Academic Journal
Docetaxel with or without Ramucirumab after Platinum-Based Chemotherapy and Checkpoint Inhibitors in Advanced Urothelial Carcinoma: A Pre-Specified Subgroup Analysis from the Phase 3 RANGE Trial
| العنوان: | Docetaxel with or without Ramucirumab after Platinum-Based Chemotherapy and Checkpoint Inhibitors in Advanced Urothelial Carcinoma: A Pre-Specified Subgroup Analysis from the Phase 3 RANGE Trial |
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| المؤلفون: | Drakaki A., Kirby C. J., Van Der Heijden M. S., Petrylak D. P., Powles T., Chi K. N., Flechon A., Necchi A., Geczi L., Lee J. -L., Gakis G., Bracarda S., Chowdhury S., Lin C. -C., Keizman D., Vaishampayan U. N., Zimmermann A. H., Bell-Mcguinn K., Castellano D. |
| المساهمون: | Drakaki, A., Kirby, C. J., Van Der Heijden, M. S., Petrylak, D. P., Powles, T., Chi, K. N., Flechon, A., Necchi, A., Geczi, L., Lee, J. -L., Gakis, G., Bracarda, S., Chowdhury, S., Lin, C. -C., Keizman, D., Vaishampayan, U. N., Zimmermann, A. H., Bell-Mcguinn, K., Castellano, D. |
| بيانات النشر: | IOS Press |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Immune checkpoint inhibitor, platinum-refractory, ramucirumab, urothelial carcinoma, VEGFR inhibitor |
| الوصف: | BACKGROUND: The phase 3 RANGE trial found ramucirumab/docetaxel improved progression-free survival (PFS) versus placebo/docetaxel (median 4.1 vs 2.8 months; hazard ratio [HR]=0.757, p=0.0118) for treatment of platinum-refractory metastatic urothelial carcinoma (UC). Some patients received an immune checkpoint inhibitor (ICI) prior to RANGE. In other studies, unselected patients with platinum-refractory UC exhibited an overall response rate (ORR) of 15-31% to ICIs. OBJECTIVE: Efficacy and safety data from the subgroup of patients treated with prior ICI were examined using prespecified analyses to compare outcomes between RANGE treatment arms. METHODS: Randomized, double-blind RANGE study (n=530) took place July 2015-April 2017 in 23 countries. Forty-five patients (8.5%) received prior ICI. PFS was evaluated using the Kaplan-Meier method and unstratified Cox proportional hazards model. RESULTS: 17 ramucirumab/docetaxel arm, 28 placebo/docetaxel arm patients were treated with an ICI. The prior-ICI ramucirumab subgroup had worse Bellmunt scores at baseline versus placebo (score of 2-3:70.6% vs 25%, respectively). Most patients (84.4%) received the ICI immediately following platinum and immediately prior to RANGE. ORR to prior ICI was 6.7% Responses were achieved by 5/17 (29.4%) on ramucirumab/docetaxel, compared to 2/28 (7.1%) on placebo/docetaxel. Median PFS was 3.15 months on ramucirumab/docetaxel versus 2.73 months on placebo/docetaxel (HR=0.786, 95% CI=0.404-1.528, p=0.4877). The frequency of grade≥3 adverse events was similar between arms. Limitations include sample size and treatment setting of the analyzed population. CONCLUSIONS: Ramucirumab/docetaxel may provide a clinical benefit with acceptable safety in the third-line setting for metastatic UC patients whose disease has progressed on both prior platinum chemotherapy and ICI therapy. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/wos/WOS:000523301600005; volume:6; issue:1; firstpage:43; lastpage:52; numberofpages:10; journal:BLADDER CANCER; http://hdl.handle.net/20.500.11768/118346 |
| DOI: | 10.3233/BLC-190252 |
| الاتاحة: | https://hdl.handle.net/20.500.11768/118346 https://doi.org/10.3233/BLC-190252 |
| رقم الانضمام: | edsbas.4C37C306 |
| قاعدة البيانات: | BASE |
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