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Volumn 97, Issue 5, 2015, Pages 502-507

The Role of Nonrandomized Trials in the Evaluation of Oncology Drugs

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ANTINEOPLASTIC AGENT;

EID: 84932113310     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/CPT.86     Document Type: Article
Times cited : (59)

References (21)
  • 1
    • 0037986306 scopus 로고    scopus 로고
    • End points and United States Food and Drug Administration approval of oncology drugs
    • Johnson, J.R., Williams, G. & Pazdur, R. End points and United States Food and Drug Administration approval of oncology drugs. J. Clin. Oncol. 21, 1404–1411 (2003).
    • (2003) J. Clin. Oncol. , vol.21 , pp. 1404-1411
    • Johnson, J.R.1    Williams, G.2    Pazdur, R.3
  • 2
    • 58549094955 scopus 로고    scopus 로고
    • Cancer: The road to Amiens
    • Stewart, D.J. & Kurzrock, R. Cancer: the road to Amiens. J. Clin. Oncol. 27 328–333 (2009).
    • (2009) J. Clin. Oncol. , vol.27 , pp. 328-333
    • Stewart, D.J.1    Kurzrock, R.2
  • 3
    • 84859377987 scopus 로고    scopus 로고
    • Role of randomized phase III trials in an era of effective targeted therapies
    • Sharma, M.R. & Schilsky, R.L. Role of randomized phase III trials in an era of effective targeted therapies. Nat. Rev. Clin. Oncol. 9, 208– 214 (2012).
    • (2012) Nat. Rev. Clin. Oncol. , vol.9 , pp. 208-214
    • Sharma, M.R.1    Schilsky, R.L.2
  • 4
    • 84995344898 scopus 로고    scopus 로고
    • Development paths for new drugs with large treatment effects seen early
    • Fleming, T. et al. Development paths for new drugs with large treatment effects seen early. Conference on Clinical Cancer Research. (2011).
    • (2011) Conference on Clinical Cancer Research
    • Fleming, T.1
  • 5
    • 42949113031 scopus 로고    scopus 로고
    • Assessing the measure of a new drug: Is survival the only thing that matters?
    • Sargent, D.J. & Hayes, D.F. Assessing the measure of a new drug: is survival the only thing that matters? J. Clin. Oncol. 26, 1922–1923 (2008).
    • (2008) J. Clin. Oncol. , vol.26 , pp. 1922-1923
    • Sargent, D.J.1    Hayes, D.F.2
  • 6
    • 52049089936 scopus 로고    scopus 로고
    • Phase II, open-label study evaluating the activity of imatinib in treating life-threatening malignancies known to be associated with imatinib-sensitive tyrosine kinases
    • Heinrich, M.C. et al. Phase II, open-label study evaluating the activity of imatinib in treating life-threatening malignancies known to be associated with imatinib-sensitive tyrosine kinases. Clin. Cancer Res. 14, 2717–2725 (2008).
    • (2008) Clin. Cancer Res. , vol.14 , pp. 2717-2725
    • Heinrich, M.C.1
  • 7
    • 84877089372 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration approval: Vismodegib for recurrent, locally advanced, or metastatic basal cell carcinoma
    • Axelson, M. et al. U.S. Food and Drug Administration approval: vismodegib for recurrent, locally advanced, or metastatic basal cell carcinoma. Clin. Cancer Res. 19, 2289–2293 (2013).
    • (2013) Clin. Cancer Res. , vol.19 , pp. 2289-2293
    • Axelson, M.1
  • 8
    • 84867696992 scopus 로고    scopus 로고
    • When progressive disease does not mean treatment failure: Reconsidering the criteria for progression
    • Oxnard, G.R. et al. When progressive disease does not mean treatment failure: reconsidering the criteria for progression. J. Natl. Cancer Inst. 104, 1534–1541 (2012).
    • (2012) J. Natl. Cancer Inst. , vol.104 , pp. 1534-1541
    • Oxnard, G.R.1
  • 9
    • 20644459413 scopus 로고
    • Appraisal of methods for the study of chemotherapy of cancer in man: Comparative therapeutic trial of nitrogen mustard and triethylene thiophosphoramide
    • Zubrod, C.G. et al. Appraisal of methods for the study of chemotherapy of cancer in man: comparative therapeutic trial of nitrogen mustard and triethylene thiophosphoramide. J. Chronic Dis. 11, 7–33 (1960).
    • (1960) J. Chronic Dis. , vol.11 , pp. 7-33
    • Zubrod, C.G.1
  • 10
    • 84873931584 scopus 로고    scopus 로고
    • Review of meta-analyses evaluating surrogate endpoints for overall survival in oncology
    • Sherrill, B., Kaye, J.A., Sandin, R., Cappelleri, J.C. & Chen, C. Review of meta-analyses evaluating surrogate endpoints for overall survival in oncology. Oncol. Targets Ther. 5, 287–296 (2012).
    • (2012) Oncol. Targets Ther. , vol.5 , pp. 287-296
    • Sherrill, B.1    Kaye, J.A.2    Sandin, R.3    Cappelleri, J.C.4    Chen, C.5
  • 11
    • 0026568376 scopus 로고
    • Statistical model to determine the relationship of response and survival in patients with advanced ovarian cancer treated with chemotherapy
    • Torri, V., Simon, R., Russek-Cohen, E., Midthune, D. & Friedman, M. Statistical model to determine the relationship of response and survival in patients with advanced ovarian cancer treated with chemotherapy. J. Natl. Cancer Inst. 84, 407–414 (1992).
    • (1992) J. Natl. Cancer Inst. , vol.84 , pp. 407-414
    • Torri, V.1    Simon, R.2    Russek-Cohen, E.3    Midthune, D.4    Friedman, M.5
  • 13
    • 84869209150 scopus 로고    scopus 로고
    • Outcomes of phase II clinical trials with single-agent therapies in advanced/metastatic non-small cell lung cancer published between 2000 and 2009
    • Janku, F., Berry, D.A., Gong, J., Parsons, H.A., Stewart, D.J. & Kurzrock, R. Outcomes of phase II clinical trials with single-agent therapies in advanced/metastatic non-small cell lung cancer published between 2000 and 2009. Clin. Cancer Res. 18, 6356– 6363 (2012).
    • (2012) Clin. Cancer Res. , vol.18 , pp. 6356-6363
    • Janku, F.1    Berry, D.A.2    Gong, J.3    Parsons, H.A.4    Stewart, D.J.5    Kurzrock, R.6
  • 15
    • 84864047388 scopus 로고    scopus 로고
    • Change in tumor size by RECIST correlates linearly with overall survival in phase I oncology studies
    • Jain, R.K. et al. Change in tumor size by RECIST correlates linearly with overall survival in phase I oncology studies. J. Clin. Oncol. 30, 2684–2690 (2012).
    • (2012) J. Clin. Oncol. , vol.30 , pp. 2684-2690
    • Jain, R.K.1
  • 16
    • 85138172200 scopus 로고    scopus 로고
    • .
  • 17
    • 33747601326 scopus 로고    scopus 로고
    • Conditional power calculations for clinical trials with historical controls
    • Korn, E.L. & Freidlin, B. Conditional power calculations for clinical trials with historical controls. Stat. Med. 25, 2922– 2931 (2006).
    • (2006) Stat. Med. , vol.25 , pp. 2922-2931
    • Korn, E.L.1    Freidlin, B.2
  • 18
    • 80053386829 scopus 로고    scopus 로고
    • Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: A retrospective analysis
    • Shaw, A.T. et al. Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis. Lancet Oncol. 12, 1004– 1012 (2011).
    • (2011) Lancet Oncol , vol.12 , pp. 1004-1012
    • Shaw, A.T.1
  • 19
    • 79955445696 scopus 로고    scopus 로고
    • Accelerated approval of oncology products: The Food and Drug Administration experience
    • Johnson, J.R., Ning, Y.M., Farrell, A., Justice, R., Keegan, P. & Pazdur, R. Accelerated approval of oncology products: the Food and Drug Administration experience. J. Natl. Cancer Inst. 103, 636–644 (2011).
    • (2011) J. Natl. Cancer Inst. , vol.103 , pp. 636-644
    • Johnson, J.R.1    Ning, Y.M.2    Farrell, A.3    Justice, R.4    Keegan, P.5    Pazdur, R.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.