Overall survival: Still the gold standard: Why overall survival remains the definitive end point in cancer clinical trials

Cancer Journal

Volumn 15, Issue 5, 2009, Pages 401-405

  Driscoll, James J ^a   Rixe, Oliver ^b  

^a NATIONAL CANCER INSTITUTE   (United States)

^b UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

Author keywords

Biomarker; End point; Overall survival; Surrogate; Targeted therapy

Indexed keywords

BIOLOGICAL MARKER; VACCINE;

BIOLOGICAL THERAPY; CANCER GROWTH; CANCER SURVIVAL; CELL THERAPY; COST EFFECTIVENESS ANALYSIS; HUMAN; METASTASIS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG APPROVAL; DRUG DELIVERY SYSTEMS; HUMANS; NEOPLASMS; TREATMENT OUTCOME;

EID: 70350146497     PISSN: 15289117     EISSN: 1540336X     Source Type: Journal    
DOI: 10.1097/PPO.0b013e3181bdc2e0     Document Type: Review

References (23)

1. Daugherty CK, Ratain MJ, Emanuel EJ, et al. Ethical, scientific, and regulatory perspectives regarding the use of placebos in cancer clinical trials. J Clin Oncol. 2008;26:1371-1378.
2. Hirschfeld S, Nagamura F, Keegan P. Food and Drug Administration with the accelerated approval program for oncology drugs. Proc Am Soc Clin Oncol. 2003;22:520, abstract no. 2094.
3. Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol. 2003;21: 1404-1411.
4. Dagher R, Johnson J, Williams G, et al. Accelerated approval of oncology products: a decade of experience. J Natl Cancer Inst. 2004;96:1500-1509.
5. Clinton W, Gore A. Reinventing the Regulation of Cancer Drugs: National Performance Review. 1996. Available at: http://www.fda.gov/ohrms/dockets/ ac/03/briefing/3936B1-01-C-Attachment%202.pdf.
6. Motzer RJ, Rini BI, Bukowski RM, et al. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006;295:2516-2524.
7. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer. 1981;47:207-214.
8. Fukuoka M, Yano S, Giaccone G, et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-smallcell lung cancer (The IDEAL 1 Trial) [corrected.] J Clin Oncol. 2003;21: 2237-2246.
9. Kris MG, Natale RB, Herbst R, et al. A phase II trial of ZD1839 in advanced non small cell lung cancer patients who had failed platinum and docetaxelbased regimens. Proc Am Soc Clin Oncol. 2002;21:292a, abstract no. 1116.
10. Herbst RS, Giaccone G, Schiller JH, et al. Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 2. J Clin Oncol. 2004;22:785-794.
11. Giaccone G, Herbst RS, Manegold C, et al. Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 1. J Clin Oncol. 2004;22:777-784.
12. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228-247.
13. Hillman SL, An MW, O'Connell MJ, et al. Evaluation of the optimal number of lesions needed for tumor evaluation using the response evaluation criteria in solid tumors: a north central cancer treatment group investigation. J Clin Oncol. 2009;27:3205-3210.
14. Stein WD, Yang J, Bates SE, et al. Bevacizumab reduces the growth rate constants of renal carcinomas: a novel algorithm suggests early discontinuation of bevacizumab resulted in a lack of survival advantage. Oncologist. 2008;13:1055-1062.
15. Bruzzi P, Del Mastro L, Sormani MP, et al. Objective response to chemotherapy as a potential surrogate end point of survival in metastatic breast cancer patients. J Clin Oncol. 2005;23:5117-5125.
16. Burzykowski T, Buyse M, Piccart-Gebhart MJ, et al. Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer. J Clin Oncol. 2008;26:1987-1992.
17. Fleming TR. Surrogate endpoints and FDA's accelerated approval process. Health Aff (Millwood). 2005;24:67-78.
18. Karaman MW, Herrgard S, Treiber DK, et al. A quantitative analysis of kinase inhibitor selectivity. Nat Biotechnol. 2008;26:127-132.
19. Lauer MS, Topol EJ. Clinical trials-multiple treatments, multiple end points, and multiple lessons. JAMA. 2003;289:2575-2577.
20. Ray ME, Bae K, Hussain MHA, et al. Potential surrogate endpoints for prostate cancer survival: analysis of a phase III randomized trial. JNCI J Natl Cancer Inst. 2009;101:228-236.
21. Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI). Lancet. 1986;1:397-402.
22. Schilsky RL. Hurry up and wait: is accelerated approval of new cancer drugs in the best interests of cancer patients? J Clin Oncol. 2003;21:3718-3720.
23. Minna JD, Girard L, Xie Y. Tumor mRNA expression profiles predict responses to chemotherapy. J Clin Oncol. 2007;25:4329-4336.