References
- Sung H, Ferlay J, Siegel RL et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 71(3), 209–249 (2021).
- Rudin CM, Brambilla E, Faivre-Finn C, Sage J. Small-cell lung cancer. Nat Rev Dis Primers. 7(1), 3 (2021).
- European Medicines Agency. Public summary of opinion on orphan designation: lurbinectedin for the treatment of small cell lung cancer (2019). Available at: www.ema.europa.eu/en/documents/orphan-designation/eu/3/19/2143-public-summary-opinion-orphan-designation-lurbinectedin-treatment-small-cell-lung-cancer_en.pdf ( Accessed November 2022).
- Dingemans AC, Fruh M, Ardizzoni A et al. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 32(7), 839–853 (2021).
- Byers LA, Rudin CM. Small cell lung cancer: where do we go from here? Cancer 121(5), 664–672 (2015).
- Cancer. Net. Lung Cancer-Small Cell: statistics. Updated February 2022. www.cancer.net/cancer-types/lung-cancer-small-cell/statistics ( Accessed November 2022).
- Huber RM, Tufman A. Update on small cell lung cancer management. Breathe. 8(4), 314–330 (2012).
- DiBonaventura MD, Shah-Manek B, Higginbottom K, Penrod JR, Yuan Y. Adherence to recommended clinical guidelines in extensive disease small-cell lung cancer across the US, Europe, and Japan. Ther Clin Risk Manag. 15, 355–366 (2019).
- Oronsky B, Reid TR, Oronsky A, Carter CA. What's new in SCLC? A review. Neoplasia. 19(10), 842–847 (2017).
- National Comprehensive Cancer Network. Small Cell Lung Cancer (Version 2.2023). www.nccn.org/professionals/physician_gls/pdf/sclc.pdf ( Accessed November 15, 2022).
- U.S Food & Drug Administration. FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer (2020). www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer
- PharmaMar. PharmaMar and Jazz Pharmaceuticals announce initiation of confirmatory phase III clinical trial of Zepzelca® (lurbinectedin) for the treatment of patients with relapsed Small Cell Lung Cancer (2021). https://pharmamar.com/en/pharmamar-and-jazz-pharmaceuticals-announce-initiation-of-confirmatory-phase-iii-clinical-trial-of-zepzelca-lurbinectedin-for-the-treatment-of-patients-with-relapsed-small-cell-lung-cancer
- Roche. European Commission approves Roche's Tecentriq in combination with chemotherapy for the initial treatment of people with extensive-stage small cell lung cancer. Published September 06, 2019. https://www.roche.com/media/releases/med-cor-2019-09-06b ( Accessed November 2022).
- AstraZeneca. Imfinzi approved in the EU for the treatment of extensive-stage small cell lung cancer. Published September 1, 2020. www.astrazeneca.com/media-centre/press-releases/2020/imfinzi-approved-in-EU-for-small-cell-lung-cancer.html# ( Accessed 1 October 2022).
- Domine M, Moran T, Isla D et al. SEOM clinical guidelines for the treatment of small-cell lung cancer (SCLC) (2019). Clin Transl Oncol. 22(2), 245–255 (2020).
- Cramer-van der Welle CM, Schramel F, van Leeuwen AS, Groen HJM, van de Garde EMW, Santeon SSG. Real-world treatment patterns and outcomes of patients with extensive disease small cell lung cancer. Eur J Cancer Care (Engl). 29(5), e13250 (2020).
- Moser SS, Bar J, Kan I et al. Real world analysis of small cell lung cancer patients: prognostic factors and treatment outcomes. Curr Oncol. 28(1), 317–331 (2021).
- Ganti AK, Katranji K, Seal BS, Brannman L. Treatment patterns in extensive-stage small cell lung cancer: a retrospective real-world data study. J. Clin. Oncol. 38(Suppl. 29), 288–288 (2020).
- Alymova S, Kostev K, Casey V et al. Evaluation of the representativeness of the German Oncology Dynamics dataset. Int. J. Clin. Pharmacol. Ther. 60(5), 207–216 (2022).
- Committee on Strategies for Responsible Sharing of Clinical Trial Data; Board on Health Sciences Policy; Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. National Academies Press (US); Appendix B, Concepts and Methods for De-identifying Clinical Trial Data, Washington (DC) (Published 20 April 2015). Available from: www.ncbi.nlm.nih.gov/books/NBK285994/ ( Accessed 28 November 2022).
- Rodriguez-Lescure A, de la Pena FA, Aranda E et al. Study of the Spanish Society of Medical Oncology (SEOM) on the access to oncology drugs and predictive biomarkers in Spain. Clin Transl Oncol. 22(12), 2253–2263 (2020).
- Oliva-Moreno J, Puig-Junoy J, Trapero-Bertran M, Epstein D, Pinyol C, Sacristan JA. Economic evaluation for pricing and reimbursement of new drugs in Spain: fable or desideratum? Value Health. 23(1), 25–31 (2020).
- Uyl-de Groot CA, Heine R, Krol M, Verweij J. Unequal access to newly registered cancer drugs leads to potential loss of life-years in Europe. Cancers (Basel). 12(8), (2020).
- Organisation for Economic Co-operation and Development. Addressing challenges in access to oncology medicines. analytical Report Published: (2020). https://www.oecd.org/health/health-systems/Addressing-Challenges-in-Access-to-Oncology-Medicines-Analytical-Report.pdf ( Accessed 29 November 2022).
- Pham FY, Jacquet E, Taleb A et al. Survival, cost and added therapeutic benefit of drugs granted early access through the French temporary authorization for use program in solid tumors from 2009 to 2019. Int. J. Cancer 151(8), 1345–1354 (2022).
- European Medicines Agency. Tecentriq (atezolizumab).Summary of Opinion (Post Authorization) (2019). www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tecentriq-ii/0019_en.pdf
- Lawlor R, Wilsdon T, Darquennes E et al. Accelerating patient access to oncology medicines with multiple indications in Europe. J Mark Access Health Policy. 9(1), 1964791 (2021).
- Lubloy A. Factors affecting the uptake of new medicines: a systematic literature review. BMC Health Serv Res. 14, 469 (2014).
- European Medicines Agency. Hycamtin: product information (2010). Available at: www.ema.europa.eu/en/documents/product-information/hycamtin-epar-product-information_en.pdf ( Accessed 19 November 2022).
- Das M, Padda SK, Weiss J, Owonikoko TK. Advances in treatment of recurrent small cell lung cancer (SCLC): insights for optimizing patient outcomes from an expert roundtable discussion. Adv Ther. 38(11), 5431–5451 (2021).
- Horita N, Yamamoto M, Sato T et al. Topotecan for relapsed small-cell lung cancer: systematic review and meta-analysis of 1347 patients. Sci Rep. 5, 15437 (2015).
- Trigo J, Subbiah V, Besse B et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 21(5), 645–654 (2020).
- Aix SP, Ciuleanu TE, Navarro A et al. Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. Lancet Respir Med. 11(1), 74–86 (2023).
- Wermke M, Felip E, Gambardella V et al. Phase I trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas. Future Oncol. 18(24), 2639–2649 (2022).
- Johnson ML, Dy GK, Mamdani H et al. Interim results of an ongoing phase 1/2 study of HPN328, a tri-specific half-life extended DLL3-targeting T-cell engager, in patients with small cell lung cancer and other neuroendocrine cancers. Poster presented at: American Society of Clinical Oncology Annual Meeting. Chicago, USA (June 3–7, 2022).
- Safety, tolerability and pharmacokinetics study of QLS31904 in patients with advanced solid tumors. ClinicalTrials.gov Identifier: NCT05461287. Updated November 10, 2022. https://clinicaltrials.gov/ct2/show/NCT05461287 ( Accessed 15 November 2022).
- Borghaei HP, Paz-Ares L, Johnson M et al. Phase 1 updated exploration and first expansion data for DLL3-targeted T-cell engager tarlatamab in small cell lung cancer. J Thorac Oncol. 17(9), S33 (2022). Conference Abstract.
- AMG 757 and AMG 404 in subjects with small cell lung cancer (SCLC). ClinicalTrials.gov Identifier: NCT04885998 Updated September 29, 2022. https://clinicaltrials.gov/ct2/show/NCT04885998 ( Accessed 15 November 2022).
- First-line tarlatamab in combination with carboplatin, etoposide, and PD-L1 inhibitor in subjects with extensive stage small cell lung cancer (ES-SCLC). ClinicalTrials.gov Identifier: NCT05361395 Updated November 15, 2022. https://clinicaltrials.gov/ct2/show/NCT05361395 ( Accessed 15 November 2022).
- Kalemkerian GP, Loo BW, Akerley W et al. NCCN guidelines insights: small cell lung cancer, Version 2.2018. J Natl Compr Canc Netw. 16(10), 1171–1182 (2018).
- Fruh M, De Ruysscher D, Popat S et al. Small-cell lung cancer (SCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 24(Suppl. 6), vi99–105 (2013).
- Horn L, Mansfield AS, Szczesna A et al. First-Line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N. Engl. J. Med. 379(23), 2220–2229 (2018).
- Paz-Ares L, Dvorkin M, Chen Y et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet 394(10212), 1929–1939 (2019).