1.Efficacy of the granisetron transdermal system for the control of nausea and vomiting induced by highly emetogenic chemotherapy: a multicenter, randomized, controlled trial
Der Sheng SUN ; Yoon Ho KO ; Jong Youl JIN ; In Sook WOO ; Suk Young PARK ; Yun Ae EOM ; Jin Hyoung KANG ; Hoon Kyo KIM
The Korean Journal of Internal Medicine 2023;38(3):406-416
Background/Aims:
We compared the efficacy of the granisetron transdermal system (GTS) with that of ondansetron for controlling chemotherapy-induced nausea and vomiting (CINV) in patients treated with highly emetogenic chemotherapy (HEC).
Methods:
We randomized a total of 389 patients to groups treated by GTS and ondansetron before HEC. The primary endpoint was the percentage of patients achieving complete response (CR; no retching/vomiting/rescue medication) of CINV from the time of chemotherapy initiation to 24 hours after the last administration of chemotherapy (prespecified non-inferiority margin of 15%). Quality of life (QoL) was also assessed using the Functional Living Index-Emesis (FLIE).
Results:
The per protocol analysis included 152 (47.80%) and 166 patients (52.20%) in the GTS and ondansetron groups, respectively. In the full analysis set, the most common diagnosis, regimen, and period of chemotherapy were lung cancer (149 patients, 40.27%), cisplatin-based regimen (297 patients, 80.27%), and 1 day chemotherapy (221 patients, 59.73%). The CR rates were 86.84% and 90.36% in the GTS and ondansetron groups, respectively; the treatment difference was −3.52% (95% confidence interval, −10.52 to 3.48) and met the primary endpoint, indicating that GTS was not inferior to ondansetron. Patient satisfaction, assessed on the FLIE, showed significantly higher scores in the GTS group compared to the ondansetron group (mean ± standard deviation, 1,547.38 ± 306.00 and 1,494.07 ± 312.05 mm, respectively; p = 0.0449).
Conclusions
GTS provided effective, safe, and well-tolerated control of CINV and improved the QoL in HEC.
2.A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation
Guk Jin LEE ; Hyunho KIM ; Sung Shim CHO ; Hyung Soon PARK ; Ho Jung AN ; In Sook WOO ; Jae Ho BYUN ; Ji Hyung HONG ; Yoon Ho KO ; Der Sheng SUN ; Hye Sung WON ; Jong Youl JIN ; Ji Chan PARK ; In-Ho KIM ; Sang Young ROH ; Byoung Yong SHIM
Journal of Gastric Cancer 2023;23(2):315-327
Purpose:
Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy.
Materials and Methods:
Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level.
Results:
Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250–0.890; P=0.020).
Conclusions
After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.
3.Prognostic implications of stromal hyaluronic acid protein expression in resected oropharyngeal and oral cavity cancers
Der Sheng SUN ; Hye Sung WON ; Soon Auck HONG ; Ji Hyung HONG ; Heejoon JO ; Heejin LEE ; Okran KIM ; Myung Ah LEE ; Yoon Ho KO
The Korean Journal of Internal Medicine 2020;35(2):408-420
Background/Aims:
Hyaluronic acid (HA) regulates cell adhesion, migration and proliferation in various cancers. The clinical implications of HA in resected head and neck squamous cell carcinoma have not been elucidated. We investigated the clinical significance and prognostic value of the expression of tumoral and stromal HA and its related proteins in oropharyngeal and oral cavity cancer.
Methods:
Resected tissues from oropharyngeal or oral cavity cancer patients undergoing surgery were analysed in tissue microarrays divided into stroma and cancer panels. The expression levels of HA, HA synthases and hyaluronidases were also assessed by immunohistochemistry.
Results:
A total of 160 resected oropharyngeal or oral cavity cancer tissues were analysed. Stromal HA expression was observed more frequently in human papilloma virus (HPV)-negative tumors, but other clinicopathological characteristics did not differ. In patients with HPV-negative oral cavity cancers, high stromal HA expression was associated with significantly shorter recurrence-free survival and overall survival compared with low stromal HA expression. The expression of HA in both tumors and stroma was significantly correlated with poorer outcomes than other combinations in patients with HPV-negative oral cavity cancers. However, these prognostic roles of HA were not observed in patients with HPV-negative oropharyngeal cancers. In the HPV-stratified multivariate analysis, high stromal HA expression remained an independent indicator of poor prognosis in terms of recurrence-free survival.
Conclusions
High stromal HA and expression of HA in both tumors and stroma were correlated with poor prognosis in HPV-negative oral cavity cancer, but not in HPV-negative oropharyngeal cancers.
4.Clinical Characteristics of Clear Cell Ovarian Cancer: A Retrospective Multicenter Experience of 308 Patients in South Korea
Hee Yeon LEE ; Ji Hyung HONG ; Jae Ho BYUN ; Hee-Jun KIM ; Sun Kyung BAEK ; Jin Young KIM ; Ki Hyang KIM ; Jina YUN ; Jung A KIM ; Kwonoh PARK ; Hyo Jin LEE ; Jung Lim LEE ; Young-Woong WON ; Il Hwan KIM ; Woo Kyun BAE ; Kyong Hwa PARK ; Der-Sheng SUN ; Suee LEE ; Min-Young LEE ; Guk Jin LEE ; Sook Hee HONG ; Yun Hwa JUNG ; Ho Jung AN
Cancer Research and Treatment 2020;52(1):277-283
Purpose:
The purpose of this study was to evaluate clinical characteristics and treatment pattern of ovarian clear cell carcinoma (OCCC) in Korea and the role of adjuvant chemotherapy in earlystage.
Materials and Methods:
Medical records of 308 cases of from 21 institutions were reviewed and data including age, performance status, endometriosis, thromboembolism, stage, cancer antigen 125, treatment, recurrence, and death were collected.
Results:
Regarding stage of OCCC, it was stage I in 194 (63.6%), stage II in 34 (11.1%), stage III in 66 (21.6%), and stage IV in 11 (3.6%) patients. All patients underwent surgery. Optimal surgery (residual disease ≤ 1 cm) was achieved in 89.3%. Majority of patients (80.5%) received postoperative chemotherapy. The most common regimen was taxane-platinum combination (96%). Median relapse-free survival (RFS) was 138.5 months for stage I, 33.4 for stage II, 19.3 for stage III, and 9.7 for stage IV. Median overall survival (OS) were not reached, 112.4, 48.7, and 18.3 months for stage I, II, III, and IV, respectively. Early-stage (stage I), endometriosis, and optimal debulking were identified as favorable prognostic factors for RFS. Early-stage and optimal debulking were also favorable prognostic factors for OS. Majority of patients with early-stage received adjuvant chemotherapy. However, additional survival benefit was not found in terms of recurrence.
Conclusion
Majority of patients had early-stage and received postoperative chemotherapy regardless of stage. Early-stage and optimal debulking were identified as favorable prognostic factors. In stage IA or IB, adding adjuvant chemotherapy did not show difference in survival. Further study focusing on OCCC is required.
5.Factors associated with treatment interruption in elderly patients with cancer.
Hye Sung WON ; Der Sheng SUN ; Ji Young CHOI ; Ho Jung AN ; Yoon Ho KO
The Korean Journal of Internal Medicine 2019;34(1):156-164
BACKGROUND/AIMS: This study was conducted to identify risk factors that predict vulnerability to cancer therapy on the basis of the clinical, geriatric, and quality of life assessment before starting treatment in elderly patients. METHODS: Seventy-five patients aged 65 years and over with newly diagnosed stage IV solid cancer receiving chemotherapy were analyzed. Clinical and laboratory data were collected. The geriatric assessment was performed using the Korean versions of the Modified Barthel Index, Instrumental Activities of Daily Living, Mini-Mental State Examination, and Geriatric Depression Scale. The European Organisation for Research and Treatment of Cancer Quality-of-Life Core Questionnaire (EORTC-QLQ-C30) was also performed. RESULTS: Forty-one patients stopped cancer treatment during or after the end of first-line therapy and were classified as the treatment interruption group. By univariate analysis, treatment interruption was associated with metastases to ≥ 2 distant sites, lower albumin level, lower EORTC-QLQ-C30 physical and role functioning scores, and higher EORTC-QLQ-C30 fatigue and appetite loss symptom scores. By multivariate analysis, treatment interruption was significantly associated with low score for the EORTC-QLQ-C30 physical functioning scale (odds ratio [OR], 1.020; 95% confidence interval [CI], 1.002 to 1.039; p = 0.030), and ≥ 2 sites of distant metastases (OR, 2.965; 95% CI, 1.012 to 8.681; p = 0.047). CONCLUSIONS: The EORTC-QLQ-C30 physical functioning score and metastases to ≥ 2 organs, which indicate a poor physical functional status and metastatic high tumor burden, were significantly associated with interruption of first-line treatment in elderly patients with cancer.
Activities of Daily Living
;
Aged*
;
Appetite
;
Depression
;
Drug Therapy
;
Fatigue
;
Geriatric Assessment
;
Humans
;
Multivariate Analysis
;
Neoplasm Metastasis
;
Quality of Life
;
Risk Factors
;
Tumor Burden
6.The impact of sarcopenia on health-related quality of life in elderly people: Korean NationalHealth and Nutrition Examination Survey
Der Sheng SUN ; Hyunyong LEE ; Hyeon Woo YIM ; Hye Sung WON ; Yoon Ho KO
The Korean Journal of Internal Medicine 2019;34(4):877-884
BACKGROUND/AIMS:
The purpose of the study is to investigate the associations between sarcopenia and health-related quality of life in elderly men and women in Korea.
METHODS:
In a cross-sectional study using data from 2008 to 2011 Korean National Health and Nutrition Examination Survey, 4,937 adults aged 60 years and older who underwent a dual-energy X-ray absorptiometry scan were included in the study. Sarcopenia is defined as an appendicular skeletal muscle index of two standard deviations or more below the mean for young, healthy reference populations. The health-related quality of life was measured using the EuroQol-5 dimension questionnaire.
RESULTS:
The overall prevalence of sarcopenia was 6.6% in these Korean people over the age of 60 years: 11.1% for men and 3.2% for women. Sarcopenic men tended to have lower income, lower physical activity, lower body mass index, and smaller waist circumference compared with nonsarcopenic men. Sarcopenic women tended to have higher body mass index and larger waist circumference compared with nonsarcopenic women. Sarcopenic men showed higher impairments in mobility, self-care, usual activities, and pain/discomfort compared with nonsarcopenic men. Women with sarcopenia also showed higher impairments in mobility, self-care, usual activities, and anxiety/depression compared with nonsarcopenic women. Sarcopenia showed an association with impairments in selfcare for men, and with impairments in self-care, usual activities, and anxiety/depression for women, after adjusting for other confounding factors.
CONCLUSIONS
There is a significant association between sarcopenia and impaired health-related quality of life in this elderly Korean population, and these results differ between men and women.
7.Multicenter Retrospective Analysis of Clinical Characteristics, Treatment Patterns, and Outcomes in Very Elderly Patients with Diffuse Large B-Cell Lymphoma: The Korean Cancer Study Group LY16-01.
Jung Hye CHOI ; Tae Min KIM ; Hyo Jung KIM ; Sung Ae KOH ; Yeung Chul MUN ; Hye Jin KANG ; Yun Hwa JUNG ; Hyeok SHIM ; So Young CHONG ; Der Sheng SUN ; Soonil LEE ; Byeong Bae PARK ; Jung Hye KWON ; Seung Hyun NAM ; Jun Ho YI ; Young Jin YUH ; Jong Youl JIN ; Jae Joon HAN ; Seok Hyun KIM
Cancer Research and Treatment 2018;50(2):590-598
PURPOSE: The treatment strategy for elderly patients older than 80 years with diffuse large B-cell lymphoma (DLBCL) has not been established because of poor treatment tolerability and lack of data. MATERIALS AND METHODS: This multicenter retrospective study was conducted to investigate clinical characteristics, treatment patterns and outcomes of patients older than 80 years who were diagnosed with DLBCL at 19 institutions in Korea between 2005 and 2016. RESULTS: A total of 194 patients were identified (median age, 83.3 years). Of these, 114 patients had an age-adjusted International Prognostic Index (aaIPI) score of 2-3 and 48 had a Charlson index score of 4 or more. R-CHOP was given in 124 cases, R-CVP in 13 cases, other chemotherapy in 17 cases, radiation alone in nine cases, and surgery alone in two cases. Twenty-nine patients did not undergo any treatment. The median number of chemotherapy cycles was three. Only 37 patients completed the planned treatment cycles. The overall response rate from 105 evaluable patients was 90.5% (complete response, 41.9%). Twentynine patients died due to treatment-related toxicities (TRT). Thirteen patients died due to TRT after the first cycle. Median overall survival was 14.0 months. The main causes of death were disease progression (30.8%) and TRT (27.1%). In multivariate analysis, overall survival was affected by aaIPI, hypoalbuminemia, elevated creatinine, and treatment. CONCLUSION: Age itself should not be a contraindication to treatment. However, since elderly patients show higher rates of TRT due to infection, careful monitoring and dose modification of chemotherapeutic agents is needed.
Aged*
;
B-Lymphocytes*
;
Cause of Death
;
Creatinine
;
Disease Progression
;
Drug Therapy
;
Humans
;
Hypoalbuminemia
;
Korea
;
Lymphoma, B-Cell*
;
Multivariate Analysis
;
Retrospective Studies*
8.Circulating Microparticles and Coagulation Profiles in Patients with Advanced Stage Solid Tumors.
Der Sheng SUN ; Hae Kyung LEE ; Yonggoo KIM ; Je Hoon LEE ; Hye Sung WON ; Yoon Ho KO ; Hyunjung KIM
Annals of Laboratory Medicine 2018;38(3):274-276
No abstract available.
Humans
9.Wernicke encephalopathy as initial presentation of lymphoma.
Ju Hyun SEO ; Ju Hee KIM ; Der Sheng SUN ; Hye Sung WON ; Jeong Wook PARK ; Yoon Ho KO
The Korean Journal of Internal Medicine 2017;32(6):1112-1114
No abstract available.
Drug Therapy
;
Lymphoma*
;
Wernicke Encephalopathy*
10.Triple-negative breast cancer that progressed as estrogen receptor-positive skin metastases.
Sang Min LEE ; Eun Jin KANG ; Ju Hee KIM ; Jong Min YUN ; Der Sheng SUN ; Yoon Ho KO ; Hye Sung WON
The Korean Journal of Internal Medicine 2015;30(3):411-414
No abstract available.
Adult
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use
;
Biomarkers, Tumor/*analysis
;
Biopsy
;
Carcinoma, Ductal, Breast/*chemistry/*secondary/therapy
;
Chemotherapy, Adjuvant
;
Disease Progression
;
Female
;
Humans
;
Immunohistochemistry
;
Lymph Node Excision
;
Lymphatic Metastasis
;
Magnetic Resonance Imaging
;
Mastectomy
;
Neoadjuvant Therapy
;
Neoplasm Staging
;
Receptors, Estrogen/*analysis
;
Skin Neoplasms/*chemistry/*secondary
;
Time Factors
;
Treatment Outcome
;
Triple Negative Breast Neoplasms/*chemistry/*pathology/therapy

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