دورية أكاديمية
A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas.
| العنوان: | A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas. |
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| المؤلفون: | Jones, RL, Chawla, SP, Attia, S, Schöffski, P, Gelderblom, H, Chmielowski, B, Le Cesne, A, Van Tine, BA, Trent, JC, Patel, S, Wagner, AJ, Chugh, R, Heyburn, JW, Weil, SC, Wang, W, Viele, K, Maki, RG |
| المساهمون: | Jones, Robin |
| بيانات النشر: | WILEY |
| سنة النشر: | 2022 |
| المجموعة: | The Institute of Cancer Research (ICR): Publications Repository |
| مصطلحات موضوعية: | MORAb-004, endosialin, ontuxizumab, sarcomas, tumor endothelial marker 1 (TEM-1), Adult, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antigens, CD, Neoplasm, Antimetabolites, Antineoplastic, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Cohort Studies, Deoxycytidine, Docetaxel, Double-Blind Method, Female, Humans, Male, Middle Aged, Progression-Free Survival, Sarcoma, Young Adult |
| جغرافية الموضوع: | United States |
| الوصف: | BACKGROUND: Ontuxizumab, a humanized monoclonal antibody, targets endosialin (tumor endothelial marker 1 [TEM-1] or CD248), which is expressed on sarcoma cells and is believed to be involved in tumor angiogenesis. This is the first trial to evaluate ontuxizumab in patients with sarcoma. METHODS: Part 1 was an open-label, dose-finding, safety lead-in: 4, 6, or 8 mg/kg with gemcitabine and docetaxel (G/D; 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8). In part 2, patients were randomized in a double-blind fashion in 2:1 ratio to ontuxizumab (8 mg/kg) or a placebo with G/D. Randomization was stratified by 4 histological cohorts. RESULTS: In part 2 with 209 patients, no significant difference in progression-free survival between ontuxizumab plus G/D (4.3 months; 95% confidence interval [CI], 2.7-6.3 months) and the placebo plus G/D (5.6 months; 95% CI, 2.6-8.3 months) was observed (P = .67; hazard ratio [HR], 1.07; 95% CI, 0.77-1.49). Similarly, there was no significant difference in median overall survival between the 2 groups: 18.3 months for the ontuxizumab plus G/D group (95% CI, 16.2-21.1 months) and 21.1 months for the placebo plus G/D group (95% CI, 14.2 months to not reached; P = .32; HR, 1.23; 95% CI, 0.82-1.82). No significant differences between the treatment groups occurred for any efficacy parameter by sarcoma cohort. The combination of ontuxizumab plus G/D was generally well tolerated. CONCLUSIONS: Ontuxizumab plus G/D showed no enhanced activity over chemotherapy alone in soft-tissue sarcomas, whereas the safety profile of the combination was consistent with G/D alone. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | Print-Electronic; 2454; application/pdf |
| اللغة: | English |
| تدمد: | 0008-543X 1097-0142 |
| العلاقة: | Cancer, 2019, 125 (14), pp. 2445 - 2454; https://repository.icr.ac.uk/handle/internal/5394Test |
| DOI: | 10.1002/cncr.32084 |
| الإتاحة: | https://doi.org/10.1002/cncr.32084Test https://repository.icr.ac.uk/handle/internal/5394Test |
| حقوق: | https://creativecommons.org/licenses/by-nc-nd/4.0Test/ |
| رقم الانضمام: | edsbas.EFCF0F36 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 0008543X 10970142 |
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| DOI: | 10.1002/cncr.32084 |