1. Dose-dense adjuvant chemotherapy involving sequential epirubicin/cyclophosphamide and docetaxel showed improved breast cancer recurrence-free survival and event-free survival compared to standard adjuvant chemotherapy involving docetaxel. 

Evidence Rating Level: 1 (Excellent)

Study Rundown: A dose-dense sequential adjuvant chemotherapy regimen involving an anthracycline and a taxane has been shown to confer survival benefit in previous studies. However, such studies used paclitaxel once every 3 weeks as the control regimen which is inferior to other currently available regimens. This study therefore sought to compare the efficacy of adjuvant tailored and dose-dense (tDD) chemotherapy with a standard chemotherapy regimen.

In this international randomized phase III trial, 2003 patients were included in the intent-to-treat population between February 2007 and September 2011. 1001 patients were randomized to an experimental cohort receiving tDD chemotherapy while 1002 patients were randomized to a control cohort receiving a standard chemotherapy regimen including docetaxel every 3 weeks. Participants receiving tDD chemotherapy showed an improved breast cancer recurrence free survival (BCRFS) of 3.7% compared to participants in the control cohort. Furthermore, treatment with tDD chemotherapy improved event-free survival (EFS) by 4.4% compared to standard chemotherapy. Treatment with tDD chemotherapy also improved distant disease-free survival (DDFS) by 3.7%.

Overall, this study found that tDD adjuvant chemotherapy improved outcomes compared to a standard adjuvant chemotherapy regimen which included docetaxel every 3 weeks. As such, this study confirms the superiority of dose-dense regimens compared to standard chemotherapy and supports their use in clinical care.

Click to read the study in Journal of Clinical Oncology

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In-Depth [Randomized Control Trial]: Dose-dense sequential administration of adjuvant chemotherapy involving an anthracycline and a taxane has previously been shown to improve breast cancer outcomes following surgery. However, previous studies which showed these findings used paclitaxel every 3 weeks for the control cohort when more potent alternatives currently exist, making it difficult to determine the relative benefit of the dose-dense regimen. This international randomized phase III trial therefore sought to compare the efficacy of a tDD adjuvant chemotherapy regimen with a standard regimen including docitaxel every 3 weeks.

1001 patients (median age = 51.1 years) were randomized to receive epirubicin and cyclophosphamide (EC) every 2 weeks for four cycles, followed by four cycles of docetaxel once every 2 weeks with dose tailoring during each cycle determined based on a pre-defined algorithm. 1002 patients (median age = 50.7 years) were randomized to the control cohort receiving three cycles of fluorouracil and EC once every 3 weeks, followed by three cycles of docetaxel once every 3 weeks. After a median follow-up period of 10.3 years, treatment with tDD chemotherapy improved BCRFS (hazard ratio [HR], 0.80 [95% CI, 0.65 to 0.98]; P = .030) as well as EFS (HR, 0.78 [95% CI, 0.65 to 0.94]; P = .009). Treatment with tDD chemotherapy also improved DDFS (HR, 0.79 [95% CI, 0.64 to 0.98]; P = .030). No safety signals were reported throughout this study. 

Image: PD

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