1.A Phase II Trial of Nintedanib in Patients with Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma: In-Depth Analysis of Nintedanib Arm from the KCSG HN 15-16 TRIUMPH Trial
Kyoo Hyun KIM ; Sun Min LIM ; Hee Kyung AHN ; Yun-Gyoo LEE ; Keun-Wook LEE ; Myung-Ju AHN ; Bhumsuk KEAM ; Hye Ryun KIM ; Hyun Woo LEE ; Ho Jung AN ; Jin-Soo KIM
Cancer Research and Treatment 2024;56(1):37-47
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.
Materials and Methods:
The TRIUMPH study was a multicenter, open-label, single-arm phase 2 trial, in which patients were assigned to treatment arms based on next-generation sequencing (NGS)–based, matching genomic profiles. Patients whose tumors harbor fibroblast growth factor receptor (FGFR) alteration were enrolled in the nintedanib arm (arm 3) as part of the TRIUMPH study. The primary endpoint was the overall response rate (ORR), and secondary endpoints included overall survival (OS), progression-free survival (PFS), safety, and biomarker analysis.
Results:
Between October 2017 and August 2020, 207 were enrolled in the TRIUMPH study, and eight were enrolled in the nintedanib arm. ORR and disease control rate were 42.9% and 57.1%, respectively. The median PFS was 5.6 months and the median duration of response was 9.1 months. Median OS was 11.1 months. One patient maintained the partial response for 36 months. Overall, the toxicity profiles were manageable.
Conclusion
Single-agent nintedanib has demonstrated significant efficacy in FGFR-mutated, recurrent or metastatic HNSCC patients, with tolerable toxicity profiles. The results from the study have provided the basis for routine NGS screening and FGFR-targeted therapy. Because of the small number of patients due to slow accrual in this study, further studies with a larger cohort are warranted for statistical power.
2.Weight Changes and Unhealthy Weight Control Behaviors Are Associated With Dysmenorrhea in Young Women
Kyunghee HAN ; Nam-Kyoo LIM ; Hansol CHOI ; Bo Mi SONG ; Hyun-Young PARK
Journal of Korean Medical Science 2023;38(18):e136-
Background:
This study aimed to evaluate the prevalence of dysmenorrhea and to investigate the effect of weight changes or unhealthy weight control behaviors on dysmenorrhea in young Korean women.
Methods:
We used large-scale data of women, aged 14 to 44 years, who participated in the Korean Study of Women’s Health-Related Issues. Dysmenorrhea was measured using a visual analog scale and was categorized as none, mild, moderate, and severe according to the severity. Weight changes and unhealthy weight control behaviors (any of the behaviors, fasting/meal skipping, drugs, the use of unapproved dietary supplements, and one-food diets) over the past year were self-reported. We used multinomial logistic regression to investigate the association between weight changes or unhealthy weight control behaviors and dysmenorrhea.
Results:
Of the 5,829 young women participating in the study, 5,245 (90.0%) participants experienced dysmenorrhea [2,184 (37.5%) had moderate and 1,358 (23.3%) had severe].After adjusting for confounders, the odds ratios for moderate and severe dysmenorrhea in participants with weight changes ≥ 3 kg (vs. < 3 kg) were 1.19 (95% confidence interval:1.05–1.35) and 1.25 (95% confidence interval: 1.08–1.45), respectively. The odds ratios in participants with any unhealthy weight control behaviors were 1.22 (95% confidence interval:1.04–1.42) and 1.41 (95% confidence interval: 1.19–1.67) for those with moderate and severe dysmenorrhea, respectively.
Conclusion
Weight changes (≥ 3 kg) or unhealthy weight control behaviors are common among young women, which may adversely affect dysmenorrhea. Therefore, attention needs to be paid to excessive weight changes and unhealthy weight control behaviors to improve dysmenorrhea in young women.
3.Use of Menstrual Sanitary Products in Women of Reproductive Age: Korea Nurses’ Health Study
Hansol CHOI ; Nam-Kyoo LIM ; Heeja JUNG ; Oksoo KIM ; Hyun-Young PARK
Osong Public Health and Research Perspectives 2021;12(1):20-28
Objectives:
The use of menstrual hygiene products and its effect on women’s health remains under studied. Patterns of menstrual hygiene product use and the rationale behind choices among Korean women aged 18-45 years were examined.
Methods:
This cross-sectional study was a part of the Korea Nurses’ Health Study. A total of 20,613 nurses participated, and 8,658 nurses participated in Module 7 which included a menstrual hygiene productsrelated survey. The data were collected through the mobile survey using a self-reported questionnaire.Participants’ use of menstrual hygiene products and related characteristics were analyzed using frequency (percentage) or mean (SD).
Results:
The most common types of menstrual hygiene products across all age groups were disposable menstrual pads (89.0%), followed by cloth menstrual pads (4.5%), tampons (4.2%), and only 1.6% used a menstrual cup. Disposable menstrual pads were the most common across all age groups, but in those aged under 30 years this was followed by tampon use (6%). The most important criteria when choosing a menstrual hygiene product was comfort for disposable menstrual pads (31.3%) and tampons (41.5%), natural ingredients or organic products for cloth menstrual pads (51.4%), and custom fit for the menstrual cup (50.7%). However, for all menstrual hygiene products (except cloth menstrual pads), there was a higher proportion of anxiety than perception of safety, and low awareness of toxic shock syndrome.
Conclusion
It is important for women to use menstrual hygiene products with confidence. More research is needed to better understand potential health effects of menstrual hygiene products.
4.Evaluation of Prognostic Factors for the Parotid Cancer Treated With Surgery and Postoperative Radiotherapy
Yong-Hyub KIM ; Woong-Ki CHUNG ; Jae-Uk JEONG ; Ick Joon CHO ; Mee Sun YOON ; Ju-Young SONG ; Taek-Keun NAM ; Sung-Ja AHN ; Dong Hoon LEE ; Tae Mi YOON ; Joon Kyoo LEE ; Sang Chul LIM
Clinical and Experimental Otorhinolaryngology 2020;13(1):69-76
Objectives:
. To investigate the prognostic factors and treatment outcomes of primary parotid carcinoma treated with surgery and postoperative radiotherapy (PORT).
Methods:
. We reviewed retrospectively 57 patients with primary parotid carcinoma who were treated with surgery and PORT between 2005 and 2014. Superficial parotidectomy was performed in 19 patients, total parotidectomy in 10 patients, and total parotidectomy with lymph node dissection in 28 patients PORT on the tumor bed was performed in 41 patients, while PORT on tumor bed and ipsilateral cervical lymph nodes was performed in 16 patients.
Results:
. With a median follow-up of 66 months, the 5-year overall survival, disease-free survival, locoregional control, and distant control rates were 77.0%, 60.2%, 77.6%, and 72.8%, respectively. The 5-year overall survival by stage was 100%, 100%, 80.0%, and 46.4% in stage I, II, III, and IV, respectively. Recurrences at primary lesions were found in seven patients, while at cervical nodes in six patients. Distant recurrences were developed in 12 patients. No patient with the low and intermediate histologic grade developed distant failure. As prognostic factors, the histologic grade for overall survival (P=0.005), pathological T-stage (P=0.009) and differentiation grade (P=0.009) for disease-free survival, pathological T-stage for locoregional control (P=0.007), and lympho-vascular invasion (P=0.023) for distant recurrence were significant on multivariate analysis.
Conclusion
. This study revealed that differentiation grade, histologic grade, pathological T-stage, and lympho-vascular invasion were significant independent prognostic factors on clinical outcomes.
5.Comparison of Skin Graft for the Defect of the Radial Forearm Free Flap
Joon Kyoo LEE ; Sung Ho YOON ; Tae Gu KANG ; Jae Gu KIM ; Hee Young KIM ; Hye Rin LIM ; Se Hyun JEONG ; Kyeong Suk PARK
Korean Journal of Otolaryngology - Head and Neck Surgery 2019;62(9):515-519
BACKGROUND AND OBJECTIVES:
This study compared two types of skin graft reconstruction for the defect of the radial forearm free flap. SUBJECTS AND METHOD: Ten cases of split-thickness skin graft (STSG) harvested from the thigh were analyzed. Also, ten cases of full-thickness skin graft (FTSG) harvest from the inguinal area applied with vacuum-assisted closure (VAC) system were analyzed.
RESULTS:
The defect size of the radial forearm was increased more in the STSG group than in the FTSG group (p<0.05). Skin grafts were recovered completely sooner in the FTSG group than in the STSG group although it was not statistically significant (p=0.082). Five complications (pruritus, hypertrophic scar) were found in the donor site in the STSG group (p<0.05). FTSG gave better scores according to the Vancouver Scar Scale in terms of pigmentation, pliability, and height (p<0.05).
CONCLUSION
FTSG harvested from the inguinal area with the application of VAC system has many advantages for the defect of the radial forearm free flap although it is usually used for smaller size defects than for STSGs.
6.Intensity-modulated radiotherapy for stage I glottic cancer: a short-term outcomes compared with three-dimensional conformal radiotherapy
Ick Joon CHO ; Woong Ki CHUNG ; Joon Kyoo LEE ; Min Cheol LEE ; Jayeong PAEK ; Yong Hyub KIM ; Jae Uk JEONG ; Mee Sun YOON ; Ju Young SONG ; Taek Keun NAM ; Sung Ja AHN ; Dong Hoon LEE ; Tae Mi YOON ; Sang Chul LIM
Radiation Oncology Journal 2019;37(4):271-278
PURPOSE: To investigate the differences in treatment outcomes between two radiation techniques, intensity-modulated radiotherapy (IMRT) and three-dimensional conformal radiotherapy (3DCRT).MATERIALS AND METHODS: We retrospectively analyzed 160 (IMRT = 23, 3DCRT = 137) patients with stage I glottic cancer treated from January 2005 through December 2016. The IMRT was performed with TomoTherapy (16 patients), volumetric-modulated arc therapy (6 patients), and step-and-shoot technique (1 patient), respectively. The 3DCRT was performed with bilateral parallel opposing fields. The median follow-up duration was 30 months (range, 31 to 42 months) in the IMRT group and 65 months (range, 20 to 143 months) in the 3DCRT group.RESULTS: The 5-year overall survival and 3-year local control rates of the 160 patients were 95.7% and 91.4%, respectively. There was no significant difference in 3-year local control rates between the IMRT and 3DCRT groups (94.4% vs. 91.0%; p = 0.587). Thirteen of 137 patients in the 3DCRT group had recurrences. In the IMRT group, one patient had a recurrence at the true vocal cord. Patients treated with IMRT had less grade 2 skin reaction than the 3DCRT group, but this had no statistical significance (4.3% vs. 21.2%; p = 0.080).CONCLUSION: IMRT had comparable outcomes with 3DCRT, and a trend of less acute skin reaction in stage I glottic cancer patients
Follow-Up Studies
;
Glottis
;
Humans
;
Laryngeal Neoplasms
;
Radiotherapy, Conformal
;
Radiotherapy, Intensity-Modulated
;
Recurrence
;
Retrospective Studies
;
Skin
;
Vocal Cords
7.Comparison of Skin Graft for the Defect of the Radial Forearm Free Flap
Joon Kyoo LEE ; Sung Ho YOON ; Tae Gu KANG ; Jae Gu KIM ; Hee Young KIM ; Hye Rin LIM ; Se Hyun JEONG ; Kyeong Suk PARK
Korean Journal of Otolaryngology - Head and Neck Surgery 2019;62(9):515-519
BACKGROUND AND OBJECTIVES: This study compared two types of skin graft reconstruction for the defect of the radial forearm free flap. SUBJECTS AND METHOD: Ten cases of split-thickness skin graft (STSG) harvested from the thigh were analyzed. Also, ten cases of full-thickness skin graft (FTSG) harvest from the inguinal area applied with vacuum-assisted closure (VAC) system were analyzed. RESULTS: The defect size of the radial forearm was increased more in the STSG group than in the FTSG group (p<0.05). Skin grafts were recovered completely sooner in the FTSG group than in the STSG group although it was not statistically significant (p=0.082). Five complications (pruritus, hypertrophic scar) were found in the donor site in the STSG group (p<0.05). FTSG gave better scores according to the Vancouver Scar Scale in terms of pigmentation, pliability, and height (p<0.05). CONCLUSION: FTSG harvested from the inguinal area with the application of VAC system has many advantages for the defect of the radial forearm free flap although it is usually used for smaller size defects than for STSGs.
Cicatrix
;
Forearm
;
Free Tissue Flaps
;
Humans
;
Methods
;
Negative-Pressure Wound Therapy
;
Pigmentation
;
Pliability
;
Reconstructive Surgical Procedures
;
Skin Transplantation
;
Skin
;
Thigh
;
Tissue Donors
;
Transplants
8.Guidelines for the Surgical Management of Oral Cancer: Korean Society of Thyroid-Head and Neck Surgery
Young hoon JOO ; Jae keun CHO ; Bon seok KOO ; Minsu KWON ; Seong keun KWON ; Soon young KWON ; Min su KIM ; Jeong kyu KIM ; Heejin KIM ; Innchul NAM ; Jong lyel ROH ; Young min PARK ; Il seok PARK ; Jung je PARK ; Sung chan SHIN ; Soon hyun AHN ; Seongjun WON ; Chang hwan RYU ; Tae mi YOON ; Giljoon LEE ; Doh young LEE ; Myung chul LEE ; Joon kyoo LEE ; Jin choon LEE ; Jae yol LIM ; Jae won CHANG ; Jeon yeob JANG ; Man ki CHUNG ; Yuh seok JUNG ; Jae gu CHO ; Yoon seok CHOI ; Jeong seok CHOI ; Guk haeng LEE ; Phil sang CHUNG
Clinical and Experimental Otorhinolaryngology 2019;12(2):107-144
Korean Society of Thyroid-Head and Neck Surgery appointed a Task Force to provide guidance on the implementation of a surgical treatment of oral cancer. MEDLINE databases were searched for articles on subjects related to “surgical management of oral cancer” published in English. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. The quality of evidence was rated with use RoBANS (Risk of Bias Assessment Tool for Nonrandomized Studies) and AMSTAR (A Measurement Tool to Assess the Methodological Quality of Systematic Reviews). Evidence-based recommendations for practice were ranked according to the American College of Physicians grading system. Additional directives are provided as expert opinions and Delphi questionnaire when insufficient evidence existed. The Committee developed 68 evidence-based recommendations in 34 categories intended to assist clinicians and patients and counselors, and health policy-makers. Proper surgical treatment selection for oral cancer, which is directed by patient- and subsite-specific factors, remains the greatest predictor of successful treatment outcomes. These guidelines are intended for use in conjunction with the individual patient's treatment goals.
Advisory Committees
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Bias (Epidemiology)
;
Carcinoma, Squamous Cell
;
Counseling
;
Expert Testimony
;
Humans
;
Mouth Neoplasms
;
Neck
;
Republic of Korea
9.Fractionated Stereotactic Radiosurgery for Brain Metastases Using the Novalis Tx® System
Tae Kyoo LIM ; Woo Kyung KIM ; Chan Jong YOO ; Eun Young KIM ; Myeong Jin KIM ; Gi Taek YEE
Journal of Korean Neurosurgical Society 2018;61(4):525-529
OBJECTIVE: To evaluate the efficacy of fractionated stereotactic radiosurgery (FSRS) performed using the Novalis Tx® system (BrainLAB AG, Feldkirchen, Germany; Varian Medical Systems, Palo Alto, CA, USA) for brain metastases.METHODS: Between March 2013 and July 2016, 23 brain metastases patients were admitted at a single institute. Twenty-nine lesions too large for single session stereotactic radiosurgery or located in the vicinity of eloquent structures were treated by FSRS. Based on the results obtained, we reviewed the efficacy and toxicity of FSRS for the treatment of brain metastases.RESULTS: The most common lesion origin was lung (55%) followed by breast (21%). Median overall survival was 10.0 months (95% confidence interval [CI], 4.9–15.0), and median progression-free survival was 10.0 months (95% CI, 2.1–13.9). Overall survival rates at 1 and 2 years were 58.6% and 36.0%, respectively. Local recurrence and neurological complications affecting morbidity each occurred in two cases.CONCLUSION: FSRS using the Novalis-Tx® system would appear to be an effective, safe noninvasive treatment modality for large and eloquently situated brain metastases. Further investigation is required on a larger number of patients.
Brain Neoplasms
;
Brain
;
Breast
;
Disease-Free Survival
;
Germany
;
Humans
;
Lung
;
Neoplasm Metastasis
;
Radiosurgery
;
Recurrence
;
Survival Rate
10.Imaging Findings of Venous Malformation in Neck
Dong Hoon LEE ; Tae Mi YOON ; Joon Kyoo LEE ; Sang Chul LIM
Chonnam Medical Journal 2018;54(1):76-77
No abstract available.
Neck

Result Analysis
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