Nationwide survival benefit after implementation of first-line immunotherapy for patients with advanced nsclc—real world efficacy

Mette T. Mouritzen; Andreas Carus; Morten Ladekarl; Peter Meldgaard; Anders W.M. Nielsen; Anna Livbjerg; Jacob W. Larsen; Halla Skuladottir; Charlotte Kristiansen; Kim Wedervang; Tine Schytte; Karin H. Hansen; Anne Cathrine Østby; Malene S. Frank; Jakob Lauritsen; Jens B. Sørensen; Seppo W. Langer; Gitte F. Persson; Jon L. Andersen; Johanna M.C. Frary; Lars B. Drivsholm; Charles Vesteghem; Heidi S. Christensen; Birgitte Bjørnhart; Mette Pøhl

doi:10.3390/cancers13194846

Nationwide survival benefit after implementation of first-line immunotherapy for patients with advanced nsclc—real world efficacy

Mette T. Mouritzen^*
, Andreas Carus
, Morten Ladekarl
, Peter Meldgaard
, Anders W.M. Nielsen
, Anna Livbjerg
, Jacob W. Larsen
, Halla Skuladottir
, Charlotte Kristiansen
, Kim Wedervang
, Tine Schytte
, Karin H. Hansen
, Anne Cathrine Østby
, Malene S. Frank
, Jakob Lauritsen
, Jens B. Sørensen
, Seppo W. Langer
, Gitte F. Persson
, Jon L. Andersen
, Johanna M.C. Frary

Lars B. Drivsholm, Charles Vesteghem, Heidi S. Christensen, Birgitte Bjørnhart, Mette Pøhl

^*Corresponding author for this work

Aalborg University Hospital
Aalborg University
Aarhus University Hospital
Regional Hospital West Jutland
Zealand University Hospital, Roskilde
University of Copenhagen
Rigshospitalet
Copenhagen University Hospital
Nordsjællands Hospital

Research output: Contribution to journal › Journal article › Research › peer-review

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Abstract

Background The selection of patients with non-small cell lung cancer (NSCLC) for immune checkpoint inhibitor (ICI) treatment remains challenging. This real-world study aimed to compare the overall survival (OS) before and after the implementation of ICIs, to identify OS prognostic factors, and to assess treatment data in first-line (1L) ICI-treated patients without epidermal growth factor receptor mutation or anaplastic lymphoma kinase translocation. Methods Data from the Danish NSCLC population initiated with 1L palliative antineoplastic treatment from 1 January 2013 to 1 October 2018, were extracted from the Danish Lung Cancer Registry (DLCR). Long-term survival and median OS pre-and post-approval of 1L ICI were compared. From electronic health records, additional clinical and treatment data were obtained for ICI-treated patients from 1 March 2017 to 1 October 2018. Results The OS was significantly improved in the DLCR post-approval cohort (n = 2055) compared to the pre-approval cohort (n = 1658). The 3-year OS rates were 18% (95% CI 15.6–20.0) and 6% (95% CI 5.1–7.4), respectively. On multivariable Cox regression, bone (HR = 1.63) and liver metastases (HR = 1.47), performance status (PS) 1 (HR = 1.86), and PS ≥ 2 (HR = 2.19) were significantly associated with poor OS in ICI-treated patients. Conclusion OS significantly improved in patients with advanced NSCLC after ICI implementation in Denmark. In ICI-treated patients, PS ≥ 1, and bone and liver metastases were associated with a worse prognosis.

Original language	English
Article number	4846
Journal	Cancers
Volume	13
Issue number	19
Number of pages	13
ISSN	2072-6694
DOIs	https://doi.org/10.3390/cancers13194846
Publication status	Published - 1. Oct 2021

Bibliographical note

Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Funding

Conflicts of Interest: The funding sources were not involved in the study design, collection, analysis, and interpretation of data, in the writing of the report, or in the decision to submit the article for publication. GF Persson: Advisory board Roche, Astra Zeneca, BMS, MSD, Takeda, Pfizer. Congress travels with Roche, Astra Zeneca, BMS, MSD, Takeda, Pierre Fabre. Research grants from Varian Medical Systems. M Pøhl: Honoraria for lectures and consultancy from AstraZeneca, BMS, MSD, Pfizer, Roche. SW Langer: Advisory board MSD, Roche, Pfizer. The remaining authors declare no conflict of interest. Funding: This research was funded by the Danish Health Authority’s ‘Cancer Immunotherapy Research Grant’ (grant number 05-0400-44) and the Medical Fund of the Danish Regions (2 December 2019).

Keywords

Advanced lung cancer
Anti-PD-1
Cancer immunotherapy
Clinical prognostic factors
Danish registry
First-line treatment
Immune checkpoint inhibitors
Non-small cell lung cancer
Overall survival
Real-world evidence

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Mouritzen, M. T., Carus, A., Ladekarl, M., Meldgaard, P., Nielsen, A. W. M., Livbjerg, A., Larsen, J. W., Skuladottir, H., Kristiansen, C., Wedervang, K., Schytte, T., Hansen, K. H., Østby, A. C., Frank, M. S., Lauritsen, J., Sørensen, J. B., Langer, S. W., Persson, G. F., Andersen, J. L., ... Pøhl, M. (2021). Nationwide survival benefit after implementation of first-line immunotherapy for patients with advanced nsclc—real world efficacy. Cancers, 13(19), Article 4846. https://doi.org/10.3390/cancers13194846

@article{9233f1aa5ba749bf899f5d65515b67bc,

title = "Nationwide survival benefit after implementation of first-line immunotherapy for patients with advanced nsclc{\textemdash}real world efficacy",

abstract = "Background The selection of patients with non-small cell lung cancer (NSCLC) for immune checkpoint inhibitor (ICI) treatment remains challenging. This real-world study aimed to compare the overall survival (OS) before and after the implementation of ICIs, to identify OS prognostic factors, and to assess treatment data in first-line (1L) ICI-treated patients without epidermal growth factor receptor mutation or anaplastic lymphoma kinase translocation. Methods Data from the Danish NSCLC population initiated with 1L palliative antineoplastic treatment from 1 January 2013 to 1 October 2018, were extracted from the Danish Lung Cancer Registry (DLCR). Long-term survival and median OS pre-and post-approval of 1L ICI were compared. From electronic health records, additional clinical and treatment data were obtained for ICI-treated patients from 1 March 2017 to 1 October 2018. Results The OS was significantly improved in the DLCR post-approval cohort (n = 2055) compared to the pre-approval cohort (n = 1658). The 3-year OS rates were 18\% (95\% CI 15.6{\textendash}20.0) and 6\% (95\% CI 5.1{\textendash}7.4), respectively. On multivariable Cox regression, bone (HR = 1.63) and liver metastases (HR = 1.47), performance status (PS) 1 (HR = 1.86), and PS ≥ 2 (HR = 2.19) were significantly associated with poor OS in ICI-treated patients. Conclusion OS significantly improved in patients with advanced NSCLC after ICI implementation in Denmark. In ICI-treated patients, PS ≥ 1, and bone and liver metastases were associated with a worse prognosis.",

keywords = "Advanced lung cancer, Anti-PD-1, Cancer immunotherapy, Clinical prognostic factors, Danish registry, First-line treatment, Immune checkpoint inhibitors, Non-small cell lung cancer, Overall survival, Real-world evidence",

author = "Mouritzen, \{Mette T.\} and Andreas Carus and Morten Ladekarl and Peter Meldgaard and Nielsen, \{Anders W.M.\} and Anna Livbjerg and Larsen, \{Jacob W.\} and Halla Skuladottir and Charlotte Kristiansen and Kim Wedervang and Tine Schytte and Hansen, \{Karin H.\} and {\O}stby, \{Anne Cathrine\} and Frank, \{Malene S.\} and Jakob Lauritsen and S{\o}rensen, \{Jens B.\} and Langer, \{Seppo W.\} and Persson, \{Gitte F.\} and Andersen, \{Jon L.\} and Frary, \{Johanna M.C.\} and Drivsholm, \{Lars B.\} and Charles Vesteghem and Christensen, \{Heidi S.\} and Birgitte Bj{\o}rnhart and Mette P{\o}hl",

note = "Publisher Copyright: {\textcopyright} 2021 by the authors. Licensee MDPI, Basel, Switzerland.",

year = "2021",

month = oct,

day = "1",

doi = "10.3390/cancers13194846",

language = "English",

volume = "13",

journal = "Cancers",

issn = "2072-6694",

publisher = "MDPI",

number = "19",

}

Mouritzen, MT, Carus, A, Ladekarl, M, Meldgaard, P, Nielsen, AWM, Livbjerg, A, Larsen, JW, Skuladottir, H, Kristiansen, C, Wedervang, K, Schytte, T, Hansen, KH, Østby, AC, Frank, MS, Lauritsen, J, Sørensen, JB, Langer, SW, Persson, GF, Andersen, JL, Frary, JMC, Drivsholm, LB, Vesteghem, C, Christensen, HS, Bjørnhart, B & Pøhl, M 2021, 'Nationwide survival benefit after implementation of first-line immunotherapy for patients with advanced nsclc—real world efficacy', Cancers, vol. 13, no. 19, 4846. https://doi.org/10.3390/cancers13194846

TY - JOUR

T1 - Nationwide survival benefit after implementation of first-line immunotherapy for patients with advanced nsclc—real world efficacy

AU - Mouritzen, Mette T.

AU - Carus, Andreas

AU - Ladekarl, Morten

AU - Meldgaard, Peter

AU - Nielsen, Anders W.M.

AU - Livbjerg, Anna

AU - Larsen, Jacob W.

AU - Skuladottir, Halla

AU - Kristiansen, Charlotte

AU - Wedervang, Kim

AU - Schytte, Tine

AU - Hansen, Karin H.

AU - Østby, Anne Cathrine

AU - Frank, Malene S.

AU - Lauritsen, Jakob

AU - Sørensen, Jens B.

AU - Langer, Seppo W.

AU - Persson, Gitte F.

AU - Andersen, Jon L.

AU - Frary, Johanna M.C.

AU - Drivsholm, Lars B.

AU - Vesteghem, Charles

AU - Christensen, Heidi S.

AU - Bjørnhart, Birgitte

AU - Pøhl, Mette

PY - 2021/10/1

Y1 - 2021/10/1

N2 - Background The selection of patients with non-small cell lung cancer (NSCLC) for immune checkpoint inhibitor (ICI) treatment remains challenging. This real-world study aimed to compare the overall survival (OS) before and after the implementation of ICIs, to identify OS prognostic factors, and to assess treatment data in first-line (1L) ICI-treated patients without epidermal growth factor receptor mutation or anaplastic lymphoma kinase translocation. Methods Data from the Danish NSCLC population initiated with 1L palliative antineoplastic treatment from 1 January 2013 to 1 October 2018, were extracted from the Danish Lung Cancer Registry (DLCR). Long-term survival and median OS pre-and post-approval of 1L ICI were compared. From electronic health records, additional clinical and treatment data were obtained for ICI-treated patients from 1 March 2017 to 1 October 2018. Results The OS was significantly improved in the DLCR post-approval cohort (n = 2055) compared to the pre-approval cohort (n = 1658). The 3-year OS rates were 18% (95% CI 15.6–20.0) and 6% (95% CI 5.1–7.4), respectively. On multivariable Cox regression, bone (HR = 1.63) and liver metastases (HR = 1.47), performance status (PS) 1 (HR = 1.86), and PS ≥ 2 (HR = 2.19) were significantly associated with poor OS in ICI-treated patients. Conclusion OS significantly improved in patients with advanced NSCLC after ICI implementation in Denmark. In ICI-treated patients, PS ≥ 1, and bone and liver metastases were associated with a worse prognosis.

AB - Background The selection of patients with non-small cell lung cancer (NSCLC) for immune checkpoint inhibitor (ICI) treatment remains challenging. This real-world study aimed to compare the overall survival (OS) before and after the implementation of ICIs, to identify OS prognostic factors, and to assess treatment data in first-line (1L) ICI-treated patients without epidermal growth factor receptor mutation or anaplastic lymphoma kinase translocation. Methods Data from the Danish NSCLC population initiated with 1L palliative antineoplastic treatment from 1 January 2013 to 1 October 2018, were extracted from the Danish Lung Cancer Registry (DLCR). Long-term survival and median OS pre-and post-approval of 1L ICI were compared. From electronic health records, additional clinical and treatment data were obtained for ICI-treated patients from 1 March 2017 to 1 October 2018. Results The OS was significantly improved in the DLCR post-approval cohort (n = 2055) compared to the pre-approval cohort (n = 1658). The 3-year OS rates were 18% (95% CI 15.6–20.0) and 6% (95% CI 5.1–7.4), respectively. On multivariable Cox regression, bone (HR = 1.63) and liver metastases (HR = 1.47), performance status (PS) 1 (HR = 1.86), and PS ≥ 2 (HR = 2.19) were significantly associated with poor OS in ICI-treated patients. Conclusion OS significantly improved in patients with advanced NSCLC after ICI implementation in Denmark. In ICI-treated patients, PS ≥ 1, and bone and liver metastases were associated with a worse prognosis.

KW - Advanced lung cancer

KW - Anti-PD-1

KW - Cancer immunotherapy

KW - Clinical prognostic factors

KW - Danish registry

KW - First-line treatment

KW - Immune checkpoint inhibitors

KW - Non-small cell lung cancer

KW - Overall survival

KW - Real-world evidence

U2 - 10.3390/cancers13194846

DO - 10.3390/cancers13194846

M3 - Journal article

C2 - 34638329

AN - SCOPUS:85115874983

SN - 2072-6694

VL - 13

JO - Cancers

JF - Cancers

IS - 19

M1 - 4846

ER -

Nationwide survival benefit after implementation of first-line immunotherapy for patients with advanced nsclc—real world efficacy

Abstract

Bibliographical note

Funding

Keywords

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