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2. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial

Author

Hertzberg, Mark, Grigg, Andrew, Cannell, Paul, Quach, Hang, Opat, Stephen, Tam, Constantine, Marlton, Paula, Janssens, Ann, Offner, Fritz, Van eygen, Koen, Sangha, Randeep, Mckay, Pam, Wilson, Jonathan, Van Der Jagt, Richard, Roitman, Daryl, Trneny, Marek, Mayer, Jiri, Le Du, Katell, Solal-Celigny, Philippe, Cartron, Guillaume, Foussard, Charles, Frickhofen, Norbert, Schmidt, Peter, Graeven, Ullrich, Gaska, Tobias, Schlag, Rudolf, Sökler, Martin, Prange-Krex, Gabriele, Florschütz, Axel, Lindemann, Hans-Walter, Schimmelpfennig, Christoph, Tonndorf, Solveig, Hänel, Mathias, Hess, Georg, Schalk, Enrico, Hütten, Heiko, Doelken, Gottfried, Pfreundschuh, Michael, Keller, Ulrich, Herold, Michael, Forstpointner, Roswitha, Vehling-Kaiser, Ursula, Hoffmann, Martin, Borbenyi, Zita, Udvardy, Miklos, Demeter, Judit, Rambaldi, Alessandro, Morra, Enrica, Massimo, Federico, Majolino, Ignazio, Balzarotti, Monica, Semenzato, Gianpietro, Canales Albendea, Miguel Angel, Peñalver Parraga, Francisco Javier, Soler Campos, Alfonso, Sancho Cia, Juan Manuel, Marquez Navarro, Jose Antonio, Grande Garcia, Carlos, Nilsson-Ehle, Herman, Mccarthy, Helen, Pocock, Chris, Sadullah, Shalal, Malladi, Ram, Radford, John, Kanfer, Ed, Kruger, Anton, Culligan, Dominic, Dyer, Martin, Pettengell, Ruth, Seymour, John, Gribben, John, Al-Ismail, Saad, Al-Refaie, Faris, Blesing, Norbert, Macnamara, Christopher, O'callaghan, Ann, Haynes, Andrew, Follows, George, Johnson, Roderick, Cunningham, David, Bowles, Kristian, Collins, Graham, Gallop-Evans, Eve, Robinson, Stephen, Subash, Chezhian, Bailey, James, Holden, Viran, Neidhart, Jeffrey, De Oliveira, Moacyr, Tezcan, Haluk, Kim, Kevin, Kambhampati, Suman, Lanier, Keith, Mcclean, John, Tobinai, Kensei, Hatake, Kiyohiko, Ogura, Michinori, Uchida, Toshiki, Ando, Kiyoshi, Kinoshita, Tomohiro, Höhler, Thomas, Stauder, Heribert, Kirsch, Andreas, Koenigsmann, Michael, Kremers, Stephan, Illmer, Thomas, Witzens-Harig, Mathias, La Roseé, Paul, Dürig, Jan, Kneba, Michael, Hensel, Manfred, Fuxius, Stefan, Bergmann, Lothar, Hübel, Kai, Buske, Christian, Marks, Reinhard, Wulf, Gerald, Lerchenmueller, Christian, Schmits, Rudolf, Reinwald, Mark, Lengfelder, Eva, Scott, Fiona, Chou, Takaaki, Taniwaki, Masafumi, Yoshida, Isao, Ishizawa, Kenichi, Uike, Naokuni, Uoshima, Nobuhiko, Kamitsuji, Yuri, Iida, Shinsuke, Ohmine, Ken, Nosaka, Kisato, Ide, Kazuhiko, Ishikawa, Takayuki, Desjardins, Pierre, Finn, Nicholas, Zhu, Jun, Li, Wei, Yu, Li, Ren, Hanyun, Shi, Yuan Kai, Wu, Gang, Hong, Xiaonan, Zhang, Qingyuan, Feng, Jifeng, Zhan, Rong, Lin, Tongyu, Leppa, Sirpa, Costello, Regis, Tempescul, Adrian, Sanhes, Laurence, Tournilhac, Olivier, Kirchen, Heinz, Hebart, Holger, Weide, Rudolf, Jentsch-Ullrich, Kathleen, Avivi, Irit, Nagler, Arnon, Gurion, Ronit, Shpilberg, Ofer, Leoni, Pietro, Baldini, Luca, Samoylova, Olga, Myasnikov, Alexandr, Tan, Tran-Der, Chang, Hung, Kumagai, Kyoya, Tsukamoto, Norifumi, Tsukasaki, Kunihiro, Beatty, Patrick, Usui, Noriko, Izutsu, Koji, Murayama, Tohru, Ichinohe, Tatsuo, Kubo, Kohmei, Ishida, Fumihiro, Beck, J. Thaddeus, Griesinger, Frank, Osmanov, Dzhelil, Dakhil, Shaker, Clavert, Aline, Maruyama, Dai, Terui, Yasuhito, Yamamoto, Kazuhito, Eigendorff, Ekkehard, Kobayashi, Tsutomu, Ichikawa, Satoshi, Choi, Ilseung, Wada, Katsuya, Kikukawa, Yoshitaka, Matsuoka, Masao, Yoshino, Takayuki, Minami, Yosuke, Trotman, Judith, Barrington, Sally F, Belada, David, Meignan, Michel, MacEwan, Robert, Owen, Carolyn, Ptáčník, Václav, Rosta, András, Fingerle-Rowson, Günter R, Zhu, Jiawen, Nielsen, Tina, Sahin, Deniz, Hiddemann, Wolfgang, Marcus, Robert E, and Davies, Andrew

Published
2018
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3. First-in-human phase 1/2a trial of CRLX101, a cyclodextrin-containing polymer-camptothecin nanopharmaceutical in patients with advanced solid tumor malignancies

Author

Weiss, Glen J., Chao, Joseph, Neidhart, Jeffrey D., Ramanathan, Ramesh K., Bassett, Dawn, Neidhart, James A., Choi, Chung Hang J., Chow, Warren, Chung, Vincent, Forman, Stephen J., Garmey, Edward, Hwang, Jungyeon, Kalinoski, D. Lynn, Koczywas, Marianna, Longmate, Jeffrey, Melton, Roger J., Morgan, Robert, Oliver, Jamie, Peterkin, Joanna J., Ryan, John L., Schluep, Thomas, Synold, Timothy W., Twardowski, Przemyslaw, Davis, Mark E., and Yen, Yun

Published
2013
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4. Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia

Author

Salama, Carlos, primary, Han, Jian, additional, Yau, Linda, additional, Reiss, William G., additional, Kramer, Benjamin, additional, Neidhart, Jeffrey D., additional, Criner, Gerard J., additional, Kaplan-Lewis, Emma, additional, Baden, Rachel, additional, Pandit, Lavannya, additional, Cameron, Miriam L., additional, Garcia-Diaz, Julia, additional, Chávez, Victoria, additional, Mekebeb-Reuter, Martha, additional, Lima de Menezes, Ferdinando, additional, Shah, Reena, additional, González-Lara, Maria F., additional, Assman, Beverly, additional, Freedman, Jamie, additional, and Mohan, Shalini V., additional

Published
2021
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5. Tocilizumab in nonventilated patients hospitalized with Covid-19 pneumonia

Author

Salama, Carlos, primary, Han, Jian, additional, Yau, Linda, additional, Reiss, William G., additional, Kramer, Benjamin, additional, Neidhart, Jeffrey D., additional, Criner, Gerard J., additional, Kaplan-Lewis, Emma, additional, Baden, Rachel, additional, Pandit, Lavannya, additional, Cameron, Miriam L., additional, Garcia-Diaz, Julia, additional, Chávez, Victoria, additional, Mekebeb-Reuter, Martha, additional, Menezes, Ferdinando Lima, additional, Shah, Reena, additional, González-Lara, Maria F., additional, Assman, Beverly, additional, Freedman, Jamie, additional, and Mohan, Shalini V., additional

Published
2020
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8. Prolonged survival after splenectomy in Wiskott-Aldrich syndrome: a case report

Author

Tsimpoukis Sotirios, Moutsos Michael, Neidhart Jeffrey, Makrilia Nektaria, Syrigos Kostas N, Kiagia Maria, and Saif Muhammad W

Subjects
Wiskott-Aldrich syndrome, thrombocytopenia, splenectomy, survival, treatment, Pediatrics, RJ1-570
Abstract

Abstract Wiskott-Aldrich syndrome is a rare X-linked immunodeficiency disorder that is characterized by a variable clinical phenotype. Matched donor bone marrow transplantation is currently the only curative therapeutic option. We present the case of a 24-year-old male who was diagnosed at the age of seven with Wiskott-Aldrich syndrome. He did not respond to intravenous gammaglobulin and he experienced recurrent pulmonary infections despite prophylactic antibiotics. The patient had no matched donor. At the age of nine, he was submitted to splenectomy and his platelet count was normalized. Fifteen years later, the patient remains asymptomatic with a normal platelet count. He is still receiving prophylactic antibiotics and no bleeding episodes or septic complications have been reported. This case demonstrates that splenectomy can represent a safe therapeutic option in selected WAS patients, provided that there is a tight follow-up program, patient education and adherence to guidelines regarding post-splenectomy prophylaxis.

Published
2011
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9. Obinutuzumab-Based Immunochemotherapy Prolongs Progression-Free Survival and Time to Next Anti-Lymphoma Treatment in Patients with Previously Untreated Follicular Lymphoma: Four-Year Results from the Phase III GALLIUM Study

Author

Townsend, William, primary, Buske, Christian, additional, Cartron, Guillaume, additional, Cunningham, David, additional, Dyer, Martin JS, additional, Gribben, John G., additional, Hess, Georg, additional, Ishikawa, Takayuki, additional, Keller, Ulrich, additional, Kneba, Michael, additional, Malladi, Ram, additional, Neidhart, Jeffrey D, additional, Rusconi, Chiara, additional, Zhu, Jun, additional, Catalani, Olivier, additional, Knapp, Andrea, additional, Zeuner, Harald, additional, Herold, Michael, additional, Hiddemann, Wolfgang, additional, and Marcus, Robert, additional

Published
2018
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10. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial

Author

Trotman, Judith, primary, Barrington, Sally F, additional, Belada, David, additional, Meignan, Michel, additional, MacEwan, Robert, additional, Owen, Carolyn, additional, Ptáčník, Václav, additional, Rosta, András, additional, Fingerle-Rowson, Günter R, additional, Zhu, Jiawen, additional, Nielsen, Tina, additional, Sahin, Deniz, additional, Hiddemann, Wolfgang, additional, Marcus, Robert E, additional, Davies, Andrew, additional, Hertzberg, Mark, additional, Grigg, Andrew, additional, Cannell, Paul, additional, Quach, Hang, additional, Opat, Stephen, additional, Tam, Constantine, additional, Marlton, Paula, additional, Janssens, Ann, additional, Offner, Fritz, additional, Van eygen, Koen, additional, Sangha, Randeep, additional, Mckay, Pam, additional, Wilson, Jonathan, additional, Van Der Jagt, Richard, additional, Roitman, Daryl, additional, Trneny, Marek, additional, Mayer, Jiri, additional, Le Du, Katell, additional, Solal-Celigny, Philippe, additional, Cartron, Guillaume, additional, Foussard, Charles, additional, Frickhofen, Norbert, additional, Schmidt, Peter, additional, Graeven, Ullrich, additional, Gaska, Tobias, additional, Schlag, Rudolf, additional, Sökler, Martin, additional, Prange-Krex, Gabriele, additional, Florschütz, Axel, additional, Lindemann, Hans-Walter, additional, Schimmelpfennig, Christoph, additional, Tonndorf, Solveig, additional, Hänel, Mathias, additional, Hess, Georg, additional, Schalk, Enrico, additional, Hütten, Heiko, additional, Doelken, Gottfried, additional, Pfreundschuh, Michael, additional, Keller, Ulrich, additional, Herold, Michael, additional, Forstpointner, Roswitha, additional, Vehling-Kaiser, Ursula, additional, Hoffmann, Martin, additional, Borbenyi, Zita, additional, Udvardy, Miklos, additional, Demeter, Judit, additional, Rambaldi, Alessandro, additional, Morra, Enrica, additional, Massimo, Federico, additional, Majolino, Ignazio, additional, Balzarotti, Monica, additional, Semenzato, Gianpietro, additional, Canales Albendea, Miguel Angel, additional, Peñalver Parraga, Francisco Javier, additional, Soler Campos, Alfonso, additional, Sancho Cia, Juan Manuel, additional, Marquez Navarro, Jose Antonio, additional, Grande Garcia, Carlos, additional, Nilsson-Ehle, Herman, additional, Mccarthy, Helen, additional, Pocock, Chris, additional, Sadullah, Shalal, additional, Malladi, Ram, additional, Radford, John, additional, Kanfer, Ed, additional, Kruger, Anton, additional, Culligan, Dominic, additional, Dyer, Martin, additional, Pettengell, Ruth, additional, Seymour, John, additional, Gribben, John, additional, Al-Ismail, Saad, additional, Al-Refaie, Faris, additional, Blesing, Norbert, additional, Macnamara, Christopher, additional, O'callaghan, Ann, additional, Haynes, Andrew, additional, Follows, George, additional, Johnson, Roderick, additional, Cunningham, David, additional, Bowles, Kristian, additional, Collins, Graham, additional, Gallop-Evans, Eve, additional, Robinson, Stephen, additional, Subash, Chezhian, additional, Bailey, James, additional, Holden, Viran, additional, Neidhart, Jeffrey, additional, De Oliveira, Moacyr, additional, Tezcan, Haluk, additional, Kim, Kevin, additional, Kambhampati, Suman, additional, Lanier, Keith, additional, Mcclean, John, additional, Tobinai, Kensei, additional, Hatake, Kiyohiko, additional, Ogura, Michinori, additional, Uchida, Toshiki, additional, Ando, Kiyoshi, additional, Kinoshita, Tomohiro, additional, Höhler, Thomas, additional, Stauder, Heribert, additional, Kirsch, Andreas, additional, Koenigsmann, Michael, additional, Kremers, Stephan, additional, Illmer, Thomas, additional, Witzens-Harig, Mathias, additional, La Roseé, Paul, additional, Dürig, Jan, additional, Kneba, Michael, additional, Hensel, Manfred, additional, Fuxius, Stefan, additional, Bergmann, Lothar, additional, Hübel, Kai, additional, Buske, Christian, additional, Marks, Reinhard, additional, Wulf, Gerald, additional, Lerchenmueller, Christian, additional, Schmits, Rudolf, additional, Reinwald, Mark, additional, Lengfelder, Eva, additional, Scott, Fiona, additional, Chou, Takaaki, additional, Taniwaki, Masafumi, additional, Yoshida, Isao, additional, Ishizawa, Kenichi, additional, Uike, Naokuni, additional, Uoshima, Nobuhiko, additional, Kamitsuji, Yuri, additional, Iida, Shinsuke, additional, Ohmine, Ken, additional, Nosaka, Kisato, additional, Ide, Kazuhiko, additional, Ishikawa, Takayuki, additional, Desjardins, Pierre, additional, Finn, Nicholas, additional, Zhu, Jun, additional, Li, Wei, additional, Yu, Li, additional, Ren, Hanyun, additional, Shi, Yuan Kai, additional, Wu, Gang, additional, Hong, Xiaonan, additional, Zhang, Qingyuan, additional, Feng, Jifeng, additional, Zhan, Rong, additional, Lin, Tongyu, additional, Leppa, Sirpa, additional, Costello, Regis, additional, Tempescul, Adrian, additional, Sanhes, Laurence, additional, Tournilhac, Olivier, additional, Kirchen, Heinz, additional, Hebart, Holger, additional, Weide, Rudolf, additional, Jentsch-Ullrich, Kathleen, additional, Avivi, Irit, additional, Nagler, Arnon, additional, Gurion, Ronit, additional, Shpilberg, Ofer, additional, Leoni, Pietro, additional, Baldini, Luca, additional, Samoylova, Olga, additional, Myasnikov, Alexandr, additional, Tan, Tran-Der, additional, Chang, Hung, additional, Kumagai, Kyoya, additional, Tsukamoto, Norifumi, additional, Tsukasaki, Kunihiro, additional, Beatty, Patrick, additional, Usui, Noriko, additional, Izutsu, Koji, additional, Murayama, Tohru, additional, Ichinohe, Tatsuo, additional, Kubo, Kohmei, additional, Ishida, Fumihiro, additional, Beck, J. Thaddeus, additional, Griesinger, Frank, additional, Osmanov, Dzhelil, additional, Dakhil, Shaker, additional, Clavert, Aline, additional, Maruyama, Dai, additional, Terui, Yasuhito, additional, Yamamoto, Kazuhito, additional, Eigendorff, Ekkehard, additional, Kobayashi, Tsutomu, additional, Ichikawa, Satoshi, additional, Choi, Ilseung, additional, Wada, Katsuya, additional, Kikukawa, Yoshitaka, additional, Matsuoka, Masao, additional, Yoshino, Takayuki, additional, and Minami, Yosuke, additional

Published
2018
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11. Efficacy and safety of pomalidomide as a replacement therapy for lenalidomide for relapsed/refractory multiple myeloma patients refractory to a lenalidomide-containing combination regimen.

Author

Berenson, James R., primary, Cohen, Alexa, additional, Spektor, Tanya M., additional, Lashkari, Ashkan, additional, Mackintosh, Roy, additional, Bessudo, Alberto, additional, Robinson, Michael Oren, additional, Jhangiani, Haresh S., additional, Gabrail, Nashat Y., additional, Nakhoul, Ibrahim, additional, Kubba, Samir V., additional, Neidhart, Jeffrey D., additional, Maluso, Tina, additional, Swift, Regina A., additional, and Vescio, Robert A., additional

Published
2018
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12. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer

Author

Mirza, Mansoor R, Monk, Bradley J, Herrstedt, Jørn, Oza, Amit M, Mahner, Sven, Redondo, Andrés, Fabbro, Michel, Ledermann, Jonathan A, Lorusso, Domenica, Vergote, Ignace, Ben-Baruch, Noa E, Marth, Christian, Madry, Radoslaw, Christensen, René D, Berek, Jonathan S, Dørum, Anne, Tinker, Anna V, du Bois, Andreas, González-Martín, Antonio, Follana, Philippe, Benigno, Benedict, Rosenberg, Per, Gilbert, Lucy, Rimel, Bobbie J, Buscema, Joseph, Balser, John P, Agarwal, Shefali, Matulonis, Ursula A, Lund, Bente, Malander, Susanne, Woie, Kathrine, Hellman, Kristina, Nøttrup, Trine Juhler, Havsteen, Hanne, Sehouli, Jalid, Harter, Philipp, Canzler, Ulrich, Lück, Hans-Joachim, Wölber, Linn, Marmé, Frederik, Meier, Werner, Heubner, Martin, Hilpert, Felix, Emons, Günter, Burges, Alexander, Bover Barcelo, Isabel Maria, Gil Martín, Marta, Palacio Vázquez, Isabel, Casado Herráez, Antonio, Maria del Campo, José, Lesoin, Anne, Berton-Rigaud, Dominique, N'Guyen, Thierry, Hardy-Bessard, Anne-Claire, Banerjee, Susana, Lord, Rosemary, Waters, Justin, Montes, Ana, Chan, Stephen, Williams, Sarah J, Barlow, Claire, Mullard, Anna, Colombo, Nicoletta, Scambia, Giovanni, Tognon, Germana, Scollo, Paolo, Kridelka, Frédéric, Leroy, Chantal, Debruyne, Philip, Huizing, Manon, Rosengarten, Ora, Levy, Talia, Frommer, Ronnie Shapira, Fishman, Ami, Edelman, David, Safra, Tamar, Amit, Amnon, Pikiel, Joanna, Suzin, Jacek, Mackowiak-Matejczyk, Beata, Reinthaller, Alexander, Petru, Edgar, Csoszi, Tibor, Bessette, Paul, Provencher, Diane, Lau, Susie, Ellard, Susan, Ghatage, Prafull, Moore, Kathleen, Wenham, Robert, Pineda, Mario, Azodi, Masoud, Mantia-Smaldone, Gina, Cloven, Noelle, Bailey, Cheryl, Lee, Christine, Secord, Angeles, Patel, Manish, Method, Michael, Callahan, Michael, Veena, John, Chan, John, Zarwan, Corrine, DiSilvestro, Paul, Teneriello, Michael, Gupta, Divya, Geller, Melissa, Burris, Howard, Slomovitz, Brian, Hendrickson, Andrea Wahner, McCormick, Colleen, Hanjani, Parviz, Blank, Stephanie, Haluska, Paul, Matei, Daniela, Vasilev, Stephen, Neidhart, Jeffrey, Boente, Matthew, Tchabo, Nana, Miller, David, and Targeted Gynaecologic Oncology (TARGON)

Subjects
0301 basic medicine, Oncology, Medizin, Genes, BRCA1, Platinum Compounds, POLY(ADP-RIBOSE) POLYMERASE, Kaplan-Meier Estimate, 030226 pharmacology & pharmacy, chemistry.chemical_compound, 0302 clinical medicine, Piperidines, Maintenance therapy, Bone Marrow, Medicine, Merck Sharp & Dohme, Homologous Recombination, Indazoles/adverse effects, Ovarian Neoplasms, Aged, 80 and over, Platinum compounds, OLAPARIB, Ovarian Neoplasms/drug therapy, Obstetrics and Gynecology, Bone Marrow/drug effects, General Medicine, Middle Aged, SOLID TUMORS, BRCA MUTATION CARRIERS, 030220 oncology & carcinogenesis, TRIAL, Female, Platinum sensitive, Adult, Piperidines/adverse effects, medicine.medical_specialty, Indazoles, Adolescent, Antineoplastic Agents, Disease-Free Survival, Olaparib, Maintenance Chemotherapy, Young Adult, 03 medical and health sciences, Platinum Compounds/therapeutic use, Double-Blind Method, Internal medicine, Humans, Rucaparib, Germ-Line Mutation, Aged, Neoplasm Staging, Cancer och onkologi, business.industry, Antineoplastic Agents/adverse effects, NEGATIVE BREAST-CANCER, 030104 developmental biology, chemistry, Recurrent Ovarian Cancer, Cancer and Oncology, Johnson Johnson, business
Abstract

BACKGROUND Niraparib is an oral poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) 1/2 inhibitor that has shown clinical activity in patients with ovarian cancer. We sought to evaluate the efficacy of niraparib versus placebo as maintenance treatment for patients with platinum-sensitive, recurrent ovarian cancer. METHODS In this randomized, double-blind, phase 3 trial, patients were categorized according to the presence or absence of a germline BRCA mutation (gBRCA cohort and non-gBRCA cohort) and the type of non-gBRCA mutation and were randomly assigned in a 2: 1 ratio to receive niraparib (300 mg) or placebo once daily. The primary end point was progression-free survival. RESULTS Of 553 enrolled patients, 203 were in the gBRCA cohort (with 138 assigned to niraparib and 65 to placebo), and 350 patients were in the non-gBRCA cohort (with 234 assigned to niraparib and 116 to placebo). Patients in the niraparib group had a significantly longer median duration of progression-free survival than did those in the placebo group, including 21.0 vs. 5.5 months in the gBRCA cohort (hazard ratio, 0.27; 95% confidence interval [CI], 0.17 to 0.41), as compared with 12.9 months vs. 3.8 months in the non-gBRCA cohort for patients who had tumors with homologous recombination deficiency (HRD) (hazard ratio, 0.38; 95% CI, 0.24 to 0.59) and 9.3 months vs. 3.9 months in the overall non-gBRCA cohort (hazard ratio, 0.45; 95% CI, 0.34 to 0.61; P amp;lt; 0.001 for all three comparisons). The most common grade 3 or 4 adverse events that were reported in the niraparib group were thrombocytopenia (in 33.8%), anemia (in 25.3%), and neutropenia (in 19.6%), which were managed with dose modifications. CONCLUSIONS Among patients with platinum-sensitive, recurrent ovarian cancer, the median duration of progression-free survival was significantly longer among those receiving niraparib than among those receiving placebo, regardless of the presence or absence of gBRCA mutations or HRD status, with moderate bone marrow toxicity. (Funded by Tesaro; ClinicalTrials.gov number, NCT01847274.) Funding Agencies|Tesaro; Amgen; Genentech; Roche; AstraZeneca; Myriad Genetics; Merck; Gradalis; Cerulean; Vermillion; ImmunoGen; Pfizer; Bayer; Nu-Cana BioMed; INSYS Therapeutics; GlaxoSmithKline; Verastem; Mateon Therapeutics; Pharmaceutical Product Development; Clovis Oncology; Janssen/Johnson Johnson; Eli Lilly; Merck Sharp Dohme

Published
2016
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13. B-F1RST: Assessment of novel blood-based biomarkers in patients with first-line advanced or metastatic NSCLC receiving atezolizumab monotherapy.

Author

Kim, Edward S., primary, Socinski, Mark A., additional, Dakhil, Shaker R., additional, Mackler, Niklas J., additional, Ikhlaque, Nadeem, additional, Mekhail, Tarek, additional, Volterra, Fabio, additional, El Khoury, Christian Antoine, additional, Schiller, Joan H., additional, Tsai, Michaela L., additional, Hayek, Fadi, additional, Neidhart, Jeffrey D., additional, Hunis, Brian, additional, Hu, Sylvia, additional, Paul, Sarah M., additional, Shames, David S., additional, Phan, See-Chun, additional, Yun, Cindy, additional, and Velcheti, Vamsidhar, additional

Published
2017
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14. Analysis of efficacy and safety of POM as a replacement therapy for lenalidomide for relapsed/refractory multiple myeloma pts refractory to a lenalidomide-containing combination regimen.

Author

Berenson, James R., primary, Cohen, Alexa, additional, Spektor, Tanya M., additional, Lashkari, Ashkan, additional, Mackintosh, Roy, additional, Bessudo, Alberto, additional, Robinson, Michael Oren, additional, Jhangiani, Haresh S., additional, Gabrail, Nashat Y., additional, Nakhoul, Ibrahim, additional, Kubba, Samir V., additional, Neidhart, Jeffrey D., additional, Maluso, Tina, additional, Swift, Regina A., additional, Vescio, Robert A., additional, and Eshaghian, Shahrooz, additional

Published
2017
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15. A randomized Phase II trial of the tumor vascular disrupting agent CA4P (fosbretabulin tromethamine) with carboplatin, paclitaxel, and bevacizumab in advanced nonsquamous non-small-cell lung cancer

Author

Garon,Edward B, Neidhart,Jeffrey D, Gabrail,Nashat Y, de Oliveira,Moacyr R, Balkissoon,Jai, Kabbinavar,Fairooz, Garon,Edward B, Neidhart,Jeffrey D, Gabrail,Nashat Y, de Oliveira,Moacyr R, Balkissoon,Jai, and Kabbinavar,Fairooz

Abstract

Edward B Garon,1,2 Jeffrey D Neidhart,3 Nashat Y Gabrail,4 Moacyr R de Oliveira,5 Jai Balkissoon,6 Fairooz Kabbinavar1,2 1Department of Medicine, 2Department of Hematology and Oncology, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, 3San Juan Oncology Associates, Farmington, NM, 4Gabrail Cancer Center, Canton, OH, 5Northwest Medical Specialties, Tacoma, WA, 6Global Product Development and Immuno-Oncology, PPD, Wilmington, NC, USA Introduction: Combretastatin A4-phosphate, fosbretabulin tromethamine (CA4P) is a vascular disrupting agent that targets tumor vasculature. This study evaluated the safety of CA4P when combined with carboplatin, paclitaxel, and bevacizumab in chemotherapy-naïve subjects with advanced nonsquamous, non-small-cell lung cancer. Methods: Adult subjects with confirmed American Joint Committee on Cancer six stage IIIB/IV non-small-cell lung cancer and an Eastern Cooperative Oncology Group performance score of 0 or 1 were randomized to receive six cycles (treatment phase) of paclitaxel (200 mg/m2), carboplatin (area under the concentration versus time curve 6), and bevacizumab (15 mg/kg) on day 1 and repeated every 21 days, or this regimen plus CA4P (60 mg/m2) on days 7, 14, and 21 of each cycle. Subjects could then receive additional maintenance treatment (excluding carboplatin and paclitaxel) for up to 1 year. Results: Sixty-three subjects were randomized, 31 to control and 32 to CA4P, and 19 (61.3%) and 17 (53.1%), respectively, completed the treatment phase. Exposure to study treatment and dose modifications were comparable between the randomized groups. The overall incidence of treatment-emergent adverse events was similar between groups, with increased neutropenia, leukopenia, and hypertension in the CA4P group. Deaths, serious adverse events, and early discontinuations from treatment were comparable between the randomized treatment groups. The overall tumor response rate with CA4P was 50% v

Published
2016

17. Prolonged survival after splenectomy in Wiskott-Aldrich syndrome: a case report

Author

Syrigos, Kostas N. Makrilia, Nektaria Neidhart, Jeffrey and Moutsos, Michael Tsimpoukis, Sotirios Kiagia, Maria Saif, Muhammad W.

Subjects
hemic and lymphatic diseases
Abstract

Wiskott-Aldrich syndrome is a rare X-linked immunodeficiency disorder that is characterized by a variable clinical phenotype. Matched donor bone marrow transplantation is currently the only curative therapeutic option. We present the case of a 24-year-old male who was diagnosed at the age of seven with Wiskott-Aldrich syndrome. He did not respond to intravenous gammaglobulin and he experienced recurrent pulmonary infections despite prophylactic antibiotics. The patient had no matched donor. At the age of nine, he was submitted to splenectomy and his platelet count was normalized. Fifteen years later, the patient remains asymptomatic with a normal platelet count. He is still receiving prophylactic antibiotics and no bleeding episodes or septic complications have been reported. This case demonstrates that splenectomy can represent a safe therapeutic option in selected WAS patients, provided that there is a tight follow-up program, patient education and adherence to guidelines regarding post-splenectomy prophylaxis.

Published
2011

19. Abstract A97: Final phase 1/2a results evaluating the cyclodextrin-containing nanoparticle CRLX101 in patients with advanced solid tumor malignancies.

Author

Yen, Yun, primary, Coerver, Lori A., additional, Garmey, Edward G., additional, Kalinoski, D. Lynn, additional, Koczywas, Marianna, additional, Neidhart, James A., additional, Neidhart, Jeffrey D., additional, Peterkin, Joanna J., additional, Ramanathan, Ramesh K., additional, Ryan, John, additional, and Weiss, Glen J., additional

Published
2011
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