1.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
2.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
3.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
4.Comparative Olfactory Profiles in Parkinson’s Disease and Drug-Induced Parkinsonism
In Hee KWAK ; Young Eun KIM ; Suk Yun KANG ; Joong Seob LEE ; Jeongjae LEE ; Min Seung KIM ; Dong A YEA ; Hyeo-il MA
Journal of Movement Disorders 2024;17(1):64-70
Objective:
Drug-induced parkinsonism (DIP) is a frequently encountered diagnostic possibility when considering Parkinson’s disease (PD). While olfactory dysfunction is a common clinical feature in PD, the comparison of olfactory function between the two conditions remains insufficient. This study aimed to compare olfactory function, including threshold, discrimination, and identification (TDI) profiles, between PD and DIP.
Methods:
Consecutive patients with drug-naïve PD (n = 78) or DIP (n = 31) confirmed through dopamine transporter imaging were enrolled in this study. The YSK olfactory function (YOF) test, composed of TDI domains culturally familiar odorants to Koreans, was administered to all patients.
Results:
In the study population, patients with DIP were significantly older than patients with PD. Over 70% of patients in each group had hyposmia or anosmia, and there was no significant difference in the occurrence of olfactory dysfunction between the two groups. In addition, there were no differences in the total YOF score and threshold score between the two groups. Meanwhile, the PD group had a significantly lower discrimination and identification score than the DIP group after adjusting for age, sex, the existence of diabetes, disease duration, and cognitive function.
Conclusion
This study demonstrated that detailed olfactory profiles are different in PD and DIP, even though olfactory dysfunction can be observed in both conditions.
6.Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With DoubleTract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05Randomized Clinical Trial
Sun-Hwi HWANG ; Do Joong PARK ; Hyung-Ho KIM ; Woo Jin HYUNG ; Hoon HUR ; Han-Kwang YANG ; Hyuk-Joon LEE ; Hyoung-Il KIM ; Seong-Ho KONG ; Young Woo KIM ; Han Hong LEE ; Beom Su KIM ; Young-Kyu PARK ; Young-Joon LEE ; Sang-Hoon AHN ; In-Seob LEE ; Yun-Suhk SUH ; Ji-Ho PARK ; Soyeon AHN ; Sang-Uk HAN
Journal of Gastric Cancer 2022;22(2):94-106
Purpose:
Laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a function-preserving procedure performed for treating upper early gastric cancer (EGC).However, few studies have compared the outcomes of LPG-DTR with those of laparoscopic total gastrectomy (LTG). This study aimed at comparing the short-term outcomes of LPGDTR between LTG and upper EGC.
Materials and Methods:
For upper-third EGC, a multicenter, prospective, randomized trial was performed to compare those who underwent LPG-DTR with those who underwent LTG. Short-term outcomes, including clinicopathologic results, morbidity, mortality, and postoperative courses, were evaluated using a full analysis set based on the intention-to-treat principle and the per-protocol set.
Results:
Of the patients, 138 who fulfilled the criteria were randomized to each group. One patient in the LPG-DTR group withdrew consent. Sixty-eight patients underwent LPGDTR and 69 underwent LTG. The operative time (LPG-DTR=219.4 minutes; LTG=201.8 minutes; P=0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P=0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P=0.373) between the groups were not significantly different. No mortality occurred in either of the study groups. Two weeks post operation, the Visick scores for postprandial symptoms, including reflux symptoms, were not significantly different between the groups (P=0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups.
Conclusions
The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG.Trial Registration: ClinicalTrials.gov Identifier: NCT02892643
7.Increased Radiosensitivity of Solid Tumors Harboring ATM and BRCA1/2 Mutations
Kyung Hwan KIM ; Han Sang KIM ; Seung-seob KIM ; Hyo Sup SHIM ; Andrew Jihoon YANG ; Jason Joon Bock LEE ; Hong In YOON ; Joong Bae AHN ; Jee Suk CHANG
Cancer Research and Treatment 2022;54(1):54-64
Purpose:
Preclinical data indicate that response to radiotherapy (RT) depends on DNA damage repair. In this study, we investigated the role of mutations in genes related to DNA damage repair in treatment outcome after RT.
Materials and Methods:
Patients with solid tumor who participated in next generation sequencing panel screening using biopsied tumor tissue between October 2013 and February 2019 were reviewed and 97 patients that received RT were included in this study. Best response to RT and the cumulative local recurrence rate (LRR) were compared according to absence or presence of missense, nonsense, and frameshift mutations in ATM and/or BRCA1/2.
Results:
Of the 97 patients, five patients harbored mutation only in ATM, 22 in only BRCA1/2, and six in both ATM and BRCA1/2 (ATMmtBRCAmt). Propensity score matching was performed to select the control group without mutations (ATMwtBRCAwt, n=33). In total, 90 RT-treated target lesions were evaluated in 66 patients. Highest objective response rate of 80% was observed in ATMmtBRCAmt lesions (p=0.007), which was mostly durable. Furthermore, the cumulative 1-year LRR was the lowest in ATMmtBRCAmt lesions and the highest in ATMwtBRCAwt lesions (0% vs. 47.9%, p=0.008). RT-associated toxicities were observed in 10 treatments with no significant difference among the subgroups (p=0.680).
Conclusion
Tumors with ATM and BRCA1/2 mutations exhibited superior tumor response and local control after RT compared to tumors without these mutations. The results are hypothesis generating and suggest the need for integrating the tumor mutation profile of DNA repair genes during treatment planning.
8.Effect of Combination Therapy of Oral Famotidine with Mosapride on Intragastric pH and Gastric Emptying in Rats
Hyun Seok CHOI ; Eui Joong KIM ; Min Seob KIM ; Ji Yeon MYUNG ; Myeong Hwan YU ; Yong Sung KIM ; Moon Young LEE
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2021;21(3):220-225
Background/Aims:
Studies in healthy humans have reported that the addition of mosapride to acid suppressants resulted in higher intragastric pH than acid suppressant administration alone. We investigated the effect of the addition of mosapride to famotidine on the intragastric pH and gastric emptying rate (GER) in rats.
Materials and Methods:
Sixty male Wistar rats were used in this study. Experimental groups were divided into control, famotidine-only, mosapride-only, and famotidine with mosapride (combination). The first experiment was performed in non-stressed rats. Mosapride was administered by oral gavage 1 hour before the meal, and famotidine was administered just before the meal. The rats were provided with food for 30 minutes. The intragastric pH was measured under isoflurane anesthesia, and the GER was measured after harvesting the stomach. In the stress experiment, rats were exposed to 1-hour restraint stress immediately after mosapride administration and subjected to the same process as in the experiment with the non-stressed rats.
Results:
The famotidine-only and combination groups showed significantly higher gastric pH levels than the control group in non-stressed (P<0.01 and P<0.001, respectively) and stressed (P<0.001 and P<0.001, respectively) rats. The combination group also showed significantly higher intragastric pH levels than the famotidine-only group in non-stressed (P<0.01) and stressed (P<0.05) rats. Additionally, combination groups showed a significantly higher GER than the famotidine-only group in non-stressed (P<0.001) and stressed (P<0.01) rats.
Conclusions
The combination of mosapride with famotidine significantly increased intragastric pH compared to famotidine alone in the non-stressed and stressed rats.
9.Effect of Combination Therapy of Oral Famotidine with Mosapride on Intragastric pH and Gastric Emptying in Rats
Hyun Seok CHOI ; Eui Joong KIM ; Min Seob KIM ; Ji Yeon MYUNG ; Myeong Hwan YU ; Yong Sung KIM ; Moon Young LEE
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2021;21(3):220-225
Background/Aims:
Studies in healthy humans have reported that the addition of mosapride to acid suppressants resulted in higher intragastric pH than acid suppressant administration alone. We investigated the effect of the addition of mosapride to famotidine on the intragastric pH and gastric emptying rate (GER) in rats.
Materials and Methods:
Sixty male Wistar rats were used in this study. Experimental groups were divided into control, famotidine-only, mosapride-only, and famotidine with mosapride (combination). The first experiment was performed in non-stressed rats. Mosapride was administered by oral gavage 1 hour before the meal, and famotidine was administered just before the meal. The rats were provided with food for 30 minutes. The intragastric pH was measured under isoflurane anesthesia, and the GER was measured after harvesting the stomach. In the stress experiment, rats were exposed to 1-hour restraint stress immediately after mosapride administration and subjected to the same process as in the experiment with the non-stressed rats.
Results:
The famotidine-only and combination groups showed significantly higher gastric pH levels than the control group in non-stressed (P<0.01 and P<0.001, respectively) and stressed (P<0.001 and P<0.001, respectively) rats. The combination group also showed significantly higher intragastric pH levels than the famotidine-only group in non-stressed (P<0.01) and stressed (P<0.05) rats. Additionally, combination groups showed a significantly higher GER than the famotidine-only group in non-stressed (P<0.001) and stressed (P<0.01) rats.
Conclusions
The combination of mosapride with famotidine significantly increased intragastric pH compared to famotidine alone in the non-stressed and stressed rats.
10.Long-term Efficacy of S-1 Monotherapy or Capecitabine Plus Oxaliplatin as Adjuvant Chemotherapy for Patients with Stage II or III Gastric Cancer after Curative Gastrectomy: a Propensity Score-Matched Multicenter Cohort Study
Chang Min LEE ; Moon-Won YOO ; Young-Gil SON ; Sung Jin OH ; Jong-Han KIM ; Hyoung-Il KIM ; Joong-Min PARK ; Hoon HUR ; Ye Seob JEE ; Sun-Hwi HWANG ; Sung-Ho JIN ; Sang Eok LEE ; Ji-Ho PARK ; Kyung Won SEO ; Sungsoo PARK ; Chang Hyun KIM ; In Ho JEONG ; Han Hong LEE ; Sung Il CHOI ; Sang-Il LEE ; Chan Young KIM ; In-Hwan KIM ; Myoung-Won SON ; Kyung Ho PAK ; Sungsoo KIM ; Moon-Soo LEE ; Jae-Seok MIN
Journal of Gastric Cancer 2020;20(2):152-164
Purpose:
To compare long-term disease-free survival (DFS) between patients receiving tegafur/gimeracil/oteracil (S-1) or capecitabine plus oxaliplatin (CAPOX) adjuvant chemotherapy (AC) for gastric cancer (GC).
Materials and Methods:
This retrospective multicenter observational study enrolled 983 patients who underwent curative gastrectomy with consecutive AC with S-1 or CAPOX for stage II or III GC at 27 hospitals in Korea between February 2012 and December 2013. We conducted propensity score matching to reduce selection bias. Long-term oncologic outcomes, including DFS rate over 5 years (over-5yr DFS), were analyzed postoperatively.
Results:
The median and longest follow-up period were 59.0 and 87.6 months, respectively. DFS rate did not differ between patients who received S-1 and CAPOX for pathologic stage II (P=0.677) and stage III (P=0.899) GC. Moreover, hazard ratio (HR) for recurrence did not differ significantly between S-1 and CAPOX (reference) in stage II (HR, 1.846; 95% confidence interval [CI], 0.693–4.919; P=0.220) and stage III (HR, 0.942; 95% CI, 0.664–1.337; P=0.738) GC. After adjustment for significance in multivariate analysis, pT (4 vs. 1) (HR, 11.667; 95% CI, 1.595–85.351; P=0.016), pN stage (0 vs. 3) (HR, 2.788; 95% CI, 1.502–5.174; P=0.001), and completion of planned chemotherapy (HR, 2.213; 95% CI, 1.618–3.028; P<0.001) were determined as independent prognostic factors for DFS.
Conclusions
S-1 and CAPOX AC regimens did not show significant difference in over-5yr DFS after curative gastrectomy in patients with stage II or III GC. The pT, pN stage, and completion of planned chemotherapy were prognostic factors for GC recurrence.

Result Analysis
Print
Save
E-mail