Keun Ho Lee

Real world effectiveness and safety of pegylated liposomal doxorubicin in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer: a Korean multicenter retrospective cohort study

To evaluate the effectiveness and safety of the combination of pegylated liposomal doxorubicin with carboplatin (CD) compared with those of carboplatin and paclitaxel (CP) for platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer in a real-world setting in Korea. We enrolled relevant patients from 9 institutions. All patients received CD or CP as the second- or third-line chemotherapy in routine clinical practice during 2013-2018. The primary endpoints were progression-free survival (PFS) and toxicity. The secondary endpoint included the objective response rate (ORR). Overall, 432 patients (224 and 208 in the CD and CP groups, respectively) were included. With a median follow-up of 18.9 months, the median PFS was not different between the groups (12.7 vs. 13.6 months; hazard ratio, 1.161; 95% confidence interval, 0.923-1.460; p=0.202). The ORR was 74.6% and 80.1% in the CD and CP group, respectively (p=0.556). Age and surgery at relapse were independent prognostic factors. More patients in the CD group significantly experienced a grade 3 to 4 hematologic toxicity and hand-foot syndrome (13.8% vs. 6.3%), whereas grade 2 or more alopecia (6.2% vs. 36.1%), peripheral neuropathy (4.4% vs. 11.4%), and allergic/hypersensitivity reaction (0.4% vs. 8.5%) developed more often in the CP group. The safety and effectiveness of chemotherapy with CD in a real-world setting were consistent with the results from a randomized controlled study. The different toxicity profiles between the 2 chemotherapy (CD and CP) regimens should be considered in the clinical practice. ClinicalTrials.gov Identifier: NCT03562533.

Improved Prognostic Stratification With 2023 International Federation of Gynecology and Obstetrics Staging in Endometrial Cancer Reflecting Poor Prognosis of Aggressive Histological Types and p53 Abnormality

This study compares the distribution and prognostic impact of the 2009 and 2023 International Federation of Gynecology and Obstetrics (FIGO) staging systems for endometrial cancer and their impact on the 2022 European Society for Medical Oncology (ESMO) risk classification. Patients were restaged according to the 2009 FIGO staging system, the 2023 FIGO staging system, and the 2023 FIGO staging system with molecular classification. Risk groups were assigned according to the 2022 ESMO guidelines using each staging system. Among 679 patients, 139 (20.5%) experienced stage migration when transitioning from the 2009 FIGO staging system to the 2023 FIGO staging system with molecular classification, with 121 (17.8%) upstaged and 18 (2.7%) downstaged. Most changes were from FIGO stage I to stage II, primarily due to p53 abnormality, aggressive histological type, or extensive/substantial lymphovascular space invasion. Hazard ratios for overall survival, disease-free survival, and event-free survival increased with advancing stage groups in all systems, showing the greatest differences when the 2023 FIGO staging system with molecular classification was used. The newly introduced FIGO stages IC, IIC (both representing aggressive histological types), and IICmp53abn (associated with p53 abnormality) in the 2023 FIGO staging system were associated with worse outcomes, similar to FIGO stage III. The prognostic predictability of the 2022 ESMO risk group was minimally affected by the transition from the 2009 FIGO to the 2023 FIGO staging system, as the factors introduced in the new FIGO system were already incorporated into the 2022 ESMO risk classification. Only 17 (2.5%) patients experienced a change in their assigned risk group. The 2023 FIGO staging system showed improved prognostic stratification over the 2009 FIGO staging system, particularly by reflecting the poor prognosis of aggressive histological types and p53 abnormality.

Clinical practice guidelines for cervical cancer: an update of the Korean Society of Gynecologic Oncology Guidelines

We describe the updated Korean Society of Gynecologic Oncology (KSGO) practice guideline for the management of cervical cancer, version 5.1. The KSGO announced the fifth version of its clinical practice guidelines for the management of cervical cancer in March 2024. The selection of the key questions and the systematic reviews were based on data available up to December 2022. Between 2023 and 2024, substantial findings from large-scale clinical trials and new advancements in cervical cancer research remarkably emerged. Therefore, based on the existing version 5.0, we updated the guidelines with newly accumulated clinical data and added 4 new key questions reflecting the latest insights in the field of cervical cancer. For each question, recommendation was formulated with corresponding level of evidence and grade of recommendation, all established through expert consensus.

Clinical practice guidelines for cervical cancer: the Korean Society of Gynecologic Oncology guidelines

This fifth revised version of the Korean Society of Gynecologic Oncology practice guidelines for the management of cervical cancer incorporates recent research findings and changes in treatment strategies based on version 4.0 released in 2020. Each key question was developed by focusing on recent notable insights and crucial contemporary issues in the field of cervical cancer. These questions were evaluated for their significance and impact on the current treatment and were finalized through voting by the development committee. The selected key questions were as follows: the efficacy and safety of immune checkpoint inhibitors as first- or second-line treatment for recurrent or metastatic cervical cancer; the oncologic safety of minimally invasive radical hysterectomy in early stage cervical cancer; the efficacy and safety of adjuvant systemic treatment after concurrent chemoradiotherapy in locally advanced cervical cancer; and the oncologic safety of sentinel lymph node mapping compared to pelvic lymph node dissection. The recommendations, directions, and strengths of this guideline were based on systematic reviews and meta-analyses, and were finally confirmed through public hearings and external reviews. In this study, we describe the revised practice guidelines for the management of cervical cancer.

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.

Real-World Effectiveness of PLD in Platinum- Sensitive Recurrent Ovarian Cancer

This retrospective multicenter study aimed to evaluate the effectiveness of pegylated liposomal doxorubicin (PLD) with carboplatin (CD) compared with carboplatin and paclitaxel (CP) in patients who had disease progression longer than 6 months after first-line platinum+taxane chemotherapy for ovarian cancer in real world clinical practice.