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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Nature Portfolio
2021
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oai:doaj.org-article:41c7b00b4fff4204abca055bdf4c66492021-11-28T12:29:06ZNeoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): a multicenter, two-cohort, non-randomized phase II trial10.1038/s41523-021-00351-42374-4677https://doaj.org/article/41c7b00b4fff4204abca055bdf4c66492021-11-01T00:00:00Zhttps://doi.org/10.1038/s41523-021-00351-4https://doaj.org/toc/2374-4677Abstract 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.Tomás PascualMafalda OliveiraPatricia VillagrasaVanesa OrtegaLaia ParéBegoña BermejoSerafín MoralesKepa AmillanoRafael LópezPatricia GalvánJordi CanesFernando SalvadorPaolo NuciforoIsabel T. RubioAntonio Llombart-CussacSerena Di CosimoJosé BaselgaNadia HarbeckAleix PratJavier CortésNature PortfolioarticleNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENnpj Breast Cancer, Vol 7, Iss 1, Pp 1-11 (2021) |
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 |
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 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 |
| 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. |
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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 |
| title |
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_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_sort |
neoadjuvant eribulin in her2-negative early-stage breast cancer (solti-1007-neoeribulin): a multicenter, two-cohort, non-randomized phase ii trial |
| publisher |
Nature Portfolio |
| publishDate |
2021 |
| url |
https://doaj.org/article/41c7b00b4fff4204abca055bdf4c6649 |
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