Real-world effectiveness of dual HER2 blockade with pertuzumab and trastuzumab for neoadjuvant treatment of HER2-positive early breast cancer (The NEOPETRA Study)

González-Santiago, Santiago; Saura, Cristina; Ciruelos, Eva; Alonsó, José Luis; Morena, Pilar de la; Eslava, Marta Santisteban; Sancho, María I. Gallegos; Luna, Alicia de; Dalmau, E.; Servitja, Sònia; Ruíz-Borrego, Manuel; Chacón, José Ignacio

doi:10.1007/s10549-020-05866-1

Cited by 19 publications

(16 citation statements)

References 33 publications

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“…Several clinical trials have evaluated the efficacy and safety of the TCbH-P regimen as a perioperative treatment [ 5 , 8 , 11 ]. In most publications, the percentage of pCR was 55–66% [ 8 , 9 , 27 ], whereas in our study we identified pCR in only 52.9% of women. We believe this is due to the high proportion of HER2-positive luminal cancer patients, with pCR found in only 33.3% (vs. 66.7% in ER-negative, HER2-positive patients), and the significantly lower chance of pCR observed in our patients aged 60 years and older, compared with younger patients (11.1% vs. 89.9%).…”

Section: Discussioncontrasting

confidence: 82%

“…The most common adverse events found in our study were anaemia, weakness, neuropathy, and neutropenia. Diarrhoea was observed in our patients less frequently (26%) than in other studies, whereas most publications report the occurrence of diarrhoea in 40–56% of patients started on the treatment [ 8 , 9 , 27 , 32 , 33 ]. It should be noted, then, that we observed diarrhoea significantly more often in patients aged 60 years and older (71%) than in younger patients.…”

Section: Discussioncontrasting

confidence: 80%

“…Anthracyclines may be used sequentially, followed by taxanes in combination with anti-HER2 drugs, or an anthracycline-free regimen containing taxanes and carboplatin with targeted therapy is recommended [ 1 , 2 , 3 ]. The results of previous studies confirm the similar efficacy of both treatment modalities, with a lower risk of cardiotoxicity in the case of anthracycline-free regimens [ 8 , 9 , 10 , 11 ].…”

Section: Introductionsupporting

confidence: 77%

“…Improved long-term outcomes were also achieved when neoadjuvant treatment with anti-HER2 therapy was included in the standard of care [ 4 , 5 , 6 , 7 , 8 , 9 ]. The use of neoadjuvant therapy can facilitate surgical treatment, increase the number of patients eligible for breast-conserving therapy (BCT), determine the degree of sensitivity to the therapy used, and identify patients who do not achieve pCR and thus should be treated more intensively after surgery [ 1 , 2 , 3 , 13 ].…”

Section: Discussionmentioning

confidence: 99%

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Neoadjuvant Pertuzumab Plus Trastuzumab in Combination with Docetaxel and Carboplatin in Patients with HER2-Positive Breast Cancer: Real-World Data from the National Institute of Oncology in Poland

Jagiełło-Gruszfeld

Rosińska

Meluch

et al. 2022

Cancers

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Neoadjuvant systemic therapy has now become the standard in early breast cancer management. Chemotherapy in combination with trastuzumab +/− pertuzumab targeted therapy can improve the rates of pathologic complete response (pCR) in patients with HER2-positive breast cancer. Achieving a pCR is considered a good prognostic factor, in particular, in patients with more aggressive breast cancer subtypes such as TNBC or HER2-positive cancers. Furthermore, most studies demonstrate that chemotherapy in combination with trastuzumab and pertuzumab is well tolerated. The retrospective analysis presented here concentrates on neoadjuvant therapy with the TCbH-P regimen, with a particular emphasis on patients over 60 years of age. We analysed the factors affecting the achievement of pCR and present the adverse effects of the applied therapies, opening discussion about optimizing the therapy of older patients with HER-2 positive breast cancer.

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Section: Discussioncontrasting

confidence: 82%

Section: Discussioncontrasting

confidence: 80%

Section: Introductionsupporting

confidence: 77%

Section: Discussionmentioning

confidence: 99%

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Neoadjuvant Pertuzumab Plus Trastuzumab in Combination with Docetaxel and Carboplatin in Patients with HER2-Positive Breast Cancer: Real-World Data from the National Institute of Oncology in Poland

Jagiełło-Gruszfeld

Rosińska

Meluch

et al. 2022

Cancers

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“…Using these to predict the pCR for HER2+ breast cancer patients might not be suitable. There were lots of studies that aimed to evaluate the predictive values of some clinical and pathological factors, such as hormone receptor (23,24), trastuzumab use (24). The nomograms based on these factors were proposed (25,26).…”

Section: Discussionmentioning

confidence: 99%

Clinical and Genetic Predictive Models for the Prediction of Pathological Complete Response to Optimize the Effectiveness for Trastuzumab Based Chemotherapy

Chen

Zheng

et al. 2021

Front. Oncol.

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BackgroundTrastuzumab shows excellent benefits for HER2+ breast cancer patients, although 20% treated remain unresponsive. We conducted a retrospective cohort study to optimize neoadjuvant chemotherapy and trastuzumab treatment in HER2+ breast cancer patients.MethodsSix hundred patients were analyzed to identify clinical characteristics of those not achieving a pathological complete response (pCR) to develop a clinical predictive model. Available RNA sequence data was also reviewed to develop a genetic model for pCR.ResultsThe pCR rate was 39.8% and pCR was associated with superior disease free survival and overall survival. ER negativity and PR negativity, higher HER2 IHC scores, higher Ki-67, and trastuzumab use were associated with improved pCR. Weekly paclitaxel and carboplatin had the highest pCR rate (46.70%) and the anthracycline+taxanes regimen had the lowest rate (11.11%). Four published GEO datasets were analyzed and a 10-gene model and immune signature for pCR were developed. Non-pCR patients were ER+PR+ and had a lower immune signature and gene model score. Hormone receptor status and immune signatures were independent predictive factors of pCR.ConclusionHormone receptor status and a 10-gene model could predict pCR independently and may be applied for patient selection and drug effectiveness optimization.

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Clinicopathological and molecular predictors of [18F]FDG-PET disease detection in HER2-positive early breast cancer: RESPONSE, a substudy of the randomized PHERGain trial

Llombart-Cussac,

Prat,

Pérez-García

et al. 2024

Eur J Nucl Med Mol Imaging

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Background The PHERGain study (NCT03161353) is assessing early metabolic responses to neoadjuvant treatment with trastuzumab-pertuzumab and chemotherapy de-escalation using a [18Fluorine]fluorodeoxyglucose-positron emission tomography ([18F]FDG-PET) and a pathological complete response-adapted strategy in HER2-positive (HER2+) early breast cancer (EBC). Herein, we present RESPONSE, a PHERGain substudy, where clinicopathological and molecular predictors of [18F]FDG-PET disease detection were evaluated. Methods A total of 500 patients with HER2 + EBC screened in the PHERGain trial with a tumor size > 1.5 cm by magnetic resonance imaging (MRI) were included in the RESPONSE substudy. PET[−] criteria entailed the absence of ≥ 1 breast lesion with maximum standardized uptake value (SUVmax) ≥ 1.5 × SUVmean liver + 2 standard deviation. Among 75 PET[−] patients screened, 21 with SUVmax levels < 2.5 were randomly selected and matched with 21 PET[+] patients with SUVmax levels ≥ 2.5 based on patient characteristics associated with [18F]FDG-PET status. The association between baseline SUVmax and [18F]FDG-PET status ([−] or [+]) with clinicopathological characteristics was assessed. In addition, evaluation of stromal tumor-infiltrating lymphocytes (sTILs) and gene expression analysis using PAM50 and Vantage 3D™ Cancer Metabolism Panel were specifically compared in a matched cohort of excluded and enrolled patients based on the [18F]FDG-PET eligibility criteria. Results Median SUVmax at baseline was 7.2 (range, 1–39.3). Among all analyzed patients, a higher SUVmax was associated with a higher tumor stage, larger tumor size, lymph node involvement, hormone receptor-negative status, higher HER2 protein expression, increased Ki67 proliferation index, and higher histological grade (p < 0.05). [18F]FDG-PET [−] criteria patients had smaller tumor size (p = 0.014) along with the absence of lymph node involvement and lower histological grade than [18F]FDG-PET [+] patients (p < 0.01). Although no difference in the levels of sTILs was found among 42 matched [18F]FDG-PET [−]/[+] criteria patients (p = 0.73), [18F]FDG-PET [−] criteria patients showed a decreased risk of recurrence (ROR) and a lower proportion of PAM50 HER2-enriched subtype than [18F]FDG-PET[+] patients (p < 0.05). Differences in the expression of genes involved in cancer metabolism were observed between [18F]FDG-PET [−] and [18F]FDG-PET[+] criteria patients. Conclusions These results highlight the clinical, biological, and metabolic heterogeneity of HER2+ breast cancer, which may facilitate the selection of HER2+ EBC patients likely to benefit from [18F]FDG-PET imaging as a tool to guide therapy. Trial registration Clinicaltrials.gov; NCT03161353; registration date: May 15, 2017.

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Real-world effectiveness of dual HER2 blockade with pertuzumab and trastuzumab for neoadjuvant treatment of HER2-positive early breast cancer (The NEOPETRA Study)

Cited by 19 publications

References 33 publications

Neoadjuvant Pertuzumab Plus Trastuzumab in Combination with Docetaxel and Carboplatin in Patients with HER2-Positive Breast Cancer: Real-World Data from the National Institute of Oncology in Poland

Neoadjuvant Pertuzumab Plus Trastuzumab in Combination with Docetaxel and Carboplatin in Patients with HER2-Positive Breast Cancer: Real-World Data from the National Institute of Oncology in Poland

Clinical and Genetic Predictive Models for the Prediction of Pathological Complete Response to Optimize the Effectiveness for Trastuzumab Based Chemotherapy

Clinicopathological and molecular predictors of [18F]FDG-PET disease detection in HER2-positive early breast cancer: RESPONSE, a substudy of the randomized PHERGain trial

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