Randomized phase II study of dulanermin in combination with paclitaxel, carboplatin, and bevacizumab in advanced non-small-cell lung cancer
| Autor: | Jean-Louis Pujol, Jerzy Kozielski, Lukas C. Amler, Nigel Baker, Petr Zatloukal, Avi Ashkenazi, Yang Pan, Yong Jiang Hei, Fiona H Blackhall, Istvan Albert, Jean-Charles Soria, Barna Szima, D. Smethurst, Erzsébet Juhász, Howard M. Stern, Zsuzsanna Mark |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Lung Neoplasms Bevacizumab Paclitaxel Urology Phases of clinical research Antibodies Monoclonal Humanized Carboplatin TNF-Related Apoptosis-Inducing Ligand chemistry.chemical_compound Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols Clinical endpoint medicine Humans Lung cancer Dulanermin Aged Keratin-18 business.industry Odds ratio Middle Aged medicine.disease Surgery Oncology chemistry N-Acetylgalactosaminyltransferases Female business medicine.drug |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 29(33) |
| ISSN: | 1527-7755 |
| Popis: | Purpose To evaluate the efficacy and safety of dulanermin combined with paclitaxel and carboplatin (PC) and bevacizumab (PCB) as first-line treatment for advanced or recurrent non–small-cell lung cancer (NSCLC). Patients and Methods Patients with squamous NSCLC and/or CNS metastases received PC every 3 weeks alone (arm 1) or with dulanermin 8 mg/kg for 5 days (arm 2). Patients with nonsquamous NSCLC received PCB alone (arm 3) or with dulanermin 8 mg/kg for 5 days (arm 4) or 20 mg/kg for 2 days (arm 5). The primary end point was the objective response rate (ORR). Results Overall, 213 patients were randomly assigned (arm 1, n = 41; arm 2, n = 39; arm 3, n = 42; arm 4, n = 40; arm 5, n = 41). The ORR in arms 1 to 5 was 39% (95% CI, 24% to 56%), 38% (95% CI, 24% to 54%), 50% (95% CI, 35% to 65%), 40% (95% CI, 25% to 56%), and 40% (95% CI, 25% to 56%), respectively. The odds ratio for ORR was 1.04 (P = 1.000) for arm 1 versus arm 2, 1.53 (P = .391) for arm 3 and versus arm 4, and 1.53 (P = .391) for arm 3 versus arm 5. The most common grade ≥ 3 adverse events were neutropenia, asthenia, anemia, thrombocytopenia, and hemoptysis. Of 161 available serum samples, a trend toward increased caspase-cleaved cytokeratin-18 was observed after dulanermin treatment in cycles 1 and 2. Among 84 patients evaluated for GalNT14 expression, there was a trend toward favorable progression-free survival and overall survival with dulanermin treatment in those with high GalNT14 expression. Conclusion The addition of dulanermin to PC and PCB did not improve outcomes in unselected patients with previously untreated advanced or recurrent NSCLC. |
| Databáze: | OpenAIRE |
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