Disease-free survival as an end-point in the treatment of solid tumours - Perspectives from clinical trials and clinical practice

European Journal of Cancer

Volumn 50, Issue 13, 2014, Pages 2298-2302

  Robinson, Andrew G ^a   Booth, Christopher M ^a   Eisenhauer, Elizabeth A ^a  

^a QUEEN S UNIVERSITY   (Canada)

Author keywords

Clinical trials; Disease free survival; Drug approval; Patient perspectives; Solid tumours

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; CANCER ADJUVANT THERAPY; CANCER SURVIVAL; CANCER THERAPY; CASE STUDY; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); COLON CANCER; DISEASE FREE SURVIVAL; DRUG APPROVAL; HUMAN; PRIORITY JOURNAL; SOLID TUMOR; STUDY DESIGN; BIOASSAY; NEOPLASMS; TREATMENT OUTCOME;

ANTINEOPLASTIC AGENTS; DISEASE-FREE SURVIVAL; DRUG APPROVAL; ENDPOINT DETERMINATION; HUMANS; NEOPLASMS; TREATMENT OUTCOME;

EID: 84905095446     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2014.05.016     Document Type: Review

References (23)

1. R. Sridhara, J.R. Johnson, R. Justice, P. Keegan, A. Chakravarty, and R. Pazdur Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007 J Natl Cancer Inst 102 4 2010 230 243
2. R.P. Dematteo, K.V. Ballman, C.R. Antonescu, R.G. Maki, P.W. Pisters, and G.D. Demetri et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial Lancet 373 9669 2009 1097 1104
3. M.R. Posner, D.M. Hershock, C.R. Blajman, E. Mickiewicz, E. Winquist, and V. Gorbounova et al. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer The New England journal of medicine. 357 17 2007 1705 1715
4. J.A. Bonner, P.M. Harari, J. Giralt, N. Azarnia, D.M. Shin, and R.B. Cohen et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck New Engl J Med 354 6 2006 567 578
5. Administration USFaD. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. Available from: http://www.fda.gov/cber/guidelines.htm; 2014 [cited 15.02.14].
6. Agency EM. Guideline on the Evaluation of Anticancer Medicinal Products in Man. Available from: http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2009/12/WC500017748.pdf [cited15.02.14].
7. D.J. Sargent, S. Patiyil, G. Yothers, D.G. Haller, R. Gray, and J. Benedetti et al. End points for colon cancer adjuvant trials: observations and recommendations based on individual patient data from 20,898 patients enrolled onto 18 randomized trials from the ACCENT Group J Clin Oncol 25 29 2007 4569 4574
8. A. Grothey, A. de Gramont, and D.J. Sargent Disease-free survival in colon cancer: still relevant after all these years! J Clin Oncol 31 12 2013 1609 1610
9. A. Mauguen, J.P. Pignon, S. Burdett, C. Domerg, D. Fisher, and R. Paulus et al. Surrogate endpoints for overall survival in chemotherapy and radiotherapy trials in operable and locally advanced lung cancer: a re-analysis of meta-analyses of individual patients' data Lancet Oncol 14 7 2013 619 626
10. A.B. Miller, B. Hoogstraten, M. Staquet, and A. Winkler Reporting results of cancer treatment Cancer 47 1 1981 207 214
11. D.X. Nguyen, P.D. Bos, and J. Massague Metastasis: from dissemination to organ-specific colonization Nat Rev Cancer 9 4 2009 274 284
12. J.N. Primrose, R. Perera, A. Gray, P. Rose, A. Fuller, and A. Corkhill et al. Effect of 3 to 5 years of scheduled CEA and CT follow-up to detect recurrence of colorectal cancer: the FACS randomized clinical trial JAMA 311 3 2014 263 270
13. C. Tournigand, T. Andre, F. Bonnetain, B. Chibaudel, G. Lledo, and T. Hickish et al. Adjuvant therapy with fluorouracil and oxaliplatin in stage II and elderly patients (between ages 70 and 75 years) with colon cancer: subgroup analyses of the Multicenter International Study of Oxaliplatin, Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer trial J Clin Oncol 30 27 2012 3353 3360
14. E.A. Perez, E.H. Romond, V.J. Suman, J.H. Jeong, N.E. Davidson, and C.E. Geyer Jr et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31 J Clin Oncol 29 25 2011 3366 3373
15. M. Baum, A.U. Budzar, J. Cuzick, J. Forbes, J.H. Houghton, and J.G. Klijn et al. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial Lancet 359 9324 2002 2131 2139
16. R.E. Coleman, H. Marshall, D. Cameron, D. Dodwell, R. Burkinshaw, and M. Keane et al. Breast-cancer adjuvant therapy with zoledronic acid New Engl J Med 365 15 2011 1396 1405
17. S.R. Alberts, D.J. Sargent, S. Nair, M.R. Mahoney, M. Mooney, and S.N. Thibodeau et al. Effect of oxaliplatin, fluorouracil, and leucovorin with or without cetuximab on survival among patients with resected stage III colon cancer: a randomized trial JAMA 307 13 2012 1383 1393
18. C.J. Allegra, G. Yothers, M.J. O'Connell, S. Sharif, N.J. Petrelli, and S.H. Lopa et al. Bevacizumab in stage II-III colon cancer: 5-year update of the National Surgical Adjuvant Breast and Bowel Project C-08 trial J Clin Oncol 31 3 2013 359 364
19. S.M. Swain, G. Tang, C.E. Geyer Jr., P. Rastogi, J.N. Atkins, and P.P. Donnellan et al. Definitive results of a phase III adjuvant trial comparing three chemotherapy regimens in women with operable, node-positive breast cancer: the NSABP B-38 trial J Clin Oncol 31 26 2013 3197 3204
20. D. Cameron, J. Brown, R. Dent, C. Jackisch, J. Mackey, and X. Pivot et al. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial Lancet Oncol 14 10 2013 933 942
21. L. Gianni, G.H. Romieu, M. Lichinitser, S.V. Serrano, M. Mansutti, and X. Pivot et al. AVEREL: a randomized phase III Trial evaluating bevacizumab in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer J Clin Oncol 31 14 2013 1719 1725
22. M.D. Brundage, D. Feldman-Stewart, R. Cosby, R. Gregg, P. Dixon, and Y. Youssef et al. Cancer patients' attitudes toward treatment options for advanced non-small cell lung cancer: implications for patient education and decision support Patient Educ Couns 45 2 2001 149 157
23. V.M. Duric, M.R. Stockler, S. Heritier, F. Boyle, J. Beith, and A. Sullivan et al. Patients' preferences for adjuvant chemotherapy in early breast cancer: what makes AC and CMF worthwhile now? Ann Oncol 16 11 2005 1786 1794