Dose-dense chemotherapy, a method of administering chemotherapy at shorter intervals to decrease toxic effects, is not associated with an improvement in recurrence-free survival among patients with early-stage, high-risk breast cancer, according to a study published in JAMA.1
Dose-dense chemotherapy regimens yield inconsistent drug safety, efficacy, and pharmacokinetic results. The objective of this study was to analyze the effects of dose-dense chemotherapy vs traditional therapy this patient population.
In this phase 3 clinical study (Clinicaltrials.gov Identifier: NCT00798070), researchers analyzed 2017 patients who had resected invasive breast cancer and had an Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1. Efficacy endpoints included breast cancer recurrence-free survival (BCRFS), distant disease-free survival (DDFS), event-free survival (EFS), and overall survival (OS).
Although BCRFS rate for dose-tailored therapy vs conventional dosing method were not significantly different (hazard ratio, 0.79; 95% CI 0.61-1.01; P = 0.06), EFS rates were significantly higher for tailored dose group (hazard ratio, 0.79; 95% CI 0.63-0.99; P = 0.04).
The dose-tailored study arm displayed more grade 3 or 4 adverse effects, such as fatigue and neutropenic infections, than the control group. There were also more quality of life measure reductions in the dose-tailored group than the control group.
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According to the study’s authors, dose-tailored chemotherapy may not improve outcomes over conventional chemotherapy among patients with high-risk, early-stage breast cancer.
- Foukakis T, von Minckwitz G, Bengtsson NO, et al. Effect of tailored dose-dense chemotherapy vs standard 3-weekly adjuvant chemotherapy on recurrence-free survival among women with high-risk early breast cancer: A randomized clinical trial. JAMA. 2016;316(18):1888-96. doi: 10.1001/jama.2016.15865