Effectiveness of Nivolumab in Second-Line and Later in Patients with Advanced Non-Small Cell Lung Cancer in Real-Life Practice in France and Germany: Analysis of the ESME-AMLC and CRISP Cohorts

被引：6

作者：

Chouaid, Christos ^{[1
]}

Thomas, Michael ^{[2
,3
,4
,5
]}

Debieuvre, Didier ^{[6
]}

Durand-Zaleski, Isabelle ^{[7
]}

Zacharias, Stefan ^{[8
]}

Bosquet, Lise ^{[9
]}

Groth, Annika ^{[10
]}

Fleitz, Annette ^{[11
]}

Calleja, Alan ^{[12
]}

Patel, Sonya ^{[12
]}

Lacoin, Laure ^{[13
]}

Daumont, Melinda J. ^{[14
]}

Penrod, John R. ^{[15
]}

Carroll, Robert ^{[16
]}

Waldenberger, Daniela ^{[18
]}

Cotte, Francois-Emery

Audigier-Valette, Clarisse

Griesinger, Frank ^{[17
]}

机构：

[1] Ctr Hosp Intercommunal Creteil, Pneumol Unit, 40 Ave Verdun, F-94000 Creteil, France

[2] Translat Lung Res Ctr Heidelberg, D-69126 Heidelberg, Germany

[3] German Ctr Lung Res DZL, D-69126 Heidelberg, Germany

[4] Heidelberg Univ Hosp, Thoraxklin, Rontgenstr 1, D-69126 Heidelberg, Germany

[5] Heidelberg Univ Hosp, Natl Ctr Tumor Dis, Rontgenstr 1, D-69126 Heidelberg, Germany

[6] Emile Muller Hosp, Chest Dis Dept, GHRMSA, F-68070 Mulhouse, France

[7] Hop Hotel Dieu, AP HP, Clin Epidemiol Methods Res Team, INSERM UMR 1153 CRESS,Hlth Econ Res Unit, F-75004 Paris, France

[8] iOMEDICO, Dept Biostat, Ellen Gottlieb Str 19, D-79106 Freiburg, Germany

[9] Unicanc, Hlth Data & Partnerships Dept, 101 Rue Tolbiac, F-75654 Paris 13, France

[10] AIO Studien gGmbH, Bristol Myers Squibb, Kuno F Str 8, D-14057 Berlin, Germany

[11] iOMEDICO, Clin Epidemiol & Hlth Econ, Ellen Gottlieb Str 19, D-79106 Freiburg, Germany

[12] Real World Solut, IQVIA, 37 North Wharf Rd, London W2 1AF, England

[13] Epi Fit, 261 Rue Mandron, F-33000 Bordeaux, France

[14] Bristol Myers Squibb, Worldwide Hlth Econ & Outcomes Res, Ave Finlande 4, B-1420 Mol, Belgium

[15] Bristol Myers Squibb, Worldwide Hlth Econ & Outcomes Res, 3551 Lawrenceville,Princeton Rd, Princeton, NJ USA

[16] Bristol Myers Squibb, Ctr Observat Res & Data Sci, Business Pk,Sanderson Rd, Uxbridge UB8, England

[17] Univ Med Oldenburg, Univ Dept Internal Med Oncol, Pius Hosp, Dept Haematol & Oncol, Georgstr 12, D-26121 Oldenburg, Germany

[18] Bristol Myers Squibb GmbH & Co KGaA, Med Oncol, Arnulfstrasse 29, D-80636 Munich, Germany

来源：

CANCERS | 2022年 / 14卷 / 24期

关键词：

nivolumab; non-small cell lung cancer; immune checkpoint inhibitor; clinical practice; I-O Optimise; real-world evidence; immunotherapy; programmed death-ligand 1; TRIALS CHECKMATE 017; ITALIAN COHORT; DOCETAXEL; MONOTHERAPY; OUTCOMES;

D O I：

10.3390/cancers14246148

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Simple Summary There is a need to better understand the effectiveness of new treatments, such as the recently approved nivolumab, in patients with locally advanced or metastatic non-small cell lung cancer in clinical practice. This study aims to report the characteristics and outcomes of 2784 patients with locally advanced or metastatic non-small cell lung cancer receiving nivolumab in second-line or later in France (ESME-AMLC) and Germany (CRISP) between 2015 and 2020. Two-year survival rates were 26.7% in patients with tumors with squamous histology and 32.8% in patients with non-squamous/others histologies in ESME-AMLC, and 20.9% and 18.9%, respectively, in CRISP. Poorer performance score and shorter duration from the previous line of therapy initiation were significantly associated with shorter treatment duration with nivolumab and overall survival. These real-world data provide insight into the characteristics of patients receiving nivolumab in France and Germany and confirm the efficacy of nivolumab previously observed in clinical trials. This study reports characteristics and outcomes in patients with locally advanced or metastatic non-small cell lung cancer (aNSCLC) receiving nivolumab in second-line or later (2L+) in France and Germany between 2015 and 2020. Patients with aNSCLC (stage IIIB-C/IV) receiving nivolumab in 2L+ were included from the retrospective Epidemiological Strategy and Medical Economics of Advanced and Metastatic Lung Cancer cohort (ESME-AMLC, France; 2015-2019) and Clinical Research platform Into molecular testing, treatment and outcome of non-Small cell lung carcinoma Patients (CRISP, Germany; 2016-2020). Overall, 2262 ESME-AMLC and 522 CRISP patients were included. Median treatment duration (95% confidence intervals) was 2.8 months (2.5-3.2) in squamous and 2.5 months (2.3-2.8) in non-squamous/others patients in ESME-AMLC, and 2.3 months (1.4-3.1) and 2.3 months (2.0-2.8), respectively in CRISP. One-year and two-year overall survival (OS) were 47.2% and 26.7% in squamous and 50.8% and 32.8% in non-squamous/others patients in ESME-AMLC, and 43.1% and 20.9%, and 37.7% and 18.9%, respectively in CRISP. Poorer performance score and shorter time from start of previous line of therapy initiation were significantly associated with shorter treatment duration and OS. This study confirms, in real-world clinical databases, the efficacy of nivolumab previously observed in clinical trials.

引用

页数：20

共 30 条

[1]

[2] Real world data of nivolumab for previously treated non-small cell lung cancer patients: a Galician lung cancer group clinical experience [J].

Areses Manrique, Ma Carmen ;

Mosquera Martinez, Joaquin ;

Garcia Gonzalez, Jorge ;

Afonso Afonso, Francisco Javier ;

Lazaro Quintela, Martin ;

Fernandez Nunez, Natalia ;

Azpitarte Raposeiras, Cristina ;

Amenedo Gancedo, Margarita ;

Santome Couto, Lucia ;

Garcia Campelo, Ma Rosario ;

Munoz Iglesias, Jose ;

Cortegoso Mosquera, Alexandra ;

Vilchez Simo, Rocio ;

Casal Rubio, Joaquin ;

Campos Balea, Begona ;

Carou Frieiro, Iria ;

Alonso-Jaudenes Curbera, Guillermo ;

Anido Herranz, Urbano ;

Garcia Mata, Jesus ;

Firvida Perez, Jose Luis .

TRANSLATIONAL LUNG CANCER RESEARCH, 2018, 7 (03) :404-415

[3] Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study [J].

Barlesi, Fabrice ;

Dixmier, Adrien ;

Debieuvre, Didier ;

Raspaud, Christophe ;

Auliac, Jean-Bernard ;

Benoit, Nicolas ;

Bombaron, Pierre ;

Moro-Sibilot, Denis ;

Audigier-Valette, Clarisse ;

Asselain, Bernard ;

Egenod, Thomas ;

Rabeau, Audrey ;

Fayette, Jerome ;

Sanchez, Myriam Locatelli ;

Labourey, Jean-Luc ;

Westeel, Virginie ;

Lamoureux, Pauline ;

Cotte, Francois-Emery ;

Allan, Victoria ;

Daumont, Melinda ;

Dumanoir, Juliette ;

Reynaud, Dorothee ;

Calvet, Christophe Yannick ;

Ozan, Nicolas ;

Perol, Maurice .

ONCOIMMUNOLOGY, 2020, 9 (01)

[4] Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer [J].

Borghaei, H. ;

Paz-Ares, L. ;

Horn, L. ;

Spigel, D. R. ;

Steins, M. ;

Ready, N. E. ;

Chow, L. Q. ;

Vokes, E. E. ;

Felip, E. ;

Holgado, E. ;

Barlesi, F. ;

Kohlhaeufl, M. ;

Arrieta, O. ;

Burgio, M. A. ;

Fayette, J. ;

Lena, H. ;

Poddubskaya, E. ;

Gerber, D. E. ;

Gettinger, S. N. ;

Rudin, C. M. ;

Rizvi, N. ;

Crino, L. ;

Blumenschein, G. R. ;

Antonia, S. J. ;

Dorange, C. ;

Harbison, C. T. ;

Finckenstein, F. Graf ;

Brahmer, J. R. .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (17) :1627-1639

[5]

Borghaei H, 2021, J CLIN ONCOL, V39, P723, DOI 10.1200/JCO.20.01605

[6] Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer [J].

Brahmer, Julie ;

Reckamp, Karen L. ;

Baas, Paul ;

Crino, Lucio ;

Eberhardt, Wilfried E. E. ;

Poddubskaya, Elena ;

Antonia, Scott ;

Pluzanski, Adam ;

Vokes, Everett E. ;

Holgado, Esther ;

Waterhouse, David ;

Ready, Neal ;

Gainor, Justin ;

Aren Frontera, Osvaldo ;

Havel, Libor ;

Steins, Martin ;

Garassino, Marina C. ;

Aerts, Joachim G. ;

Domine, Manuel ;

Paz-Ares, Luis ;

Reck, Martin ;

Baudelet, Christine ;

Harbison, Christopher T. ;

Lestini, Brian ;

Spigel, David R. .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (02) :123-135

[7] Effectiveness and safety of nivolumab in advanced non-small cell lung cancer: The real-life data [J].

Dudnik, Elizabeth ;

Moskovitz, Mor ;

Daher, Sameh ;

Shamai, Sivan ;

Hanovich, Ekaterina ;

Grubstein, Ahuva ;

Shochat, Tzippy ;

Wollner, Mira ;

Bar, Jair ;

Merimsky, Ofer ;

Zer, Alona ;

Goldstein, Daniel A. ;

Hammerman, Ariel ;

Cyjon, Arnold ;

Shechtman, Yelena ;

Abu-Amna, Mahmood ;

Flex, Dov ;

Roisman, Laila C. ;

Peled, Nir .

LUNG CANCER, 2018, 126 :217-223

[8] I-O Optimise: a novel multinational real-world research platform in thoracic malignancies [J].

Ekman, Simon ;

Griesinger, Frank ;

Baas, Paul ;

Chao, David ;

Chouaid, Christos ;

O'Donnell, John C. ;

Penrod, John R. ;

Daumont, Melinda ;

Lacoin, Laure ;

McKenney, Alexia ;

Khovratovich, Masha ;

Munro, Robin E. J. ;

Durand-Zaleski, Isabelle ;

Johnsen, Soren Paaske .

FUTURE ONCOLOGY, 2019, 15 (14) :1551-1563

[9]

ESMO, MET NONSM CELL LUNG

[10]

ESMO Non-Small-Cell Lung Cancer (NSCLC), NONSM CELL LUNG CANC

← 1 2 3 →