Key result
Sequential epirubicin and paclitaxel achieves noninferior response rates versus concomitant therapy in metastatic breast cancer.
Why the study?
The comparative efficacy and toxicity of sequential versus concomitant administration of epirubicin and paclitaxel in metastatic breast carcinoma were uncertain.
Does sequential administration of epirubicin and paclitaxel provide noninferior objective response rates compared to concomitant administration in patients with metastatic breast carcinoma?
RCT (n=202)
Does sequential administration of epirubicin and paclitaxel provide noninferior objective response rates compared to concomitant administration in patients with metastatic breast carcinoma?
Absolute Event Rate: 57.6% vs 58.5%
Sequential administration of epirubicin and paclitaxel is as active as concomitant administration for metastatic breast carcinoma, offering an acceptable alternative with a different toxicity profile.
Sequential administration offers a toxicity-differentiated alternative in metastatic breast cancer; confirms noninferior efficacy and extends scheduling flexibility.
BACKGROUND: The authors performed a randomized trial comprising patients with metastatic breast carcinoma (MBC). They used a noninferiority design to evaluate whether the results of sequential administration of epirubicin and paclitaxel were not markedly worse than the concomitant administration in terms of objective response rates (ORRs). Toxicity profile, quality of life (QOL), and pharmacoeconomic evaluations were evaluated as well. METHODS: In the current study, 202 patients with MBC were randomized to receive either the combination of epirubicin at a dose of 90 mg/m2 plus paclitaxel at a dose of 200 mg/m2 for 8 cycles (concomitant arm, n = 108) or epirubicin at a dose of 120 mg/m2 for 4 cycles followed by paclitaxel at a dose of 250 mg/m2 over 3 hours for 4 cycles every 21 days (sequential arm, n = 94). RESULTS: The authors rejected the null hypothesis that the sequential treatment is less active than the standard concomitant regimen (ORRs: concomitant = 58.5%, sequential = 57.6%). The median progression-free and overall survival periods were 11.0 months (95% confidence interval [95% CI], 9.7-12.3) and 20.0 months (95% CI, 17.2-22.6), respectively, in the concomitant arm and 10.8 months (95% CI, 7.9-13.6) and 26 months (95% CI, 18.1-33.8), respectively, in the sequential arm (P = not significant). Patients who received the sequential regimen experienced a higher incidence of Grade 3/4 (according to the World Health Organization grading system) neutropenia (62.2% of courses vs. 50.62%; P = 0.003) and Grade > or = 2 neuropathy (45.5% vs. 30.4% of patients; P = 0.03), whereas 6 patients who received the concomitant regimen developed Grade II cardiotoxicity according to New York Heart Association criteria. QOL analyses failed to provide clear differences. CONCLUSIONS: The sequential administration of epirubicin and paclitaxel at full doses was found to be as active as their association. Therefore, both the sequential and the combined administration were acceptable options.
No takes yet. Share an insight, caveat, or question.
Conte et al. (2004) conducted an RCT in metastatic breast carcinoma (MBC) (n=202). Sequential administration of epirubicin and paclitaxel vs. Concomitant administration of epirubicin 90 mg/m2 plus paclitaxel 200 mg/m2 for 8 cycles was evaluated on objective response rates (ORRs). Sequential administration of epirubicin and paclitaxel was noninferior to concomitant administration for objective response rates (57.6% vs 58.5%) in metastatic breast carcinoma.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: