Phase I clinical trial to assess safety and efficacy of Oraxol, a novel oral paclitaxel chemotherapy agent, in patients with previously treated metastatic breast cancer
Abstract Oraxol, a novel oral paclitaxel chemotherapy agent, has emerged as a potential alternative for treating metastatic breast cancer (MBC). However, its safety and efficacy remain uncertain due to insufficient evidence supporting it. This open‐label, single‐arm, phase I trial was designed to as...
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2025-03-01
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| Online Access: | https://doi.org/10.1002/mco2.70097 |
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| author | Yunfang Yu Ying Wang Luhui Mao Suiwen Ye Xiuping Lai Junyi Chen Yiwen Zhang Jieqiong Liu Junyan Wu Tao Qin Herui Yao |
| author_facet | Yunfang Yu Ying Wang Luhui Mao Suiwen Ye Xiuping Lai Junyi Chen Yiwen Zhang Jieqiong Liu Junyan Wu Tao Qin Herui Yao |
| author_sort | Yunfang Yu |
| collection | DOAJ |
| description | Abstract Oraxol, a novel oral paclitaxel chemotherapy agent, has emerged as a potential alternative for treating metastatic breast cancer (MBC). However, its safety and efficacy remain uncertain due to insufficient evidence supporting it. This open‐label, single‐arm, phase I trial was designed to assess the pharmacokinetics, safety, and preliminary antitumor activity of Oraxol in previously treated MBC. The primary objective was to investigate the pharmacokinetics of Oraxol, while secondary endpoints included assessing safety, tolerability, and antitumor activity. Twenty‐four patients (median age, 53 years) were enrolled, and pharmacokinetic analysis showed consistent and reproducible absorption of Oraxol. Note that 96% patients experienced treatment‐related adverse events (TRAEs) and no deaths attributed to TRAEs. The overall response rate was 34.8%, including 34.8% achieving partial response and 56.5% having stable disease. The median follow‐up was 45.7 months, with median progression‐free survival (PFS) of 3.41 months and median overall survival of 17.80 months. Notably, among patients with triple‐negative breast cancer, the disease control rate was 100%, and the median PFS was 8.90 months, which notably exceeded the outcomes observed in other subtypes. Oraxol significantly alters metabolism and correlates with response and survival. In conclusion, Oraxol exhibited promising antitumor efficacy and manageable safety profiles in MBC patients. |
| format | Article |
| id | doaj-art-4de2ce7fe46648679610c766c2c7b079 |
| institution | Kabale University |
| issn | 2688-2663 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | MedComm |
| spelling | doaj-art-4de2ce7fe46648679610c766c2c7b0792025-08-20T03:40:28ZengWileyMedComm2688-26632025-03-0163n/an/a10.1002/mco2.70097Phase I clinical trial to assess safety and efficacy of Oraxol, a novel oral paclitaxel chemotherapy agent, in patients with previously treated metastatic breast cancerYunfang Yu0Ying Wang1Luhui Mao2Suiwen Ye3Xiuping Lai4Junyi Chen5Yiwen Zhang6Jieqiong Liu7Junyan Wu8Tao Qin9Herui Yao10Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangdong‐Hong Kong Joint Laboratory for RNA Medicine, Phase I Clinical Trial Centre, Department of Medical Oncology Breast Tumor Centre, Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University Guangzhou ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangdong‐Hong Kong Joint Laboratory for RNA Medicine, Phase I Clinical Trial Centre, Department of Medical Oncology Breast Tumor Centre, Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University Guangzhou ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangdong‐Hong Kong Joint Laboratory for RNA Medicine, Phase I Clinical Trial Centre, Department of Medical Oncology Breast Tumor Centre, Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University Guangzhou ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangdong‐Hong Kong Joint Laboratory for RNA Medicine, Phase I Clinical Trial Centre, Department of Medical Oncology Breast Tumor Centre, Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University Guangzhou ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangdong‐Hong Kong Joint Laboratory for RNA Medicine, Phase I Clinical Trial Centre, Department of Medical Oncology Breast Tumor Centre, Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University Guangzhou ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangdong‐Hong Kong Joint Laboratory for RNA Medicine, Phase I Clinical Trial Centre, Department of Medical Oncology Breast Tumor Centre, Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University Guangzhou ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangdong‐Hong Kong Joint Laboratory for RNA Medicine, Phase I Clinical Trial Centre, Department of Medical Oncology Breast Tumor Centre, Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University Guangzhou ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangdong‐Hong Kong Joint Laboratory for RNA Medicine, Phase I Clinical Trial Centre, Department of Medical Oncology Breast Tumor Centre, Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University Guangzhou ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangdong‐Hong Kong Joint Laboratory for RNA Medicine, Phase I Clinical Trial Centre, Department of Medical Oncology Breast Tumor Centre, Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University Guangzhou ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangdong‐Hong Kong Joint Laboratory for RNA Medicine, Phase I Clinical Trial Centre, Department of Medical Oncology Breast Tumor Centre, Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University Guangzhou ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangdong‐Hong Kong Joint Laboratory for RNA Medicine, Phase I Clinical Trial Centre, Department of Medical Oncology Breast Tumor Centre, Sun Yat‐sen Memorial Hospital, Sun Yat‐sen University Guangzhou ChinaAbstract Oraxol, a novel oral paclitaxel chemotherapy agent, has emerged as a potential alternative for treating metastatic breast cancer (MBC). However, its safety and efficacy remain uncertain due to insufficient evidence supporting it. This open‐label, single‐arm, phase I trial was designed to assess the pharmacokinetics, safety, and preliminary antitumor activity of Oraxol in previously treated MBC. The primary objective was to investigate the pharmacokinetics of Oraxol, while secondary endpoints included assessing safety, tolerability, and antitumor activity. Twenty‐four patients (median age, 53 years) were enrolled, and pharmacokinetic analysis showed consistent and reproducible absorption of Oraxol. Note that 96% patients experienced treatment‐related adverse events (TRAEs) and no deaths attributed to TRAEs. The overall response rate was 34.8%, including 34.8% achieving partial response and 56.5% having stable disease. The median follow‐up was 45.7 months, with median progression‐free survival (PFS) of 3.41 months and median overall survival of 17.80 months. Notably, among patients with triple‐negative breast cancer, the disease control rate was 100%, and the median PFS was 8.90 months, which notably exceeded the outcomes observed in other subtypes. Oraxol significantly alters metabolism and correlates with response and survival. In conclusion, Oraxol exhibited promising antitumor efficacy and manageable safety profiles in MBC patients.https://doi.org/10.1002/mco2.70097efficacymetastatic breast canceroraxolphase I clinical trialsafety |
| spellingShingle | Yunfang Yu Ying Wang Luhui Mao Suiwen Ye Xiuping Lai Junyi Chen Yiwen Zhang Jieqiong Liu Junyan Wu Tao Qin Herui Yao Phase I clinical trial to assess safety and efficacy of Oraxol, a novel oral paclitaxel chemotherapy agent, in patients with previously treated metastatic breast cancer MedComm efficacy metastatic breast cancer oraxol phase I clinical trial safety |
| title | Phase I clinical trial to assess safety and efficacy of Oraxol, a novel oral paclitaxel chemotherapy agent, in patients with previously treated metastatic breast cancer |
| title_full | Phase I clinical trial to assess safety and efficacy of Oraxol, a novel oral paclitaxel chemotherapy agent, in patients with previously treated metastatic breast cancer |
| title_fullStr | Phase I clinical trial to assess safety and efficacy of Oraxol, a novel oral paclitaxel chemotherapy agent, in patients with previously treated metastatic breast cancer |
| title_full_unstemmed | Phase I clinical trial to assess safety and efficacy of Oraxol, a novel oral paclitaxel chemotherapy agent, in patients with previously treated metastatic breast cancer |
| title_short | Phase I clinical trial to assess safety and efficacy of Oraxol, a novel oral paclitaxel chemotherapy agent, in patients with previously treated metastatic breast cancer |
| title_sort | phase i clinical trial to assess safety and efficacy of oraxol a novel oral paclitaxel chemotherapy agent in patients with previously treated metastatic breast cancer |
| topic | efficacy metastatic breast cancer oraxol phase I clinical trial safety |
| url | https://doi.org/10.1002/mco2.70097 |
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