Neoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): a multicenter, two-cohort, non-randomized phase II trial
Abstract Eribulin prolongs overall survival in patients with pre-treated advanced breast cancer. However, no biomarker exists to prospectively select patients who will benefit the most from this drug. SOLTI-1007-NeoEribulin is a phase II, open-label, two-cohort, exploratory pharmacogenomic study in...
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| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2021-11-01
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| Series: | npj Breast Cancer |
| Online Access: | https://doi.org/10.1038/s41523-021-00351-4 |
| _version_ | 1827775079864336384 |
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| author | Tomás Pascual Mafalda Oliveira Patricia Villagrasa Vanesa Ortega Laia Paré Begoña Bermejo Serafín Morales Kepa Amillano Rafael López Patricia Galván Jordi Canes Fernando Salvador Paolo Nuciforo Isabel T. Rubio Antonio Llombart-Cussac Serena Di Cosimo José Baselga Nadia Harbeck Aleix Prat Javier Cortés |
| author_facet | Tomás Pascual Mafalda Oliveira Patricia Villagrasa Vanesa Ortega Laia Paré Begoña Bermejo Serafín Morales Kepa Amillano Rafael López Patricia Galván Jordi Canes Fernando Salvador Paolo Nuciforo Isabel T. Rubio Antonio Llombart-Cussac Serena Di Cosimo José Baselga Nadia Harbeck Aleix Prat Javier Cortés |
| author_sort | Tomás Pascual |
| collection | DOAJ |
| description | Abstract Eribulin prolongs overall survival in patients with pre-treated advanced breast cancer. However, no biomarker exists to prospectively select patients who will benefit the most from this drug. SOLTI-1007-NeoEribulin is a phase II, open-label, two-cohort, exploratory pharmacogenomic study in patients with clinical stage I–II HER2-negative breast cancer receiving neoadjuvant eribulin monotherapy treatment. Primary objective was to explore the association of baseline tumor gene expression with pathological complete response in the breast (pCRB) at surgery. Key secondary objectives were pCRB rates in all patients and according to HR status, gene expression changes during treatment and safety. One-hundred one hormonal receptor-positive (HR + ) and seventy-three triple-negative breast cancer (TNBC) patients were recruited. The pCRB rates were 6.4% in all patients, 4.9% in HR + disease and 8.2% in TNBC. The TNBC cohort was interrupted due to a progression disease rate of 30.1%. The pCRB rates differed according to intrinsic subtypes: 28.6% in HER2-enriched, 11.1% in Normal-like, 7.9% in Luminal B, 5.9% in Basal-like and 0% in Luminal A (HER2-enriched vs. others odds ratio = 7.05, 95% CI 1.80–42.14; p-value = 0.032). Intrinsic subtype changes at surgery occurred in 33.3% of cases, mostly (49.0%) Luminal B converting to Luminal A or Basal-like converting to Normal-like. Baseline tumor-infiltrating lymphocytes (TILs) were significantly associated with pCR. Eribulin showed a good safety profile with a low response and pCRB rates. Patients with HER2-negative disease with a HER2-enriched profile may benefit the most from eribulin. In addition, significant biological activity of eribulin is observed in Luminal B and Basal-like subtypes. |
| first_indexed | 2024-03-11T13:47:07Z |
| format | Article |
| id | doaj.art-41c7b00b4fff4204abca055bdf4c6649 |
| institution | Directory Open Access Journal |
| issn | 2374-4677 |
| language | English |
| last_indexed | 2024-03-11T13:47:07Z |
| publishDate | 2021-11-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Breast Cancer |
| spelling | doaj.art-41c7b00b4fff4204abca055bdf4c66492023-11-02T10:05:41ZengNature Portfolionpj Breast Cancer2374-46772021-11-017111110.1038/s41523-021-00351-4Neoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): a multicenter, two-cohort, non-randomized phase II trialTomás Pascual0Mafalda Oliveira1Patricia Villagrasa2Vanesa Ortega3Laia Paré4Begoña Bermejo5Serafín Morales6Kepa Amillano7Rafael López8Patricia Galván9Jordi Canes10Fernando Salvador11Paolo Nuciforo12Isabel T. Rubio13Antonio Llombart-Cussac14Serena Di Cosimo15José Baselga16Nadia Harbeck17Aleix Prat18Javier Cortés19SOLTI Breast Cancer Research GroupSOLTI Breast Cancer Research GroupSOLTI Breast Cancer Research GroupMedical Oncology Department, Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital CampusSOLTI Breast Cancer Research GroupDepartment of Medical Oncology, Hospital Clínico Universitario de ValenciaDepartment of Medical Oncology, Hospital Universitario Arnau de VilanovaDepartment of Medical Oncology, Hospital Universitari Sant JoanDepartment of Medical Oncology, Hospital Clínico Universitario de SantiagoTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS)SOLTI Breast Cancer Research GroupSOLTI Breast Cancer Research GroupMolecular Oncology Lab, Vall d’Hebron Institute of OncologyBreast Cancer Program, Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital CampusMedical Oncology Department, Hospital Arnau de Vilanova, Fundación para el Fomento de la Investigación Sanitaria i Biomédica de la Comunidad Valenciana (FISABIO)Biomarkers Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei TumoriHuman Oncology & Pathogenesis Program (HOPP), Memorial Sloan Kettering Cancer CenterBreast Center, Department OB&GYN and CCCLMU, LMU University HospitalSOLTI Breast Cancer Research GroupMedical Oncology Department, Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital CampusAbstract Eribulin prolongs overall survival in patients with pre-treated advanced breast cancer. However, no biomarker exists to prospectively select patients who will benefit the most from this drug. SOLTI-1007-NeoEribulin is a phase II, open-label, two-cohort, exploratory pharmacogenomic study in patients with clinical stage I–II HER2-negative breast cancer receiving neoadjuvant eribulin monotherapy treatment. Primary objective was to explore the association of baseline tumor gene expression with pathological complete response in the breast (pCRB) at surgery. Key secondary objectives were pCRB rates in all patients and according to HR status, gene expression changes during treatment and safety. One-hundred one hormonal receptor-positive (HR + ) and seventy-three triple-negative breast cancer (TNBC) patients were recruited. The pCRB rates were 6.4% in all patients, 4.9% in HR + disease and 8.2% in TNBC. The TNBC cohort was interrupted due to a progression disease rate of 30.1%. The pCRB rates differed according to intrinsic subtypes: 28.6% in HER2-enriched, 11.1% in Normal-like, 7.9% in Luminal B, 5.9% in Basal-like and 0% in Luminal A (HER2-enriched vs. others odds ratio = 7.05, 95% CI 1.80–42.14; p-value = 0.032). Intrinsic subtype changes at surgery occurred in 33.3% of cases, mostly (49.0%) Luminal B converting to Luminal A or Basal-like converting to Normal-like. Baseline tumor-infiltrating lymphocytes (TILs) were significantly associated with pCR. Eribulin showed a good safety profile with a low response and pCRB rates. Patients with HER2-negative disease with a HER2-enriched profile may benefit the most from eribulin. In addition, significant biological activity of eribulin is observed in Luminal B and Basal-like subtypes.https://doi.org/10.1038/s41523-021-00351-4 |
| spellingShingle | Tomás Pascual Mafalda Oliveira Patricia Villagrasa Vanesa Ortega Laia Paré Begoña Bermejo Serafín Morales Kepa Amillano Rafael López Patricia Galván Jordi Canes Fernando Salvador Paolo Nuciforo Isabel T. Rubio Antonio Llombart-Cussac Serena Di Cosimo José Baselga Nadia Harbeck Aleix Prat Javier Cortés Neoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): a multicenter, two-cohort, non-randomized phase II trial npj Breast Cancer |
| title | Neoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): a multicenter, two-cohort, non-randomized phase II trial |
| title_full | Neoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): a multicenter, two-cohort, non-randomized phase II trial |
| title_fullStr | Neoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): a multicenter, two-cohort, non-randomized phase II trial |
| title_full_unstemmed | Neoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): a multicenter, two-cohort, non-randomized phase II trial |
| title_short | Neoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): a multicenter, two-cohort, non-randomized phase II trial |
| title_sort | neoadjuvant eribulin in her2 negative early stage breast cancer solti 1007 neoeribulin a multicenter two cohort non randomized phase ii trial |
| url | https://doi.org/10.1038/s41523-021-00351-4 |
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