Effect of tailored dose-dense chemotherapy vs standard 3-weekly adjuvant chemotherapy on recurrence-free survival amongwomen with high-risk early breast cancer: A randomized clinical trial

JAMA - Journal of the American Medical Association

Volumn 316, Issue 18, 2016, Pages 1888-1896

  Foukakis, Theodoros ^a   Von Minckwitz, Gunter ^b   Bengtsson, Nils Olof ^c   Brandberg, Yvonne ^a   Wallberg, Birgitta ^a   Fornander, Tommy ^a   Mlineritsch, Brigitte ^d   Schmatloch, Sabine ^e   Singer, Christian F ^f   Steger, Günther ^g   Egle, Daniel ^h   Karlsson, Eva ⁱ   Carlsson, Lena ^j   Loibl, Sibylle ^b   Untch, Michael ^k   Hellström, Mats ^a   Johansson, Hemming ^a   Anderson, Harald ^l   Malmström, Per ^m   Gnant, Michael ^g   Greil, Richard ^d   Möbus, Volker ⁿ   Bergh, Jonas ^a   more..

^a KAROLINSKA INSTITUTE   (Sweden)

^b GERMAN BREAST GROUP   (Germany)

^c UMEÅ UNIVERSITY HOSPITAL   (Sweden)

^d PARACELSUS MEDICAL UNIVERSITY   (Austria)

^e Breast Center   (Germany)

^f UNIV KLIN FÜR FRAUENHEILKUNDE   (Austria)

^g MEDICAL UNIVERSITY OF VIENNA   (Austria)

^h INNSBRUCK MEDICAL UNIVERSITY   (Austria)

ⁱ CENTRAL HOSPITAL   (Sweden)

^j Clinical Department of Obstetrics and Gynaecology   (Sweden)

^k Helios Klinikum   (Germany)

^l LUND UNIVERSITY   (Sweden)

^m LUND UNIVERSITY HOSPITAL   (Sweden)

ⁿ UNIVERSITY HOSPITAL FRANKFURT   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; DOCETAXEL; EPIRUBICIN; FLUOROURACIL; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC ANTIBIOTIC; TAXOID;

ADULT; AGED; ANEMIA; ARTICLE; AUSTRIA; BREAST CANCER; CANCER CHEMOTHERAPY; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG SAFETY; EVENT FREE SURVIVAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; GERMANY; HAND FOOT SYNDROME; HEMATOLOGIC DISEASE; HIGH RISK PATIENT; HUMAN; HUMAN CELL; LEUKOPENIA; MAJOR CLINICAL STUDY; MOTOR NEUROPATHY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAIL DISEASE; NAUSEA; NEUTROPENIA; OPEN STUDY; ORAL MUCOSITIS; OVERALL SURVIVAL; PAIN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENCE FREE SURVIVAL; SENSORY NEUROPATHY; SWEDEN; THROMBOCYTOPENIA; VOMITING; ADJUVANT CHEMOTHERAPY; ADVERSE EFFECTS; BREAST NEOPLASMS; CLINICAL TRIAL; DRUG ADMINISTRATION; MIDDLE AGED; MORTALITY; PATHOLOGY; PROCEDURES; QUALITY OF LIFE; TUMOR RECURRENCE;

ADULT; AGED; ANTIBIOTICS, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AUSTRIA; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; EPIRUBICIN; FEMALE; FLUOROURACIL; GERMANY; HUMANS; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; QUALITY OF LIFE; SWEDEN; TAXOIDS;

EID: 84995814981     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2016.15865     Document Type: Article

References (21)

1. Berry DA, Cronin KA, Plevritis SK, et al; Cancer Intervention and Surveillance Modeling Network (CISNET) Collaborators. Effect of screening and adjuvant therapy on mortality from breast cancer. N Engl J Med. 2005;353(17):1784-1792.
2. Peto R, Davies C, Godwin J, et al; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012;379(9814):432-444.
3. 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. 2003;21(8):1431-1439.
4. Bonilla L, Ben-Aharon I, Vidal L, Gafter-Gvili A, Leibovici L, Stemmer SM. Dose-dense chemotherapy in nonmetastatic breast cancer: a systematic review and meta-analysis of randomized controlled trials. J Natl Cancer Inst. 2010;102(24):1845-1854.
5. Baker SD, Verweij J, Rowinsky EK, et al. Role of body surface area in dosing of investigational anticancer agents in adults, 1991-2001. J Natl Cancer Inst. 2002;94(24):1883-1888.
6. Cameron DA, Massie C, Kerr G, Leonard RC. Moderate neutropenia with adjuvant CMF confers improved survival in early breast cancer. Br J Cancer. 2003;89(10):1837-1842.
7. Colleoni M, Price K, Castiglione-Gertsch M, et al; International Breast Cancer Study Group. Dose-response effect of adjuvant cyclophosphamide,methotrexate, 5-fluorouracil (CMF) in node-positive breast cancer. Eur J Cancer. 1998;34(11):1693-1700.
8. Saarto T, Blomqvist C, Rissanen P, Auvinen A, Elomaa I. Haematological toxicity: a marker of adjuvant chemotherapy efficacy in stage II and III breast cancer. Br J Cancer. 1997;75(2):301-305.
9. Bonnefoi H, PiccartM, Bogaerts J, et al; EORTC 10994/BIG 1-00 Study Investigators. TP53 status for prediction of sensitivity to taxane versus non-taxane neoadjuvant chemotherapy in breast cancer (EORTC 10994/BIG 1-00): a randomised phase 3 trial. Lancet Oncol. 2011;12(6):527-539.
10. Wilking N, Lidbrink E, Wiklund T, et al. Long-term follow-up of the SBG 9401 study comparing tailored FEC-based therapy versus marrow-supported high-dose therapy. Ann Oncol. 2007;18(4):694-700.
11. Margolin S, Bengtsson NO, Carlsson L, et al; Scandinavian Breast Group Study SBG 2004-1. A randomised feasibility/phase II study (SBG 2004-1) with dose-dense/tailored epirubicin, cyclophoshamide (EC) followed by docetaxel (T) or fixed dosed dose-dense EC/T versus T, doxorubicin and C (TAC) in node-positive breast cancer. Acta Oncol. 2011;50(1):35-41.
12. Perez EA, Suman VJ, Davidson NE, et al. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. J Clin Oncol. 2011;29(34):4491-4497.
13. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365-376.
14. Sprangers MA, Groenvold M, Arraras JI, et al. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996; 14(10):2756-2768.
15. Fayers P, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A. EORTC QLQ-C30 Scoring Manual. 3rd ed. Brussels, Belgium: European Organization for Research & Treatment of Cancer; 2001.
16. Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Stat Med. 1982;1(2):121-129.
17. Schemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Control Clin Trials. 1996;17(4):343-346.
18. Del Mastro L, De Placido S, Bruzzi P, et al; Gruppo Italiano Mammella (GIM) Investigators. Fluorouracil and dose-dense chemotherapy in adjuvant treatment of patients with early-stage breast cancer: an open-label, 2 × 2 factorial, randomised phase 3 trial. Lancet. 2015;385(9980): 1863-1872.
19. Moebus V, Jackisch C, Lueck HJ, et al. Intense dose-dense sequential chemotherapy with epirubicin, paclitaxel, and cyclophosphamide compared with conventionally scheduled chemotherapy in high-risk primary breast cancer: mature results of an AGO phase III study. J Clin Oncol. 2010;28(17):2874-2880.
20. Norton L. A Gompertzian model of human breast cancer growth. Cancer Res. 1988;48(24, pt 1):7067-7071.
21. Sparano JA,WangM, Martino S, et al.Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med. 2008;358(16):1663-1671.