Exploring the Cost Effectiveness of a Whole-Genome Sequencing-Based Biomarker for Treatment Selection in Patients with Advanced Lung Cancer Ineligible for Targeted Therapy

Hendriks LE, Kerr KM, Menis J, Mok TS, Nestle U, Passaro A, et al. Non-oncogene-addicted metastatic non-small-cell lung cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(4):358–76.

Article  CAS  PubMed  Google Scholar 

Hendriks LE, Kerr KM, Menis J, Mok TS, Nestle U, Passaro A, et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(4):339–57.

Article  CAS  PubMed  Google Scholar 

Federatie Medisch Specialisten. Non-small cell lung carcinoma [in Dutch: Niet kleincellig longcarcinoom]. 2023.

National Comprehensive Cancer Network. Non-small cell lung cancer (version 3.2023). 2023. https://www.nccn.org/guidelines/category_1. Accessed 3 Oct 2023.

Steeghs EMP, Groen HJM, Schuuring E, Aarts MJ, Damhuis RAM, Voorham QJM, et al. Mutation-tailored treatment selection in non-small cell lung cancer patients in daily clinical practice. Lung Cancer. 2022;167:87–97.

Article  CAS  PubMed  Google Scholar 

Ettinger DS, Wood DE, Aisner DL, Akerley W, Bauman JR, Bharat A, et al. NCCN guidelines insights: non-small cell lung cancer, version 2.2021. J Natl Compr Canc Netw. 2021;19(3):254–66.

Article  CAS  PubMed  Google Scholar 

Haslam A, Prasad V. Estimation of the percentage of US patients with cancer who are eligible for and respond to checkpoint inhibitor immunotherapy drugs. JAMA Netw Open. 2019;2(5): e192535.

Article  PubMed  PubMed Central  Google Scholar 

Greillier L, Tomasini P, Barlesi F. The clinical utility of tumor mutational burden in non-small cell lung cancer. Transl Lung Cancer Res. 2018;7(6):639–46.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Fumet JD, Truntzer C, Yarchoan M, Ghiringhelli F. Tumour mutational burden as a biomarker for immunotherapy: current data and emerging concepts. Eur J Cancer. 2020;131:40–50.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Champiat S, Dercle L, Ammari S, Massard C, Hollebecque A, Postel-Vinay S, et al. Hyperprogressive disease is a new pattern of progression in cancer patients treated by anti-PD-1/PD-L1. Clin Cancer Res. 2017;23(8):1920–8.

Article  CAS  PubMed  Google Scholar 

Simons MJHG, Retel VP, Ramaekers BLT, Butter R, Mankor JM, Paats MS, et al. Early cost effectiveness of whole-genome sequencing as a clinical diagnostic test for patients with inoperable stage IIIB, C/IV non-squamous non-small-cell lung cancer. Pharmacoeconomics. 2021;39(12):1429–42.

Article  PubMed  PubMed Central  Google Scholar 

Mok TSK, Wu YL, Kudaba I, Kowalski DM, Cho BC, Turna HZ, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019;393(10183):1819–30.

Article  CAS  PubMed  Google Scholar 

Gandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, et al. Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med. 2018;378(22):2078–92.

Article  CAS  PubMed  Google Scholar 

US Food and Drug Administration. PD-L1 IHC 22C3 PHARMDX [premarket approval]. Immunohistochemistry assay, antibody, programmed death-ligand 1. 2015.

US Food and Drug Administration. Pembrolizumab (Keytruda) checkpoint inhibitor. 2016.

European Medicines Agency [EMA]. Keytruda. Pembrolizumab. 2016.

Merino DM, McShane LM, Fabrizio D, Funari V, Chen SJ, White JR, et al. Establishing guidelines to harmonize tumor mutational burden (TMB): in silico assessment of variation in TMB quantification across diagnostic platforms: phase I of the Friends of Cancer Research TMB Harmonization Project. J Immunother Cancer. 2020;8(1):e000147.

Article  PubMed  PubMed Central  Google Scholar 

Mankor JM, Paats MS, Groenendijk FH, Roepman P, Dinjens WNM, Dubbink HJ, et al. Impact of panel design and cut-off on tumour mutational burden assessment in metastatic solid tumour samples. Br J Cancer. 2020;122(7):953–6.

Article  PubMed  PubMed Central  Google Scholar 

Sutherland KD, Vissers JHA. Balancing the count: harmonizing panel-based tumor mutational burden assessment. J Thorac Oncol. 2020;15(7):1106–9.

Article  PubMed  Google Scholar 

Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, et al. First-line nivolumab in stage IV or recurrent non-small-cell lung cancer. N Engl J Med. 2017;376(25):2415–26.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Galvano A, Gristina V, Malapelle U, Pisapia P, Pepe F, Barraco N, et al. The prognostic impact of tumor mutational burden (TMB) in the first-line management of advanced non-oncogene addicted non-small-cell lung cancer (NSCLC): a systematic review and meta-analysis of randomized controlled trials. ESMO Open. 2021;6(3): 100124.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Hellmann MD, Ciuleanu TE, Pluzanski A, Lee JS, Otterson G, Audigier-Valette C, et al. Nivolumab (nivo) plus ipilimumab (ipi) vs platinum-doublet chemotherapy (PT-DC) as first-line (1L) treatment (tx) for advanced non-small cell lung cancer (NSCLC): initial results from CheckMate 227. Cancer Res. 2018;78(13):CT077.

Article  Google Scholar 

Meng G, Liu X, Ma T, Lv D, Sun G. Predictive value of tumor mutational burden for immunotherapy in non-small cell lung cancer: a systematic review and meta-analysis. PLoS One. 2022;17(2): e0263629.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kao C, Powers E, Wu Y, Datto MB, Green MF, Strickler JH, et al. Predictive value of combining biomarkers for clinical outcomes in advanced non-small cell lung cancer patients receiving immune checkpoint inhibitors. Clin Lung Cancer. 2021;22(6):500–9.

Article  CAS  PubMed  Google Scholar 

Mfumbilwa ZA, Wilschut JA, Simons M, Ramaekers B, Joore M, Retel V, et al. Development and validation of a decision model for the evaluation of novel lung cancer treatments in the Netherlands. Sci Rep. 2023;13(1):2349.

Article  ADS  CAS  PubMed  PubMed Central  Google Scholar 

Netherlands comprehensive cancer organisation [IKNL]. Prevalence by year, 5 year prevalence: non small-cell lung carcinoma. 2023. https://iknl.nl/en/ncr/ncr-data-figures. Accessed 6 Nov 2023.

Zorginstituut Nederland [ZIN]. Package advice pembrolizumab (Keytruda®) [in Dutch: Pakketadvies pembrolizumab (Keytruda®)]. Zorginstituut Nederland. 2016. Dec 14.

Kanters TA, Bouwmans CAM, van der Linden N, Tan SS, Hakkaart-van RL. Update of the Dutch manual for costing studies in health care. PLoS One. 2017;12(11): e0187477.

Article  PubMed  PubMed Central  Google Scholar 

Vijgen S, van Heesch F, Obradovic M. Ziektelast in de praktijk; de theorie en praktijk van het berekenen van ziektelast bij pakketbeoordelingen. Zorginstituut Nederland. 2018.

Paulden M. Calculating and Interpreting ICERs and Net benefit. Pharmacoeconomics. 2020;38(8):785–807.

Article  PubMed  Google Scholar 

Cramer-vander Welle CM, Peters BJM, Schramel F, Klungel OH, Groen HJM, van de Garde EMW, et al. Systematic evaluation of the efficacy-effectiveness gap of systemic treatments in metastatic nonsmall cell lung cancer. Eur Respir J. 2018;52(6):1801101.

Google Scholar 

Wolff HB, Alberts L, van der Linden N, Bongers ML, Verstegen NE, Lagerwaard FJ, et al. Cost-effectiveness of stereotactic body radiation therapy versus video assisted thoracic surgery in medically operable stage I non-small cell lung cancer: a modeling study. Lung Cancer. 2020;141:89–96.

Article  PubMed  Google Scholar 

Higuera Gomez O, Moreno Paul A, Ortega Granados AL, Ros Martinez S, Perez Parente D, Ruiz Gracia P, et al. “High tumor burden” in metastatic non-small cell lung cancer: defining the concept. Cancer Manag Res. 2021;13:4665–70.

Article  PubMed  PubMed Central  Google Scholar 

Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016;375(19):1823–33.

Article  CAS  PubMed  Google Scholar 

Gadgeel S, Rodriguez-Abreu D, Speranza G, Esteban E, Felip E, Domine M, et al. Updated analysis from KEYNOTE-189: pembrolizumab or placebo plus pemetrexed and platinum for previously untreated metastatic nonsquamous non-small-cell lung cancer. J Clin Oncol. 2020;38(14):1505–17.

Article  CAS  PubMed  Google Scholar 

Garon EB, Hellmann MD, Rizvi NA, Carcereny E, Leighl NB, Ahn MJ, et al. Five-year overall survival for patients with advanced nonsmall-cell lung cancer treated with pembrolizumab: results from the phase I KEYNOTE-001 study. J Clin Oncol. 2019;37(28):2518–27.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, et al. Five-year outcomes with pembrolizumab versus chemotherapy for metastatic non-small-cell lung cancer with PD-L1 tumor proportion score >/= 50. J Clin Oncol. 2021;39(21):2339–49.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Garassino MC, Gadgeel S, Speranza G, Felip E, Esteban E, Domine M, et al. Pembrolizumab plus pemetrexed and platinum in nonsquamous non-small-cell lung cancer: 5-year outcomes from the phase 3 KEYNOTE-189 Study. J Clin Oncol. 2023. https://doi.org/10.1200/JCO.22.01989.

Article  PubMed  PubMed Central  Google Scholar 

Bullement A, Latimer NR, Bell GH. Survival extrapolation in cancer immunotherapy: a validation-based case study. Value Health. 2019;22(3):276–83.

Article  PubMed  Google Scholar 

Othus M, Bansal A, Koepl L, Wagner S, Ramsey S. Accounting for cured patients in cost-effectiveness analysis. Value Health. 2017;20(4):705–9.

Article  PubMed  Google Scholar 

Ouwens M, Mukhopadhyay P, Zhang Y, Huang M, Latimer N, Briggs A. Estimating lifetime benefits associated with immuno-oncology therapies: challenges and approaches for overall survival extrapolations. Pharmacoeconomics. 2019;37(9):1129–38.

Article  PubMed 

留言 (0)

沒有登入
gif