Search

Your search keyword '"Charu, Veena"' showing total 43 results
Start Over Author "Charu, Veena"
43 results on '"Charu, Veena"'

1. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, Zurawski, Bogdan, Spicer, Jonathan D, Garassino, Marina C, Majem, Margarita, Martinengo, Gastón L, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, and Samkari, Ayman

Published
2024
Full Text
View/download PDF

2. Feasibility of Long-term Proteasome Inhibition in Multiple Myeloma by in-class Transition From Bortezomib to Ixazomib

Author

Manda, Sudhir, Yimer, Habte A., Noga, Stephen J., Girnius, Saulius, Yasenchak, Christopher A., Charu, Veena, Lyons, Roger, Aiello, Jack, Bogard, Kimberly, Ferrari, Renda H., Cherepanov, Dasha, Demers, Brittany, Lu, Vickie, Whidden, Presley, Kambhampati, Suman, Birhiray, Ruemu E., Jhangiani, Haresh S., Boccia, Ralph, and Rifkin, Robert M.

Published
2020
Full Text
View/download PDF

3. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study

Author

Agajanian, Richy, Ahmad, Rizvana, Aktas, Bahriye, Alencar, Victor Hugo, Amadori, Dino, Andrade, Jurandyr, André Franke, Fábio, Angiolini, Catia, Aogi, Kenjiro, Armor, Jess, Arpornwirat, Wichit, Assersohn, Laura, Audeh, William, Aulitzky, Walter, Azevedo, Sergio, Bartoli, Maria Alejandra, Batista Lopez, Norberto, Bianconi, María, Biganzoli, Laura, Birhiray, Ruemu, Bitina, Marianna, Blachy, Ron, Blackwell, Kimberly, Blanchard, Rita, Blanchet, Paulette, Boiangiu, Ion, Bower, Barbara, Brezden-Masley, Christine, Brufsky, Adam, Budde, Leanne, Caguioa, Priscilla, Calvo, Lourdes, Campone, Mario, Carroll, Robert R., Castro, Hugo, Chan, Valorie, Charu, Veena, Cinieri, Saverio, Clemens, Michael, Conejo, Emilio Alba, Côrtes, Eduardo, Coudert, Bruno, Cronemberger, Eduardo, Cubero, Daniel, Dakhil, Shaker, Daniel, Brooke, Davidson, Neville, De Fatima Gaui, Maria, De La Cruz, Susana, Del Pilar, Maria, Delgado, Gilson, Ellerton, John A., Estuardo, Cesar, Fehrenbacher, Louis, Ferrero, Jean-Marc, Flynn, Patrick J., Foszczynska-Kloda, Malgorzata, Franco, Sandra, Fujii, Hirofumi, Gallagher, Chris, Gamucci, Teresa, Giacomi, Nora, Gil I Gil, Miguel, Gonzalez Martin, Antonio, Gorbunova, Vera, Gotovkin, Eugeny, Green, Nathan, Grincuka, Elza, Grischke, Eva-Maria, Hansen, Vincent, Hargis, Jeffrey, Hauschild, Maik, Hegg, Roberto, Hendricks, Carolyn, Hermann, Robert, Hoff, Paulo, Horiguchi, Jun, Hornedo Muguiro, Javier, Iacobelli, Stefano, Inoue, Kenichi, Ismael, Gustavo, Itoh, Yoshinori, Iwata, Dr Hiroji, Jendiroba, Davi, Jochim, Rosa, Jones, Alison, Just, Marianne, Kallab, Andre, Karwal, Mark, Kashiwaba, Masahiro, Kato, Giraldo, Kaufman, Peter A., Kellokumpu-Lehtinen, Pirkko, Kirsch, Andreas, Kiselev, Igor, Klein, Paula, Kohno, Norio, Kopp, Mikhail, Kostovska-Maneva, Liljana, Kotliar, Mauricio, Kudaba, Iveta, Kümmel, Sherko, Kuroi, Katsumasa, Lacava, Juan, Latini, Luciano, Lee, Soo Chin, Lichinitser, Mikhail, Lobo, Christopher, Maintz, Christoph, Maneecahvakajorn, Jedzada, Marmé, Alexander, Martinez, Gloria, Masuda, Norikazu, Matwiejuk, Mario, Merculov, Vladimir, Michaelson, Richard, Miguel, Luis, Monroy, Hernandez, Montemurro, Filippo, Morales, Serafin, Moura, Rodrigo, Mueller, Volkmar, Mulatero, Clive, Nakagami, Kazuhiko, Nakayama, Takahiro, Neidhart, Jeff, Nguyen, An, Nishimura, Reiki, Ogata, Haruki, O'reilly, Susan, O'rourke, Timothy, Otero Reye, Douglas, Ouyang, Xuenong, Patel, Ravi, Patel, Taral, Pedrini, Jose Luiz, Pereira, Rodrigo, Perez, Alejandra, Peterson, Carol, Pienkowski, Tadeusz, Pinczowski, Helio, Polikoff, Jonathan, Polkowski, Wojciech, Price, Paola Edith, Prill, Sue, Priou, Frank, Purkalne, Gunta, Pyrhoenen, Seppo, Quackenbush, Robert, Rai, Yoshiaki, Ribelles, Nuria, Ro, Jungsil, Robinson, Anne, Robles, Robert, Rodriguez, Gladys, Roman, Laslo, Saji, Shigehira, Sanchez-Rovira, Pedro, Sato, Nobuaki, Schmidt, Marcus, Schumacher, Claudia, Senecal, Frank, Sharma, Priyanka, Shen, Zhenzhou, Shirinkin, Vadim, Simoncini, Edda, Sirisinha, Thitiya, Smith, Raymond, Sohn, Joo-Hyuk, Soldic, Zeljko, Soria, Tania, Spicer, Darcy, Srimuninnimit, Vichien, Sriuranpong, Virote, Staroslawska, Elzbieta, Stefanovski, Petar, Sunpaweravong, Patrapim, Taguchi, Julie, Takeda, Koji, Tellez-Trevilla, Gabriel, Thomas, Randall, Thomssen, Christoph, Toache, Zetina, Tokuda, Yutaka, Tomczak, Piotr, Tosello, Celia, Tsugawa, Koichiro, Tudtud, Dennis, Ueno, Takayuki, Van Eyll, Brigitte, Varela, Mirta, Vasev, Nikola, Vrbanec, Damir, Wang, Xiaojia, Wang, Liwei, Watanabe, Junichiro, Waterhouse, David, Wesenberg, Birgitta, Wheatley, Duncan, Wong, Zee Wan, Yadav, Sanjay, Yardley, Denise, Yau, Tsz-Kok, Yeo, Winnie, Ying, Cheng, Youn Oh, Do, Swain, Sandra M, Miles, David, Kim, Sung-Bae, Im, Young-Hyuck, Im, Seock-Ah, Semiglazov, Vladimir, Ciruelos, Eva, Schneeweiss, Andreas, Loi, Sherene, Monturus, Estefanía, Clark, Emma, Knott, Adam, Restuccia, Eleonora, Benyunes, Mark C, and Cortés, Javier

Published
2020
Full Text
View/download PDF

4. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Spicer, Jonathan D, Garassino, Marina C, Wakelee, Heather, Liberman, Moishe, Kato, Terufumi, Tsuboi, Masahiro, Lee, Se-Hoon, Chen, Ke-Neng, Dooms, Christophe, Majem, Margarita, Eigendorff, Ekkehard, Martinengo, Gastón L, Bylicki, Olivier, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Novello, Silvia, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, Samkari, Ayman, Gao, Shugeng, Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, and Zurawski, Bogdan

Abstract

At the first interim analysis of the KEYNOTE-671 trial, adding perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved event-free survival in participants with early-stage non-small-cell lung cancer (NSCLC). We report overall survival and health-related quality of life outcomes from the second interim analysis.

Published
2024
Full Text
View/download PDF

5. Supplementary Data from Changes in 18F-Fluorodeoxyglucose and 18F-Fluorodeoxythymidine Positron Emission Tomography Imaging in Patients with Non–Small Cell Lung Cancer Treated with Erlotinib

Author

Mileshkin, Linda, primary, Hicks, Rodney J., primary, Hughes, Brett G.M., primary, Mitchell, Paul L.R., primary, Charu, Veena, primary, Gitlitz, Barbara J., primary, Macfarlane, David, primary, Solomon, Benjamin, primary, Amler, Lukas C., primary, Yu, Wei, primary, Pirzkall, Andrea, primary, and Fine, Bernard M., primary

Published
2023
Full Text
View/download PDF

6. Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: A combined analysis of 3 pivotal, randomised, phase 3 trials

Author

Lipton, Allan, Fizazi, Karim, Stopeck, Alison T., Henry, David H., Brown, Janet E., Yardley, Denise A., Richardson, Gary E., Siena, Salvatore, Maroto, Pablo, Clemens, Michael, Bilynskyy, Boris, Charu, Veena, Beuzeboc, Philippe, Rader, Michael, Viniegra, Maria, Saad, Fred, Ke, Chunlei, Braun, Ada, and Jun, Susie

Published
2012
Full Text
View/download PDF

9. Long-term proteasome inhibition in US community multiple myeloma (MM) patients (pts) following in-class transition (iCT) from parenteral bortezomib (V) to oral ixazomib (I): Updated real-world (RW) data from US MM-6.

Author

Girnius, Saulius Kazmiems, primary, Yimer, Habte Aragaw, additional, Manda, Sudhir, additional, Yasenchak, Christopher A., additional, Charu, Veena, additional, Lyons, Roger M., additional, Kambhampati, Suman, additional, Birhiray, Reumu E., additional, Jhangiani, Haresh S., additional, Boccia, Ralph V., additional, Whidden, Presley, additional, Bogard, Kim, additional, Cherepanov, Dasha, additional, Noga, Stephen Joseph, additional, and Rifkin, Robert M., additional

Published
2020
Full Text
View/download PDF

10. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study

Author

Swain, Sandra M, primary, Miles, David, additional, Kim, Sung-Bae, additional, Im, Young-Hyuck, additional, Im, Seock-Ah, additional, Semiglazov, Vladimir, additional, Ciruelos, Eva, additional, Schneeweiss, Andreas, additional, Loi, Sherene, additional, Monturus, Estefanía, additional, Clark, Emma, additional, Knott, Adam, additional, Restuccia, Eleonora, additional, Benyunes, Mark C, additional, Cortés, Javier, additional, Agajanian, Richy, additional, Ahmad, Rizvana, additional, Aktas, Bahriye, additional, Alencar, Victor Hugo, additional, Amadori, Dino, additional, Andrade, Jurandyr, additional, André Franke, Fábio, additional, Angiolini, Catia, additional, Aogi, Kenjiro, additional, Armor, Jess, additional, Arpornwirat, Wichit, additional, Assersohn, Laura, additional, Audeh, William, additional, Aulitzky, Walter, additional, Azevedo, Sergio, additional, Bartoli, Maria Alejandra, additional, Batista Lopez, Norberto, additional, Bianconi, María, additional, Biganzoli, Laura, additional, Birhiray, Ruemu, additional, Bitina, Marianna, additional, Blachy, Ron, additional, Blackwell, Kimberly, additional, Blanchard, Rita, additional, Blanchet, Paulette, additional, Boiangiu, Ion, additional, Bower, Barbara, additional, Brezden-Masley, Christine, additional, Brufsky, Adam, additional, Budde, Leanne, additional, Caguioa, Priscilla, additional, Calvo, Lourdes, additional, Campone, Mario, additional, Carroll, Robert R., additional, Castro, Hugo, additional, Chan, Valorie, additional, Charu, Veena, additional, Cinieri, Saverio, additional, Clemens, Michael, additional, Conejo, Emilio Alba, additional, Côrtes, Eduardo, additional, Coudert, Bruno, additional, Cronemberger, Eduardo, additional, Cubero, Daniel, additional, Dakhil, Shaker, additional, Daniel, Brooke, additional, Davidson, Neville, additional, De Fatima Gaui, Maria, additional, De La Cruz, Susana, additional, Del Pilar, Maria, additional, Delgado, Gilson, additional, Ellerton, John A., additional, Estuardo, Cesar, additional, Fehrenbacher, Louis, additional, Ferrero, Jean-Marc, additional, Flynn, Patrick J., additional, Foszczynska-Kloda, Malgorzata, additional, Franco, Sandra, additional, Fujii, Hirofumi, additional, Gallagher, Chris, additional, Gamucci, Teresa, additional, Giacomi, Nora, additional, Gil I Gil, Miguel, additional, Gonzalez Martin, Antonio, additional, Gorbunova, Vera, additional, Gotovkin, Eugeny, additional, Green, Nathan, additional, Grincuka, Elza, additional, Grischke, Eva-Maria, additional, Hansen, Vincent, additional, Hargis, Jeffrey, additional, Hauschild, Maik, additional, Hegg, Roberto, additional, Hendricks, Carolyn, additional, Hermann, Robert, additional, Hoff, Paulo, additional, Horiguchi, Jun, additional, Hornedo Muguiro, Javier, additional, Iacobelli, Stefano, additional, Inoue, Kenichi, additional, Ismael, Gustavo, additional, Itoh, Yoshinori, additional, Iwata, Dr Hiroji, additional, Jendiroba, Davi, additional, Jochim, Rosa, additional, Jones, Alison, additional, Just, Marianne, additional, Kallab, Andre, additional, Karwal, Mark, additional, Kashiwaba, Masahiro, additional, Kato, Giraldo, additional, Kaufman, Peter A., additional, Kellokumpu-Lehtinen, Pirkko, additional, Kirsch, Andreas, additional, Kiselev, Igor, additional, Klein, Paula, additional, Kohno, Norio, additional, Kopp, Mikhail, additional, Kostovska-Maneva, Liljana, additional, Kotliar, Mauricio, additional, Kudaba, Iveta, additional, Kümmel, Sherko, additional, Kuroi, Katsumasa, additional, Lacava, Juan, additional, Latini, Luciano, additional, Lee, Soo Chin, additional, Lichinitser, Mikhail, additional, Lobo, Christopher, additional, Maintz, Christoph, additional, Maneecahvakajorn, Jedzada, additional, Marmé, Alexander, additional, Martinez, Gloria, additional, Masuda, Norikazu, additional, Matwiejuk, Mario, additional, Merculov, Vladimir, additional, Michaelson, Richard, additional, Miguel, Luis, additional, Monroy, Hernandez, additional, Montemurro, Filippo, additional, Morales, Serafin, additional, Moura, Rodrigo, additional, Mueller, Volkmar, additional, Mulatero, Clive, additional, Nakagami, Kazuhiko, additional, Nakayama, Takahiro, additional, Neidhart, Jeff, additional, Nguyen, An, additional, Nishimura, Reiki, additional, Ogata, Haruki, additional, O'reilly, Susan, additional, O'rourke, Timothy, additional, Otero Reye, Douglas, additional, Ouyang, Xuenong, additional, Patel, Ravi, additional, Patel, Taral, additional, Pedrini, Jose Luiz, additional, Pereira, Rodrigo, additional, Perez, Alejandra, additional, Peterson, Carol, additional, Pienkowski, Tadeusz, additional, Pinczowski, Helio, additional, Polikoff, Jonathan, additional, Polkowski, Wojciech, additional, Price, Paola Edith, additional, Prill, Sue, additional, Priou, Frank, additional, Purkalne, Gunta, additional, Pyrhoenen, Seppo, additional, Quackenbush, Robert, additional, Rai, Yoshiaki, additional, Ribelles, Nuria, additional, Ro, Jungsil, additional, Robinson, Anne, additional, Robles, Robert, additional, Rodriguez, Gladys, additional, Roman, Laslo, additional, Saji, Shigehira, additional, Sanchez-Rovira, Pedro, additional, Sato, Nobuaki, additional, Schmidt, Marcus, additional, Schumacher, Claudia, additional, Senecal, Frank, additional, Sharma, Priyanka, additional, Shen, Zhenzhou, additional, Shirinkin, Vadim, additional, Simoncini, Edda, additional, Sirisinha, Thitiya, additional, Smith, Raymond, additional, Sohn, Joo-Hyuk, additional, Soldic, Zeljko, additional, Soria, Tania, additional, Spicer, Darcy, additional, Srimuninnimit, Vichien, additional, Sriuranpong, Virote, additional, Staroslawska, Elzbieta, additional, Stefanovski, Petar, additional, Sunpaweravong, Patrapim, additional, Taguchi, Julie, additional, Takeda, Koji, additional, Tellez-Trevilla, Gabriel, additional, Thomas, Randall, additional, Thomssen, Christoph, additional, Toache, Zetina, additional, Tokuda, Yutaka, additional, Tomczak, Piotr, additional, Tosello, Celia, additional, Tsugawa, Koichiro, additional, Tudtud, Dennis, additional, Ueno, Takayuki, additional, Van Eyll, Brigitte, additional, Varela, Mirta, additional, Vasev, Nikola, additional, Vrbanec, Damir, additional, Wang, Xiaojia, additional, Wang, Liwei, additional, Watanabe, Junichiro, additional, Waterhouse, David, additional, Wesenberg, Birgitta, additional, Wheatley, Duncan, additional, Wong, Zee Wan, additional, Yadav, Sanjay, additional, Yardley, Denise, additional, Yau, Tsz-Kok, additional, Yeo, Winnie, additional, Ying, Cheng, additional, and Youn Oh, Do, additional

Published
2020
Full Text
View/download PDF

13. Initiation of epoetin-(alpha) therapy at a starting dose of 120,000 units once every 3 weeks in patients with cancer receiving chemotherapy: an open-label, multicenter study with randomized and nonrandomized treatment arms

Author

Glaspy, John A., Charu, Veena, Luo, Donghan, Moyo, Victor, Kamin, Marc, and Wilhelm, Francois E.

Subjects
Erythropoietin, Recombinant -- Dosage and administration, Erythropoietin, Recombinant -- Research, Chemotherapy -- Complications and side effects, Chemotherapy -- Research, Anemia -- Care and treatment, Anemia -- Research, Cancer -- Chemotherapy, Cancer -- Complications and side effects, Cancer -- Research, Health
Published
2009

18. Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens

Author

Niesvizky, Ruben, primary, Flinn, Ian W., additional, Rifkin, Robert, additional, Gabrail, Nashat, additional, Charu, Veena, additional, Clowney, Billy, additional, Essell, James, additional, Gaffar, Yousuf, additional, Warr, Thomas, additional, Neuwirth, Rachel, additional, Zhu, Yanyan, additional, Elliott, Jennifer, additional, Esseltine, Dixie-Lee, additional, Niculescu, Liviu, additional, and Reeves, James, additional

Published
2015
Full Text
View/download PDF

19. A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma

Author

Berenson, James R., primary, Yellin, Ori, additional, Shamasunder, Hesaraghatta K., additional, Chen, Chien-Shing, additional, Charu, Veena, additional, Woliver, Thomas B., additional, Sanani, Shamel, additional, Schlutz, Michael, additional, Nassir, Youram, additional, Swift, Regina A., additional, Andreu-Vieyra, Claudia, additional, and Vescio, Robert, additional

Published
2014
Full Text
View/download PDF

20. Patient-Reported Quality of Life (QoL) in Elderly, Newly Diagnosed Multiple Myeloma (MM) Patients Receiving Bortezomib-Based Combinations: Results From All Randomized Patients in the Community-Based, Phase 3b UPFRONT Study

Author

Niesvizky, Ruben, primary, Flinn, Ian W., additional, Rifkin, Robert, additional, Gabrail, Nashat, additional, Charu, Veena, additional, Clowney, Billy, additional, Gaffar, Yousuf, additional, Warr, Thomas A., additional, Neuwirth, Rachel, additional, Huang, Hui, additional, Choi, Sanggyu, additional, and Corzo, Deyanira, additional

Published
2011
Full Text
View/download PDF

21. Efficacy and Safety of Three Bortezomib-Based Combinations in Elderly, Newly Diagnosed Multiple Myeloma Patients: Results From All Randomized Patients in the Community-Based, Phase 3b UPFRONT Study

Author

Niesvizky, Ruben, primary, Flinn, Ian W., additional, Rifkin, Robert, additional, Gabrail, Nashat, additional, Charu, Veena, additional, Clowney, Billy, additional, Essell, James, additional, Gaffar, Yousuf, additional, Warr, Thomas A., additional, Neuwirth, Rachel, additional, Corzo, Deyanira, additional, and Reeves, James, additional

Published
2011
Full Text
View/download PDF

22. Changes in 18F-Fluorodeoxyglucose and 18F-Fluorodeoxythymidine Positron Emission Tomography Imaging in Patients with Non–Small Cell Lung Cancer Treated with Erlotinib

Author

Mileshkin, Linda, primary, Hicks, Rodney J., additional, Hughes, Brett G.M., additional, Mitchell, Paul L.R., additional, Charu, Veena, additional, Gitlitz, Barbara J., additional, Macfarlane, David, additional, Solomon, Benjamin, additional, Amler, Lukas C., additional, Yu, Wei, additional, Pirzkall, Andrea, additional, and Fine, Bernard M., additional

Published
2011
Full Text
View/download PDF

23. Phase 3b UPFRONT Study: Safety and Efficacy of Weekly Bortezomib Maintenance Therapy After Bortezomib-Based Induction Regimens In Elderly, Newly Diagnosed Multiple Myeloma Patients

Author

Niesvizky, Ruben, primary, Flinn, Ian W., additional, Rifkin, Robert M., additional, Gabrail, Nashat Y, additional, Charu, Veena, additional, Clowney, Billy, additional, Essell, James, additional, Gaffar, Yousuf A, additional, Warr, Thomas A., additional, Neuwirth, Rachel, additional, Corzo, Deyanira, additional, and Reeves, James A, additional

Published
2010
Full Text
View/download PDF

24. Patient-Reported Quality of Life In Elderly, Newly Diagnosed Multiple Myeloma Patients Treated with Bortezomib-Based Regimens: Results From the Phase 3b UPFRONT Study

Author

Niesvizky, Ruben, primary, Flinn, Ian W., additional, Rifkin, Robert M., additional, Gabrail, Nashat Y, additional, Charu, Veena, additional, Clowney, Billy, additional, Essell, James, additional, Gaffar, Yousuf A, additional, Warr, Thomas A., additional, Neuwirth, Rachel, additional, Corzo, Deyanira, additional, and Reeves, James A, additional

Published
2010
Full Text
View/download PDF

25. Phase 3b UPFRONT Study: Interim Results From a Community Practice-Based Prospective Randomized Trial Evaluating Three Bortezomib-Based Regimens in Elderly, Newly Diagnosed Multiple Myeloma Patients.

Author

Niesvizky, Ruben, primary, Reeves, James, additional, Flinn, Ian W, additional, Rifkin, Robert M., additional, Clowney, Billy, additional, Gabrail, Nashat, additional, Phooshkooru, Vijay R., additional, Charu, Veena, additional, Chay, Christopher H., additional, Corzo, Deyanira, additional, Neuwirth, Rachel, additional, Manges, Robert F., additional, and Warr, Thomas A., additional

Published
2009
Full Text
View/download PDF

38. Randomized, open-label comparison of epoetin alfa extended dosing (80 000 U Q2W) vs weekly dosing (40 000 U QW) in patients with chemotherapy-induced anemia*

Author

Henry, David H., Gordan, Lucio N., Charu, Veena, Wilhelm, Francois E., Williams, Denise, Xie, John, and Woodman, Richard C.

Abstract

ABSTRACTObjective:This randomized, open-label, multicenter study compared the efficacy and safety of epoetin alfa (EPO) 80 000 U every 2 weeks (Q2W) to the FDA-approved regimen of 40 000 U weekly (QW) in patients with chemotherapy-induced anemia.Research design and methods:A total of 310 patients with nonmyeloid malignancy and baseline hemoglobin (Hb) < 11 g/dL who were scheduled to receive chemotherapy for a minimum of 12 weeks were randomized to EPO Q2W or QW for up to 12 weeks, with dose modification to maintain Hb at approximately 12 g/dL. Efficacy analyses used the per-protocol population (patients who completed the study with a value for Hb change) for the primary endpoint only and the modified intent-to-treat (mITT) population (patients who received study drug and had at least one postbaseline Hb value) for the primary and secondary endpoints.Results:Analysis of the primary endpoint revealed that the mean change in Hb from baseline to study end was comparable between the Q2W and QW groups in the per-protocol population (1.6 g/dL vs 1.8 g/dL, respectively; treatment difference, −0.2 g/dL; one-sided 95% confidence interval [‐0.56, ‐]); similar results were observed in the mITT population. Among patients on study at Day 29, 9.6% (13/135) and 11.1% (14/126) of patients in the Q2W and QW groups, respectively, received a transfusion between Day 29 and the end of the study (p = 0.709). Dose withholds (21% vs 42%, p < 0.001) and dose reductions (41% vs 59%, p = 0.003) were less common for Q2W than QW. Safety profiles were similar between groups; clinically relevant thrombotic vascular events occurred in 8% of patients in each group. The open-label dosing and the patient attrition rate did not appear to influence overall study results.Conclusions:Extended dosing (80 000 U Q2W) and once-weekly dosing (40 000 U QW) of EPO provided comparable safety and efficacy for chemotherapy-induced anemia.

Published
2006
Full Text
View/download PDF

39. Randomized, double-blind, placebo-controlled trial of every-3-week darbepoetin alfa 300 micrograms for treatment of chemotherapy-induced anemia.

Author

Hernandez E, Ganly P, Charu V, Dibenedetto J, Tomita D, Lillie T, and Taylor K

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Algorithms, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Darbepoetin alfa, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Erythropoietin administration & dosage, Female, Humans, Male, Middle Aged, Neoplasms drug therapy, Placebos, Young Adult, Anemia drug therapy, Anemia etiology, Antineoplastic Combined Chemotherapy Protocols adverse effects, Erythropoietin analogs & derivatives
Abstract

Objective: Darbepoetin alfa is effective in treating chemotherapy-induced anemia (CIA). Administration of subcutaneous darbepoetin alfa every 3 weeks (Q3W) could simplify treatment through synchronization with common Q3W chemotherapy regimens. We report results from a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial evaluating the efficacy and safety of fixed-dose Q3W darbepoetin alfa in patients with a wide variety of tumor types who experienced CIA., Research Design and Methods: Patients aged > or = 18 years with anemia (hemoglobin <11 g/dL) being treated for nonmyeloid malignancy were randomized 1:1 to receive darbepoetin alfa 300 microg (n = 193) or placebo (n = 193) subcutaneously Q3W from weeks 1 to 13 in this 16-week study. Doses could be adjusted per prespecified rules., Main Outcome Measures: The primary endpoint was the proportion of patients who received > or =1 red blood cell (RBC) transfusion between week 5 and the end of the treatment period (EOTP). The study also analyzed the proportions of patients achieving a hemoglobin concentration > or =11 g/dL and subsequently maintaining hemoglobin levels above 11 g/dL, and the change in hemoglobin concentration over time., Results: The proportion of patients requiring RBC transfusions between week 5 and EOTP was significantly lower in the darbepoetin alfa-treated group than in the placebo-treated group (24 vs. 41% of patients, a 16.3% difference, p < 0.001). There were no differences between the two treatment arms in quality-of-life measures. Cardiovascular/thromboembolic adverse events were uncommon and were not associated with increases in hemoglobin levels. Study limitations suggest caution in the interpretation of these results: transfusions, the primary endpoint, were recommended but not required if hemoglobin concentrations were < or =8.0 g/dL, and protocol deviations (primarily dosing errors) occurred in approximately one-half of the patients in both treatment groups., Conclusions: In this study, fixed-dose Q3W darbepoetin alfa appeared to be well-tolerated and effective for the treatment of CIA., Trial Registration: Study 20030232; ClinicalTrials.Gov Identifier: NCT00110955.

Published
2009
Full Text
View/download PDF

40. Combination therapy for chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy: palonosetron, dexamethasone, and aprepitant.

Author

Grote T, Hajdenberg J, Cartmell A, Ferguson S, Ginkel A, and Charu V

Subjects
Adult, Aged, Aged, 80 and over, Antiemetics adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Aprepitant, Dexamethasone adverse effects, Dexamethasone therapeutic use, Female, Humans, Isoquinolines adverse effects, Isoquinolines therapeutic use, Male, Middle Aged, Morpholines adverse effects, Morpholines therapeutic use, Nausea chemically induced, Neoplasms drug therapy, Palonosetron, Quinuclidines adverse effects, Quinuclidines therapeutic use, Serotonin Antagonists adverse effects, Serotonin Antagonists therapeutic use, Vomiting chemically induced, Antiemetics therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Nausea prevention & control, Vomiting prevention & control
Abstract

The objective of this multicenter, phase II, open-label study was to evaluate the safety and efficacy of the newest 5-hydroxytryptamine3 (5-HT3) receptor antagonist, palonosetron, plus dexamethasone and aprepitant in preventing nausea and vomiting in patients receiving moderately emetogenic chemotherapy. Eligible patients received a single intravenous dose of palonosetron (0.25 mg on day 1 of chemotherapy), along with 3 daily oral doses of aprepitant (125 mg on day 1,80 mg on days 2 and 3) and dexamethasone (12 mg on day 1,8 mg on days 2 and 3). Efficacy and safety data were obtained from patient diaries and adverse event reporting. Fifty-eight patients were evaluable; 47% were women with breast cancer and 52% received cyclophosphamide-based chemotherapy. The proportion of patients with complete response (no emesis and no rescue medication) was 88% during the acute (0-24 hours) interval, 78% during the delayed (> 24-120 hours) interval, and 78% during the overall (0-120 hours post chemotherapy) interval. More than 90% of patients during all time intervals had no emetic episodes, and between 57% and 71% of patients reported no nausea during each of the 5 days post chemotherapy. Treatment was well tolerated, with no unexpected adverse events. These data demonstrate that palonosetron in combination with dexamethasone and aprepitant is safe and highly effective in preventing chemotherapy-induced nausea and vomiting in the days following administration of moderately emetogenic chemotherapy.

Published
2006

41. Randomized comparison of epoetin alfa (40,000 U weekly) and darbepoetin alfa (200 microg every 2 weeks) in anemic patients with cancer receiving chemotherapy.

Author

Waltzman R, Croot C, Justice GR, Fesen MR, Charu V, and Williams D

Subjects
Aged, Anemia chemically induced, Anemia etiology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Darbepoetin alfa, Epoetin Alfa, Female, Humans, Male, Middle Aged, Quality of Life, Recombinant Proteins, Anemia drug therapy, Antineoplastic Combined Chemotherapy Protocols adverse effects, Erythropoietin administration & dosage, Erythropoietin analogs & derivatives, Neoplasms blood, Neoplasms drug therapy
Abstract

This is the first randomized, open-label, multicenter trial designed and powered to directly compare the hemoglobin (Hb) response to epoetin alfa (EPO), 40,000 U once weekly (QW), with that to darbepoetin alfa (DARB), 200 microg every 2 weeks (Q2W), in anemic patients with cancer receiving chemotherapy (CT). Transfusion requirements, quality of life (QOL), and safety also were evaluated. Adults with solid tumors scheduled to receive CT for > or =12 weeks and with baseline Hb < or =11 g/dl were randomized to receive either EPO 40,000 U QW (n = 178) or DARB 200 microg Q2W (n = 180) s.c. for up to 16 weeks. Doses were increased for nonresponders (Hb increase <1 g/dl) after 4 (EPO) or 6 (DARB) weeks, as per National Comprehensive Cancer Network guidelines, and were reduced for a rapid rise in Hb (>1.3 g/dl [EPO] or >1.0 g/dl [DARB] within any 2-week period) or for an Hb level >13 g/dl. The proportion of patients achieving a > or =1-g/dl Hb rise by week 5, the primary end point, was significantly higher with EPO (47.0%) than with DARB (32.5%), and EPO-treated patients achieved a > or =1-g/dl Hb increase significantly earlier than those receiving DARB (median, 35 days versus 46 days). The mean increase in Hb from baseline was significantly higher at weeks 5, 9, 13, and the end of the study with EPO than with DARB. The number of units transfused per patient was significantly lower for the EPO group than for the DARB group. The proportions of patients requiring transfusions, mean QOL improvements, and tolerability profiles were similar in the two groups.

Published
2005
Full Text
View/download PDF

42. Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks.

Author

Vadhan-Raj S, Mirtsching B, Charu V, Terry D, Rossi G, Tomita D, and McGuire WP

Subjects
Adult, Aged, Aged, 80 and over, Biomarkers blood, Darbepoetin alfa, Dose-Response Relationship, Drug, Erythropoietin administration & dosage, Erythropoietin therapeutic use, Female, Hemoglobins drug effects, Humans, Injections, Subcutaneous, Male, Middle Aged, Neoplasms drug therapy, Sickness Impact Profile, Time Factors, Treatment Outcome, Anemia, Hypochromic chemically induced, Anemia, Hypochromic drug therapy, Antineoplastic Agents adverse effects, Erythropoietin analogs & derivatives, Fatigue chemically induced, Fatigue drug therapy
Abstract

The objective of this ongoing trial is to study the ability of darbepoetin alfa to reverse chemotherapy-induced anemia in cancer patients, and to relate improvement in hemoglobin with changes in fatigue and functional capacity. Eligible subjects had a nonmyeloid malignancy, were receiving multicycle chemotherapy, and were anemic, as defined by a screening hemoglobin < or = 11 g/dL. Darbepoetin alfa was administered at a starting dosage of 3 microg/kg every 2 weeks for up to eight doses (16 weeks) in an open-label, noncomparative setting. A total of 194 oncology practices contributed 1,173 subjects to this interim analysis. The mean increase in hemoglobin was 1.7 g/dL (95% CI: 1.6, 1.8) to last value on study (intent-to-treat analysis) and 2.1 g/dL (95% CI: 1.9, 2.2) for those patients receiving the full 16 weeks of therapy. The Kaplan-Meier estimate of the proportion of subjects with a hematopoietic response (increase in hemoglobin > or = 2 g/dL and/or hemoglobin value > or = 12 g/dL) was 84% (95% CI:81,86). Subjects in the lower baseline hemoglobin category (< 10 g/dL) tended to have a greater hemoglobin response during treatment. The Functional Assessment of Cancer Therapy-Fatigue (FACT-Fatigue) subscale score increased by a mean of 6.8 points (26%) during the study, and improvements in fatigue paralleled the increases observed in hemoglobin. Study treatment-related toxicity was minimal, with the most common event being injection-site pain, seen in 2% of subjects. Experience to date with an every-2-week regimen of darbepoetin alfa indicated efficacy comparable to historical experience with weekly and 3-times-weekly regimens of epoetin alfa in treating chemotherapy-induced anemia in cancer subjects.

Published
2003

43. Every-2-week darbepoetin alfa is comparable to rHuEPO in treating chemotherapy-induced anemia. Results of a combined analysis.

Author

Mirtsching B, Charu V, Vadhan-Raj S, Colowick AB, Rossi G, Tomita D, and McGuire WP

Subjects
Anemia blood, Darbepoetin alfa, Drug Administration Schedule, Erythropoietin administration & dosage, Erythropoietin adverse effects, Female, Hemoglobins metabolism, Humans, Injections, Subcutaneous, Male, Middle Aged, Recombinant Proteins, Treatment Outcome, Anemia chemically induced, Anemia drug therapy, Erythropoietin analogs & derivatives, Erythropoietin therapeutic use
Abstract

The safety and efficacy of darbepoetin alfa (Aranesp) at 3.0 microg/kg administered every 2 weeks and recombinant human erythropoietin (rHuEPO) given as 40,000 U weekly or 150 U/kg three times weekly were evaluated by pooling data from three darbepoetin alfa clinical studies. All studies enrolled anemic (hemoglobin < or = 11.0 g/dL) patients receiving multicycle chemotherapy. Open-label study drug was administered by subcutaneous injection. Hemoglobin concentrations, red blood cell transfusion requirements, and standard safety parameters were evaluated. Of 260 patients who received darbepoetin alfa at 3.0 microg/kg every 2 weeks and 115 patients who received rHuEPO three times weekly or once weekly, hematopoietic response (change in hemoglobin from baseline of > or = 2 g/dL or hemoglobin concentration of > or = 12 g/dL) was achieved in 71% (95% confidence interval [CI] = 65%-78%) of patients who received darbepoetin alfa every 2 weeks, comparable to the response in patients who received rHuEPO (71%; 95% CI = 61%-81%). The mean increase in hemoglobin concentration over 13 weeks was also similar: 1.48 g/dL (95% CI = 1.28-1.68 g/dL) for darbepoetin alfa and 1.31 g/dL (95% CI = 0.97-1.64 g/dL) for rHuEPO. The proportion of patients in the darbepoetin alfa group requiring transfusions was lower (7%; 95% CI = 4%-11%) than that in the rHuEPO group (14%; 95% CI = 8%-22%). Darbepoetin alfa every 2 weeks was well tolerated with a safety profile comparable to that of rHuEPO. In conclusion, darbepoetin alfa at a dose of 3.0 microg/kg given every 2 weeks safely increases hemoglobin concentration to the same extent as rHuEPO.

Published
2002

Catalog

Books, media, physical & digital resources
See catalog results