Patients with TOP2A-normal early breast cancer do not benefit from adjuvant anthracycline-therapy, according to a study published in the Journal of Clinical Oncology.1
Adjuvant anthracycline and taxane therapies are standard treatments for breast cancer, but studies suggest that anthracycline administration may benefit only patients with particular tumor characteristics.
DBCG 07-READ (ClinicalTrials.gov ID: NCT00689156) was a phase 3 randomized trial that enrolled 2012 patients with TOP2A-normal breast cancer and at least 1 high-risk factor.
Study participants were assigned 1:1 to receive docetaxel 75mg/m2 and cyclophosphamide 600mg/m2 for 6 cycles every 3 weeks (DC) or epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 for 3 cycles followed by docetaxel 100 mg/m2 for 3 cycles (EC-D).
The primary endpoint was 5-year median disease-free survival (DFS); secondary endpoints were overall survival (OS), distant disease-free survival (DDFS), and toxicity.
There was no significant difference in 5-year DFS between the EC-D (87.9% [95% CI: 85.6%-89.8%]) and DC (88.3% [95% CI: 86.1%-90.1%]) arms.
No significant differences were observed in mortality (hazard ratio, 1.15; 95% CI: 0.83-1.59; P = .41); the OS rate in the EC-D arm was 94.8% (95% CI: 93.2-96.0%) and 93.9% (95% CI: 92.2%-95.3%) in the DC arm.
Significant differences in the rates of toxicity were, however, observed. Compared with the DC arm, patients in the EC-D group had higher rates of grade 3 or 4 neutropenia, stomatitis, myalgia or arthralgia, vomiting, nausea, fatigue, and peripheral neuropathy.
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The authors concluded that “although the data are in favor of DC in patients with TOP2A-normal breast cancer, a statistical heterogeneity was identified, and a subgroup of patients may therefore derive benefit from treatment with anthracyclines.”
- Ejlertsen B, Tuxen MK, Jakobsen EH, et al. Adjuvant cyclophosphamide and docetaxel with or without epirubicin for early TOP2A-normal breast cancer: DBCG 07-READ, an open-label, phase III, randomized trial. J Clin Oncol. 2017 Jun 29. doi: 10.1200/JCO.2017.72.3494 [Epub ahead of print]