Neoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): A multicenter, two-cohort, non-randomized phase II trial Journal Article
| Authors: | Pascual, T.; Oliveira, M.; Villagrasa, P.; Ortega, V.; Paré, L.; Bermejo, B.; Morales, S.; Amillano, K.; López, R.; Galván, P.; Canes, J.; Salvador, F.; Nuciforo, P.; Rubio, I. T.; Llombart-Cussac, A.; Di Cosimo, S.; Baselga, J.; Harbeck, N.; Prat, A.; Cortés, J. |
| Article Title: | 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 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. © 2021, The Author(s). |
| Keywords: | adult; treatment response; aged; major clinical study; fatigue; neutropenia; paresthesia; cancer growth; diarrhea; drug safety; monotherapy; cancer staging; tumor associated leukocyte; phase 2 clinical trial; gene expression; tumor volume; mucosa inflammation; nausea; thrombocytopenia; cohort analysis; asthenia; drug hypersensitivity; hyperglycemia; hypokalemia; multicenter study; hyperbilirubinemia; neoadjuvant chemotherapy; hematoma; mastitis; alopecia; tremor; cerebrovascular accident; eribulin; cellulitis; triple negative breast cancer; gait disorder; hypertransaminasemia; dysarthria; overall response rate; biliary colic; human epidermal growth factor receptor 2 positive breast cancer; very elderly; intention to treat analysis; luminal a breast cancer; basal like breast cancer; human; male; female; article; differential gene expression; luminal b breast cancer; human epidermal growth factor receptor 2 negative breast cancer; aphonia |
| Journal Title: | npj Breast Cancer |
| Volume: | 7 |
| ISSN: | 2374-4677 |
| Publisher: | Nature Publishing Group |
| Date Published: | 2021-11-25 |
| Start Page: | 145 |
| Language: | English |
| DOI: | 10.1038/s41523-021-00351-4 |
| PROVIDER: | scopus |
| PMCID: | PMC8616926 |
| PUBMED: | 34824288 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 3 January 2022 -- Source: Scopus |
