Low-dose oral cyclophosphamide and methotrexate maintenance for hormone receptor-negative early breast cancer: International Breast Cancer Study Group Trial 22-00

Journal of Clinical Oncology

Volumn 34, Issue 28, 2016, Pages 3400-3408

  Colleoni, Marco ^a   Gray, Kathryn P ^g,h,i   Gelber, Shari ^g,h   Láng, István ^l   Thürlimann, Beat ^m,n   Gianni, Lorenzo ^c   Abdi, Ehtesham A ^q,r,s   Gomez, Henry L ^v   Linderholm, Barbro K ^w   Puglisi, Fabio ^d   Tondini, Carlo ^e   Kralidis, Elena ^n,o   Eniu, Alexandru ^x   Cagossi, Katia ^f   Rauch, Daniel ^n,p   Chirgwin, Jacquie ^s,t   Gelber, Richard D ^g,h,i,j,k   Regan, Meredith M ^g,h,j   Coates, Alan S ^u   Price, Karen N ^g,k   Viale, Giuseppe ^a,b   Goldhirsch, Aron ^a   more..

^a EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^b UNIVERSITY OF MILAN   (Italy)

^c OSPEDALE DEGLI INFERMI   (Italy)

^d UNIVERSITY HOSPITAL OF UDINE   (Italy)

^e PAPA GIOVANNI XXIII HOSPITAL   (Italy)

^f Ospedale di Carpi   (Italy)

^g International Breast Cancer Study Group Statistical Center   (United States)

^h DANA FARBER CANCER INSTITUTE   (United States)

ⁱ HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^j HARVARD MEDICAL SCHOOL   (United States)

^k Frontier Science Research and Technology   (United States)

^l NATIONAL INSTITUTE OF ONCOLOGY   (Hungary)

^m CANTONAL HOSPITAL ST GALLEN   (Switzerland)

ⁿ SWISS GROUP FOR CLINICAL CANCER RESEARCH SAKK   (Switzerland)

^o CANTONAL HOSPITAL AARAU   (Switzerland)

^p Spital Thun STS AG   (Switzerland)

^q Tweed Heads Hospital   (Australia)

^r GRIFFITH UNIVERSITY   (Australia)

^s Australian New Zealand Breast Cancer Trials Group   (Australia)

^t MONASH UNIVERSITY   (Australia)

^u UNIVERSITY OF SYDNEY   (Australia)

^v INSTITUTO NACIONAL DE ENFERMEDADES NEOPLÁSICAS   (Peru)

^w SAHLGRENSKA ACADEMY AT UNIVERSITY OF GOTHENBURG   (Sweden)

^x Cancer Institute Ion Chiricuta Cluj Napoca   (Romania)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; AMINOTRANSFERASE; ANTHRACYCLINE; CYCLOPHOSPHAMIDE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ESTROGEN RECEPTOR; HORMONE RECEPTOR; METHOTREXATE; PROGESTERONE RECEPTOR; TAXANE DERIVATIVE; TRASTUZUMAB; ANTINEOPLASTIC AGENT;

ACUTE MYELOBLASTIC LEUKEMIA; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER RADIOTHERAPY; CANCER RECURRENCE; CONTROLLED STUDY; DEATH; DISEASE FREE SURVIVAL; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HUMAN; HUMAN CELL; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; LEUKOPENIA; LOW DRUG DOSE; LUMPECTOMY; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; OPEN STUDY; PARTIAL MASTECTOMY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SIMPLE MASTECTOMY; TRIPLE NEGATIVE BREAST CANCER; ADJUVANT CHEMOTHERAPY; CLINICAL TRIAL; MIDDLE AGED; MULTICENTER STUDY; TRIPLE NEGATIVE BREAST NEOPLASMS; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; METHOTREXATE; MIDDLE AGED; TRIPLE NEGATIVE BREAST NEOPLASMS; YOUNG ADULT;

EID: 84990043408     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.65.6595     Document Type: Article

References (30)

1. Saphner T, Tormey DC, Gray R: Annual hazard rates of recurrence for breast cancer after primary therapy. J Clin Oncol 14:2738-2746, 1996
2. Metzger-Filho O, Sun Z, Viale G, et al: Patterns of recurrence and outcome according to breast cancer subtypes in lymph node-negative disease: Results from international breast cancer study group trials VIII and IX. J Clin Oncol 31:3083-3090, 2013
3. Colleoni M, Cole BF, Viale G, et al: Classical cyclophosphamide, methotrexate, and fluorouracil chemotherapy is more effective in triple-negative, node-negative breast cancer: Results from two randomized trials of adjuvant chemoendocrine therapy for node-negative breast cancer. J Clin Oncol 28:2966-2973, 2010
4. Early Breast Cancer Trialists' Collaborative Group (EBCTCG): 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, 2005
5. Peto R, Davies C, Godwin J, et al: Comparisons between different polychemotherapy regimens for early breast cancer: Meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet 379:432-444, 2012
6. Early Breast Cancer Trialists' Collaborative Group: Polychemotherapy for early breast cancer: An overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet 352:930-942, 1998
7. Early Breast Cancer Trialists' Collaborative Group: 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, 2005
8. Clahsen PC, van de Velde CJ, Welvaart K, et al: Ten-year results of a randomized trial evaluating prolonged low-dose adjuvant chemotherapy in node-positive breast cancer: A joint European Organization for Research and Treatment of Cancer-Dutch Breast Cancer Working Party study. J Clin Oncol 13:33-41, 1995
9. Hanahan D, Bergers G, Bergsland E: Less is more, regularly: Metronomic dosing of cytotoxic drugs can target tumor angiogenesis in mice. J Clin Invest 105:1045-1047, 2000
10. Hirata S, Matsubara T, Saura R, et al: Inhibition of in vitro vascular endothelial cell proliferation and in vivo neovascularization by low-dose methotrexate. Arthritis Rheum 32:1065-1073, 1989
11. Browder T, Butterfield CE, Kräling BM, et al: Antiangiogenic scheduling of chemotherapy improves efficacy against experimental drug-resistant cancer. Cancer Res 60:1878-1886, 2000
12. Colleoni M, Orlando L, Sanna G, et al: Metronomic low-dose oral cyclophosphamide and methotrexate plus or minus thalidomide in metastatic breast cancer: Antitumor activity and biological effects. Ann Oncol 17:232-238, 2006
13. Colleoni M, Rocca A, Sandri MT, et al: Low-dose oral methotrexate and cyclophosphamide in metastatic breast cancer: Antitumor activity and correlation with vascular endothelial growth factor levels. Ann Oncol 13:73-80, 2002
14. Galimberti V, Cole BF, Zurrida S, et al: Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): A phase 3 randomised controlled trial. Lancet Oncol 14:297-305, 2013
15. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Amer Statist Assn 53:457-481, 1958
16. Cox DR: Regression models and life tables. J Roy Stat Soc B 34:187-220, 1972
17. Giobbie-Hurder A, Gelber RD, Regan MM: Challenges of guarantee-time bias. J Clin Oncol 31:2963-2969, 2013
18. Cameron D, Brown J, Dent R, et al: Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): Primary results of a randomised, phase 3 trial. Lancet Oncol 14:933-942, 2013
19. Citron ML, Berry DA, Cirrincione C, et al: Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol 21:1431-1439, 2003
20. Gluz O, Nitz UA, Harbeck N, et al: Triple-negative high-risk breast cancer derives particular benefit from dose intensification of adjuvant chemotherapy: Results of WSG AM-01 trial. Ann Oncol 19:861-870, 2008
21. Coates AS, Winer EP, Goldhirsch A, et al: Tailoring therapies: Improving the management of early breast cancer - St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. Ann Oncol 26:1533-1546, 2015
22. André N, Banavali S, Snihur Y, et al: Has the time come for metronomics in low-income and middle-income countries? Lancet Oncol 14:e239-e248, 2013
23. Perez EA, Romond EH, Suman VJ, et al: Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: Planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol 32:3744-3752, 2014
24. Gianni L, Dafni U, Gelber RD, et al: Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: A 4-year follow-up of a randomised controlled trial. Lancet Oncol 12:236-244, 2011
25. Castiglione-Gertsch M, Johnsen C, Goldhirsch A, et al: The International (Ludwig) Breast Cancer Study Group Trials I-IV: 15 years follow-up. Ann Oncol 5:717-724, 1994
26. Chlebowski RT, Kim J, Haque R: Adherence to endocrine therapy in breast cancer adjuvant and prevention settings. Cancer Prev Res (Phila) 7:378-387, 2014
27. Folkman J: The influence of angiogenesis research on management of patients with breast cancer. Breast Cancer Res Treat 36:109-118, 1995
28. Miller K, O'Neill AM, Dang CT, et al: Bevacizumab (Bv) in the adjuvant treatment of HER2-negative breast cancer: Final results from Eastern Cooperative Oncology Group E5103. J Clin Oncol 32:5s, 2014 (suppl; abstr 500)
29. Slamon DJ, Swain SM, Buyse M, et al: Abstract S1-03: Primary results from BETH, a phase 3 controlled study of adjuvant chemotherapy and trastuzumab ± bevacizumab in patients with HER2-positive, node-positive or high risk node-negative breast cancer. Cancer Res 73:S1-03, 2013
30. Toi M, Lee S-J, Lee ES, et al: A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04). Presented at the San Antonio Breast Cancer Symposium, San Antonio, TX, December 9, 2015 (abstr S1-07).