CEF is superior to CMF for tumours with TOP2A aberrations: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis on Danish Breast Cancer Cooperative Group Study 89D

Breast Cancer Research and Treatment

Volumn 123, Issue 1, 2010, Pages 163-169

  Gunnarsdóttir, Katrín Á ^a   Jensen, Maj Britt ^a   Zahrieh, David ^b   Gelber, Richard D ^b   Knoop, Ann ^a   Bonetti, Marco ^c   Mouridsen, Henning ^a   Ejlertsen, Bent ^a  

^a Rigshospitalet   (Denmark)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c BOCCONI UNIVERSITY   (Italy)

Author keywords

Anthracycline; Breast cancer; STEPP; TOP2A; Treatment

Indexed keywords

CYCLOPHOSPHAMIDE; DNA TOPOISOMERASE (ATP HYDROLYSING); DNA TOPOISOMERASE (ATP HYDROLYSING) ALPHA; EPIRUBICIN; FLUOROURACIL; METHOTREXATE; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; CISPLATIN; DNA BINDING PROTEIN; DNA TOPOISOMERASE II ALPHA; TUMOR ANTIGEN;

ARTICLE; BREAST CANCER; CANCER PATIENT; CANCER TISSUE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COPY NUMBER VARIATION; DENMARK; DISEASE FREE SURVIVAL; DRUG EFFICACY; GENE AMPLIFICATION; GENETIC ASSOCIATION; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; PHARMACOGENETICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REFERENCE VALUE; RETROSPECTIVE STUDY; BREAST NEOPLASMS; DRUG RESISTANCE; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE DOSAGE; GENETICS; MORTALITY; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICAL ANALYSIS; TREATMENT OUTCOME;

ANTIGENS, NEOPLASM; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CISPLATIN; CYCLOPHOSPHAMIDE; DATA INTERPRETATION, STATISTICAL; DISEASE-FREE SURVIVAL; DNA TOPOISOMERASES, TYPE II, EUKARYOTIC; DNA-BINDING PROTEINS; DRUG RESISTANCE, NEOPLASM; EPIRUBICIN; FEMALE; FLUOROURACIL; GENE DOSAGE; HUMANS; IN SITU HYBRIDIZATION, FLUORESCENCE; METHOTREXATE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME; DNA TOPOISOMERASES, TYPE II;

EID: 77955771686     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-010-0931-y     Document Type: Article

References (24)

1. AV Gudkov CR Zelnick AR Kazarov R Thimmapaya DP Suttle WT Beck IB Roninson 1993 Isolation of genetic suppressor elements, inducing resistance to topoisomerase II-interactive cytotoxic drugs, from human topoisomerase II cDNA Proc Natl Acad Sci USA 90 3231 3235 10.1073/pnas.90.8.3231 1:CAS:528: DyaK3sXktVWqtL4%3D 8386368
2. B Ejlertsen HT Mouridsen MB Jensen J Andersen S Cold P Edlund M Ewertz BB Jensen C Kamby B Nordenskjold J Bergh 2007 Improved outcome from substituting methotrexate with epirubicin: results from a randomised comparison of CMF versus CEF in patients with primary breast cancer Eur J Cancer 43 877 884 10.1016/j.ejca.2007.01.009 1:CAS:528:DC%2BD2sXisleitL0%3D 17306974 (Pubitemid 46394520)
3. RC Coombes JM Bliss J Wils F Morvan M Espie D Amadori P Gambrosier M Richards M Aapro A Villar-Grimalt C McArdle FR Perez-Lopez P Vassilopoulos EP Ferreira CE Chilvers G Coombes EM Woods M Marty 1996 Adjuvant cyclophosphamide, methotrexate, and fluorouracil versus fluorouracil, epirubicin, and cyclophosphamide chemotherapy in premenopausal women with axillary node-positive operable breast cancer: results of a randomized trial. The International Collaborative Cancer Group J Clin Oncol 14 35 45 1:CAS:528:DyaK28XhtVOjtrY%3D 8558217
4. MN Levine VH Bramwell KI Pritchard BD Norris LE Shepherd H Abu-Zahra B Findlay D Warr D Bowman J Myles A Arnold T Vandenberg R MacKenzie J Robert J Ottaway M Burnell CK Williams D Tu 1998 Randomized trial of intensive cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil in premenopausal women with node-positive breast cancer. National Cancer Institute of Canada Clinical Trials Group J Clin Oncol 16 2651 2658 1:CAS:528:DyaK1cXlsFCguro%3D 9704715
5. JT Carpenter E Velez-Garcia BS Aron,, et al. 1991 Five year results of a randomized comparison of cyclophosphamide, doxorubicin and fluorouracil (CAF) versus cyclophosphamide, methotrexate and fluorouracil (CMF) for node positive breast cancer: a Southeastern Cancer Group Study Proc Am Soc Clin Oncol 13 66 (abstr 68)
6. M Martin A Villar A Sole-Calvo R Gonzalez B Massuti J Lizon C Camps A Carrato A Casado MT Candel J Albanell J Aranda B Munarriz J Campbell E Diaz-Rubio 2003 Doxorubicin in combination with fluorouracil and cyclophosphamide (i.v. FAC regimen, day 1, 21) versus methotrexate in combination with fluorouracil and cyclophosphamide (i.v. CMF regimen, day 1, 21) as adjuvant chemotherapy for operable breast cancer: a study by the GEICAM group Ann Oncol 14 833 842 10.1093/annonc/mdg260 1:STN:280: DC%2BD3s3mvFGnsw%3D%3D 12796019 (Pubitemid 36827198)
7. LF Hutchins SJ Green PM Ravdin D Lew S Martino M Abeloff AP Lyss C Allred SE Rivkin CK Osborne 2005 Randomized, controlled trial of cyclophosphamide, methotrexate, and fluorouracil versus cyclophosphamide, doxorubicin, and fluorouracil with and without tamoxifen for high-risk, node-negative breast cancer: treatment results of Intergroup Protocol INT-0102 J Clin Oncol 23 8313 8321 10.1200/JCO.2005.08.071 1:CAS:528:DC%2BD2MXhtlWhtrjK 16293862
8. Early Breast Cancer Trialists' Collaborative Group 2005 Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials Lancet 365 1687 1717 10.1016/S0140-6736(05)66544-0 (Pubitemid 40719106)
9. CJ Poole HM Earl L Hiller,, et al. 2006 Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer N Engl J Med 355 1851 1862 10.1056/NEJMoa052084 1:CAS:528:DC%2BD28XhtFKjsLjP 17079759 (Pubitemid 44664643)
10. B Fisher AM Brown NV Dimitrov,, et al. 1990 Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15 J Clin Oncol 8 1483 1496 1:STN:280:DyaK3czmt1Wltg%3D%3D 2202791
11. AS Knoop H Knudsen E Balslev BB Rasmussen J Overgaard KV Nielsen A Schonau KA Gunnarsdóttir KE Olsen H Mouridsen B Ejlertsen 2005 Retrospective analysis of topoisomerase IIα amplifications and deletions as predictive markers in primary breast cancer patients randomly assigned to cyclophosphamide, epirubicin and fluorouracil: Danish Breast Cancer Cooperative Group J Clin Oncol 23 7483 7490 10.1200/JCO.2005.11.007 1:CAS:528: DC%2BD2MXht1WrsrzK 16234514 (Pubitemid 46291811)
12. FP O'Malley S Chia D Tu LE Shepherd MN Levine VH Bramwell IL Andrulis KI Pritchard 2009 Topoisomerase II alpha and responsiveness of breast cancer to adjuvant chemotherapy J Natl Cancer Inst 101 644 650 10.1093/jnci/djp067 19401546
13. KV Nielsen B Ejlertsen S Møller JT Jørgensen A Knoop H Knudsen HT Mouridsen 2008 The value of TOP2A gene copy number variation as a biomarker in breast cancer: update of DBCG trial 89D Acta Oncol 47 725 734 10.1080/02841860801995396 1:CAS:528:DC%2BD1cXnsFeiur8%3D 18465341 (Pubitemid 351878451)
14. LN Harris G Broadwater M Abu-Khalaf,, et al. 2009 Topoisomerase IIα amplification does not predict benefit from dose intense cyclophosphamide, doxorubicin, and fluorouracil therapy in HER2-amplified early breast cancer: results of CALGB 8541/150013 J Clin Oncol 27 3430 3436 10.1200/JCO.2008.18.4085 1:CAS:528:DC%2BD1MXhtVSqtLvL 19470942
15. RR Tubbs WE Barlow GT Budd E Swain,, et al. 2009 Outcome of patients with early-stage breast cancer treated with doxorubicin-based adjuvant chemotherapy as a function of HER2 and TOP2A status J Clin Oncol 27 3881 3886 10.1200/JCO.2008.20.1566 1:CAS:528:DC%2BD1MXhtFCgsb3P 19620488
16. TAH Järvinen M Tanner V Rantanen M Bärlund Å Borg S Grénman J Isola 2000 Amplification and deletion of topoisomerase IIα associate with ErbB-2 amplification and affect sensitivity to topoisomerase II inhibitor doxorubicin in breast cancer Am J Pathol 156 839 847 10702400
17. KE Olsen H Knudsen BB Rasmussen E Balslev A Knoop B Ejlertsen KV Nielsen A Schönau J Overgaard 2004 Amplification of HER2 and TOP2A and deletion of TOP2A genes in breast cancer investigated by new FISH probes Acta Oncol 43 35 42 10.1080/02841860310019007 1:CAS:528:DC%2BD2cXis1Kisrk%3D 15068318 (Pubitemid 38283171)
18. A Di Leo D Larsimont D Gancberg M Tanner T Jarvinen G Rouas S Dolci J Leroy M Paesmans J Isola M Piccart 2002 HER-2 amplification and topoisomerase IIα gene aberrations as predictive markers in node-positive breast cancer patients randomly treated either with an anthracycline-based therapy or with cyclophosphamide, methotrexate and 5-fluorouracil Clin Cancer Res 8 1107 1116 1:CAS:528:DC%2BD38XksVSqu7s%3D 12006526
19. JMS Bartlett A Munro DA Cameron J Thomas R Prescott C Twelves 2008 Type 1 receptor tyrosine kinase profiles identify patients with enhanced benefit from anthracyclines in the BR9601 Adjuvant Breast Cancer Chemotherapy Trial J Clin Oncol 26 5027 5035 10.1200/JCO.2007.14.6597 1:CAS:528:DC%2BD1cXhsVGhsrrE 18768436
20. M Bonetti R Gelber 2000 A graphical method to assess treatment-covariate interactions using the Cox model on subsets of the data Stat Med 19 2595 2609 10.1002/1097-0258(20001015)19:19<2595::AID-SIM562>3.0.CO;2-M 1:STN:280:DC%2BD3M7htFOjsA%3D%3D 10986536
21. M Bonetti R Gelber 2004 Patterns of treatment effects in subsets of patients in clinical trials Biostatistics 5 465 481 10.1093/biostatistics/kxh002 15208206 (Pubitemid 41180219)
22. M Bonetti D Zahrieh BF Cole RD Gelber 2009 A small sample study of the STEPP approach to assessing treatment-covariate interactions in survival data Stat Med 28 1255 1268 10.1002/sim.3524 19170050
23. JMS Bartlett AF Munro JA Dunn C McConkey,, et al. 2010 Predictive markers of anthracycline benefit: a prospectively planned analysis of the UK National Epirubicin Adjuvant Trial (NEAT/BR9601) Lancet Oncol 11 266 274 10.1016/S1470-2045(10)70006-1 1:CAS:528:DC%2BC3cXisFGrtr8%3D 20079691
24. M Tanner J Isola T Wiklund B Erikstein P Kellokumpu-Lehtinen P Malmström N Wilking J Nilsson J Bergh 2006 Topoisomerase IIα gene amplification predicts favourable treatment response to tailored and dose-escalated anthracycline based adjuvant chemotherapy in HER-2/neu-amplified breast cancer: Scandinavian Breast Group Trial 9401 J Clin Oncol 24 2428 2436 10.1200/JCO.2005.02.9264 1:CAS:528:DC%2BD28XmtVOmsLc%3D 16682728 (Pubitemid 46630618)