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Objectives@#. Particulate matter (PM) is a risk factor for various diseases. Recent studies have established an association between otitis media (OM) and PM exposure. To confirm this relationship, we developed a novel exposure model designed to control the concentration of PM, and we observed the effects of PM exposure on the Eustachian tube (ET) and middle ear mucosa of rats. @*Methods@#. Forty healthy, 10-week-old, male Sprague-Dawley rats were divided into 3-day, 7-day, 14-day exposure, and control groups (each, n=10). The rats were exposed to incense smoke as the PM source for 3 hours per day. After exposure, bilateral ETs and mastoid bullae were harvested, and histopathological findings were compared using microscopy and transmission electron microscopy (TEM). The expression levels of interleukin (IL)-1β, IL-6, tumor necrosis factor-α, and vascular endothelial growth factor (VEGF) in the middle ear mucosa of each group were compared using real-time reverse transcription polymerase chain reaction (RT-PCR). @*Results@#. In the ET mucosa of the exposure group, the goblet cell count significantly increased after PM exposure (P=0.032). In the middle ear mucosa, subepithelial space thickening, increased angio-capillary tissue, and inflammatory cell infiltration were observed. Moreover, the thickness of the middle ear mucosa in the exposure groups increased compared to the control group (P<0.01). The TEM findings showed PM particles on the surface of the ET and middle ear mucosa, and RT-PCR revealed that messenger RNA (mRNA) expression of IL-1β significantly increased in the 3-day and 7-day exposure groups compared to the control group (P=0.035). VEGF expression significantly increased in the 7-day exposure group compared to the control and 3-day exposure groups (P<0.01). @*Conclusion@#. The ET and middle ear mucosa of rats showed histopathologic changes after acute exposure to PM that directly reached the ET and middle ear mucosa. Therefore, acute exposure to PM may play a role in the development of OM.
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Purpose@#The purpose of this phase II trial was to evaluate whether the addition of simvastatin, a synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, to preoperative chemoradiotherapy (CRT) with capecitabine confers a clinical benefit to patients with locally advanced rectal cancer (LARC). @*Materials and Methods@#Patients with LARC (defined by clinical stage T3/4 and/or lymph node positivity) received preoperative radiation (45-50.4 Gy in 25-28 daily fractions) with concomitant capecitabine (825 mg/m2 twice per day) and simvastatin (80 mg, daily). Curative surgery was planned 4-8 weeks after completion of the CRT regimen. The primary endpoint was pathologic complete response (pCR). The secondary endpoints included sphincter-sparing surgery, R0 resection, disease-free survival, overall survival, the pattern of failure, and toxicity. @*Results@#Between October 2014 and July 2017, 61 patients were enrolled; 53 patients completed CRT regimen and underwent total mesorectal excision. The pCR rate was 18.9% (n=10) by per-protocol analysis. Sphincter-sparing surgery was performed in 51 patients (96.2%). R0 resection was achieved in 51 patients (96.2%). One patient experienced grade 3 liver enzyme elevation. No patient experienced additional toxicity caused by simvastatin. @*Conclusion@#The combination of 80 mg simvastatin with CRT and capecitabine did not improve pCR in patients with LARC, although it did not increase toxicity.
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Bilateral internal auditory canal (IAC) tumors are usually pathognomonic for vestibular schwannomas in the setting of neurofibromatosis type 2 (NF2). Descriptions of bilateral nonschwannomatous IAC tumors, such as metastasis that may mimic NF2, are limited to case reports. Here, we report a case of unusual metastatic bilateral IAC tumor originating from the ovary with a rapidly progressive pattern, which we initially suspected to be NF2.
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Flap surgery may be required in cases of severe contact burns. The authors report a patient with an exposed knee joint. A 47-year-old man experienced a wide and deep contact burn on his right knee from a stove while under the influence of alcohol. The patient underwent escharectomy, medial and lateral gastrocnemius muscle flap surgery, pedicled anterolateral thigh flap surgery with a meshed scalp split-thickness skin graft, and secondary antegrade peroneal fasciocutaneous flap surgery with a thigh split-thickness skin graft. The patient was able to walk with a hinged brace at 2 months after surgery.
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Flap surgery may be required in cases of severe contact burns. The authors report a patient with an exposed knee joint. A 47-year-old man experienced a wide and deep contact burn on his right knee from a stove while under the influence of alcohol. The patient underwent escharectomy, medial and lateral gastrocnemius muscle flap surgery, pedicled anterolateral thigh flap surgery with a meshed scalp split-thickness skin graft, and secondary antegrade peroneal fasciocutaneous flap surgery with a thigh split-thickness skin graft. The patient was able to walk with a hinged brace at 2 months after surgery.
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Purpose@#Diagnostic biomarkers of pancreatic ductal adenocarcinoma (PDAC) have been used for early detection to reduce its dismal survival rate. However, clinically feasible biomarkers are still rare. Therefore, in this study, we developed an automated multi-marker enzyme-linked immunosorbent assay (ELISA) kit using 3 biomarkers (leucine-rich alpha-2-glycoprotein [LRG1], transthyretin [TTR], and CA 19-9) that were previously discovered and proposed a diagnostic model for PDAC based on this kit for clinical usage. @*Methods@#Individual LRG1, TTR, and CA 19-9 panels were combined into a single automated ELISA panel and tested on 728 plasma samples, including PDAC (n = 381) and normal samples (n = 347). The consistency between individual panels of 3 biomarkers and the automated multi-panel ELISA kit were accessed by correlation. The diagnostic model was developed using logistic regression according to the automated ELISA kit to predict the risk of pancreatic cancer (high-, intermediate-, and low-risk groups). @*Results@#The Pearson correlation coefficient of predicted values between the triple-marker automated ELISA panel and the former individual ELISA was 0.865. The proposed model provided reliable prediction results with a positive predictive value of 92.05%, negative predictive value of 90.69%, specificity of 90.69%, and sensitivity of 92.05%, which all simultaneously exceed 90% cutoff value. @*Conclusion@#This diagnostic model based on the triple ELISA kit showed better diagnostic performance than previous markers for PDAC. In the future, it needs external validation to be used in the clinic.
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Objective@#To investigate the effect of gestational weight gain (GWG) on maternal and neonatal outcomes based on the Institute of Medicine (IOM) guidelines for twin pregnancies. @*Methods@#This study included women with twin pregnancies who delivered at Seoul National University Bundang Hospital. Based on the weight gain per gestational week according to the 2009 IOM guidelines, the subjects were divided into the following 3 groups: inadequate, adequate, and excessive GWG. We compared the maternal and neonatal outcomes of each group. @*Results@#A total of 1,738 twin pregnancies were included in our study. Of these cases, 881, 694, and 163 (50.7%, 39.9%, and 9.4%, respectively) twin pregnancies were categorized into the inadequate, adequate, and excessive GWG groups, respectively. In the inadequate GWG group, the risks of preterm birth <34 weeks (aOR, 2.33, 95% confidence interval [CI], 1.63–3.34) and delivering neonates who were small for gestational age (aOR, 1.92, 95% CI, 1.42–2.60) were increased, and the risk of preeclampsia (aOR, 0.49, 95% CI, 0.32–0.76) was decreased. The excessive GWG group had an increased risk of the neonates being large for gestational age (aOR, 1.79, 95% CI, 1.15–2.81). @*Conclusion@#The 2009 IOM recommendations for GWG can be applied to Korean women with twin pregnancies to help achieve optimal maternal and neonatal outcomes. However, more than half of the women were categorized as having inadequate weight gain according to the guidelines. Further studies should be performed to obtain Korean national references for GWG in twin pregnancies.
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Background and Objectives@#The combined intratympanic and oral steroid treatment has been accepted as effective treatment strategy for idiopathic sudden sensorineural hearing loss (ISSNHL). However, the treatment protocol of combined treatment for ISSNHL has not been established. In this study, we investigated whether hearing outcome differed according to different starting timing of intratympanic steroid injection (ITSI) in combined treatment for ISSNHL.Subjects and Method Tertiary academic referral center-based retrospective medical records of idiopathic 144 ISSNHL patients who received combined treatment from January 2015 to April 2018 were reviewed. All patients underwent a 2-week oral systemic steroid treatment and multiple ITSI. The hearing results of 3 months after treatment were compared according to the timing of ITSI. @*Results@#The mean pure tone audiogram gain was 24.3±23.6 dB. When Siegel’s criteria was applied, the overall rate of hearing improvement was 63.9% (92/144). The rate of hearing improvement was significantly higher in women (p=0.043) statistically, and there was a statistically significant lower rate of recovery in the former history of hearing loss (p＜0.01) or otitis media (p＜0.01). Moreover, the shorter the delay between symptom onset and initial ITSI, greater the statistical significance of hearing recovery rate became (p＜0.01). @*Conclusion@#The result of this study suggests that early ITSI during combined intratympanic and oral steroid treatment increases the chance of hearing recovery.
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For proper treatment of recurrent anterior instability of the shoulder with a bone defect, the defect size should be assessed preoperatively with three-dimensional computed tomography or magnetic resonance imaging. In general, the risk of postoperative recurrence of instability is estimated on the basis of preoperative imaging of bipolar bone defects: more than 20%–25% glenoid bone loss and off-track Hill-Sachs lesions have been considered risk factors for recurrence. In patients with a glenoid bone defect more than 20%–25%, a bone graft procedure, such as the Latarjet procedure, is preferred regardless of the glenoid track concept, because compared with arthroscopic stabilization procedure, it provides greater postoperative stability. For patients with a borderline glenoid bone defect (around 20%), surgeons should discuss surgical options with the patients, considering their demand and physical activity level. In addition, the surgeon should take care to prevent postoperative instability and long-term complications. Arthroscopic soft-tissue reconstruction including labral repair and capsular plication combined with the additional remplissage procedure is an anatomical procedure and could be considered as one of the primary treatment methods for patients with glenoid bone defects around 20%. Therefore, treatment strategies for recurrent anterior shoulder instability combined with bone defects should be determined more flexibly on the basis of the patient’s individual condition.
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Objectives@#. Balloon Eustachian tuboplasty (BET) is a novel treatment method for Eustachian tube dilatory dysfunction (ETD). However, surgeons cannot identify the insertion depth of the catheter during BET, resulting in potential risks such as internal carotid artery (ICA) injury. Therefore, we developed an image-guided navigation balloon catheter to identify the insertion depth of the catheter and to establish awareness of the proximity of the ICA. This study aimed to evaluate the technical feasibility of this image-guided navigation balloon catheter system in patients with ETD. @*Methods@#. Twenty-nine patients (38 ears; nine bilateral; 21 right ears, and 17 left ears) diagnosed with ETD were assessed. All patients who showed no improvement despite medical therapy with topical steroids, anti-reflux medication, and the Valsalva maneuver for a minimum of 6 weeks received image-guided navigation-assisted BET. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score and Valsalva maneuver were used to evaluate patients’ symptoms preoperatively and at the postoperative follow-up. @*Results@#. Image-guided navigation-assisted BET was safely performed in all patients. The mean total ETDQ-7 score was 25.4±7.1 preoperatively, 17.5±6.2 at 1 month, and 15.2±7.0 at 6 months (P<0.001). In total, a Valsalva maneuver was possible for 28 of 38 ears (73.7%) at the time of the patient’s final visit at 6 months post-procedure. @*Conclusion@#. Image-guided navigation balloon catheters are a potentially valuable tool in patients with ETD. Their use is also technically feasible and safe when performing BET to treat ETD.
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Objectives@#. This study aimed to investigate whether optical coherence tomography (OCT) provides useful information about the microstructures of the middle and inner ear via extratympanic approach and thereby could be utilized as an alternative diagnostic technology in ear imaging. @*Methods@#. Five rats and mice were included, and the swept-source OCT system was applied to confirm the extent of visibility of the middle and inner ear and measure the length or thickness of the microstructures in the ear. The cochlea was subsequently dissected following OCT and histologically evaluated to compare with the OCT images. @*Results@#. The middle ear microstructures such as ossicles, stapedial artery and oval window through the tympanic membrane with the OCT could be confirmed in both rats and mice. It was also possible to obtain the inner ear images such as each compartment of the cochlea in the mice, but the bone covering bulla needed to be removed to visualize the inner ear structures in the rats which had thicker bulla. The bony thickness covering the cochlea could be measured, which showed no significant differences between OCT and histologic image at all turns of cochlea. @*Conclusion@#. OCT has been shown a promising technology to assess real-time middle and inner ear microstructures noninvasively with a high-resolution in the animal model. Therefore, OCT could be utilized to provide additional diagnostic information about the diseases of the middle and inner ear.
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Purpose@#We evaluated the efficacy and safety of avelumab, an anti-PD-L1 antibody, in patients with metastatic or unresectable colorectal cancer (mCRC) with mismatch repair deficiency (dMMR)/microsatellite instability-high (MSI-H) or POLE mutations. @*Materials and Methods@#In this prospective, open-label, multicenter phase II study, 33 patients with mCRC harboring dMMR/MSI-H or POLE mutations after failure of ≥1st-line chemotherapy received avelumab 10 mg/kg every 2 weeks. dMMR/MSI-H was confirmed with immunohistochemical staining (IHC) by loss of expression of MMR proteins or polymerase chain reaction (PCR) for microsatellite sequences. POLE mutation was confirmed by next-generation sequencing (NGS). The primary endpoint was the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors ver. 1.1. @*Results@#The median age was 60 years, and 78.8% were male. Thirty patients were dMMR/MSI-H and three had POLE mutations. The ORR was 24.2%, and all of the responders were dMMR/MSI-H. For 21 patients with MSI-H by PCR or NGS, the ORR was 28.6%. At a median follow-up duration of 16.3 months, median progression-free survival and overall survival were 3.9 and 13.2 months in all patients, and 8.1 months and not reached, respectively, in patients with MSI-H by PCR or NGS. Dose interruption and discontinuation due to treatment-related adverse events occurred in 4 and 2 patients, respectively, with no treatment-related deaths. @*Conclusion@#Avelumab displayed antitumor activity with manageable toxicity in patients with previously treated mCRC harboring dMMR/MSI-H. Diagnosis of dMMR/MSI-H with PCR or NGS could be complementary to IHC to select patients who would benefit from immunotherapy.
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Purpose@#The purpose of this study was to investigate the role of carcinoembryonic antigen (CEA) levelsin improving the performance of magnetic resonance imaging (MRI) for the predictionof pathologic response after the neoadjuvant chemoradiation (NCRT) for patients with rectalcancer. @*Materials and Methods@#We retrospectively reviewed the medical records of 524 rectal cancer patients who underwentNCRT and total mesorectal excision between January 2009 and December 2014. Theperformances of MRI with or without CEA parameters (initial CEA and CEA dynamics) forprediction of pathologic tumor response grade (pTRG) were compared by receiver-operatingcharacteristic analysis with DeLong’s method. Cox regression was used to identify the independentfactors associated to pTRG and disease-free survival (DFS) after NCRT. @*Results@#The median follow-up was 64.0 months (range, 3.0 to 113.0 months). On multivariate analysis,poor tumor regression grade on MRI (mrTRG; p < 0.001), initial CEA (p < 0.001) andthe mesorectal fascia involvement on MRI before NCRT (mrMFI; p=0.054) showed associationwith poor pTRG. The mrTRG plus CEA parameters showed significantly improved performancesin the prediction of pTRG than mrTRG alone. All of mrTRG, mrMFI, and initial CEAwere also identified as independent factors associated with DFS. The initial CEA further discriminatedDFS in the subgroups with good mrTRG or that without mrMFI. @*Conclusion@#The CEA parameters significantly improved the performance of MRI in the prediction ofpTRG after NCRT for patients with rectal cancer. The DFS was further discriminated by initialCEA level in the groups with favorable MRI parameters.
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Split-thickness skin grafting (STSG) is the gold standard for coverage of acute burns and reconstructive wounds. However, the choice of the donor site for STSG varies among surgeons, and the scalp represents a relatively under-utilized donor site. Understanding the validity of potential risks will assist in optimizing wound management. A comprehensive literature search was conducted of the PubMed database to identify studies evaluating scalp skin grafting in human subjects published between January 1, 1964 and December 31, 2019. Data were collected on early and late complications at the scalp donor site. In total, 27 articles comparing scalp donor site complications were included. The selected studies included analyses of acute burn patients only (21 of 27 articles), mean total body surface area (20 of 27), age distribution (22 of 27), sex (12 of 27), ethnicity (5 of 27), tumescent technique (21 of 27), depth setting of the dermatome (24 of 27), number of harvests (20 of 27), mean days of epithelization (18 of 27), and early and late complications (27 of 27). The total rate of early complications was 3.82% (117 of 3,062 patients). The total rate of late complications was 5.19% (159 of 3,062 patients). The literature on scalp skin grafting has not yet identified an ideal surgical technique for preventing donor site complications. Although scalp skin grafting provided superior outcomes with fewer donor site complications, there continues to be a lack of standardization. The use of scalp donor sites for STSG can prevent early and late complications if proper surgical planning, procedures, and postoperative care are performed.
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OBJECTIVE: To compare subsequent pregnancy outcomes according to the presence of acute histologic chorioamnionitis (HCA) in women with spontaneous preterm delivery (SPTD).METHODS: Among 1,706 women who gave birth twice or more at our institution, 138 women delivered spontaneously at preterm (<37.0 weeks). Subsequent deliveries occurred at our institution and placental biopsy results were available. The study population was categorized into 2 groups based on the presence of acute HCA at the time of SPTD: HCA group (n=52) and non-HCA group (n=86). The primary outcome measures were gestational age at delivery, birthweight, and frequency of preterm delivery in subsequent pregnancies.RESULTS: The median gestational age at the time of SPTD was 34.0 weeks (interquartile range [IQR], 28.9–35.3 weeks), and the frequency of acute HCA was 52/138 (38%). There were no differences in gestational age at delivery, birthweight, and frequency of preterm delivery between the HCA group and non-HCA group (median gestational age at delivery, 38.0 weeks (IQR, 36.7–38.8 weeks) in the HCA group vs. 37.9 weeks (IQR, 35.7–39.0 weeks) in the non-HCA group; frequency of preterm delivery, 14/52 (27%) in the HCA group vs. 33/86 (38%) in the non-HCA group; and median birthweight, 3.14 kg (IQR, 2.64–3.45 kg) in the HCA group vs. 2.95 kg (IQR, 2.44–3.36 kg) in the non-HCA group; P>0.1 for all.CONCLUSION: The presence of acute HCA in women at prior SPTD did not significantly affect their subsequent pregnancy outcomes.
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Objective@#To investigate the effect of gestational weight gain (GWG) on maternal and neonatal outcomes based on the Institute of Medicine (IOM) guidelines for twin pregnancies. @*Methods@#This study included women with twin pregnancies who delivered at Seoul National University Bundang Hospital. Based on the weight gain per gestational week according to the 2009 IOM guidelines, the subjects were divided into the following 3 groups: inadequate, adequate, and excessive GWG. We compared the maternal and neonatal outcomes of each group. @*Results@#A total of 1,738 twin pregnancies were included in our study. Of these cases, 881, 694, and 163 (50.7%, 39.9%, and 9.4%, respectively) twin pregnancies were categorized into the inadequate, adequate, and excessive GWG groups, respectively. In the inadequate GWG group, the risks of preterm birth <34 weeks (aOR, 2.33, 95% confidence interval [CI], 1.63–3.34) and delivering neonates who were small for gestational age (aOR, 1.92, 95% CI, 1.42–2.60) were increased, and the risk of preeclampsia (aOR, 0.49, 95% CI, 0.32–0.76) was decreased. The excessive GWG group had an increased risk of the neonates being large for gestational age (aOR, 1.79, 95% CI, 1.15–2.81). @*Conclusion@#The 2009 IOM recommendations for GWG can be applied to Korean women with twin pregnancies to help achieve optimal maternal and neonatal outcomes. However, more than half of the women were categorized as having inadequate weight gain according to the guidelines. Further studies should be performed to obtain Korean national references for GWG in twin pregnancies.
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BACKGROUND@#The scalp, an excellent donor site for thin skin grafts, presents a limited surface but is rich in stem cells. The purpose of this study was to test a double harvesting procedure from the scalp and to evaluate the capacity of the dermal layer.@*METHODS@#Two layers corresponding to a split-thickness skin graft (SSG) and a split-thickness dermal graft (SDG) were harvested from the scalp using a Zimmer dermatome during the same procedure. Healing of the scalp donor site, reason for recipient site grafting, and the percentage of graft loss were evaluated.@*RESULTS@#Fourteen patients, comprising six men and eight women with a mean age of 34.2 years, were treated according to our protocol. The most common reason for a recipient site graft was a postburn scar deformity (10/14 patients). The mean area of scalp SSGs was 151.8 cm². The mean area of scalp SDGs was 88.2 cm². The mean healing time of scalp donors was 9.9 days. The only donor complication was a tufted scar deformity.@*CONCLUSIONS@#Skin defects in the scalp of donors healed faster and led to less scarring than defects at other donor sites. Scalp SDGs needed 10 days for adequate epithelization. The scalp was the best donor site for SSGs and SDGs for burn reconstructive patients.
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OBJECTIVES: To investigate the effect of surgical treatment with eustachian tube (ET) catheter insertion in patients with acquired cholesteatoma associated with patulous eustachian tube (PET) and habitual sniffing. METHODS: Nine ears of nine patients (two men and seven women; age, 20 to 65 years; average, 37.9±12.0 years) of acquired cholesteatoma associated with PET and habitual sniffing who underwent cholesteatoma surgery with simultaneous additional ET catheter insertion were examined in this study. Successful treatment was defined as stoppage of sniffing, a relief of a PET handicap inventory-10 (PHI-10), an improvement of autophony grade and no cholesteatoma recurrence. RESULTS: ET catheter insertion was performed in all ears. Follow-up duration ranged from 16 to 37 months (average, 25.4 months). Cases consisted of nine pars flaccida type (100%). All patients obtained relief from aural symptoms and stopped sniffing. Postoperative PHI-10 scores were significantly lower than preoperative scores (P<0.001). During an average follow-up of 25.4 months, no cholesteatoma recurrence has occurred to date. One patient developed otitis media with effusion (OME) post-catheterization; OME resolved spontaneously without treatment. Four patients had a consecutive ET catheter insertion on the other side to resolve PET-related aural symptoms. CONCLUSION: In case of acquired cholesteatoma with PET and habitual sniffing, ET catheter insertion performed simultaneously with cholesteatoma surgery could help reduce aural symptoms and stop sniffing. Moreover, the procedure might help in preventing cholesteatoma recurrence.
Subject(s)
Female , Humans , Male , Catheters , Cholesteatoma , Ear , Eustachian Tube , Follow-Up Studies , Otitis Media with Effusion , RecurrenceABSTRACT
PURPOSE: The purpose of this study was to compare prognostic differentiation performances of the 7th and the 8th edition of American Joint Committee on Cancer (AJCC) staging system for gastric cancer (GC) patients. MATERIALS AND METHODS: A total of 1,633 GC patients who underwent curative D2 resection followed by adjuvant chemotherapy alone (CA) or concurrent chemo-radiotherapy (CCRT) from 2004 to 2013 were included. Concordance index (c-index) was applied to compare the discriminatory ability. RESULTS: In the 8th edition, migration of stage was detected in 248 patients (15.2%). Among them, 121 patients were up-staged while 127 patients were down-staged. Overall, there was no statistically significant difference in the discriminatory ability between the 7th and 8th editions. The new edition of staging system, however, showed a trend of better prognostic performance not only in recurrence-free survival (c-index=0.734; 95% confidence interval [CI], 0.706 to 0.762 in the 7th edition vs. c-index=0.740; 95% CI, 0.712 to 0.768 in the 8th edition; p=0.14), but also in overall survival (c-index=0.717; 95% CI, 0.688 to 0.745 in the 7th edition vs. c-index=0.722; 95% CI, 0.694 to 0.751 in the 8th edition; p=0.19), especially in stage III. This finding was repeated in the subgroup analysis regardless of adjuvant CA or CCRT. CONCLUSION: Generally, the 8th edition of AJCC staging system had failed to show a superior discriminatory ability for curatively D2 resected GC patients than the 7th edition, although there was a trend of better prognostic performance of the new edition, regardless of adjuvant treatment method.
Subject(s)
Humans , Chemotherapy, Adjuvant , Joints , Methods , Neoplasm Staging , Prognosis , Radiotherapy , Recurrence , Stomach NeoplasmsABSTRACT
PURPOSE: Simvastatin has demonstrated anti-tumor activity in preclinical studies via tumor cell senescence, apoptosis, and anti-angiogenesis. This phase II trial evaluated the efficacy and toxicity profile of conventional XELOX and bevacizumab chemotherapy plus simvastatin in metastatic colorectal cancer patients (MCRC). MATERIALS AND METHODS: Patients with MCRC received first-line XELOX in 3-week treatment cycles of intravenous oxaliplatin 130 mg/m² plus bevacizumab 7.5 mg/kg (day 1), followed by oral capecitabine 1,000 mg/m² twice daily (day 1-14). Simvastatin 80 mg tablets were taken orally once daily every day during the period of chemotherapy. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, duration of response, overall survival (OS), time to progression, and toxicity. RESULTS: From January 2014 to April 2015, 60 patients were enrolled and 55 patients were evaluable for tumor response. The median follow-up duration was 30.1 months (range, 28.5 to 31.7 months). The median PFS was 10.4 months (95% confidence interval [CI], 9.6 to 11.1). The median OS of all patients was 19.0 months (95% CI, 11.9 to 26.0). The disease-control rate and overall response rate were 88.3% (95% CI, 74 to 96) and 58.3% (95% CI, 44 to 77), respectively, by intent-to-treat protocol analysis. There was one complete response and 34 partial responses. One patient experienced grade 3 creatine kinase elevation and liver enzyme elevation. CONCLUSION: Based on the current study, the addition of 80 mg simvastatin to XELOX and bevacizumab showed comparable clinical efficacy in patients with MCRC as first-line chemotherapy and did not increase toxicity.