Publications by authors named "Jae L Lee"

Purpose: Platinum-based chemotherapy is the standard treatment for advanced urothelial carcinoma (aUC). Switch maintenance therapy after first-line (1L) treatment may delay disease progression. This study evaluated pemetrexed as switch maintenance therapy versus observation in aUC patients without disease progression after initial chemotherapy.

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  • - The study focused on understanding recurrence risks in early-stage adrenocortical carcinoma (ACC) patients after surgical removal of tumors, highlighting that ACC is rare and typically has a poor outlook.
  • - Out of 38 patients, 55.3% experienced tumor recurrence, with no notable difference between stages 1 and 2 and higher recurrence rates in those opting for minimally invasive surgery.
  • - It was noted that having clear surgical margins (both gross and pathologic) did not guarantee lower recurrence rates, and no definitive factors were identified that could predict prognosis.
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Introduction: This study aimed to assess the survival outcomes of four versus six cycles of first-line platinum-based chemotherapy (PBCT) in the era of immune checkpoint inhibitor (ICI) for patients with advanced urothelial carcinoma (UC).

Patients And Methods: Patients with histologically confirmed advanced UC were allocated to either the 4-cycle PBCT (C4) or 6-cycle PBCT (C6) groups and retrospectively analyzed. After the planned cycles, active surveillance was conducted every 6-8 weeks, followed by second-line treatments, including ICIs, upon progression.

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Background: Belzutifan, a hypoxia-inducible factor 2α inhibitor, showed clinical activity in clear-cell renal-cell carcinoma in early-phase studies.

Methods: In a phase 3, multicenter, open-label, active-controlled trial, we enrolled participants with advanced clear-cell renal-cell carcinoma who had previously received immune checkpoint and antiangiogenic therapies and randomly assigned them, in a 1:1 ratio, to receive 120 mg of belzutifan or 10 mg of everolimus orally once daily until disease progression or unacceptable toxic effects occurred. The dual primary end points were progression-free survival and overall survival.

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Background: Immunotherapy-based combinations have emerged as standard therapies for patients with metastatic renal cell carcinoma (mRCC). Pembrolizumab, a PD-1 inhibitor, combined with epacadostat, an indoleamine 2,3-deoxygenase 1 selective inhibitor, demonstrated promising antitumor activity in a phase 1 study in advanced solid tumors, including mRCC.

Methods: KEYNOTE-679/ECHO-302 was a randomized, open-label, parallel-group, multicenter, phase 3 study (NCT03260894) that compared pembrolizumab plus epacadostat with sunitinib or pazopanib as first-line treatment for mRCC.

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Purpose: The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.

Materials And Methods: We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants.

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Digital positron emission tomography/computed tomography (PET/CT) has shown enhanced sensitivity and spatial resolution compared with analog PET/CT. The present study compared the diagnostic performance of digital and analog PET/CT with [Ga]Ga-PSMA-11 in prostate cancer patients who experienced biochemical recurrence (BCR) after prostatectomy. Forty prostate cancer patients who experienced BCR, defined as serum prostate-specific antigen (PSA) concentrations exceeding 0.

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  • This review summarizes current treatments and research developments for adrenocortical carcinoma (ACC), specifically in advanced stages of the disease.! -
  • Recent studies have identified genetic targets for therapy and are exploring new treatment methods, including inhibitors and combination therapies, though ACC remains difficult to treat.! -
  • The frontline therapy is EDP-M, but there is ongoing research into effective second-line therapies, with a focus on targeted and immunotherapy combinations to improve outcomes for patients with ACC.!
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  • Metastatic pheochromocytomas and paragangliomas (PPGLs) affect about 15%-17% of patients, with limited treatment options primarily from small trials; the effect of germline mutation on treatment outcomes is unclear.
  • A retrospective study analyzed 33 patients treated for metastatic PPGLs from 2004 to 2021, revealing a median age of 49 and a 39.1% mutation rate among those tested, mostly involving the SDHB mutation.
  • Results showed that the CVD chemotherapy had a 22% objective response rate and 67% disease control rate, while sunitinib had a 33% response rate; patients with specific mutations experienced better overall survival with CVD treatment
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  • Small cell carcinoma of the genitourinary tract (GU SCC) is a rare and aggressive disease, with limited treatment options and poor overall survival rates.
  • A study analyzed 77 patients, finding that those with extensive disease had a median overall survival of 9.7 months, while those with localized disease had a 24-month overall survival rate of 63.6%.
  • The research also highlighted that a higher presence of specific immune cells in non-prostate SCC patients significantly correlated with worse survival outcomes, suggesting new avenues for treatment.
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  • Radical cystectomy combined with cisplatin-based neoadjuvant chemotherapy is the standard treatment for muscle-invasive bladder cancers, but many patients do not respond well to this therapy.
  • Research shows that alterations in the glutathione (GSH) pathway play a key role in the resistance of muscle-invasive bladder cancers to this chemotherapy.
  • A machine-learning analysis highlights certain proteins related to GSH dynamics, revealing their potential to predict treatment response and suggesting that combining GSH modulators with cisplatin could enhance treatment effectiveness.
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Purpose: The MORPHEUS platform was designed to identify early efficacy signals and evaluate the safety of novel immunotherapy combinations across cancer types. The phase Ib/II MORPHEUS-UC trial (NCT03869190) is evaluating atezolizumab plus magrolimab, niraparib, or tocilizumab in platinum-refractory locally advanced or metastatic urothelial carcinoma (mUC). Additional treatment combinations were evaluated and will be reported separately.

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Background: In patients with renal cell carcinoma (RCC) enrolled in the phase III KEYNOTE-564 trial (NCT03142334), disease-free survival (DFS) following nephrectomy was prolonged with use of adjuvant pembrolizumab therapy versus placebo. Patient-reported outcomes (PROs) provide an important measure of health-related quality of life (HRQoL) and can complement efficacy and safety results.

Patients And Methods: In KEYNOTE-564, 994 patients were randomly assigned to receive pembrolizumab 200 mg (n = 496) or placebo (n = 498) intravenously every 3 weeks for ≤17 cycles.

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Background: Treatment options for penile squamous cell carcinoma are limited. We sought to investigate clinical outcomes and safety profiles of patients with penile squamous cell carcinoma receiving immune checkpoint inhibitors.

Methods: This retrospective study included patients with locally advanced or metastatic penile squamous cell carcinoma receiving immune checkpoint inhibitors between 2015 and 2022 across 24 centers in the United States, Europe, and Asia.

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Background: Immunotherapy-based combinations including pembrolizumab plus lenvatinib are the standard of care for patients with first-line clear-cell renal cell carcinoma, but these combinations are not well characterised in non-clear-cell renal cell carcinoma. We aimed to assess the activity and safety of pembrolizumab plus lenvatinib as a first-line treatment for patients with advanced non-clear-cell renal cell carcinoma.

Methods: KEYNOTE-B61 is a single-arm, phase 2 trial being conducted at 48 sites (hospitals and cancer centres) in 14 countries (Australia, Canada, France, Hungary, Ireland, Italy, Poland, South Korea, Russia, Spain, Türkiye, Ukraine, the UK, and the USA).

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  • Immune-related adverse events (irAEs) from checkpoint inhibitors are influenced by various risk factors, which were analyzed using genetic and clinical data from 672 cancer patients.
  • The study found that irAE samples had lower neutrophil levels and that genetic variations in HLA-B were linked to increased irAE risk.
  • A significant discovery was a mutation in the TMEM162 gene, associated with changes in B cell activity and regulatory T cell suppression, and machine learning models were developed to predict irAEs.
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  • - The CLEAR trial demonstrated that lenvatinib plus pembrolizumab was more effective than sunitinib in treating advanced renal cell carcinoma, particularly in the East Asian patient subset, which showed a median progression-free survival of 22.1 months versus 11.1 months with sunitinib.
  • - In the East Asian group (213 patients), the objective response rate was also higher for the lenvatinib plus pembrolizumab combo at 65.3% compared to 49.2% for sunitinib.
  • - Treatment-related side effects were common, with hand-foot syndrome appearing in 66.7% of those on lenvatinib plus pembrolizumab, indicating
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Purpose: There is an unmet need for therapeutic options that prolong survival for patients with heavily pretreated, metastatic castration-resistant prostate cancer (mCRPC). The phase III, open-label KEYLYNK-010 study evaluated pembrolizumab plus olaparib versus a next-generation hormonal agent (NHA) for biomarker-unselected, previously treated mCRPC.

Methods: Eligible participants had mCRPC that progressed on or after abiraterone or enzalutamide (but not both) and docetaxel.

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Background: Limited studies have evaluated anti-angiogenesis-related adverse events involving oral vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKIs) in metastatic renal cell carcinoma using real-world data.

Objective: This study aimed to investigate the incidence, patterns, and impact on the dose intensity of anti-angiogenesis-related adverse events associated with the use of VEGFR-TKIs in patients with metastatic renal cell carcinoma using real-world data.

Methods: This cross-sectional study included patients with a diagnosis of metastatic renal cell carcinoma who received axitinib, cabozantinib, pazopanib, sorafenib, and sunitinib at a tertiary hospital in South Korea.

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Purpose: Evidence in favor of adding docetaxel in treatment of metastatic hormone-sensitive prostate cancer (mHSPC) has led to docetaxel in conjunction with androgen deprivation therapy (ADT) as standard therapy. The aim of this study was to examine the effectiveness of docetaxel with ADT for Korean patients with mHSPC in real-world practice.

Materials And Methods: A retrospective cohort study was performed at six Korean hospitals for patients with mHSPC treated with docetaxel plus ADT.

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Purpose: This post-marketing surveillance (PMS) study was conducted to monitor the usage of axitinib (Inlyta) in clinical practice of Korean patients with advanced renal cell carcinoma (RCC) with disease progression during or after a prior systemic therapy in real world.

Materials And Methods: In this multicenter, observational study, patients indicated for oral axitinib 5 mg twice daily as second-line therapy for advanced RCC were followed up under routine clinical practices, and their safety and effectiveness outcomes were collected.

Results: Between 2012 and 2021, 125 patients were enrolled, and data from 111 patients were analyzed.

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Background: Adrenocortical carcinoma, a rare malignancy, has a poor prognosis, and the treatment modalities have not been well established. This study aimed to analyze the trend of treatment modalities and outcomes of patients with adrenocortical carcinoma.

Methods: We retrospectively analyzed 94 patients with adrenocortical carcinoma between January 1995 and June 2020 for distributions according to the American Joint Committee on Cancer (AJCC) 8th edition tumor-node-metastasis (TNM) staging, the yearly trend of demographic features, differences in multidisciplinary treatment, and prognostic outcomes.

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Purpose: Immune checkpoint inhibitors (ICIs) such as nivolumab and ipilimumab (N/I) are important treatment options for advanced renal cell carcinoma (RCC). The tumor microenvironment (TME) in these ICI-treated patients is largely unknown.

Methods: Twenty-four patients treated with N/I between July 2015 and June 2020 were analyzed.

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Article Synopsis
  • A study called KEYNOTE-564 tested a treatment called pembrolizumab for adults with a type of kidney cancer called clear cell renal cell carcinoma that is likely to come back after surgery.
  • The study included 213 hospitals across several continents and involved giving one group pembrolizumab and the other group a placebo (a fake treatment) without telling anyone which group they were in.
  • The main goal was to see how long patients could live without the disease returning, and the initial results showed that the patients who received pembrolizumab did better than those who got the placebo.
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Purpose: To analyse the incidence of pneumonitis related to enfortumab vedotin (EV) in patients with metastatic urothelial cell carcinoma (mUC).

Methods: Patients with mUC who participated in two EV clinical trials in South Korea were analysed for the incidence and clinical course of EV-related pneumonitis through retrospective, independent review. The clinical characteristics and radiologic attributes of potential pneumonitis were identified and reviewed by the participating investigators and pulmonologists.

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