Response rate as an endpoint in clinical trials

Journal of the National Cancer Institute

Volumn 99, Issue 2, 2007, Pages 98-99

  George, Stephen L ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; DOXORUBICIN; GRANULOCYTE COLONY STIMULATING FACTOR; ANTINEOPLASTIC AGENT;

ACUTE LEUKEMIA; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; DRUG RESPONSE; DRUG SCREENING; DRUG SENSITIVITY; EDITORIAL; HEMATOLOGIC MALIGNANCY; HUMAN; MULTIPLE CYCLE TREATMENT; OSTEOSARCOMA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; BONE TUMOR; CONTROLLED CLINICAL TRIAL; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG ADMINISTRATION; EUROPE; MORTALITY; MULTICENTER STUDY; NOTE; PATHOLOGY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE NEOPLASMS; CLINICAL TRIALS, PHASE III; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; EUROPE; HUMANS; MULTICENTER STUDIES; OSTEOSARCOMA; RANDOMIZED CONTROLLED TRIALS; TREATMENT OUTCOME;

EID: 33846987947     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djk024     Document Type: Editorial

References (8)

1. Lewis IJ, Nooij M, Whelan J, Sydes MR, Grimer R, Hogendoorn PCW, et al. Improvement in histological response but not survival in osteosarcoma patients treated with intensified chemotherapy: a randomized phase III trial of the European Osteosarcoma Intergroup. J Natl Cancer Inst 2007;99:112-28.
2. Torri V, Simon R, Russek-Cohen E, Midthune D, Friedman M, Torri V, et al. Statistical model to determine the relationship of response and survival in patients with advanced ovarian cancer treated with chemotherapy. J Natl Cancer Inst 1992;84:407-14.
3. Bruzzi P, Del ML, Sormani MP, Bastholt L, Danova M, Focan C, et al. Objective response to chemotherapy as a potential surrogate end point of survival in metastatic breast cancer patients. J Clin Oncol 2005;23:5117-25.
4. Pazdur R. Response rates, survival, and chemotherapy trials. J Natl Cancer Inst 2000;92:1552-3.
5. Buyse M, Piedbois P. On the relationship between response to treatment and survival time. Stat Med 1996;15:2797-812.
6. De Gruttola VG, Clax P, Demets DL, Downing GJ, Ellenberg SS, Friedman L, et al. Considerations in the evaluation of surrogate endpoints in clinical trials. Summary of a National Institutes of Health workshop. Control Clin Trials 2001;22:485-502.
7. Molenberghs G, Burzykowski T, Alonso A, Buyse M. A perspective on surrogate endpoints in controlled clinical trials. Stat Methods Med Res 2004;13:177-206.
8. Fleming TR. Objective response rate as a surrogate end point: a commentary. J Clin Oncol 2005;23:4845-6.