Ten-year Results of Intense Dose-dense chemotherapy show superior survival compared to a conventional schedule in High-risk Primary Breast Cancer: Final results of AGO Phase III iddEPC trial.

Abstract

Background

Primary breast cancer patients with extensive axillary lymph-node involvement have a limited prognosis. The AGO (Arbeitsgemeinschaft fuer Gynaekologische Onkologie) trial compared intense dose-dense adjuvant chemotherapy with conventionally scheduled chemotherapy in high-risk breast cancer patients. Here we report the final, 10-year follow-up analysis.

Patients and methods

Enrolment took place between December 1998 until April 2003. 1284 patients with four or more involved axillary lymph nodes were randomly assigned to receive three courses each of intense dose-dense sequential epirubicin, paclitaxel and cyclophosphamide (iddEPC) q2w or standard epirubicin/cyclophosphamide followed by paclitaxel (EC&cenveo_unknown_entity_wingdings_F0E0;P) q3w. Event-free survival (EFS) was the primary endpoint.

Results

658 patients were assigned to receive iddEPC and 626 patients were assigned to receive EC&cenveo_unknown_entity_wingdings_F0E0;P. The median duration of follow-up was 122 months. EFS was 47% (95% CI 43%-52%) in the standard group and 56% (95% CI 52%-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. 10-year overall survival (OS) was 59% (95% CI 55%-63%) for patients in the standard group and 69% (95% CI 65%-73%) for patients in the iddEPC group (HR = 0.72, 95% CI 0.60-0.87; log-rank P=0.0007, two sided). Nine vs. two cases of secondary myeloid leukaemia/MDS were observed in the iddEPC and the EC&cenveo_unknown_entity_wingdings_F0E0;P arm, respectively.

Conclusion

The previously reported OS benefit of intense dose-dense EPC in comparison to conventionally dosed EC&cenveo_unknown_entity_wingdings_F0E0;P has been further increased and achieved an absolute difference of 10% after 10 years of follow-up.

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