Overall survival in non-small cell lung cancer-What is clinically meaningful?

Translational Lung Cancer Research

Volumn 5, Issue 1, 2016, Pages 115-119

  Fenchel, Klaus ^a   Sellmann, Ludger ^b   Dempke, Wolfram C M ^c  

^a Asklepios Medical School Hamburg   (Germany)

^b UNIVERSITY OF MUNICH   (Germany)

^c Medical Oncology Unit   (Germany)

Author keywords

Clinical relevance; Non small cell lung cancer (NSCLC); Overall survival (OS)

Indexed keywords

EID: 84960128221     PISSN: 22186751     EISSN: 22264477     Source Type: Journal    
DOI: 10.3978/j.issn.2218-6751.2016.01.06     Document Type: Editorial

References (21)

1. Ramalingam S, Belani C. Systemic chemotherapy for advanced non-small cell lung cancer: recent advances and future directions. Oncologist 2008;13 Suppl 1:5-13.
2. Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N Engl J Med 2002;346:92-8.
3. Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 2008;26:3543-51.
4. Paz-Ares LG, de Marinis F, Dediu M, et al. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol 2013;31:2895-902.
5. Sellmann L, Fenchel K, Dempke WC. Improved overall survival following tyrosine kinase inhibitor treatment in advanced or metastatic non-small-cell lung cancer-the Holy Grail in cancer treatment? Transl Lung Cancer Res 2015;4:223-7.
6. Dempke WC, Fenchel K. Targeted therapy for NSCLC--a double-edged sword? Anticancer Res 2015;35:2503-12.
7. Dempke WC, Sellmann L, Fenchel K, et al. Immunotherapies for NSCLC: Are We Cutting the Gordian Helix? Anticancer Res 2015;35:5745-57.
8. Booth CM, Eisenhauer EA. Progression-free survival: meaningful or simply measurable? J Clin Oncol 2012;30:1030-3.
9. Buyse ME, Squifflet P, Laporte S, et al. Prediction of survival benefits from progression-free survival in patients with advanced non-small cell lung cancer: evidence from a pooled analysis of 2,838 patients randomized in 7 trials. J Clin Oncol 2008;26:abstr 8019.
10. Cheema PK, Burkes EL. Overall survival should be the primary endpoint in clinical trials for advanced non-smallcell lung cancer. Curr Oncol 2013;20:e150-60.
11. Pirker R, Pereira JR, Szczesna A, et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet 2009;373:1525-31.
12. Thatcher N, Hirsch FR, Luft AV, et al. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol 2015;16:763-74.
13. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006;355:2542-50.
14. Garon EB, Ciuleanu TE, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for secondline treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet 2014;384:665-73.
15. Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med 2015;373:123-35.
16. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med 2015;373:1627-39.
17. Reck M, Kaiser R, Mellemgaard A, et al. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUMELung 1): a phase 3, double-blind, randomised controlled trial. Lancet Oncol 2014;15:143-55.
18. Yang JC, Wu YL, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol 2015;16:141-51.
19. FDA. Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics: Guidance for Industry (published April 2015): Available online: http://www.fda.gov/downloads/drugs/guidancecompliance regulatoryinformation/guidances/ucm259421.pdf
20. Ellis LM, Bernstein DS, Voest EE, et al. American Society of Clinical Oncology Perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol 2014;32:1277-80.
21. Revicki DA, Feeny D, Hunt TL, et al. Analyzing oncology clinical trial data using the Q-TWiST method: clinical importance and sources for health state preference data. Qual Life Res 2006;15:411-23.