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52. Randomized Phase II Trial of Cisplatin and Etoposide in Combination With Veliparib or Placebo for Extensive-Stage Small-Cell Lung Cancer: ECOG-ACRIN 2511 Study

Author

James L. Wade, Taofeek K. Owonikoko, Ticiana Leal, Suzanne E. Dahlberg, Bradley Walter Lash, Gabriel Sica, Charu Aggarwal, Suresh S. Ramalingam, Gordan Srkalovic, Lynne I. Wagner, and Joseph W. Leach

Subjects
0301 basic medicine, Oncology, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Veliparib, medicine.medical_treatment, Placebo, Placebos, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Double-Blind Method, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Progression-free survival, Lung cancer, Survival rate, Etoposide, Aged, Cisplatin, Chemotherapy, business.industry, ORIGINAL REPORTS, Middle Aged, medicine.disease, Small Cell Lung Carcinoma, Progression-Free Survival, Survival Rate, 030104 developmental biology, chemistry, 030220 oncology & carcinogenesis, Benzimidazoles, Female, business, medicine.drug
Abstract

Purpose Veliparib, a poly (ADP ribose) polymerase inhibitor, potentiated standard chemotherapy against small-cell lung cancer (SCLC) in preclinical studies. We evaluated the combination of veliparib with cisplatin and etoposide (CE; CE+V) doublet in untreated, extensive-stage SCLC (ES-SCLC). Materials and Methods Patients with ES-SCLC, stratified by sex and serum lactate dehydrogenase levels, were randomly assigned to receive four 3-week cycles of CE (75 mg/m2 intravenously on day 1 and 100 mg/m2 on days 1 through 3) along with veliparib (100 mg orally twice per day on days 1 through 7) or placebo (CE+P). The primary end point was progression-free survival (PFS). Using an overall one-sided 0.10-level log-rank test, the study had 88% power to demonstrate a 37.5% reduction in the PFS hazard rate. Results A total of 128 eligible patients received treatment on protocol. The median age was 66 years, 52% of patients were men, and Eastern Cooperative Oncology Group performance status was 0 for 29% of patients and 1 for 71%. The respective median PFS for the CE+V arm versus the CE+P arm was 6.1 versus 5.5 months (unstratified hazard ratio [HR], 0.75 [one-sided P = .06]; stratified HR, 0.63 [one-sided P = .01]), favoring CE+V. The median overall survival was 10.3 versus 8.9 months (stratified HR, 0.83; 80% CI, 0.64 to 1.07; one-sided P = .17) for the CE+V and CE+P arms, respectively. The overall response rate was 71.9% versus 65.6% (two-sided P = .57) for CE+V and CE+P, respectively. There was a significant treatment-by-strata interaction in PFS: Male patients with high lactate dehydrogenase levels derived significant benefit (PFS HR, 0.34; 80% CI, 0.22 to 0.51) but there was no evidence of benefit among patients in other strata (PFS HR, 0.81; 80% CI, 0.60 to 1.09). The following grade ≥ 3 hematology toxicities were more frequent in the CE+V arm than the CE+P arm: CD4 lymphopenia (8% v 0%; P = .06) and neutropenia (49% v 32%; P = .08), but treatment delivery was comparable. Conclusion The addition of veliparib to frontline chemotherapy showed signal of efficacy in patients with ES-SCLC and the study met its prespecified end point.

Published
2018

53. Diagnosis and Treatment of Chronic Immune-mediated Neuropathies

Author

Latov, Norman, Gorson, Kenneth C., Brannagan, Thomas H., III, Freeman, Roy L., Apostolski, Slobodan, Berger, Alan R., Bradley, Walter G., Briani, Chiara, Bril, Vera, Busis, Neil A., Cros, Didier P., Dalakas, Marinos C., Donofrio, Peter D., Dyck, P. James B., England, John D., Fisher, Morris A., Herrmann, David N., Menkes, Daniel L., Sahenk, Zarife, Sander, Howard W., Triggs, William J., and Vallat, Jean Michel

Published
2006
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62. Progressive myopathy in hyperkalemic periodic paralysis

Author

Bradley, Walter G., Taylor, Reid, Rice, David R., Hausmanowa-Petruzewicz, Irena, Adelman, Lester S., Jenkison, Margaret, and Jedrzejowska, Hanna

Subjects
Adynamia episodica hereditaria -- Physiological aspects, Adynamia episodica hereditaria -- Genetic aspects, Muscle diseases -- Development and progression, Genetic disorders -- Case studies, Potassium metabolism -- Genetic aspects, Adynamia episodica hereditaria -- Complications, Hyperkalemia -- Physiological aspects, Health
Abstract

The phrase ''periodic paralysis'' describes a symptom, and thus it is not surprising that this heading comprises a collection of disorders, including hypokalemic and hyperkalemic periodic paralysis. In hypokalemic periodic paralysis, serum potassium drops during an attack; in hyperkalemic periodic paralysis, serum potassium rises during an attack. In both cases, however, the return of serum potassium values to normal reflects the return of strength. These disorders are inherited as autosomal dominant traits. Progressive muscle degeneration has long been recognized as a potential complication of hypokalemic periodic paralysis. It is less widely appreciated that progressive myopathy may be a complication of hyperkalemic periodic paralysis, as well. The cases of five individuals from four affected families are presented to illustrate the myopathy that may occur with hyperkalemic periodic paralysis. The pathological mechanisms responsible for the muscle degeneration are not clear. Some researchers have suggested that this myopathy simply represents the cumulative damage of the attacks of paralysis. However, attacks of periodic paralysis often decrease in frequency in the later years of life; in some of the cases presented, muscle degeneration continued despite a reduction in the number of attacks. This suggests that the muscle degeneration observed in hyperkalemic periodic paralysis may be due directly to the underlying genetic abnormality, and does not occur as a secondary consequence of paralysis. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1990

63. Nusinersen versus sham control in later-onset spinal muscular atrophy

Author

Vogt, Sibylle, Krueger, Marcus, Pechmann, Astrid, Rippberger, Bianca, Eckenweiler, Matthias, Schara, Ulrike, Koelbel, Heike, Andres, Barbara, Rupprich, Katrin, Gangfuss, Andrea, Jachertz, Philipp, Della Marina, Adela, Sponemann, Nina, Pane, Markia, Palermo, Concetta, Piastra, Marco, Fanelli, Lavinia, de Sanctis, Roberto, Genovese, Orazio, Antonaci, Laura, Pera, Maria Carmela, Lamendola, Priscilla, Messina, Sonia, Vita, Gianluca, Di Bella, Vincenzo, Sframeli, Maria, Rosa, Matteo, Barcellona, Costanza, Distefano, Maria Grazia, Cavallaro, Filippo, Versaci, Antonio, de Luca, Francesco, Vita, Giuseppe, Nacimento Osorio, Andres, Tizzano, Eduardo, Ortez Gonzalez, Carlos Ignacio, Ortigoza Escobar, Juan Dario, Colomer Oferil, Juame, Medina Cantillo, Julita, Febrer Rotger, Anna, Vigo Morancho, Meritxell, Eldblom, Johanneh, Darin, Niklas, Kroksmark, Anna Karin, Lindstedt, Asa, Michael, Eva, Kimber, Eva, Wahlgren, Lisa, Chan, Sophelia Hoi-Shan, Chim, Stella, Chiu, Joseph, Ho, Alvin Chi Chung, Ip, Jing Kun Janice, Lam, Wendy Wai Man, Ng, Maggie Chui-San, Wan, Connie, Wong, Virginia Chun Nei, Yue, Yvonne, Arakawa, Reiko, Yamauchi, Akemi, Nagata, Satoru, Ito, Yasushi, Nakatsukasa, Hidetsugu, Takeshita, Akiko, Hirasawa, Kyoko, Ikai, Tetsuo, Eto, Kaoru, Otamni, Yui, Takeshima, Yasuhiro, Fukuda, Noroki, Tanaka, Yasuhiro, Shimomura, Hideki, Lee, Tomoko, Shibano, Takayuki, Mercuri, E., Tachikawa, Tomohiro, Darras, B. T., Chae, Jong-Hee, Chiriboga, C. A., Lim, Byung Chan, Day, J. W., Shin, Hyung-Ik, Campbell, C., Kim, Soo Yeon, Connolly, A. M., Choi, Sun Ah, Iannaccone, S. T., Son, Woo Sung, Kirschner, J., Jo, Hyemi, Kuntz, N. L., Chun, Seong Min, Saito, K., Kim, Hyuna, Shieh, P. B., Tulinius, M., Mazzone, E. S., Montes, J., Bishop, K. M., Yang, Q., Foster, R., Gheuens, S., Bennett, C. F., Farwell, W., Schneider, E., de Vivo, D. C., Finkel, R. S., Bradley, Walter G., Kaufmann, Petra, Dickson, Patricia I., Reingold, Stephen C., Davis, Charles S., Arredondo, Kristen, Castro, Diana, Cowie, Margaret, Farrow-Gillespie, Alan, Hebert, Andrew, Kauk, Melissa, Miller, Nancy, Nelson, Leslie, Spain, Thomas, Cappell, Joshua, Constantinescu, Andrei, Cruz, Rosangel, Dastgir, Jahannaz, de Vivo, Darryl, Dunaway, Sally, Engelstad, Kristin, Khandji, Alexander G., Kramer, Samantha, Marra, Jonathan, Popolizio, Molly, Salazar, Rachel, Weimer, Louis H., Aziz-Zaman, Sonya, Lamarca, Nicole, Ghosh, Partha, Al-Ghamdi, Fouad, Liew, Wendy, Graham, Robert, Berde, Charles, Sethna, Navil, Koka, Anjali, Wang, Luke, Laine, Regina, Souris, Michelle, Ordonez, Grace, Harrington, Timothy, Szelag, Heather, Pasternak, Amy, Mirek, Elizabeth, Quigley, Janet, Finkel, Richard, Berry, Debbie, Civitello, Matthew, Endsley, Julie Duke, Eden, Candace, Leon, Wendy, O'Reardon, Kathleen, Sigurdardottir, Laufey, Johnson, Craig, Turner, Jenna, Vega, Melisa, Weber-Guzman, Fabiola, Zinn, Matthias, Rocha, Ana Carolina Tesi, Watson, Karolina, d'Souza, Genevieve, Ramamurthi, R. J., Gee, Richard, Kitsuwa-Lowe, Janis, Hagerman, Katharine, Crasta, Sheela, Welsh, Lesly, Paulose, Shirley, Mcfall, Danielle, Perez, Jennifer, Patnaik, Swetapadma, Sanjanwala, Bharati, Sakamuri, Sarada, Proud, Crystal, Purse, Bona Park, Duong, Trinh Tina, Sampson, Jacinda, Tennekoon, Gihan, Brandsema, John, Glanzman, Allan, Flickinger, Jean, Toms, Michele, Adang, Laura, Stanford, Delores, Mayer, Oscar, Zigmont, Joshua, Chadehumbe, Madeline, Kichula, Elizabeth, Finanger, Erika, Russman, Barry, Roberts, Colin, Frank, Andrea, Benjamin, Danielle, Zilke, Kirsten, Golumbek, Paul T., Zaidman, Craig M., Anand, Pallavi, Gadeken, Rebecca, Siener, Catherine, Kuntz, Nancy, Epstein, Leon, Krueger, Jena, Goldman, Stewart, Krosschell, Kristin, Blomgren, Colleen, Choi, Hyoung Won, Kurz, Jonathan, Parsons, Julie, Janas, Joanne, Yang, Michele, Ballard, Alison, Carry, Terri, Shea, Stephanie, Bielsky, Alan, Booker, Kaylee, Camuto, Alicia, Lord-Halvorson, Sierra, Gibbons, Melissa, Zimmerman, Carl, Allen, Victoria, Fuhr, Peter, Johnson, Hannah, Tran, Vi, Vanderveen, Gina, Shieh, Perry, Fowler, Eileen, Parziale, Nicholas, Rao, Lekha, Skura, Christy, Kelley, Carolyn, Shu, Francy, Oskoui, Maryam, Zielinski, David, Poulin, Chantal, Ingelmo, Pablo Mauricio, Desilets, Sarah Turgeon, Dinunzio, Pamela, Rivera, Gonzalo, Srour, Myriam, Arpin, Stephanie, Goobie, Sharan, Gibson, Paul, Scholtes, Cheryl, Mcdonald, Wendy, Zapata, Eugenio, Nguyen, Cam-Tu Emilie, Servais, Laurent, Gargaun, Elena, Le Moing, Anne-Gaelle, Gidaro, Teresa, Vialle, Raphael, Guye, Marie-Laurence, Lilien, Charlotte, Olliver, Gwenn, Gilabert, Stephanie, Borell, Sabine, Wider, Sabine, Stein, Sabine, Universität Duisburg-Essen = University of Duisburg-Essen [Essen], Department of Paediatrics, Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), Vall d'Hebron University Hospital [Barcelona], CIBER de Enfermedades Raras (CIBERER), Handicaps génétiques de l'enfant (Inserm U393), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Seoul National University Hospital, Max-Planck-Institut für Mikrostrukturphysik (MPI-HALLE), Max-Planck-Gesellschaft, The University of Tokyo (UTokyo), Institut de Chimie Organique et Analytique (ICOA), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université d'Orléans (UO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Institute of Plasma Physics, Chinese Academy of Sciences (ASIPP), Institut Necker Enfants-Malades (INEM - UM 111 (UMR 8253 / U1151)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Laboratoire de mécanique des solides (LMS), École polytechnique (X)-Mines Paris - PSL (École nationale supérieure des mines de Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Centre National de la Recherche Scientifique (CNRS), CureSMA [Elk Grove Village, IL, USA], Harvard Medical School [Boston] (HMS), Institute for Marine and Antarctic Studies [Hobart] (IMAS), University of Tasmania [Hobart, Australia] (UTAS), The Hospital for sick children [Toronto] (SickKids), University of Toronto, The Open University [Milton Keynes] (OU), Department of Pediatrics, Feinberg School of Medicine, Northwestern University [Evanston]-Northwestern University [Evanston]-Northwestern University, University Hospital Basel [Basel], McGill University Health Center [Montreal] (MUHC), Service de génétique [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau, Service of Clinical Trials and Databases, Institut de Myologie, Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Association française contre les myopathies (AFM-Téléthon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Association française contre les myopathies (AFM-Téléthon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Association française contre les myopathies (AFM-Téléthon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), CHU Amiens-Picardie, Groupe de Recherche sur l'Analyse Multimodale de la Fonction Cérébrale - UMR INSERM_S 1105 (GRAMFC), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), University of Oxford, Schara, Ulrike (Beitragende*r), Koelbel, Heike (Beitragende*r), Rupprich, Katrin (Beitragende*r), Gangfuss, Andrea (Beitragende*r), Della Marina, Adela (Beitragende*r), and Sponemann, Nina (Beitragende*r)

Subjects
0301 basic medicine, Male, [SDV]Life Sciences [q-bio], spinal, Medizin, Oligonucleotides, Spinal Muscular Atrophies of Childhood, Pediatrics, law.invention, Age of Onset, Child, Child, Preschool, Double-Blind Method, Female, Humans, Infant, Injections, Spinal, Least-Squares Analysis, Motor Skills, Oligonucleotides, Antisense, Medicine (all), 0302 clinical medicine, age of onset, Randomized controlled trial, law, Clinical endpoint, inglese, injections, Motor skill, motor skills, General Medicine, SMA, Settore MED/26 - NEUROLOGIA, medicine.anatomical_structure, female, Anesthesia, Nusinersen, Spinal, antisense, preschool, Injections, 03 medical and health sciences, least-squares analysis, Settore MED/39 - NEUROPSICHIATRIA INFANTILE, Settore MED/41 - ANESTESIOLOGIA, medicine, Antisense, Preschool, business.industry, Spinal muscular atrophy, Motor neuron, medicine.disease, 030104 developmental biology, Age of onset, business, 030217 neurology & neurosurgery
Abstract

Background: Nusinersen is an antisense oligonucleotide drug that modulates pre–messenger RNA splicing of the survival motor neuron 2 (SMN2) gene. It has been developed for the treatment of spinal muscular atrophy (SMA). Methods: We conducted a multicenter, double-blind, sham-controlled, phase 3 trial of nusinersen in 126 children with SMA who had symptom onset after 6 months of age. The children were randomly assigned, in a 2:1 ratio, to undergo intrathecal administration of nusinersen at a dose of 12 mg (nusinersen group) or a sham procedure (control group) on days 1, 29, 85, and 274. The primary end point was the least-squares mean change from baseline in the Hammersmith Functional Motor Scale–Expanded (HFMSE) score at 15 months of treatment; HFMSE scores range from 0 to 66, with higher scores indicating better motor function. Secondary end points included the percentage of children with a clinically meaningful increase from baseline in the HFMSE score (≥3 points), an outcome that indicates improvement in at least two motor skills. Results: In the prespecified interim analysis, there was a least-squares mean increase from baseline to month 15 in the HFMSE score in the nusinersen group (by 4.0 points) and a least-squares mean decrease in the control group (by –1.9 points), with a significant between-group difference favoring nusinersen (least-squares mean difference in change, 5.9 points; 95% confidence interval, 3.7 to 8.1; P Conclusions: Among children with later-onset SMA, those who received nusinersen had significant and clinically meaningful improvement in motor function as compared with those in the control group. (Funded by Biogen and Ionis Pharmaceuticals; CHERISH ClinicalTrials.gov number, NCT02292537. opens in new tab.)

Published
2018

64. Phase II multicenter study of antroquinonol in patients with stage IV non-small cell lung cancer who have failed at least two lines of anti-cancer therapy.

Author

Ho, Ching-Liang, primary, Ettinger, David S., additional, Chen, Pei-Ni, additional, Cheng, Howard, additional, Wen, Wu-Che, additional, Wu, Shang-Yin, additional, Jahan, Thierry Marie, additional, Fidler, Mary J., additional, Lash, Bradley Walter, additional, Rybkin, Igor I., additional, and Stanton, Natalie, additional

Published
2019
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65. Cyanobacterial neurotoxin BMAA and brain pathology in stranded dolphins

Author

Davis, David A., primary, Mondo, Kiyo, additional, Stern, Erica, additional, Annor, Ama K., additional, Murch, Susan J., additional, Coyne, Thomas M., additional, Brand, Larry E., additional, Niemeyer, Misty E., additional, Sharp, Sarah, additional, Bradley, Walter G., additional, Cox, Paul Alan, additional, and Mash, Deborah C., additional

Published
2019
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72. Risk factors for amyotrophic lateral sclerosis: A regional United States case-control study.

Author

Andrew, Angeline S., Bradley, Walter G., Peipert, Daniel, Butt, Tanya, Amoako, Kwadwo, Pioro, Erik P., Tandan, Rup, Novak, John, Quick, Adam, Pugar, K. Doug, Sawlani, Komal, Katirji, Bashar, Hayes, Todd A., Cazzolli, Pamela, Gui, Jiang, Mehta, Paul, Horton, D. Kevin, and Stommel, Elijah W.

Subjects
*LIFESTYLES, *RESEARCH, *RESEARCH methodology, *OCCUPATIONAL exposure, *EVALUATION research, *MEDICAL cooperation, *COMPARATIVE studies, *JOB Descriptive Index, *AMYOTROPHIC lateral sclerosis, *RESEARCH funding, *LOGISTIC regression analysis, *ENVIRONMENTAL exposure
Abstract

Most amyotrophic lateral sclerosis (ALS) cases are considered sporadic, without a known genetic basis, and environmental exposures are thought to play a causal role. To learn more about sporadic ALS etiology, we recruited n = 188 ALS patients from northern New England and Ohio and matched controls 2:1 from the general population of the same regions. Questionnaires evaluated the association between a variety of lifestyle, behavioral (ie, hobbies and activities), and occupational factors and the risk of ALS, including the duration of time between exposure and ALS onset, and exposure frequency. Head trauma was associated with increased ALS risk (adjusted odds ratio [OR] 1.60 95% confidence interval [CI] 1.04-2.45), with significantly greater effects for injuries occurring 10 or more years prior to symptom onset (P = .037). ALS risk was increased for those reporting severe electrical burns (adjusted OR 2.86, 95% CI 1.37-6.03), with odds ratios highest for burns after age 30 (OR 3.14), and for burns 10 or more years prior to symptom onset (OR 3.09). Hobbies involving lead were the most strongly associated with ALS risk (adjusted OR 2.92, 95% CI 1.45-5.91). Exposures to lead 20 or more years prior to diagnosis had larger effect sizes compared to those occurring more recently. Holding a job in mechanics, painting, or construction was associated with ALS. The identification of these specific environmental factors associated with ALS highlight the need for future prospective and laboratory studies to assess causality, biological mechanisms, and find prevention or treatment opportunities. [ABSTRACT FROM AUTHOR]

Published
2021
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74. Microbial cell factories for the production of specialised plant metabolites

Author

De Bruyn, Frederik, Van Brempt, Maarten, De Paepe, Brecht, Maertens, Jo, Bauwens, David, Coussement, Pieter, Lim, Chin Giaw, Biggs, Bradley Walter, Philippe, Ryan, Ajikumar, Parayil Kumaran, and De Mey, Marjan

Subjects
microbial cell factories, Biology and Life Sciences, plant metabolites
Published
2017

75. A parametric study of variables that affect fiber microbuckling initiation in composite laminates. I - Analyses. II - Experiments

Author

Guynn, E. G, Ochoa, Ozden O, and Bradley, Walter L

Subjects
Structural Mechanics
Abstract

The effects of the stacking sequence (orientation of plies adjacent to the 0-deg plies), free surfaces, fiber/matrix interfacial bond strength, initial fiber waviness, resin-rich regions, and nonlinear shear constitutive behavior of the resin on the initiation of fiber microbuckling in thermoplastic composites were investigated using nonlinear geometric and nonlinear 2D finite-element analyses. Results show that reductions in the resin shear tangent modulus, large amplitudes of the initial fiber waviness, and debonds each cause increases in the localized matrix shear strains; these increases lead in turn to premature initiation of fiber microbuckling. The numerical results are compared to experimental data obtained using three thermoplastic composite material systems: (1) commercial APC-2, (2) QUADRAX Unidirectional Interlaced Tape, and AU4U/PEEK.

Published
1992

76. Phase II multicenter study of antroquinonol in patients with stage IV non-small cell lung cancer who have failed at least two lines of anti-cancer therapy

Author

David S. Ettinger, Thierry Jahan, Wu-Che Wen, Howard Cheng, Ching-Liang Ho, Pei-Ni Chen, Bradley Walter Lash, Igor I. Rybkin, Shang-Yin Wu, Mary J. Fidler, and Natalie Stanton

Subjects
Oncology, Cancer Research, medicine.medical_specialty, business.industry, Cancer therapy, Stage IV non-small cell lung cancer, Multicenter study, Internal medicine, Antroquinonol, Medicine, In patient, business, Stage iv
Abstract

e20522 Background: The aim of this study was to assess the efficacy of Antroquinonol in patients with stage IV NSCLC after failure in two-lines of anti-cancer therapy. Methods: Patients with stage IV non-squamous NSCLC who have failed at 2-4 lines of anti-cancer therapy were eligible, though early stage or naïve patients may voluntarily participate. A maximum of 30 evaluable patients were to receive Antroquinonol 600mg per day, of which 15 patients were to be KRAS-positive and 15 patients KRAS negative. The primary endpoint of the study was progression-free survival from the start of treatment to week 12 with disease control rate and overall survival as key secondary endpoints. Results: There were 31 patients enrolled with evaluable population 30 patients, of which 15 patients were KRAS positive and 15 patients KRAS negative. 73% were with at least two prior chemotherapy. The median PFS of 7 patients with 2 prior chemotherapy was 22.9 weeks (95% confidence interval [CI]: 5.0, 31.1); and 11 patients with more than 2 prior chemotherapy was 11.9 weeks (95% confidence interval [CI]: 6.0, 14.1), with a 1-year PFS of 11.4%. Of 11 patients who had had more than 2 prior chemotherapy, the median OS was 47.3 weeks (95% CI: 14.1,-), with a 1-year OS of 39.3%, and the overall disease control rate was 72.7%, with 100% in KRAS negative and 50% in KRAS positive. No systemic toxicities were observed. Conclusions: The monotherapy of Antroquinonol brought up higher disease control rates and longer progression-free survival and overall survival, compared with historical data. Although KRAS negative shows much better than KRAS positive group, Antroquinonol still work well with KRAS positive patients. Clinical trial information: NCT02047344.

Published
2019

78. A comparison of experimental observations and numerical predictions for the initiation of fiber microbuckling in notched composite laminates

Author

Guynn, E. G, Bradley, Walter L, Ochoa, Ozden O, and Whitcomb, John D

Subjects
Structural Mechanics
Abstract

The results of the present experimental study of fiber microbuckling indicates that free surfaces, ply orientations, and resin-rich regions affect the strain level for the initiation of in-plane fiber microbuckling. Nonlinear matrix constitutive behavior, in conjunction with initial fiber waviness, cause significant reductions of fiber microbuckling initiation strain level; these two factors generate nonlinear global stress-strain responses in the models. The fiber microbuckling initiation strains correlate well with the applied strain associated with asymptotic local shear strains.

Published
1991

79. Experimental observations and finite element analysis of the initiation of fiber microbuckling in notched composite laminates

Author

Guynn, E. Gail, Bradley, Walter L, and Ochoa, Ozden O

Subjects
Structural Mechanics
Abstract

A better understanding of the factors that affect the semi-circular edge-notched compressive strength is developed, and the associated failure mode(s) of thermoplastic composite laminates with multidirectional stacking sequences are identified. The primary variables in this investigation are the resin nonlinear shear constitutive behavior, stacking sequence (orientation of plies adjacent to the 0 degree plies), resin-rich regions between the 0 degree plies and the off-axis supporting plies, fiber/matrix interfacial bond strength, and initial fiber waviness. Two thermoplastic composite material systems are used in this investigation. The materials are the commercial APC-2 (AS4/PEEK) and a poor interface experimental material, AU4U/PEEK, designed for this investigation. Notched compression specimens are studied at 21, 77, and 132 C. Geometric and material nonlinear two-dimensional finite element analysis is used to model the initiation of fiber microbuckling of both the ideal straight fiber and the more realistic initially wavy fiber. The effects of free surface, fiber constitutive properties, matrix constitutive behavior, initial fiber curvature, and fiber/matrix interfacial bond strength on fiber microbuckling initiation strain levels are considered.

Published
1990

85. The Pluto Energetic Particle Spectrometer Science Investigation (PEPSSI) on the New Horizons Mission

Author

McNutt, Jr., Ralph L., Livi, Stefano A., Gurnee, Reid S., Hill, Matthew E., Cooper, Kim A., Andrews, G. Bruce, Keath, Edwin P., Krimigis, Stamatios M., Mitchell, Donald G., Tossman, Barry, Bagenal, Fran, Boldt, John D., Bradley, Walter, Devereux, William S., Ho, George C., Jaskulek, Stephen E., LeFevere, Thomas W., Malcom, Horace, Marcus, Geoffrey A., Hayes, John R., Moore, G. Ty, Paschalidis, Nikolaos P., Perry, Mark E., Williams, Bruce D., Wilson, IV, Paul, Brown, Lawrence E., Kusterer, Martha B., and Vandegriff, Jon D.

Published
2009
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86. Phase I clinical trial of safety of L-serine for ALS patients

Author

Levine, Todd D., Miller, Robert G., Bradley, Walter G., Moore, Dan H., Saperstein, David S., Flynn, Lynne E., Katz, Jonathan S., Forshew, Dallas A., Metcalf, James S., Banack, Sandra A., and Cox, Paul A.

Abstract

We performed a randomized, double-blind phase I clinical trial for six months on the effects of oral L-serine in patients with ALS. The protocol called for enrollment of patients with a diagnosis of probable or definite ALS, age 18–85 years, disease duration of less than three years and forced vital capacity (FVC) ≥ 60%. Patients were randomly assigned to four different oral twice-daily dose regimens (0.5, 2.5, 7.5, or 15 g/dose). Blood, urine and CSF samples, ALS Functional Rating Scale-Revised (ALSFRS-R) scores and forced vital capacity (FVC) were obtained throughout the trial. Disease progression was compared with matched historical placebo controls from five previous ALS therapeutic trials. Of 20 patients enrolled, one withdrew before receiving study drug and two withdrew with gastro-intestinal problems. Three patients died during the trial. L-serine was generally well tolerated by the patients and L-serine did not appear to accelerate functional decline of patients as measured by slope of their ALSFRS-R scores. Based on this small study, L-serine appears to be generally safe for patients with ALS.

Published
2016
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87. Randomized trial of cisplatin and etoposide in combination with veliparib or placebo for extensive stage small cell lung cancer: ECOG-ACRIN 2511 study.

Author

Owonikoko, Taofeek Kunle, primary, Dahlberg, Suzanne Eleanor, additional, Sica, Gabriel, additional, Wagner, Lynne I., additional, Wade, James Lloyd, additional, Srkalovic, Gordan, additional, Lash, Bradley Walter, additional, Leach, Joseph W., additional, Leal, Ticiana A.B., additional, Aggarwal, Charu, additional, and Ramalingam, Suresh S., additional

Published
2017
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89. Aerosol Exposure to Cyanobacteria as a Potential Risk Factor for Neurological Disease (P5.086)

Author

Henegan, Patricia, primary, Andrew, Angeline, additional, Kuczmarski, Thomas, additional, Michaelson, Nara, additional, Storm, Jackson, additional, Atkinson, Aaron, additional, Waters, Brenda, additional, Crothers, Jessica, additional, Gallagher, Torrey, additional, Tsongalis, Gregory, additional, Bradley, Walter, additional, and Stommel, Elijah, additional

Published
2017
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93. Estimation of environmental exposure: interpolation, kernel density estimation or snapshotting.

Author

Shi, Xun, Li, Meifang, Hunter, Olivia, Guetti, Bart, Andrew, Angeline, Stommel, Elijah, Bradley, Walter, and Karagas, Margaret

Subjects
ENVIRONMENTAL exposure, ENVIRONMENTAL health, SPATIAL analysis (Statistics), POLLUTION, INTERPOLATION
Abstract

In environmental health researches and practices, spatial analysis became an important approach to estimation of environmental exposure of human subjects under concern. A typical situation in this kind of application is that the data of pollution are available only at certain locations, and thus, inference is needed to convert a limited number of values at discrete locations into a continuous surface. This paper intends to clarify the distinction among three methods that can be used to achieve this conversion, namely interpolation, kernel density estimation and snapshotting. Due to the apparent similarity of the three, they may cause confusions that lead to misuses. We compare and contrast the three methods, in terms of nature of the input data, mathematical process of the inference, and essential meaning of the output. For each method, we suggest appropriate applications within the context of estimation of environmental exposure. [ABSTRACT FROM AUTHOR]

Published
2019
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94. Theme 1 Epidemiology and informatics.

Author

Armon, Carmel, Pupillo, Elisabetta, Bianchi, Elisa, Vanacore, Nicola, Montalto, Carla, della Cuna, Francesco Saverio Robustelli, Beghi, Ettore, Miller, Christopher, Arndt, Theresa, Russo, Pierantonio, Shukla, Oodaye, Merrill, Charlotte, Agnese, Wendy, Apple, Stephen, Bradley, Walter, Stommel, Elijah, Andrew, Angeline, Shi, Xun, Butt, Tanya, and Guetti, Bart

Subjects
EPIDEMIOLOGY, BIOLOGICAL tags, NERVES, NEUROLOGY
Published
2019
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95. The Crisis in Clinical Research

Author

Lee, Sharon, Genel, Myron, Jonas, Harry, Tuckson, Reed V., Korn, David, Meyer, Roger E., Moskowitz, Jay, Thompson, James N., Rockey, Don, Ringel, Steven P., Bradley, Walter G., Spencer, Susan S., Nathan, David G., Schechter, Alan N., and Shine, Kenneth

Subjects
Medical research -- Terminology
Published
1999

96. Randomized trial of cisplatin and etoposide in combination with veliparib or placebo for extensive stage small cell lung cancer: ECOG-ACRIN 2511 study

Author

Taofeek Kunle Owonikoko, Suzanne Eleanor Dahlberg, Gabriel Sica, Lynne I. Wagner, James Lloyd Wade, Gordan Srkalovic, Bradley Walter Lash, Joseph W. Leach, Ticiana A.B. Leal, Charu Aggarwal, and Suresh S. Ramalingam

Subjects
Cancer Research, Oncology
Abstract

8505 Background: Veliparib, a potent inhibitor of Poly (ADP) ribose polymerase (PARP) enzyme potentiates standard chemotherapy against small cell lung cancer (SCLC) in preclinical studies. We evaluated the combination of veliparib (V) with cisplatin/etoposide (CE) doublet for first-line therapy of extensive stage SCLC (ES-SCLC). Methods: Patients with ES-SCLC stratified by gender and serum LDH levels, were randomized to receive four 3-wk cycles of CE (75mg/m2 and 100 mg/m2) along with V (100mg bid on d1-7) or placebo (P). The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS). Using an overall one-sided 0.10 level logrank test, this study had 88% power to detect a 37.5% reduction in the PFS hazard rate. Results: 128 eligible pts were enrolled across 33 US sites. Median age, 66 yrs; men, 52%; PS 0/1 (29%/71%). The estimated median PFS was 6.1 m vs. 5.5 m [unstratified HR: 0.75; 1-sided p = 0.06) favoring CE+V. The median OS was 10.3 m vs. 8.9 m respectively for CE+V and CE+P [stratified HR: 0.83 (80% CI 0.64-1.07); 1-sided p = 0.17]. There was a significant treatment by strata interaction in PFS: male pts with high LDH derived benefit [PFS HR of 0.34 (80% CI: 0.22-0.51)]; among pts not in this strata: PFS HR = 0.81 (80% CI: 0.60-1.09). The best objective response rate was 71.9% vs. 65.6% (2-sided p = 0.57). Salient grade ≥3 adverse events occurring in 5% of patients are summarized in the table below. Analysis of tumor samples for predictive biomarkers is planned. Conclusions: The addition of veliparib to doublet chemotherapy was associated with improved PFS in patients with extensive stage SCLC. Clinical trial information: NCT01642251. [Table: see text]

Published
2017

97. Phase I clinical trial of safety of L-serine for ALS patients

Author

Levine, Todd D., primary, Miller, Robert G., additional, Bradley, Walter G., additional, Moore, Dan H., additional, Saperstein, David S., additional, Flynn, Lynne E., additional, Katz, Jonathan S., additional, Forshew, Dallas A., additional, Metcalf, James S., additional, Banack, Sandra A., additional, and Cox, Paul A., additional

Published
2016
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100. Studies of Environmental Risk Factors in Amyotrophic Lateral Sclerosis (ALS) and a Phase I Clinical Trial of l-Serine.

Author

Bradley, Walter G., Miller, R. X., Levine, T. D., Stommel, E. W., and Cox, P. A.

Subjects
*AMYOTROPHIC lateral sclerosis treatment, *AMYOTROPHIC lateral sclerosis, *EPIDEMIOLOGY, *NEURODEGENERATION, *CYANOBACTERIA, *PATIENTS
Abstract

β- N-Methylamino- l-alanine (BMAA) has been linked to Guam ALS/PDC and shown to produce neurodegeneration in vitro and in vivo ( Drosophila, mice, rats, primates). BMAA misincorporation into neuroproteins produces protein misfolding and is inhibited by l-serine. Case-control studies in Northern New England indicate that living near to water-bodies with cyanobacterial blooms increases the risk of developing amyotrophic lateral sclerosis (ALS). The distribution of addresses of ALS cases in New Hampshire, Vermont, and Florida was compared to that of controls. Areas of statistically significantly increased numbers of ALS cases were examined for sources of environmental toxins. A phase I trial of oral l-serine was performed in 20 ALS patients (0.5 to 15 g twice daily). Safety and tolerability were assessed by comparing the rate of deterioration with 430 matched placebo controls. The distribution of residential addresses of ALS cases in New England and Florida revealed many areas where the age- and gender-adjusted frequency of ALS was greater than expected ( P < 0.01). GIS studies of these 'hot spots' in relation to sources of environmental pollutants, like cyanobacterial blooms, Superfund and Brownfield sites, and landfills, are ongoing. In the phase I trial of l-serine, two patients withdrew from because of gastrointestinal side effects. Three patients died during the study, which was about the expected number. The ALSFRS-R in the l-serine-treated patients showed a dose-related decrease in the rate of progression (34% reduction in slope, P = 0.044). The non-random distribution of addresses of ALS patients suggests that residential exposure to environmental pollutants may play an important role in the etiology of ALS. l-Serine in doses up to 15 g twice daily appears to be safe in patients with ALS. Exploratory studies of efficacy suggested that l-serine might slow disease progression. A phase II trial is planned. [ABSTRACT FROM AUTHOR]

Published
2018
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