Dae Hoon Jeong

A single-arm, phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive, recurrent ovarian cancer patients previously treated with a PARP inhibitor: Korean Gynecologic Oncology Group (KGOG 3056)/NIRVANA-R trial

Given the expanding clinical use of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors (PARPis), there is a significant need for optimal strategies with which to treat patients whose cancer progresses while using a PARPi. However, the treatment consensus after PARPi has not been established. The aim of the Korean Gynecologic Oncology Group (KGOG) 3056/NIRVANA-R trial is to investigate the efficacy of niraparib in combination with bevacizumab as a maintenance therapy in platinum-sensitive ovarian cancer patients who were previously treated with a PARPi. The KGOG 3056/NIRVANA-R is a multi-centre, investigator-initiated, single-arm, phase II trial of patients with platinum-sensitive recurrent ovarian cancer recruited from seven KGOG sites. This study included patients with platinum-sensitive recurrent epithelial ovarian cancer who received at least 2 previous courses of platinum-containing therapy and had been treated with a PARPi. Mucinous histology type was excluded. Patients who had responded to the last platinum regimen (either complete or partial response) were eligible to participate in this study. Forty-four patients will be recruited. All enrolled patients are treated with niraparib and bevacizumab for maintenance therapy until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint of the study is 6-month progression-free survival rate. Accrual is expected to be completed in 2022, followed by presentation of results in 2023. ClinicalTrials.gov Identifier: NCT04734665.

Perioperative outcomes in patients with very low‐risk endometrial cancer undergoing surgery without lymph node dissection: Results from KGOG 2021

AbstractAimTo evaluate the perioperative outcomes of patients with endometrial cancer meeting the Korean Gynecologic Oncology Group (KGOG) criteria who underwent surgery without lymph node dissection.MethodsThis study included 153 patients who met the KGOG criteria: (1) endometrioid histology, (2) myometrial invasion <50%, (3) tumor confined to the corpus, (4) no lymph node >1 cm, and (5) serum CA125 ≤ 35 U/mL. The patients underwent surgery without lymph node dissection at 11 hospitals in Korea between February 2020 and May 2024. Perioperative outcomes were collected prospectively.ResultsAmong the 153 patients, 89 (58%) underwent surgery without lymph node removal, while 64 (42%) underwent surgery with lymph node removal. Minimally invasive surgery was performed in >90% of cases, with a conversion rate to laparotomy of 1%. The mean surgery time was 109.37 ± 37.67 min. Estimated blood loss was minimal (93.74 ± 93.13 mL), with a mean hemoglobin drop of 1.32 ± 1.01 g/dL. Transfusions were required in only three patients (2%). Postoperative hospital stays exceeded 2 days in 51% of cases. Lymph node metastasis was observed in just one case (1%). Adverse events included 52 grade 1 and 2 grade 2 events (e.g., headache, paresthesia). Patients undergoing lymph node removal (primarily sentinel lymph node biopsy) had significantly longer surgery times and postoperative hospital stays compared to those without lymph node removal.ConclusionSurgery without lymph node dissection demonstrated excellent perioperative outcomes and minimal adverse events in patients meeting KGOG criteria.

Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)

Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, well-planned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests. The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m²), 4-6 times administered intravenously. The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs. ClinicalTrials.gov Identifier: NCT05421650; Clinical Research Information Service Identifier: KCT0007137.

Niraparib and Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor

This study is phase II, open label, clinical trial to determine the efficacy of Niraparib re-treatment with Bevacizumab of assessment progression-free survival(6 months PFS rate) with platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor.