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.

Background: Traditionally, dental implants require a healing period of 4 to 9 months for osseointegration, with longer recovery times considered when bone grafting is needed. This retrospective study evaluates the clinical efficacy of demineralized dentin matrix (DDM) combined with recombinant human bone morphogenetic protein-2 (rhBMP-2) during dental implant placement to expedite the osseointegration period for early loading. Methods: Thirty patients (17 male, 13 female; mean age 55.0 ± 8.8 years) requiring bone grafts due to implant fixture exposure (more than four threads; ≥ 3.2 mm) were included, with a total of 96 implants placed. Implants were inserted using a two-stage protocol with DDM/rhBMP-2 grafts. Early loading was initiated at two months postoperatively in the mandible and three months in the maxilla. Clinical outcomes evaluated included primary and secondary stability (implant stability quotient values), healing period, bone width, and marginal bone level assessed via cone-beam computed tomography. Results: All implants successfully supported final prosthetics with a torque of 50Ncm, without any osseointegration failures. The average healing period was 69.6 days in the mandible and 90.5 days in the maxilla, with significantly higher secondary stability in the mandible (80.7 ± 6.7) compared to the maxilla (73.0 ± 9.2, p < 0.001). Histological analysis confirmed new bone formation and vascularization. Conclusion DDM/rhBMP-2 grafting appears to significantly reduce the healing period, enabling early loading with stable and favorable clinical outcomes.

Background: Traditionally, dental implants require a healing period of 4 to 9 months for osseointegration, with longer recovery times considered when bone grafting is needed. This retrospective study evaluates the clinical efficacy of demineralized dentin matrix (DDM) combined with recombinant human bone morphogenetic protein-2 (rhBMP-2) during dental implant placement to expedite the osseointegration period for early loading. Methods: Thirty patients (17 male, 13 female; mean age 55.0 ± 8.8 years) requiring bone grafts due to implant fixture exposure (more than four threads; ≥ 3.2 mm) were included, with a total of 96 implants placed. Implants were inserted using a two-stage protocol with DDM/rhBMP-2 grafts. Early loading was initiated at two months postoperatively in the mandible and three months in the maxilla. Clinical outcomes evaluated included primary and secondary stability (implant stability quotient values), healing period, bone width, and marginal bone level assessed via cone-beam computed tomography. Results: All implants successfully supported final prosthetics with a torque of 50Ncm, without any osseointegration failures. The average healing period was 69.6 days in the mandible and 90.5 days in the maxilla, with significantly higher secondary stability in the mandible (80.7 ± 6.7) compared to the maxilla (73.0 ± 9.2, p < 0.001). Histological analysis confirmed new bone formation and vascularization. Conclusion DDM/rhBMP-2 grafting appears to significantly reduce the healing period, enabling early loading with stable and favorable clinical outcomes.

Background: Traditionally, dental implants require a healing period of 4 to 9 months for osseointegration, with longer recovery times considered when bone grafting is needed. This retrospective study evaluates the clinical efficacy of demineralized dentin matrix (DDM) combined with recombinant human bone morphogenetic protein-2 (rhBMP-2) during dental implant placement to expedite the osseointegration period for early loading. Methods: Thirty patients (17 male, 13 female; mean age 55.0 ± 8.8 years) requiring bone grafts due to implant fixture exposure (more than four threads; ≥ 3.2 mm) were included, with a total of 96 implants placed. Implants were inserted using a two-stage protocol with DDM/rhBMP-2 grafts. Early loading was initiated at two months postoperatively in the mandible and three months in the maxilla. Clinical outcomes evaluated included primary and secondary stability (implant stability quotient values), healing period, bone width, and marginal bone level assessed via cone-beam computed tomography. Results: All implants successfully supported final prosthetics with a torque of 50Ncm, without any osseointegration failures. The average healing period was 69.6 days in the mandible and 90.5 days in the maxilla, with significantly higher secondary stability in the mandible (80.7 ± 6.7) compared to the maxilla (73.0 ± 9.2, p < 0.001). Histological analysis confirmed new bone formation and vascularization. Conclusion DDM/rhBMP-2 grafting appears to significantly reduce the healing period, enabling early loading with stable and favorable clinical outcomes.

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.

Background: Traditionally, dental implants require a healing period of 4 to 9 months for osseointegration, with longer recovery times considered when bone grafting is needed. This retrospective study evaluates the clinical efficacy of demineralized dentin matrix (DDM) combined with recombinant human bone morphogenetic protein-2 (rhBMP-2) during dental implant placement to expedite the osseointegration period for early loading. Methods: Thirty patients (17 male, 13 female; mean age 55.0 ± 8.8 years) requiring bone grafts due to implant fixture exposure (more than four threads; ≥ 3.2 mm) were included, with a total of 96 implants placed. Implants were inserted using a two-stage protocol with DDM/rhBMP-2 grafts. Early loading was initiated at two months postoperatively in the mandible and three months in the maxilla. Clinical outcomes evaluated included primary and secondary stability (implant stability quotient values), healing period, bone width, and marginal bone level assessed via cone-beam computed tomography. Results: All implants successfully supported final prosthetics with a torque of 50Ncm, without any osseointegration failures. The average healing period was 69.6 days in the mandible and 90.5 days in the maxilla, with significantly higher secondary stability in the mandible (80.7 ± 6.7) compared to the maxilla (73.0 ± 9.2, p < 0.001). Histological analysis confirmed new bone formation and vascularization. Conclusion DDM/rhBMP-2 grafting appears to significantly reduce the healing period, enabling early loading with stable and favorable clinical outcomes.

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.

Background: Traditionally, dental implants require a healing period of 4 to 9 months for osseointegration, with longer recovery times considered when bone grafting is needed. This retrospective study evaluates the clinical efficacy of demineralized dentin matrix (DDM) combined with recombinant human bone morphogenetic protein-2 (rhBMP-2) during dental implant placement to expedite the osseointegration period for early loading. Methods: Thirty patients (17 male, 13 female; mean age 55.0 ± 8.8 years) requiring bone grafts due to implant fixture exposure (more than four threads; ≥ 3.2 mm) were included, with a total of 96 implants placed. Implants were inserted using a two-stage protocol with DDM/rhBMP-2 grafts. Early loading was initiated at two months postoperatively in the mandible and three months in the maxilla. Clinical outcomes evaluated included primary and secondary stability (implant stability quotient values), healing period, bone width, and marginal bone level assessed via cone-beam computed tomography. Results: All implants successfully supported final prosthetics with a torque of 50Ncm, without any osseointegration failures. The average healing period was 69.6 days in the mandible and 90.5 days in the maxilla, with significantly higher secondary stability in the mandible (80.7 ± 6.7) compared to the maxilla (73.0 ± 9.2, p < 0.001). Histological analysis confirmed new bone formation and vascularization. Conclusion DDM/rhBMP-2 grafting appears to significantly reduce the healing period, enabling early loading with stable and favorable clinical outcomes.

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.

Purpose: Hemophilia A is a genetic disorder characterized by a lack of factor VIII (FVIII). Emicizumab, a recombinant humanized bispecific monoclonal antibody, mimics the function of FVIII. In this article, we present data on an initial real-world evaluation of emicizumab use in Korean children with severe hemophilia A without inhibitors. Methods: This study was conducted from June 2020 to March 2024 at 4 centers in Korea. The participants were pediatric patients with severe hemophilia A without inhibitors who had received emicizumab treatment for over 6 months. The mean and median annualized bleeding rates (ABRs) and mean and median annual joint bleeding rates (AJBRs) were compared. Results: Each of the 21 patients in the study received an emicizumab loading regimen of 3 mg/kg weekly for 4 weeks, followed by a modified maintenance regimen of which 2 patients (9.5%) received a 1.5 mg/kg weekly dose, 3 patients (14.3%) received a 6 mg/kg dose every 4 weeks, and the remaining 16 patients (76.2%) received a 3 mg/kg dose every 2 weeks. Before emicizumab prophylaxis initiation, the mean and median ABRs for all patients were 7.04 (SD ± 5.83) and 6.52 (range 0–21.74), respectively. After receiving emicizumab treatment, the mean and mediam ABRs decreased to 0.41 and zero, respectively. Additionally, 85.7% of the patients achieved no bleeding events within 6 months of starting the treatment. Conclusion These first real-world data in Korea indicate that emicizumab is effective and safe for pediatric patients with severe hemophilia A without inhibitors.