PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel and CMF versus a standard-dosed epirubicin/cyclophosphamide followed by paclitaxel ± darbepoetin alfa in primary breast cancer--results at the time of surgery.
Ann Oncol
; 22(9): 1988-1998, 2011 Sep.
Article
de En
| MEDLINE
| ID: mdl-21385882
ABSTRACT
BACKGROUND:
Preoperative chemotherapy is a recommended treatment of both primary operable and locally advanced breast cancer. Strategies to improve efficacy include the use of anthracyclines, taxanes, and intensified dose with bone marrow support. PATIENTS ANDMETHODS:
Patients received neoadjuvant epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) followed by paclitaxel 175 mg/m(2) (ECâT), each 3-weekly for four cycles (n = 370), or epirubicin 150 mg/m(2) followed by paclitaxel 225 mg/m(2) with pegfilgrastim followed by CMF (cyclophosphamide 500 mg/m(2), methotrexate 40 mg/m(2), fluorouracil 600 mg/m(2)) on days 1 and 8 (E(dd)âT(dd)âCMF), each 2-weekly and for three cycles (n = 363). Patients were randomly allocated to either simultaneous darbepoetin alfa (DA) (n = 356) or none (n = 377).RESULTS:
Pathological complete response (pCR) rate (breast) was higher with E(dd)âT(dd)âCMF, 18.7% versus 13.2% with ECâT; P = 0.043, ypT0/Tis; ypN0 was reported in 20.9% versus 14.3% respectively; P = 0.019. Patients with grade 3 tumors and negative hormone receptor status had a significantly higher pCR rate. Mean hemoglobin values maintained higher with DA (13.6 versus 12.6 g/dl). E(dd)âT(dd)âCMF regimen showed more grade 3-4 mucositis, sensory neuropathy, and neurological complaints. Thromboembolic events were more frequent on DA (3% versus 6%; P = 0.055).CONCLUSION:
Dose-dense and -intensified neoadjuvant chemotherapy with E(dd)âT(dd)âCMF was potentially superior to ECâT in terms of pCR. Primary use of DA did not affect pCR.
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Tumeurs du sein
/
Protocoles de polychimiothérapie antinéoplasique
Type d'étude:
Clinical_trials
Langue:
En
Journal:
Ann Oncol
Sujet du journal:
NEOPLASIAS
Année:
2011
Type de document:
Article