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189 results on '"Biesma, Bonne"'

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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3. Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Patients With Advanced Non–Squamous Non–Small Cell Lung Cancer

Author

Govindan, Ramaswamy, Lind, Mike, Insa, Amelia, Khan, Saad A., Uskov, Dmitry, Tafreshi, Ali, Guclu, Salih, Bar, Jair, Kato, Terufumi, Lee, Ki Hyeong, Nakagawa, Kazuhiko, Hansen, Olfred, Biesma, Bonne, Kundu, Madan G., Dunbar, Martin, He, Lei, Ansell, Peter, Sehgal, Vasudha, Huang, Xin, Glasgow, Jaimee, and Bach, Bruce A.

Published
2022
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4. Switch-maintenance gemcitabine after first-line chemotherapy in patients with malignant mesothelioma (NVALT19): an investigator-initiated, randomised, open-label, phase 2 trial

Author

de Gooijer, Cornedine J, van der Noort, Vincent, Stigt, Jos A, Baas, Paul, Biesma, Bonne, Cornelissen, Robin, van Walree, Nico, van Heemst, Robbert C, Soud, Magdolen Youssef-El, Groen, Harry J M, den Brekel, Agnes J Staal-van, Buikhuisen, Wieneke A, Bootsma, Gerben P, Dammeijer, Floris, van Tinteren, Harm, Lalezari, Ferry, Aerts, Joachim G, and Burgers, Jacobus A

Published
2021
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5. 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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6. Phase III Study Comparing Cisplatin Plus Gemcitabine With Cisplatin Plus Pemetrexed in Chemotherapy-Naive Patients With Advanced-Stage Non–Small-Cell Lung Cancer

Author

Scagliotti, Giorgio Vittorio, primary, Parikh, Purvish, additional, von Pawel, Joachim, additional, Biesma, Bonne, additional, Vansteenkiste, Johan, additional, Manegold, Christian, additional, Serwatowski, Piotr, additional, Gatzemeier, Ulrich, additional, Digumarti, Raghunadharao, additional, Zukin, Mauro, additional, Lee, Jin S., additional, Mellemgaard, Anders, additional, Park, Keunchil, additional, Patil, Shehkar, additional, Rolski, Janusz, additional, Goksel, Tuncay, additional, de Marinis, Filippo, additional, Simms, Lorinda, additional, Sugarman, Katherine P., additional, and Gandara, David, additional

Published
2023
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7. Renal function-based versus standard dosing of pemetrexed: a randomized controlled trial

Author

Apotheek O&O&O, Cancer, de Rouw, Nikki, Boosman, René J., Burgers, Jacobus A., Huitema, Alwin D.R., Dingemans, Anne Marie C., Derijks, Hieronymus J., Burger, David M., Piet, Berber, Hendriks, Lizza E.L., Biesma, Bonne, Pruis, Melinda A., Dumoulin, Daphne W., Croes, Sander, Mathijssen, Ron H.J., van den Heuvel, Michel M., ter Heine, Rob, Apotheek O&O&O, Cancer, de Rouw, Nikki, Boosman, René J., Burgers, Jacobus A., Huitema, Alwin D.R., Dingemans, Anne Marie C., Derijks, Hieronymus J., Burger, David M., Piet, Berber, Hendriks, Lizza E.L., Biesma, Bonne, Pruis, Melinda A., Dumoulin, Daphne W., Croes, Sander, Mathijssen, Ron H.J., van den Heuvel, Michel M., and ter Heine, Rob

Published
2023

9. Renal function-based versus standard dosing of pemetrexed: a randomized controlled trial

Author

de Rouw, Nikki, primary, Boosman, René J., additional, Burgers, Jacobus A., additional, Huitema, Alwin D. R., additional, Dingemans, Anne-Marie C., additional, Derijks, Hieronymus. J., additional, Burger, David M., additional, Piet, Berber, additional, Hendriks, Lizza E. L., additional, Biesma, Bonne, additional, Pruis, Melinda A., additional, Dumoulin, Daphne W., additional, Croes, Sander, additional, Mathijssen, Ron H. J., additional, van den Heuvel, Michel M., additional, and ter Heine, Rob, additional

Published
2022
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10. Hyperhydration with cisplatin does not influence pemetrexed exposure

Author

de Rouw, Nikki, Derijks, Hieronymus J., Hilbrands, Luuk B., Boosman, René J., Piet, Berber, Koolen, Stijn L.W., Burgers, Jacobus A., Dingemans, Anne Marie C., van den Heuvel, Michel M., Hendriks, Lizza E.L., Aerts, Joachim G.J.V., Croes, Sander, Mathijssen, Ron H.J., Huitema, Alwin D.R., Burger, David M., Biesma, Bonne, ter Heine, Rob, de Rouw, Nikki, Derijks, Hieronymus J., Hilbrands, Luuk B., Boosman, René J., Piet, Berber, Koolen, Stijn L.W., Burgers, Jacobus A., Dingemans, Anne Marie C., van den Heuvel, Michel M., Hendriks, Lizza E.L., Aerts, Joachim G.J.V., Croes, Sander, Mathijssen, Ron H.J., Huitema, Alwin D.R., Burger, David M., Biesma, Bonne, and ter Heine, Rob

Abstract

Pemetrexed is a cytotoxic drug for first-line treatment of lung cancer. It is often combined with other anticancer drugs such as cisplatin or carboplatin. In clinical practice, hyperhydration regimens are applied to overcome cisplatin-related nephrotoxicity. As pemetrexed is almost completely eliminated from the body by the kidneys, hyperhydration can result in augmented clearance. Furthermore, administration of large quantities of fluid may increase the volume of distribution of pemetrexed. Pharmacokinetics and, thus, efficacy and toxicity may be influenced by hyperhydration. This has not yet been properly studied. We performed a population pharmacokinetic analysis to assess hyperhydration as a covariate for pemetrexed clearance and for volume of distribution A relevant change was defined as >25% increase in clearance or volume of distribution. In our extensive dataset of 133 individuals, we found that hyperhydration did not significantly or relevantly explain variability in pemetrexed clearance (unchanged, P =.196) or volume of distribution (+7% change, P =.002), despite a power of >99% to detect a relevant change. Therefore, dose adjustments of pemetrexed are not required during hyperhydration with cisplatin.

Published
2022

12. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial

Author

Herbst, Roy S, Sun, Yan, Eberhardt, Wilfried EE, Germonpré, Paul, Saijo, Nagahiro, Zhou, Caicun, Wang, Jie, Li, Longyun, Kabbinavar, Fairooz, Ichinose, Yukito, Qin, Shukui, Zhang, Li, Biesma, Bonne, Heymach, John V, Langmuir, Peter, Kennedy, Sarah J, Tada, Hiroomi, and Johnson, Bruce E

Published
2010
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13. Hyperhydration with cisplatin does not influence pemetrexed exposure

Author

de Rouw, Nikki, primary, Derijks, Hieronymus J., additional, Hilbrands, Luuk B., additional, Boosman, René J., additional, Piet, Berber, additional, Koolen, Stijn L. W., additional, Burgers, Jacobus A., additional, Dingemans, Anne‐Marie C., additional, van den Heuvel, Michel M., additional, Hendriks, Lizza E. L., additional, Aerts, Joachim G. J. V., additional, Croes, Sander, additional, Mathijssen, Ron H. J., additional, Huitema, Alwin D. R., additional, Burger, David M., additional, Biesma, Bonne, additional, and ter Heine, Rob, additional

Published
2021
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14. Toxicity of pemetrexed during renal impairment explained—Implications for safe treatment

Author

Boosman, René J., primary, Dorlo, Thomas P. C., additional, Rouw, Nikki, additional, Burgers, Jacobus A., additional, Dingemans, Anne‐Marie C., additional, Heuvel, Michel M., additional, Hendriks, Lizza E. L., additional, Biesma, Bonne, additional, Aerts, Joachim G. J. V., additional, Croes, Sander, additional, Mathijssen, Ron H. J., additional, Huitema, Alwin D. R., additional, and Heine, Rob, additional

Published
2021
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16. Toxicity of pemetrexed during renal impairment explained-Implications for safe treatment

Author

Boosman, René J, Dorlo, Thomas P. C., de Rouw, Nikki, Burgers, Jacobus A, Dingemans, Anne-Marie C, van den Heuvel, Michel M, Hendriks, Lizza E L, Biesma, Bonne, Aerts, Joachim G J V, Croes, Sander, Mathijssen, Ron H J, Huitema, Alwin D R, Ter Heine, Rob, Boosman, René J, Dorlo, Thomas P. C., de Rouw, Nikki, Burgers, Jacobus A, Dingemans, Anne-Marie C, van den Heuvel, Michel M, Hendriks, Lizza E L, Biesma, Bonne, Aerts, Joachim G J V, Croes, Sander, Mathijssen, Ron H J, Huitema, Alwin D R, and Ter Heine, Rob

Abstract

Pemetrexed is an important component of first line treatment in patients with non-squamous non-small cell lung cancer. However, a limitation is the contraindication in patients with renal impairment due to hematological toxicity. Currently, it is unknown how to safely dose pemetrexed in these patients. The aim of our study was to elucidate the relationship between pemetrexed exposure and toxicity to support the development of a safe dosing regimen in patients with renal impairment. A population pharmacokinetic/pharmacodynamic analysis was performed based on phase II study results in three patients with renal dysfunction, supplemented with data from 106 patients in early clinical studies. Findings were externally validated with data of different pemetrexed dosing regimens. Alternative dosing regimens were evaluated using the developed model. We found that pemetrexed toxicity was driven by the time above a toxicity threshold concentration. The threshold for vitamin-supplemented patients was 0.110 mg/mL (95% CI: 0.092-0.146 mg/mL). It was observed that in patients with renal impairment (estimated glomerular filtration rate [eGFR]: <45 mL/min) the approved dose of 500 mg/m2 would yield a high probability of severe neutropenia in the range of 51.0% to 92.6%. A pemetrexed dose of 20 mg for patients (eGFR: 20 mL/min) is shown to be neutropenic-equivalent to the approved dose in patients with adequate renal function (eGFR: 90 mL/min), but would result in an approximately 13-fold lower area under the concentration-time curve. The pemetrexed exposure-toxicity relationship is explained by a toxicity threshold and substantially different from previously thought. Without prophylaxis for toxicity, it is unlikely that a therapeutic dose can be safely administered to patients with renal impairment.

Published
2021
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17. Toxicity of pemetrexed during renal impairment explained—Implications for safe treatment

Author

Apotheek O&O&O, Cancer, Boosman, René J., Dorlo, Thomas P.C., de Rouw, Nikki, Burgers, Jacobus A., Dingemans, Anne Marie C., van den Heuvel, Michel M., Hendriks, Lizza E.L., Biesma, Bonne, Aerts, Joachim G.J.V., Croes, Sander, Mathijssen, Ron H.J., Huitema, Alwin D.R., ter Heine, Rob, Apotheek O&O&O, Cancer, Boosman, René J., Dorlo, Thomas P.C., de Rouw, Nikki, Burgers, Jacobus A., Dingemans, Anne Marie C., van den Heuvel, Michel M., Hendriks, Lizza E.L., Biesma, Bonne, Aerts, Joachim G.J.V., Croes, Sander, Mathijssen, Ron H.J., Huitema, Alwin D.R., and ter Heine, Rob

Published
2021

19. Immune monitoring in mesothelioma patients identifies novel immune-modulatory functions of gemcitabine associating with clinical response

Author

Dammeijer, Floris, primary, De Gooijer, Cornedine J., additional, van Gulijk, Mandy, additional, Lukkes, Melanie, additional, Klaase, Larissa, additional, Lievense, Lysanne A., additional, Waasdorp, Cynthia, additional, Jebbink, Merel, additional, Bootsma, Gerben P., additional, Stigt, Jos A., additional, Biesma, Bonne, additional, Kaijen-Lambers, Margaretha E.H., additional, Mankor, Joanne, additional, Vroman, Heleen, additional, Cornelissen, Robin, additional, Baas, Paul, additional, Van der Noort, Vincent, additional, Burgers, Jacobus A., additional, and Aerts, Joachim G., additional

Published
2021
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21. Efficacy of Ibandronate Loading Dose on Rapid Pain Relief in Patients With Non-Small Cell Lung Cancer and Cancer Induced Bone Pain:The NVALT-9 Trial

Author

Brouns, Anita J.W.M., Hendriks, Lizza E.L., van der Noort, Vincent, van de Borne, Ben E.E.M., Schramel, Franz M.N.H., Groen, Harry J.M., Biesma, Bonne, Smit, Hans J.M., Dingemans, Anne Marie C., Brouns, Anita J.W.M., Hendriks, Lizza E.L., van der Noort, Vincent, van de Borne, Ben E.E.M., Schramel, Franz M.N.H., Groen, Harry J.M., Biesma, Bonne, Smit, Hans J.M., and Dingemans, Anne Marie C.

Abstract

Introduction: Approximately 80% of non-small cell lung cancer (NSCLC) patients with bone metastases have cancer induced bone pain (CIBP). Methods: The NVALT-9 was an open-label, single arm, phase II, multicenter study. Main inclusion criterion: bone metastasized NSCLC patients with uncontrolled CIBP [brief pain inventory [BPI] ≥ 5 over last 7 days]. Patients were treated with six milligram ibandronate intravenously (day 1–3) once a day. Main exclusion criteria: active secondary malignancy, systemic anti-tumor treatment and radiotherapy ≤4 weeks before study start, previous bisphosphonate treatment. Statistics: Simon's Optimal two-stage design with a 90% power to declare the treatment active if the pain response rate is ≥ 80% and 95% confidence to declare the treatment inactive if the pain response rate is ≤ 60%. If pain response is observed in ≤ 12 of the first 19 patients further enrollment will be stopped. Primary endpoint: bone pain response, defined as 25% decrease in worst pain score (PSc) over a 3-day period (day 5–7) compared to baseline PSc with maximum of 25% increase in mean analgesic consumption during the same period. Secondary endpoints: BPI score, quality of life, toxicity and World Health Organization Performance Score. Results: Of the 19 enrolled patients in the first stage, 18 were evaluable for response. All completed ibandronate treatment according to protocol. In 4 (22.2%), a bone pain response was observed. According to the stopping rule, further enrollment was halted. Discussion: Ibandronate loading doses lead to insufficient pain relief in NSCLC patients with CIBP.

Published
2020

23. International real-world study of DLL3 expression in patients with small cell lung cancer

Author

Rojo, Federico, primary, Corassa, Marcelo, additional, Mavroudis, Dimitrios, additional, Öz, Aysim Büge, additional, Biesma, Bonne, additional, Brcic, Luka, additional, Pauwels, Patrick, additional, Sailer, Verena, additional, Gosney, John, additional, Miljkovic, Darko, additional, Hader, Carlos, additional, Wu, Meijing, additional, Almarez, Todd, additional, and Penault-Llorca, Frédérique, additional

Published
2020
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24. Efficacy of Ibandronate Loading Dose on Rapid Pain Relief in Patients With Non-Small Cell Lung Cancer and Cancer Induced Bone Pain: The NVALT-9 Trial

Author

Brouns, Anita J. W. M., primary, Hendriks, Lizza E. L., additional, van der Noort, Vincent, additional, van de Borne, Ben E. E. M, additional, Schramel, Franz M. N. H., additional, Groen, Harry J. M., additional, Biesma, Bonne, additional, Smit, Hans J. M., additional, and Dingemans, Anne-Marie C., additional

Published
2020
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25. Implementation of Novel Molecular Biomarkers for Non-small Cell Lung Cancer in the Netherlands: How to Deal With Increasing Complexity

Author

van den Broek, Daan, primary, Hiltermann, T. Jeroen N., additional, Biesma, Bonne, additional, Dinjens, Winand N. M., additional, 't Hart, Nils A., additional, Hinrichs, John W. J., additional, Leers, Mathie P. G., additional, Monkhorst, Kim, additional, van Oosterhout, Matthijs, additional, Scharnhorst, Volkher, additional, Schuuring, Ed, additional, Speel, Ernst-Jan M., additional, van den Heuvel, Michel M., additional, van Schaik, Ron H. N., additional, von der Thüsen, Jan, additional, Willems, Stefan M., additional, de Visser, Leonie, additional, and Ligtenberg, Marjolijn J. L., additional

Published
2020
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26. Switch Maintenance Gemcitabine after First Line Chemotherapy in Patients with Malignant Mesothelioma: A Randomized Open Label Phase II Trial (NVALT19)

Author

de Gooijer, Cornedine J., primary, van der Noort, Vincent, additional, Stigt, Jos A., additional, Baas, Paul, additional, Biesma, Bonne, additional, Cornelissen, Robin, additional, van Walree, Nico, additional, van Heemst, Robbert C., additional, Youssef-El Soud, Magdolen, additional, Groen, Harry J.M., additional, Staal-van den Brekel, Agnes J., additional, Buikhuisen, Wieneke A., additional, Bootsma, Gerben P., additional, Dammeijer, Floris, additional, van Tinteren, Harm, additional, Lalezari, Ferry, additional, Aerts, Joachim G. J. V., additional, and Burgers, Jacobus A., additional

Published
2020
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31. Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer: the NVALT-8 study

Author

Groen, Harry J.M., Heijden, E. van der, Klinkenberg, Theo J., Biesma, Bonne, Aerts, Joachim, Verhagen, A.F., Smit, Egbert F., Dingemans, Anne-Marie C., Groen, Harry J.M., Heijden, E. van der, Klinkenberg, Theo J., Biesma, Bonne, Aerts, Joachim, Verhagen, A.F., Smit, Egbert F., and Dingemans, Anne-Marie C.

Abstract

Contains fulltext : 207334.pdf (publisher's version ) (Open Access)

Published
2019

33. Standard Versus Intensified Chemotherapy With Granulocyte Colony-Stimulating Factor Support in Small-Cell Lung Cancer: A Prospective European Organization for Research and Treatment of Cancer–Lung Cancer Group Phase III Trial—08923

Author

Ardizzoni, Andrea, Tjan-Heijnen, Vivianne C.G., Postmus, Pieter E., Buchholz, Erica, Biesma, Bonne, Karnicka-Mlodkowska, Hanna, Dziadziuszko, Rafal, Burghouts, Jos, van Meerbeeck, Jan P., Gans, Steven, Legrand, Catherine, Debruyne, Channa, Giaccone, Giuseppe, and Manegold for the, Christian

Published
2002

35. Estimating quality adjusted progression free survival of first-line treatments for EGFR mutation positive non small cell lung cancer patients in The Netherlands

Author

Verduyn S, Biesma Bonne, Schramel Franz MNH, van der Scheer Feike W, Langenfeld Merel K, de Peuter Maria A, and Dingemans Anne-Marie C

Subjects
Advanced non-small cell lung cancer, Tyrosine kinase inhibitors, EGFR mutation, Gefitinib, Quality of life, Progression free survival, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

Abstract Background Gefitinib, a tyrosine kinase inhibitor, is an effective treatment in advanced non-small cell lung cancer (NSCLC) patients with an activating mutation in the epidermal growth factor receptor (EGFR). Randomised clinical trials showed a benefit in progression free survival for gefitinib versus doublet chemotherapy regimens in patients with an activated EGFR mutation (EGFR M+). From a patient perspective, progression free survival is important, but so is health-related quality of life. Therefore, this analysis evaluates the Quality Adjusted progression free survival of gefitinib versus three relevant doublet chemotherapies (gemcitabine/cisplatin (Gem/Cis); pemetrexed/cisplatin (Pem/Cis); paclitaxel/carboplatin (Pac/Carb)) in a Dutch health care setting in patients with EGFR M+ stage IIIB/IV NSCLC. This study uses progression free survival rather than overall survival for its time frame in order to better compare the treatments and to account for the influence that subsequent treatment lines would have on overall survival analysis. Methods Mean progression free survival for Pac/Carb was obtained by extrapolating the median progression free survival as reported in the Iressa-Pan-Asia Study (IPASS). Data from a network meta-analysis was used to estimate the mean progression free survival for therapies of interest relative to Pac/Carb. Adjustment for health-related quality of life was done by incorporating utilities for the Dutch population, obtained by converting FACT-L data (from IPASS) to utility values and multiplying these with the mean progression free survival for each treatment arm to determine the Quality Adjusted progression free survival. Probabilistic sensitivity analysis was carried out to determine 95% credibility intervals. Results The Quality Adjusted progression free survival (PFS) (mean, (95% credibility interval)) was 5.2 months (4.5; 5.8) for Gem/Cis, 5.3 months (4.6; 6.1) for Pem/Cis; 4.9 months (4.4; 5.5) for Pac/Carb and 8.3 (7.0; 9.9) for gefitinib. Conclusions In the Dutch health care setting, the previously established progression free survival benefit of first-line gefitinib in advanced NSCLC EGFR M+ patients in comparison to standard doublet chemotherapy is further supported by the Quality Adjusted PFS, which takes into account the additional health-related quality of life benefits of gefitinib over doublet chemotherapy.

Published
2012
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36. Randomized Phase III Trial of Erlotinib versus Docetaxel in Patients with Advanced Squamous Cell Non–Small Cell Lung Cancer Failing First-Line Platinum-Based Doublet Chemotherapy Stratified by VeriStrat Good versus VeriStrat Poor. The European Thoracic Oncology Platform (ETOP) EMPHASIS-lung Trial

Author

Peters, Solange, Stahel, Rolf A., Dafni, Urania, Ponce Aix, Santiago, Massutí, Bartomeu, Gautschi, Oliver, Coate, Linda, López Martín, Ana, van Heemst, Robbert, Berghmans, Thierry, Meldgaard, Peter, Cobo Dols, Manuel, Garde Noguera, Javier, Curioni-Fontecedro, Alessandra, Rauch, Daniel, Mark, Michael T., Cuffe, Sinead, Biesma, Bonne, van Henten, Arjen M.J., Juan Vidal, Óscar, Palmero Sanchez, Ramón, Villa Guzmán, José Carlos, Collado Martin, Ricardo, Peralta, Sergio, Insa, Amelia, Summers, Yvonne, Láng, István, Horgan, Anne, Ciardiello, Fortunato, de Hosson, Sander, Pieterman, Remge, Groen, Harry J.M., van den Berg, Paul M., Zielinski, Christoph C., Chittazhathu Kurian Kuruvilla, Yojena, Gasca-Ruchti, Adriana, Kassapian, Marie, Novello, Silvia, Torri, Valter, Tsourti, Zoi, Gregorc, Vanesa, and Smit, Egbert F.

Published
2017
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37. Randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer failing first line platinum-based doublet chemotherapy stratified by Veristrat good versus Veristrat poor. The European Thoracic Oncology Platform (ETOP) EMPHASIS-lung trial

Author

Stahel, Rolf A, Kassapian, Marie, Curioni-Fontecedro, Alessandra, Smit, Egbert F, Aix, Santiago Ponce, Massutí, Bartomeu, Meldgaard, Peter, Láng, István, Noguera, Javier Garde, Novello, Silvia, Horgan, Anne, Pieterman, Remge, Van Heemst, Robbert, Chittazhathu Kurian Kuruvilla, Yojena, Ciardiello, Fortunato, Van Henten, Arjen Mj, Coate, Linda, Vidal, Óscar Juan, Peters, Solange, Tsourti, Zoi, Groen, Harry Jm, Zielinski, Christoph C, Martin, Ricardo Collado, Rauch, Daniel, López Martín, Ana, Villa Guzmán, José Carlos, Gasca-Ruchti, Adriana, Peralta, Sergio, Biesma, Bonne, Torri, Valter, Sanchez, Ramón Palmero, Gautschi, Oliver, Berghmans, Thierry, Mark, Michael T, Cuffe, Sinead, Cobo Dols, Manuel, Gregorc, Vanesa, Van Den Berg, Paul M, Insa, Amelia, Summers, Yvonne, De Hosson, Sander, and Dafni, Urania

Subjects
610 Medicine & health, neoplasms, respiratory tract diseases
Abstract

INTRODUCTION Docetaxel and erlotinib are registered second-line treatments for wild-type EGFR NSCLC. Previous studies suggested a predictive value of the Veristrat test in second-line therapy of NSCLC, classifying patients as either Veristrat "good" or "poor". EMPHASIS-lung aimed at exploring this predictive effect in patients with squamous cell NSCLC. The trial closed prematurely due to low accrual and results from other trials. Our analysis includes an exploratory combined analysis with results from the PROSE trial. METHODS EMPHASIS-lung is a randomized phase III multicenter trial exploring the differential activity of second-line erlotinib versus docetaxel on progression-free survival (PFS) in Veristrat good versus poor patients with squamous cell NSCLC. RESULTS A total of 80 patients were randomized, with 72.5% categorized as Veristrat good. Patient characteristics were balanced between Veristrat status and treatment groups. Median PFS under docetaxel and erlotinib in the Veristrat good cohort was 4.1 and 1.6 months respectively, and 1.9 and 2.1 months in the Veristrat poor cohort. Median overall survival (OS) under docetaxel and erlotinib in the Veristrat good cohort was 7.8 and 8.4 and 4.4 and 5.2 months in the Veristrat poor cohort. An additional exploratory analysis was performed, where 47 patients from the squamous cell subgroup of PROSE were included in a combined analysis contributing with 45 PFS and 41 OS events. CONCLUSION The final analysis of EMPHASIS-lung did not show differential activity on PFS for erlotinib versus docetaxel stratified by Veristrat status. Similarly, in the combined analysis, no significant treatment by Veristrat status interaction was observed (interaction P=0.24 for PFS and 0.45 for OS, stratified by study).

Published
2017
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38. Pulmonary injury associated with spray of a water-based nano-sized waterproofing product: a case study

Author

Scheepers, Paul T. J., primary, Masen-Poos, Lucie, additional, van Rooy, Frits G. B. G. J., additional, Oerlemans, Arné, additional, van Daalen, Eline, additional, Cremers, Robbert, additional, Lichtenbeld, Hera, additional, Biesma, Bonne, additional, Sørli, Jorid B., additional, Koponen, Ismo K., additional, Larsen, Søren Thor, additional, Wolkoff, Peder, additional, and Nørgaard, Asger W., additional

Published
2017
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39. P2.02-021 Extracranial Progression (ePD) after Chemoradiotherapy (CRT) for Stage III NSCLC: Does the Chemotherapy Regimen Matter?

Author

Hendriks, Lizza, primary, Brouns, Anita, additional, Amini, Mohammad, additional, Uyterlinde, Wilma, additional, Wijsman, Robin, additional, Bussink, Jan, additional, Biesma, Bonne, additional, Oei, S. Bing, additional, Stigt, Jos, additional, Bootsma, Gerben, additional, Belderbos, José, additional, De Ruysscher, Dirk, additional, Van Den Heuvel, Michel, additional, and Dingemans, Anne-Marie, additional

Published
2017
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40. Development of symptomatic brain metastases after chemoradiotherapy for stage III non-small cell lung cancer: Does the type of chemotherapy regimen matter?

Author

Hendriks, Lizza E.L., primary, Brouns, -->Anita J.W.M., additional, Amini, Mohammad, additional, Uyterlinde, Wilma, additional, Wijsman, Robin, additional, Bussink, Jan, additional, Biesma, Bonne, additional, Oei, S. Bing, additional, Stigt, Jos -->A., additional, Bootsma, Gerben P., additional, Belderbos, José S.A., additional, De Ruysscher, Dirk K.M., additional, Van den Heuvel, Michel M., additional, and Dingemans, Anne-Marie C., additional

Published
2016
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41. Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer: the NVALT-8 study.

Author

Groen, Harry J. M., van der Heijden, Erik H. F. M., Klinkenberg, Theo J., Biesma, Bonne, Aerts, Joachim, Verhagen, Ad, Kloosterziel, Corinne, Pieterman, Remge, van den Borne, Ben, Smit, Hans J. M., Hoekstra, Otto, Schramel, Frans M. N. H., van der Noort, Vincent, van Tinteren, Harm, Smit, Egbert F., Dingemans, Anne-Marie C., and NVALT Study Group, the Netherlands

Abstract

Background: Retrospective studies suggest that low molecular weight heparin may delay the development of metastasis in patients with resected NSCLC.Methods: Multicentre phase 3 study with patients with completely resected NSCLC who were randomised after surgery to receive chemotherapy with or without nadroparin. The main exclusion criteria were R1/2 and wedge/segmental resection. FDG-PET was required. The primary endpoint was recurrence-free survival (RFS).Results: Among 235 registered patients, 202 were randomised (nadroparin: n = 100; control n = 102). Slow accrual enabled a decrease in the number of patients needed from 600 to 202, providing 80% power to compare RFS with 94 events (α = 0.05; 2-sided). There were no differences in bleeding events between the two groups. The median RFS was 65.2 months (95% CI, 36-NA) in the nadroparin arm and 37.7 months (95% CI, 22.7-NA) in the control arm (HR 0.77 (95% CI, 0.53-1.13, P = 0.19). FDG-PET SUVmax ≥10 predicted a greater likelihood of recurrence in the first year (HR 0.48, 95% CI 0.22-0.9, P = 0.05).Conclusions: Adjuvant nadroparin did not improve RFS in patients with resected NSCLC. In this study, a high SUVmax predicted a greater likelihood of recurrence in the first year.Clinical Trial Registration: Netherlands Trial registry: NTR1250/1217. [ABSTRACT FROM AUTHOR]

Published
2019
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43. Randomized phase III study of adjuvant chemotherapy with or without low-molecular weight heparin in completely resected non-small cell lung cancer patients: The NVALT-8 study.

Author

Groen, Harry J.M., primary, van der Heijden, Erik, additional, Klinkenberg, Theo J, additional, Biesma, Bonne, additional, Aerts, Joachim, additional, Verhagen, Ad, additional, Kloosterziel, Corinne, additional, Smit, Hans J.M., additional, Schramel, Franz, additional, van der Noort, Vincent, additional, van Tinteren, Harm, additional, Smit, Egbert F., additional, and Dingemans, Anne-Marie C., additional

Published
2016
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44. PROCLAIM: Randomized Phase III Trial of Pemetrexed-Cisplatin or Etoposide-Cisplatin Plus Thoracic Radiation Therapy Followed by Consolidation Chemotherapy in Locally Advanced Nonsquamous Non–Small-Cell Lung Cancer

Author

Senan, Suresh, primary, Brade, Anthony, additional, Wang, Lu-hua, additional, Vansteenkiste, Johan, additional, Dakhil, Shaker, additional, Biesma, Bonne, additional, Martinez Aguillo, Maite, additional, Aerts, Joachim, additional, Govindan, Ramaswamy, additional, Rubio-Viqueira, Belén, additional, Lewanski, Conrad, additional, Gandara, David, additional, Choy, Hak, additional, Mok, Tony, additional, Hossain, Anwar, additional, Iscoe, Neill, additional, Treat, Joseph, additional, Koustenis, Andrew, additional, San Antonio, Bélen, additional, Chouaki, Nadia, additional, and Vokes, Everett, additional

Published
2016
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45. Phase II study of pemetrexed and cisplatin plus cetuximab followed by pemetrexed and cetuximab maintenance therapy in patients with advanced nonsquamous non-small cell lung cancer

Author

Schmid-Bindert, Gerald Gebbia, Vittorio Mayer, Frank and Arriola, Edurne Marquez-Medina, Diego Syrigos, Kostas and Biesma, Bonne Leschinger, Monika Iris Frimodt-Moller, Bente and Ripoche, Veronique Myrand, Scott P. Nguyen, Tuan S. Hozak, Rebecca R. Zimmermann, Annamaria Visseren-Grul, Carla and Schuette, Wolfgang

Abstract

Objectives: The aim was to determine if combined pemetrexed, cisplatin, and cetuximab was efficacious and safe as first-line treatment in advanced nonsquamous non-small cell lung cancer (NSCLC). Patients and methods: In this single-arm, multicenter clinical trial, patients with Stage IIIB/IV nonsquamous NSCLC received first-line therapy consisting of pemetrexed (500 mg/m(2)) and cisplatin (75 mg/m2) on Day 1 (21-day cycles) plus weekly cetuximab (400 mg/m(2) loading dose, then 250 mg/m(2)) for 4-6 cycles. Non-progressing patients received maintenance therapy consisting of pemetrexed and cetuximab as above until disease progression. All patients received vitamin supplementation, dexamethasone, and antihistamine prophylaxis. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), 1-year survival rate, translational research (TR) and safety. Results: Of the 113 patients receiving study drug, 109 were protocol-qualified. All patients completed >= 1 cycle of induction, and 51 (45%) and 49 (43%) patients completed >= 1 cycle of maintenance with pemetrexed and cetuximab, respectively. The ORR (n=109) was 38.5% (80% confidence interval [CI], 32.3-45.1%), all partial responses. Median PFS was 5.8 (80% CI, 4.4-6.7) months. One-year survival rate was 45% (80% CI, 39-51%). In exploratory analyses, there was some preliminary evidence of potential prognostic relationships with efficacy outcomes for epidermal growth factor receptor and thyroid transcription factor-1 protein expression, but not for KRAS mutation or for thymidylate synthase or folate receptor-alpha protein expression. Seventy-three (64.6%) patients had study drug-related Grade 3/4 adverse events (AEs). Drug-related serious AEs were reported in 31 (27.4%) patients. There were 3 (2.7%) potentially drug-related deaths on-study or within 30 days of follow up. Conclusion: Pemetrexed, cisplatin, and cetuximab appeared efficacious and tolerable in advanced nonsquamous NSCLC patients. The TR outcomes are hypothesis-generating given the study’s size and nonrandomized nature. (C) 2013 Elsevier Ireland Ltd. All rights reserved.

Published
2013

46. Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Gemcitabine/Cisplatin Alone or With Sorafenib for the First-Line Treatment of Advanced, Nonsquamous Non-Small-Cell Lung Cancer

Author

Paz-Ares, Luis G. Biesma, Bonne Heigener, David von Pawel, Joachim Eisen, Timothy Bennouna, Jaafar Zhang, Li Liao, Meilin Sun, Yan Gans, Steven Syrigos, Kostas Le Marie, Etienne Gottfried, Maya Vansteenkiste, Johan Alberola, Vincente Strauss, Uwe Phillip Montegriffo, Elaine Ong, Teng Jin Santoro, Armando

Subjects
neoplasms
Abstract

Purpose This trial evaluated the efficacy and safety of sorafenib plus gemcitabine/cisplatin in chemotherapy-naive patients with unresectable stage IIIB to IV nonsquamous non-small-cell lung cancer (NSCLC). Patients and Methods Between February 2007 and March 2009, 904 patients were randomly assigned to daily sorafenib (400 mg twice a day) or matching placebo plus gemcitabine (1,250 mg/m(2) per day on days 1 and 8) and cisplatin (75 mg/m(2) on day 1) for up to six 21-day cycles. Because of safety findings from the Evaluation of Sorafenib, Carboplatin and Paclitaxel Efficacy in NSCLC (ESCAPE) trial, patients with squamous cell histology were withdrawn from the trial in February 2008 and excluded from analysis. The primary end point was overall survival (OS), and secondary end points included progression-free survival (PFS) and time-to-progression (TTP). Results The primary analysis population consisted of 772 patients (sorafenib, 385; placebo, 387); the two groups had similar demographic and baseline characteristics. Median OS was similar in the sorafenib and placebo groups (12.4 v 12.5 months; hazard ratio [HR], 0.98; P = .401). By investigator assessment, sorafenib improved median PFS (6.0 v 5.5 months; HR, 0.83; P = .008) and TTP (6.1 v 5.5 months; HR, 0.73; P < .001). Grade 3 to 4 drug-related adverse events more than two-fold higher in the sorafenib group included hand-foot skin reaction (8.6% v 0.3%), fatigue (7.3% v 3.6%), rash (5.7% v 0.5%), and hypertension (4.2% v 1.8%). No unexpected toxicities were observed. Conclusion This study did not meet its primary end point of improved OS when sorafenib was added to first-line gemcitabine/cisplatin in patients with advanced nonsquamous NSCLC. Identification of predictive biomarkers is warranted in future trials of sorafenib. J Clin Oncol 30: 3084-3092. (C) 2012 by American Society of Clinical Oncology

Published
2012

47. Final overall survival (OS) results of the phase III PROCLAIM trial: Pemetrexed (Pem), cisplatin (Cis) or etoposide (Eto), Cis plus thoracic radiation therapy (TRT) followed by consolidation cytotoxic chemotherapy (CTX) in locally advanced nonsquamous non-small cell lung cancer (nsNSCLC).

Author

Senan, Suresh, primary, Brade, Anthony M., additional, Wang, Luhua, additional, Vansteenkiste, Johan F., additional, Dakhil, Shaker R., additional, Biesma, Bonne, additional, Martinez Aguillo, Maite, additional, Aerts, Joachim, additional, Govindan, Ramaswamy, additional, Rubio-Viqueira, Belén, additional, Lewanski, Conrad R., additional, Gandara, David R., additional, Choy, Hak, additional, Mok, Tony, additional, Hossain, Anwar, additional, Iscoe, Neill Allan, additional, Treat, Joseph, additional, Koustenis, Andrew G., additional, Chouaki, Nadia, additional, and Vokes, Everett E., additional

Published
2015
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