Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study)
- Authors
- Kim, Sung-Bae; Seo, Jae Hong; Ahn, Jin-Hee; Kim, Tae-Yong; Kang, Seok Yun; Sohn, Joohyuk; Yang, Yaewon; Park, Kyong Hwa; Moon, Yong Wha; Lim, Seungtaek; Kang, Myoung Joo; Yoon, Koung Eun; Cho, Hyun Ju; Lee, Keun Seok
- Issue Date
- 12월-2021
- Publisher
- SAGE PUBLICATIONS LTD
- Keywords
- DHP107; HER2-negative; first-line; metastatic breast cancer; oral paclitaxel
- Citation
- THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY, v.13
- Indexed
- SCIE
SCOPUS
- Journal Title
- THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY
- Volume
- 13
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/135647
- DOI
- 10.1177/17588359211061989
- ISSN
- 1758-8340
- Abstract
- Background: Standard intravenous (IV) paclitaxel is associated with hypersensitivity/toxicity. Alternative IV formulations have improved tolerability but still require frequent hospital visits and IV infusion. DHP107 is a novel oral formulation of paclitaxel that is approved in South Korea for the treatment of gastric cancer. Methods: This multicenter, phase II study using a Simon's two-stage design investigated the efficacy and safety of DHP107 200 mg/m(2) administered orally twice daily on days 1, 8, and 15 every 4 weeks for the first-line treatment of recurrent or metastatic HER2-negative breast cancer. Results: Thirty-six patients were enrolled and 31 were assessable for efficacy. Patient median age was 57 years (range = 34-81) and 11 (31%) had triple-negative disease. A median of seven cycles (range = 1-28) of DHP107 was administered. Objective response rate was 55% (17 patients), all partial responses, according to the investigator's decision and independent central review (ICR), and 44% (4/9 patients) in those with triple-negative disease. Disease control rate (partial response and stable disease) was 74% (23 patients) according to the investigator's decision and ICR. In the intention-to-treat (ITT) population of all enrolled participants, the objective response rate was 50% (18/36 patients). Median progression-free survival was 8.9 months [95% confidence interval [CI]: 5.2-12.3) and median time to treatment failure was 8.0 months (95% CI: 4.2-10.0). DHP107 had an acceptable toxicity profile. All patients experienced treatment-emergent adverse events; the most common adverse events were decreased neutrophil count (81% all grades and 78% grade > 3) followed by peripheral sensory neuropathy (61% all grades and 8% grade 3). However, there was no febrile neutropenia or sepsis. Conclusion: DHP107 showed promising efficacy and acceptable tolerability in this phase II study and is currently being investigated in the OPTIMAL phase III study (NCT03315364).
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