The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) applied to pivotal phase III randomized-controlled trials of tyrosine kinase inhibitors in first-line for advanced non-small cell lung cancer with activating epidermal growth factor receptor mutations

References

• Besse B, Adjei A, Baas P, et al. 2nd ESMO Consensus Conference on Lung Cancer: non-small-cell lung cancer first-line/second and further lines of treatment in advanced disease. Ann Oncol. 2014;25:1475–1484.
   PubMed Web of Science ®Google Scholar
• Giuliani J, Bonetti A. Pharmacologic costs of tyrosine kinase inhibitors in first-line therapy for advanced non-small-cell lung cancer with activating epidermal growth factor receptor mutations: a review of pivotal phase III randomized controlled trials. Clin Lung Cancer. 2016;17:91–94.
   PubMed Web of Science ®Google Scholar
• Haspinger ER, Agustoni F, Torri V, et al. Is there evidence for different effects among EGFR-TKIs? systematic review and meta-analysis of EGFR tyrosine kinase inhibitors (TKIs) versus chemotherapy as first-line treatment for patients harboring EGFR mutations. Crit Rev Oncol Hematol. 2015;94:213–227.
   PubMed Web of Science ®Google Scholar
• Cherny NI, Sullivan R, Dafni U, et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Ann Oncol. 2015;26:1547–1573.
   PubMed Web of Science ®Google Scholar
• Zhou C, Wu YL, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2011;12:735–742.
   PubMed Web of Science ®Google Scholar
• Rosell R, Carcereny E, Gervais R, et al. Spanish lung cancer group in collaboration with groupe français de Pneumo-cancérologie and associazione italiana oncologia toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012;13:239–246.
   PubMed Web of Science ®Google Scholar
• Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361:947–957.
   PubMed Web of Science ®Google Scholar
• Maemondo M, Inoue A, Kobayashi K, et al. North-East japan study group. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362:2380–2388.
   PubMed Web of Science ®Google Scholar
• Mitsudomi T, Morita S, Yatabe Y, et al., West Japan Oncology Group. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol. 2010;11:121–128.
   PubMed Web of Science ®Google Scholar
• Han JY, Park K, Kim SW, et al. First-SIGNAL: first-line single-agent iressa versus gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung. J Clin Oncol. 2012;30:1122–1128.
   PubMed Web of Science ®Google Scholar
• Sequist LV, Yang JC, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31:3327–3334.
   PubMed Web of Science ®Google Scholar
• Wu Y, Zhou C, Hu CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15:213–222.
   PubMed Web of Science ®Google Scholar
• Smith TJ, Hillner BE. Bending the cost curve in cancer care. New Engl J Med. 2011;364:2060–2065.
   PubMed Web of Science ®Google Scholar
• Sullivan R, Peppecorn J, Sikora K, et al. Delivering affordable cancer care in high-income countries. Lancet Oncol. 2011;12:933–980.
   PubMed Web of Science ®Google Scholar
• Drummond MF, Mason AR. European perspective on the costs and cost-effectiveness of cancer therapies. J Clin Oncol. 2007;25:191–195.
   PubMed Web of Science ®Google Scholar
• Sarin R. Criteria for deciding cost-effectiveness for expensive anti-cancer agents. J Cancer Res Ther. 2008;4:1–2.
   PubMed Web of Science ®Google Scholar
• Olchanski N, Zhong Y, Cohen JT, et al. The peculiar economics of life-extending therapies: a review of costing methods in health economic evaluations in oncology. Expert Rev Pharmacoecon Outcomes Res. 2015;15:931–940.
   PubMed Web of Science ®Google Scholar
• Cohn DE, Kim KH, Resnick KE, et al. At what cost does a potential survival advantage of bevacizumab make sense for the primary treatment of ovarian cancer? A cost-effectiveness analysis. J Clin Oncol. 2011;29:1247–1251.
   PubMed Web of Science ®Google Scholar
• Shi Q, De Gramont A, Grothey A, et al. Individual patient data analysis of progression-free survival versus overall survival as a first-line end point for metastatic colorectal cancer in modern randomized trials: findings from the analysis and research in cancers of the digestive system database. J Clin Oncol. 2015;33:22–28.
   PubMed Web of Science ®Google Scholar
• Park K, Tan EH, O’Byrne K, et al. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol. 2016;17:577–589.
   PubMed Web of Science ®Google Scholar
• Lindgren P, Jönsson B, Wilking N. Assessing the esmo magnitude of clinical benefit scale from a health economics perspective. Value Health. 2015;18:A569.
   Google Scholar