Evidence map›Paper›PMID 35738633›Full record

Trial reportIn vivo (Athens, Greece)

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).

Yong Jae Lee, Aeran Seol, Maria Lee, Jae-Weon Kim, Hee Seung Kim, Kidong Kim, Dong Hoon Suh, Sunghoon Kim, Sang Wun Kim, Jung-Yun Lee

Registry-linked trialOpen access · diamondAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in In vivo (Athens, Greece). The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03509246 (A Phase II Trial to Evaluate the Efficacy of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.0field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03509246 phase2unknown statusnot on this map

A Phase II Trial to Evaluate the Efficacy of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With BRCA Wild-type Platinum-resistant Recurrent Ovarian Cancer

TypeinterventionalSponsorSeoul National University HospitalRan2018 to 2022Enrolled44ConditionsOvarian Neoplasm Epithelial, High Grade Serous CarcinomaArmsPegylated liposomal doxorubicin plus Bortezomib
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Yong Jae LeeDepartment of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Republic of Korea.
Aeran SeolDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
Maria LeeDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
Jae-Weon KimDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
Hee Seung KimDepartment of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
Kidong KimDepartment of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Dong Hoon SuhDepartment of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Sunghoon KimDepartment of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Republic of Korea.
Sang Wun KimDepartment of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Republic of Korea.
Jung-Yun LeeDepartment of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Republic of Korea; jungyunlee@yuhs.ac.
Seoul National University · KRYonsei University · KRSeoul National University Bundang Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimThe 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 platinum-resistant 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

methodsOvarian 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

resultsThe 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, and 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.

conclusionThe combination of bortezomib and PLD was well tolerated; however, antitumor activity was not sufficient to warrant further investigation in ovarian cancer.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsOvarian NeoplasmsBortezomibCarcinoma, Ovarian EpithelialDoxorubicinFemaleHumansNeoplasm Recurrence, LocalPlatinumPolyethylene GlycolsBortezomibDoxorubicinliposomal doxorubicinPlatinumPolyethylene Glycolsantitumor activityBortezomibBRCApegylated liposomal doxorubicinplatinum-resistant recurrent ovarian cancer

Identifiers

PMID35738633
PMCPMC9301410
OpenAlexW4283464621

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.