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
Abstract Objective This study aimed to assess the safety and efficacy of generic nab-paclitaxel in the Chinese population in a real-world setting. Methods This prospective, multicenter, observational study enrolled patients with malignancies who received any generic nab-paclitaxel-based regimens in...
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| Format: | Article |
| Language: | English |
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Springer
2024-11-01
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| Series: | Discover Oncology |
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| Online Access: | https://doi.org/10.1007/s12672-024-01609-6 |
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| author | Fei He Yancai Sun Wenzhou Zhang Qiongshi Wu Donghang Xu Zaixian Bai Zhiying Hao Weiyi Feng Kanghuai Zhang Jiang Liu Mei Dong Guangxuan Liu Guohui Li |
| author_facet | Fei He Yancai Sun Wenzhou Zhang Qiongshi Wu Donghang Xu Zaixian Bai Zhiying Hao Weiyi Feng Kanghuai Zhang Jiang Liu Mei Dong Guangxuan Liu Guohui Li |
| author_sort | Fei He |
| collection | DOAJ |
| description | Abstract Objective This study aimed to assess the safety and efficacy of generic nab-paclitaxel in the Chinese population in a real-world setting. Methods This 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). Results Between 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. Conclusions This 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 |
| format | Article |
| id | doaj-art-f32a9da5a0fc44ef8becfcf6b50fc057 |
| institution | DOAJ |
| issn | 2730-6011 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Springer |
| record_format | Article |
| series | Discover Oncology |
| spelling | doaj-art-f32a9da5a0fc44ef8becfcf6b50fc0572025-08-20T02:49:09ZengSpringerDiscover Oncology2730-60112024-11-0115111210.1007/s12672-024-01609-6Safety and efficacy of generic nab-paclitaxel-based therapy in Chinese patients with malignant tumors in a real-world setting: a multicenter prospective observational studyFei He0Yancai Sun1Wenzhou Zhang2Qiongshi Wu3Donghang Xu4Zaixian Bai5Zhiying Hao6Weiyi Feng7Kanghuai Zhang8Jiang Liu9Mei Dong10Guangxuan Liu11Guohui Li12Department of Pharmacy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeDepartment of Pharmacy, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of ChinaDepartment of Pharmacy, The Affiliated Cancer Hospital of Zhengzhou UniversityFaculty of Pharmacy, Hainan Provincial People’s HospitalDepartment of Pharmacy, Second Affiliated Hospital, Zhejiang University School of MedicineDepartment of Pharmacy, Inner Mongolia Medical University Cancer HospitalDepartment of Pharmacy, Shanxi Province Cancer Hospital/Shanxi Hospital Affliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affliated to Shanxi Medical UniversityDepartment of Pharmacy, The First Affiliated Hospital of Xi’an Jiao Tong UniversityDepartment of Pharmacy, The Second Affiliated Hospital of Xi’an Jiao Tong UniversityDepartment of Pharmacy, The Fourth Hospital of Hebei Medical UniversityDepartment of Pharmacy, Harbin Medical University Cancer HospitalDepartment of Pharmacy, Liaoning Cancer Hospital & InstituteDepartment of Pharmacy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeAbstract Objective This study aimed to assess the safety and efficacy of generic nab-paclitaxel in the Chinese population in a real-world setting. Methods This 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). Results Between 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. Conclusions This 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 NCT04060290https://doi.org/10.1007/s12672-024-01609-6Generic Nab-paclitaxelChinese populationMalignant tumorsReal-world studySafetyEfficacy |
| spellingShingle | Fei He Yancai Sun Wenzhou Zhang Qiongshi Wu Donghang Xu Zaixian Bai Zhiying Hao Weiyi Feng Kanghuai Zhang Jiang Liu Mei Dong Guangxuan Liu Guohui Li 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 Discover Oncology Generic Nab-paclitaxel Chinese population Malignant tumors Real-world study Safety Efficacy |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Generic Nab-paclitaxel Chinese population Malignant tumors Real-world study Safety Efficacy |
| url | https://doi.org/10.1007/s12672-024-01609-6 |
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