Brigatinib in patients with ALK-positive advanced non-small-cell lung cancer pretreated with sequential ALK inhibitors: A multicentric real-world study (BRIGALK study)

被引:20
作者
Descourt, Renaud [1 ]
Perol, Maurice [2 ]
Rousseau-Bussac, Gaelle [3 ]
Planchard, David [4 ]
Mennecier, Bertrand [5 ]
Wislez, Marie [6 ,13 ]
Cortot, Alexis [7 ]
Guisier, Florian [8 ]
Galland, Loick [9 ]
Do, Pascal [10 ]
Schott, Roland [11 ]
Dansin, Eric [12 ]
Arrondeau, Jennifer [13 ]
Auliac, Jean-Bernard [3 ]
Chouaid, Christos [3 ]
机构
[1] CHU Brest, Oncol Dept, Brest, France
[2] Leon Berard Canc Ctr, Lyon, France
[3] CHIC Creteil, Creteil, France
[4] Gustave Roussy, Dept Med Oncol, Thorac Grp, Villejuif, France
[5] CHU Strasbourg, Chest Dept, Strasbourg, France
[6] Hop Univ Est Parisien, Tenon Hosp, AP HP, Chest Dept, Paris, France
[7] CHU Lille, Thorac Oncol Unit, Lille, France
[8] CHU Rouen, Chest Dept, Rouen, France
[9] Georges Francois Leclerc Canc Ctr, Med Oncol Dept, Dijon, France
[10] Francois Baclesse Canc Ctr, Med Oncol Dept, Caen, France
[11] Paul Strauss Canc Ctr, Med Oncol Dept, Strasbourg, France
[12] Oscar Lambret Canc Ctr, Med Oncol Dept, Lille, France
[13] Hop Univ Paris Ctr, Cochin Hosp, AP HP, Thorac Oncol Unit,Dept Pneumol, Paris, France
关键词
Advanced non-small cell lung cancer; ALK rearrangement; Brigatinib; Crizotinib; ALK inhibitor; Early access program; OPEN-LABEL; CRIZOTINIB; CERITINIB; CHEMOTHERAPY; SAFETY;
D O I
10.1016/j.lungcan.2019.08.010
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Objectives: Brigatinib is a next-generation ALK inhibitor initially developed in ALK-positive NSCLC pretreated with crizotinib. Materials and Methods: This retrospective multicentric study analyzed ALK-positive advanced NSCLC patients pretreated with at least one tyrosine-kinase inhibitor, including crizotinib, and enrolled in the brigatinib French early access program. The primary endpoint was investigator-assessed progression-free survival (PFS). Results: 104 patients were included (mean age, 56.6 years; never smokers, 61.5%; adenocarcinoma, 98.1%). Patients had received a median of 3 previous treatment lines, including at least 2 ALK inhibitors (mainly crizotinib then ceritinib). At brigatinib initiation, 59.1% had performance status 0-1, 51.9% had a >= 3 metastatic sites, 74.5% had central nervous system metastases (CNS) and 8.8% had carcinomatous meningitis. Median duration of brigatinib treatment was 6.7 (95% CI, 0.06-20.7) months. Median PFS was 6.6 (4.8-9.9) months for the entire population. For patients who received 2, 3-4 and > 4 lines of treatment before brigatinib, PFS was 4.3 (2.5-8.9), 10.4 (5.9-13.9) and 3.8 (0.8-7.4) months, respectively. In the 91 evaluable patients, disease control rate was 78.2%. From brigatinib start, median overall survival was 17.2 (11.0 not reached) months. Among the 68 patients with progressive disease after brigatinib, CNS was involved in 29.4% of cases. Median OS from the diagnosis of NSCLC was 75.3 (38.2-174.6) months. Conclusion: These real-world results confirm the efficacy of brigatinib in a cohort of patients heavily pretreated for ALK-positive advanced NSCLC.
引用
收藏
页码:109 / 114
页数:6
相关论文
共 23 条
[1]  
Ahn M.-J., 2017, TRIAL, V35
[2]  
[Anonymous], 2018, Lancet Oncol
[3]   Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT) [J].
Barlesi, Fabrice ;
Mazieres, Julien ;
Merlio, Jean-Philippe ;
Debieuvre, Didier ;
Mosser, Jean ;
Lena, Herve ;
Ouafik, L'Houcine ;
Besse, Benjamin ;
Rouquette, Isabelle ;
Westeel, Virginie ;
Escande, Fabienne ;
Monnet, Isabelle ;
Lemoine, Antoinette ;
Veillon, Remi ;
Blons, Helene ;
Audigier-Valette, Clarisse ;
Bringuier, Pierre-Paul ;
Lamy, Regine ;
Beau-Faller, Michele ;
Pujol, Jean-Louis ;
Sabourin, Jean-Christophe ;
Penault-Llorca, Frederique ;
Denis, Marc G. ;
Lantuejoul, Sylvie ;
Morin, Franck ;
Quan Tran ;
Missy, Pascale ;
Langlais, Alexandra ;
Milleron, Bernard ;
Cadranel, Jacques ;
Soria, Jean-Charles ;
Zalcman, Gerard .
LANCET, 2016, 387 (10026) :1415-1426
[4]   Brigatinib versus Crizotinib in ALK-Positive Non-Small-Cell Lung Cancer [J].
Camidge, D. R. ;
Kim, H. R. ;
Ahn, M. -J. ;
Yang, J. C. -H. ;
Han, J. -Y. ;
Lee, J. -S. ;
Hochmair, M. J. ;
Li, J. Y. -C. ;
Chang, G. -C. ;
Lee, K. H. ;
Gridelli, C. ;
Delmonte, A. ;
Garcia Campelo, R. ;
Kim, D. -W. ;
Bearz, A. ;
Griesinger, F. ;
Morabito, A. ;
Felip, E. ;
Califano, R. ;
Ghosh, S. ;
Spira, A. ;
Gettinger, S. N. ;
Tiseo, M. ;
Gupta, N. ;
Haney, J. ;
Kerstein, D. ;
Popat, S. .
NEW ENGLAND JOURNAL OF MEDICINE, 2018, 379 (21) :2027-2039
[5]   Exploratory Analysis of Brigatinib Activity in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer and Brain Metastases in Two Clinical Trials [J].
Camidge, D. Ross ;
Kim, Dong-Wan ;
Tiseo, Marcello ;
Langer, Corey J. ;
Ahn, Myung-Ju ;
Shaw, Alice T. ;
Huber, Rudolf M. ;
Hochmair, Maximilian J. ;
Lee, Dae Ho ;
Bazhenova, Lyudmila A. ;
Gold, Kathryn A. ;
Ou, Sai-Hong Ignatius ;
West, Howard L. ;
Reichmann, William ;
Haney, Jeff ;
Clackson, Tim ;
Kerstein, David ;
Gettinger, Scott N. .
JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (26) :2693-+
[6]   Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study [J].
Camidge, D. Ross ;
Bang, Yung-Jue ;
Kwak, Eunice L. ;
Iafrate, A. John ;
Varella-Garcia, Marileila ;
Fox, Stephen B. ;
Riely, Gregory J. ;
Solomon, Benjamin ;
Ou, Sai-Hong I. ;
Kim, Dong-Wan ;
Salgia, Ravi ;
Fidias, Panagiotis ;
Engelman, Jeffrey A. ;
Gandhi, Leena ;
Jaenne, Pasi A. ;
Costa, Daniel B. ;
Shapiro, Geoffrey I. ;
LoRusso, Patricia ;
Ruffner, Katherine ;
Stephenson, Patricia ;
Tang, Yiyun ;
Wilner, Keith ;
Clark, Jeffrey W. ;
Shaw, Alice T. .
LANCET ONCOLOGY, 2012, 13 (10) :1011-1019
[7]   Re-Evaluating Progression in an Era of Progress: A Review of First- and Second-Line Treatment Options in Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer [J].
Castellanos, Emily H. ;
Horn, Leora .
ONCOLOGIST, 2016, 21 (06) :755-761
[8]   Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2 [J].
Crino, Lucio ;
Ahn, Myung-Ju ;
De Marinis, Filippo ;
Groen, Harry J. M. ;
Wakelee, Heather ;
Hida, Toyoaki ;
Mok, Tony ;
Spigel, David ;
Felip, Enriqueta ;
Nishio, Makoto ;
Scagliotti, Giorgio ;
Branle, Fabrice ;
Emeremni, Chetachi ;
Quadrigli, Massimiliano ;
Zhang, Jie ;
Shaw, Alice T. .
JOURNAL OF CLINICAL ONCOLOGY, 2016, 34 (24) :2866-+
[9]   Overall survival with crizotinib and next-generation ALK inhibitors in ALK-positive non-small-cell lung cancer (IFCT-1302 CLINALK): a French nationwide cohort retrospective study [J].
Duruisseaux, Michael ;
Besse, Benjamin ;
Cadranel, Jacques ;
Perol, Maurice ;
Mennecier, Bertrand ;
Bigay-Game, Laurence ;
Descourt, Renaud ;
Dansin, Eric ;
Audigier-Valette, Clarisse ;
Moreau, Lionel ;
Hureaux, Jose ;
Veillon, Remi ;
Otto, Josiane ;
Madroszyk-Flandin, Anne ;
Cortot, Alexis ;
Guichard, Francois ;
Boudou-Rouquette, Pascaline ;
Langlais, Alexandra ;
Missy, Pascale ;
Morin, Franck ;
Moro-Sibilot, Denis .
ONCOTARGET, 2017, 8 (13) :21903-21917
[10]   New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) [J].
Eisenhauer, E. A. ;
Therasse, P. ;
Bogaerts, J. ;
Schwartz, L. H. ;
Sargent, D. ;
Ford, R. ;
Dancey, J. ;
Arbuck, S. ;
Gwyther, S. ;
Mooney, M. ;
Rubinstein, L. ;
Shankar, L. ;
Dodd, L. ;
Kaplan, R. ;
Lacombe, D. ;
Verweij, J. .
EUROPEAN JOURNAL OF CANCER, 2009, 45 (02) :228-247