메뉴 건너뛰기




Volumn 51, Issue 8, 2015, Pages 907-914

Do participants in adjuvant breast cancer trials reflect the breast cancer patient population?

Author keywords

Adjuvant treatment; Applicability; Breast cancer; Generalisabilty; Phase III trials; Record linkage

Indexed keywords

ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER CHEMOTHERAPY; CANCER HORMONE THERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; COHORT ANALYSIS; FEMALE; HUMAN; MAJOR CLINICAL STUDY; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); ADJUVANT CHEMOTHERAPY; BREAST NEOPLASMS; MULTIMODALITY CANCER THERAPY; PATIENT PARTICIPATION; PATIENT SELECTION; POPULATION; STATISTICS AND NUMERICAL DATA; UNITED KINGDOM;

EID: 84928957523     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2015.01.064     Document Type: Article
Times cited : (14)

References (37)
  • 1
    • 11444261579 scopus 로고    scopus 로고
    • External validity of randomised controlled trials: "to whom do the results of this trial apply?"
    • P.M. Rothwell External validity of randomised controlled trials: "to whom do the results of this trial apply?" Lancet 365 9453 2005 82 93
    • (2005) Lancet , vol.365 , Issue.9453 , pp. 82-93
    • Rothwell, P.M.1
  • 2
    • 0014115513 scopus 로고
    • Explanatory and pragmatic attitudes in therapeutical trials
    • D. Schwartz, and J. Lellouch Explanatory and pragmatic attitudes in therapeutical trials J Chronic Dis 20 1967 637 648
    • (1967) J Chronic Dis , vol.20 , pp. 637-648
    • Schwartz, D.1    Lellouch, J.2
  • 3
    • 67649661825 scopus 로고    scopus 로고
    • Making trials matter: Pragmatic and explanatory trials and the problem of applicability
    • S. Treweek, and M. Zwarenstein Making trials matter: pragmatic and explanatory trials and the problem of applicability Trials 10 2009 37
    • (2009) Trials , vol.10 , pp. 37
    • Treweek, S.1    Zwarenstein, M.2
  • 4
    • 33947579183 scopus 로고    scopus 로고
    • External validity of randomised controlled trials in asthma: To whom do the results of the trials apply?
    • J. Travers, S. Marsh, M. Williams, M. Weatherall, B. Caldwell, and P. Shirtcliffe External validity of randomised controlled trials in asthma: to whom do the results of the trials apply? Thorax 62 2007 219 223
    • (2007) Thorax , vol.62 , pp. 219-223
    • Travers, J.1    Marsh, S.2    Williams, M.3    Weatherall, M.4    Caldwell, B.5    Shirtcliffe, P.6
  • 6
    • 84874174557 scopus 로고    scopus 로고
    • External validity of randomized controlled trials of glycaemic control and vascular disease: How representative are participants?
    • C. Saunders, C.D. Byrne, B. Guthrie, R.S. Lindsay, J.A. McKnight, and S. Philip External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants? Diabet Med 30 3 2013 300 308
    • (2013) Diabet Med , vol.30 , Issue.3 , pp. 300-308
    • Saunders, C.1    Byrne, C.D.2    Guthrie, B.3    Lindsay, R.S.4    McKnight, J.A.5    Philip, S.6
  • 7
    • 78650695919 scopus 로고    scopus 로고
    • Are patients in clinical trials representative of the general population? Dose intensity and toxicities associated with FE100C-D chemotherapy in a non-trial population of node positive breast cancer patients compared with PACS-01 trial group
    • J. Fraser, N. Steele, A. Al Zaman, and A. Yule Are patients in clinical trials representative of the general population? Dose intensity and toxicities associated with FE100C-D chemotherapy in a non-trial population of node positive breast cancer patients compared with PACS-01 trial group Eur J Cancer 47 2011 215 220
    • (2011) Eur J Cancer , vol.47 , pp. 215-220
    • Fraser, J.1    Steele, N.2    Al Zaman, A.3    Yule, A.4
  • 9
    • 63449084190 scopus 로고    scopus 로고
    • What kind of randomized trials do we need?
    • M. Zwarenstein, and S. Treweek What kind of randomized trials do we need? J Clin Epidemiol 62 2009 461 463
    • (2009) J Clin Epidemiol , vol.62 , pp. 461-463
    • Zwarenstein, M.1    Treweek, S.2
  • 10
    • 34247530125 scopus 로고    scopus 로고
    • Factors that can affect the external validity of randomised controlled trials
    • P.M. Rothwell Factors that can affect the external validity of randomised controlled trials PLoS Clin Trials 1 2006 e9
    • (2006) PLoS Clin Trials , vol.1 , pp. e9
    • Rothwell, P.M.1
  • 11
    • 0141684982 scopus 로고    scopus 로고
    • Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy
    • S.R. Tunis, D.B. Stryer, and C.M. Clancy Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy JAMA 290 2003 1624 1632
    • (2003) JAMA , vol.290 , pp. 1624-1632
    • Tunis, S.R.1    Stryer, D.B.2    Clancy, C.M.3
  • 12
    • 56749152357 scopus 로고    scopus 로고
    • Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer
    • C. McCowan, J. Shearer, P.T. Donnan, J.A. Dewar, M. Crilly, and A.M. Thompson Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer Br J Cancer 99 2008 1763 1768
    • (2008) Br J Cancer , vol.99 , pp. 1763-1768
    • McCowan, C.1    Shearer, J.2    Donnan, P.T.3    Dewar, J.A.4    Crilly, M.5    Thompson, A.M.6
  • 13
    • 84859996304 scopus 로고    scopus 로고
    • The importance of nonpharmacogenetic factors in endocrine therapy
    • C. McCowan, and A.M. Thompson The importance of nonpharmacogenetic factors in endocrine therapy Pharmacogenomics 13 2012 721 728
    • (2012) Pharmacogenomics , vol.13 , pp. 721-728
    • McCowan, C.1    Thompson, A.M.2
  • 14
    • 61549105328 scopus 로고    scopus 로고
    • Early and locally advanced breast cancer: Diagnosis and treatment National Institute for Health and Clinical Excellence guideline 2009
    • J. Yarnold Early and locally advanced breast cancer: diagnosis and treatment National Institute for Health and Clinical Excellence guideline 2009 Clin Oncol (R Coll Radiol) 21 2009 159 160
    • (2009) Clin Oncol (R Coll Radiol) , vol.21 , pp. 159-160
    • Yarnold, J.1
  • 15
    • 77955551055 scopus 로고    scopus 로고
    • American Society of Clinical Oncology clinical practice guideline: Update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer
    • H.J. Burstein, A.A. Prestrud, J. Seidenfeld, H. Anderson, T.A. Buchholz, and N.E. Davidson American Society of Clinical Oncology clinical practice guideline: update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer J Clin Oncol 28 23 2010 3784 3796
    • (2010) J Clin Oncol , vol.28 , Issue.23 , pp. 3784-3796
    • Burstein, H.J.1    Prestrud, A.A.2    Seidenfeld, J.3    Anderson, H.4    Buchholz, T.A.5    Davidson, N.E.6
  • 16
    • 79961128669 scopus 로고    scopus 로고
    • Fractionation for whole breast irradiation: An American Society for Radiation Oncology (ASTRO) evidence-based guideline
    • B.D. Smith, S.M. Bentzen, C.R. Correa, C.A. Hahn, P.H. Hardenbergh, and G.S. Ibbott Fractionation for whole breast irradiation: an American Society for Radiation Oncology (ASTRO) evidence-based guideline Int J Radiat Oncol Biol Phys 81 1 2011 59 68
    • (2011) Int J Radiat Oncol Biol Phys , vol.81 , Issue.1 , pp. 59-68
    • Smith, B.D.1    Bentzen, S.M.2    Correa, C.R.3    Hahn, C.A.4    Hardenbergh, P.H.5    Ibbott, G.S.6
  • 19
    • 84876496508 scopus 로고    scopus 로고
    • Cohort study of adherence to adjuvant endocrine therapy, breast cancer recurrence and mortality
    • B. Makubate, P.T. Donnan, J.A. Dewar, A.M. Thompson, and C. McCowan Cohort study of adherence to adjuvant endocrine therapy, breast cancer recurrence and mortality Br J Cancer 108 2013 1515 1524
    • (2013) Br J Cancer , vol.108 , pp. 1515-1524
    • Makubate, B.1    Donnan, P.T.2    Dewar, J.A.3    Thompson, A.M.4    McCowan, C.5
  • 20
    • 0023092594 scopus 로고
    • A new method of classifying prognostic comorbidity in longitudinal studies: Development and validation
    • M.E. Charlson, P. Pompei, K.L. Ales, and C.R. MacKenzie A new method of classifying prognostic comorbidity in longitudinal studies: development and validation J Chronic Dis 40 1987 373 383
    • (1987) J Chronic Dis , vol.40 , pp. 373-383
    • Charlson, M.E.1    Pompei, P.2    Ales, K.L.3    MacKenzie, C.R.4
  • 21
    • 84863882613 scopus 로고    scopus 로고
    • A comparison of systemic therapy utilization in British Columbia, Scotland, and Western Australia with models of "optimal" therapy
    • A. Fong, J. Shafiq, C. Saunders, A. Thompson, S. Tyldesley, and M.B. Barton A comparison of systemic therapy utilization in British Columbia, Scotland, and Western Australia with models of "optimal" therapy Breast 21 2012 562 569
    • (2012) Breast , vol.21 , pp. 562-569
    • Fong, A.1    Shafiq, J.2    Saunders, C.3    Thompson, A.4    Tyldesley, S.5    Barton, M.B.6
  • 22
    • 0037157603 scopus 로고    scopus 로고
    • (Arimidex, tamoxifen alone or in combination) trialists' group. 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 randomized trial
    • A.T.A.C. The (Arimidex, tamoxifen alone or in combination) trialists' group. 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 randomized trial Lancet 359 2002 2131 2139
    • (2002) Lancet , vol.359 , pp. 2131-2139
    • The, A.T.A.C.1
  • 23
    • 29544433211 scopus 로고    scopus 로고
    • A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer
    • The Breast International Group(BIG) 1-98 Collaborative Group A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer N Engl J Med 353 2005 2747 2757
    • (2005) N Engl J Med , vol.353 , pp. 2747-2757
  • 24
    • 0037036664 scopus 로고    scopus 로고
    • Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer
    • T. Whelan, R. MacKenzie, J. Julian, M. Levine, W. Shelley, and L. Grimond Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer J Natl Cancer Inst 94 2002 1143 1150
    • (2002) J Natl Cancer Inst , vol.94 , pp. 1143-1150
    • Whelan, T.1    MacKenzie, R.2    Julian, J.3    Levine, M.4    Shelley, W.5    Grimond, L.6
  • 25
    • 0035829843 scopus 로고    scopus 로고
    • Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation
    • H. Bartelink, J.-C. Horiot, P. Poortmans, H. Struikmans, W. Van den Bogaert, and I. Barillot Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation N Engl J Med 345 2001 1378 1387
    • (2001) N Engl J Med , vol.345 , pp. 1378-1387
    • Bartelink, H.1    Horiot, J.-C.2    Poortmans, P.3    Struikmans, H.4    Van Den Bogaert, W.5    Barillot, I.6
  • 26
    • 10744223655 scopus 로고    scopus 로고
    • A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer
    • R.C. Coombes, E. Hall, L.J. Gibson, R. Paridaens, J. Jassem, and T. Delozier A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer N Engl J Med 350 2004 1081 1092
    • (2004) N Engl J Med , vol.350 , pp. 1081-1092
    • Coombes, R.C.1    Hall, E.2    Gibson, L.J.3    Paridaens, R.4    Jassem, J.5    Delozier, T.6
  • 27
    • 7444259675 scopus 로고    scopus 로고
    • Randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer
    • P.E. Goss, J.N. Ingle, S. Martino, N.J. Robert, H.B. Muss, and M.J. Piccart Randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer N Engl J Med 349 2003 1793 1802
    • (2003) N Engl J Med , vol.349 , pp. 1793-1802
    • Goss, P.E.1    Ingle, J.N.2    Martino, S.3    Robert, N.J.4    Muss, H.B.5    Piccart, M.J.6
  • 28
    • 20544434991 scopus 로고    scopus 로고
    • Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: Results from NSABP B-28
    • E.P. Mamounas, J. Bryant, B. Lembersky, L. Fehrenbacher, S.M. Sedlacek, and B. Fisher Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28 J Clin Oncol 23 2005 3686 3696
    • (2005) J Clin Oncol , vol.23 , pp. 3686-3696
    • Mamounas, E.P.1    Bryant, J.2    Lembersky, B.3    Fehrenbacher, L.4    Sedlacek, S.M.5    Fisher, B.6
  • 29
    • 40949094327 scopus 로고    scopus 로고
    • The UK Standardisation of Breast Radiotherapy (START) trial A of radiotherapy hypofractionation for treatment of early breast cancer: A randomised trial
    • The START Trialists' Group The UK Standardisation of Breast Radiotherapy (START) trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial Lancet Oncol 9 2008 331 341
    • (2008) Lancet Oncol , vol.9 , pp. 331-341
  • 30
    • 40949161752 scopus 로고    scopus 로고
    • The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: A randomised trial
    • The START Trialists' Group The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial Lancet 371 2008 1098 1107
    • (2008) Lancet , vol.371 , pp. 1098-1107
  • 31
    • 65549146500 scopus 로고    scopus 로고
    • TACT Trial Management Group; tact trialists. Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): An open-label, phase III, randomized controlled trial
    • P. Ellis, L.P. Barrett, L. Johnson, D. Cameron, A. Wardley, and S. O'Reilly TACT Trial Management Group; tact trialists. sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, phase III, randomized controlled trial Lancet 373 2009 1681 1692
    • (2009) Lancet , vol.373 , pp. 1681-1692
    • Ellis, P.1    Barrett, L.P.2    Johnson, L.3    Cameron, D.4    Wardley, A.5    O'reilly, S.6
  • 32
    • 77955013406 scopus 로고    scopus 로고
    • Targeted intra-operative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A Trial): An international, prospective, randomized, non-inferiority phase 3 trial
    • J.S. Vaidya, D.J. Joseph, J.S. Tobias, M. Bulsara, F. Wenz, and C. Saunders Targeted intra-operative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A Trial): an international, prospective, randomized, non-inferiority phase 3 trial Lancet 376 2010 91 102
    • (2010) Lancet , vol.376 , pp. 91-102
    • Vaidya, J.S.1    Joseph, D.J.2    Tobias, J.S.3    Bulsara, M.4    Wenz, F.5    Saunders, C.6
  • 33
    • 78751647876 scopus 로고    scopus 로고
    • Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): A randomized phase 3 trial
    • C.J.H. Van de Velde, D. Rea, C. Seynaeve, H. Putter, A. Hasenburg, and J.-M. Vannetzel Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomized phase 3 trial Lancet 377 2011 321 331
    • (2011) Lancet , vol.377 , pp. 321-331
    • Van De Velde, C.J.H.1    Rea, D.2    Seynaeve, C.3    Putter, H.4    Hasenburg, A.5    Vannetzel, J.-M.6
  • 34
    • 11444251764 scopus 로고    scopus 로고
    • ATAC Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer
    • A. Howell, J. Cuzick, M. Baum, A. Buzdar, M. Dowsett, and J.F. Forbes ATAC Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer Lancet 365 2005 60 62
    • (2005) Lancet , vol.365 , pp. 60-62
    • Howell, A.1    Cuzick, J.2    Baum, M.3    Buzdar, A.4    Dowsett, M.5    Forbes, J.F.6
  • 35
    • 33947498821 scopus 로고    scopus 로고
    • Eligibility criteria of randomized controlled trials published in high-impact general medical journals
    • Eligibility criteria of randomized controlled trials published in high-impact general medical journals. JAMA 2007;297:1233-40.
    • (2007) JAMA , vol.297 , pp. 1233-1240
  • 36
    • 0642373288 scopus 로고    scopus 로고
    • Assessment of differences in patient populations selected for or excluded from participation in clinical phase III acute myelogenous leukemia trials
    • C. Mengis, S. Aebi, A. Tobler, W. Dahler, and M.F. Fey Assessment of differences in patient populations selected for or excluded from participation in clinical phase III acute myelogenous leukemia trials J Clin Oncol 21 2003 3933 3939
    • (2003) J Clin Oncol , vol.21 , pp. 3933-3939
    • Mengis, C.1    Aebi, S.2    Tobler, A.3    Dahler, W.4    Fey, M.F.5
  • 37
    • 26844503270 scopus 로고    scopus 로고
    • Herceptin adjuvant (HERA) trial study team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer
    • M.J. Piccart-Gebhart, M. Procter, B. Leyland-Jones, A. Goldhirsch, M. Untch, and I. Smith Herceptin adjuvant (HERA) trial study team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer N Engl J Med 353 2005 1659 1672
    • (2005) N Engl J Med , vol.353 , pp. 1659-1672
    • Piccart-Gebhart, M.J.1    Procter, M.2    Leyland-Jones, B.3    Goldhirsch, A.4    Untch, M.5    Smith, I.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.