4.Varlitinib and Paclitaxel for EGFR/HER2 Co-expressing Advanced Gastric Cancer: A Multicenter Phase Ib/II Study (K-MASTER-13)
Dong-Hoe KOO ; Minkyu JUNG ; Yeul Hong KIM ; Hei-Cheul JEUNG ; Dae Young ZANG ; Woo Kyun BAE ; Hyunki KIM ; Hyo Song KIM ; Choong-kun LEE ; Woo Sun KWON ; Hyun Cheol CHUNG ; Sun Young RHA
Cancer Research and Treatment 2024;56(4):1136-1145
Purpose:
Varlitinib is a pan-human epidermal growth factor receptor (HER) inhibitor targeting epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (HER2), and HER4. We present a phase Ib/II study of a combination of varlitinib and weekly paclitaxel as a second-line treatment for patients with EGFR/HER2 co-expressing advanced gastric cancer (AGC).
Materials and Methods:
Patients whose tumors with EGFR and HER2 overexpression by immunohistochemistry (≥ 1+) were enrolled. Varlitinib and paclitaxel were investigated every 4 weeks. After determining the recommended phase II dose (RP2D) in phase Ib, a phase II study was conducted to evaluate the antitumor activity.
Results:
RP2D was treated with a combination of varlitinib (300 mg twice daily) and paclitaxel. Among 27 patients treated with RP2D, the median progression-free survival and overall survival (OS) were 3.3 months (95% confidence interval [CI], 1.7 to 4.9) and 7.9 months (95% CI, 5.0 to 10.8), respectively, with a median follow-up of 15.7 months. Among 16 patients with measurable disease, the objective response rate (ORR) and disease control rate were 31% and 88%, respectively. Patients with strong HER2 expression (n=8) had a higher ORR and longer OS, whereas those with strong EGFR expression (n=3) had poorer outcomes. The most common adverse events (AEs) of any grade were neutropenia (52%), diarrhea (27%), aspartate aminotransferase/alanine transaminase elevation (22%), and nausea (19%). No treatment-related deaths or unexpected AEs resulting from treatment cessation were observed in patients with RP2D.
Conclusion
A combination of varlitinib and paclitaxel displayed manageable toxicity and modest antitumor activity in patients with EGFR/HER2 co-expressing AGC who progressed after first-line chemotherapy.
5.Comparative Study on the Immunogenicity of COVID-19 mRNA Vaccines in Patients Receiving Adjuvant and Palliative Chemotherapy
Hyun-Woo CHOI ; Younggon JUNG ; Uh Jin KIM ; Sang-Cheol LEE ; Jung Hye KWON ; Hyeonjong KIM ; Sarah KIM ; Yoonjung LEE ; Hyun-Jung SHIM ; Sang-Hee CHO ; Ik-Joo CHUNG ; Eu Chang HWANG ; Seung Ji KANG ; Woo Kyun BAE ; Seung-Jung KEE
Chonnam Medical Journal 2024;60(1):69-77
This study was conducted to investigate potential differences in vaccine efficacy between patients undergoing palliative chemotherapy and receiving adjuvant chemotherapy. Additionally, the study proved the influence of vaccination timing on vaccine efficacy during active chemotherapy. Anti-receptor-binding domain (RBD) IgG binding antibody assays and surrogate neutralizing antibody assays were performed after BNT162b2 or mRNA-1273 vaccination in 45 solid cancer patients (23 adjuvant and 22 palliative chemotherapy) and in 24 healthy controls before vaccination (baseline), at every two to four weeks after the first (post-dose 1) and the second vaccination (post-dose 2). The levels of anti-RBD IgG and neutralizing antibodies increased significantly from baseline through post-dose 1 to post-dose 2 in all three groups. At the post-dose 1, the anti-RBD IgG and neutralizing antibody levels were significantly lower in cancer patients than in healthy controls. However, by post-dose 2, the seropositivity of anti-RBD IgG and neutralizing antibodies uniformly reached 100% across all groups, with no significant disparity in antibody levels among the three groups. Moreover, the antibody titers were not significantly different between patients with a vaccine and chemotherapy interval of more than 14 days or those with less than 14 days. This study demonstrated that after second doses of mRNA COVID-19 vaccines, humoral immune responses in patients receiving chemotherapy were comparable to those of healthy controls, regardless of whether the purpose of the anti-cancer treatment was palliative or adjuvant. Furthermore, the timing of vaccination did not affect the level of humoral immunity after the second vaccination.
6.Benefits of Adjuvant Chemotherapy for Clinical T3-4N0 Rectal Cancer After Preoperative Chemoradiotherapy
Hyun Jin BANG ; Hyun Jeong SHIM ; Jun Eul HWANG ; Woo Kyun BAE ; Ik Joo CHUNG ; Sang Hee CHO
Chonnam Medical Journal 2023;59(1):76-82
While the guidelines for adjuvant chemotherapy (AC) for colon cancer are relatively standardized, those for early rectal cancer are still lacking. We therefore evaluated the role of AC in clinical stage II rectal cancer treatment after preoperative chemoradiotherapy (CRT). Patients diagnosed with early rectal cancer (defined by clinical stage T3/4, N0) who completed CRT followed by surgery were enrolled in this retrospective study. To evaluate the role of AC, we analyzed the risk of recurrence and survival based on clinicopathologic parameters and adjuvant chemotherapy. Of the 112 patients, 11 patients (9.8%) experienced recurrence and five patients (4.8%) died. In a multivariate analysis, circumferential resection margin involvement (CRM+) on magnetic resonance imaging at diagnosis, CRM involvement following neoadjuvant therapy (ypCRM+), tumor regression grade (≤G1) and no-AC were considered poor prognostic factors for recurrence free survival (RFS). In addition, ypCRM+ and no-AC were associated with poor overall survival (OS) in the multivariate analysis. AC including 5-FU monotherapy demonstrated the benefits of reduced recurrence and prolonged survival in clinical stage II rectal cancer, even in pathologic stage following neoadjuvant therapy (ypStage) 0-I. Further prospective studies are needed to verify the benefit of each regimen of AC and the development of a method that can accurately predict CRM status before surgery, and a vigorous treatment that can induce CRM non-involvement (CRM−) should be considered even in early stages of rectal cancer.
7.Fracture Liaison Service in Korea: 2022 Position Statement of the Korean Society for Bone and Mineral Research
Jae-Young LIM ; Young Yul KIM ; Jin-Woo KIM ; Seongbin HONG ; Kyunghoon MIN ; Jaewon BEOM ; Byung-Ho YOON ; Sang Yoon LEE ; Sung Hye KONG ; Jun-Il YOO ; Myung Sook PARK ; Jae-Hwi NHO ; Sangbong KO ; Min Wook JOO ; Dong Hwan KIM ; Chan Ho PARK ; Tae-Young KIM ; Seil SOHN ; So Young PARK ; A Ram HONG ; Young Joo KWON ; Sung Bae PARK ; Young-Kyun LEE ; Nam Hoon MOON ; Bo Ryun KIM ; Yongsoon PARK ; Yonghan CHA ; Yong-Chan HA
Journal of Bone Metabolism 2023;30(1):31-36
Osteoporosis and osteoporotic fractures cause socioeconomic concerns, and medical system and policies appear insufficient to prepare for these issues in Korea, where the older adult population is rapidly increasing. Many countries around the world are already responding to osteoporosis and osteoporotic fractures by adopting fracture liaison service (FLS), and such an attempt has only begun in Korea. In this article, we introduce the operation methods for institutions implementing FLS and characteristics of services, and activities of the FLS Committee for FLS implementation in the Korean Society for Bone and Mineral Research. In addition, we hope that the current position statement will contribute to the implementation of FLS in Korea and impel policy changes to enable a multidisciplinary and integrated FLS operated under the medical system.
8.Korean Practice Guidelines for Gastric Cancer 2022: An Evidence-based, Multidisciplinary Approach
Tae-Han KIM ; In-Ho KIM ; Seung Joo KANG ; Miyoung CHOI ; Baek-Hui KIM ; Bang Wool EOM ; Bum Jun KIM ; Byung-Hoon MIN ; Chang In CHOI ; Cheol Min SHIN ; Chung Hyun TAE ; Chung sik GONG ; Dong Jin KIM ; Arthur Eung-Hyuck CHO ; Eun Jeong GONG ; Geum Jong SONG ; Hyeon-Su IM ; Hye Seong AHN ; Hyun LIM ; Hyung-Don KIM ; Jae-Joon KIM ; Jeong Il YU ; Jeong Won LEE ; Ji Yeon PARK ; Jwa Hoon KIM ; Kyoung Doo SONG ; Minkyu JUNG ; Mi Ran JUNG ; Sang-Yong SON ; Shin-Hoo PARK ; Soo Jin KIM ; Sung Hak LEE ; Tae-Yong KIM ; Woo Kyun BAE ; Woong Sub KOOM ; Yeseob JEE ; Yoo Min KIM ; Yoonjin KWAK ; Young Suk PARK ; Hye Sook HAN ; Su Youn NAM ; Seong-Ho KONG ;
Journal of Gastric Cancer 2023;23(1):3-106
Gastric cancer is one of the most common cancers in Korea and the world. Since 2004, this is the 4th gastric cancer guideline published in Korea which is the revised version of previous evidence-based approach in 2018. Current guideline is a collaborative work of the interdisciplinary working group including experts in the field of gastric surgery, gastroenterology, endoscopy, medical oncology, abdominal radiology, pathology, nuclear medicine, radiation oncology and guideline development methodology. Total of 33 key questions were updated or proposed after a collaborative review by the working group and 40 statements were developed according to the systematic review using the MEDLINE, Embase, Cochrane Library and KoreaMed database. The level of evidence and the grading of recommendations were categorized according to the Grading of Recommendations, Assessment, Development and Evaluation proposition. Evidence level, benefit, harm, and clinical applicability was considered as the significant factors for recommendation. The working group reviewed recommendations and discussed for consensus. In the earlier part, general consideration discusses screening, diagnosis and staging of endoscopy, pathology, radiology, and nuclear medicine. Flowchart is depicted with statements which is supported by meta-analysis and references. Since clinical trial and systematic review was not suitable for postoperative oncologic and nutritional follow-up, working group agreed to conduct a nationwide survey investigating the clinical practice of all tertiary or general hospitals in Korea. The purpose of this survey was to provide baseline information on follow up. Herein we present a multidisciplinary-evidence based gastric cancer guideline.
10.Effects of Telephone Hotline Counseling Program on Stroke Care
Baik Kyun KIM ; Dong-Wan KANG ; Do Yeon KIM ; Jung Hyun PARK ; Ji-Seok WOO ; Young-Hee KIM ; Hyun-Sook KIM ; Min-Joo MOON ; Jeong-Yoon LEE ; Hyung Seok GUK ; Nakhoon KIM ; Sang-Won CHOI ; Hakyeu AHN ; Bosco Seong Kyu YANG ; Jun Yup KIM ; Jihoon KANG ; Moon-Ku HAN ; Hee-Joon BAE ; Beom Joon KIM
Health Policy and Management 2023;33(2):185-193
Background:
This study focuses on the establishment and operation of a stroke patient hotline program to help patients and their caregivers determine when acute neurological changes require emergency attention.Method: The stroke hotline was established at the Gyeonggi Regional Cerebrovascular Center, Seoul National University Bundang Hospital, in June 2016. Patients diagnosed with stroke during admission or in outpatient clinics were registered and provided with stroke education. Consulting nurses managed hotline calls and made decisions about outpatient schedules or emergency room referrals, consulting physicians when necessary. The study analyzed consultation records from June 2016 to December 2020, assessing consultation volumes and types. Outcomes and hotline satisfaction were also evaluated.
Results:
Over this period, 6,851 patients were registered, with 1,173 patients (18%) undergoing 3,356 hotline consultations. The average monthly consultation volume increased from 29.2 cases in 2016 to 92.3 cases in 2020. Common consultation types included stroke symptoms (22.3%), blood pressure/glucose inquiries (12.8%), and surgery/procedure questions (12.6%). Unexpected outpatient visits decreased from 103 cases before the hotline to 81 cases after. Among the 2,244 consultations between January 2019 and December 2020, 9.6% were recommended hospital visits, with two cases requiring intra-arterial thrombectomy. Patient satisfaction ratings of 9–10 points increased from 64% in 2019 to 69% in 2020.
Conclusion
The stroke hotline program effectively reduced unexpected outpatient visits and achieved high patient satisfaction.Expanding the program could enhance the management of stroke-related neurological symptoms and minimize unnecessary healthcare resource utilization.

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