Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study)
DC Field | Value | Language |
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dc.contributor.author | Kim, Sung-Bae | - |
dc.contributor.author | Seo, Jae Hong | - |
dc.contributor.author | Ahn, Jin-Hee | - |
dc.contributor.author | Kim, Tae-Yong | - |
dc.contributor.author | Kang, Seok Yun | - |
dc.contributor.author | Sohn, Joohyuk | - |
dc.contributor.author | Yang, Yaewon | - |
dc.contributor.author | Park, Kyong Hwa | - |
dc.contributor.author | Moon, Yong Wha | - |
dc.contributor.author | Lim, Seungtaek | - |
dc.contributor.author | Kang, Myoung Joo | - |
dc.contributor.author | Yoon, Koung Eun | - |
dc.contributor.author | Cho, Hyun Ju | - |
dc.contributor.author | Lee, Keun Seok | - |
dc.date.accessioned | 2022-02-13T17:40:53Z | - |
dc.date.available | 2022-02-13T17:40:53Z | - |
dc.date.created | 2022-01-19 | - |
dc.date.issued | 2021-12 | - |
dc.identifier.issn | 1758-8340 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/135647 | - |
dc.description.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). | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | SAGE PUBLICATIONS LTD | - |
dc.subject | NAB-PACLITAXEL | - |
dc.subject | CREMOPHOR EL | - |
dc.title | Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study) | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Seo, Jae Hong | - |
dc.contributor.affiliatedAuthor | Park, Kyong Hwa | - |
dc.identifier.doi | 10.1177/17588359211061989 | - |
dc.identifier.scopusid | 2-s2.0-85121332636 | - |
dc.identifier.wosid | 000730612700002 | - |
dc.identifier.bibliographicCitation | THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY, v.13 | - |
dc.relation.isPartOf | THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY | - |
dc.citation.title | THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY | - |
dc.citation.volume | 13 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordPlus | CREMOPHOR EL | - |
dc.subject.keywordPlus | NAB-PACLITAXEL | - |
dc.subject.keywordAuthor | DHP107 | - |
dc.subject.keywordAuthor | HER2-negative | - |
dc.subject.keywordAuthor | first-line | - |
dc.subject.keywordAuthor | metastatic breast cancer | - |
dc.subject.keywordAuthor | oral paclitaxel | - |
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