Stable disease is a valid end point in clinical trials

Cancer Journal

Volumn 15, Issue 5, 2009, Pages 374-378

  Tolcher, Anthony W ^a  

^a South Texas Accelerated Research Therapeutics   (United States)

Author keywords

Cancer; Stable disease; Two dimensional waterfall plot; Waterfall plot

Indexed keywords

BEVACIZUMAB; ERLOTINIB; EVEROLIMUS; PLACEBO; RAPAMYCIN; SORAFENIB; SUNITINIB; TEMSIROLIMUS;

CANCER CHEMOTHERAPY; CANCER RESEARCH; CANCER SURVIVAL; CLINICAL RESEARCH; CLINICAL TRIAL; DISEASE DURATION; DRUG SCREENING; GASTROINTESTINAL STROMAL TUMOR; HUMAN; KIDNEY CARCINOMA; LIVER CELL CARCINOMA; LUNG NON SMALL CELL CANCER; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REVIEW; SOLID TUMOR; TREATMENT RESPONSE; TUMOR VOLUME;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE II AS TOPIC; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; HUMANS; NEOPLASMS; TREATMENT OUTCOME;

EID: 70350157882     PISSN: 15289117     EISSN: 1540336X     Source Type: Journal    
DOI: 10.1097/PPO.0b013e3181bdbb05     Document Type: Review

References (17)

1. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Nat Cancer Inst. 2000;92:205-216.
2. Giaccone G, Gallegos Ruiz M, Le Chevalier T, et al. Erlotinib for frontline treatment of advanced non-small cell lung cancer: a phase II study. Clin Cancer Res. 2006;12:6049-6055.
3. Jackman DM, Yeap BY, Lindeman NI, et al. Phase II clinical trial of chemotherapy-naive patients- or- 70 years of age treated with erlotinib for advanced non-small-cell lung cancer. J Clin Oncol. 2007;25:760-766.
4. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-smallcell lung cancer. N Engl J Med. 2005;353:123-132.
5. Atkins MB, Hidalgo M, Stadler WM, et al. Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma. J Clin Oncol. 2004;22:909-918.
6. Motzer RJ, Escudier B, Oudard S, et al; RECORD-1 Study Group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008;372:449-456.
7. Ratain MJ, Eisen T, Stadler WM, et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006;24:2505-2512.
8. Escudier B, Eisen T, Stadler WM, et al; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356:125-134.
9. Yang JC, Haworth L, Sherry RM, et al. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med. 2003;349:427-434.
10. Rini BI, Halabi S, Rosenberg JE, et al. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol. 2008;26:5422-5428.
11. Hudes G, Carducci M, Tomczak P, et al; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356:2271-2281.
12. Amato RJ, Jac J, Giessinger S, et al. A phase 2 study with a daily regimen of the oral mTOR inhibitor RAD001 (everolimus) in patients with metastatic clear cell renal cell cancer. Cancer. 2009;115:2438-2446.
13. Abou-Alfa GK, Schwartz L, Ricci S, et al. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006;24: 4293-4300.
14. Llovet JM, Ricci S, Mazzaferro V, et al; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359: 378-390.
15. Heinrich MC, Maki RG, Corless CL, et al. Primary and secondary kinase genotypes correlate with the biological and clinical activity of sunitinib in imatinib-resistant gastrointestinal stromal tumor. J Clin Oncol. 2008;26: 5352-5359.
16. Demetri GD, van Oosterom AT, Garrett CR, et al. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006;368:1329-1338.
17. 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. Available at: http://www.eortc.be/recist/.