1.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
Purpose:
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods:
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results:
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.
2.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
Purpose:
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods:
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results:
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.
3.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
Purpose:
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods:
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results:
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.
4.Totally Thoracoscopic Ablation in Patients With Recurrent Atrial Fibrillation After Catheter Ablation
Suk Kyung LIM ; Suryeun CHUNG ; Ilkun PARK ; Sang Ah CHI ; Kyunga KIM ; Kyoung-Min PARK ; Seung-Jung PARK ; Ju Youn KIM ; June Soo KIM ; Young Keun ON ; Dong Seop JEONG
Journal of Korean Medical Science 2023;38(39):e320-
Background:
The objective of this study was to evaluate the efficacy and safety of totally thoracoscopic ablation (TTA) in patients with recurrent atrial fibrillation (AF) after radiofrequency catheter ablation (RFCA).
Methods:
From February 2012 to May 2020, 460 patients who underwent TTA were classified into two groups: CA (presence of RFCA history, n = 74) and nCA groups (absence of RFCA history, n = 386). Inverse probability of treatment weighting (IPTW) analyses were used to adjust for confounders. The primary endpoint was freedom from the composite of AF, typical atrial flutter, atypical atrial flutter and any atrial tachyarrhythmia, lasting more than 30 seconds during the follow-up. All patients were followed up at 3, 6, and 12 months via electrocardiogram and 24-hour Holter monitoring.
Results:
Bilateral pulmonary vein isolation (PVI) was conducted in all patients and the conduction block tests were confirmed. In the CA group, difficult PVI occasionally occurred due to structural changes, such as pericardial adhesion and fibrosis of the pulmonary venous structure, caused by a previous catheter ablation. Early complications such as stroke and pacemaker insertion were not different between the two groups. The normal sinus rhythm was maintained in 70.1% (317/460) patients after a median follow-up period of 38.1 months.The IPTW-weighted Kaplan-Meier curves revealed that freedom from AF events at 5 years was 68.4% (95% confidence interval, 62.8–74.5) in the nCA group and 31.2% (95% confidence interval, 16.9–57.5) in the CA group (P < 0.001). In IPTW-weighted Cox regression, preoperative left atrial diameter, persistent or long-standing AF, the presence of congestive heart failure and catheter ablation history were associated with AF events.
Conclusion
Patients in the CA group showed a higher recurrence rate of AF than those in the nCA group, while TTA was safely performed in both the groups.
5.Minimal-incision Tenorrhaphy in Flexor Tendon Injury.
Ju Yun JANG ; Sang Ah OH ; Dong Hee KANG ; Chi Ho LEE
Journal of the Korean Society of Plastic and Reconstructive Surgeons 2009;36(4):515-518
PURPOSE: To retrieve the retracted flexor tendon, additional incision and wide dissection are conventionally required. We introduce minimal-incision tenorrhaphy using 1cm-long incision and minimal dissection. METHODS: Transverse incision about 1cm in length is made over the level of retracted tendon. Nelaton's catheter is advanced into tendon sheath from distal primary laceration wound to emerge proximally through the incisional wound. A catheter is sutured to proximal tendon in end-to- end fashion. By gently pulling the catheter, retracted tendon is delivered to distal wound. Tenorrhaphy with core suture and epitendinous suture is then carried out. RESULTS: This retrieving technique provides minimal incision, minimal dissection, minimal bleeding, minimal injury to tendon end, and shorter operation time with preservation of vincula tendinum and pulley system. CONCLUSION: In case of flexor tendon rupture with retraction, this operative method is believed to allow reliable and effective tenorrhaphy and excellent postoperative outcomes.
Catheters
;
Hemorrhage
;
Lacerations
;
Rupture
;
Sutures
;
Tendon Injuries
;
Tendons
6.Reattachment of Amputated Auricle using Postauricular Subcutaneous Pocket.
Ju Yun JANG ; Dong Hee KANG ; Chi Ho LEE ; Sang Ah OH
Journal of the Korean Society of Plastic and Reconstructive Surgeons 2009;36(5):660-662
PURPOSE: There are several modalities to reattach the amputated auricle. Although microvascular replantation can achieve the best outcome, it is technically difficult. Conventional composite graft is technically easy, but uniformly unsuccessful. Our successful experience of reattachment using postauricular subcutaneous pocket is presented. METHODS: The amputated tissue was placed in its anatomical position with buried sutures. The amputated part is dermabraded to remove the epidermis and outer layer of dermis(Fig. 1, Center, left). Postauricular skin flap was then raised and the reattached dermabraded ear was buried beneath the flap(Fig. 1, Center, right). Two weeks after the original surgery, the buried ear was removed from its pocket(Fig. 1, Below, left). RESULTS: The ear was reepithelialized spontaneously in 7 days. In 3 months, the reattached ear shows satisfactory appearance without contour deformity(Fig. 1, Below, right). CONCLUSION: This technique provides increase in contact surface between the amputated segment and the surrounding tissues which supply blood, serum, oxygen and nutrients, maximizing the probability of "take". Minimally injured dermis can be healed from spontaneous reepithelialization and provides minimal contour deformity. We have used this non-microsurgical technique with very satisfying outcome.
Amputation, Traumatic
;
Congenital Abnormalities
;
Dermis
;
Ear
;
Ear Auricle
;
Epidermis
;
Oxygen
;
Replantation
;
Skin
;
Sutures
;
Transplants
7.CT Enteroclysis and Intraoperative Endoscopic Polypectomy for Peutz-Jeghers Syndrome with Advanced Rectal Carcinoma: A Case Report.
Sang Ah HAN ; Chi Min PARK ; Seong Hyeon YUN ; Woo Yong LEE ; Ho Kyung CHUN
Journal of the Korean Society of Coloproctology 2007;23(5):381-385
Patients with Peutz-Jeghers syndrome often suffer from complications of polyps, such as intussusception, bowel obstruction, and bleeding. Another major problem of these patients is malignancy through the hamartoma-adenoma-carcinoma sequence. If the complications and the cancer risk of small intestinal polyps are to be reduced, early detection of these polyps and a polypectomy are important. Traditionally, a small bowel series, small bowel enteroclysis, and conventional endoscopy have been used for the proper evaluation, and management of polyps. Recently, several reports showed the advantages of enteroscopy and intraoperative endoscopy for achieving a more complete polypectomy of the small intestine. However, CT enteroclysis, which has been introduced as a reliable, less invasive, and tolerable diagnostic tool for small intestinal disease, may be useful for the evaluation of patients with gastrointestinal polyposis. We report the case of a patient with Peutz-Jeghers syndrome who had small-bowel polyposis and a rectal adenocarcinoma and who underwent preoperative CT enteroclysis and intraoperative endoscopy.
Adenocarcinoma
;
Endoscopy
;
Hemorrhage
;
Humans
;
Intestinal Diseases
;
Intestinal Polyps
;
Intestine, Small
;
Intussusception
;
Peutz-Jeghers Syndrome*
;
Polyps
8.Double Primary Cancers Developed at the Colorectum and Stomach.
Chi Min PARK ; Sang Ah HAN ; Seong Hyeon YUN ; Woo Yong LEE ; Jae Heong RHO ; Tae Sung SON ; Sung KIM ; Ho Kyung CHUN
Journal of the Korean Surgical Society 2006;70(3):182-187
PURPOSE: Stomach cancer is the most prevalent extracolonic malignancy of the many primary cancers that occur together with colorectal cancer in Koreans. The purpose of this study was to evaluate the characteristics of patients who present with double primary cancer of the stomach and colorectum. METHODS: From Sep. 1994 to Dec. 2004, in 4,305 patients were diagnosed with colorectal cancer. Among these patients, 51 patients were diagnosed synchronously or metachronously as also having stomach cancer. The mean age these patients was 60.8 years and the median follow up duration was 31.0 months. RESULTS: The incidence of double primary cancer of the stomach and colorectum was 1.2% of the total colorecal cancer patients and they were 0.6% of the total stomach cancer patients. There were 17 (33.3%) metachronous cases and 34 (66.7%) synchronous cases. For the metachronous cases, the mean interval was 15 months (12~98) and detection methods were postoperative CT, symptom of second a cancer, and routine endoscopic examination. In synchronous cases, second cancer was detected by routine endoscopic examination, preoperative radiologic evaluation, and intraoperative exploration. Intraoperatively the detected cancers were all colorectal cancer during the operation for stomach cancer. The stage of the colorectal cancer was higher than that of the stomach cancer in 30 cases. Local or systemic recurrences were seen in 9 cases (17.6%), and 7 cases were recurrence of colorectal cancer. The 5-year disease free survival rates was 55.8%. CONCLUSION: The incidence of cancer arising from colorectum and stomach has been reported to be increasing. Careful attention should always be paid to the possible presence of a second cancer in preoperative or postoperative evaluation of cancer patients.
Colonic Neoplasms
;
Colorectal Neoplasms
;
Disease-Free Survival
;
Follow-Up Studies
;
Humans
;
Incidence
;
Neoplasms, Second Primary
;
Recurrence
;
Stomach Neoplasms
;
Stomach*
9.Laparoscopy-assisted Surgical Removal of a Retained Wireless Capsule Endoscopy: A case report.
Sang Hoon LEE ; Sang Ah HAN ; Chi Min PARK ; Seong Hyeon YUN ; Woo Yong LEE ; HoKyung CHUN
Journal of the Korean Society of Coloproctology 2006;22(3):192-196
Occult bleeding of the gastrointestinal tract is a major cause of iron deficiency anemia. Even with endoscopic evaluation of the upper and the lower gastrointestinal tract in these patients, in 30~50% of the cases, the cause of bleeding still remains undiscovered. Wireless capsule endoscopy (WCE) is a novel method of evaluating the small bowel mucosa by using a small capsule equipped with a camera and transmission device. Complications of WCE include impaction within the gastrointestinal tract, sometimes requiring surgical removal. The authors report a case of capsule impaction in the small bowel in a patient evaluated for anemia due to occult gastrointestinal tract bleeding. The patient is a 19 year-old female with a history of anemia since age 4. The stool guaiac test was positive, but upper and lower gastrointestinal tract endoscopy showed no abnormalities, so WCE was done. A short segment of circular ulcers with lumen narrowing were seen in the distal jejunum. Seven days after ingestion of the capsule, the patient denied passage of the capsule. Small bowel enteroclysis was performed, and the capsule was seen along with a segment of lumen narrowing distal to the site of retention. Surgery was done, and upon laparoscopic examination, the entire bowel appeared normal. Retrieval of the capsule was done along with a resection of an 8 cm segment of the small bowel. Three linear ulcers were seen in the resected bowel specimen. Pathology revealed no evidence of Crohn's disease or tuberculosis. The patient is still on iron supplements, but her hemoglobin level remains stable at 11~12 g/dl.
Anemia
;
Anemia, Iron-Deficiency
;
Capsule Endoscopy*
;
Crohn Disease
;
Eating
;
Endoscopy
;
Female
;
Gastrointestinal Tract
;
Guaiac
;
Hemorrhage
;
Humans
;
Iron
;
Jejunum
;
Lower Gastrointestinal Tract
;
Mucous Membrane
;
Pathology
;
Tuberculosis
;
Ulcer
;
Young Adult
10.Decision of Salvage Treatment after Transanal Endoscopic Microsurgery: Clinical Experience on 36 Cases of Rectal Cancer.
Suk Hee SHIN ; Sang Ah HAN ; Chi Min PARK ; Seong Hyeon YUN ; Woo Yong LEE ; Dong Wook CHOI ; Hokyung CHUN
Journal of the Korean Society of Coloproctology 2005;21(6):406-412
PURPOSE: Local excision, including transanal endoscopic microsurgery (TEM), has become an alternative to the classic radical operation for early rectal cancer. However, radical resection for rectal cancer is necessary for advanced tumor, poor differentiation, a narrow resection margin, and positive lymphovascular invasion. This study presents the factors related to recurrence in patients who required secondary radical surgery after TEM, but did not undergo the operation. METHODS: From November 1994 to December 2004, 167 patients underwent TEM for rectal cancer. Thirty-six of those patients were included in this study. Inclusion criteria were poor differentiation, a mucinous carcinoma, invasion to a proper muscle layer, lymphovascular invasion, and a positive resection margin. RESULTS: Twelve of the 36 patients underwent a secondary radical operation, but 24 of them did not due to poor general condition or refusal. One of 12 patients (8.3%) who underwent a secondary radical operation had a systemic recurrence. Five of 24 patients (20.8%) who did not receive surgery had recurrences; 3 of 5 were local recurrence, and the others were distant metastases. Among the 24 patients who did not undergo a secondary radical operation, there were no recurrences in 2 cases of poor differentiation or mucinous carcinoma and in 2 cases of positive resection margin. There were 2 cases of recurrences in the 7 patients (25.0%) who had lymphovascular invasion, 1 case in the 1 patient (100%) who had a T3 lesion, 3 cases in the 17 patients (12.5%) who had T2 lesions. CONCLUSIONS: In high-risk patients, TEM followed by radical surgery is most beneficial in preventing local recurrence. A radical operation is strongly recommended especially if pathologic results after TEM shows T3 lesions or lymphovascular invasion.
Adenocarcinoma, Mucinous
;
Disulfiram
;
Humans
;
Microsurgery*
;
Neoplasm Metastasis
;
Rectal Neoplasms*
;
Recurrence

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