Key result
Neoadjuvant PH-FECH linked to ~45% higher pCR vs. TCH in HER2-positive breast cancer.
Why the study?
The efficacy of neoadjuvant systemic therapy with trastuzumab combined with anthracycline- or nonanthracycline-based regimens in HER2-positive breast cancer patients was evaluated to determine differences in pathologic complete response and survival outcomes.
Does PH-FECH improve pCR and survival compared to TCH in patients with HER2-positive breast cancer?
Cohort (n=300)
Does PH-FECH improve pCR and survival compared to TCH in patients with HER2-positive breast cancer?
Odds Ratio: 1.45 (95% CI 1.06–1.98)
Absolute Event Rate: 60.6% vs 43.3%
p-value: p=0.02
In HER2-positive breast cancer, neoadjuvant therapy with an anthracycline-based regimen (PH-FECH) showed higher pCR rates and improved relapse-free survival compared to a nonanthracycline regimen (TCH), without a significant difference in cardiac ejection fraction decline.
May guide neoadjuvant choices in HER2-positive disease; leaves open randomized confirmation of survival benefit.
BACKGROUND: The aim of this study was to evaluate the pathologic complete response (pCR) rates and relapse-free survival (RFS) and overall survival (OS) of patients receiving neoadjuvant systemic therapy (NST) with trastuzumab in combination with an anthracycline- or nonanthracycline-based regimen. METHODS: In this retrospective nonrandomized study, the authors reviewed records of 300 patients with HER2-positive breast cancer treated with either sequential paclitaxel and trastuzumab and FEC75 in combination with trastuzumab (PH-FECH) or docetaxel, carboplatin, and trastuzumab (TCH). The Kaplan-Meier product-limit method was used to estimate RFS and OS rates. Logistic regression models and Cox proportional hazards models were fit to determine the associations between NST, pCR, and survival. RESULTS: There was no significant difference in the decline in cardiac ejection fraction; however, patients who received PH-FECH had fewer cardiac comorbidities at baseline (P = .002). pCR rates were 60.6% and 43.3% for patients who received PH-FECH (n = 235) and TCH (n = 65), respectively (P = .016). Patients who received PH-FECH were 1.45 times more likely to have a pCR (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.06-1.98; P = .02). Three-year RFS rates were 93% and 71% (P < .001), and 3-year OS rates were 96% and 86% (P = .008) for patients who received PH-FECH and TCH, respectively. Patients who received PH-FECH had a lower risk of recurrence (hazard ratio [HR], 0.27; 95% CI, 0.12-0.60; P = .001) and death (HR, 0.37; 95% CI, 0.12-1.13; P = .08) than those treated with TCH. CONCLUSIONS: The type of NST in HER2-positive breast cancer is predictive of pCR rate independent of disease and patient characteristics. Although TCH is active, PH-FECH shows a higher pCR rate and RFS advantage.
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Bayraktar et al. (2011) conducted a cohort in HER2-positive breast cancer (n=300). PH-FECH (sequential paclitaxel and trastuzumab and FEC75 in combination with trastuzumab) vs. TCH (docetaxel, carboplatin, and trastuzumab) was evaluated on pathologic complete response (pCR) (OR 1.45, 95% CI 1.06-1.98, p=0.02). Neoadjuvant therapy with PH-FECH was associated with a higher pathologic complete response rate than TCH (60.6% vs 43.3%; OR 1.45; 95% CI 1.06-1.98; P=0.02) in HER2-positive breast cancer.
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