OPTIMAL: a multinational phase III study of oral paclitaxel (DHP107) versus intravenous weekly paclitaxel in HER2-negative recurrent or metastatic breast cancer

IF 80.4 1区医学 Q1 ONCOLOGY

Annals of Oncology Pub Date : 2026-07-01 Epub Date: 2026-03-14 DOI:10.1016/j.annonc.2026.03.002

B. Xu, H. Jeong, T. Sun, J. Sohn, Q. Zhang, S. Kostic, X. Wang, Z. Tong, S. Wang, J. Wang, W. Li, K.S. Lee, Y.W. Moon, M.J. Kang, X. Hu, T.Y. Kim, D. Milenković, J.H. Seo, J.H. Kim, J. Lee, S.-B. Kim

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引用次数: 0

Abstract

Background

Intravenous (i.v.) paclitaxel (Taxol) requires prolonged infusion and is associated with hypersensitivity reactions and peripheral neuropathy. This study evaluated the efficacy and safety of DHP107, a novel oral formulation of paclitaxel, compared with i.v. paclitaxel in patients with HER2-negative, recurrent, or metastatic breast cancer.

Patients and methods

This multinational, multicenter, open-label, randomized phase III trial evaluated the noninferiority of DHP107 compared with i.v. paclitaxel, with a predefined noninferiority margin of 1.33. Eligible patients had recurrent or metastatic breast cancer and had received no prior chemotherapy in the metastatic setting. Patients were randomly assigned to receive either DHP107 (200 mg/m² orally twice daily on days 1, 8, and 15) or paclitaxel (80 mg/m² i.v. on days 1, 8, and 15) in a 28-day cycle. The primary endpoint was investigator-assessed progression-free survival (PFS) in the per-protocol set (PPS). Secondary endpoints included independent central review-assessed PFS, overall survival (OS), tumor response, quality of life, and safety.

Results

Between January 2018 and December 2023, 549 patients were randomly assigned to receive either DHP107 (n = 277) or paclitaxel (n = 272); 519 patients were included in the PPS. DHP107 demonstrated noninferiority in PFS with a median PFS of 10.0 months compared with 8.5 months for paclitaxel (hazard ratio [HR] 0.869; 95% confidence interval [CI] 0.707-1.068). The median OS was 32.6 months for DHP107 and 31.8 months for paclitaxel (HR 0.967, 95% CI 0.762-1.227). DHP107 was associated with higher rates of neutropenia, febrile neutropenia, nausea, diarrhea, and vomiting, whereas peripheral neuropathy and hypersensitivity reactions were more common with paclitaxel. No treatment-related death occurred in the DHP107 group, and one (0.4%) in the paclitaxel group. Quality of life was comparable between the two groups.

Conclusions

DHP107 demonstrated noninferior efficacy compared with i.v. paclitaxel, with a manageable safety profile, supporting its use as an effective and convenient alternative in HER2-negative breast cancer.

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一项多国III期研究：口服紫杉醇（DHP107）与每周静脉注射紫杉醇治疗her2阴性复发或转移性乳腺癌。

背景：静脉（IV）紫杉醇需要长时间输注，并与过敏反应和周围神经病变相关。该研究评估了DHP107（一种新型口服紫杉醇制剂）在her2阴性、复发性或转移性乳腺癌患者中的疗效和安全性，并与IV紫杉醇进行了比较。患者和方法：这项多国、多中心、开放标签、随机III期试验评估了DHP107与IV紫杉醇相比的非劣效性，预定的非劣效边际为1.33。符合条件的患者患有复发性或转移性乳腺癌，并且之前没有接受过转移性化疗。患者随机接受DHP107 （200mg /m2口服，第1、8和15天，每天两次）或紫杉醇（80mg /m2静脉注射，第1、8和15天），疗程28天。主要终点是每个方案集（PPS）中研究者评估的无进展生存期（PFS）。次要终点包括独立中心评价的PFS、总生存期（OS）、肿瘤反应、生活质量（QoL）和安全性。结果：2018年1月至2023年12月，549例患者随机接受DHP107 （n=277）或紫杉醇（n=272）治疗；519例患者纳入PPS。DHP107在PFS方面表现出非劣效性，中位PFS为10.0个月，而紫杉醇的中位PFS为8.5个月（风险比[HR]， 0.869； 95%可信区间[CI]， 0.707-1.068）。DHP107的中位OS为32.6个月，紫杉醇的中位OS为31.8个月（HR 0.967; 95% CI, 0.762-1.227）。DHP107与中性粒细胞减少、发热性中性粒细胞减少、恶心、腹泻和呕吐的发生率较高相关，而周围神经病变和超敏反应在紫杉醇中更为常见。DHP107组无治疗相关死亡，紫杉醇组1例（0.4%）。两组患者的生活质量相当。结论：与IV紫杉醇相比，DHP107的疗效不逊于IV紫杉醇，具有可管理的安全性，支持其作为her2阴性乳腺癌的有效和方便的替代方案。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of Oncology 医学-肿瘤学

CiteScore

63.90

自引率

1.00%

发文量

3712

审稿时长

2-3 weeks

期刊介绍： Annals of Oncology, the official journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology, offers rapid and efficient peer-reviewed publications on innovative cancer treatments and translational research in oncology and precision medicine. The journal primarily focuses on areas such as systemic anticancer therapy, with a specific emphasis on molecular targeted agents and new immune therapies. We also welcome randomized trials, including negative results, as well as top-level guidelines. Additionally, we encourage submissions in emerging fields that are crucial to personalized medicine, such as molecular pathology, bioinformatics, modern statistics, and biotechnologies. Manuscripts related to radiotherapy, surgery, and pediatrics will be considered if they demonstrate a clear interaction with any of the aforementioned fields or if they present groundbreaking findings. Our international editorial board comprises renowned experts who are leaders in their respective fields. Through Annals of Oncology, we strive to provide the most effective communication on the dynamic and ever-evolving global oncology landscape.