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Your search keyword '"Parmar, Mahesh K.B."' showing total 144 results
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144 results on '"Parmar, Mahesh K.B."'

1. Early trajectories of virological and immunological biomarkers and clinical outcomes in patients admitted to hospital for COVID-19: an international, prospective cohort study

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Sahner, David, Tierney, John, Vogel, Susan E., Herpin, Betsey R., Smolskis, Mary C., McKay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Raim, Sharon Segal, Hensely, Lisa, Lorenzo, Johsua, Mock, Rebecca, Zuckerman, Judith, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Kang, Nayon, Barrett, Kevin, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Currier, Judy, Hughes, Eric, Harrigan, Rachel H., Amos, Laura, Carlsen, Amy, Carter, Anita, Collins, Gary, Davis, Bionca, Denning, Eileen, DuChene, Alain, Eckroth, Kate, Engen, Nicole, Frase, Alex, Gandits, Greg, Grund, Birgit, Harrison, Merrie, Hurlbut, Nancy, Kaiser, Payton, Koopmeiners, Joseph, Larson, Gregg, Meger, Sue, Mistry, Shweta Sharma, Murray, Thomas, Nelson, Ray, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Siegel, Lianne, Thompson, Greg, Vock, David, Walski, Jamie, Gelijns, Annetine C., Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Burris, Sarah, Bedoya, Gabriela, Gupta, Lola, Overbey, Jessica R., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Sandkovsky, Uriel, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samatha, Wang, Samatha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacious, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Smith, Peter K., Barkauskas, Christina E., Vekstein, Andrew M., Ko, Emily R., Dreyer, Grace R., Stafford, Neil, Brooks, Megan, Der, Tatyana, Witte, Marie, Gamarallage, Ruwan, Franzone, John, Ivey, Noel, Lumsden, Rebecca H., Mosaly, Nilima, Mourad, Ahmaad, Holland, Thomas L., Motta, Mary, Lane, Kathleen, McGowan, Lauren M., Stout, Jennifer, Aloor, Heather, Bragg, Kennesha M., Toledo, Barvina, McLendon-Arvik, Beth, Bussadori, Barbara, Hollister, Beth A., Griffin, Michelle, Giangiacomo, Dana M., Rodriguez, Vicente, Bokhart, Gordon, Eichman, Sharon M., Parrino, Patrick E., Spindel, Stephen, Bansal, Aditya, Baumgarten, Katherine, Hand, Johnathan, Vonderhaar, Derek, Nossaman, Bobby, Sylvia Laudun, Ames, DeAnna, Broussard, Shane, Hernandez, Nilmo, Isaac, Geralyn, Dinh, Huan, Zheng, Yiling, Tran, Sonny, McDaniel, Hunter, Crovetto, Nicolle, Perin, Emerson, Costello, Briana, Manian, Prasad, Sohail, M. Rizwan, Postalian, Alexander, Hinsu, Punit, Watson, Carolyn, Chen, James, Fink, Melyssa, Sturgis, Lydia, Walker, Kim, Mahon, Kim, Parenti, Jennifer, Kappenman, Casey, Knight, Aryn, Sturek, Jeffrey M., Barros, Andrew, Enfield, Kyle B., Kadl, Alexandra, Green, China J., Simon, Rachel M., Fox, Ashley, Thornton, Kara, Adams, Amy, Badhwar, Vinay, Sharma, Sunil, Peppers, Briana, McCarthy, Paul, Krupica, Troy, Sarwari, Arif, Reece, Rebecca, Fornaresico, Lisa, Glaze, Chad, Evans, Raquel, Di, Fang, Carlson, Shawn, Aucremanne, Tanja, Tennant, Connie, Sutton, Lisa Giblin, Buterbaugh, Sabrina, Williams, Roger, Bunner, Robin, Traverse, Jay H., Rhame, Frank, Huelster, Joshua, Kethireddy, Rajesh, Davies, Irena, Salamanca, Julianne, Majeski, Christine, Skelton, Paige, Zarambo, Maria, Sarafolean, Andrea, Bowdish, Michael E., Borok, Zea, Wald-Dickler, Noah, Hutcheon, Douglass, Towfighi, Amytis, Lee, Mary, Lewis, Meghan R., Spellberg, Brad, Sher, Linda, Sharma, Aniket, Olds, Anna P., Justino, Chris, Loxano, Edward, Romero, Chris, Leong, Janet, Rodina, Valentina, Quesada, Christine, Hamilton, Luke, Escobar, Jose, Leshnower, Brad, Bender, William, Sharifpour, Milad, Miller, Jeffrey, Farrington, Woodrow, Baio, Kim T., McBride, Mary, Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Maton, Missy, Ponder, Chari, Haley, Elisabeth, Spainhour, Christine, Rogers, Susan, Tyler, Derrick, Madathil, Ronson J., Rabin, Joseph, Levine, Andrea, Saharia, Kapil, Tabatabai, Ali, Lau, Christine, Gammie, James S., Peguero, Maya-Loren, McKernan, Kimberly, Audette, Mathew, Fleischmann, Emily, Akbari, Kreshta, Lee, Myounghee, Chi, Andrew, Salehi, Hanna, Pariser, Alan, Nyguyen, Phuong Tran, Moore, Jessica, Gee, Adrienne, Vincent, Shelika, Zuckerman, Richard A., Iribarne, Alexander, Metzler, Sara, Shipman, Samantha, Johnson, Haley, Newton, Crystallee, Parr, Doug, Miller, Leslie, Schelle, Beth, McLean, Sherry, Rothbaum, Howard R., Alvarez, Michael S., Kalan, Shivam P., Germann, Heather H., Hendershot, Jennifer, Moroney, Karen, Herring, Karen, Cook, Sharri, Paul, Pam, Walker-Ignasiak, Rebecca, North, Crystal, Oldmixon, Cathryn, Ringwood, Nancy, Muzikansky, Ariela, Morse, Richard, Fitzgerald, Laura, Morin, Haley D., Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Steingrub, Jay H., Hou, Peter K., Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, DeSouza, Leslie, Romain, Sarah, Thornton-Thompson, Sherell, Talmor, Daniel, Shapiro, Nathan, Andromidas, Konstantinos, Banner-Goodspeed, Valerie, Bolstad, Michael, Boyle, Katherine L., Cabrera, Payton, deVilla, Arnaldo, Ellis, Joshua C., Grafals, Ana, Hayes, Sharon, Higgins, Conor, Kurt, Lisa, Kurtzman, Nicholas, Redman, Kimberly, Rosseto, Elinita, Scaffidi, Douglas, Filbin, Michael R., Hibbert, Kathryn A., Parry, Blair, Margolin, Justin, Hillis, Brooklynn, Hamer, Rhonda, Brait, Kelsey, Beakes, Caroline, McKaig, Brenna, Kugener, Eleonore, Jones, Alan E., Galbraith, James, Nandi, Utsav, Peacock, Rebekah, Hendey, Gregory, Kangelaris, Kirsten, Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Yee, Kimberley J., Jauregui, Alejandra E., Zhuo, Hanjing, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley A., Hughes, Alyssa R., Garcia, Rebekah L., Lim, George W., Chang, Steven Y., Lin, Michael Y., Vargas, Julia, Sihota, Hena, Beutler, Rebecca, Agarwal, Trisha, Wilson, Jennifer G., Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan H., Roque, Jonasel, Wang, Henry, Huebinger, Ryan M., Patel, Bela, Vidales, Elizabeth, Albertson, Timothy, Hardy, Erin, Harper, Richart, Moss, Marc A., Baduashvili, Amiran, Chauhan, Lakshmi, Douin, David J., Martinez, Flora, Finck, Lani L., Bastman, Jill, Howell, Michelle, Higgins, Carrie, McKeehan, Jeffrey, Finigan, Jay, Stubenrauch, Peter, Janssen, William J., Griesmer, Christine, VerBurg, Olivia, Hyzy, Robert C., Park, Pauline K., Nelson, Kristine, McSparron, Jake I., Co, Ivan N., Wang, Bonnie R., Jimenez, Jose, Olbrich, Norman, McDonough, Kelli, Jia, Shijing, Hanna, Sinan, Gong, Michelle N., Richardson, Lynne D., Nair, Rahul, Lopez, Brenda, Amosu, Omowunmi, Offor, Obiageli, Tzehaie, Hiwet, Nkemdirim, William, Boujid, Sabah, Mosier, Jarrod M., Hypes, Cameron, Campbell, Elizabeth Salvagio, Bixby, Billie, Gilson, Boris, Lopez, Anitza, Bime, Christian, Parthasarathy, Sairam, Cano, Ariana M., Hite, R. Duncan, Terndrup, Thomas E., Wiedemann, Herbert P., Hudock, Kristin, Tanzeem, Hammad, More, Harshada, Martinkovic, Jamie, Sellers, Susan, Houston, Judy, Burns, Mary, Kiran, Simra, Roads, Tammy, Kennedy, Sarah, Duggal, Abhijit, Thiruchelvam, Nirosshan, Ashok, Kiran, King, Alexander H., Mehkri, Omar, Dugar, Siddharth, Sahoo, Debasis, Yealy, Donald M., Angus, Derek C., Weissman, Alexandra J., Vita, Tina M., Berryman, Emily, Hough, Catherine L., Khan, Akram, Krol, Olivia F., Mills, Emmanuel, Kinjal, Mistry, Briceno, Genesis, Reddy, Raju, Hubel, Kinsley, Jouzestani, Milad K., McDougal, Madeline, Deshmukh, Rupali, Johnston, Nicholas J., Robinson, Bryce H., Gundel, Staphanie J., Katsandres, Sarah C., Chen, Peter, Torbati, Sam S., Parimon, Tanyalak, Caudill, Antonina, Mattison, Brittany, Jackman, Susan E., Chen, Po-En, Bayoumi, Emad, Ojukwu, Cristabelle, Fine, Devin, Weissberg, Gwendolyn, Isip, Katherine, Choi-Kuaea, Yunhee, Mehdikhani, Shaunt, Dar, Tahir B., Fleury Augustin, Nsole Biteghe, Tran, Dana, Dukov, Jennifer Emilow, Matusov, Yuri, Choe, June, Hindoyan, Niree A., Wynter, Timothy, Pascual, Ethan, Clapham, Gregg J., Herrera, Lisa, Caudill, Antonia, O’Mahony, D. Shane, Nyatsatsang, Sonam T., Wilson, David M., Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Miller, Chadwick, Files, D. Clark, Gibbs, Kevin W., Flores, Lori S., LaRose, Mary E., Landreth, Leigha D., Palacios, D. Rafael, Parks, Lisa, Hicks, Madeline, Goodwin, Andrew J., Kilb, Edward F., Lematty, Caitlan T., Patti, Kerilyn, Grady, Abigail, Rasberry, April, Morris, Peter E., Sturgill, Jamie L., Cassity, Evan P., Dhar, Sanjay, Montgomery-Yates, Ashley A., Pasha, Sarah N., Mayer, Kirby P., Pharm.D., Brittany Bissel, Trott, Terren, Rehman, Shahnaz, de Wit, Marjolein, Mason, Jessica, Bledsoe, Joseph, Knowlton, Kirk U., Brown, Samuel, Lanspa, Michael, Leither, Lindsey, Pelton, Ithan, Armbruster, Brent P., Montgomery, Quinn, Kumar, Naresh, Fergus, Melissa, Imel, Karah, Palmer, Ghazal, Webb, Brandon, Klippel, Carolyn, Jensen, Hannah, Duckworth, Sarah, Gray, Andrew, Burke, Tyler, Knox, Dan, Lumpkin, Jenna, Aston, Valerie T., Applegate, Darrin, Serezlic, Erna, Brown, Katie, Merril, Mardee, Harris, Estelle S., Middleton, Elizabeth A., Barrios, Macy A.G., Greer, Jorden, Schmidt, Amber D., Webb, Melissa K., Paine, Roert, Callahan, Sean J., Waddoups, Lindsey J., Yamane, Misty B., Self, Wesley H., Rice, Todd W., Casey, Jonathan D., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Menon, Vidya, Kasubhai, Moiz, Pillai, Anjana, Daniel, Jean, Sittler, Daniel, Kanna, Balavenkatesh, Jilani, Nargis, Amaro, Francisco, Santana, Jessica, Lyakovestsky, Aleksandr, Madhoun, Issa, Desroches, Louis Marie, Amadon, Nicole, Bahr, Alaa, Ezzat, Imaan, Guerrero, Maryanne, Padilla, Joane, Fullmer, Jessie, Singh, Inderpreet, Ali Shah, Syed Hamad, Narang, Rajeev, Mock, Polly, Shadle, Melissa, Hernandez, Brenda, Welch, Kevin, Payne, Andrea, Ertl, Gabriela, Canario, Daniel, Barrientos, Isabel, Goss, Danielle, DeVries, Mattie, Folowosele, Ibidolapo, Garner, Dorothy, Gomez, Mariana, Price, Justin, Bansal, Ekta, Wong, Jim, Faulhaber, Jason, Fazili, Tasaduq, Yeary, Brian, Ndolo, Ruth, Bryant, Christina, Smigeil, Bridgette, Robinson, Philip, Najjar, Rana, Jones, Patrice, Nguyen, Julie, Chin, Christina, Taha, Hassan, Najm, Salah, Smith, Christopher, Moore, Jason, Nassar, Talal, Gallinger, Nick, Christian, Amy, Mauer, D’Amber, Phipps, Ashley, Waters, Michael, Zepeda, Karla, Coslet, Jordan, Landazuri, Rosalynn, Pineda, Jacob, Uribe, Nicole, Garcia, Jose Ruiz, Barbabosa, Cecilia, Sandler, Kaitlyn, Overcash, J. Scott, Marquez, Adrienna, Chu, Hanh, Lee, Kia, Quillin, Kimberly, Garcia, Andrea, Lew, Pauline, Rogers, Ralph, Shehadeh, Fadi, Mylona, Evangelia K., Kaczynski, Matthew, Tran, Quynh-Lam, Benitez, Gregorio, Mishra, Biswajit, Felix, Lewis Oscar, Vafea, Maria Tsikala, Atalla, Eleftheria, Davies, Robin, Hedili, Salma, Monkeberg, Maria Andrea, Tabler, Sandra, Harrington, Britt, Meegada, Sreenath, Koripalli, Venkata Sandeep, Muddana, Prithvi, Jain, Lakshay, Undavalli, Chaitanya, Kavya, Parasa, Ibiwoye, Mofoluwaso, Akilo, Hameed, Lovette, Bryce D., Wylie, Jamie-Crystal, Smith, Diana M., Poon, Kenneth, Eckardt, Paula, Heysu, Rubio-Gomez, Sundararaman, Nithya, Alaby, Doris, Sareli, Candice, Sánchez, Adriana, Popielski, Laura, Kambo, Amy, Viens, Kimberley, Turner, Melissa, Vjecha, Michael J., Weintrob, Amy, Brar, Indira, Markowitz, Norman, Pastor, Erika, Corpuz, Roweena, Alangaden, George, McKinnon, John, Ramesh, Mayur, Herc, Erica, Yared, Nicholas, Lanfranco, Odaliz Abreu, Rivers, Emanuel, Swiderek, Jennifer, Gupta, Ariella Hodari, Pabla, Pardeep, Eliya, Sonia, Jazrawi, Jehan, Delor, Jeremy, Desai, Mona, Cook, Aaron, Jaehne, Anja Kathrina, Gill, Jasreen Kaur, Renaud, Sheri, Sarveswaran, Siva, Gardner, Edward, Scott, James, Bianchini, Monica, Melvin, Casey, Kim, Gina, Wyles, David, Kamis, Kevin, Miller, Rachel, Douglas, Ivor, Haukoos, Jason, Hicks, Carrie, Lazarte, Susana, Marines-Price, Rubria, Osuji, Alice, Agbor Agbor, Barbine Tchamba, Petersen, Tianna, Kamel, Dena, Hansen, Laura, Garcia, Angie, Cha, Christine, Mozaffari, Azadeh, Hernandez, Rosa, Cutrell, James, Kim, Mina, DellaValle, Natalie, Gonzales, Sonia, Somboonwit, Charurut, Oxner, Asa, Guerra, Lucy, Hayes, Michael, Nguyen, Thi, Tran, Thanh, Pinto, Avenette, Hatlen, Timothy, Anderson, Betty, Zepeda-Gutierrez, Ana, Martin, Dannae, Temblador, Cindi, Cuenca, Avon, Tanoviceanu, Roxanne, Prieto, Martha, Guerrero, Mario, Daar, Eric, Correa, Ramiro, Hartnell, Gabe, Wortmann, Glenn, Doshi, Saumil, Moriarty, Theresa, Gonzales, Melissa, Garman, Kristin, Baker, Jason V., Frosch, Anne, Goldsmith, Rachael, Driver, Brian, Frank, Christine, Leviton, Tzivia, Prekker, Matthew, Jibrell, Hodan, Lo, Melanie, Klaphake, Jonathan, Mackedanz, Shari, Ngo, Linh, Garcia-Myers, Kelly, Kunisaki, Ken M., Wendt, Chris, Melzer, Anne, Wetherbee, Erin, Drekonja, Dimitri, Pragman, Alexa, Hamel, Aimee, Thielen, Abbie, Hassler, Miranda, Walquist, Mary, Augenbraun, Michael, George, Jensen, Demeo, Lynette, Mishko, Motria, Thomas, Lorraine, Tatem, Luis, Dehovitz, Jack, Abassi, Mahsa, Leuck, Anne-Marie, Rao, Via, Pullen, Matthew, Luke, Darlette, LaBar, Derek, Christiansen, Theresa, Howard, Diondra, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Davis-Karim, Anne, Pittman, David, Vasudeva, Shikha S., Johnstone, Jaylynn R., Agnetti, Kate, Davis, Ruby, Trautner, Barbara, Hines-Munson, Casey, Van, John, Dillon, Laura, Wang, Yiqun, Nagy-Agren, Stephanie, Vasudeva, Shikha, Ochalek, Tracy, Caldwell, Erin, Humerickhouse, Edward, Boone, David, McGraw, William, Looney, David J., Mehta, Sanjay R., Johns, Scott Thompson, St. John, Melissa, Raceles, Jacqueline, Sear, Emily, Funk, Stephen, Cesarini, Rosa, Fang, Michelle, Nicalo, Keith, Drake, Wonder, Jones, Beatrice, Holtman, Teresa, Nguyen, Hien H., Maniar, Archana, Johnson, Eric A., Nguyen, Lam, Tran, Michelle T., Barrett, Thomas W., Johnston, Tera, Huggins, John T., Beiko, Tatsiana Y., Hughes, Heather Y., McManigle, William C., Tanner, Nichole T., Washburn, Ronald G., Ardelt, Magdalena, Tuohy, Patricia A., Mixson, Jennifer L., Hinton, Charles G., Thornley, Nicola, Allen, Heather, Elam, Shannon, Boatman, Barry, Baber, Brittany J., Ryant, Rudell, Roller, Brentin, Nguyen, Chinh, Mikail, Amani Morgan, Research, Marivic Hansen, Lichtenberger, Paola, Baracco, Gio, Ramos, Carol, Bjork, Lauren, Sueiro, Melyssa, Tien, Phyllis, Freasier, Heather, Buck, Theresa, Nekach, Hafida, Holodniy, Mark, Chary, Aarthi, Lu, Kan, Peters, Theresa, Lopez, Jessica, Tan, Susanna Yu, Lee, Robert H., Asghar, Aliya, Karyn Isip, Tasadduq Karim, Le, Katherine, Nguyen, Thao, Wong, Shinn, Raben, Dorthe, Murray, Daniel D., Jensen, Tomas O., Peters, Lars, Aagaard, Bitten, Nielsen, Charlotte B., Krapp, Katharina, Nykjær, Bente Rosdahl, Olsson, Christina, Kanne, Katja Lisa, Grevsen, Anne Louise, Joensen, Zillah Maria, Bruun, Tina, Bojesen, Ane, Woldbye, Frederik, Normand, Nick E., Esman, Frederik V.L., Benfield, Thomas, Clausen, Clara Lundetoft, Hovmand, Nichlas, Israelsen, Simone Bastrup, Iversen, Katrine, Leding, Caecilie, Pedersen, Karen Brorup, Thorlacius-Ussing, Louise, Tinggaard, Michaela, Tingsgard, Sandra, Krohn-Dehli, Louise, Pedersen, Dorthe, Villadsen, Signe, Staehr Jensen, Jens-Ulrik, Overgaard, Rikke, Rastoder, Ema, Heerfordt, Christian, Hedsund, Caroline, Ronn, Christian Phillip, Kamstrup, Peter Thobias, Hogsberg, Dorthe Sandbaek, Bergsoe, Christina, Søborg, Christian, Hissabu, Nuria M.S., Arp, Bodil C., Ostergaard, Lars, Staerke, Nina Breinholt, Yehdego, Yordanos, Sondergaard, Ane, Johansen, Isik S., Pedersen, Andreas Arnholdt, Knudtzen, Fredrikke C., Larsen, Lykke, Hertz, Mathias A., Fabricius, Thilde, Holden, Inge K., Lindvig, Susan O., Helleberg, Marie, Gerstoft, Jan, Kirk, Ole, Jensen, Tomas Ostergaard, Madsen, Birgitte Lindegaard, Pedersen, Thomas Ingemann, Harboe, Zitta Barrella, Roge, Birgit Thorup, Hansen, Thomas Michael, Glesner, Matilde Kanstrup, Lofberg, Sandra Valborg, Nielsen, Ariella Denize, Leicht von Huth, Sebastian, Nielsen, Henrik, Thisted, Rikke Krog, Petersen, Kristine Toft, Juhl, Maria Ruwald, Podlekareva, Daria, Johnsen, Stine, Andreassen, Helle Frost, Pedersen, Lars, Clara Ellinor Lindnér, Cecilia Ebba, Wiese, Lothar, Knudsen, Lene Surland, Skrøder Nytofte, Nikolaj Julian, Havmøller, Signe Ravn, Expósito, Maria, Badillo, José, Martínez, Ana, Abad, Elena, Chamorro, Ana, Figuerola, Ariadna, Mateu, Lourdes, España, Sergio, Lucero, Maria Constanza, Santos, José Ramón, Lladós, Gemma, Lopez, Cristina, Carabias, Lydia, Molina-Morant, Daniel, Loste, Cora, Bracke, Carmen, Siles, Adrian, Fernández-Cruz, Eduardo, Di Natale, Marisa, Padure, Sergiu, Gomez, Jimena, Ausin, Cristina, Cervilla, Eva, Balastegui, Héctor, Sainz, Carmen Rodríguez, Lopez, Paco, Carbone, Javier, Escobar, Mariam, Balerdi, Leire, Legarda, Almudena, Roldan, Montserrat, Letona, Laura, Muñoz, José, Camprubí, Daniel, Arribas, Jose R., Sánchez, Rocio Montejano, Díaz-Pollán, Beatriz, Stewart, Stefan Mark, Garcia, Irene, Borobia, Alberto, Mora-Rillo, Marta, Estrada, Vicente, Cabello, Noemi, Nuñez-Orantos, M.J., Sagastagoitia, I., Homen, J.R., Orviz, E., Montalvá, Adrián Sánchez, Espinosa-Pereiro, Juan, Bosch-Nicolau, Pau, Salvador, Fernando, Burgos, Joaquin, Morales-Rull, Jose Luis, Moreno Pena, Anna Maria, Acosta, Cristina, Solé-Felip, Cristina, Horcajada, Juan P., Sendra, Elena, Castañeda, Silvia, López-Montesinos, Inmaculada, Gómez-Junyent, Joan, Gonzáles, Carlota Gudiol, Cuervo, Guilermo, Pujol, Miquel, Carratalà, Jordi, Videla, Sebastià, Günthard, Huldrych, Braun, Dominique L., West, Emily, M’Rabeth-Bensalah, Khadija, Eichinger, Mareile L., Grüttner-Durmaz, Manuela, Grube, Christina, Zink, Veronika, pharmacist, Goes pharmacist, Josefine, Fätkenheuer, Gerd, Malin, Jakob J., Tsertsvadze, Tengiz, Abutidze, Akaki, Chkhartishvili, Nikoloz, Metchurtchlishvili, Revaz, Endeladze, Marina, Paciorek, Marcin, Bursa, Dominik, Krogulec, Dominika, Pulik, Piotr, Ignatowska, Anna, Horban, Andrzej, Bakowska, Elzbieta, Kowaska, Justyna, Bednarska, Agnieszka, Jurek, Natalia, Skrzat-Klapaczynska, Agata, Bienkowski, Carlo, Hackiewicz, Malgorzata, Makowiecki, Michal, Platowski, Antoni, Fishchuk, Roman, Kobrynska, Olena, Levandovska, Khrystyna, Kirieieva, Ivanna, Kuziuk, Mykhailo, Naucler, Pontus, Perlhamre, Emma, Mazouch, Lotta, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina C., Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Young, Barnaby E., Chia, Po Ying, Lee, Tau Hong, Lin, Ray J., Lye, David C., Ong, Sean W.X., Puah, Ser Hon, Yeo, Tsin Wen, Diong, Shiau Hui, Ongko, Juwinda, Yeo, He Ping, Eriobu, Nnakelu, Kwaghe, Vivian, Zaiyad, Habib, Idoko, Godwin, Uche, Blessing, Selvamuthu, Poongulali, Kumarasamy, Nagalingeswaran, Beulah, Faith Ester, Govindarajan, Narayan, Mariyappan, Kowsalya, Losso, Marcelo H., Abela, Cecilia, Moretto, Renzo, Belloc, Carlos G., Ludueña, Jael, Amar, Josefina, Toibaro, Javier, Macias, Laura Moreno, Fernandez, Lucia, Frare, Pablo S., Chaio, Sebastian R., Pachioli, Valeria, Timpano, Stella M., Sanchez, Marisa del Lujan, de Paz Sierra, Mariana, Stanek, Vanina, Belloso, Waldo, Cilenti, Flavia L., Valentini, Ricardo N., Stryjewski, Martin E., Locatelli, Nicolas, Soler Riera, Maria C., Salgado, Clara, Baeck, Ines M., Di Castelnuovo, Valentina, Zarza, Stella M., Hudson, Fleur, Parmar, Mahesh K.B., Goodman, Anna L., Dphil, Badrock, Jonathan, Gregory, Adam, Goodall, Katharine, Harris, Nicola, Wyncoll, James, Bhagani, S., Rodger, A., Luntiel, A., Patterson, C., Morales, J., Witele, E., Preston, A.-M., Nandani, A., Price, D.A., Hanrath, Aiden, Nell, Jeremy, Patel, Bijal, Hays, Carole, Jones, Geraldine, Davidson, Jade, Bawa, T., Mathews, M., Mazzella, A., Bisnauthsing, K., Aguilar-Jimenez, L., Borchini, F., Hammett, S., Touloumi, Giota, Pantazis, Nikos, Gioukari, Vicky, Souliou, Tania, Antoniadou, A., Protopapas, K., Kavatha, D., Grigoropoulou, S., Oikonomopoulo, C., Moschopoulos, C., Koulouris, N.G., Tzimopoulos, K., Koromilias, A., Argyraki, K., Lourida, P., Bakakos, P., Kalomenidis, I., Vlachakos, V., Barmparessou, Z., Balis, E., Zakynthinos, S., Sigala, I., Gianniou, N., Dima, E., Magkouta, S., Synolaki, E., Konstanta, S., Vlachou, M., Stathopoulou, P., Panagopoulos, P., Petrakis, V., Papazoglou, D., Tompaidou, E., Isaakidou, E., Poulakou, G., Rapti, V., Leontis, K., Nitsotolis, T., Athanasiou, K., Syrigos, K., Kyriakoulis, K., Trontzas, I., Arfara-Melanini, M., Kolonis, V., Kityo, Cissy, Mugerwa, Henry, Kiweewa, Francis, Kimuli, Ivan, Lukaakome, Joseph, Nsereko, Christoher, Lubega, Gloria, Kibirige, Moses, Nakahima, William, Wangi, Deus, Aguti, Evelyne, Generous, Lilian, Massa, Rosemary, Nalaki, Margaret, Magala, Felix, Nabaggala, Phiona Kaweesi, Kidega, Robert, Faith, Oryem Daizy, Florence, Apio, Emmanuel, Ocung, Beacham, Mugoonyi Paul, Geoffrey, Amone, Nakiboneka, Dridah, Apiyo, Paska, Kirenga, Bruce, Atukunda, Angella, Muttamba, Winters, Remmy, Kyeyume, Segawa, Ivan, Pheona, Nsubuga, Kigere, David, Mbabazi, Queen Lailah, Boersalino, Ledra, Nyakoolo, Grace, Fred, Aniongo, Alupo, Alice, Ebong, Doryn, Monday, Edson, Nalubwama, Ritah Norah, Kainja, Milton, Ambrose, Munu, Kwehayo, Vanon, Nalubega, Mary Grace, Ongoli, Augustine, Obbo, Stephen, Sebudde, Nicholus, Alaba, Jeniffer, Magombe, Geoffrey, Tino, Harriet, Obonya, Emmanuel, Lutaakome, Joseph, Kitonsa, Jonathan, Onyango, Martin, Naboth, Tukamwesiga, Naluyinda, Hadijah, Nanyunja, Regina, Irene, Muttiibwa, Jane, Biira, Wimfred, Kyobejja, Leonard, Ssemazzi, Deus, Tkiinomuhisha, Babra, Namasaba, Taire, Paul, Nabankema, Evelyn, Ogavu, Joseph, Mugerwa, Oscar, Okoth, Ivan, Mwebaze, Raymond, Mugabi, Timothy, Makhoba, Anthony, Arikiriza, Phiona, Theresa, Nabuuma, Nakayima, Hope, Frank, Kisuule, Ramgi, Patrícia, Pereira, Kássia, Osinusi, Anu, Cao, Huyen, Klekotka, Paul, Price, Karen, Nirula, Ajay, Osei, Suzette, Tipple, Craig, Wills, Angela, Peppercorn, Amanda, Watson, Helen, Gupta, Rajesh, Alexander, Elizabeth, Mogalian, Erik, Lin, Leo, Ding, Xiao, Margolis, David, Yan, Li, Girardet, Jean-Luc, Ma, Ji, Hong, Zhi, Zhu, Quing, Seegobin, Seth, Gibbs, Michael, Latchman, Mickel, Hasior, Katarzyna, Bouquet, Jerome, Wei, Jianxin, Streicher, Katie, Schmelzer, Albert, Brooks, Dennis, Butcher, Jonny, Tonev, Dimitar, Arbetter, Douglas, Damstetter, Philippe, Legenne, Philippe, Stumpp, Michael, Goncalves, Susana, Ramanathan, Krishnan, Chandra, Richa, Baseler, Beth, Teitelbaum, Marc, Schechner, Adam, Holley, H. Preston, Jankelevich, Shirley, Becker, Nancy, Dolney, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Asomah, Mabel, Jato, Yvonne, Stottlemyer, April, Tang, Olivia, Vanderpuye, Sharon, Yeon, Lindsey, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonald, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Schaffhauser, Marylu, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, C.K., Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Kopka, Stacey, Shelley, Denise M., Mendez, Gregg, Brown, Shawn, Albert, Sara, Balde, Abby, Baracz, Michelle, Bielica, Mona, Billouin-Frazier, Shere, Choudary, Jay, Dixon, Mary, Eyler, Carolyn, Frye, Leanne, Gertz, Jensen, Giebeig, Lisa, Gulati, Neelam, Hankinson, Liz, Hogarty, Debi, Huber, Lynda, Krauss, Gary, Lake, Eileen, Manandhar, Meryan, Rudzinski, Erin, Sandrus, Jen, Suders, Connie, Natarajan, Ven, Rupert, Adam W., Baseler, Michael, Lynam, Danielle, Imamichi, Tom, Laverdure, Sylvain, McCormack, Ashley, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Khan, Ayub, Hazen, Allison, Badralmaa, Yunden, Smith, Kenneth, Patel, Bhakti, Kubernac, Amanda, Kubernac, Robert, Hoover, Marie L., Solomon, Courtney, Rashid, Marium, Murphy, Joseph, Brown, Craig, DuChateau, Nadine, Ellis, Sadie, Flosi, Adam, Fox, Lisa, Johnson, Les, Nelson, Rich, Stojanovic, Jelena, Treagus, Amy, Wenner, Christine, Williams, Richard, Jensen, Tomas O, Murray, Thomas A, Grandits, Greg A, Jain, Mamta K, Shaw-Saliba, Kathryn, Matthay, Michael A, Baker, Jason V, Dewar, Robin L, Goodman, Anna L, Hatlen, Timothy J, Highbarger, Helene C, Lallemand, Perrine, Leshnower, Bradley G, Looney, David, Moschopoulos, Charalampos D, Murray, Daniel D, Mylonakis, Eleftherios, Rehman, M Tauseef, Rupert, Adam, Stevens, Randy, Turville, Stuart, Wick, Katherine, Lundgren, Jens, and Ko, Emily R

Published
2024
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2. 204 REFINE-Lung is a multicentre phase III study to determine the optimal frequency of pembrolizumab in advanced non-small cell lung cancer (NSCLC) utilising a novel multi-arm design

Author

Ghorani, Ehsan, primary, Quartagno, Matteo, additional, Blackhall, Fiona, additional, O'Brien, Mary, additional, Ottensmeier, Christian, additional, Pizzo, Elena, additional, Spicer, James, additional, Gilbert, Duncan, additional, Baker, Alex, additional, Badman, Philip, additional, Milner-Watts, Charlotte, additional, D. d'Arienzo, Paolo, additional, Dangoor, Adam, additional, Adhikaree, Jason, additional, Evans, Joanne, additional, Leite, Pollyanna, additional, Keni, Manjusha, additional, Steele, Nicola, additional, Gomes, Fabio, additional, Gomez-Randulfe, Igor, additional, Belitei, Petru, additional, Stewart, Grant, additional, Barrie, Colin, additional, Geldart, Tom, additional, Jain, Pooja, additional, Liu, Justin KH, additional, Zubairi, Ishtaiq, additional, Muthukumar, Dakshinamoorthy, additional, Gray, Lucy, additional, Treece, Sarah, additional, Aleksic, Aleksandar, additional, Tsaknis, Georgios, additional, Rathbone, Emma, additional, Shaw, Paul, additional, Tarver, Kathryn, additional, Parmar, Mahesh K.B., additional, and Seckl, Michael J., additional

Published
2024
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3. The Automated Bone Scan Index as a Predictor of Response to Prostate Radiotherapy in Men with Newly Diagnosed Metastatic Prostate Cancer: An Exploratory Analysis of STAMPEDE’s “M1|RT Comparison”

Author

Ali, Adnan, Hoyle, Alex P., Parker, Christopher C., Brawley, Christopher D., Cook, Adrian, Amos, Claire, Calvert, Joanna, Douis, Hassan, Mason, Malcolm D., Attard, Gerhardt, Parmar, Mahesh K.B., Sydes, Matthew R., James, Nicholas D., and Clarke, Noel W.

Published
2020
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4. A repurposing programme evaluating repurposing transdermal Estradiol (tE2) patches for the treatment of prostate cancer within the PATCH and STAMPEDE trials: Current results and adapting trial design

Author

Gilbert, Duncan C., primary, Nankivell, Matthew, additional, Rush, Hannah, additional, Clarke, Noel W., additional, Mangar, Stephen, additional, Al-hasso, Abdullah, additional, Rosen, Stuart, additional, Kockelbergh, Roger, additional, Sundaram, Subramaniam Kananga, additional, Dixit, Sanjay, additional, Laniado, Marc, additional, McPhail, Neil, additional, Shaheen, Ahmed, additional, Brown, Simon, additional, Gale, Joanna, additional, Deighan, John, additional, Marshall, John, additional, Duong, Trinh, additional, Macnair, Archie, additional, Griffiths, Anna, additional, Amos, Claire L., additional, Sydes, Matthew R., additional, James, Nicholas D., additional, Parmar, Mahesh K.B., additional, and Langley, Ruth E., additional

Published
2023
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5. Salvage Radiation Therapy After Radical Prostatectomy: Analysis of Toxicity by Dose-Fractionation in the RADICALS-RT Trial

Author

Petersen, Peter Meidahl, primary, Cook, Adrian D., additional, Sydes, Matthew R., additional, Clarke, Noel, additional, Cross, William, additional, Kynaston, Howard, additional, Logue, John, additional, Neville, Peter, additional, Payne, Heather, additional, Parmar, Mahesh K.B., additional, Parulekar, Wendy, additional, Persad, Rajendra, additional, Saad, Fred, additional, Stirling, Alan, additional, Parker, Christopher C., additional, and Catton, Charles, additional

Published
2023
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6. The Accuracy of Clinical Staging of Stage I-IIIa Non-Small Cell Lung Cancer: An Analysis Based on Individual Participant Data

Author

Burdett, Sarah, Rydzewska, Larysa H.M., Tierney, Jayne F., Auperin, Anne, Le Chevalier, Thierry, Le Pechoux, Cécile, Pignon, Jean-Pierre, Arriagada, Rodrigo, Johnson, David H., van Meerbeeck, Jan, Parmar, Mahesh K.B., Stephens, Richard J., Stewart, Lesley A., Bunn, Paul A., Dautzenberg, Bertrand, Gilligan, David, Groen, Harry, Knuuttila, Aija, Vallieres, Eric, Rosell, Rafael, Roth, Jack, Scagliotti, Giorgio, Tsuboi, Masahiro, Waller, David, Westeel, Virginie, Wu, Yi-Long, Yang, Xue-Ning, Navani, Neal, and Fisher, David J.

Published
2019
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7. Exploratory outcome analyses according to stage and/or residual disease in the ICON7 trial of carboplatin and paclitaxel with or without bevacizumab for newly diagnosed ovarian cancer

Author

González Martín, Antonio, Oza, Amit M., Embleton, Andrew C., Pfisterer, Jacobus, Ledermann, Jonathan A., Pujade-Lauraine, Eric, Kristensen, Gunnar, Bertrand, Monique A., Beale, Philip, Cervantes, Andrés, Kent, Emma, Kaplan, Richard S., Parmar, Mahesh K.B., Scotto, Nana, and Perren, Timothy J.

Published
2019
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8. Addition of Docetaxel to First-line Long-term Hormone Therapy in Prostate Cancer (STAMPEDE): Modelling to Estimate Long-term Survival, Quality-adjusted Survival, and Cost-effectiveness

Author

Woods, Beth S., Sideris, Eleftherios, Sydes, Matthew R., Gannon, Melissa R., Parmar, Mahesh K.B., Alzouebi, Mymoona, Attard, Gerhardt, Birtle, Alison J., Brock, Susannah, Cathomas, Richard, Chakraborti, Prabir R., Cook, Audrey, Cross, William R., Dearnaley, David P., Gale, Joanna, Gibbs, Stephanie, Graham, John D., Hughes, Robert, Jones, Rob J., Laing, Robert, Mason, Malcolm D., Matheson, David, McLaren, Duncan B., Millman, Robin, O'Sullivan, Joe M., Parikh, Omi, Parker, Christopher C., Peedell, Clive, Protheroe, Andrew, Ritchie, Alastair W.S., Robinson, Angus, Russell, J. Martin, Simms, Matthew S., Srihari, Narayanan N., Srinivasan, Rajaguru, Staffurth, John N., Sundar, Santhanam, Thalmann, George N., Tolan, Shaun, Tran, Anna T.H., Tsang, David, Wagstaff, John, James, Nicholas D., and Sculpher, Mark J.

Published
2018
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13. External Validation of the 2003 Leibovich Prognostic Score in Patients Randomly Assigned to SORCE, an International Phase III Trial of Adjuvant Sorafenib in Renal Cell Cancer

Author

Oza, Bhavna, primary, Eisen, Tim, additional, Frangou, Eleni, additional, Stewart, Grant D., additional, Bex, Axel, additional, Ritchie, Alastair W.S., additional, Kaplan, Rick, additional, Smith, Benjamin, additional, Davis, Ian D., additional, Stockler, Martin R., additional, Albiges, Laurence, additional, Escudier, Bernard, additional, Larkin, James, additional, Joniau, Steven, additional, Hancock, Barry, additional, Hermann, Gregers G., additional, Bellmunt, Joaquim, additional, Parmar, Mahesh K.B., additional, Royston, Patrick, additional, and Meade, Angela, additional

Published
2022
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14. Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5‐year follow‐up results from the STAMPEDE randomised trial (NCT00268476)

Author

James, Nicholas D., Clarke, Noel W., Cook, Adrian, Ali, Adnan, Hoyle, Alex P., Attard, Gert, Brawley, Chris D., Chowdhury, Simon, Cross, William R., Dearnaley, David P., Bono, Johann S., Montana, Carlos Diaz, Gilbert, Duncan, Gillessen, Silke, Gilson, Clare, Jones, Rob J., Langley, Ruth E., Malik, Zafar I., Matheson, David J., Millman, Robin, Parker, Chris C., Pugh, Cheryl, Rush, Hannah, Russell, J. Martin, Berthold, Dominic R., Buckner, Michelle L., Mason, Malcolm D., Ritchie, Alastair W.S., Birtle, Alison J., Brock, Susannah J., Das, Prantik, Ford, Dan, Gale, Joanna, Grant, Warren, Gray, Emma K., Hoskin, Peter, Khan, Mohammad M., Manetta, Caroline, McPhail, Neil J., O'Sullivan, Joe M., Parikh, Omi, Perna, Carla, Pezaro, Carmel J., Protheroe, Andrew S., Robinson, Angus J., Rudman, Sarah M., Sheehan, Denise J., Srihari, Narayanan N., Syndikus, Isabel, Tanguay, Jacob, Thomas, Carys W., Vengalil, Salil, Wagstaff, John, Wylie, James P., Parmar, Mahesh K.B., and Sydes, Matthew R.

Subjects
Male, Cancer Research, Prednisolone, Abiraterone Acetate, Prostatic Neoplasms, Androgen Antagonists, B700, Hormones, Prostatic Neoplasms, Castration-Resistant, Treatment Outcome, Oncology, SDG 3 - Good Health and Well-being, Antineoplastic Combined Chemotherapy Protocols, Humans, Prednisone, Aged, Follow-Up Studies, Retrospective Studies
Abstract

Abiraterone acetate plus prednisolone (AAP) previously demonstrated improved survival in STAMPEDE, a multi-arm, multi-stage platform trial in men starting long-term hormone therapy for prostate cancer. This long-term analysis in metastatic patients was planned for 3 yrs after the first results. Standard-of-care (SOC) was androgen deprivation therapy. The comparison randomized patients 1:1 to SOC-alone with or without daily abiraterone acetate 1000 mg + prednisolone 5 mg (SOC + AAP), continued until disease progression. The primary outcome measure was overall survival. Metastatic disease risk group was classified retrospectively using baseline CT and bone scans by central radiological review and pathology reports. Analyses used Cox proportional hazards & flexible parametric models, adjusted for baseline stratification factors. 1003 patients were contemporaneously randomized (Nov-2011--Jan-2014): median age 67 yr; 94% newly-diagnosed; metastatic disease risk group: 48% high, 44% low, 8% un-assessable; median PSA 97 ng/mL. At 6.1 yr median follow-up, 329 SOC-alone deaths (118 low-risk, 178 high-risk) and 244 SOC + AAP deaths (75 low-risk, 145 high-risk) were reported. Adjusted HR = 0·60 (95%CI:0·50—0·71; P = 0.31x10−9) favoured SOC + AAP, with 5-yr survival improved from 41% SOC-alone to 60% SOC + AAP. This was similar in low-risk (HR = 0·55; 95%CI:0·41—0·76) and high-risk (HR = 0·54; 95%CI:0·43—0·69) patients. Median and current maximum time on SOC + AAP was 2.4 yr and 8.1 yr. Toxicity at 4 yr post-randomisation was similar, with 16% patients in each group reporting grade 3 or higher toxicity. A sustained and substantial improvement in overall survival of all metastatic prostate cancer patients was achieved with SOC + abiraterone acetate + prednisolone, irrespective of metastatic disease risk group.\ud \ud This article is protected by copyright. All rights reserved.

Published
2022

15. Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents:Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)

Author

Murray, Daniel D., Babiker, Abdel G., Baker, Jason V., Barkauskas, Christina E., Brown, Samuel M., Chang, Christina C., Davey, Victoria J., Gelijns, Annetine C., Ginde, Adit A., Grund, Birgit, Higgs, Elizabeth, Hudson, Fleur, Kan, Virginia L., Lane, H. Clifford, Murray, Thomas A., Paredes, Roger, Parmar, Mahesh K.B., Pett, Sarah, Phillips, Andrew N., Polizzotto, Mark N., Reilly, Cavan, Sandkovsky, Uriel, Sharma, Shweta, Teitelbaum, Marc, Thompson, B. Taylor, Young, Barnaby E., Neaton, James D., Lundgren, Jens D., Murray, Daniel D., Babiker, Abdel G., Baker, Jason V., Barkauskas, Christina E., Brown, Samuel M., Chang, Christina C., Davey, Victoria J., Gelijns, Annetine C., Ginde, Adit A., Grund, Birgit, Higgs, Elizabeth, Hudson, Fleur, Kan, Virginia L., Lane, H. Clifford, Murray, Thomas A., Paredes, Roger, Parmar, Mahesh K.B., Pett, Sarah, Phillips, Andrew N., Polizzotto, Mark N., Reilly, Cavan, Sandkovsky, Uriel, Sharma, Shweta, Teitelbaum, Marc, Thompson, B. Taylor, Young, Barnaby E., Neaton, James D., and Lundgren, Jens D.

Abstract

Background/aims: Safe and effective therapies for COVID-19 are urgently needed. In order to meet this need, the Accelerating COVID-19 Therapeutic Interventions and Vaccines public–private partnership initiated the Therapeutics for Inpatients with COVID-19. Therapeutics for Inpatients with COVID-19 is a multi-arm, multi-stage platform master protocol, which facilitates the rapid evaluation of the safety and efficacy of novel candidate antiviral therapeutic agents for adults hospitalized with COVID-19. Five agents have so far entered the protocol, with rapid answers already provided for three of these. Other agents are expected to enter the protocol throughout 2021. This protocol contains a number of key design and implementation features that, along with challenges faced by the protocol team, are presented and discussed. Methods: Three clinical trial networks, encompassing a global network of clinical sites, participated in the protocol development and implementation. Therapeutics for Inpatients with COVID-19 utilizes a multi-arm, multi-stage design with an agile and robust approach to futility and safety evaluation at 300 patients enrolled, with subsequent expansion to full sample size and an expanded target population if the agent shows an acceptable safety profile and evidence of efficacy. Rapid recruitment to multiple agents is enabled through the sharing of placebo, the confining of agent-specific information to protocol appendices, and modular consent forms. In collaboration with the Food and Drug Administration, a thorough safety data collection and Data and Safety Monitoring Board schedule was developed for the study of potential therapeutic agents with limited in-human data in hospitalized patients with COVID-19. Results: As of 8 August 2021, five agents have entered the Therapeutics for Inpatients with COVID-19 master protocol and a total of 1909 participants have been randomized to one of these agents or matching placebo. There were a number of challeng

Published
2022

17. Adjuvant Chemotherapy for Muscle-invasive Bladder Cancer: A Systematic Review and Meta-analysis of Individual Participant Data from Randomised Controlled Trials

Author

Burdett, Sarah, primary, Fisher, David J., additional, Vale, Claire L., additional, Sternberg, Cora N., additional, Clarke, Noel W., additional, Parmar, Mahesh K.B., additional, Bono, Aldo V., additional, Cognetti, Francesco, additional, Collette, Laurence, additional, Cote, Richard J., additional, Goebell, Peter J., additional, Groshen, Susan, additional, Lehmann, Jan, additional, Rolevich, Alexander I., additional, Sonntag, Roland W., additional, Stockle, Michael, additional, Studer, Urs E., additional, Torti, Frank M., additional, Zhegalik, Alexander G., additional, and Tierney, Jayne F., additional

Published
2022
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18. Lung cancer mortality reduction by LDCT screening: UKLS randomised trial results and international meta-analysis

Author

Field, John K., primary, Vulkan, Daniel, additional, Davies, Michael P.A., additional, Baldwin, David R., additional, Brain, Kate E., additional, Devaraj, Anand, additional, Eisen, Tim, additional, Gosney, John, additional, Green, Beverley A., additional, Holemans, John A., additional, Kavanagh, Terry, additional, Kerr, Keith M., additional, Ledson, Martin, additional, Lifford, Kate J., additional, McRonald, Fiona E., additional, Nair, Arjun, additional, Page, Richard D., additional, Parmar, Mahesh K.B., additional, Rassl, Doris M., additional, Rintoul, Robert C., additional, Screaton, Nicholas J., additional, Wald, Nicholas J., additional, Weller, David, additional, Whynes, David K., additional, Williamson, Paula R., additional, Yadegarfar, Gasham, additional, Gabe, Rhian, additional, and Duffy, Stephen W., additional

Published
2021
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20. RAMPART: A phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse

Author

Oza, Bhavna, primary, Frangou, Eleni, additional, Smith, Ben, additional, Bryant, Hanna, additional, Kaplan, Rick, additional, Choodari-Oskooei, Babak, additional, Powles, Tom, additional, Stewart, Grant D., additional, Albiges, Laurence, additional, Bex, Axel, additional, Choueiri, Toni K., additional, Davis, Ian D., additional, Eisen, Tim, additional, Fielding, Alison, additional, Harrison, David, additional, McWhirter, Anita, additional, Mulhere, Salena, additional, Nathan, Paul, additional, Rini, Brian, additional, Ritchie, Alastair, additional, Scovell, Sarah, additional, Shakeshaft, Clare, additional, Stockler, Martin R., additional, Thorogood, Nat, additional, Parmar, Mahesh K.B., additional, Larkin, James, additional, and Meade, Angela, additional

Published
2021
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21. RAMPART: A model for a regulatory-ready academic-led phase III trial in the adjuvant renal cell carcinoma setting

Author

Meade, Angela, primary, Oza, Bhavna, additional, Frangou, Eleni, additional, Smith, Ben, additional, Bryant, Hanna, additional, Kaplan, Rick, additional, Choodari-Oskooei, Babak, additional, Powles, Tom, additional, Stewart, Grant D., additional, Albiges, Laurence, additional, Bex, Axel, additional, Choueiri, Toni K., additional, Davis, Ian D., additional, Eisen, Tim, additional, Fielding, Alison, additional, Harrison, David J., additional, McWhirter, Anita, additional, Mulhere, Salena, additional, Nathan, Paul, additional, Rini, Brian, additional, Ritchie, Alastair, additional, Scovell, Sarah, additional, Shakeshaft, Clare, additional, Stockler, Martin R., additional, Thorogood, Nat, additional, Larkin, James, additional, and Parmar, Mahesh K.B., additional

Published
2021
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25. Timing of radiotherapy after radical prostatectomy (RADICALS-RT):a randomised, controlled phase 3 trial

Author

Parker, Christopher C., Clarke, Noel W., Cook, Adrian D., Kynaston, Howard G., Petersen, Peter Meidahl, Catton, Charles, Cross, William, Logue, John, Parulekar, Wendy, Payne, Heather, Persad, Rajendra, Pickering, Holly, Saad, Fred, Anderson, Juliette, Bahl, Amit, Bottomley, David, Brasso, Klaus, Chahal, Rohit, Cooke, Peter W., Eddy, Ben, Gibbs, Stephanie, Goh, Chee, Gujral, Sandeep, Heath, Catherine, Henderson, Alastair, Jaganathan, Ramasamy, Jakobsen, Henrik, James, Nicholas D., Kanaga Sundaram, Subramanian, Lees, Kathryn, Lester, Jason, Lindberg, Henriette, Money-Kyrle, Julian, Morris, Stephen, O'Sullivan, Joe, Ostler, Peter, Owen, Lisa, Patel, Prashant, Pope, Alvan, Popert, Richard, Raman, Rakesh, Røder, Martin Andreas, Sayers, Ian, Simms, Matthew, Wilson, Jim, Zarkar, Anjali, Parmar, Mahesh K.B., Sydes, Matthew R., Parker, Christopher C., Clarke, Noel W., Cook, Adrian D., Kynaston, Howard G., Petersen, Peter Meidahl, Catton, Charles, Cross, William, Logue, John, Parulekar, Wendy, Payne, Heather, Persad, Rajendra, Pickering, Holly, Saad, Fred, Anderson, Juliette, Bahl, Amit, Bottomley, David, Brasso, Klaus, Chahal, Rohit, Cooke, Peter W., Eddy, Ben, Gibbs, Stephanie, Goh, Chee, Gujral, Sandeep, Heath, Catherine, Henderson, Alastair, Jaganathan, Ramasamy, Jakobsen, Henrik, James, Nicholas D., Kanaga Sundaram, Subramanian, Lees, Kathryn, Lester, Jason, Lindberg, Henriette, Money-Kyrle, Julian, Morris, Stephen, O'Sullivan, Joe, Ostler, Peter, Owen, Lisa, Patel, Prashant, Pope, Alvan, Popert, Richard, Raman, Rakesh, Røder, Martin Andreas, Sayers, Ian, Simms, Matthew, Wilson, Jim, Zarkar, Anjali, Parmar, Mahesh K.B., and Sydes, Matthew R.

Abstract

Background: The optimal timing of radiotherapy after radical prostatectomy for prostate cancer is uncertain. We aimed to compare the efficacy and safety of adjuvant radiotherapy versus an observation policy with salvage radiotherapy for prostate-specific antigen (PSA) biochemical progression. Methods: We did a randomised controlled trial enrolling patients with at least one risk factor (pathological T-stage 3 or 4, Gleason score of 7–10, positive margins, or preoperative PSA ≥10 ng/mL) for biochemical progression after radical prostatectomy (RADICALS-RT). The study took place in trial-accredited centres in Canada, Denmark, Ireland, and the UK. Patients were randomly assigned in a 1:1 ratio to adjuvant radiotherapy or an observation policy with salvage radiotherapy for PSA biochemical progression (PSA ≥0·1 ng/mL or three consecutive rises). Masking was not deemed feasible. Stratification factors were Gleason score, margin status, planned radiotherapy schedule (52·5 Gy in 20 fractions or 66 Gy in 33 fractions), and centre. The primary outcome measure was freedom from distant metastases, designed with 80% power to detect an improvement from 90% with salvage radiotherapy (control) to 95% at 10 years with adjuvant radiotherapy. We report on biochemical progression-free survival, freedom from non-protocol hormone therapy, safety, and patient-reported outcomes. Standard survival analysis methods were used. A hazard ratio (HR) of less than 1 favoured adjuvant radiotherapy. This study is registered with ClinicalTrials.gov, NCT00541047. Findings: Between Nov 22, 2007, and Dec 30, 2016, 1396 patients were randomly assigned, 699 (50%) to salvage radiotherapy and 697 (50%) to adjuvant radiotherapy. Allocated groups were balanced with a median age of 65 years (IQR 60–68). Median follow-up was 4·9 years (IQR 3·0–6·1). 649 (93%) of 697 participants in the adjuvant radiotherapy group reported radiotherapy within 6 months; 228 (33%) of 699 in the salvage radiotherapy group reporte

Published
2020

26. Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse: Results From the SORCE Randomized Phase III Intergroup Trial

Author

Eisen, Tim, primary, Frangou, Eleni, additional, Oza, Bhavna, additional, Ritchie, Alastair W.S., additional, Smith, Benjamin, additional, Kaplan, Rick, additional, Davis, Ian D., additional, Stockler, Martin R., additional, Albiges, Laurence, additional, Escudier, Bernard, additional, Larkin, James, additional, Bex, Axel, additional, Joniau, Steven, additional, Hancock, Barry, additional, Hermann, Gregers G., additional, Bellmunt, Joaquim, additional, Hodgkinson, Elizabeth, additional, Stewart, Grant D., additional, Barber, Jim, additional, Brown, Janet, additional, McMenemin, Rhona, additional, Nathan, Paul, additional, Pickering, Lisa M., additional, Parmar, Mahesh K.B., additional, and Meade, Angela, additional

Published
2020
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28. Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)

Author

Murray, Daniel D., primary, Babiker, Abdel G., additional, Baker, Jason V., additional, Barkauskas, Christina E., additional, Brown, Samuel M., additional, Chang, Christina C., additional, Davey, Victoria J., additional, Gelijns, Annetine C., additional, Ginde, Adit A., additional, Grund, Birgit, additional, Higgs, Elizabeth, additional, Hudson, Fleur, additional, Kan, Virginia L., additional, Lane, H. Clifford, additional, Murray, Thomas A., additional, Paredes, Roger, additional, Parmar, Mahesh K.B., additional, Pett, Sarah, additional, Phillips, Andrew N., additional, Polizzotto, Mark N., additional, Reilly, Cavan, additional, Sandkovsky, Uriel, additional, Sharma, Shweta, additional, Teitelbaum, Marc, additional, Thompson, B. Taylor, additional, Young, Barnaby E., additional, Neaton, James D., additional, and Lundgren, Jens D., additional

Published
2020
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30. A Phase 3 Trial of Bevacizumab in Ovarian Cancer

Author

Perren, Timothy J., Swart, Ann Marie, Pfisterer, Jacobus, Ledermann, Jonathan A., Pujade-Lauraine, Eric, Kristensen, Gunnar, Carey, Mark S., Beale, Philip, Cervantes, Andrés, Kurzeder, Christian, du Bois, Andreas, Sehouli, Jalid, Kimmig, Rainer, Stähle, Anne, Collinson, Fiona, Essapen, Sharadah, Gourley, Charlie, Lortholary, Alain, Selle, Frédéric, Mirza, Mansoor R., Leminen, Arto, Plante, Marie, Stark, Dan, Qian, Wendi, Parmar, Mahesh K.B., and Oza, Amit M.

Published
2011

32. Abiraterone in “High-” and “Low-risk” Metastatic Hormone-sensitive Prostate Cancer

Author

Hoyle, Alex P., primary, Ali, Adnan, additional, James, Nicholas D., additional, Cook, Adrian, additional, Parker, Christopher C., additional, de Bono, Johann S., additional, Attard, Gerhardt, additional, Chowdhury, Simon, additional, Cross, William R., additional, Dearnaley, David P., additional, Brawley, Christopher D., additional, Gilson, Clare, additional, Ingleby, Fiona, additional, Gillessen, Silke, additional, Aebersold, Daniel M., additional, Jones, Rob J., additional, Matheson, David, additional, Millman, Robin, additional, Mason, Malcolm D., additional, Ritchie, Alastair W.S., additional, Russell, Martin, additional, Douis, Hassan, additional, Parmar, Mahesh K.B., additional, Sydes, Matthew R., additional, and Clarke, Noel W., additional

Published
2019
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34. Speeding up the evaluation of new agents in cancer

Author

Parmar, Mahesh K.B., Barthel, Friederike M.-S., Sydes, Matthew, Langley, Ruth, Kaplan, Rick, Eisenhauer, Elizabeth, Brady, Mark, James, Nicholas, Bookman, Michael A., Swart, Ann-Marie, Qian, Wendi, and Royston, Patrick

Subjects
Antimitotic agents -- Dosage and administration, Antineoplastic agents -- Dosage and administration, Cancer -- Diagnosis, Cancer -- Drug therapy, Cancer -- Research, Health
Abstract

Despite both the increase in basic biologic knowledge and the fact that many new agents have reached various stages of development during the last 10 years, the number of new treatments that have been approved for patients has not increased as expected. We propose the multi-arm, multi-stage trial design as a way to evaluate treatments faster and more efficiently than current standard trial designs. By using intermediate outcomes and testing a number of new agents (and combinations) simultaneously, the new design requires fewer patients. Three trials using this methodology are presented.

Published
2008

35. Radiotherapy and androgen deprivation in combination after local surgery (RADICALS): A new Medical Research Council/National Cancer Institute of Canada phase III trial of adjuvant treatment after radical prostatectomy

Author

Parker, Chris, Sydes, Matthew R., Catton, Charles, Kynaston, Howard, Logue, John, Murphy, Claire, Morgan, Rachel C., Mellon, Kilian, Morash, Chris, Parulekar, Wendy, Parmar, Mahesh K.B., Payne, Heather, Savage, Colleen, Stansfeld, Jim, and Clarke, Noel W.

Published
2007

36. Visualizing length of survival in time-to-event studies: a complement to Kaplan-Meier plots

Author

Royston, Patrick, Parmar, Mahesh K.B., and Altman, Douglas G.

Subjects
Cancer survivors -- Research, Kidney cancer -- Patient outcomes, Statistical methods -- Usage, Health
Abstract

Because of censoring, standard methods of plotting individual survival times are invalid. Therefore, graphic display of time-to-event data usually takes the form of a Kaplan--Meier survival plot. Kaplan--Meier plots, however, make differences between groups seem larger than they really are. To overcome these limitations, we developed a technique for producing scatter plots with survival data and applied it to data from a randomized trial of patients with renal cancer. As of June 21, 2001, 25 of the 347 patients with kidney cancer in the Medical Research Council RE01 randomized treatment trial for whom data were available had been censored, and the remainder had died. Values of the censored survival times were imputed by assuming a log-normal distribution in survival times and by drawing a random sample given that that each patient with censored data survived at least to the point of censoring. The combined original and imputed data were then examined by use of dot plots and scatter plots. In the RE01 trial, median survival of patients treated with interferon was 3.0 months (95% confidence interval = 0.3 to 5.5 months) Ionger than that in patients treated with medroxyprogesterone acetate. The Kaplan--Meier analysis showed clear separation between treatment groups and between prognostic groups. In contrast, comparisons of individual observed and imputed survival times between groups of patients showed considerable overlap and gave a more realistic idea of the modest between-group differences than Kaplan--Meier comparisons. These graphs of the distribution of survival times for individuals in each study group, which are simple to produce, may usefully complement Kaplan--Meier plots.

Published
2008

37. Oral sodium clodronate for nonmetastatic prostate cancer--results of a randomized double-blind placebo-controlled trial: Medical Research Council PRO4 (ISRCTN61384873)

Author

Mason, Malcolm D., Sydes, Matthew R., Glaholm, John, Langley, Ruth E., Huddart, Robert A., Sokal, Michael, Stott, Mark, Robinson, Anne C., James, Nicholas D., Parmar, Mahesh K.B., and Dearnaley, David P.

Subjects
Prostate cancer -- Care and treatment, Prostate cancer -- Complications and side effects, Prostate cancer -- Analysis, Metastasis -- Control, Metastasis -- Care and treatment, Health
Abstract

Background The most frequent site of metastases from prostate cancer is bone. Adjuvant bisphosphonate treatment improves outcomes of patients with bone metastasis-negative breast cancer, but the effects of bisphosphonates on bone metastases in prostate cancer are not known. Methods We performed a randomized double-blind placebo-controlled trial to determine whether a first-generation bisphosphonate could improve symptomatic bone metastasis-free survival (time to symptomatic bone metastases or death from prostate cancer) in men with nonmetastatic prostate cancer who were at high risk of developing bone metastases. Between June 1, 1994, and December 31, 1997, 508 men from 26 UK sites and one New Zealand site who were within 3 years of initial prostate cancer diagnosis with no evidence of metastases from current bone scanning were randomly assigned to daily oral sodium clodronate (2080 mg/day, n = 254) or placebo (n = 254) for a maximum of 5 years. Estimates of outcome risks were compared using Kaplan-Meier analyses. Results The groups allocated to each treatment were well balanced. After a median follow-up of nearly 10 years, no evidence of benefit to the clodronate group was observed in terms of bone metastases-free survival (clodronate versus placebo, 80 events versus 68 events; hazard ratio [HR] = 1.22; 95% confidence interval [CI] = 0.88 to 1.68) or overall survival (clodronate versus placebo, 130 deaths versus 127 deaths; HR = 1.02; 95% CI = 0.80 to 1.30). Adverse events, notably gastrointestinal problems and increased lactate dehydrogenase levels, were more frequent in the clodronate group than in the placebo group; otherwise, clodronate was well tolerated. Modification of trial drug dose was more frequent in the clodronate group than the placebo group (HR = 1.63, 95% CI = 1.21 to 2.19). Conclusion Adjuvant sodium clodronate does not modify the natural history of nonmetastatic prostate cancer. DOI: 10.1093/jnci/djk178

Published
2007

39. A double-blind, placebo-controlled, randomized trial of oral sodium clodronate for metastatic prostate cancer (MRC PR05 trial)

Author

Dearnaley, David P., Sydes, Matthew R., Mason, Malcolm D., Stott, Mark, Powell, Christopher S., Robinson, Anne C.R., Thompson, Peter M., Moffat, Leslie E., Naylor, Sharon L., and Parmar, Mahesh K.B.

Subjects
Diphosphonates -- Evaluation, Antineoplastic agents -- Evaluation, Antimitotic agents -- Evaluation, Metastasis -- Care and treatment, Prostate cancer -- Care and treatment, Health
Abstract

Background: The most frequent site of metastases from prostate cancer is bone. Bisphosphonates reduce excessive bone turnover while preserving bone structure and mineralization in patients with other tumor types. We conducted a double-blind, placebo-controlled, randomized trial to determine whether the first-generation bisphosphonate sodium clodronate could improve bone progression--free survival (BPFS) times among men with bone metastases from prostate cancer. Methods: Between June 1994 and July 1998, 311 men who were starting or responding to first-line hormone therapy for bone metastases were randomly assigned to receive oral sodium clodronate (2080 mg/day) or placebo for a maximum of 3 years. The primary endpoint of the trial was symptomatic BPFS. Secondary endpoints included overall survival, treatment toxicity, and change in World Health Organization (WHO) performance status. Time-to-event data were analyzed using the log-rank chi-square test and Kaplan--Meier curves. All statistical tests were two-sided. Results: Baseline characteristics were balanced across the two groups. After a median follow-up of 59 months, the sodium clodronate group showed statistically nonsignificant better symptomatic BPFS (hazard ratio [HR] = 0.79, 95% confidence interval [CI] = 0.61 to 1.02; P =.066) and overall survival (HR = 0.80, 95% CI = 0.62 to 1.03; P = .082) than the control group. Patients in the clodronate group were less likely to have a worsened WHO performance status (HR = 0.71, 95% CI = 0.56 to 0.92; P = .008). However, the clodronate group reported more gastrointestinal problems and increased lactate dehydrogenase levels and required more frequent modification of the trial drug dose (HR for any adverse event = 1.71, 95% CI = 1.21 to 2.41; P = .002). Results of subgroup analyses suggested that clodronate might be more effective the sooner after diagnosis of metastatic bone disease it is started. Conclusion: These results suggest that further studies of the effect of newer generation bisphosphonates on BPFS in men with metastatic prostate cancer are warranted. [J Natl Cancer Inst 2003;95:1300-11]

Published
2003

42. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial

Author

Parker, Christopher C., James, Nicholas D., Brawley, Christopher D., Clarke, Noel W., Hoyle, Alex P., Ali, Adnan, Ritchie, Alastair W.S., Attard, Gerhardt, Chowdhury, Simon, Cross, William, Dearnaley, David P., Gillessen, Silke, Gilson, Clare, Jones, Robert J., Langley, Ruth E., Malik, Zafar I., Mason, Malcolm D., Matheson, David, Millman, Robin, Russell, J. Martin, Thalmann, George N., Amos, Claire L., Alonzi, Roberto, Bahl, Amit, Birtle, Alison, Din, Omar, Douis, Hassan, Eswar, Chinnamani, Gale, Joanna, Gannon, Melissa R., Jonnada, Sai, Khaksar, Sara, Lester, Jason F., O'Sullivan, Joe M., Parikh, Omi A., Pedley, Ian D., Pudney, Delia M., Sheehan, Denise J., Srihari, Narayanan Nair, Tran, Anna T.H., Parmar, Mahesh K.B., and Sydes, Matthew R.

Subjects
Oncology, Male, medicine.medical_specialty, Urology, medicine.medical_treatment, MEDLINE, Antineoplastic Agents, 610 Medicine & health, Newly diagnosed, Docetaxel, Article, Disease-Free Survival, Gonadotropin-Releasing Hormone, Prostate cancer, Internal medicine, Medicine, Humans, Neoplasm Metastasis, Docetaxel/therapeutic use, Aged, Gonadotropin-Releasing Hormone/agonists, Radiotherapy, Manchester Cancer Research Centre, business.industry, ResearchInstitutes_Networks_Beacons/mcrc, Androgen Antagonists, Antineoplastic Agents/therapeutic use, Prostatic Neoplasms, Standard of Care, Middle Aged, medicine.disease, Survival Analysis, Radiotherapy/adverse effects, Radiation therapy, Treatment Outcome, Lymph Nodes/pathology, Prostatic Neoplasms/drug therapy, Lymph Nodes, business, Orchiectomy
Abstract

BACKGROUND Based on previous findings, we hypothesised that radiotherapy to the prostate would improve overall survival in men with metastatic prostate cancer, and that the benefit would be greatest in patients with a low metastatic burden. We aimed to compare standard of care for metastatic prostate cancer, with and without radiotherapy. METHODS We did a randomised controlled phase 3 trial at 117 hospitals in Switzerland and the UK. Eligible patients had newly diagnosed metastatic prostate cancer. We randomly allocated patients open-label in a 1:1 ratio to standard of care (control group) or standard of care and radiotherapy (radiotherapy group). Randomisation was stratified by hospital, age at randomisation, nodal involvement, WHO performance status, planned androgen deprivation therapy, planned docetaxel use (from December, 2015), and regular aspirin or non-steroidal anti-inflammatory drug use. Standard of care was lifelong androgen deprivation therapy, with up-front docetaxel permitted from December, 2015. Men allocated radiotherapy received either a daily (55 Gy in 20 fractions over 4 weeks) or weekly (36 Gy in six fractions over 6 weeks) schedule that was nominated before randomisation. The primary outcome was overall survival, measured as the number of deaths; this analysis had 90% power with a one-sided α of 2·5% for a hazard ratio (HR) of 0·75. Secondary outcomes were failure-free survival, progression-free survival, metastatic progression-free survival, prostate cancer-specific survival, and symptomatic local event-free survival. Analyses used Cox proportional hazards and flexible parametric models, adjusted for stratification factors. The primary outcome analysis was by intention to treat. Two prespecified subgroup analyses tested the effects of prostate radiotherapy by baseline metastatic burden and radiotherapy schedule. This trial is registered with ClinicalTrials.gov, number NCT00268476. FINDINGS Between Jan 22, 2013, and Sept 2, 2016, 2061 men underwent randomisation, 1029 were allocated the control and 1032 radiotherapy. Allocated groups were balanced, with a median age of 68 years (IQR 63-73) and median amount of prostate-specific antigen of 97 ng/mL (33-315). 367 (18%) patients received early docetaxel. 1082 (52%) participants nominated the daily radiotherapy schedule before randomisation and 979 (48%) the weekly schedule. 819 (40%) men had a low metastatic burden, 1120 (54%) had a high metastatic burden, and the metastatic burden was unknown for 122 (6%). Radiotherapy improved failure-free survival (HR 0·76, 95% CI 0·68-0·84; p

Published
2018

43. The Accuracy of Clinical Staging of Stage I-IIIa Non-Small Cell Lung Cancer

Author

Navani, Neal, primary, Fisher, David J., additional, Tierney, Jayne F., additional, Stephens, Richard J., additional, Burdett, Sarah, additional, Rydzewska, Larysa H.M., additional, Auperin, Anne, additional, Le Chevalier, Thierry, additional, Le Pechoux, Cécile, additional, Pignon, Jean-Pierre, additional, Arriagada, Rodrigo, additional, Johnson, David H., additional, van Meerbeeck, Jan, additional, Parmar, Mahesh K.B., additional, Stewart, Lesley A., additional, Bunn, Paul A., additional, Dautzenberg, Bertrand, additional, Gilligan, David, additional, Groen, Harry, additional, Knuuttila, Aija, additional, Vallieres, Eric, additional, Rosell, Rafael, additional, Roth, Jack, additional, Scagliotti, Giorgio, additional, Tsuboi, Masahiro, additional, Waller, David, additional, Westeel, Virginie, additional, Wu, Yi-Long, additional, and Yang, Xue-Ning, additional

Published
2019
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44. Predictive Classifier for Intensive Treatment of Head and Neck Cancer

Author

Zakeri, Kaveh, primary, Rotolo, Federico, additional, Lacas, Benjamin, additional, Vitzthum, Lucas K., additional, Le, Quynh-Thu, additional, Gregoire, Vincent, additional, Overgaard, Jens, additional, Hackshaw, Allan, additional, Zackrisson, Björn, additional, Parmar, Mahesh K.B., additional, Burtness, Barbara, additional, Ghi, Maria Grazia, additional, Sanguineti, Giuseppe, additional, O’Sullivan, Brian, additional, Fortpied, Catherine, additional, Bourhis, Jean, additional, Shen, Hanjie, additional, Harris, Jonathan, additional, Michiels, Stefan, additional, Pignon, Jean-Pierre, additional, Mell, Loren, additional, Group, MARCH/MACH-NC Collaborative, additional, and (HNCIG), the Head and Neck Cancer Intergroup, additional

Published
2019
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47. Assessing whether to perform a confirmatory randomized clinical trial

Author

Parmar, Mahesh K.B., Ungerleider, Richard S., and Simon, Richard, French biblical critic

Subjects
Clinical trials -- Usage, Cancer -- Research, Health
Abstract

Background: A confirmatory randomized clinical trial is a trial that is aimed at assessing whether a treatment effect observed in a previous randomized trial (or trials) is real and important. There is often considerable disagreement about the need for such confirmatory trials. Purpose: Our aim is to provide a general statistical framework for evaluating whether a confirmatory trial is warranted in a particular situation. Methods and Results: The results of two clinical trials are considered: 1) a Cancer and Leukemia Group B trial comparing induction chemotherapy plus radiotherapy with radiotherapy alone in the treatment of patients with locally advanced non-small-cell lung cancer and 2) a North Central Cancer Treatment Group trial comparing surgery plus adjuvant chemotherapy with surgery alone in the :treatment of patients with advanced colon cancer. In our analysis, we argue that differences in the interpretation of results from a randomized trial are based on differences in prior beliefs about the efficacy of the treatment(s) under study. We believe that a major factor in the decision to perform a confirmatory trial is prior skepticism about the clinical worth of the treatment in question. Both the level of prior skepticism and the minimum treatment effect deemed clinically worthwhile require subjective judgment. We develop a Bayesian framework to allow differences in interpretation to be examined systematically and the need for a confirmatory trial to be assessed. Our model allows the addition of prior belief (specified in the form of a prior distribution of treatment effect) to the results of a trial to yield a posterior distribution. The interpretation of trial results is based on the posterior distribution and will vary as the prior distribution (i.e., the prior belief) varies. To aid in the interpretation of trial results, we also advocate the specification of a minimum clinically worthwhile treatment effect at the start of a trial. Conclusions and Implications: Our approach acknowledges that a number of different prior beliefs are possible, giving rise to a range of interpretations of results from a clinical trial. This approach provides a formal and systematic basis for considering both the range of likely opinions and the subsequent decision to be made with regard to the need for a confirmatory trial. We recommend that this approach be considered in the discussion of future confirmatory randomized clinical trials.

Published
1996

48. Meta-analysis

Author

Stewart, Lesley and Parmar, Mahesh K.B.

Published
1993

49. Adding Celecoxib With or Without Zoledronic Acid for Hormone-Naïve Prostate Cancer: Long-Term Survival Results From an Adaptive, Multiarm, Multistage, Platform, Randomized Controlled Trial

Author

Mason, Malcolm D., Clarke, Noel W., James, Nicholas D., Dearnaley, David P., Spears, Melissa R., Ritchie, Alastair W.S., Attard, Gerhardt, Cross, William, Jones, Rob J., Parker, Christopher C., Russell, J. Martin, Thalmann, George N., Schiavone, Francesca, Cassoly, Estelle, Matheson, David, Millman, Robin, Rentsch, Cyrill A., Barber, Jim, Gilson, Clare, Ibrahim, Azman, Logue, John, Lydon, Anna, Nikapota, Ashok D., O'Sullivan, Joe M., Porfiri, Emilio, Protheroe, Andrew, Srihari, Narayanan Nair, Tsang, David, Wagstaff, John, Wallace, Jan, Walmsley, Catherine, Parmar, Mahesh K.B., and Sydes, Matthew R.

Subjects
Adult, Aged, 80 and over, Male, Time Factors, Diphosphonates, Imidazoles, Prostatic Neoplasms, 610 Medicine & health, Middle Aged, Prostate-Specific Antigen, Zoledronic Acid, Disease-Free Survival, Gonadotropin-Releasing Hormone, Survival Rate, Celecoxib, Cause of Death, Lymphatic Metastasis, Antineoplastic Combined Chemotherapy Protocols, Early Termination of Clinical Trials, Humans, Orchiectomy, Aged, Follow-Up Studies, Proportional Hazards Models
Abstract

Purpose: Systemic Therapy for Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy is a randomized controlled trial using a multiarm, multistage, platform design. It recruits men with high-risk, locally advanced or metastatic prostate cancer who were initiating long-term hormone therapy. We report survival data for two celecoxib (Cel)-containing comparisons, which stopped accrual early at interim analysis on the basis of failure-free survival. Patients and Methods: Standard of care (SOC) was hormone therapy continuously (metastatic) or for ≥ 2 years (nonmetastatic); prostate (± pelvic node) radiotherapy was encouraged for men without metastases. Cel 400 mg was administered twice a day for 1 year. Zoledronic acid (ZA) 4 mg was administered for six 3-weekly cycles, then 4-weekly for 2 years. Stratified random assignment allocated patients 2:1:1 to SOC (control), SOC + Cel, or SOC + ZA + Cel. The primary outcome measure was all-cause mortality. Results were analyzed with Cox proportional hazards and flexible parametric models adjusted for stratification factors. Results: A total of 1,245 men were randomly assigned (Oct 2005 to April 2011). Groups were balanced: median age, 65 years; 61% metastatic, 14% N+/X M0, 25% N0M0; 94% newly diagnosed; median prostate-specific antigen, 66 ng/mL. Median follow-up was 69 months. Grade 3 to 5 adverse events were seen in 36% SOC-only, 33% SOC + Cel, and 32% SOC + ZA + Cel patients. There were 303 control arm deaths (83% prostate cancer), and median survival was 66 months. Compared with SOC, the adjusted hazard ratio was 0.98 (95% CI, 0.80 to 1.20; P = .847; median survival, 70 months) for SOC + Cel and 0.86 (95% CI, 0.70 to 1.05; P =.130; median survival, 76 months) for SOC + ZA + Cel. Preplanned subgroup analyses in men with metastatic disease showed a hazard ratio of 0.78 (95% CI, 0.62 to 0.98; P = .033) for SOC + ZA + Cel. Conclusion: These data show no overall evidence of improved survival with Cel. Preplanned subgroup analyses provide hypotheses for future studies.

Published
2017

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