Efficacy and safety findings from DREAM: a phase III study of DHP107 (oral paclitaxel) versus i.v. paclitaxel in patients with advanced gastric cancer after failure of first-line chemotherapy
DC Field | Value | Language |
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dc.contributor.author | Kang, Y-K | - |
dc.contributor.author | Ryu, M-H | - |
dc.contributor.author | Park, S. H. | - |
dc.contributor.author | Kim, J. G. | - |
dc.contributor.author | Kim, J. W. | - |
dc.contributor.author | Cho, S-H | - |
dc.contributor.author | Park, Y-, I | - |
dc.contributor.author | Park, S. R. | - |
dc.contributor.author | Rha, S. Y. | - |
dc.contributor.author | Kang, M. J. | - |
dc.contributor.author | Cho, J. Y. | - |
dc.contributor.author | Kang, S. Y. | - |
dc.contributor.author | Roh, S. Y. | - |
dc.contributor.author | Ryoo, B-Y | - |
dc.contributor.author | Nam, B-H | - |
dc.contributor.author | Jo, Y-W | - |
dc.contributor.author | Yoon, K-E | - |
dc.contributor.author | Oh, S. C. | - |
dc.date.accessioned | 2021-09-02T12:27:18Z | - |
dc.date.available | 2021-09-02T12:27:18Z | - |
dc.date.created | 2021-06-18 | - |
dc.date.issued | 2018-05 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/76024 | - |
dc.description.abstract | Background: Paclitaxel is currently only available as an intravenous (i.v.) formulation. DHP107 is a novel oral formulation of lipid ingredients and paclitaxel. DHP107 demonstrated comparable efficacy, safety, and pharmacokinetics to i.v. paclitaxel as a secondline therapy in patients with advanced gastric cancer (AGC). DREAM is a multicenter, open-label, prospective, randomized phase III study of patients with histologically/cytologically confirmed, unresectable/recurrent AGC after first-line therapy failure. Methods and materials: Patients were randomized 1 : 1 to DHP107 (200 mg/m(2) orally twice daily days 1, 8, 15 every 4 weeks) or i.v. paclitaxel (175 mg/m(2) day 1 every 3 weeks). Patients were stratified by Eastern Cooperative Oncology Group performance status, disease status, and prior treatment; response was assessed (Response Evaluation Criteria in Solid Tumors) every 6 weeks. Primary end point: non-inferiority of progression-free survival (PFS); secondary end points: overall response rate (ORR), overall survival (OS), and safety. For the efficacy analysis, sequential tests for non-inferiority were carried out, first with a non-inferiority margin of 1.48, then with a margin of 1.25. Results: Baseline characteristics were balanced in the 236 randomized patients (n = 118 per arm). Median PFS (per-protocol) was 3.0 (95% CI 1.7-4.0) months for DHP107 and 2.6 (95% CI 1.8-2.8) months for paclitaxel (hazard ratio [HR] = 0.85; 95% CI 0.64 1.13). A sensitivity analysis on PFS using independent central review showed similar results (HR = 0.93; 95% CI 0.70-1.24). Median OS (full analysis set) was 9.7 (95% CI 7.1 - 11.5) months for DHP107 versus 8.9 (95% CI 7.1-12.2) months for paclitaxel (HR = 1.04; 95% CI 0.76-1.41). ORR was 17.8% for DHP107 (CR 4.2%; PR 13.6%) versus 25.4% for paclitaxel (CR 3.4%; PR 22.0%). Nausea, vomiting, diarrhea, and mucositis were more common with DHP107; peripheral neuropathy was more common with paclitaxel. There were only few Grade >= 3 adverse events, most commonly neutropenia (42% versus 53%); febrile neutropenia was reported infrequently (5.9% versus 2.5%). No hypersensitivity reactions occurred with DHP107 (paclitaxel 2.5%). Conclusions: DHP107 as a second-line treatment of AGC was non-inferior to paclitaxel for PFS; other efficacy and safety parameters were comparable. DHP107 is the first oral paclitaxel with proven efficacy/safety for the treatment of AGC. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | OXFORD UNIV PRESS | - |
dc.subject | ADVANCED SOLID TUMORS | - |
dc.subject | P-GLYCOPROTEIN | - |
dc.subject | FORMULATION | - |
dc.subject | TAXOL | - |
dc.subject | METABOLISM | - |
dc.subject | COMBINATION | - |
dc.subject | TRIAL | - |
dc.title | Efficacy and safety findings from DREAM: a phase III study of DHP107 (oral paclitaxel) versus i.v. paclitaxel in patients with advanced gastric cancer after failure of first-line chemotherapy | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Oh, S. C. | - |
dc.identifier.doi | 10.1093/annonc/mdy055 | - |
dc.identifier.scopusid | 2-s2.0-85047626260 | - |
dc.identifier.wosid | 000432668100022 | - |
dc.identifier.bibliographicCitation | ANNALS OF ONCOLOGY, v.29, no.5, pp.1220 - 1226 | - |
dc.relation.isPartOf | ANNALS OF ONCOLOGY | - |
dc.citation.title | ANNALS OF ONCOLOGY | - |
dc.citation.volume | 29 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 1220 | - |
dc.citation.endPage | 1226 | - |
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 | ADVANCED SOLID TUMORS | - |
dc.subject.keywordPlus | P-GLYCOPROTEIN | - |
dc.subject.keywordPlus | FORMULATION | - |
dc.subject.keywordPlus | TAXOL | - |
dc.subject.keywordPlus | METABOLISM | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordAuthor | oral paclitaxel | - |
dc.subject.keywordAuthor | DHP107 | - |
dc.subject.keywordAuthor | gastric cancer | - |
dc.subject.keywordAuthor | progression free survival | - |
dc.subject.keywordAuthor | non-inferiority | - |
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