilag, Amgen, Gilead, AbbVie, Sanofi: Consultancy; Roche, Amgen, Gilead: Speakers Bureau. Feldman:KITE: Honoraria, Speakers Bureau; Abbvie: Honoraria, Speakers Bureau; Morphosis: Other: Ad board; AstraZeneca: Other: Ad board; BMS/Celgene: Consultancy, Honoraria, Speakers Bureau; Seattle Genetics: Consultancy, Speakers Bureau; Janssen: Honoraria, Speakers Bureau; Pharmacyclics: Honoraria, Speakers Bureau; Takeda: Honoraria, Speakers Bureau. Smolewski:Roche Poland: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Sandoz: Honoraria; Morphosis: Honoraria. Savage:Roche (institutional): Research Funding; Merck, BMS, Seattle Genetics, Gilead, AstraZeneca, AbbVie, Servier: Consultancy; BeiGene: Other: Steering Committee; Merck, BMS, Seattle Genetics, Gilead, AstraZeneca, AbbVie: Honoraria. Bartlett:Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pharmacyclics: Research Funding; Seattle Genetics: Consultancy, Research Funding; Roche/Genentech: Consultancy, Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees, Research Funding; BTG: Consultancy; Acerta: Consultancy; Affimed Therapeutics: Research Funding; ADC Therapeutics: Consultancy; Autolus: Research Funding; BMS/Celgene: Research Funding; Forty Seven: Research Funding; Immune Design: Research Funding; Janssen: Research Funding; Kite, a Gilead Company: Research Funding; Merck: Research Funding; Millennium: Research Funding. Walewski:Gilead: Consultancy, Honoraria; Servier: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria, Other: Travel Support, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; GSK: Research Funding. Ramchandren:Janssen: Research Funding; Pharmacyclics LLC, an AbbVie Company: Consultancy, Research Funding. Zinzani:Eusapharma: Consultancy, Speakers Bureau; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Immune Design: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Kyowa Kirin: Consultancy, Speakers Bureau; MSD: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Immune Design: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; TG Therapeutics, Inc.: Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; EUSA Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Kirin Kyowa: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; ADC Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Verastem: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celltrion: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen-Cilag: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sandoz: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Hutchings:Celgene, Genmab, Janssen, Novartis, F. Hoffmann-La Roche, Takeda: Research Funding; Genmab, F. Hoffmann-La Roche, Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Munoz:Juno/Celgene/BMS: Consultancy, Research Funding, Speakers Bureau; Alexion: Consultancy; Beigene: Consultancy, Speakers Bureau; Fosunkite: Consultancy; Innovent: Consultancy; Acrotech/Aurobindo: Speakers Bureau; Verastem: Speakers Bureau; AstraZeneca: Speakers Bureau; Kyowa: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Research Funding, Speakers Bureau; Seattle Genetics: Consultancy, Honoraria, Research Funding, Speakers Bureau; Genentech/Roche: Research Funding, Speakers Bureau; AbbVie: Consultancy, Speakers Bureau; Merck: Research Funding; Portola: Research Funding; Incyte: Research Funding; Millenium: Research Funding; Pfizer: Consultancy; Kite, a Gilead Company: Consultancy, Research Funding, Speakers Bureau; Pharmacyclics: Consultancy, Research Funding, Speakers Bureau; Bayer: Consultancy, Research Funding, Speakers Bureau. Kim:JJ: Research Funding; Celltrion: Research Funding; Kyowa Kirn: Research Funding; Donga: Research Funding; Mundipharma: Research Funding; Pfizer: Research Funding; F. Hoffmann-La Roche: Research Funding. Advani:Astra Zeneca, Bayer Healthcare Pharmaceuticals, Cell Medica, Celgene, Genentech/Roche, Gilead, KitePharma, Kyowa, Portola Pharmaceuticals, Sanofi, Seattle Genetics, Takeda: Consultancy; Celgene, Forty Seven, Inc., Genentech/Roche, Janssen Pharmaceutical, Kura, Merck, Millenium, Pharmacyclics, Regeneron, Seattle Genetics: Research Funding. Ansell:Bristol Myers Squibb: Research Funding; Takeda: Research Funding; ADC Therapeutics: Research Funding; AI Therapeutics: Research Funding; Trillium: Research Funding; Affimed: Research Funding; Regeneron: Research Funding; Seattle Genetics: Research Funding. Younes:HCM: Consultancy; Daiichi Sankyo: Consultancy; Curis: Consultancy; BMS: Consultancy; Novartis: Consultancy; Epizyme: Consultancy; BioPath: Consultancy; AstraZeneca: Current Employment; Janssen: Consultancy; Takeda: Consultancy. Gallamini:Takeda: Other: Speaker. Liu:Takeda Pharmaceuticals: Current Employment. Little:Takeda: Current Employment, Current equity holder in publicly-traded company. Fenton:Seattle Genetics: Current Employment, Current equity holder in publicly-traded company. Fanale:Seattle Genetics: Current Employment, Current equity holder in publicly-traded company. Radford:GlaxoSmithKline: Current equity holder in publicly-traded company, Other: Spouse; AstraZeneca: Current equity holder in publicly-traded company, Other: Spouse; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Pfizer: Research Funding; ADCT: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Consultancy, Honoraria, Speakers Bureau; Novartis: Consultancy, Honoraria; Seattle Genetics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.
Shared Decision Making in the Era of Telehealth: Implications for Practice and Research
Ozanne, Elissa M. , Cameron, Kenzie A. , Schmidt, Monika M. , Pershing, Mandy L. , Guzmán, Adriana , Sivly, Angela , Cavanaugh, Kerri , Ozanne, Elissa M , Noseworthy, Peter A. , Cavanaugh, Kerri L. , Guzman, Adriana, Fagerlin, Angela

MDM Policy & Practice | December 10, 2020 | Volume: 5 | Issue: 2 | Pages: No page available

10.1177/2381468320976364 | PMID 33344769 Get It

Overview of dominantly inherited AD and top‐line DIAN‐TU results of solanezumab and gantenerumab
Clifford, David B., Coalier, Kelley A., Fagan, Anne M. , Farlow, Martin R. , Mills, Susan , Salloway, Stephen , Santacruz, Anna , Wang, Guoqiao , Snider, B. Joy, Mummery, Catherine J. , Surti, Ghulam M., Hannequin, Didier , Jiménez‐Velázquez, Ivonne Z. , Dyck, Christopher H. van , Gauthier, Serge , Galasko, Doug, Jayadev, Suman , Formaglio, Maïté, Clarnette, Roger, Pariente, Jérémie , Dubois, Bruno, Andersen, Scott W. , Holdridge, Karen C. , Mintun, Mark A., Sims, John R. , Yaari, R. , Baudler, Monika, Doody, Rachelle S., Fontoura, Paulo , Kerchner, Geoffrey A. , Team, DIAN‐TU Study, Bateman, Randall J. , Aschenbrenner, Andrew J. , Benzinger, Tammie L.S. , Cruchaga, Carlos , Goate, Alison , Gordon, Brian A. , Hassenstab, Jason , Jack, Clifford R. , Koeppe, Robert A. , McDade, Eric , Morris, John C. , Snyder, Peter J. , Xiong, Chengjie , Wallon, David , Berman, Sarah , Lah, James J. , Roberson, Erik D. , Honig, Lawrence S. , Sánchez‐Valle, Raquel , Brooks, William S. , Masters, Colin L. , Brosch, Jared R. , Hsiung, Ging‐Yuek Robin , Masellis, Mario , Dubois, Bruno, Pasquier, Florence , Delmar, Paul , Team, DIAN‐TU Study

Alzheimer's & Dementia | December 7, 2020 | Volume: 16 | Issue: S9 | Pages: No page available

10.1002/alz.041129 Get It

AbstractBackgroundAlzheimer’s disease (AD) prevention trials aim to intervene prior to significant neuronal loss, brain damage, and symptom onset to delay or slow cognitive decline. In dominantly inherited AD (DIAD), mutation carriers develop symptomatic AD at predictable ages with near 100% penetrance. In 2012, the Dominantly Inherited Alzheimer Network Trials Unit Adaptive Prevention Trial (DIAN‐TU APT) platform launched a double‐blind, randomized, placebo‐controlled, parallel group trial of two anti‐amyloid‐beta monoclonal antibodies with two different antigenic targets, gantenerumab and solanezumab (NCT01760005). The DIAN‐TU scientific development, implementation of the first AD prevention trial, trial challenges and opportunities, including dose escalation, and top‐line results will be presented.MethodDIAN was established in 2008 in response to a call from the National Institute of Aging to establish a network to study DIAD and enable future clinical trials. Successive breakthroughs in understanding disease processes enabled the launch of the DIAN‐TU adaptive prevention trial, a global adaptive platform trial supporting testing multiple drugs in parallel. The DIAN‐TU partners include patients and families at risk for DIAD, global academic researchers, the NIH, Alzheimer’s Association, philanthropic supporters, the DIAN‐TU Pharma Consortium, and pharmaceutical companies with drugs being tested. Important milestones include developing a platform to enable a comprehensive efficient treatment trial for this rare population, adding tau PET as part of AMP AD, adapting dosing mid‐trial and extending the original biomarker trial to continue randomized dosing to test a cognitive endpoint until the last patient reaches 4 years, developing a disease progression statistical model and inclusion of DIAN observational data to increase the power to determine drug effects.ResultThe primary and key secondary outcomes of the DIAN‐TU trial will be presented for each therapy in the context of targeting amyloid‐beta at pre‐clinical and clinically symptomatic stages of disease.ConclusionThese results inform about AD hypotheses, timing of treatment and the prospect of slowing, or preventing AD in DIAD and sporadic AD.
Gantenerumab in‐depth outcomes
Salloway, Stephen , Clifford, David B., Coalier, Kelley A., Fagan, Anne M. , Farlow, Martin R. , Mills, Susan , Santacruz, Anna , Wang, Guoqiao , Snider, B. Joy, Mummery, Catherine J. , Surti, Ghulam M., Hannequin, Didier , Jiménez‐Velázquez, Ivonne Z. , Dyck, Christopher H. van , Gauthier, Serge , Galasko, Doug, Jayadev, Suman , Formaglio, Maïté, Clarnette, Roger, Pariente, Jérémie , Dubois, Bruno, Baudler, Monika, Doody, Rachelle S., Fontoura, Paulo , Kerchner, Geoffrey A. , Team, DIAN‐TU Study, Bateman, Randall J. , Aschenbrenner, Andrew J. , Benzinger, Tammie L.S. , Cruchaga, Carlos , Goate, Alison , Gordon, Brian A. , Hassenstab, Jason , Jack, Clifford R. , Koeppe, Robert A. , McDade, Eric , Morris, John C. , Snyder, Peter J. , Xiong, Chengjie , Wallon, David , Berman, Sarah , Lah, James J. , Roberson, Erik D. , Honig, Lawrence S. , Sánchez‐Valle, Raquel , Brooks, William S. , Masters, Colin L. , Brosch, Jared R. , Hsiung, Ging‐Yuek Robin , Masellis, Mario , Dubois, Bruno, Pasquier, Florence , Delmar, Paul , Team, DIAN‐TU Study

Alzheimer's & Dementia | December 7, 2020 | Volume: 16 | Issue: S9 | Pages: No page available

10.1002/alz.038049 Get It

AbstractBackgroundGantenerumab is a humanized anti‐amyloid‐beta monoclonal antibody in clinical development for the treatment of several stages of Alzheimer disease (AD). Gantenerumab was evaluated in a phase 2/3 clinical trial program designed to evaluate its efficacy in autosomal dominant AD based on a combination of clinical and biomarker evidence.MethodThe study enrolled both mutation carriers (n=69 with 3:1 randomization of treatment (n=52) vs placebo (n=17)) and non‐carriers (n=28, all on placebo) from 15 years before to 10 years after the expected age of onset inclusive. Patients were both asymptomatic (CDR 0 and MMSE >25) and symptomatic (CDR 0.5‐1 and MMSE >16). There were 41 asymptomatic and 28 symptomatic mutation carriers. The initial dose of gantenerumab was 225 mg monthly administered subcutaneously. The dose was titrated to 1200 mg/month following a protocol amendment based on the increased amyloid lowering seen at higher doses in the gantenerumab program in symptomatic AD. The treatment duration was a minimum of 4 years (range 48‐80 months). The primary outcome was change from baseline in the DIAN‐TU multivariate cognitive endpoint. Secondary clinical outcomes included the DIAN‐TU cognitive composite, Cogstate multivariate cognitive endpoint, CDR SB, and time to CDR progression of >0.5 points. Change from baseline in amyloid PET was the primary biomarker outcome. Other biomarker outcomes included MRI, tau PET, CSF amyloid, tau and phosphotau, and CSF and plasma neurofilament light (NfL). Safety outcomes including ARIA were compared between drug and placebo groups.ResultWe will report change from baseline on the DIAN‐TU multivariate cognitive endpoint, DIAN‐TU cognitive composite, CDR‐SB and other secondary efficacy endpoints. We expect significant lowering on amyloid PET with PIB and florbetapir based on the results from recent anti‐amyloid antibodies, including Gantenerumab, in sporadic AD. We will also present the results of change in other key imaging and fluid biomarkers. The frequency, duration, and severity of ARIA will be reported and compared with studies in sporadic AD.ConclusionThis clinical trial was designed to inform future for ADAD and will provide new insights on the role of amyloid reduction in both pre‐symptomatic and clinical AD.
Nodular lymphocyte predominant Hodgkin lymphoma: executive summary of the American radium society appropriate use criteria
Metzger, Monika L. , Milgrom, Sarah A. , Advani, Ranjana H. , Bakst, Richard L. , Dabaja, Bouthaina S. , Flowers, Christopher R. , Ha, Chul S. , Mansur, David B., Roberts, Kenneth B. , Smith, Sonali M. , Terezakis, Stephanie , Advani, Ranjana H , Ballas, Leslie , Hoppe, Bradford S. , Pinnix, Chelsea C. , Plastaras, John Peter , Constine, Louis S

Leukemia & Lymphoma | December 4, 2020 | Volume: 62 | Issue: 5 | Pages: 1057-1065

10.1080/10428194.2020.1852559 | PMID 33274673 Get It

COVD-31. THE STATE OF NEURO-ONCOLOGY DURING THE COVID-19 PANDEMIC: A WORLDWIDE ASSESSMENT
Mrugała, Maciej M. , Pressley, Shelley M., Thomas, Alissa A. , Acquaye, Alvina , Haynes, Chas, Butowski, Nicholas , Hervey‐Jumper, Shawn L. , Porter, Alyx B. , Oliver, Kathy , Dunbar, Erin, Taylor, Jennie , Schiff, David , Nassiri, Farshad , Chang, Susan M. , Zadeh, Gelareh , Chheda, Milan G. , Ostrom, Quinn T. , Wefel, Jeffrey S. , Coven, Scott L. , Agnihotri, Sameer , Lim, Michael , Peters, Katherine B. , Hegi, Monika E. , Armstrong, Terri S. , Bent, Martin J. van den , Chang, Susan Marina

Neuro-Oncology | December 4, 2020 | Volume: 22 | Issue: Supplement_2 | Pages: ii27-ii27

10.1093/neuonc/noaa215.112 Get It

Abstract To assess the impact of the pandemic on the field, we performed an international web-based survey of practitioners, scientists, and trainees from 21 neuro-oncology organizations across 6 continents from April 24 through May 17. Of 582 respondents, 258 (45%) were in the US, and 314 (55%) were international. 80.4% were affiliated with academic institutions. 94% respondents reported changes in clinical practice; 95% reported conversion to telemedicine for at least some appointments. However, almost 10% practitioners felt the need to see patients in person specifically because of billing concerns and perceived institutional pressure. Over 50% believed neuro-oncology patients were at increased risk of contracting COVID-19. 67% practitioners suspended enrollment for at least one clinical trial: 53% suspended phase II and 62% suspended phase III trial enrollment. 71% clinicians feared for their or their families’ safety, specifically because of their clinical duties. 20% percent said they did not have enough PPE to work safely; about the same percentage were unhappy with their institutions’ response to the pandemic. 43% believed the pandemic would negatively affect their academic career, and 52% fellowship program directors were worried about losing funding for their training programs. While 69% respondents reported increased stress, 44% were offered no psychosocial support. 37% had their salary reduced. 36% researchers had to temporarily close their laboratories. In contrast, the pandemic created positive changes in perceived patient and family satisfaction, quality of communication, and use of technology to deliver care and interactions with other practitioners. CONCLUSIONS: The pandemic has altered standard treatment schedules and limited investigational treatment options for patients. In some cases, clinicians felt institutional pressure to continue conducting billable in-person visits when telemedicine visits would have sufficed. A lack of institutional support created anxiety among clinicians and researchers. We make specific recommendations to guide clinical and scientific infrastructure moving forward.
Targeting the RhoGEF βPIX/COOL-1 in Glioblastoma: Proof of Concept Studies
Connor, Kate , Murray, David W. , Tran, Nhan L. , White, Kieron , Dicker, Patrick , Sweeney, Kieron J. , O’Halloran, Philip J. , MacCarthy, Brian , Shiels, Liam P., Lodi, Francesca , Lambrechts, Diether , Sarkaria, Jann N. , Symons, Marc , Byrne, Annette T. , Lambrechts, Diether , O'Halloran, Philip J , MacCarthy, Brian , Lodi, Francesca , Sarkaria, Jann N , Lambrechts, Diether , Lambrechts, Diether , Tran, Nhan L , Murray, David W., Jarzabek, Monika A. , Schiffelers, Raymond Michel

Cancers | November 26, 2020 | Volume: 12 | Issue: 12 | Pages: 3531

10.3390/cancers12123531 | PMID 33256106 Get It

Glioblastoma (GBM), a highly invasive and vascular malignancy is shown to rapidly develop resistance and evolve to a more invasive phenotype following bevacizumab (Bev) therapy. Rho Guanine Nucleotide Exchange Factor proteins (RhoGEFs) are mediators of key components in Bev resistance pathways, GBM and Bev-induced invasion. To identify GEFs with enhanced mRNA expression in the leading edge of GBM tumours, a cohort of GEFs was assessed using a clinical dataset. The GEF βPix/COOL-1 was identified, and the functional effect of gene depletion assessed using 3D-boyden chamber, proliferation, and colony formation assays in GBM cells. Anti-angiogenic effects were assessed in endothelial cells using tube formation and wound healing assays. In vivo effects of βPix/COOL-1-siRNA delivered via RGD-Nanoparticle in combination with Bev was studied in an invasive model of GBM. We found that siRNA-mediated knockdown of βPix/COOL-1 in vitro decreased cell invasion, proliferation and increased apoptosis in GBM cell lines. Moreover βPix/COOL-1 mediated endothelial cell migration in vitro. Mice treated with βPix/COOL-1 siRNA-loaded RGD-Nanoparticle and Bev demonstrated a trend towards improved median survival compared with Bev monotherapy. Our hypothesis generating study suggests that the RhoGEF βPix/COOL-1 may represent a target of vulnerability in GBM, in particular to improve Bev efficacy.
Clinical features associated with COVID-19 outcome in multiple myeloma: first results from the International Myeloma Society data set
Chari, Ajai , Samur, Mehmet , Martínez‐López, Joaquín , Cook, Gordon , Biran, Noa , Yong, Kwee , Hungria, Vânia , Engelhardt, Monika , Feria, Ana García, Oliva, Stefania , Gozzetti, Alessandro , Rosenbaum, Cara A. , Kumar, Shaji , Stadtmauer, Edward A. , Beksaç, Meral , Mateos, María‐Victoria , Moreau, Philippe , Miguel, Jesús F. San , Munshi, Nikhil C. , Martinez-Lopez, Joaquin , Martinez-Lopez, Joaquin , Moreau, Philippe , Chari, Ajai , San-Miguel, Jesus , Hungria, Vania , Martinez-Lopez, Joaquin , Gozzetti, Alessandro , Beksac, Meral , Cook, Gordon , Oliva, Stefania , Yong, Kwee , Samur, Mehmet K , Gay, Francesca , Oostvogels, Rimke , Einsele, Hermann , Weisel, Katja C , Anderson, Kenneth C. , Avet‐Loiseau, Hervé

Blood | November 6, 2020 | Volume: 136 | Issue: 26 | Pages: 3033-3040

10.1182/blood.2020008150 | PMID 33367546 Get It

Abstract The primary cause of morbidity and mortality in patients with multiple myeloma (MM) is an infection. Therefore, there is great concern about susceptibility to the outcome of COVID-19–infected patients with MM. This retrospective study describes the baseline characteristics and outcome data of COVID-19 infection in 650 patients with plasma cell disorders, collected by the International Myeloma Society to understand the initial challenges faced by myeloma patients during the COVID-19 pandemic. Analyses were performed for hospitalized MM patients. Among hospitalized patients, the median age was 69 years, and nearly all patients (96%) had MM. Approximately 36% were recently diagnosed (2019-2020), and 54% of patients were receiving first-line therapy. Thirty-three percent of patients have died, with significant geographic variability, ranging from 27% to 57% of hospitalized patients. Univariate analysis identified age, International Staging System stage 3 (ISS3), high-risk disease, renal disease, suboptimal myeloma control (active or progressive disease), and 1 or more comorbidities as risk factors for higher rates of death. Neither history of transplant, including within a year of COVID-19 diagnosis, nor other anti-MM treatments were associated with outcomes. Multivariate analysis found that only age, high-risk MM, renal disease, and suboptimal MM control remained independent predictors of adverse outcome with COVID-19 infection. The management of MM in the era of COVID-19 requires careful consideration of patient- and disease-related factors to decrease the risk of acquiring COVID-19 infection, while not compromising disease control through appropriate MM treatment. This study provides initial data to develop recommendations for the management of MM patients with COVID-19 infection.
Cardiovascular Care of the Oncology Patient During COVID-19: An Expert Consensus Document From the ACC Cardio-Oncology and Imaging Councils
Baldassarre, Lauren A. , Yang, Eric H. , Cheng, Richard K. , DeCara, Jeanne M. , Liu, Jennifer E. , Rudski, Lawrence , Strom, Jordan B. , Barac, Ana , Bucciarelli‐Ducci, Chiara , Lenneman, Carrie , Villarraga, Hector R. , Ismail‐Khan, Roohi , Ky, Bonnie , Leja, Monika, Scherrer‐Crosbie, Marielle , Liu, Jennifer E , Rudski, Lawrence G , Strom, Jordan B , Thavendiranathan, Paaladinesh , Barac, Ana , Zaha, Vlad G , Bucciarelli-Ducci, Chiara , Ellahham, Samer , Deswal, Anita M , Lenneman, Carrie , Villarraga, Hector R , Blaes, Anne H , Ismail-Khan, Roohi , Ky, Bonnie , Scherrer-Crosbie, Marielle , Yang, Eric , Cheng, Richard , Dent, Susan , Blaes, Anne

JNCI: Journal of the National Cancer Institute | November 3, 2020 | Volume: 113 | Issue: 5 | Pages: 513-522

10.1093/jnci/djaa177 | PMID 33179744 Get It

Abstract In response to the coronavirus disease 2019 (COVID-19) pandemic, the Cardio-Oncology and Imaging Councils of the American College of Cardiology offers recommendations to clinicians regarding the cardiovascular care of cardio-oncology patients in this expert consensus statement. Cardio-oncology patients—individuals with an active or prior cancer history and with or at risk of cardiovascular disease—are a rapidly growing population who are at increased risk of infection, and experiencing severe and/or lethal complications by COVID-19. Recommendations for optimizing screening and monitoring visits to detect cardiac dysfunction are discussed. In addition, judicious use of multimodality imaging and biomarkers are proposed to identify myocardial, valvular, vascular, and pericardial involvement in cancer patients. The difficulties of diagnosing the etiology of cardiovascular complications in patients with cancer and COVID-19 are outlined, along with weighing the advantages against risks of exposure, with the modification of existing cardiovascular treatments and cardiotoxicity surveillance in patients with cancer during the COVID-19 pandemic.