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A Phase II Trial to Evaluate the Efficacy of Bortezomib and Liposomal Doxorubicin in Patients With BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer (KGOG 3044/EBLIN)
DC Field | Value | Language |
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dc.contributor.author | Lee, Yong Jae | - |
dc.contributor.author | Seol, Aeran | - |
dc.contributor.author | Lee, Maria | - |
dc.contributor.author | Kim, Jae-Weon | - |
dc.contributor.author | Kim, Hee Seung | - |
dc.contributor.author | Kim, Kidong | - |
dc.contributor.author | Suh, Dong Hoon | - |
dc.contributor.author | Kim, Sunghoon | - |
dc.contributor.author | Kim, Sang Wun | - |
dc.contributor.author | Lee, Jung-Yun | - |
dc.date.accessioned | 2022-09-29T03:18:05Z | - |
dc.date.available | 2022-09-29T03:18:05Z | - |
dc.date.created | 2022-07-11 | - |
dc.date.issued | 2022-07 | - |
dc.identifier.citation | In Vivo, Vol.36 No.4, pp.1949-1958 | - |
dc.identifier.issn | 0258-851X | - |
dc.identifier.uri | https://hdl.handle.net/10371/184619 | - |
dc.description.abstract | Background/Aim: The majority of targeted therapies are focused on BRCA mutations, homologous recombination repair deficiency, and BRCA wild-type platinum-sensitive recurrent ovarian cancer. There is a growing need for platinumresistant patients without BRCA mutations. Herein, we conducted a phase II multicenter study evaluated the efficacy and safety of bortezomib plus pegylated liposomal doxorubicin (PLD) in patients with BRCA wild-type platinum-resistant recurrent ovarian cancer (NCT03509246). Patients and Methods: Ovarian cancer patients with wild-type BRCA who experienced platinum-resistant recurrence after three or less prior treatment cycles from three Institutions were included. All patients received bortezomib, 1.3 mg/m(2) subcutaneously (days 1, 4, 8, and 11), and PLD, 40 mg/m(2) intravenously (day 4), every 4 weeks. The primary endpoint was best objective response rate (ORR), and secondary endpoints included disease and safety. Targeted sequencing was performed to evaluate biomarkers , their potential association with response to treatment. Results: The trial was terminated after 23 patients were recruited because of slow accrual. The median follow-up was 29.5 months. The overall ORR was 8.7% (2/23); partial response was observed in two patients. The median duration of response was 10.5 months , median PFS was 2.9 months. Treatment-related adverse events (TRAEs) of grade 3/4 were reported in 43.5% of patients. One patient who exhibited TRAEs discontinued treatment. However, grade 4/5 TRAEs were not observed. Mutations in TP53 and CDK12 were detected in 67% (14/21) and 24% (12/21) of patients, respectively. Two patients with partial response harbored mutations in genes related to homologous recombination repair deficiency, including BRCA2, ATM, and CDK12. Conclusion: The combination of bortezomib and PLD was well tolerated; however, antitumor activity was not sufficient to warrant further investigation in ovarian cancer. | - |
dc.language | 영어 | - |
dc.publisher | International Institute of Anticancer Research | - |
dc.title | A Phase II Trial to Evaluate the Efficacy of Bortezomib and Liposomal Doxorubicin in Patients With BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer (KGOG 3044/EBLIN) | - |
dc.type | Article | - |
dc.identifier.doi | 10.21873/invivo.12917 | - |
dc.citation.journaltitle | In Vivo | - |
dc.identifier.wosid | 000819266600006 | - |
dc.identifier.scopusid | 2-s2.0-85132683311 | - |
dc.citation.endpage | 1958 | - |
dc.citation.number | 4 | - |
dc.citation.startpage | 1949 | - |
dc.citation.volume | 36 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Lee, Maria | - |
dc.contributor.affiliatedAuthor | Kim, Jae-Weon | - |
dc.contributor.affiliatedAuthor | Kim, Hee Seung | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
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