Weekly carboplatin plus neoadjuvant anthracycline-taxane-based regimen in early triple-negative breast cancer: a prospective phase II trial by the Breast Cancer Task Force of the Belgian Society of Medical Oncology (BSMO)
Autor: | Leen Vanacker, Catherine Dopchie, Christel Fontaine, Peter Vuylsteke, Ahmad Awada, Lore Decoster, Philip Glorieux, V. Renard, Hans Wildiers, Heidi Van den Bulk, Jacques De Greve, Evandro de Azambuja |
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Přispěvatelé: | Medical Oncology, Laboratory of Molecular and Medical Oncology, Faculty of Medicine and Pharmacy, Clinical sciences, Medical Genetics, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'oncologie médicale |
Rok vydání: | 2019 |
Předmět: |
0301 basic medicine
Oncology Cancer Research medicine.medical_treatment Phases of clinical research Triple Negative Breast Neoplasms Carboplatin chemistry.chemical_compound 0302 clinical medicine Bridged-Ring Compounds/administration & dosage Belgium Antineoplastic Combined Chemotherapy Protocols Medicine Anthracyclines Neoadjuvant therapy Medicine(all) Middle Aged Weekly carboplatin and paclitaxel Neoadjuvant Therapy Taxoids/administration & dosage Treatment Outcome Tolerability 030220 oncology & carcinogenesis Female Taxoids Epirubicin medicine.drug Adult Bridged-Ring Compounds medicine.medical_specialty Anthracycline Neutropenia Neoadjuvant chemotherapy Anthracyclines/administration & dosage Drug Administration Schedule 03 medical and health sciences Internal medicine Biomarkers Tumor Humans Aged Neoplasm Staging Triple Negative Breast Neoplasms/diagnosis business.industry Antineoplastic Combined Chemotherapy Protocols/adverse effects Carboplatin/administration & dosage Triple-negative early breast cancer Phase 2 trial medicine.disease Survival Analysis 030104 developmental biology chemistry business Febrile neutropenia |
Zdroj: | Breast cancer research and treatment, Vol. 176, no. 3, p. 607-615 (2019) |
ISSN: | 1573-7217 |
Popis: | AIM: To evaluate the pCR rate and toxicity of the addition of weekly carboplatin (Cp) to paclitaxel (wP) and dose-dense (dd) epirubicin/cyclophosphamide (EC) in an open-label phase II study in TNBC patients. METHODS: Patients were included if they had stage II and III TNBC and received wP (80 mg/m2/week) concurrent with weekly Cp (AUC = 2) for 12 weeks, followed by bi-weekly epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) plus granulocyte colony-stimulating factor (G-CSF) for four cycles, followed by surgery. The primary endpoint was the rate of pCR [(ypT0/isypN0)]. Secondary endpoints included safety and drug delivery. RESULTS: Sixty-three eligible patients were included. Median age was 51 years (range 29-74); 88.9% had stage II disease, 46% were clinically node positive, and 77.8% had grade 3 tumors. Fifty-four percent achieved a pCR. Twelve percent missed two or more doses of wP, whereas at least two cycles of EC were missed in 9.5%. The rate of tolerance without delays or dose reductions is very low (16%). Sixty-two percent had G3/4 neutropenia. Febrile neutropenia occurred in 18 patients of which more than eighty percent occurred during EC despite primary prophylaxis with G-CSF. Thrombocytopenia grade 3/4 was noticed in 11 pts. Three patients developed grade 3 peripheral neuropathy. CONCLUSION: The addition of weekly carboplatin to neoadjuvant paclitaxel and dd EC leads to a pCR rate comparable to prior studies (54%). However, hematological toxicity and febrile neutropenia rate was unexpectedly high. Future investigations could focus on reversing the sequence, which may lead to better hematological tolerability. |
Databáze: | OpenAIRE |
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