The final analysis of the phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) trial showed improvement in overall survival (OS) and other efficacy endpoints with apalutamide plus androgen deprivation therapy (ADT) versus ADT alone in patients with metastatic castration-sensitive prostate cancer (mCSPC). As ethnicity and regional differences may affect treatment outcomes in advanced prostate cancer, a post hoc final analysis was conducted to assess the efficacy and safety of apalutamide in the Asian subpopulation. Event-driven endpoints were OS, and time from randomization to initiation of castration resistance, prostate-specific antigen (PSA) progression, and second progression-free survival (PFS2) on first subsequent therapy or death. Efficacy endpoints were assessed using the Kaplan-Meier method and Cox proportional-hazards models without formal statistical testing and adjustment for multiplicity. Participating Asian patients received once-daily apalutamide 240 mg ( n = 111) or placebo ( n = 110) plus ADT. After a median follow-up of 42.5 months and despite crossover of 47 placebo recipients to open-label apalutamide, apalutamide reduced the risk of death by 32% (hazard ratio [HR]: 0.68; 95% confidence interval [CI]: 0.42-1.13), risk of castration resistance by 69% (HR: 0.31; 95% CI: 0.21-0.46), PSA progression by 79% (HR: 0.21; 95% CI: 0.13-0.35) and PFS2 by 24% (HR: 0.76; 95% CI: 0.44-1.29) relative to placebo. The outcomes were comparable between subgroups with low- and high-volume disease at baseline. No new safety issues were identified. Apalutamide provides valuable clinical benefits to Asian patients with mCSPC, with an efficacy and safety profile consistent with that in the overall patient population.
Male ; Humans ; Prostatic Neoplasms/pathology* ; Androgen Antagonists/therapeutic use* ; Prostate-Specific Antigen ; Castration ; Prostatic Neoplasms, Castration-Resistant/drug therapy*

In 2017, Korean Society of Medical Oncology (KSMO) published the Korean management guideline of metastatic prostate cancer. This paper is the 2nd edition of the Korean management guideline of metastatic prostate cancer. We updated recent many changes of management in metastatic prostate cancer in this 2nd edition guideline. The present guideline consists of the three categories: management of metastatic hormone sensitive prostate cancer; management of metastatic castration resistant prostate cancer; and clinical consideration for treating patients with metastatic prostate cancer. In category 1 and 2, levels of evidence (LEs) have been mentioned according to the general principles of evidence-based medicine. And grades of recommendation (GR) was taken into account the quality of evidence, the balance between desirable and undesirable effects, the values and preferences, and the use of resources and GR were divided into strong recommendations (SR) and weak recommendations (WR). A total of 16 key questions are selected. And we proposed recommendations and described key evidence for each recommendation. The treatment landscape of metastatic prostate cancer is changing very rapid and many trials are ongoing. To verify the results of the future trials is necessary and should be applied to the treatment for metastatic prostate cancer patients in the clinical practice. Especially, many prostate cancer patients are old age, have multiple underlying medical comorbidities, clinicians should be aware of the significance of medical management as well as clinical efficacy of systemic treatment.

In 2017, Korean Society of Medical Oncology (KSMO) published the Korean management guideline of metastatic prostate cancer. This paper is the 2nd edition of the Korean management guideline of metastatic prostate cancer. We updated recent many changes of management in metastatic prostate cancer in this 2nd edition guideline. The present guideline consists of the three categories: management of metastatic hormone sensitive prostate cancer; management of metastatic castration resistant prostate cancer; and clinical consideration for treating patients with metastatic prostate cancer. In category 1 and 2, levels of evidence (LEs) have been mentioned according to the general principles of evidence-based medicine. And grades of recommendation (GR) was taken into account the quality of evidence, the balance between desirable and undesirable effects, the values and preferences, and the use of resources and GR were divided into strong recommendations (SR) and weak recommendations (WR). A total of 16 key questions are selected. And we proposed recommendations and described key evidence for each recommendation. The treatment landscape of metastatic prostate cancer is changing very rapid and many trials are ongoing. To verify the results of the future trials is necessary and should be applied to the treatment for metastatic prostate cancer patients in the clinical practice. Especially, many prostate cancer patients are old age, have multiple underlying medical comorbidities, clinicians should be aware of the significance of medical management as well as clinical efficacy of systemic treatment.

PURPOSE: This study investigated the factors affecting the use of empirical antibiotics in febrile infants from 1 month to less than 3 months. METHODS: We retrospectively reviewed the medical records of hospitalized previously healthy infants with fever in Pusan National University Children's Hospital from January 2010 to December 2016. Clinical features, laboratory findings and antibiotic therapy were analyzed. Respiratory viruses were identified by multiplex reverse transcriptase polymerase chain reaction (RT-PCR) and were reported after 1–3 days. Enterovirus were identified by real time polymerase chain reaction (PCR) and were reported in several hours. RESULTS: The 129 of 366 subjects used empirical antibiotics and 237 patients didn't used empirical antibiotics. Empirical antibiotics were used more frequently when the fever was longer before admission, respiratory symptoms and ill being appearances were present and C-reactive protein was elevated. The rate of readmission was low in the group not used empirical antibiotics. Most of the patients detected by enterovirus PCR in cerebrospinal fluid didn't used empirical antibiotics. The results of respiratory virus multiplex RT-PCR showed no difference in the use of empirical antibiotics. CONCLUSIONS: In our study, empirical antibiotic prescriptions were affected not respiratory virus multiplex RT-PCR but enterovirus PCR. If multiplex RT-PCR were reported more rapid turn around time, it will affect antibiotic use.
Anti-Bacterial Agents ; Busan ; C-Reactive Protein ; Cerebrospinal Fluid ; Enterovirus ; Fever ; Humans ; Infant ; Medical Records ; Polymerase Chain Reaction ; Prescriptions ; Real-Time Polymerase Chain Reaction ; Retrospective Studies ; Reverse Transcriptase Polymerase Chain Reaction

PURPOSE: The traumatic transection is located in the normal sized aortic isthmus where the angle is curved. We found a reversal of upper and lower blood pressure differences among patients who underwent thoracic endovascular aortic repair (TEVAR) for transection of the thoracic aorta. We investigated the isthmus stenosis in patients who underwent TEVAR for aortic injury using computed tomography. MATERIALS AND METHODS: Sixteen patients who underwent TEVAR for transection were divided in two groups: the aortic narrowing (AN) group and the non-aortic narrowing (NAN) group. AN was defined as stent graft folding more than 5 mm at the isthmus confirmed by computed tomography. The length of aorta at isthmus, pseudoaneurysm, and angle of isthmus were measured. RESULTS: AN was noted in five patients (31.3%). The area index in the NAN group (2.16±0.35 cm2/m2) was larger than that in the AN group (1.74±0.77 cm2/m2). The size of the pseudoaneurysm in the NAN group (31.9±4.2 mm) was smaller than that in the AN group (37.4±7.5 mm). The distance from the subclavian artery in the NAN group (15.7±9.3 mm) was longer than that in the AN group (8.4±3.2 mm) but not statistically significant. The angle of the isthmus in the NAN group (131±6 degrees) was larger than that in the AN group (107±3 degrees), and this was the only statistically significant difference (P=0.002). CONCLUSION: AN by stent graft folding should be considered when performing TE-VAR in aortic injury with an acute angle of the isthmus less than 110 degrees.
Aneurysm, False ; Aorta ; Aorta, Thoracic ; Blood Pressure ; Blood Vessel Prosthesis ; Constriction, Pathologic ; Endovascular Procedures ; Humans ; Subclavian Artery ; Thoracic Injuries

OBJECTIVE: The purpose of this study was to evaluate the applicability of data obtained from a wearable activity tracker (Fitbit Charge HR) to medical research. This was performed by comparing the wearable activity tracker (Fitbit Charge HR) with actigraphy (Actiwatch 2) for sleep evaluation and circadian rest-activity rhythm measurement. METHODS: Sixteen healthy young adults (female participants, 62.5%; mean age, 22.8 years) wore the Fitbit Charge HR and the Actiwatch 2 on the same wrist; a sleep log was recorded over a 14-day period. We compared the sleep variables and circadian rest-activity rhythm measures with Wilcoxon signed-rank tests and Spearman's correlations. RESULTS: The periods and acrophases of the circadian rest-activity rhythms and the sleep start times did not differ and correlated significantly between the Fitbit Charge HR and the Actiwatch 2. The Fitbit Charge HR tended to overestimate the sleep durations compared with the Actiwatch 2. However, the sleep durations showed high correlation between the two devices for all days. CONCLUSION: We found that the Fitbit Charge HR showed high accuracy in sleep evaluation and circadian rest-activity rhythm measurement when compared with actigraphy for healthy young adults. The results suggest that the Fitbit Charge HR could be applicable on medical research as an alternative tool to actigraphy for sleep evaluation and measurement of the circadian rest-activity rhythm.
Actigraphy* ; Humans ; Wrist ; Young Adult*

BACKGROUND/AIMS: ¹⁸F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) has been used for preoperative staging of colorectal cancer (CRC). However, the diagnostic accuracy of FDG-PET/CT for detection of lymph node or distant metastasis and its prognostic role have not been well established. We therefore evaluated the diagnostic and prognostic value of FDG-PET/CT in comparison with conventional CT for CRC. METHODS: We investigated 220 patients who underwent preoperative FDG-PET/CT and CT, followed by curative surgery for CRC. The sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FDG-PET/CT and CT for detection of lymph node metastasis and distant metastasis were evaluated. In addition, we assessed the findings of FDG-PET/CT and CT according to outcomes, including cancer recurrence and cancer-related death, for evaluation of prognostic value. RESULTS: For detection of lymph node metastasis, FDG-PET/CT had a sensitivity of 44%, a specificity of 84%, and an accuracy of 67%, compared with 59%, 65%, and 62%, respectively, for CT (P=0.029, P=0.000, and P=0.022). For distant metastasis, FDG-PET/CT had a sensitivity of 79%, a specificity of 94%, and an accuracy of 93%, compared with 79%, 87%, and 86%, respectively, for CT (P=1.000, P=0.004, and P=0.037). In addition, positive findings of lymph node metastasis and distant metastasis on FDG-PET/CT were associated significantly with cancer recurrence or cancer-related death (P=0.009, P=0.001, respectively). CONCLUSIONS: Preoperative FDG-PET/CT had a higher specificity and accuracy compared to CT for detection of lymph node metastasis and distant metastasis of CRC. In addition, FDG-PET/CT could be a valuable prognostic tool for CRC.
Colorectal Neoplasms* ; Diagnosis ; Electrons* ; Humans ; Lymph Nodes ; Neoplasm Metastasis ; Positron-Emission Tomography ; Prognosis ; Recurrence ; Sensitivity and Specificity

PURPOSE: To evaluate the clinical outcomes of a combined procedure of astigmatic keratotomy (AK) and laser in situ keratomileusis (LASIK) for the correction of high astigmatism. METHODS: Thirty-five eyes of 19 patients who had astigmatic keratotomy were studied. The patients had a secondary procedure, LASIK, to correct the residual refractive error. Follow-up visits were at 1 week, 1 month, 3 months, and 6 months. The outcome measures included uncorrected distance visual acuity, refractive error, efficacy, safety, and predictability. We compared preoperative and post-AK expected corneal ablation depth using an Amaris Ablation depth table. RESULTS: After astigmatic keratotomy, astigmatism was reduced by 61.43 ± 14.62%, and after LASIK, astigmatism was reduced by 91.65 ± 8.68%. Expected corneal ablation depth was reduced by 18.72 ± 11.77% after astigmatic keratotomy. The proportion of eyes with spherical equivalent 0.5 D or less was 85.71% at 6 months after the combined procedure of astigmatic keratotomy and LASIK. No intraoperative or postoperative complications were observed. CONCLUSIONS: This study showed the combined procedure of astigmatic keratotomy and LASIK is effective for visual acuity, refraction, and reduction in corneal ablation depth.
Astigmatism ; Follow-Up Studies ; Humans ; Keratomileusis, Laser In Situ* ; Outcome Assessment (Health Care) ; Postoperative Complications ; Refractive Errors ; Visual Acuity

Spontaneous resolution of the arterial obstruction in Takayasu's arteritis is rarely reported. We reported a case of spontaneous resolution of an obstruction of the left subclavian artery in a young female. The patient underwent a bilateral coronary patch ostioplasty for both coronary ostial lesions complicated by Takayasu's arteritis at the age of 28. Concomitant left subclavian obstruction was seen at that time but left untreated. Surprisingly, the 10-year follow-up angiogram revealed complete resolution of the left subclavian artery obstruction. Meanwhile, no specific medical treatment was administered.
Arteritis ; Female ; Follow-Up Studies ; Humans ; Subclavian Artery* ; Takayasu Arteritis*

PURPOSE: To report a case of suction loss during small incision lenticule extraction (SMILE) and a good visual outcome after switching to femtosecond laser-assisted in-situ keratomileusis (LASIK). CASE SUMMARY: A 20-year-old female was admitted to receive refractive surgery. During SMILE in the left eye, suction loss occurred at 65% of posterior cut completion. We switched to LASIK and SMILE was performed in the right eye as planned. The uncorrected distance visual acuity was 1.2 with a manifest refraction of +0.25 Dsph with 0 Dcyl. The patient had no complications at 3 months postoperatively. CONCLUSIONS: Suction loss during SMILE is a rare complication. Good visual outcome was achieved by switching to LASIK.
Female ; Humans ; Keratomileusis, Laser In Situ* ; Refractive Surgical Procedures ; Suction* ; Visual Acuity ; Young Adult