Ten-year results of intense dose-dense chemotherapy show superior survival compared with a conventional schedule in high-risk primary breast cancer: final results of AGO phase III iddEPC trial.
Ann Oncol
; 29(1): 178-185, 2018 01 01.
Article
de En
| MEDLINE
| ID: mdl-29069370
ABSTRACT
Background:
Primary breast cancer (BC) patients with extensive axillary lymph-node involvement have a limited prognosis. The Arbeitsgemeinschaft fuer Gynaekologische Onkologie (AGO) trial compared intense dose-dense (idd) adjuvant chemotherapy with conventionally scheduled chemotherapy in high-risk BC patients. Here we report the final, 10-year follow-up analysis. Patients andmethods:
Enrolment took place between December 1998 and April 2003. A total of 1284 patients with 4 or more involved axillary lymph nodes were randomly assigned to receive 3 courses each of idd sequential epirubicin, paclitaxel and cyclophosphamide (iddEPC) q2w or standard epirubicin/cyclophosphamide followed by paclitaxel (EC â P) q3w. Event-free survival (EFS) was the primary end point.Results:
A total of 658 patients were assigned to receive iddEPC and 626 patients were assigned to receive EC â P. The median duration of follow-up was 122 months. EFS was 47% (95% CI 43% to 52%) in the standard group and 56% (95% CI 52% to 60%) in the iddEPC group [hazard ratio (HR) 0.74, 95% CI 0.63-0.87; log-rank P = 0.00014, one-sided]. This benefit was independent of menopausal, hormone receptor or HER2 status. Ten-year overall survival (OS) was 59% (95% CI 55% to 63%) for patients in the standard group and 69% (95% CI 65% to 73%) for patients in the iddEPC group (HR = 0.72, 95% CI 0.60-0.87; log-rank P = 0.0007, two-sided). Nine versus two cases of secondary myeloid leukemia/myelodysplastic syndrome were observed in the iddEPC and the EC â P arm, respectively.Conclusion:
The previously reported OS benefit of iddEPC in comparison to conventionally dosed EC â P has been further increased and achieved an absolute difference of 10% after 10 years of follow-up.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Tumeurs du sein
/
Protocoles de polychimiothérapie antinéoplasique
Type d'étude:
Clinical_trials
/
Etiology_studies
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Prognostic_studies
/
Risk_factors_studies
Limites:
Adult
/
Aged
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Female
/
Humans
/
Middle aged
Langue:
En
Journal:
Ann Oncol
Sujet du journal:
NEOPLASIAS
Année:
2018
Type de document:
Article
Pays d'affiliation:
Allemagne