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.Feasibility and accuracy of pediatric core temperature measurement using an esophageal probe inserted through the gastric lumen of a second-generation supraglottic airway device: a prospective observational study
Yeon-Ju KIM ; Eundong LEE ; Jaedo LEE ; Hyungtae KIM ; Won Uk KOH ; Young-Jin RO ; Ha-Jung KIM
Anesthesia and Pain Medicine 2024;19(Suppl 1):S105-S112
Background:
Accurate core temperature measurement in children is crucial; however, measuring esophageal temperature (TE) using a supraglottic airway device (SAD) can be challenging. Second-generation SADs, which have a gastric channel, can measure TE, and reduce gastric air volume. This study aimed to compare TE, measured using a probe inserted through the SAD gastric channel, with tympanic membrane (TTM) and forehead (TZHF) temperatures, measured using a zero-heat-flux cutaneous thermometer, with rectal temperature (TR).
Methods:
Temperature was recorded at 10-min intervals from 10 min after probe insertion until completion of surgery. We performed an equivalence test to evaluate whether the TE, TTM, and TZHF were equivalent to TR, with a margin of 0.3°C. Additionally, intraclass correlation coefficients (ICC) were calculated to assess the reliability of TE and TR at each time point.
Results:
We included 41 patients in the final analysis. In all patients, the esophageal probe was successfully inserted through the gastric channel of the SAD. When assessing agreement with TR as a reference, TE demonstrated equivalent results at all time points (P < 0.001 at 0, 10, 20, 30, and 40-min intervals and P = 0.018 at the 50-min interval), except at the completion of surgery (P = 0.697). TE also demonstrated good reliability with TR as a reference throughout the surgery (ICC > 0.75).
Conclusions
In children with SAD insertion, TE can be accurately and feasibly measured through the SAD’s gastric channel, making it suitable for routine application.
5.Feasibility and accuracy of pediatric core temperature measurement using an esophageal probe inserted through the gastric lumen of a second-generation supraglottic airway device: a prospective observational study
Yeon-Ju KIM ; Eundong LEE ; Jaedo LEE ; Hyungtae KIM ; Won Uk KOH ; Young-Jin RO ; Ha-Jung KIM
Anesthesia and Pain Medicine 2024;19(Suppl 1):S105-S112
Background:
Accurate core temperature measurement in children is crucial; however, measuring esophageal temperature (TE) using a supraglottic airway device (SAD) can be challenging. Second-generation SADs, which have a gastric channel, can measure TE, and reduce gastric air volume. This study aimed to compare TE, measured using a probe inserted through the SAD gastric channel, with tympanic membrane (TTM) and forehead (TZHF) temperatures, measured using a zero-heat-flux cutaneous thermometer, with rectal temperature (TR).
Methods:
Temperature was recorded at 10-min intervals from 10 min after probe insertion until completion of surgery. We performed an equivalence test to evaluate whether the TE, TTM, and TZHF were equivalent to TR, with a margin of 0.3°C. Additionally, intraclass correlation coefficients (ICC) were calculated to assess the reliability of TE and TR at each time point.
Results:
We included 41 patients in the final analysis. In all patients, the esophageal probe was successfully inserted through the gastric channel of the SAD. When assessing agreement with TR as a reference, TE demonstrated equivalent results at all time points (P < 0.001 at 0, 10, 20, 30, and 40-min intervals and P = 0.018 at the 50-min interval), except at the completion of surgery (P = 0.697). TE also demonstrated good reliability with TR as a reference throughout the surgery (ICC > 0.75).
Conclusions
In children with SAD insertion, TE can be accurately and feasibly measured through the SAD’s gastric channel, making it suitable for routine application.
6.Feasibility and accuracy of pediatric core temperature measurement using an esophageal probe inserted through the gastric lumen of a second-generation supraglottic airway device: a prospective observational study
Yeon-Ju KIM ; Eundong LEE ; Jaedo LEE ; Hyungtae KIM ; Won Uk KOH ; Young-Jin RO ; Ha-Jung KIM
Anesthesia and Pain Medicine 2024;19(Suppl 1):S105-S112
Background:
Accurate core temperature measurement in children is crucial; however, measuring esophageal temperature (TE) using a supraglottic airway device (SAD) can be challenging. Second-generation SADs, which have a gastric channel, can measure TE, and reduce gastric air volume. This study aimed to compare TE, measured using a probe inserted through the SAD gastric channel, with tympanic membrane (TTM) and forehead (TZHF) temperatures, measured using a zero-heat-flux cutaneous thermometer, with rectal temperature (TR).
Methods:
Temperature was recorded at 10-min intervals from 10 min after probe insertion until completion of surgery. We performed an equivalence test to evaluate whether the TE, TTM, and TZHF were equivalent to TR, with a margin of 0.3°C. Additionally, intraclass correlation coefficients (ICC) were calculated to assess the reliability of TE and TR at each time point.
Results:
We included 41 patients in the final analysis. In all patients, the esophageal probe was successfully inserted through the gastric channel of the SAD. When assessing agreement with TR as a reference, TE demonstrated equivalent results at all time points (P < 0.001 at 0, 10, 20, 30, and 40-min intervals and P = 0.018 at the 50-min interval), except at the completion of surgery (P = 0.697). TE also demonstrated good reliability with TR as a reference throughout the surgery (ICC > 0.75).
Conclusions
In children with SAD insertion, TE can be accurately and feasibly measured through the SAD’s gastric channel, making it suitable for routine application.
7.Feasibility and accuracy of pediatric core temperature measurement using an esophageal probe inserted through the gastric lumen of a second-generation supraglottic airway device: a prospective observational study
Yeon-Ju KIM ; Eundong LEE ; Jaedo LEE ; Hyungtae KIM ; Won Uk KOH ; Young-Jin RO ; Ha-Jung KIM
Anesthesia and Pain Medicine 2024;19(Suppl 1):S105-S112
Background:
Accurate core temperature measurement in children is crucial; however, measuring esophageal temperature (TE) using a supraglottic airway device (SAD) can be challenging. Second-generation SADs, which have a gastric channel, can measure TE, and reduce gastric air volume. This study aimed to compare TE, measured using a probe inserted through the SAD gastric channel, with tympanic membrane (TTM) and forehead (TZHF) temperatures, measured using a zero-heat-flux cutaneous thermometer, with rectal temperature (TR).
Methods:
Temperature was recorded at 10-min intervals from 10 min after probe insertion until completion of surgery. We performed an equivalence test to evaluate whether the TE, TTM, and TZHF were equivalent to TR, with a margin of 0.3°C. Additionally, intraclass correlation coefficients (ICC) were calculated to assess the reliability of TE and TR at each time point.
Results:
We included 41 patients in the final analysis. In all patients, the esophageal probe was successfully inserted through the gastric channel of the SAD. When assessing agreement with TR as a reference, TE demonstrated equivalent results at all time points (P < 0.001 at 0, 10, 20, 30, and 40-min intervals and P = 0.018 at the 50-min interval), except at the completion of surgery (P = 0.697). TE also demonstrated good reliability with TR as a reference throughout the surgery (ICC > 0.75).
Conclusions
In children with SAD insertion, TE can be accurately and feasibly measured through the SAD’s gastric channel, making it suitable for routine application.
8.Feasibility and accuracy of pediatric core temperature measurement using an esophageal probe inserted through the gastric lumen of a second-generation supraglottic airway device: a prospective observational study
Yeon-Ju KIM ; Eundong LEE ; Jaedo LEE ; Hyungtae KIM ; Won Uk KOH ; Young-Jin RO ; Ha-Jung KIM
Anesthesia and Pain Medicine 2024;19(Suppl 1):S105-S112
Background:
Accurate core temperature measurement in children is crucial; however, measuring esophageal temperature (TE) using a supraglottic airway device (SAD) can be challenging. Second-generation SADs, which have a gastric channel, can measure TE, and reduce gastric air volume. This study aimed to compare TE, measured using a probe inserted through the SAD gastric channel, with tympanic membrane (TTM) and forehead (TZHF) temperatures, measured using a zero-heat-flux cutaneous thermometer, with rectal temperature (TR).
Methods:
Temperature was recorded at 10-min intervals from 10 min after probe insertion until completion of surgery. We performed an equivalence test to evaluate whether the TE, TTM, and TZHF were equivalent to TR, with a margin of 0.3°C. Additionally, intraclass correlation coefficients (ICC) were calculated to assess the reliability of TE and TR at each time point.
Results:
We included 41 patients in the final analysis. In all patients, the esophageal probe was successfully inserted through the gastric channel of the SAD. When assessing agreement with TR as a reference, TE demonstrated equivalent results at all time points (P < 0.001 at 0, 10, 20, 30, and 40-min intervals and P = 0.018 at the 50-min interval), except at the completion of surgery (P = 0.697). TE also demonstrated good reliability with TR as a reference throughout the surgery (ICC > 0.75).
Conclusions
In children with SAD insertion, TE can be accurately and feasibly measured through the SAD’s gastric channel, making it suitable for routine application.
9.Real‑world incidence and risk factors of bortezomib‑related cardiovascular adverse events in patients with multiple myeloma
Bitna JANG ; Jonghyun JEONG ; Kyu‑Nam HEO ; Youngil KOH ; Ju‑Yeun LEE
Blood Research 2024;59():3-
Background:
Although most studies on the cardiovascular toxicity of proteasome inhibitors have focused on carfil‑ zomib, the risk of cardiotoxicity associated with bortezomib remains controversial. This study aimed to evaluate the incidence and risk factors of cardiovascular adverse events (CVAEs) associated with bortezomib in patients with multiple myeloma in a real-world setting.
Methods:
This cross-sectional study included patients who were treated with bortezomib at a tertiary hospital in South Korea. CVAEs, defined as hypertension, arrhythmia, heart failure, myocardial infarction, pulmonary arterial hypertension, angina, and venous thromboembolism, were detected using cardiac markers, ECG, echocardiography, medications, or documentation by clinicians. The patients were observed for at least 6 months and up to 2 years after starting bortezomib administration.
Results:
Among the 395 patients, 20.8% experienced CVAEs of any grade, and 14.7% experienced severe adverse events. The median onset time for any CVAE was 101.5 days (IQR, 42–182 days), and new-onset/worsened hyperten‑ sion was the most prevalent CVAE. The risk of CVAEs increased in patients with a body mass index lower than 18.5 (adjusted HR (aHR) 3.50, 95% confidence interval (CI) 1.05-11.72), light chain (1.80, 1.04-3.13), and IgD (4.63, 1.06-20.20) as the multiple myeloma subtype, baseline stroke (4.52, 1.59-12.80), and hypertension (1.99, 1.23-3.23). However, CVAEs did not significantly affect the 2-year overall survival and progression-free survival.
Conclusion
Approximately 15% of the Korean patients treated with bortezomib experienced severe CVAEs. Thus, patients, especially those with identified risk factors, should be closely monitored for CVAE symptoms during bort‑ ezomib treatment.
10.Comparison of preemptive and preventive intravenous acetaminophen on opioid consumption in pediatrics undergoing posterior spinal fusion surgery: a randomized controlled trial
Yeon Ju KIM ; Ha-Jung KIM ; Sehee KIM ; Hyungtae KIM ; Choon Sung LEE ; Chang Ju HWANG ; Jae Hwan CHO ; Young-Jin RO ; Won Uk KOH
Korean Journal of Anesthesiology 2024;77(3):326-334
Background:
Posterior spinal fusion (PSF), commonly used for adolescent idiopathic scoliosis (AIS), causes severe postoperative pain. Intravenous (IV) administration of acetaminophen has shown promise for opioid-sparing analgesia; however, its analgesic effect and optimal timing for its standard use remain unclear. Our study aimed to evaluate the analgesic effect and optimal timing of IV acetaminophen administration in pediatric and adolescent patients undergoing PSF and requiring adequate pain control.
Methods:
This prospective, randomized, triple-blind trial was conducted in patients aged 11–20 undergoing PSF. Participants were randomized into three groups: the preemptive group (received IV acetaminophen 15 mg/kg after anesthetic induction/before surgical incision), the preventive group (received IV acetaminophen 15 mg/kg at the end of surgery/before skin closure), and the placebo group. The primary outcome was cumulative opioid consumption during the first 24 h postoperatively.
Results:
Among the 99 enrolled patients, the mean ± standard deviation (SD) amount of opioid consumption during the postoperative 24 h was 60.66 ± 23.84, 52.23 ± 22.43, and 66.70 ± 23.01 mg in the preemptive, preventive, and placebo groups, respectively (overall P = 0.043). A post hoc analysis revealed that the preventive group had significantly lower opioid consumption than the placebo group (P = 0.013). However, no significant differences between the groups were observed for the secondary outcomes.
Conclusions
The preventive administration of scheduled IV acetaminophen reduces cumulative opioid consumption without increasing the incidence of drug-induced adverse events in pediatric and adolescent patients undergoing PSF.

Result Analysis
Print
Save
E-mail