Trial reportThe oncologist2025
Efficacy and safety of anamorelin in patients with metastatic urothelial carcinoma receiving systemic chemotherapy: a randomized controlled study.
Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
14 authors.
Funding
Abstract
backgroundCancer cachexia reduces chemotherapy efficacy in patients with metastatic urothelial carcinoma (mUC). Anamorelin improves cancer cachexia by increasing serum insulin-like growth factor 1 (IGF-1). The aim of this study was to evaluate the efficacy and safety of anamorelin in patients with mUC.
methodsA total of 38 patients with mUC who received platinum-based chemotherapy were enrolled in an interventional prospective study. Patients were randomized to anamorelin (Ana; n = 20) or control (n = 18) groups. The primary endpoint was the change in prealbumin. Secondary endpoints were changes in albumin, IGF-1, body weight, skeletal muscle mass index (SMI), interleukin-6 (IL-6) and median overall survival (mOS).
resultsChanges in prealbumin, albumin, body weight, and SMI were similar between groups. Compared to control, serum IGF-1 levels in the anamorelin-treated group were higher after 1 week (P < .05). Changes in IGF-1 and SMI positively correlated in the anamorelin group (R = 0.61, P < .05). When the anamorelin group was divided into 2 groups by the median serum IGF-1 level after 1 week (Ana-IGF-1 high and Ana-IGF-1 low groups), the SMI in the latter group showed a decreased tendency (P = .14). The Ana-IGF-1 low group showed significantly higher IL-6 levels (P < .05) at baseline and significantly shorter mOS compared to the Ana-IGF-1 high group (P < .05). Treatment-related adverse events were comparable between the 2 groups (any grade: 100% vs 100%; grade ≥3: 88.9% vs 90.0%).
conclusionsAnamorelin was well tolerated in patients with mUC. A higher serum IGF-1 level might be associated with anamorelin efficacy; however, a larger study is needed to confirm this.
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