Neoadjuvant Sequential Docetaxel Followed by High‐Dose Epirubicin in Combination With Cyclophosphamide Administered Concurrently With Trastuzumab. The DECT Trial

Pizzuti, Laura; Barba, Maddalena; Giannarelli, Diana; Sergi, Domenico; Botti, Claudio; Marchetti, Paolo; Anzà, M; Maugeri‐Saccà, Marcello; Natoli, Clara; Filippo, Simona Di; Catenaro, Teresa; Tomao, Federica; Amodio, Antonella; Carpano, Silvia; Perracchio, Letizia; Mottolese, Marcella; Lauro, Luigi Di; Sanguineti, Giuseppe; Benedetto, Anna Di; Giordano, Antonio; Vici, Patrizia

doi:10.1002/jcp.25432

Cited by 12 publications

(12 citation statements)

References 41 publications

(54 reference statements)

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“…In a phase II clinical trial exploring efficacy and toxicity outcomes of the combined use of epirubicin and trastuzumab in 45 HER2-positive breast cancer patients with locally advanced operable disease, we observed better outcomes in patients with BMI25 and whose tumors did not express hormone receptors. 10 Beyond the not negligible differences in terms of patients characteristics, disease features and study design, these findings are fully consistent with what reported in the study herein presented. Conversely, in young breast cancer patients, i.e., women aged 45 or less, treated with neoadjuvant CT, we observed that lower values of BMI were associated with longer OS, along with non-TN molecular subtype and adjuvant RT.…”

Section: Discussionsupporting

confidence: 91%

“…7 In light of the evidence emerged from recent literature and within our previously established research pipeline on the role of anthropometric and metabolic determinants of treatment efficacy in breast and ovarian cancer, we have now focused on a more restricted subgroup of patients from the original cohort with available data on body mass index (BMI) values at baseline assessment. [8][9][10][11][12][13][14][15] In this patient subgroup, data on several patient-and disease-related features were also analyzed and reinterpreted in light of the evidence emerging from the BMIrelated analysis. This study was designed and implemented within a real world setting.…”

Section: Introductionmentioning

confidence: 99%

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Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab

Pizzuti

Sergi

Sperduti

et al. 2018

Cancer Biology & Therapy

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The evidence emerged from the TOURANDOT trial encourages evaluating the role of anthropometric determinants on treatment outcomes in HER2-negative metastatic breast cancer patients treated with bevacizumab-including regimens. We thus analyzed data from a subgroup of these patients from a larger cohort previously assessed for treatment outcomes. Patients were included in the present analysis if body mass index values had been recorded at baseline. Clinical benefit rates, progression free survival and overall survival were assessed for the overall study population and subgroups defined upon molecular subtype. One hundred ninety six patients were included (N:196). Body mass index showed no impact on clinical benefit rates in the overall study sample and in the luminal cancer subset (p = 0.12 and p = 0.79, respectively), but did so in the triple negative subgroup, with higher rates in patients with body mass index ≥25 (p = 0.03). In the overall study sample, body mass index did no impact progression free or overall survival (p = 0.33 and p = 0.67, respectively). Conversely, in triple negative patients, progression free survival was significantly longer with body mass index ≥25 (6 vs 14 months, p = 0.04). In this subset, overall survival was more favorable (25 vs 19 months, p = 0.02). The impact of the molecular subtype was confirmed in multivariate models including the length of progression free survival, and number of metastatic sites (p < 0.0001). Further studies are warranted to confirm our findings in more adequately sized, ad hoc, prospective studies.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab

Pizzuti

Sergi

Sperduti

et al. 2018

Cancer Biology & Therapy

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“…A subsequent study by Dawood et al in this same setting confirmed this outcome also in patients having received standard duration of trastuzumab [45]. A recent Italian phase II trial also explored the use of trastuzumab concomitantly to taxane and anthracycline treatment in the neoadjuvant setting, showing no increase in the rates of clinically overt HF and higher percentage of pCR than usually reported in trials assessing consecutive administration of these agents [46]. All these studies reported a reversible and rapidly recovering LVEF values in most of the cases.…”

Section: Discussionmentioning

confidence: 74%

Long-Term Safety and Real-World Effectiveness of Trastuzumab in Breast Cancer

Mazzotta

Krasniqi

Barchiesi

et al. 2019

JCM

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Trastuzumab is a milestone in the treatment of human epidermal growth factor receptor 2 positive (HER2+) breast cancer (BC), in both the early and metastatic settings. Over the last two decades, clinical trials have established the good safety profile of trastuzumab. Cardiotoxicity remains the most frequent adverse event, more commonly exemplified by an asymptomatic decline in the left ventricular ejection fraction rather than congestive heart failure. Results from several long-term (>5 years) safety analyses have been recently published, with the inherent evidence substantially confirming the findings from previous trials. The clinical experience gained over the years in the use of trastuzumab has also fueled a number of observational studies focused on the effectiveness of this drug in the real-world settings. We herein reviewed the evidence available from tree major databases, namely, PubMed, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL), to explore and critically discuss key issues related to the long-term safety and effectiveness of trastuzumab in clinical practice.

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“…However, previous studies did not conducted subgroup analysis for efficacy of the concurrent use of trastuzumab and anthracyclines, corresponding pCR rates and toxic effects were not reported. Considering the cardiotoxicity of both trastuzumab and anthracyclines, the concurrent use of trastuzumab and anthracycline-based NAC for HER2-positive breast cancer patients should be more careful 23 - 25 . Several randomized studies 10 - 14 had evaluated the efficacy and toxic effects of the concurrent use of trastuzumab and anthracycline-based NAC for HER2-positive breast cancer, thus we performed this meta-analysis to make a further study.…”

Section: Discussionmentioning

confidence: 99%

Significantly higher pathologic complete response (pCR) after the concurrent use of trastuzumab and anthracycline-based neoadjuvant chemotherapy for HER2-positive breast cancer: Evidence from a meta-analysis of randomized controlled trials

Arshad

et al. 2018

J. Cancer

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Objectives: To investigate the effect of the concurrent use of trastuzumab and anthracycline-based neoadjuvant chemotherapy (NAC) for HER2-positive breast cancer in terms of pCR and cardiotoxicity.Methods: We systematically searched Pubmed, Embase, Cochrane and SinoMed databases from inception until 1 July 2017 for relevant articles of randomized controlled studies. After identified all relevant studies that reported the concurrent use of trastuzumab and anthracycline-based NAC for HER2-positive locally advanced breast cancer, five eligible randomized studies were extracted relevant data and assessed for design and quality, and the meta-analysis was conducted to evaluate the risk ratio (RR) of pCR and other interesting outcomes, such as left ventricular ejection fraction (LVEF) decrease more than 10%, responses, recurrence free survival (RFS) and overall survival (OS).Results: A total of five randomized controlled studies were included in the meta-analysis, including 232 HER2-positive locally advanced breast cancer patients received the concurrent use of trastuzumab and anthracycline-based NAC. The results showed that the pCR rate was significantly higher in the group received the concurrent use of trastuzumab and anthracycline-based NAC (48%) than that in the non-concurrent use of trastuzumab and anthracycline-based NAC group (26%) (RR: 1.76, 95%CI: 1.37-2.26, p<0.0001). Besides, higher rate of RFS (RR: 1.14, 95%CI: 1.03-1.26, p=0.009) was observed in the concurrent use of trastuzumab and anthracycline-based NAC group. No significant differences in LVEF decreased more than 10% (p=0.50) between both groups.Conclusions: Our meta-analysis of randomized controlled studies showed that pCR rates are significantly higher in the concurrent use of trastuzumab and anthracycline-based NAC compared with the non-concurrent use of trastuzumab and anthracycline-based NAC for certain HER2-positive breast cancer, meanwhile without significant increase of the cardiotoxicity.

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Neoadjuvant Sequential Docetaxel Followed by High‐Dose Epirubicin in Combination With Cyclophosphamide Administered Concurrently With Trastuzumab. The DECT Trial

Cited by 12 publications

References 41 publications

Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab

Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab

Long-Term Safety and Real-World Effectiveness of Trastuzumab in Breast Cancer

Significantly higher pathologic complete response (pCR) after the concurrent use of trastuzumab and anthracycline-based neoadjuvant chemotherapy for HER2-positive breast cancer: Evidence from a meta-analysis of randomized controlled trials

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