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23 results on '"Garcia Campelo, Maria"'

1. SAPPHIRE: phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer

Author

Abdel-Karim, Isam, Abdelsalam, Mahmoud, Addeo, Alfredo, Aguado, Carlos, Alexander, Patrick, Alt, Jürgen, Azzi, Georges, Balaraman, Rama, Biesma, Bonne, Blackhall, Fiona, Bohnet, Sabine, Boleti, Ekaterini, Borghaei, Hossein, Bradbury, Penelope, Brighenti, Matteo, Campbell, Nicholas, Campbell, Toby, Canon, Jean-Luc, Cappuzzo, Federico, Costa, Enric Carcereny, Cavanna, Luigi, Cetnar, Jeremy, Chella, Antonio, Chouaid, Christos, Christoph, Daniel, Castán, Javier Cortés, Dakhil, Shaker, de Castro Carpeño, Francisco Javier, de Marinis, Filippo, Delmonte, Angelo, Demedts, Ingel, Demey, Wim, Dits, Joyce, del Pilar Diz Taín, Maria, Gómez, Manuel Dómine, Dorius, Timothy, Dumoulin, Daphne, Duruisseaux, Michaël, Eaton, Keith, González, Emilio Esteban, Evans, Devon, Faehling, Martin, Farrell, Nicholas, Feinstein, Trevor, Font, Enriqueta Felip, Garcia Campelo, Maria Rosario, Garon, Edward, Garrido López, María Pilar, Germonpré, Paul, Gersten, Todd, Cao, Maria Gonzalez, Gopaluni, Srivalli, Greillier, Laurent, Grossi, Francesco, Guisier, Florian, Gurubhagavatula, Sarada, Calderón, Vanesa Gutiérrez, Hakimian, David, Hall, Richard, Jr., Hao, Desirée, Harris, Ronald, Hashemi, Sayed, He, Kai, Hendriks, Lizza, Huang, Chao, Ibrahim, Emad, Jain, Sharad, Johnson, Melissa, Jones, Benjamin, Jones, Monte, Juan Vidal, Óscar José, Juergens, Rosalyn, Kaderbhai, Courèche, Kastelijn, Elisabeth A (Lisanne), Keresztes, Roger, Kio, Ebenezer, Kokowski, Konrad, Konduri, Kartik, Kulkarni, Swati, Kuon, Jonas, Kurkjian, Carla, Labbé, Catherine, Lerner, Rachel, Lim, Farah, Madroszyk-Flandin, Anne, Marathe, Omkar, Martincic, Danko, McClay, Edward, McIntyre, Kristi, Mekhail, Tarek, Misino, Andrea, Molinier, Olivier, Morabito, Alessandro, Morócz, Éva, Müller, Veronika, Nagy, Tünde, Nguyen, Anthony V., Nidhiry, Emmanuel, Okazaki, Ian, Ortega-Granados, Ana Laura, Ostoros, Gyula, Oubre, David, Owen, Scott, Pachipala, Krishna, Park, David, Patel, Pareshkumar, Percent, Ivor, Pérol, Maurice, Peters, Solange, Piet, Berber, Planchard, David, Polychronis, Andreas, Aix, Santiago Ponce, Pons-Tostivint, Elvire, Popat, Sanjaykumar, Pulla, Mariano Provencio, Quantin, Xavier, Quéré, Gilles, Rafique, Noman, Ramaekers, Ryan, Reck, Martin, Reiman, Anthony, Reinmuth, Niels, Reynolds, Craig, Rodríguez-Abreu, Delvys, Romano, Gianpiero, Roque, Tammy, Salzberg, Matthew, Sanborn, Rachel, Sandiego, Sergio, Schaefer, Eric, Schreeder, Marshall, Seetharamu, Nagashree, Seneviratne, Lasika, Shah, Purvi, Shunyakov, Leonid, Slater, Dennis, Parra, Hector Soto, Stigt, Johannes, Stilwill, Joseph, Su, Jingdong, Surmont, Veerle, Swink, Alicia, Szalai, Zsuzsanna, Talbot, Toby, Garcia, Alvaro Taus, Theelen, Willemijn, Thompson, Jonathan, Tiseo, Marcello, Uprety, Dipesh, Uyeki, James, van der Leest, Kornelius Cor, Van Ho, Anthony, van Putten, John, Estévez, Sergio Vázquez, Veatch, Andrea, Vergnenègre, Alain, Ward, Patrick, Weise, Amy, Weiss, Matthias, Whitehurst, Matthew, Zai, Silvia, Zalcman, Gérard, Zuniga, Richard, Borghaei, H., de Marinis, F., Dumoulin, D., Reynolds, C., Theelen, W.S.M.E., Percent, I., Gutierrez Calderon, V., Johnson, M.L., Madroszyk-Flandin, A., Garon, E.B., He, K., Planchard, D., Reck, M., Popat, S., Herbst, R.S., Leal, T.A., Shazer, R.L., Yan, X., Harrigan, R., and Peters, S.

Published
2024
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2. Efficacy of Lorlatinib in Treatment-Naive Patients With ALK-Positive Advanced NSCLC in Relation to EML4::ALK Variant Type and ALK With or Without TP53 Mutations

Author

Bearz, Alessandra, Martini, Jean-François, Jassem, Jacek, Kim, Sang-We, Chang, Gee-Chen, Shaw, Alice T., Shepard, Deborah A., Dall’O’, Elisa, Polli, Anna, Thurm, Holger, Zalcman, Gerard, Garcia Campelo, Maria Rosario, Penkov, Konstantin, Hayashi, Hidetoshi, and Solomon, Benjamin J.

Published
2023
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3. Efficacy and safety of Nivolumab in older patients with pretreated lung cancer: A subgroup analysis of the Galician lung cancer group

Author

Arias Ron, David, Areses Manrique, Maria Carmen, Mosquera Martínez, Joaquín, García González, Jorge, Afonso Afonso, Francisco Javier, Lázaro Quintela, Martín, Fernández Núñez, Natalia, Azpitarte Raposeiras, Cristina, Amenedo Gancedo, Margarita, Santomé Couto, Lucía, García Campelo, María Rosario, Muñoz Iglesias, Jose, Ruiz Bañobre, Juan, Vilchez Simo, Rocío, Casal Rubio, Joaquín, Campos Balea, Begoña, Carou Frieiro, Iria, Alonso-Jaudenes Curbera, Guillermo, Anido Herranz, Urbano, García Mata, Jesús, and Fírvida Pérez, Jose Luis

Published
2021
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4. Brigatinib Versus Crizotinib in ALK Inhibitor–Naive Advanced ALK-Positive NSCLC: Final Results of Phase 3 ALTA-1L Trial

Author

Camidge, D. Ross, Kim, Hye Ryun, Ahn, Myung-Ju, Yang, James C.H., Han, Ji-Youn, Hochmair, Maximilian J., Lee, Ki Hyeong, Delmonte, Angelo, Garcia Campelo, Maria Rosario, Kim, Dong-Wan, Griesinger, Frank, Felip, Enriqueta, Califano, Raffaele, Spira, Alexander I., Gettinger, Scott N., Tiseo, Marcello, Lin, Huamao M., Liu, Yuyin, Vranceanu, Florin, Niu, Huifeng, Zhang, Pingkuan, and Popat, Sanjay

Published
2021
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5. Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial

Author

Provencio, Mariano, Nadal, Ernest, Insa, Amelia, García-Campelo, María Rosario, Casal-Rubio, Joaquín, Dómine, Manuel, Majem, Margarita, Rodríguez-Abreu, Delvys, Martínez-Martí, Alex, De Castro Carpeño, Javier, Cobo, Manuel, López Vivanco, Guillermo, Del Barco, Edel, Bernabé Caro, Reyes, Viñolas, Nuria, Barneto Aranda, Isidoro, Viteri, Santiago, Pereira, Eva, Royuela, Ana, Casarrubios, Marta, Salas Antón, Clara, Parra, Edwin R, Wistuba, Ignacio, Calvo, Virginia, Laza-Briviesca, Raquel, Romero, Atocha, Massuti, Bartomeu, and Cruz-Bermúdez, Alberto

Published
2020
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6. SAPPHIRE: phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer

Author

Borghaei, H., primary, de Marinis, F., additional, Dumoulin, D., additional, Reynolds, C., additional, Theelen, W.S.M.E., additional, Percent, I., additional, Gutierrez Calderon, V., additional, Johnson, M.L., additional, Madroszyk-Flandin, A., additional, Garon, E.B., additional, He, K., additional, Planchard, D., additional, Reck, M., additional, Popat, S., additional, Herbst, R.S., additional, Leal, T.A., additional, Shazer, R.L., additional, Yan, X., additional, Harrigan, R., additional, Peters, S., additional, Abdel-Karim, Isam, additional, Abdelsalam, Mahmoud, additional, Addeo, Alfredo, additional, Aguado, Carlos, additional, Alexander, Patrick, additional, Alt, Jürgen, additional, Azzi, Georges, additional, Balaraman, Rama, additional, Biesma, Bonne, additional, Blackhall, Fiona, additional, Bohnet, Sabine, additional, Boleti, Ekaterini, additional, Borghaei, Hossein, additional, Bradbury, Penelope, additional, Brighenti, Matteo, additional, Campbell, Nicholas, additional, Campbell, Toby, additional, Canon, Jean-Luc, additional, Cappuzzo, Federico, additional, Costa, Enric Carcereny, additional, Cavanna, Luigi, additional, Cetnar, Jeremy, additional, Chella, Antonio, additional, Chouaid, Christos, additional, Christoph, Daniel, additional, Castán, Javier Cortés, additional, Dakhil, Shaker, additional, de Castro Carpeño, Francisco Javier, additional, de Marinis, Filippo, additional, Delmonte, Angelo, additional, Demedts, Ingel, additional, Demey, Wim, additional, Dits, Joyce, additional, del Pilar Diz Taín, Maria, additional, Gómez, Manuel Dómine, additional, Dorius, Timothy, additional, Dumoulin, Daphne, additional, Duruisseaux, Michaël, additional, Eaton, Keith, additional, González, Emilio Esteban, additional, Evans, Devon, additional, Faehling, Martin, additional, Farrell, Nicholas, additional, Feinstein, Trevor, additional, Font, Enriqueta Felip, additional, Garcia Campelo, Maria Rosario, additional, Garon, Edward, additional, Garrido López, María Pilar, additional, Germonpré, Paul, additional, Gersten, Todd, additional, Cao, Maria Gonzalez, additional, Gopaluni, Srivalli, additional, Greillier, Laurent, additional, Grossi, Francesco, additional, Guisier, Florian, additional, Gurubhagavatula, Sarada, additional, Calderón, Vanesa Gutiérrez, additional, Hakimian, David, additional, Hall, Richard, additional, Hao, Desirée, additional, Harris, Ronald, additional, Hashemi, Sayed, additional, He, Kai, additional, Hendriks, Lizza, additional, Huang, Chao, additional, Ibrahim, Emad, additional, Jain, Sharad, additional, Johnson, Melissa, additional, Jones, Benjamin, additional, Jones, Monte, additional, Juan Vidal, Óscar José, additional, Juergens, Rosalyn, additional, Kaderbhai, Courèche, additional, Kastelijn, Elisabeth A (Lisanne), additional, Keresztes, Roger, additional, Kio, Ebenezer, additional, Kokowski, Konrad, additional, Konduri, Kartik, additional, Kulkarni, Swati, additional, Kuon, Jonas, additional, Kurkjian, Carla, additional, Labbé, Catherine, additional, Lerner, Rachel, additional, Lim, Farah, additional, Madroszyk-Flandin, Anne, additional, Marathe, Omkar, additional, Martincic, Danko, additional, McClay, Edward, additional, McIntyre, Kristi, additional, Mekhail, Tarek, additional, Misino, Andrea, additional, Molinier, Olivier, additional, Morabito, Alessandro, additional, Morócz, Éva, additional, Müller, Veronika, additional, Nagy, Tünde, additional, Nguyen, Anthony V., additional, Nidhiry, Emmanuel, additional, Okazaki, Ian, additional, Ortega-Granados, Ana Laura, additional, Ostoros, Gyula, additional, Oubre, David, additional, Owen, Scott, additional, Pachipala, Krishna, additional, Park, David, additional, Patel, Pareshkumar, additional, Percent, Ivor, additional, Pérol, Maurice, additional, Peters, Solange, additional, Piet, Berber, additional, Planchard, David, additional, Polychronis, Andreas, additional, Aix, Santiago Ponce, additional, Pons-Tostivint, Elvire, additional, Popat, Sanjaykumar, additional, Pulla, Mariano Provencio, additional, Quantin, Xavier, additional, Quéré, Gilles, additional, Rafique, Noman, additional, Ramaekers, Ryan, additional, Reck, Martin, additional, Reiman, Anthony, additional, Reinmuth, Niels, additional, Reynolds, Craig, additional, Rodríguez-Abreu, Delvys, additional, Romano, Gianpiero, additional, Roque, Tammy, additional, Salzberg, Matthew, additional, Sanborn, Rachel, additional, Sandiego, Sergio, additional, Schaefer, Eric, additional, Schreeder, Marshall, additional, Seetharamu, Nagashree, additional, Seneviratne, Lasika, additional, Shah, Purvi, additional, Shunyakov, Leonid, additional, Slater, Dennis, additional, Parra, Hector Soto, additional, Stigt, Johannes, additional, Stilwill, Joseph, additional, Su, Jingdong, additional, Surmont, Veerle, additional, Swink, Alicia, additional, Szalai, Zsuzsanna, additional, Talbot, Toby, additional, Garcia, Alvaro Taus, additional, Theelen, Willemijn, additional, Thompson, Jonathan, additional, Tiseo, Marcello, additional, Uprety, Dipesh, additional, Uyeki, James, additional, van der Leest, Kornelius Cor, additional, Van Ho, Anthony, additional, van Putten, John, additional, Estévez, Sergio Vázquez, additional, Veatch, Andrea, additional, Vergnenègre, Alain, additional, Ward, Patrick, additional, Weise, Amy, additional, Weiss, Matthias, additional, Whitehurst, Matthew, additional, Zai, Silvia, additional, Zalcman, Gérard, additional, and Zuniga, Richard, additional

Published
2023
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7. Mobocertinib in previously treated patients with EGFR exon 20 insertion (ex20ins) + metastatic NSCLC (mNSCLC): updated results from a phase 1/2 study

Author

Popat, Sanjay, primary, Ramalingam, Suresh, additional, Zhou, Caicun, additional, Kim, Tae, additional, Yang, James, additional, Riely, Gregory, additional, Mekhail, Tarek, additional, Nguyen, Danny, additional, Garcia Campelo, Maria Rosario, additional, Felip, Enriqueta, additional, Misch, Daniel, additional, Kaur, Manmit, additional, Bunn, Veronica, additional, Lin, Huamao, additional, Zhang, Pingkuan, additional, and Jänne, Pasi, additional

Published
2023
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8. Characterization and management of adverse events observed with mobocertinib (TAK-788) treatment for EGFR exon 20 insertion–positive non–small cell lung cancer

Author

Yang, James Chih-Hsin, primary, Zhou, Caicun, additional, Jänne, Pasi A., additional, Ramalingam, Suresh S., additional, Kim, Tae Min, additional, Riely, Gregory J, additional, Spira, Alexander I, additional, Piotrowska, Zofia, additional, Mekhail, Tarek, additional, Garcia Campelo, Maria Rosario, additional, Felip, Enriqueta, additional, Bazhenova, Lyudmila, additional, Jin, Shu, additional, Kaur, Manmit, additional, Diderichsen, Paul M., additional, Gupta, Neeraj, additional, Bunn, Veronica, additional, Lin, Jianchang, additional, N. Churchill, Eric, additional, Mehta, Minal, additional, and Nguyen, Danny, additional

Published
2022
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9. Mobocertinib (TAK-788) in EGFR Exon 20 Insertion+ Metastatic NSCLC: Patient-Reported Outcomes from EXCLAIM Extension Cohort

Author

Garcia Campelo, Maria Rosario, primary, Zhou, Caicun, additional, Ramalingam, Suresh S., additional, Lin, Huamao M., additional, Kim, Tae Min, additional, Riely, Gregory J., additional, Mekhail, Tarek, additional, Nguyen, Danny, additional, Goodman, Erin, additional, Mehta, Minal, additional, Popat, Sanjay, additional, and Jänne, Pasi A., additional

Published
2022
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10. Efficacy of Lorlatinib in Treatment-Naive Patients With ALK-Positive Advanced NSCLC in Relation to EML4::ALKVariant Type and ALKWith or Without TP53Mutations

Author

Bearz, Alessandra, Martini, Jean-François, Jassem, Jacek, Kim, Sang-We, Chang, Gee-Chen, Shaw, Alice T., Shepard, Deborah A., Dall’O’, Elisa, Polli, Anna, Thurm, Holger, Zalcman, Gerard, Garcia Campelo, Maria Rosario, Penkov, Konstantin, Hayashi, Hidetoshi, and Solomon, Benjamin J.

Abstract

Lorlatinib, a third-generation ALK tyrosine kinase inhibitor, improved outcomes compared with crizotinib in patients with previously untreated ALK-positive advanced NSCLC in the phase 3 CROWN study. Here, we investigated response correlates using plasma circulating tumor DNA (ctDNA) and tumor tissue profiling.

Published
2023
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11. Mobocertinib (TAK-788) in epidermal growth factor receptor gene (EGFR) exon 20 insertion mutation-positive (EGFRex20ins+) metastatic non-small cell lung cancer (mNSCLC): results from the platinum-pretreated patients (PPP) cohort of a phase 1/2 study

Author

Popat, Sanjay, primary, Ramalingam, Suresh, additional, Kim, Tae Min, additional, Yang, James, additional, Riely, Gregory, additional, Mekhail, Tarek, additional, Nguyen, Danny, additional, Garcia Campelo, Maria Rosario, additional, Felip, Enriqueta, additional, Spira, Alexander, additional, Piotrowska, Zofia, additional, Bazhenova, Lyudmila, additional, Vincent, Sylvie, additional, Jin, Shu, additional, Griffin, Celina, additional, Diderichsen, Paul, additional, Gupta, Neeraj, additional, Bunn, Veronica, additional, Lin, Jianchang, additional, Lin, Huamao, additional, Churchill, Eric, additional, Mehta, Minal, additional, Zhou, Caicun, additional, and Jänne, Pasi, additional

Published
2022
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12. Brigatinib vs crizotinib in ALK TKI-naive ALK+ NSCLC: final results from ALTA-1L

Author

Popat, Sanjay, primary, Kim, Hye Ryun, additional, Ahn, Myung-Ju, additional, Yang, James, additional, Han, Ji-Youn, additional, Hochmair, Maximilian, additional, Lee, Ki Hyeong, additional, Delmonte, Angelo, additional, Garcia Campelo, Maria, additional, Kim, Dong-Wan, additional, Griesinger, Frank, additional, Felip, Enriqueta, additional, Califano, Raffaele, additional, Spira, Alexander, additional, Gettinger, Scott, additional, Tiseo, Marcello, additional, Lin, Huamao, additional, Liu, Yuyin, additional, Vranceanu, Florin, additional, and Camidge, D, additional

Published
2022
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13. Treatment Outcomes and Safety of Mobocertinib in Platinum-Pretreated Patients With EGFR Exon 20 Insertion–Positive Metastatic Non–Small Cell Lung Cancer

Author

Zhou, Caicun, primary, Ramalingam, Suresh S., additional, Kim, Tae Min, additional, Kim, Sang-We, additional, Yang, James Chih-Hsin, additional, Riely, Gregory J., additional, Mekhail, Tarek, additional, Nguyen, Danny, additional, Garcia Campelo, Maria R., additional, Felip, Enriqueta, additional, Vincent, Sylvie, additional, Jin, Shu, additional, Griffin, Celina, additional, Bunn, Veronica, additional, Lin, Jianchang, additional, Lin, Huamao M., additional, Mehta, Minal, additional, and Jänne, Pasi A., additional

Published
2021
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14. Mobocertinib (TAK-788) in EGFR Exon 20 Insertion+ Metastatic NSCLC: Patient-Reported Outcomes from EXCLAIM Extension Cohort.

Author

Garcia Campelo, Maria Rosario, Zhou, Caicun, Ramalingam, Suresh S., Lin, Huamao M., Kim, Tae Min, Riely, Gregory J., Mekhail, Tarek, Nguyen, Danny, Goodman, Erin, Mehta, Minal, Popat, Sanjay, and Jänne, Pasi A.

Subjects
*COUGH, *PATIENT reported outcome measures, *EPIDERMAL growth factor receptors, *NON-small-cell lung carcinoma, *APPETITE loss, *PROTEIN-tyrosine kinase inhibitors
Abstract

Mobocertinib, an oral, first-in-class epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor selective for EGFR exon 20 insertions (ex20ins), achieved durable responses in adults with previously treated EGFR ex20ins+ metastatic non-small cell lung cancer (mNSCLC) in the EXCLAIM extension cohort of a phase 1/2 study (N = 96; NCT02716116). We assessed patient-reported outcomes (PROs) with mobocertinib 160 mg once daily (28-day cycles) in EXCLAIM (N = 90) with the European Organisation for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ-C30) v3.0, lung cancer module (QLQ-LC13), EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire, and selected PRO Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. Median treatment duration was 6.8 (range, 0.0–18.8) months (median follow-up: 13.0 [0.7–18.8] months; data cutoff: 1 November 2020). Clinically meaningful improvements in lung cancer symptoms measured by EORTC QLQ-LC13 were observed for dyspnea (54.4% of patients), cough (46.7%), and chest pain (38.9%), evident at cycle 2 and throughout treatment (least-squares mean [LSM] changes from baseline: dyspnea, −3.2 [p = 0.019]; cough, −9.3 [p < 0.001]; chest pain, −8.2 [p < 0.001]). EORTC QLQ-C30 results indicated no statistically significant changes in global health status/quality of life (LSM change from baseline: −1.8 [p = 0.235]). On symptom scores, significant worsening from baseline was observed for diarrhea (LSM change from baseline: +34.1; p < 0.001) and appetite loss (+6.6; p = 0.004), while improvements were observed for dyspnea (LSM change from baseline: −5.1 [p = 0.002]), insomnia (−6.5 [p = 0.001]), and constipation (−5.7 [p < 0.001]). EQ-5D-5L health status was maintained. Common PRO-CTCAE symptoms were diarrhea, dry skin, rash, and decreased appetite (mostly low grade); in the first 24 weeks of treatment, 64.4% of patients had worsening diarrhea frequency and 67.8% had worsening dry skin severity. Overall, PROs with mobocertinib showed clinically meaningful improvement in lung cancer–related symptoms, with health-related quality of life maintained despite changes in some adverse event symptom scales. [ABSTRACT FROM AUTHOR]

Published
2023
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15. Characterization and management of adverse events observed with mobocertinib (TAK-788) treatment for EGFR exon 20 insertion–positive non–small cell lung cancer.

Author

Yang, James Chih-Hsin, Zhou, Caicun, Jänne, Pasi A., Ramalingam, Suresh S., Kim, Tae Min, Riely, Gregory J, Spira, Alexander I, Piotrowska, Zofia, Mekhail, Tarek, Garcia Campelo, Maria Rosario, Felip, Enriqueta, Bazhenova, Lyudmila, Jin, Shu, Kaur, Manmit, Diderichsen, Paul M., Gupta, Neeraj, Bunn, Veronica, Lin, Jianchang, N. Churchill, Eric, and Mehta, Minal

Subjects
NON-small-cell lung carcinoma, ADVERSE health care events, EPIDERMAL growth factor receptors, LUNG cancer, CANCER patients
Abstract

Mobocertinib has demonstrated durable clinical benefit in platinum-pretreated patients (PPP) with epidermal growth factor receptor exon 20 insertion–positive non–small cell lung cancer (NSCLC). Pooled safety analysis of two studies included patients with NSCLC (N = 257) treated with the recommended phase 2 dose (RP2D) of mobocertinib (160 mg once daily). We report overall safety (treatment-emergent adverse events [TEAEs]) in the RP2D population; characterization of GI and skin-related events in 114 PPP from a phase 1/2 study (NCT02716116); and clinical activity in PPP with and without dose reductions due to TEAEs. In the RP2D population (N = 257), the most common TEAEs were diarrhea (93%), nausea (47%), rash (38%), and vomiting (37%). In PPP (N = 114), median times to diarrhea onset and resolution were 5 and 2 days, respectively. Median times to onset and resolution of skin-related events were 9 and 78 days, respectively. Among PPP with (n = 29) or without (n = 85) dose reductions due to TEAEs, overall response rates were 21% and 31% and median durations of response were 5.7 and 17.5 months, respectively. GI and skin-related events are common with mobocertinib; minimizing dose reductions with proactive management may improve clinical outcomes. NCT02716116; NCT03807778 Mobocertinib is a treatment for patients with a certain type of lung cancer. We analyzed the safety of mobocertinib in 257 patients with lung cancer. The most common side effects with mobocertinib were diarrhea, nausea, vomiting, and skin rash. In 114 patients with lung cancer who were treated in the past with chemotherapy that included platinum-based drugs, diarrhea started after about 5 days of mobocertinib treatment and went away in about 2 days. Skin-related side effects started after about 9 days and went away in about 2.5 months. One-fifth of patients who had to receive a smaller amount of mobocertinib because of side effects responded to treatment compared with one-third of patients who received the recommended mobocertinib amount. Managing side effects quickly can better help patients with lung cancer who are treated with mobocertinib. [ABSTRACT FROM AUTHOR]

Published
2023
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17. Durvalumab, with or without tremelimumab, plus platinum–etoposide versus platinum–etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial

Author

Goldman, Jonathan W, primary, Dvorkin, Mikhail, additional, Chen, Yuanbin, additional, Reinmuth, Niels, additional, Hotta, Katsuyuki, additional, Trukhin, Dmytro, additional, Statsenko, Galina, additional, Hochmair, Maximilian J, additional, Özgüroğlu, Mustafa, additional, Ji, Jun Ho, additional, Garassino, Marina Chiara, additional, Voitko, Oleksandr, additional, Poltoratskiy, Artem, additional, Ponce, Santiago, additional, Verderame, Francesco, additional, Havel, Libor, additional, Bondarenko, Igor, additional, Każarnowicz, Andrzej, additional, Losonczy, György, additional, Conev, Nikolay V, additional, Armstrong, Jon, additional, Byrne, Natalie, additional, Thiyagarajah, Piruntha, additional, Jiang, Haiyi, additional, Paz-Ares, Luis, additional, Voitko, Nataliia, additional, Kazarnowicz, Andrzej, additional, Özgüroglu, Mustafa, additional, Conev, Nikolay, additional, Hochmair, Maximilian, additional, Burghuber, Otto, additional, Çiçin, Irfan, additional, Moiseenko, Vladimir, additional, Erman, Mustafa, additional, Kowalski, Dariusz, additional, Wojtukiewicz, Marek, additional, Adamchuk, Hryhoriy, additional, Vasilyev, Alexander, additional, Shevnia, Serhii, additional, Valev, Spartak, additional, Insa Molla, Maria Amelia, additional, Ursol, Grygorii, additional, Chiang, Anne, additional, Hartl, Sylvia, additional, Horváth, Zsolt, additional, Pajkos, Gábor, additional, Kim, Sang-We, additional, Smolin, Alexey, additional, Göksel, Tuncay, additional, Dakhil, Shaker, additional, Roubec, Jaromir, additional, Bogos, Krisztina, additional, Cornelissen, Robin, additional, Lee, Jong-Seok, additional, Garcia Campelo, Maria Rosario, additional, Lopez Brea, Marta, additional, Alacacioglu, Ahmet, additional, Casarini, Ignacio, additional, Ilieva, Rumyana, additional, Tonev, Ivan, additional, Somfay, Attila, additional, Bar, Jair, additional, Zer Kuch, Alona, additional, Minelli, Mauro, additional, Bartolucci, Roberta, additional, Roila, Fausto, additional, Saito, Haruhiro, additional, Azuma, Koichi, additional, Lee, Gyeong-Won, additional, Luft, Alexander, additional, Urda, Michal, additional, Delgado Mingorance, Juan Ignacio, additional, Majem Tarruella, Margarita, additional, Spigel, David, additional, Koynov, Krassimir, additional, Zemanova, Milada, additional, Panse, Jens, additional, Schulz, Christian, additional, Pápai Székely, Zsolt, additional, Sárosi, Veronika, additional, Delmonte, Angelo, additional, Bettini, Anna Cecilia, additional, Nishio, Makoto, additional, Okamoto, Isamu, additional, Hendriks, Lizza, additional, Mandziuk, Slawomir, additional, Lee, Yun Gyoo, additional, Vladimirova, Lyubov, additional, Isla Casado, Dolores, additional, Domine Gomez, Manuel, additional, Navarro Mendivil, Alejandro, additional, Morán Bueno, Teresa, additional, Wu, Shang-Yin, additional, Knoble, Jeanna, additional, Skrickova, Jana, additional, Venkova, Violetka, additional, Hilgers, Werner, additional, Laack, Eckart, additional, Bischoff, Helge, additional, Fülöp, Andrea, additional, Laczó, Ibolya, additional, Kósa, Judit, additional, Telekes, András, additional, Yoshida, Tatsuya, additional, Kanda, Shintaro, additional, Hida, Toyoaki, additional, Hayashi, Hidetoshi, additional, Maeda, Tadashi, additional, Kawamura, Tetsuji, additional, Nakahara, Yasuharu, additional, Claessens, Niels, additional, Lee, Ki Hyeong, additional, Chiu, Chao-Hua, additional, Lin, Sheng-Hao, additional, Li, Chien-Te, additional, Demirkazik, Ahmet, additional, Schaefer, Eric, additional, Nikolinakos, Petros, additional, Schneider, Jeffrey, additional, Babu, Sunil, additional, Lamprecht, Bernd, additional, Studnicka, Michael, additional, Fausto Nino Gorini, Carlos, additional, Kultan, Juraj, additional, Kolek, Vitezslav, additional, Souquet, Pierre-Jean, additional, Moro-Sibilot, Denis, additional, Gottfried, Maya, additional, Smit, Egbert, additional, Lee, Kyung Hee, additional, Kasan, Peter, additional, Chovanec, Jozef, additional, Goloborodko, Olexandr, additional, Kolesnik, Oleksii, additional, Ostapenko, Yuriy, additional, Lakhanpal, Shailendra, additional, Haque, Basir, additional, Chua, Winston, additional, Stilwill, Joseph, additional, Sena, Susana Noemi, additional, Girotto, Gustavo Colagiovanni, additional, De Marchi, Pedro Rafael Martins, additional, Martinelli de Oliveira, Fabricio Augusto, additional, Dos Reis, Pedro, additional, Krasteva, Rositsa, additional, Zhao, Yanqiu, additional, Chen, Chengshui, additional, Koubkova, Leona, additional, Robinet, Gilles, additional, Chouaid, Christos, additional, Grohe, Christian, additional, Alt, Jürgen, additional, Csánky, Eszter, additional, Somogyiné Ezer, Éva, additional, Heching, Norman Isaac, additional, Kim, Young Hak, additional, Aatagi, Shinji, additional, Kuyama, Shoichi, additional, Harada, Daijiro, additional, Nogami, Naoyuki, additional, Nokihara, Hiroshi, additional, Goto, Hisatsugu, additional, Staal van den Brekel, Agnes, additional, Cho, Eun Kyung, additional, Kim, Joo-Hang, additional, Ganea, Doina, additional, Ciuleanu, Tudor, additional, Popova, Ekaterina, additional, Sakaeva, Dina, additional, Stresko, Marian, additional, Demo, Pavol, additional, Godal, Robert, additional, Wei, Yu-Feng, additional, Chen, Yen-Hsun, additional, Hsia, Te-Chun, additional, Lee, Kang-Yun, additional, Chang, Huang-Chih, additional, Wang, Chin-Chou, additional, Dowlati, Afshin, additional, Sumey, Christopher, additional, Powell, Steven, additional, Goldman, Jonathan, additional, Zarba, Juan Jose, additional, Batagelj, Emilio, additional, Pastor, Andrea Viviana, additional, Zukin, Mauro, additional, Baldotto, Clarissa Serodio da Rocha, additional, Schlittler, Luis Alberto, additional, Calabrich, Aknar, additional, Sette, Claudia, additional, Dudov, Asen, additional, Zhou, Caicun, additional, Lena, Hervé, additional, Lang, Susanne, additional, Pápai, Zsuzsanna, additional, Goto, Koichi, additional, Umemura, Shigeki, additional, Kanazawa, Kenya, additional, Hara, Yu, additional, Shinoda, Masahiro, additional, Morise, Masahiro, additional, Hiltermann, Jeroen, additional, Mróz, Robert, additional, Ungureanu, Andrei, additional, Andrasina, Igor, additional, Chang, Gee-Chen, additional, Vynnychenko, Ihor, additional, Shparyk, Yaroslav, additional, Kryzhanivska, Anna, additional, Ross, Helen, additional, Mi, Kailhong, additional, Jamil, Rodney, additional, Williamson, Michael, additional, Spahr, Joseph, additional, Han, Zhigang, additional, Wang, Mengzhao, additional, Yang, Zhixiong, additional, Hu, Jie, additional, Li, Wei, additional, Zhao, Jun, additional, Feng, Jifeng, additional, Ma, Shenglin, additional, Zhou, Xiangdong, additional, Liang, Zongan, additional, Hu, Yi, additional, Chen, Yuan, additional, Bi, Minghong, additional, Shu, Yongqian, additional, Nan, Kejun, additional, Zhou, Jianying, additional, Zhang, Wei, additional, Ma, Rui, additional, Yang, Nong, additional, Lin, Zhong, additional, Wu, Gang, additional, Fang, Jian, additional, Zhang, Helong, additional, Wang, Kai, additional, and Chen, Zhendong, additional

Published
2021
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19. 64 - Mobocertinib (TAK-788) in epidermal growth factor receptor gene (EGFR) exon 20 insertion mutation-positive (EGFRex20ins+) metastatic non-small cell lung cancer (mNSCLC): results from the platinum-pretreated patients (PPP) cohort of a phase 1/2 study

Author

Popat, Sanjay, Ramalingam, Suresh, Kim, Tae Min, Yang, James, Riely, Gregory, Mekhail, Tarek, Nguyen, Danny, Garcia Campelo, Maria Rosario, Felip, Enriqueta, Spira, Alexander, Piotrowska, Zofia, Bazhenova, Lyudmila, Vincent, Sylvie, Jin, Shu, Griffin, Celina, Diderichsen, Paul, Gupta, Neeraj, Bunn, Veronica, Lin, Jianchang, Lin, Huamao, Churchill, Eric, Mehta, Minal, Zhou, Caicun, and Jänne, Pasi

Published
2022
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21. Durvalumab plus platinum–etoposide versus platinum–etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial

Author

Paz-Ares, Luis, primary, Dvorkin, Mikhail, additional, Chen, Yuanbin, additional, Reinmuth, Niels, additional, Hotta, Katsuyuki, additional, Trukhin, Dmytro, additional, Statsenko, Galina, additional, Hochmair, Maximilian J, additional, Özgüroğlu, Mustafa, additional, Ji, Jun Ho, additional, Voitko, Oleksandr, additional, Poltoratskiy, Artem, additional, Ponce, Santiago, additional, Verderame, Francesco, additional, Havel, Libor, additional, Bondarenko, Igor, additional, Kazarnowicz, Andrzej, additional, Losonczy, György, additional, Conev, Nikolay V, additional, Armstrong, Jon, additional, Byrne, Natalie, additional, Shire, Norah, additional, Jiang, Haiyi, additional, Goldman, Jonathan W, additional, Batagelj, Emilio, additional, Casarini, Ignacio, additional, Pastor, Anea Viviana, additional, Sena, Susana Noemi, additional, Zarba, Juan Jose, additional, Burghuber, Otto, additional, Hartl, Sylvia, additional, Lamprecht, Bernd, additional, Studnicka, Michael, additional, Alberto Schlittler, Luis, additional, Augusto Martinelli de Oliveira, Fabricio, additional, Calabrich, Aknar, additional, Colagiovanni Girotto, Gustavo, additional, Dos Reis, Peo, additional, Fausto Nino Gorini, Carlos, additional, Rafael Martins De Marchi, Peo, additional, Serodio da Rocha Baldotto, Clarissa, additional, Sette, Claudia, additional, Zukin, Mauro, additional, Dudov, Assen, additional, Ilieva, Rumyana, additional, Koynov, Krassimir, additional, Krasteva, Rositsa, additional, Tonev, Ivan, additional, Valev, Spartak, additional, Venkova, Violetka, additional, Bi, Minghong, additional, Chen, Chengshui, additional, Chen, Yuan, additional, Chen, Zhendong, additional, Fang, Jian, additional, Feng, Jifeng, additional, Han, Zhigang, additional, Hu, Jie, additional, Hu, Yi, additional, Li, Wei, additional, Liang, Zongan, additional, Lin, Zhong, additional, Ma, Rui, additional, Ma, Shenglin, additional, Nan, Kejun, additional, Shu, Yongqian, additional, Wang, Kai, additional, Wang, Mengzhao, additional, Wu, Gang, additional, Yang, Nong, additional, Yang, Zhixiong, additional, Zhang, Helong, additional, Zhang, Wei, additional, Zhao, Jun, additional, Zhao, Yanqiu, additional, Zhou, Caicun, additional, Zhou, Jianying, additional, Zhou, Xiangdong, additional, Kolek, Vitezslav, additional, Koubkova, Leona, additional, Roubec, Jaromir, additional, Skrickova, Jana, additional, Zemanova, Milada, additional, Chouaid, Christos, additional, Hilgers, Werner, additional, Lena, Hervé, additional, Moro-Sibilot, Denis, additional, Robinet, Gilles, additional, Souquet, Pierre-Jean, additional, Alt, Jürgen, additional, Bischoff, Helge, additional, Grohe, Christian, additional, Laack, Eckart, additional, Lang, Susanne, additional, Panse, Jens, additional, Schulz, Christian, additional, Bogos, Krisztina, additional, Csánky, Eszter, additional, Fülöp, Anea, additional, Horváth, Zsolt, additional, Kósa, Judit, additional, Laczó, Ibolya, additional, Pajkos, Gábor, additional, Pápai, Zsuzsanna, additional, Pápai Székely, Zsolt, additional, Sárosi, Veronika, additional, Somfay, Attila, additional, Somogyiné Ezer, Éva, additional, Telekes, Anás, additional, Bar, Jair, additional, Gottfried, Maya, additional, Heching, Norman Isaac, additional, Zer Kuch, Alona, additional, Bartolucci, Roberta, additional, Bettini, Anna Cecilia, additional, Delmonte, Angelo, additional, Garassino, Marina Chiara, additional, Minelli, Mauro, additional, Roila, Fausto, additional, Atagi, Shinji, additional, Azuma, Koichi, additional, Goto, Hisatsugu, additional, Goto, Koichi, additional, Hara, Yu, additional, Hayashi, Hidetoshi, additional, Hida, Toyoaki, additional, Kanazawa, Kenya, additional, Kanda, Shintaro, additional, Kim, Young Hak, additional, Kuyama, Shoichi, additional, Maeda, Tadashi, additional, Morise, Masahiro, additional, Nakahara, Yasuharu, additional, Nishio, Makoto, additional, Nogami, Naoyuki, additional, Okamoto, Isamu, additional, Saito, Haruhiro, additional, Shinoda, Masahiro, additional, Umemura, Shigeki, additional, Yoshida, Tatsuya, additional, Claessens, Niels, additional, Cornelissen, Robin, additional, Heniks, Lizza, additional, Hiltermann, Jeroen, additional, Smit, Egbert, additional, Staal van den Brekel, Agnes, additional, Kowalski, Dariusz, additional, Mańdziuk, Slawomir, additional, Mróz, Robert, additional, Wojtukiewicz, Marek, additional, Ciuleanu, Tudor, additional, Ganea, Doina, additional, Ungureanu, Anei, additional, Luft, Alexander, additional, Moiseenko, Vladimir, additional, Sakaeva, Dina, additional, Smolin, Alexey, additional, Vasilyev, Alexander, additional, Vladimirova, Lyubov, additional, Anasina, Igor, additional, Chovanec, Jozef, additional, Demo, Pavol, additional, Godal, Robert, additional, Kasan, Peter, additional, Stresko, Marian, additional, Urda, Michal, additional, Cho, Eun Kyung, additional, Kim, Joo-Hang, additional, Kim, Sang-We, additional, Lee, Gyeong-Won, additional, Lee, Jong-Seok, additional, Lee, Ki Hyeong, additional, Lee, Kyung Hee, additional, Lee, Yun Gyoo, additional, Amelia Insa Molla, Maria, additional, Domine Gomez, Manuel, additional, Ignacio Delgado Mingorance, Juan, additional, Isla Casado, Dolores, additional, Lopez Brea, Marta, additional, Majem Tarruella, Margarita, additional, Morán Bueno, Teresa, additional, Navarro Mendivil, Alejano, additional, Paz-Ares Rodríguez, Luis, additional, Ponce Aix, Santiago, additional, Rosario Garcia Campelo, Maria, additional, Chang, Gee-Chen, additional, Chen, Yen-Hsun, additional, Chiu, Chao-Hua, additional, Hsia, Te-Chun, additional, Lee, Kang-Yun, additional, Li, Chien-Te, additional, Wang, Chin-Chou, additional, Wei, Yu-Feng, additional, Wu, Shang-Yin, additional, Alacacıoğlu, Ahmet, additional, Çiçin, Irfan, additional, Demirkazik, Ahmet, additional, Erman, Mustafa, additional, Göksel, Tuncay, additional, Adamchuk, Hryhoriy, additional, Kolesnik, Oleksii, additional, Kryzhanivska, Anna, additional, Ostapenko, Yuriv, additional, Shevnia, Serhii, additional, Shparyk, Yaroslav, additional, Ursol, Grygorii, additional, Voitko, Nataliia, additional, Vynnychenko, Ihor, additional, Babu, Sunil, additional, Chiang, Anne, additional, Chua, Winston, additional, Dakhil, Shaker, additional, Dowlati, Afshin, additional, Haque, Basir, additional, Jamil, Rodney, additional, Knoble, Jeanna, additional, Lakhanpal, Shailena, additional, Mi, Kailhong, additional, Nikolinakos, Petros, additional, Powell, Steven, additional, Ross, Helen, additional, Schaefer, Eric, additional, Schneider, Jeffrey, additional, Spahr, Joseph, additional, Spigel, David, additional, Stilwill, Joseph, additional, Sumey, Christopher, additional, and Williamson, Michael, additional

Published
2019
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22. Mobocertinib (TAK-788) in epidermal growth factor receptor gene (EGFR) exon 20 insertion mutation-positive (EGFRex20ins+) metastatic non-small cell lung cancer (mNSCLC): results from the platinum-pretreated patients (PPP) cohort of a phase 1/2 study

Author

Sanjay Popat, Ramalingam, Suresh, Kim, Tae Min, Yang, James, Riely, Gregory, Mekhail, Tarek, Nguyen, Danny, Garcia Campelo, Maria Rosario, Felip, Enriqueta, Spira, Alexander, Piotrowska, Zofia, Bazhenova, Lyudmila, Vincent, Sylvie, Jin, Shu, Griffin, Celina, Diderichsen, Paul, Gupta, Neeraj, Bunn, Veronica, Lin, Jianchang, Lin, Huamao, Churchill, Eric, Mehta, Minal, Zhou, Caicun, and Janne, Pasi

Subjects
Pulmonary and Respiratory Medicine, Cancer Research, Oncology

23. Health-related quality of life in the randomized phase III trial of brigatinib vs crizotinib in advanced ALK inhibitor-naive ALK + non-small cell lung cancer (ALTA-1L).

Author

Garcia Campelo MR, Lin HM, Zhu Y, Pérol M, Jahanzeb M, Popat S, Zhang P, and Camidge DR

Subjects
Anaplastic Lymphoma Kinase genetics, Crizotinib therapeutic use, Humans, Organophosphorus Compounds, Pyrimidines, Quality of Life, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy
Abstract

Objective: In ALTA-1 L, first-line brigatinib versus crizotinib significantly prolonged progression-free survival in advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC). We report health-related quality of life (HRQOL) outcomes from ALTA-1 L., Materials and Methods: HRQOL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and lung cancer-specific module (QLQ-LC13). HRQOL time to worsening, change from baseline, and duration of improvement were analyzed., Results: EORTC QLQ-C30 and QLQ-LC13 compliance was >90 % for both groups (n = 131 each). Brigatinib versus crizotinib significantly delayed time to worsening in the EORTC QLQ-C30 global health status (GHS)/QOL (median: 26.74 vs 8.31 months; hazard ratio [HR]: 0.70; 95 % CI: 0.49, 1.00; log-rank P = 0.0485); emotional functioning, social functioning, fatigue, nausea and vomiting, appetite loss, and constipation scales (log-rank P < 0.05); delays in time to worsening for the physical, role, and cognitive functioning scales were not statistically significant. Mean change from baseline showed greater improvement in GHS/QOL and most EORTC QLQ-C30 functional and symptom scales with brigatinib versus crizotinib. Among patients with GHS/QOL improvement, brigatinib had longer duration of improvement versus crizotinib (median: not reached vs 11.99 months); similar results were seen in the physical, role, emotional, and social functioning; fatigue; nausea and vomiting; and appetite loss scales. Median time to worsening in dyspnea (QLQ-LC13) was 23.98 versus 8.25 months (brigatinib vs crizotinib; HR: 0.64; 95 % CI: 0.39, 1.05)., Conclusion: Brigatinib significantly delayed time to worsening and prolonged duration of improvement in GHS/QOL versus crizotinib, supported by improvement in functional and symptom scores. These preliminary analyses suggest brigatinib is the first ALK inhibitor with better HRQOL versus another ALK inhibitor in ALK inhibitor-naive advanced ALK + NSCLC., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2021
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