METHODS: We retrospectively reviewed medical data in 232 patients who received TSGB from 2004 to 2020. Technical success and a positive outcome of TSGB were defined as a temperature increase of ≥1.5°C at 20 min and a pain reduction with ≥2 points on the 11-point Numerical Rating Scale at 2 weeks post-TSGB, respectively. Correlations were assessed using correlation coefficients (R), and multivariable regression model was used to identify factors relevant to TSGB outcomes.
RESULTS: 207 patients were ultimately analyzed; among them, 115 (55.5%) patients positively responded to TSGB, and 139 (67.1%) achieved technical success after TSGB. No significant relationship existed between the pain reduction and the temperature increase after TSGB (R=0.013, p=0.855). Comorbid diabetes (OR 4.200) and adjuvant intake (OR 3.451) were positively associated, and psychiatric comorbidity (OR 0.327) and pain duration (OR 0.973) were negatively associated with TSGB outcome.
CONCLUSIONS: We found no significant association between the temperature increase and pain reduction after TSGB. Further studies are warranted to identify significant factors associated with TSGB outcomes in patients with complex regional pain syndrome and neuropathic pain diseases.
METHOD: A retrospective study on 47 out of 52 consecutive patients who underwent elective laparoscopic colectomy for SFC from December 2006 until December 2019 at Korea University Anam Hospital was performed. Data on patients' demographic and clinical features, surgical procedures, intraoperative and postoperative complications, pathological features and follow-up were collected. Categorical data are expressed as frequencies (n) and percentages (%). Continuous data are expressed as mean ± standard deviation and median (range). The Kaplan-Meier test was used to determine the overall survival (OS), progression-free survival (PFS) and disease-free survival (DFS).
RESULTS: The median age of patients was 67.0 years (range 27-87 years) and 72.3% were men. Ten (21.3%) patients presented with an obstructing tumour and underwent an elective laparoscopic colectomy, while 68.1% of patients presented with Stage II and III disease. The conversion rate was 4.3% and the morbidity rate was 31.9%. There was one postoperative death secondary to splenic infarction and anastomotic leak leading to multi-organ failure. Four deaths occurred due to disease progression during a median follow-up of 63.8 months. The rate of recurrence was 20%, the 5-year OS was 89.6% and the 5-year PFS was 72.9%. After R0 resection, the 5-year OS was 91.5% and the 5-year DFS was 74.5%.
CONCLUSION: Laparoscopic D3 colectomy for SFC is feasible, with an acceptable morbidity and long-term oncological outcome when performed by highly skilled laparoscopic colorectal surgeons with knowledge of the complex anatomy around the splenic flexure. Further randomized trials should be performed to determine the advantage of laparoscopic D3 colectomy over conventional colectomy for SFC.
METHODS: Electroclinical phenotyping and genotyping of patients with a DNM1 variant were conducted for patients undergoing next-generation sequencing at our centre, followed by a systematic review.
RESULTS: Six patients with heterozygous DNM1 variants were identified in our cohort. Three had a typical DEE phenotype characterised by epileptic spasms, tonic seizures and severe-to-profound intellectual disability with pathogenic variants located in the GTPase or middle domain. The other three patients had atypical phenotypes of milder cognitive impairment and focal epilepsy. Genotypically, two patients with atypical phenotypes had variants located in the GTPase domain, while the third patient had a novel variant (p.M648R) in the linker region between pleckstrin homology and GTPase effector domains. The third patient with an atypical phenotype showed normal development until he developed febrile status epilepticus. Our systematic review on 55 reported cases revealed that those with GTPase or middle domain variants had more severe intellectual disability (p<0.001) and lower functional levels of ambulation (p=0.001) or speech and language (p<0.001) than the rest.
CONCLUSION: DNM1-related phenotypes encompass a wide spectrum of epilepsy and neurodevelopmental disorders, with specific variants underlying different phenotypes.
Methods: We collected information on legal measures and governance from both general citizens and workers regarding infection risks such as COVID-19 from industrial hygiene professionals in nine countries (Indonesia, India, Japan, Malaysia, New Zealand, Republic of the Philippines, Republic of Korea, Taiwan, and Thailand) using a structured questionnaire.
Results: A governmental body overseeing public health and welfare was in charge of containing the spread and occurrence of infectious diseases under an infectious disease control and prevention act or another special act, although the name of the pertinent organizations and legislation vary among countries. Unlike in the case of other traditional hazards, there have been no specific articles or clauses describing the means of mitigating virus risk in the workplace that are legally required of employers, making it difficult to define the responsibilities of the employer. Each country maintains own legal systems regarding access to the duration, administration, and financing of paid sick leave. Many workers may not have access to paid sick leave even if it is legally guaranteed.
Conclusion: Specific legal measures to manage infectious disease risks, such as providing proper personal protective equipment, education, engineering control measures, and paid sick leave are recommended to be stipulated in Industrial safety and health-related acts.
METHODS: In the TROIKA trial, patients with ERBB2-positive early breast cancer were randomized and treated with either HD201 or the referent trastuzumab. Eligible patients received 8 cycles of either HD201 or referent trastuzumab (loading dose, 8 mg/kg; maintenance dose, 6 mg/kg) every 3 weeks in combination with 8 cycles of chemotherapy (4 cycles of docetaxel, 75 mg/m2, followed by 4 cycles of epirubicin, 75 mg/m2, and cyclophosphamide, 500 mg/m2) in the neoadjuvant setting. The patients then underwent surgery followed by 10 cycles of adjuvant HD201 or referent trastuzumab according to their initial randomization to complete one year of trastuzumab-directed therapy. Event-free and overall survival rates were calculated using Kaplan-Meier analysis. The hazard ratio for event-free survival was estimated by Cox proportional hazards regression.
RESULTS: The final analysis was performed after all patients completed the study at a median follow-up of 37.7 months (Q1-Q3, 37.3-38.1 months). A total of 502 randomized patients received either HD201 or the referent trastuzumab, and 474 (94.2%) were eligible for inclusion in the per-protocol set. In this population, the 3-year event-free survival rates were 85.6% (95% CI: 80.28-89.52) and 84.9% (95% CI: 79.54-88.88) in the HD201 and referent trastuzumab groups, respectively (log rank p = 0.938) (HR 1.02, 95% CI: 0.63-1.63; p = 0.945). The 3-year overall survival rates were comparable between the HD201 (95.6%; 95% CI: 91.90-97.59) and referent trastuzumab treatment groups (96.0%, 95% CI: 92.45-97.90) (log rank p = 0.606). During the posttreatment follow-up period, adverse events were reported for 64 (27.4%) and 72 (29.8%) patients in the HD201 and the reference trastuzumab groups, respectively. Serious adverse events were rare and none of which were related to the study treatment.
CONCLUSIONS: This final analysis of the TROIKA trial further confirms the comparable efficacy and safety of HD201 and trastuzumab.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03013504.
OBJECTIVE: To compare the efficacy of HD201 with referent trastuzumab.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial (TROIKA) included 502 women with ERBB2-positive early breast cancer treated with either HD201 or referent trastuzumab. It was conducted across 70 centers in 12 countries, including Western and Eastern Europe and Asian countries. Randomization was stratified by tumor hormone receptor status, clinical stage, and geographic region of recruitment. This analysis was conducted on February 12, 2021, after the completion of the adjuvant phase at a median of 31 months (IQR, 28-33 months) of follow-up.
INTERVENTIONS: Patients with ERBB2-positive early breast cancer were randomly assigned to receive HD201 or referent trastuzumab in the neoadjuvant setting for 8 cycles, concurrently with 4 cycles of docetaxel, which was followed by 4 cycles of epirubicin and cyclophosphamide. Patients then underwent surgery, which was followed by treatment with 10 cycles of adjuvant HD201 or referent trastuzumab.
MAIN OUTCOME AND MEASURES: The primary end point was the total pathological complete response (tpCR) assessed after neoadjuvant treatment. Equivalence was concluded if the 95% CI of the absolute difference in tpCR between arms in the per-protocol set was within the margin of more or less than 15%. Other objectives included the breast pathological complete response, overall response, event-free and overall survival, safety, pharmacokinetics, and immunogenicity.
RESULTS: A total of 502 female patients (mean [range] age, 53 [26-82] years) were randomized to receive either HD201 or referent trastuzumab, and 474 (94.2%) were eligible for inclusion in the per-protocol set. The baseline characteristics were well balanced between the 2 arms; 195 tumors (38.8%) were hormone receptor-negative , and 213 patients (42.4%) had clinical stage III disease. The tpCR rates were 45% and 48.7% for HD201 and referent trastuzumab, respectively. The difference between the 2 groups was not significant at -3.8% (95% CI, -12.8% to 5.4%) and fell within the predefined equivalence margins. The ratio of the tpCR rates between the 2 arms was 0.92 (95% CI, 0.76 to 1.12). A total of 433 patients (86.1%) presented with 2232 treatment-emergent adverse events of special interest for trastuzumab during the entire treatment period, with 220 (88.0%) and 213 (84.5%) patients in the HD201 and referent trastuzumab groups, respectively.
CONCLUSIONS AND RELEVANCE: The results of this randomized clinical trial found that HD201 demonstrated equivalence to referent trastuzumab in terms of efficacy for the end point of tpCR, with a similar safety profile.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03013504.