Bortezomib plus docetaxel in advanced non-small cell lung cancer and other solid tumors: a phase I California Cancer Consortium trial
| Autor: | Primo N, Lara, Mariana, Koczywas, David I, Quinn, Heinz Josef, Lenz, Angela M, Davies, Derick H M, Lau, Paul H, Gumerlock, Jeff, Longmate, James H, Doroshow, David, Schenkein, Oscar, Kashala, David R, Gandara |
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| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Radiation-Sensitizing Agents Lung Neoplasms Dose-Response Relationship Drug Drug Administration Routes Antineoplastic Agents Docetaxel Middle Aged Boronic Acids Bortezomib Survival Rate Treatment Outcome Carcinoma Non-Small-Cell Lung Pyrazines Disease Progression Humans Drug Therapy Combination Female Taxoids Aged Follow-Up Studies |
| Zdroj: | Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 1(2) |
| ISSN: | 1556-1380 |
| Popis: | This phase I study was performed to determine the dose-limiting toxicity and maximum tolerated dose (MTD) of docetaxel in combination with bortezomib in patients with advanced non-small cell lung cancer (NSCLC) or other solid tumors.Patients were enrolled in cohorts of three over six dose levels. Each treatment cycle was 3 weeks long and consisted of one docetaxel infusion (day 1) and four bortezomib injections (days 1, 4, 8, and 11). Dose escalation and MTD determination were based on the occurrence of dose-limiting toxicities in cycle 1 only.A total of 36 patients were enrolled, 26 of whom had NSCLC. All patients received at least one dose of study drug at one of five dose levels. The MTD of the combined regimen was determined to be 1.0/75 mg/m bortezomib/docetaxel. The combination was generally well tolerated. Toxicities were manageable, and no additive toxicities were observed. The most common adverse events were fatigue (67% of patients), nausea (50%), diarrhea (39%), and neutropenia (39%). Two patients with NSCLC achieved a partial response, and seven (19%) patients achieved stable disease (including six patients with NSCLC).The combination of bortezomib and docetaxel was feasible and well tolerated in patients with advanced NSCLC or other solid tumors. The recommended phase II dose is bortezomib 1.0 mg/m on days 1, 4, 8, and 11 plus docetaxel 75 mg/m on day 1, cycled every 21 days. Therapeutic doses of docetaxel and bortezomib are achievable for this combination. |
| Databáze: | OpenAIRE |
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