Publications by authors named "Hye-Ryun Kim"

Immune checkpoint blockade (ICB) has become a standard anti-cancer treatment, offering durable clinical benefits. However, the limited response rate of ICB necessitates biomarkers to predict and modulate the efficacy of the therapy. The gut microbiome's influence on ICB efficacy is of particular interest due to its modifiability through various interventions.

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Purpose: TP53 mutations are common in head and neck squamous cell carcinoma (HNSCC). We evaluated their clinical impact in patients treated with targeted agents or immunotherapy in the KCSG HN15-16 TRIUMPH trial.

Materials And Methods: We analyzed clinical characteristics and outcomes of patients with TP53 mutations in the TRIUMPH trial, a multicenter, biomarker-driven umbrella trial in Korea.

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Background: Sinonasal squamous cell carcinoma (SCC) is a rare disease entity, comprising less than 5% of malignancies of the head and neck. While surgery is the primary treatment approach, neoadjuvant and adjuvant therapies play crucial roles in enhancing the prognosis of patients undergoing treatment with the goal of cure. In this study, we aimed to explore the treatment outcomes of neoadjuvant chemotherapy (NAC) in patients with locally advanced sinonasal SCC.

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Purpose: Small-cell lung cancer (SCLC) accounts for approximately 10-15% of all lung cancers and is characterized by a high recurrence rate, early metastasis, and poor prognosis. Before the FDA approved lurbinectedin for SCLC that progressed on or after platinum-based chemotherapy in 2020, topotecan was the sole second-line option associated with hematological toxicities and modest efficacy. Lurbinectedin received conditional approval in Korea in September 2022 for metastatic SCLC progression, with the same indications.

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Article Synopsis
  • EGFR-variant non-small cell lung cancer (NSCLC) is prone to central nervous system (CNS) metastases, making new treatment options like lazertinib important for improving patient outcomes.
  • This study was a phase 2 trial in South Korea involving patients with NSCLC and existing brain metastases who had not responded to first or second-generation EGFR inhibitors, assessing lazertinib's effectiveness.
  • Results showed a 55% intracranial objective response rate (iORR) for patients, with higher responses in those with specific genetic markers, indicating that lazertinib could be a promising option for treating CNS metastases in these patients.
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Unlabelled: Spartalizumab (PDR001) is a humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1). We conducted a single-arm, phase 2 trial to investigate the efficacy and safety of spartalizumab in patients with refractory esophageal squamous cell carcinoma (ESCC). Patients with histologically confirmed ESCC who experienced disease progression after platinum-based chemotherapy received 300 mg of intravenous spartalizumab every three weeks until disease progression or occurrence of unacceptable toxicity.

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To evaluate the performance of MRI-derived radiomic risk score (RRS) and PD-L1 expression to predict overall survival (OS) and progression-free survival (PFS) of patients with recurrent head and neck squamous cell carcinoma receiving nivolumab therapy. Three hundred forty radiomic features from pretreatment MRI were used to construct the RRS. The integrated area under the receiver operating characteristic curve (iAUC) was calculated to evaluate the performance of the RRS and PD-L1.

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  • HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) is linked to better clinical outcomes compared to HPV-negative OPSCC, but the effectiveness of immunotherapy in these patients is still uncertain.
  • Researchers conducted detailed analyses of tumor biopsies from patients to discover why some HPV-positive individuals did not respond well to immunotherapy.
  • They found that high levels of CD161 in resident memory T cells were associated with poor antitumor activity, suggesting that targeting CD161 may improve immunotherapy outcomes for HPV-positive OPSCC patients.
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  • Next-generation sequencing (NGS) has been embraced by Korean institutions for cancer molecular diagnostics since 2017, but the use of molecularly guided treatments (MGT) has been limited due to strict regulations and lack of resources.
  • The KOSMOS-II study seeks to assess the feasibility and effectiveness of MGT using a national precision medicine framework that incorporates remote molecular tumor board meetings for actionable genetic alterations in patients with metastatic solid tumors.
  • This large-scale observational study aims to enroll 1,000 patients to gather high-quality real-world data and support collateral clinical trials and genomic databases, targeting an expected MGT implementation rate of around 50%.
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Purpose: In this study, we evaluated 66 patients diagnosed with adenoid cystic carcinoma (ACC) enrolled in two Korean Cancer Study Group trials to investigate the response and progression patterns in recurrent and/or metastatic ACC treated with vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs).

Materials And Methods: We evaluated 66 patients diagnosed with ACC who were enrolled in the Korean Cancer Study Group trials. The tumor measurements, clinical data, treatment outcomes, and progression patterns of therapy were analyzed.

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  • This study explored how genetic changes in PI3KCA and cell cycle pathways affect the effectiveness of durvalumab in patients with head and neck squamous cell carcinoma who did not respond to prior platinum-based treatments.
  • Data was collected from a phase II trial involving 87 patients segmented into three groups based on their genetic alterations: PIK3CA changes (Group A), cell cycle alterations (Group B), and no significant genetic changes (Group C).
  • The results showed no significant differences in treatment outcomes between the groups, but lower neutrophil-lymphocyte and platelet-lymphocyte ratios were associated with better progression-free survival, suggesting these could be useful biomarkers for predicting treatment response.
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Purpose: Clinical implications of neoadjuvant immunotherapy in patients with locally advanced but resectable head and neck squamous cell carcinoma (HNSCC) remain largely unexplored.

Patients And Methods: Patients with resectable HNSCC were randomized to receive a single dose of preoperative durvalumab (D) with or without tremelimumab (T) before resection, followed by postoperative (chemo)radiotherapy based on multidisciplinary discretion and 1-year D treatment. Artificial intelligence (AI)-powered spatial distribution analysis of tumor-infiltrating lymphocytes and high-dimensional profiling of circulating immune cells tracked dynamic intratumoral and systemic immune responses.

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Purpose: The phase III CheckMate 722 trial (ClinicalTrials.gov identifier: NCT02864251) evaluated nivolumab plus chemotherapy versus chemotherapy in patients with epidermal growth factor receptor ()-mutated metastatic non-small-cell lung cancer (NSCLC) after disease progression on EGFR tyrosine kinase inhibitors (TKIs).

Methods: Patients with disease progression after first- or second-generation EGFR TKI therapy (without T790M mutation) or osimertinib (with/without T790M mutation) were randomly assigned 1:1 to nivolumab (360 mg once every 3 weeks) plus platinum-doublet chemotherapy (once every 3 weeks) or platinum-doublet chemotherapy alone (once every 3 weeks) for four cycles.

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Introduction: In the phase 3 KEYNOTE-604 study (NCT03066778), pembrolizumab plus etoposide and platinum chemotherapy (EP) significantly ( = 0.0023) improved progression-free survival versus placebo plus EP in previously untreated extensive-stage SCLC (ES-SCLC). We present health-related quality of life (HRQoL) results from KEYNOTE-604.

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Objectives: To assess the feasibility of the UTE-MRI radiomic model in predicting the micropapillary and/or solid (MP/S) patterns of surgically resected lung adenocarcinoma.

Materials And Methods: We prospectively enrolled 74 lesions from 71 patients who underwent UTE-MRI and CT before curative surgery for early lung adenocarcinoma. For conventional radiologic analysis, we analyzed the longest lesion diameter and lesion characteristics at both UTE-MRI and CT.

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Introduction: The implementation of bronchial washing fluid (BWF) as a diagnostic specimen may complement the low diagnostic yields of plasma in detecting EGFR mutation (mEGFR) in non-small cell lung cancer. However, the diagnostic value of BWF in detecting mEGFR has yet to be clarified.

Materials And Methods: From March 2021 to August 2022, patients with histologically confirmed NSCLC with matched tumor tissue, BWF, and/or plasma samples were enrolled.

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Purpose: CB-103 selectively inhibits the CSL-NICD (Notch intracellular domain) interaction leading to transcriptional downregulation of oncogenic Notch pathway activation. This dose-escalation/expansion study aimed to determine safety, pharmacokinetics, and preliminary antitumor activity.

Experimental Design: Patients ≥18 years of age with selected advanced solid tumors [namely, adenoid cystic carcinoma (ACC)] and hematologic malignancies were eligible.

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Article Synopsis
  • - This study investigated a targeted treatment approach for patients with platinum-refractory recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) through a genomic profile-based trial involving multiple treatment arms.
  • - Patients were assigned to different treatment groups based on their genetic profiles, with various inhibitors used, and crossover to an anti-PD-L1 treatment was allowed if their initial therapy failed.
  • - The trial enrolled 203 patients and found varying levels of disease control and response rates across different arms, while the treatments were generally well-tolerated with no treatment-related deaths reported.
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Purpose: This study aimed to determine the role of local ablative radiotherapy (LART) in oligometastatic/oligoprogressive lung adenocarcinoma.

Materials And Methods: Patients (n=176) with oligometastatic lung adenocarcinoma treated with LART were identified, and those treated with LART at the initial diagnosis of synchronous oligometastatic disease (OMD group) or treated with LART when they presented with repeat oligoprogression (OPD group) were included.

Results: In the OMD group (n=54), the 1- and 3-year progression-free survival (PFS) were 50.

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Article Synopsis
  • The ONO-4538-52/TASUKI-52 study evaluated the effectiveness and safety of nivolumab combined with chemotherapy and bevacizumab for treating advanced non-squamous non-small cell lung cancer (nsNSCLC) in Japan, Korea, and Taiwan.
  • At the interim analysis, patients receiving nivolumab showed significantly longer progression-free survival compared to those who received a placebo, although overall survival data was still early.
  • An updated analysis revealed that patients in the nivolumab group had a median overall survival of 30.8 months versus 24.7 months for the placebo group, suggesting that the nivolumab regimen could be a standard first-line treatment for this type of lung cancer.
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Background: Not all non-small cell lung cancer (NSCLC) patients will benefit from immune checkpoint therapy and use of these medications carry serious autoimmune adverse effects. Therefore, biomarkers are needed to better identify patients who will benefit from its use. Here, the correlation of overall survival (OS) with baseline and early treatment period serum biomarker responses was evaluated in patients with NSCLC undergoing immunotherapy.

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Background: Advanced or metastatic esophageal squamous cell carcinoma (ESCC) is associated with poor prognosis; new first-line systemic treatment options are needed. Combining immuno-oncology therapies with standard chemotherapy may represent a promising approach for the treatment of solid tumors. Results from a Phase Ib study evaluating durvalumab with tremelimumab and chemotherapy in patients with advanced or metastatic ESCC are reported.

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Purpose: Precision oncology approach for recurrent and metastatic head and neck squamous cell carcinoma (HNSCC) is necessary due to its dismal prognosis. We performed a genomic profile-based umbrella trial of patients with platinum-refractory HNSCC (KCSG-TRIUMPH). Here, we present an in-depth report of the the nintedanib arm (arm 3) of the current trial.

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Introduction: Circulating tumor DNA (ctDNA) has been used as a biomarker for prognostication and response to treatment. Here, we evaluate ctDNA as a potential biomarker for response to lorlatinib, a third-generation ALK tyrosine kinase inhibitor in patients with treatment-naive, advanced, ALK-positive NSCLC in the ongoing phase 3 CROWN study (NCT03052608).

Methods: Molecular responses were calculated using mean variant allele frequency (VAF), longitudinal mean change in VAF (dVAF), and ratio to baseline.

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