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Concurrent administration of trastuzumab and anthracyclines as adjuvant regimen for HER2-positive breast cancer: a randomised controlled trial.

ABSTRACT: The regimen of concurrent administration of trastuzumab and anthracyclines in the adjuvant treatment of breast cancer has never been evaluated prospectively for fear of cardiac toxicity.Patients with HER2-positive operable breast cancer were randomised to receive adjuvant treatment with concurrent or sequential administration of trastuzumab and anthracyclines. Cardiac monitoring was scheduled at baseline and every 3 months after the first dose of trastuzumab. The primary study endpoint was cardiac safety. Secondary endpoints were disease-free and overall survival.From 2011 to 2014, 201 participants were enrolled and randomised. The median follow-up time was 42 months. Nineteen patients (19.4%) in the concurrent group and 22 patients (22.4%) in the sequential group met the criteria for cardiac events with non-significant difference (P=0.598). There was no difference in the mean LVEF between the two groups at the baseline and at 3, 6, 9, 12, and 24 months after the first dose of trastuzumab. No case of congestive heart failure or cardiac death occurred. The differences between the efficacies of the two regimens, defined by disease-free or overall survival, were not significant.Concurrent administration of trastuzumab and anthracyclines is a safe adjuvant regimen and it provides evidence for further clinical trials.

SUBMITTER: Shen S

PROVIDER: S-EPMC5696221 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Concurrent administration of trastuzumab and anthracyclines as adjuvant regimen for HER2-positive breast cancer: a randomised controlled trial.

Shen Songjie S Xu Ying Y Zhou Yidong Y Mao Feng F Guan Jinghong J Sun Qiang Q

Oncotarget 20171006 54

<h4>Background</h4>The regimen of concurrent administration of trastuzumab and anthracyclines in the adjuvant treatment of breast cancer has never been evaluated prospectively for fear of cardiac toxicity.<h4>Methods</h4>Patients with HER2-positive operable breast cancer were randomised to receive adjuvant treatment with concurrent or sequential administration of trastuzumab and anthracyclines. Cardiac monitoring was scheduled at baseline and every 3 months after the first dose of trastuzumab. T ...[more]

PMID: 29190955

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Project description:BackgroundTrastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer, although combined therapy with anthracycline-based regimens has been associated with cardiac toxicity. We wanted to evaluate the efficacy and safety of a new nonanthracycline regimen with trastuzumab.MethodsWe randomly assigned 3222 women with HER2-positive early-stage breast cancer to receive doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks (AC-T), the same regimen plus 52 weeks of trastuzumab (AC-T plus trastuzumab), or docetaxel and carboplatin plus 52 weeks of trastuzumab (TCH). The primary study end point was disease-free survival. Secondary end points were overall survival and safety.ResultsAt a median follow-up of 65 months, 656 events triggered this protocol-specified analysis. The estimated disease-free survival rates at 5 years were 75% among patients receiving AC-T, 84% among those receiving AC-T plus trastuzumab, and 81% among those receiving TCH. Estimated rates of overall survival were 87%, 92%, and 91%, respectively. No significant differences in efficacy (disease-free or overall survival) were found between the two trastuzumab regimens, whereas both were superior to AC-T. The rates of congestive heart failure and cardiac dysfunction were significantly higher in the group receiving AC-T plus trastuzumab than in the TCH group (P<0.001). Eight cases of acute leukemia were reported: seven in the groups receiving the anthracycline-based regimens and one in the TCH group subsequent to receiving an anthracycline outside the study.ConclusionsThe addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer. The risk-benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia. (Funded by Sanofi-Aventis and Genentech; BCIRG-006 ClinicalTrials.gov number, NCT00021255.).

Project description:BACKGROUND:Pertuzumab increases the rate of pathological complete response in the preoperative context and increases overall survival among patients with metastatic disease when it is added to trastuzumab and chemotherapy for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. In this trial, we investigated whether pertuzumab, when added to adjuvant trastuzumab and chemotherapy, improves outcomes among patients with HER2-positive early breast cancer. METHODS:We randomly assigned patients with node-positive or high-risk node-negative HER2-positive, operable breast cancer to receive either pertuzumab or placebo added to standard adjuvant chemotherapy plus 1 year of treatment with trastuzumab. We assumed a 3-year invasive-disease-free survival rate of 91.8% with pertuzumab and 89.2% with placebo. RESULTS:In the trial population, 63% of the patients who were randomly assigned to receive pertuzumab (2400 patients) or placebo (2405 patients) had node-positive disease and 36% had hormone-receptor-negative disease. Disease recurrence occurred in 171 patients (7.1%) in the pertuzumab group and 210 patients (8.7%) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.66 to 1.00; P=0.045). The estimates of the 3-year rates of invasive-disease-free survival were 94.1% in the pertuzumab group and 93.2% in the placebo group. In the cohort of patients with node-positive disease, the 3-year rate of invasive-disease-free survival was 92.0% in the pertuzumab group, as compared with 90.2% in the placebo group (hazard ratio for an invasive-disease event, 0.77; 95% CI, 0.62 to 0.96; P=0.02). In the cohort of patients with node-negative disease, the 3-year rate of invasive-disease-free survival was 97.5% in the pertuzumab group and 98.4% in the placebo group (hazard ratio for an invasive-disease event, 1.13; 95% CI, 0.68 to 1.86; P=0.64). Heart failure, cardiac death, and cardiac dysfunction were infrequent in both treatment groups. Diarrhea of grade 3 or higher occurred almost exclusively during chemotherapy and was more frequent with pertuzumab than with placebo (9.8% vs. 3.7%). CONCLUSIONS:Pertuzumab significantly improved the rates of invasive-disease-free survival among patients with HER2-positive, operable breast cancer when it was added to trastuzumab and chemotherapy. Diarrhea was more common with pertuzumab than with placebo. (Funded by F. Hoffmann-La Roche/Genentech; APHINITY ClinicalTrials.gov number, NCT01358877 .).

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Concurrent administration of trastuzumab and anthracyclines as adjuvant regimen for HER2-positive breast cancer: a randomised controlled trial.

Publications

Concurrent administration of trastuzumab and anthracyclines as adjuvant regimen for HER2-positive breast cancer: a randomised controlled trial.

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