Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer
| Autor: | Dino Amadori, Francesco Cognetti, Antonio Lambiase, Matelda Zancan, Paola Papaldo, Diana Crivellari, Massimo Gion, Alessandro Morabito, Luigi Mariani, Giampietro Gasparini, Francesco Torino, Antonella Spada, Antonio Caputo, Livia De Sio, Vittorio Silingardi, Gianfranco Filippelli |
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| Rok vydání: | 2006 |
| Předmět: |
Oncology
Cancer Research Settore MED/06 - Oncologia Medica Receptor ErbB-2 Phases of clinical research law.invention chemistry.chemical_compound Breast cancer Randomized controlled trial law Trastuzumab Antineoplastic Combined Chemotherapy Protocols skin and connective tissue diseases Aged 80 and over Brain Neoplasms Antibodies Monoclonal Middle Aged Immunohistochemistry Carcinoma Ductal Treatment Outcome Paclitaxel Female medicine.drug Adult medicine.medical_specialty Randomization Bone Neoplasms Breast Neoplasms Antibodies Monoclonal Humanized Disease-Free Survival Drug Administration Schedule Internal medicine medicine Biomarkers Tumor Humans Aged Neoplasm Staging business.industry Cancer medicine.disease Survival Analysis Surgery Clinical trial Carcinoma Lobular chemistry business |
| Zdroj: | Breast cancer research and treatment. 101(3) |
| ISSN: | 0167-6806 |
| Popis: | A randomized Phase II study evaluated the activity of weekly paclitaxel versus its combination with trastuzumab for treatment of patients with advanced breast cancer overexpressing HER-2.Among 124 patients randomized, 123 are assessable for toxicity and 118 for response. Patients received weekly paclitaxel single agent (80 mg/m2) or combined with trastuzumab (4 mg/kg loading dose, then weekly 2 mg/kg). HER-2 overexpression was determined by immunohistochemistry (IHC). Patients with 2+/3+ IHC scores were eligible. IHC was compared with HER-2 serum extracellular domain (ECD).Patient characteristics were similar in the two arms. Both treatments were feasible and well tolerated with no grade 4 hematologic toxicity. No patient developed cardiac toxicity. The combined treatment was statistically significant superior for overall response rate (ORR) (75% vs. 56.9%; P = 0.037), particularly in the subset of IHC 3+ patients (84.5% vs. 47.5%; P = 0.00050). A statistically significant better median time to progression was seen in the subgroup with IHC 3+ (369 vs. 272 days; P = 0.030) and visceral disease (301 vs. 183 days; P = 0.0080) treated with combination. Multivariable analysis of predictive factors showed that only IHC score retained statistically significant value for ORR (P = 0.0035).Weekly paclitaxel plus trastuzumab is highly active and safe and it is superior to paclitaxel alone in patients with IHC score of 3+. |
| Databáze: | OpenAIRE |
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