A randomized phase 2 study of temozolomide and bevacizumab ornab-paclitaxel, carboplatin, and bevacizumab in patients with unresectable stage IV melanoma
| Autor: | Svetomir N. Markovic, Peter A. Cohen, Matthew L. Kosel, Robert R. McWilliams, Francois J. Geoffroy, Thomas Amatruda, Lisa A. Kottschade, Howard M. Gross, Vera J. Suman, Domingo G. Perez, Judith S. Kaur, Anthony J. Jaslowski |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Skin Neoplasms Paclitaxel Bevacizumab medicine.medical_treatment Dacarbazine Phases of clinical research Antibodies Monoclonal Humanized Gastroenterology Article Carboplatin Young Adult chemistry.chemical_compound Albumins Internal medicine Antineoplastic Combined Chemotherapy Protocols Temozolomide Humans Medicine Melanoma Survival rate Aged Neoplasm Staging Aged 80 and over Chemotherapy business.industry Middle Aged Survival Analysis Surgery Regimen Treatment Outcome Oncology chemistry Tolerability Female business medicine.drug |
| Zdroj: | Cancer. 119:586-592 |
| ISSN: | 0008-543X |
| DOI: | 10.1002/cncr.27760 |
| Popis: | BACKGROUND: Increasing evidence shows chemotherapy in combination with vascular endothelial growth factor (VEGF) inhibition is a clinically active therapy for patients with metastatic melanoma (MM). METHODS: A phase 2 trial was conducted in chemotherapy-naive patients with unresectable stage IV MM who were randomized to temozolomide (200 mg/m2 on days 1 through 5) and bevacizumab (10 mg/kg intravenously on days 1 and 15) every 28 days (Regimen TB) or nab-paclitaxel (100 mg/m2, or 80 mg/m2 post-addendum 5 secondary to toxicity, on days 1, 8, and 15), bevacizumab (10 mg/kg on days 1 and 15), and carboplatin (area under the curve [AUC] 6 on day 1, or AUC 5 post-addendum 5) every 28 days (Regimen ABC). Accrual goal was 41 patients per regimen. The primary aim of this study was to estimate progression-free survival rate at 6 months (PFS6) in each regimen. A regimen would be considered promising if its PFS6 rate was > 60%. RESULTS: Ninety-three eligible patients (42 TB and 51 ABC) were enrolled. The majority of patients had M1c disease (20 TB and 26 ABC). The median PFS and overall survival times with ABC were 6.7 months and 13.9 months, respectively. Median PFS time and median overall survival with TB were 3.8 months and 12.3 months, respectively. The most common severe toxicities (≥ grade 3) in both regimens were cytopenias, fatigue, and thrombosis. Among the first 41 patients enrolled onto each regimen, PFS6 rate was 32.8% (95% confidence interval: 21.1%-51.2%) for TB and 56.1% (90% confidence interval: 44.7%-70.4%) for ABC. CONCLUSIONS: The addition of bevacizumab to nab-paclitaxel and carboplatin shows promising activity despite tolerability issues. Cancer 2013. © 2012 American Cancer Society. |
| Databáze: | OpenAIRE |
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