ArticleDiscover oncology2024
Safety and efficacy of generic nab-paclitaxel-based therapy in Chinese patients with malignant tumors in a real-world setting: a multicenter prospective observational study.
Article in Discover oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04060290 (Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors), which is not on this 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.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study aimed to assess the safety and efficacy of generic nab-paclitaxel in the Chinese population in a real-world setting.
methodsThis prospective, multicenter, observational study enrolled patients with malignancies who received any generic nab-paclitaxel-based regimens in China. The primary endpoint was safety, and secondary endpoint was objective response rate (ORR). Logistic regression was used to explore risk factors for adverse events (AEs) of special interest (AESIs).
resultsBetween September 2019 and April 2023, 1168 patients were enrolled and evaluated for safety, and 602 were assessed for tumor response. Of 1168 patients, 169 (14.5%) received generic nab-paclitaxel monotherapy, and 999 (85.5%) received generic nab-paclitaxel-based combination therapy. Grade 3-4 AEs occurred in 19.3% (225/1168) patients, most commonly including neutrophil count decreased (7.6%), anemia (5.8%), and white blood cell decreased (5.7%). In subgroup analysis, peripheral sensory neuropathy was observed frequently in breast cancer (45.6%). Multivariate analysis showed that patients receiving combination therapy and ≥ 4 treatment cycles (OR, 1.925; 95% CI 1.363-2.719; p < 0.001) were more susceptible to the AESIs.
conclusionsThis study demonstrates a promising safety and efficacy of generic nab-paclitaxel-based regimens for Chinese patients with malignancies in a real-world setting, providing valuable insights for clinical decision-making. CLINICAL TRIALS: gov NCT04060290.
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