Biomechanical evaluation of different plunger size and plunger position on removing soft contact lenses and rigid gas permeable contact lenses.

BACKGROUND: To avoid risks of mucosal infection from contact lenses removal, a contact lens plunger is often used. OBJECTIVE: Given various types of contact lens plungers available on the market, no study has yet been done on mechanical effects of the contact lens plunger on contact lens removal. Here, this study used finite element analysis to investigate the effects of plunger size and plunger position on the removal of soft and rigid gas permeable (RGP) contact lenses. METHODS: First, we established finite element analysis models for the plunger, contact lens, cornea, and aqueous humor. The plunger is made of mostly silicone rubber, and the contact lenses are mainly made of soft and hard material. The part of the plunger used for removal was located either at the central or the edged position, with pulling 1 mm distance. The main parameters observation indicators of in this study were the reaction force at the fixed end of the cornea, aqueous humor, the von Mises stress of the plunger, the contact lenses, and the cornea. RESULTS: Results of this study showed that when a plunger of a larger diameter was used, the reaction force of the plunger was also larger, especially when applied to RGP lenses, which required a slightly larger force (∼0.27 N). Also, when removing a RGP lens from the edge, there was a greater stress at the edge of the contact lens (2.5799 MPa), and this caused a higher stress on both the cornea (0.0165 MPa) and the aqueous humor (0.00114 MPa). CONCLUSIONS: When using a plunger with a larger diameter to remove a RGP lens, although a larger force required, the relatively larger contact area likely reduced the stress on the cornea and aqueous humor, thereby reducing the risk of eye injury. In addition, when removing a RGP lens, the results of this study recommended it to be removed from the plunger edge, as that facilitated the removal of contact lens.

Comparative Biomechanical Analysis of Unilateral, Bilateral, and Lateral Pedicle Screw Implantation in Oblique Lumbar Interbody Fusion: A Finite Element Study.

Oblique lumbar interbody fusion (OLIF) can be combined with different screw instrumentations. The standard screw instrumentation is bilateral pedicle screw fixation (BPSF). However, the operation is time consuming because a lateral recumbent position must be adopted for OLIF during surgery before a prone position is adopted for BPSF. This study aimed to employ a finite element analysis to investigate the biomechanical effects of OLIF combined with BPSF, unilateral pedicle screw fixation (UPSF), or lateral pedicle screw fixation (LPSF). In this study, three lumbar vertebra finite element models for OLIF surgery with three different fixation methods were developed. The finite element models were assigned six loading conditions (flexion, extension, right lateral bending, left lateral bending, right axial rotation, and left axial rotation), and the total deformation and von Mises stress distribution of the finite element models were observed. The study results showed unremarkable differences in total deformation among different groups (the maximum difference range is approximately 0.6248% to 1.3227%), and that flexion has larger total deformation (5.3604 mm to 5.4011 mm). The groups exhibited different endplate stress because of different movements, but these differences were not large (the maximum difference range between each group is approximately 0.455% to 5.0102%). Using UPSF fixation may lead to higher cage stress (411.08 MPa); however, the stress produced on the endplate was comparable to that in the other two groups. Therefore, the length of surgery can be shortened when unilateral back screws are used for UPSF. In addition, the total deformation and endplate stress of UPSF did not differ much from that of BPSF. Hence, combining OLIF with UPSF can save time and enhance stability, which is comparable to a standard BPSF surgery; thus, this method can be considered by spine surgeons.

Optimizing Spinal Fusion Cage Design to Improve Bone Substitute Filling on Varying Disc Heights: A 3D Printing Study.

The success of spinal fusion surgery relies on the precise placement of bone grafts and minimizing scatter. This study aims to optimize cage design and bone substitute filling methods to enhance surgical outcomes. A 3D printed lumbar spine model was utilized to implant 3D printed cages of different heights (8 mm, 10 mm, 12 mm, and 14 mm) filled with BICERA® Bone Graft Substitute mixed with saline. Two filling methods, SG cage (side hole for grafting group, a specially designed innovative cage with side hole, post-implantation filling) and FP cage (finger-packing group, pre-implantation finger packing, traditional cage), were compared based on the weight of the implanted bone substitute. The results showed a significantly higher amount of bone substitute implanted in the SG cage group compared to the FP cage group. The quantity of bone substitute filled in the SG cage group increased with the height of the cage. However, in the FP cage group, no significant difference was observed between the 12 mm and 14 mm subgroups. Utilizing oblique lumbar interbody fusion cages with side holes for bone substitute filling after implantation offers several advantages. It reduces scatter and increases the amount of implanted bone substitute. Additionally, it effectively addresses the challenge of insufficient fusion surface area caused by gaps between the cage and endplates. The use of cages with side holes facilitates greater bone substitute implantation, ultimately enhancing the success of fusion. This study provides valuable insights for future advancements in oblique lumbar interbody fusion cage design, highlighting the effectiveness of using cages with side holes for bone substitute filling after implantation.

Comparison the effect of gelatin sponge and epinephrine-soaked gauze for hemostasis and pain control after hemorrhoidal surgery.

Post-operative pain and bleeding are the main complications following hemorrhoidal surgery. This study aimed to investigate whether an absorbable gelatin sponge is a superior hemostatic and analgesic agent compared to gauze soaked in epinephrine for post-hemorrhoidal surgery care. A retrospective study was conducted using data from a single institute. Data were collected from the electronic medical record database and outpatient patient questionnaire archive. The study encompassed 143 patients who received gauze soaked in epinephrine as the hemostatic agent after hemorrhoidal surgery and 148 patients who received an absorbable gelatin sponge. Most patients underwent stapled hemorrhoidopexy, with 119 (83.2%) in epinephrine group and 118 (79.7%) in gelatin sponge group. The primary outcome measurements were postoperative pain score, oral analgesic dosage and complications. Patients in the absorbable gelatin sponge group reported significantly lower pain scores from 8 h after their hemorrhoidal surgery (postoperative day 0) through postoperative day 2. The average pain scores in the absorbable gelatin sponge group and gauze soaked in epinephrine group were 5.3 ± 3.2 and 6.2 ± 3.2 (p = 0.03) on postoperative 8 h; 4.7 ± 3.0 and 5.8 ± 2.9 (p ≤ 0.01) on postoperative day one; and 4.4 ± 2.8 and 5.3 ± 2.9 (p = 0.01) on postoperative day two, respectively. There were no significant differences in postoperative recovery or complication rates between the two groups. Our study revealed that absorbable gelatin sponges provide more effective pain relief to patients during the initial postoperative days after hemorrhoidal surgery, without any adverse impact on patient outcomes. Consequently, absorbable gelatin sponges are recommended as a replacement for gauze soaked in epinephrine following hemorrhoidal surgery.

Prediction of 5-Year Weight Loss and Weight Regain According to Early Weight Loss after Sleeve Gastrectomy.

BACKGROUND: Patients with morbid obesity exhibit sustained weight loss after sleeve gastrectomy (SG), but some individuals exhibit subsequent weight regain in the following years. Early weight loss was proven as a predictor of short- and mid-term weight loss and regain. However, the long-term effects of early weight loss have yet to be fully investigated. This study investigated the predictive effects of early weight loss on long-term weight loss and regain after SG. METHODS: Data of patients who underwent SG from November 2011 to July 2016 and followed through July 2021 were collected retrospectively. Weight regain was defined by weight increase more than 25% of their lost weight at the first postoperative year. Linear regression analysis and Cox proportional hazards analysis were performed to evaluate the correlations among early weight loss, weight loss, and weight regain. RESULTS: Data of 408 patients were included. The percentages of total weight loss (%TWL) at postoperative months 1, 3, 12, and 60 were 10.6%, 18.1%, 29.3%, and 26.6%, respectively. The %TWL at months 1 and 3 were significantly correlated with %TWL after 5 years (P < .01). The weight regain rate was 29.8% at 5 years. The %TWL at months 1 and 3 significantly influenced weight regain (hazard ratio: 0.87 and 0.89, P = .017 and .008). CONCLUSION: Early weight loss may be used to predict weight loss and regain 5 years after SG. Patients with poor early weight loss are recommended to receive early interventions to achieve long-term weight loss and prevent weight regain.

The necessity of preoperative enema preparation for hemorrhoidal surgery: a single-center comparative study.

BACKGROUND: Hemorrhoidal surgery is a common treatment for high-grade hemorrhoids. The necessity of preoperative enema preparation (PEP) in hemorrhoidal surgery is inconclusive. This study aims to evaluate the benefit and safety of PEP in hemorrhoidal surgery. METHODS: This comparative study analyzed data from electronic medical record database and outpatient questionnaire archive. Data of patients who underwent hemorrhoidal surgery from March 2020 to February 2021 were obtained. Patients were allocated to either the PEP or non-PEP group. Primary outcome measurements were postoperative pain and oral analgesic use. Secondary outcomes were the number of days until first defecation, length of hospital stay, time to return to work, incidence of urinary retention, delayed bleeding, and local infection. RESULTS: Data of 270 consecutive patients, with 130 and 140 in the PEP and non-PEP groups, respectively, who underwent hemorrhoidal surgery were analyzed. Most patients underwent stapled hemorrhoidopexy, with 106 (81.54%) in PEP group and 113 (80.71%) in non-PEP group. The mean pain score was significantly higher in PEP than in non-PEP group at day 0 (6.21 ± 3.23 vs 5.31 ± 3.14), day 1 (5.79 ± 2.89 vs 4.68 ± 3.02), and day 2 (5.35 ± 2.86 vs 4.42 ± 2.76). No significant differences in postoperative recovery or complications rate were noted between groups. CONCLUSION: Our findings revealed that performing PEP before hemorrhoidal surgery produced no benefit when compared with not performing PEP. Typically, the procedure of PEP is inconvenient and discomforting for patients. Therefore, we suggest that it can be omitted in hemorrhoidal surgery.

Effect of patient decision aids on decisional conflict and regret associated with breast cancer surgery: a randomized controlled trial.

BACKGROUND: Patients with breast cancer encounter difficulties in making surgical treatment decisions. Shared decision-making (SDM) with patient decision aids (PDAs) can minimize patients' decisional conflicts. However, the effect of PDAs in Asia remains inconclusive. This study investigated the effect of SDM assisted by PDAs on the decisional conflict of patients with breast cancer. METHODS: In this two-group, outcome assessor-blind, randomized controlled trial, 151 patients diagnosed as having breast cancer were assigned to the PDA (SDM with PDA) group or the standard (SDM without PDA) group. Demographic and clinical variables were analyzed to identify variables affecting the treatment choice. The patients' decision-making difficulties were evaluated using the four-item SURE scale during preoperative hospitalization, and decisional conflicts were examined using the five-item Decision Regret scale and Hospital Anxiety and Depression Scale (HADS) 1 month after surgery. RESULTS: The choice of breast conservation therapy and mastectomy did not significantly differ between the PDA and standard groups. The PDA group had a higher level of depression after making decisions (P = 0.029) than did the standard group. No significant difference in the total scores of the SURE scale and Decision Regret scale were noted between the groups. CONCLUSION: PDAs did not assist the patients with breast cancer in making breast surgery-related decisions. Clinicians should focus on SDM grounded in evidence-based medicine with care and help patients consider their individual preferences. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03105076; April 7, 2017 ( http://www. CLINICALTRIALS: gov ).

Atypical Teratoid/Rhabdoid Tumor in Taiwan: A Nationwide, Population-Based Study.

BACKGROUND: Atypical teratoid/rhabdoid tumor (AT/RT) is a rare, highly aggressive embryonal brain tumor most commonly presenting in young children. METHODS: We performed a nationwide, population-based study of AT/RT (ICD-O-3 code: 9508/3) in Taiwan using the Taiwan Cancer Registry Database and the National Death Certificate Database. RESULTS: A total of 47 cases (male/female = 29:18; median age at diagnosis, 23.3 months (IQR: 12.5-87.9)) were diagnosed with AT/RT between 1999 and 2014. AT/RT had higher prevalence in males (61.70%), in children < 36 months (55.32%), and at infratentorial or spinal locations (46.81%). Survival analyses demonstrated that patients ≥ 3 years of age (n = 21 (45%)) had a 5y-OS of 41% (p < 0.0001), treatment with radiotherapy only (n = 5 (11%)) led to a 5y-OS of 60%, treatment with chemotherapy with or without radiotherapy (n = 27 (62%)) was associated with a 5y-OS of 45% (p < 0.0001), and patients with a supratentorial tumor (n = 11 (23%)) had a 5y-OS of 51.95%. Predictors of better survival on univariate Cox proportional hazard modeling and confirmed with multivariate analysis included older age (≥1 year), supratentorial sites, and the administration of radiotherapy, chemotherapy, or both. Gender had no effect on survival. CONCLUSION: Older age, supratentorial site, and treatment with radiotherapy, chemotherapy, or both significantly improves the survival of patients with AT/RT.

Outcomes of Sentinel Node Biopsy for Women with Breast Cancer After Neoadjuvant Therapy: Systematic Review and Meta-Analysis of Real-World Data.

BACKGROUND: Evidence on the accuracy of sentinel lymph node biopsy (SLNB) after neoadjuvant therapy (NAT) for patients with breast cancer is inconclusive. This study reviewed the real-world data to determine the acceptability of SLNB after NAT. METHODS: The study searched for articles in the PubMed, EMBASE, and Cochrane Library databases. The primary outcomes were the identification rate for sentinel lymph nodes (SLNs) and the false-negative rate (FNR) for SLNB. The study also evaluated the FNR in subgroups defined by tumor stage, nodal stage, hormone receptor status, human epidermal growth factor receptor-2 status, tumor response, mapping technique, and number of SLNs removed. RESULTS: The study retrieved 61 prospective and 18 retrospective studies with 10,680 initially cN± patients. The pooled estimate of the identification rate was 0.906 (95 % confidence interval [CI], 0.891-0.922), and the pooled FNR was 0.118 (95 % CI, 0.103-0.133). In subgroup analysis, the FNR was significantly higher for the patients with estrogen receptor (ER)-negative status and fewer than three SLNs removed. The FNR did not differ significantly between the patients with and those without complete tumor response. Among the patients with initial clinical negative axillary lymph nodes, the incidence of node metastasis was 26.8 % (275/1041) after NAT. CONCLUSION: Real-world evidence indicates that the FNR of SLNB after NAT in breast cancer is 11.8 %, exceeding only slightly the commonly adopted threshold of 10 %. The FNR is significantly higher for patients with ER-negative status and removal of fewer than three SLNs. Using a dual tracer and removing at least three SLNs may increase the accuracy of SLNB after NAT.

Iatrogenic Vocal Fold Paralysis: A Population-Based Cohort Study in Taiwan.

OBJECTIVE: Iatrogenic vocal fold paralysis is an important issue in laryngology, yet there are few population-based studies regarding the epidemiology. This study used a nationwide population-based claims database (the National Health Insurance Research Database) to investigate the epidemiology of iatrogenic unilateral and bilateral vocal fold paralysis (UVFP/BVFP) among the general adult population in Taiwan. METHOD: This study analyzed patients (20-90 years old) who underwent thyroid, parathyroid, thoracic, cardiac, or anterior cervical spine operations with vocal fold paralysis among adults in Taiwan from January 1, 2007 to December 31, 2013. The codes for vocal fold paralysis were defined by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). Claims data in the Taiwan National Health Insurance Research Database were used. RESULTS: The most commonly performed operations which were related to vocal fold paralysis in Taiwan were, in descending order of frequency, thyroid, cervical spine, cardiac, thoracic (esophagectomy), and parathyroid operations. The operations that put laryngeal nerves at risk (ONRs) most commonly associated with a diagnosis of UVFP were, in descending order of frequency, thoracic, thyroid, parathyroid, cardiac, and cervical spine. For both UVFP and BVFP, the most commonly associated age group was 51 to 60. For both UVFP and BVFP, the more commonly associated sex was women. Increased length of stay was associated with a higher incidence of UVFP and BVFP. Charlson medical co-morbidity index (CCI) was not associated with UVFP but BVFP was associated with higher Charlson medical co-morbidity scores. CONCLUSIONS: Thyroid operations, age 51 to 60, longer hospital stays are associated with vocal fold paralysis. Overall women are more surgically affected than men. This is the first population-based study of iatrogenic vocal fold paralysis.

Lifestyle and behavioral modifications made by patients with interstitial cystitis.

Interstitial cystitis/bladder pain syndrome (IC/BPS) negatively affects the quality of life. In this study, we investigated the lifestyle behavioral changes patients with IC/BPS make to cope with their symptoms. This prospective study was conducted between August 2018 and June 2019. All patients had a primary symptom of suprapubic pain with a full bladder and other lower urinary tract symptoms for more than 6 weeks as well as cystoscopic findings. All participants completed our self-developed questionnaire, which included informations about their living and work environment, occupational garments, dietary habits, and personal habits. Continuous variables were compared using an independent sample t test, and categorical variables were compared using a chi-square test. We recruited 86 patients with IC/BPS and age-matched 86 controls without IC/BPS. In our study, patients with IC/BPS had more cranberry intake (45.34% vs. 5.81%, P < 0.05) than non-IC/BPS controls; the IC/BPS group had decreased consumption of coffee and spicy food; and wore less makeup or special work garments. In conclusion, patients with IC/BPS tend to make several lifestyle behavioral changes to cope with their symptoms.

Comparison Between Transposed Brachiobasilic Fistula and Arteriovenous Graft for Upper Limb Arteriovenous Access in Patients on Hemodialysis.

BACKGROUND: Creating and maintaining a functioning arteriovenous access is essential for long-term hemodialysis patients. Transposed brachiobasilic fistula (BBF) or arteriovenous graft (AVG) becomes an option when radiocephalic or brachiocephalic fistula cannot be created or fails. This study compared the patency and complications between BBFs and AVGs among patients on hemodialysis. METHODS: A retrospective study was performed in Shuang Ho Hospital, Taiwan, from November 2015 to May 2020. All the operations were done by a single surgeon. Primary outcomes were primary patency, primary-assisted patency, and secondary patency of the BBF and AVG groups. Secondary outcomes were incidence of complications and reinterventions. RESULTS: Of the 144 consecutive patients, 20 and 124 patients underwent BBF and AVG creation, respectively. Median follow-up time was 19.2 months. Primary patency at 1 and 2 years were 67% and 19% in the BBF group and 44% and 16% in the AVG group (P = 0.126). Primary-assisted patency at 1 and 2 years were 82% and 54% in the BBF group and 54% and 30% in the AVG group (P = 0.012). Secondary patency at 1 and 2 years were 100% and 82% in the BBF group and 81% and 67% in the AVG group (P = 0.078). The incidence of complication was significantly higher in the AVG than in the BBF group (1.7 per patient-year vs 0.93, P < 0.001). CONCLUSION: Compared with the AVG group, BBF group showed better primary-assisted patency, less complication and intervention rates. Therefore, BBF is a reliable option for patients with exhausted cephalic veins if basilic vein is available for reconstruction.

Outcomes of Adjuvant Oral versus Intravenous Fluoropyrimidines for High-Risk Stage II or Stage III Colon Adenocarcinoma: A Propensity Score-Matched, Nationwide, Population-Based Cohort Study.

Objective: We conducted this propensity score (PS)-matched, nationwide, population-based cohort study to estimate the effects of adjuvant oral or intravenous (IV) fluoropyrimidine in patients with high-risk stage II or III colon adenocarcinoma. Design: Using PS matching, we minimized the confounding effects on adjuvant oral or IV fluoropyrimidine outcomes in patients with high-risk stage II or III resectable colon adenocarcinoma. Setting: We selected patients from the Taiwan Cancer Registry database receiving adjuvant fluoropyrimidine monotherapy and divided them into those receiving IV fluoropyrimidine (IV group) and those receiving oral fluoropyrimidine (oral group). Results: In both univariate and multivariate Cox regression analyses, the adjusted hazard ratio (aHR) derived for the oral group was 1.34 (95% CI: 1.19-1.51) compared with the IV group. Moreover, in both univariate and multivariate analyses, aHR derived for significant independent prognostic risk factors for poor overall survival were male sex, age ≥ 60 years old, pathologic stage III, right-sided colon cancer, low income, and high Charlson comorbidity index. However, intergroup differences were not significant among female patients or patients < 60 years old on multivariate analysis, including no difference in overall survival. Conclusions: Adjuvant IV fluoropyrimidine is more suitable than adjuvant oral fluoropyrimidine for patients with stage II colon adenocarcinoma who have high-risk pathologic features or stage III colon adenocarcinoma.

Persistence of pregabalin treatment in Taiwan: a nation-wide population-based study.

BACKGROUND: Pregabalin is approved for the treatment of neuropathic pain, fibromyalgia, and seizure disorders, although the pivotal trials were mostly carried out in Europe or North America. The prescribing patterns among different indications in Asia have rarely been explored. METHODS: This was a population-based retrospective cohort study based on the National Health Insurance Research Database in Taiwan. Prescriptions of pregabalin were identified, and data regarding demographics, indications, co-existing diagnoses, and concomitant medications were extracted. Pregabalin users were followed for at least one year, and factors associated with persistence at one year were determined by using multivariate logistic regression analysis. RESULTS: Between June 2012 and December 2016, 114,437 pregabalin users (mean age 60.7 ± 15.4 years, 57.8% female) were identified. The indications included post-herpetic neuralgia (PHN) (30.5%), musculoskeletal diseases other than fibromyalgia (21.2%), fibromyalgia (18.4%), diabetic peripheral neuropathic pain (DPNP) (11.7%) and epilepsy (2.9%). Overall, 62.5% and 6.4% of patients achieved a maximum dose of ≥150 and ≥ 300 mg/day, respectively. The median duration of persistent pregabalin use was 28 days (interquartile range 14-118 days). The one-year persistence rate was 12.1%, and the indications associated with the highest and lowest persistence rates were epilepsy (42.4%) and PHN (6.1%), respectively. Male gender (odds ratio [OR] 1.14, 95% confidence interval [CI] 1.09-1.18), older age (OR 1.01 per year, 95% CI 1.01-1.01), indications other than PHN, especially epilepsy (OR 8.04, 95% CI 7.33-8.81, PHN as reference), and a higher initial dose (OR 1.12 per 75 mg, 95% CI = 1.10-1.15) were associated with persistence at one year, whereas the initial concomitant use of antiviral agents decreased the likelihood (OR 0.41, 95% CI 0.35-0.47). CONCLUSIONS: Pregabalin prescriptions for pain disorders were limited to short-term use, which is consistent around the world. However, the average prescribed dose in Taiwan was lower than those in Western countries, and was frequently below the recommended ranges. Potential causes included the duration of natural history of PHN, and off-label prescriptions for pain in acute herpes zoster, rather than PHN, as well as intolerance to the side effects.

Antiplatelet agents maintain arteriovenous fistula and graft function in patients receiving hemodialysis: A nationwide case-control study.

BACKGROUND: In this study, we evaluated the effects of various medications on the patency of vascular access (VA) for hemodialysis. METHODS: We analyzed data from the Longitudinal Health Insurance Database of Taiwan. We adopted a case-control study design within a cohort of patients who had received regular hemodialysis between 2002 and 2012; 34,354 patients with first VA failure were identified, and the duration from VA creation date to the first VA failure date was calculated. We then classified these patients into two groups, namely arteriovenous fistula (AVF, n = 25,933) and arteriovenous graft (AVG, n = 8,421). Each group was further divided into two subgroups, namely short-term (<1 year) and long-term (≥1 year) patency. RESULTS: The risk factors for early VA failure were age ≥65 years, diabetes mellitus, hyperlipidemia, cerebral vascular disease, congestive heart failure, peripheral artery disease, and sepsis. Male sex, hypertension, cancer, and peptic ulcer were associated with early AVF failure. Antiplatelet therapy increased the AVF and AVG patency times with adjusted odds ratios of 0.748 (95% confidence interval [CI]: 0.703-0.796, p < 0.0001) and 0.810 (95% CI: 0.728-0.901, p = 0.0001), respectively. A significant decrease in the VA failure risk was observed with an increase in the cumulative defined daily dose of antiplatelet agents. CONCLUSION: This nationwide study demonstrated that some risk factors were associated with early VA failure and that the use of antiplatelet agents prevented the loss of VA patency in a dose-response manner. Thus, antiplatelet drugs should be routinely administered to high-risk patients receiving dialysis.

Efficacy of thoracic radiotherapy in patients with stage IIIB-IV epidermal growth factor receptor-mutant lung adenocarcinomas who received and responded to tyrosine kinase inhibitor treatment.

PURPOSE: Large-scale, prospective, randomized studies of the efficacy of thoracic radiotherapy (RT) in patients with unresectable stage IIIB-IV epidermal growth factor receptor (EGFR)-mutant lung adenocarcinomas who received and responded to EGFR tyrosine kinase inhibitor (TKI) treatment are not currently available. Therefore, we designed a propensity score-matched, nationwide, population-based, cohort study for estimating the effects of thoracic RT on patients with EGFR-mutant lung adenocarcinomas. PATIENTS AND METHODS: We analyzed patients with unresectable stage IIIB-IV EGFR mutant lung adenocarcinomas and categorized them into two groups according to treatment modality and compared their outcomes; groups 1 and 2 consisted of patients who received EGFR TKI treatment alone until tumor progression and those who received and responded to EGFR TKI treatment and subsequently received thoracic RT for lung tumors, respectively. The patients in groups 2 and 1 were matched at a ratio of 1:4. RESULTS: The matching process yielded a final cohort of 1475 patients (1180 and 295 patients in groups 1 and 2, respectively) who were eligible for further analysis. According to both univariate and multivariate Cox regression analyses, the adjusted hazard ratios (aHRs) (95% confidence interval [CI]) derived for thoracic RT for lung tumor after EGFR TKI use and tumor response (group 2) compared with EGFR TKI treatment alone (group 1) was 0.72 (0.60-0.85). CONCLUSIONS: Thoracic RT might be associated with overall survival in patients with unresectable stage IIIB-IV EGFR-mutant lung adenocarcinomas who received and responded to EGFR TKI treatment.

Association Between Middle Ear Cholesteatoma and Chronic Rhinosinusitis.

Importance: Chronic rhinosinusitis (CRS) can cause an obstruction of the tubal orifice and thereby compromise ventilation of the middle ear. The resulting negative pressure in the middle ear may, in turn, lead to the formation of an eardrum retraction pocket and subsequent acquired cholesteatoma. This study hypothesizes that CRS may increase the risk of cholesteatoma. Objective: To evaluate the risk of cholesteatoma in patients with CRS. Design, Setting, and Participants: This study used a nationwide, population-based claims database to test the hypothesis that CRS may increase the risk of cholesteatoma. The Longitudinal Health Insurance Database of Taiwan was used to compile data from (1) 12 670 patients with newly diagnosed CRS between January 1, 1997, and December 31, 2002, and (2) a comparison cohort of 63 350 matched individuals without CRS, resulting in a CRS vs control ratio of 1:5. Data analysis was performed from June 1 to October 27, 2015. Each patient was followed up for 8 years to identify those in whom cholesteatoma subsequently developed. The Kaplan-Meier method was used to determine the cholesteatoma-free survival rate, and the log-rank test was used to compare survival curves. Cox proportional hazards regression models were used to compute the 8-year hazard ratios (HRs). Main Outcomes and Measures: Diagnosis of cholesteatoma. Results: Among the 76 020 patients enrolled in this study, 35 220 (46.3%) were female; mean (SD) age was 27.57 (22.03) years. A total of 209 patients developed cholesteatoma, 66 (101 084 person-years) individuals from the CRS cohort and 143 (506 540 person-years) from the comparison cohort were diagnosed with cholesteatoma during the 8-year follow-up period. The incidence of cholesteatoma per 1000 person-years was more than twice as high among patients with CRS (0.65; 95% CI, 0.50-0.81 person-years) than among those without CRS (0.28; 95% CI, 0.24-0.33). The absolute difference in the incidence density between CRS and non-CRS group was 0.37 (95% CI, 0.21-0.53) per 1000 patient-years. After adjusting for potential confounders, patients with CRS had a 69% increased risk of cholesteatoma within 8 years, compared with those without CRS (HR, 1.69; 95% CI, 1.23-2.32). Patients with CRS presented a significantly lower 8-year cholesteatoma-free survival rate than did those in the comparison group. The absolute difference in the 8-year cholesteatoma-free survival rate between the CRS and non-CRS groups was 0.0029 (95% CI, 0.0016-0.0043). Conclusions and Relevance: This is the first large-scale study, to date, to demonstrate a prospective link between CRS and the subsequent development of cholesteatoma within a follow-up period of 8 years. The purpose of the study was to draw attention to the possibility of development of cholesteatoma among patients with CRS. Because that possibility exists, clinicians should keep this association in mind as well as the importance of a thorough head and neck examination.

Effectiveness of esophagectomy in patients with thoracic esophageal squamous cell carcinoma receiving definitive radiotherapy or concurrent chemoradiotherapy through intensity-modulated radiation therapy techniques.

BACKGROUND: Few large, prospective, randomized studies have investigated the effectiveness of esophagectomy in patients with thoracic esophageal squamous cell carcinoma (TESCC) who receive definitive radiotherapy (RT) or concurrent chemoradiotherapy (CCRT) through modern, intensity modulated-RT (IMRT) techniques. The therapeutic effects of esophagectomy in patients with TESCC were evaluated using modern clinical staging and RT techniques and suitable RT doses. METHODS: The authors analyzed data from patients with TESCC from the Taiwan Cancer Registry database. Patients were categorized into the following groups on the basis of treatment modality to compare their outcomes: group 1 received definitive CCRT, group 2 received neoadjuvant RT followed by esophagectomy (total IMRT dose, ≥50 grays [Gy]), and group 3 receiving neoadjuvant CCRT followed by esophagectomy (total IMRT dose, ≥ 50 Gy). The median total RT dose and fraction size were 50.4 Gy and 1.8 Gy per fraction, respectively. Group 1 was used as the control arm for investigating the risk of mortality after treatment. RESULTS: In total, 3123 patients who had TESCC without distant metastasis were enrolled. Patient ages 65 years and older, Charlson comorbidity index scores ≥3, advanced clinical stages (IIA-IIIC), alcohol consumption, and cigarette smoking were identified as significant, independent poor prognostic risk factors for overall survival in multivariate Cox regression analyses. In group 3, after adjustment for confounders, the adjusted hazard ratios (95% confidence intervals [CIs]) for overall mortality were 0.62 (95% CI, 0.41-0.93) for patients with clinical stage IIA disease, 0.61 (95% CI, 0.41-0.91) for those with clinical stage IIB disease, 0.47 (95% CI, 0.38-0.55) for those with clinical stage IIIA disease, 0.47 (95% CI, 0.39-0.56) for those with clinical stage IIIB disease, and 0.46 (95% CI, 0.37-0.57) for those with clinical stage IIIC disease. CONCLUSIONS: Esophagectomy can be beneficial in patients with TESCC after definitive CCRT, especially in those who have advanced-stage disease. Cancer 2017;123:2043-2053. © 2017 American Cancer Society.

Survival prognostic factors for metachronous second primary head and neck squamous cell carcinoma.

We examined the overall survival rates of a national cohort to determine optimal treatments and prognostic factors for patients with metachronous second primary head and neck squamous cell carcinomas (mspHNSCCs) at different stages and sites. We analyzed data of mspHNSCC patients collected from the Taiwan Cancer Registry database. The patients were categorized into four groups based on the treatment modality: Group 1 (control arm; chemotherapy [CT] alone), Group 2 (reirradiation [re-RT] alone with intensity-modulated radiotherapy [IMRT]), Group 3 (concurrent chemoradiotherapy alone [irradiation with IMRT]), and Group 4 (salvage surgery with or without RT or CT). We enrolled 1741 mspHNSCC patients without distant metastasis. Multivariate Cox regression analyses revealed that Charlson comorbidity index (CCI) ≥6, stage of second HNSCC, stage of first HNSCC, and duration from first primary HNSCC of <3 years were significant poor independent prognostic risk factors for overall survival. After adjustment, adjusted hazard ratios and 95% confidence intervals for the overall all-cause mortality risk at mspHNSCC clinical stages III and IV were 0.72 (0.40-1.82), 0.52 (0.35-0.75), and 0.32 (0.22-0.45) in Groups 2, 3, and 4, respectively. A Cox regression analysis indicated that a re-RT dose of ≥6000 cGy was an independent protective prognostic factor for treatment modalities. CCI ≥ 6, stage of second HNSCC, stage of first HNSCC, and duration from first primary HNSCC of <3 years were significant poor independent prognostic risk factors for overall survival. A re-RT dose of ≥6000 cGy may be necessary for mspHNSCCs.

Curative-Intent Aggressive Treatment Improves Survival in Elderly Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma and High Comorbidity Index.

For locally advanced head and neck squamous cell carcinoma (HNSCC), therapeutic decisions depend on comorbidity or age. We estimated the treatment outcomes of patients with different Charlson comorbidity index (CCI) scores and ages to determine whether aggressive treatment improves survival.Data from the Taiwan National Health Insurance and cancer registry databases were analyzed, and we included >20-year-old patients with American Joint Committee on Cancer (AJCC) stage III or IV HNSCC (International Classification of Diseases, Ninth Revision, Clinical Modification codes 140.0-148.9) undergoing surgery, chemotherapy (CT), radiotherapy (RT), concurrent chemoradiotherapy (CCRT), sequential CT and RT, or surgery with adjuvant treatment. The exclusion criteria were a past cancer history, distant metastasis, AJCC stage I or II, missing sex data, an age < 20 years, nasopharyngeal cancer, in situ carcinoma, sarcoma, and HNSCC recurrence. The index date was the date of first HNSCC diagnosis, and comorbidities were scored using the CCI. The enrolled patients were categorized into Group 1 (curative-intent aggressive treatments) and Group 2 (best supportive care or palliative treatments).We enrolled 21,174 stage III or IV HNSCC patients without distant metastasis (median follow-up, 3.25 years). Groups 1 and 2 comprised 18,584 and 2232 patients, respectively. After adjustment for age, sex, and clinical stage, adjusted hazard ratios (95% confidence intervals) of overall death in Group 1 were 0.33 (0.31-0.35), 0.34 (0.31-0.36), and 0.37 (0.28-0.49), and those of all-cause death among patients undergoing curative surgical aggressive treatments were 1.13 (0.82-1.55), 0.67 (0.62-0.73), and 0.49 (0.46-0.53) for CCI scores of ≥10, 5 to 9, and <5, respectively.Aggressive treatments improve survival in elderly (≥65 years) and critically ill HNSCC patients. Curative nonsurgical aggressive treatments including definitive RT or CCRT might be suitable for HNSCC patients with CCI scores ≥10.