Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries.

Background: A 9-valent human papillomavirus-6/11/16/18/31/33/45/52/58 (9vHPV) vaccine extends coverage to 5 next most common oncogenic types (31/33/45/52/58) in cervical cancer versus quadrivalent HPV (qHPV) vaccine. We describe efficacy, immunogenicity, and safety in Asian participants (India, Hong Kong, South Korea, Japan, Taiwan, and Thailand) from 2 international studies: a randomized, double-blinded, qHPV vaccine-controlled efficacy study (young women aged 16-26 years; NCT00543543; Study 001); and an immunogenicity study (girls and boys aged 9-15 years; NCT00943722; Study 002). Methods: Participants (N = 2519) were vaccinated at day 1 and months 2 and 6. Gynecological samples (Study 001 only) and serum were collected for HPV DNA and antibody assessments, respectively. Injection-site and systemic adverse events (AEs) were monitored. Data were analyzed by country and vaccination group. Results: 9vHPV vaccine prevented HPV-31/33/45/52/58-related persistent infection with 90.4%-100% efficacy across included countries. At month 7, ≥97.9% of participants seroconverted for each HPV type. Injection-site AEs occurred in 77.7%-83.1% and 81.9%-87.5% of qHPV and 9vHPV vaccine recipients in Study 001, respectively, and 62.4%-85.7% of girls/boys in Study 002; most were mild to moderate. Conclusions: The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Asian participants. Data support 9vHPV vaccination programs in Asia. Clinical Trials Registration: NCT00543543; NCT00943722.

Belching during gastroscopy and its association with gastroesophageal reflux disease.

Belching may result from transient lower esophageal sphincter relaxation; therefore, it has been proposed that belching may be a manifestation of gastroesophageal reflux disease (GERD). This study was conducted to investigate the frequency of belching during esophagogastroduodenoscopy (EGD) and its association with GERD. A retrospective review was performed on prospectively collected clinical and endoscopic data from 404 subjects who underwent EGD without sedation from December 2012 to May 2013 in a training hospital in Korea. All detectable belching events during endoscopy were counted. Frequency and severity of belching events were compared between the group with and without GERD using an ordinal logistic regression model. There were 145 GERD patients (26 erosive reflux disease and 119 nonerosive reflux disease [NERD]). In the multivariable analysis, GERD was significantly associated with a higher frequency of belching events (odds ratio = 6.59, P < 0.001). Central obesity, female, and younger age were also risk factors for frequent belching during EGD. Subgroup analyses were performed in subjects without erosive reflux disease (n = 378) and NERD (n = 293). NERD was also a predictive factor for frequent belching during EGD (odds ratio = 6.61, P < 0.001), and the frequency of belching was significantly correlated with GERD severity according to the Los Angeles classification (P < 0.05). Frequent belching during EGD was associated with GERD, including NERD. Future research should focus on its adjuvant role in the diagnosis of GERD/NERD and the necessity for applying differentiated endoscopy strategies for GERD patients, leading to less discomfort during EGD in patients at risk for intolerability.

Association between information provision and decisional conflict in cancer patients.

BACKGROUND: In this study, we aimed to identify demographic and clinical variables that correlate with perceived information provision among cancer patients and determine the association of information provision with decisional conflict (DC). PATIENTS AND METHODS: We enrolled a total of 625 patients with cancer from two Korean hospitals in 2012. We used the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire (QLQ-INFO26) to assess patients' perception of the information received from their doctors and the Decisional Conflict Scale (DCS) to assess DC. To identify predictive sociodemographic and clinical variables for adequate information provision, backward selective logistic regression analyses were conducted. In addition, adjusted multivariate logistic regression analyses were carried out to identify clinically meaningful differences of perceived level of information subscales associated with high DC. RESULTS: More than half of patients with cancer showed insufficient satisfaction with medical information about disease (56%), treatment (73%), other services (83%), and global score (80%). In multiple logistic regression analyses, lower income and education, female, unmarried status, type of cancer with good prognosis, and early stage of treatment process were associated with patients' perception of inadequate information provision. In addition, Information about the medical tests with high DCS values clarity [adjusted odds ratio (aOR), 0.54; 95% confidence interval (CI) 0.30-0.97] and support (aOR, 0.53; 95% CI 0.33-0.85) showed negative significance. For inadequate information perception about treatments and other services, all 5 DCS scales (uncertainty, informed, values clarity, support, and effective decision) were negatively related. Global score of inadequate information provision also showed negative association with high DCS effective decision (aOR, 0.43; 95% CI 0.26-0.71) and DCS uncertainty (aOR, 0.46; 95% CI 0.27-0.77). CONCLUSION: This study found that inadequate levels of perceived information correlated with several demographic and clinical characteristics. In addition, sufficient perceived information levels may be related to low levels of DC.

A genetic variation in microRNA target site of KRT81 gene is associated with survival in early-stage non-small-cell lung cancer.

BACKGROUND: MicroRNAs (miRNAs) have a key role in carcinogenesis through negative regulation of their target genes. Therefore, genetic variations in miRNAs or their target sites may affect miRNA-mRNA interactions, thereby result in altered expression of target genes. This study was conducted to investigate the associations between single-nucleotide polymorphisms (SNP) located in the miRNA target sites (poly-miRTSs) and survival of patients with early-stage non-small-cell lung cancer (NSCLC). METHODS: Using public SNP database and miRNA target sites prediction program, 354 poly-miRTSs were selected for genotyping. Among these, 154 SNPs applicable to Sequenom's MassARRAY platform were investigated in 357 patients. A replication study was carried out on an independent patient population (n = 479). Renilla luciferase assay and reverse transcription-polymerase chain reaction were conducted to examine functional relevance of potentially functional poly-miRTSs. RESULTS: Of the 154 SNPs analyzed in a discovery set, 14 SNPs were significantly associated with survival outcomes. Among these, KRT81 rs3660G>C was found to be associated with survival outcomes in the validation cohort. In the combined analysis, patients with the rs3660 GC + CC genotype had a significantly better overall survival compared with those with GG genotype [adjusted hazard ratio (aHR) for OS, 0.65; 95% confidence interval (CI) 0.50-0.85; P = 0.001]. An increased expression of the reporter gene for the C allele of rs3660 compared with the G allele was observed by luciferase assay. Consistently, the C allele was associated with higher relative expression level of KRT81 in tumor tissues. CONCLUSION: The rs3660G>C affects KRT81 expression and thus influences survival in early-stage NSCLC. The analysis of the rs3660G>C polymorphism may be useful to identify patients at high risk of a poor disease outcome.

Reliability of tumour grade 1 and endometrioid cell type on preoperative endometrial biopsy.

The aim of this study was to evaluate the reliability of using tumour grade and cell type on preoperative endometrial biopsy for the selection of patients for conservative hormone treatment. We retrospectively reviewed results of 643 patients with endometrial carcinoma for tumour grade and 817 for tumour cell type who underwent endometrial biopsy followed by surgery. Of the 357 patients with a grade 1 tumour on preoperative endometrial biopsy, 58 (16.2%) were upgraded based on a final pathology report from hysterectomy specimens. For grade 1, the preoperative endometrial biopsy showed a sensitivity of 80.4%, a specificity of 78.6%, a positive predictive value (PPV) of 83.8% and a negative predictive value (NPV) of 74.5%. Of the 672 patients with the endometrioid cell type on preoperative biopsy, 46 (5.6%) showed a different cell type on final pathology. For the endometrioid cell type, preoperative endometrial biopsy had a sensitivity of 91.3%, a specificity of 64.9%, a PPV of 93.2% and an NPV of 58.6%. This weak predictive value should be considered when selecting patients for conservative hormone treatment.

A randomised controlled trial comparing incentive spirometry with the Acapella® device for physiotherapy after thoracoscopic lung resection surgery.

Lung resection surgery has been associated with numerous postoperative complications. Seventy-eight patients scheduled for elective video-assisted thoracoscopic lung resection were randomly assigned to receive standard postoperative care with incentive spirometry or standard care plus positive vibratory expiratory pressure treatment using the Acapella(®) device. There was no significant difference between incentive spirometry and the Acapella device in the primary outcome, forced expiratory volume in 1 s, on the third postoperative day, mean (SD) 53% (16%) vs 59% (18%) respectively, p = 0.113. Patients treated with both devices simultaneously found incentive spirometry to be less comfortable compared with the Acapella device, using a numeric rating scale from 1 to 5 with lower scores indicating higher comfort, median (IQR [range]) 3 (2-3 [2-4]) vs 1 (1-2 [1-3]) respectively, p < 0.001. In addition, 37/39 patients (95%) stated a clear preference for the Acapella device. Postoperative treatment with the Acapella device did not improve pulmonary function after thoracoscopic lung resection surgery compared with incentive spirometry, but it may be more comfortable to use.

Metabolic tumour volume and total lesion glycolysis, measured using preoperative 18F-FDG PET/CT, predict the recurrence of endometrial cancer.

OBJECTIVE: To investigate the prognostic value of metabolic tumour volume (MTV) and total lesion glycolysis (TLG), measured by preoperative positron emission tomography and computerised tomography (PET/CT), in women with endometrial cancer. DESIGN: Retrospective cohort study. SETTING: A tertiary referral centre. POPULATION: Women with endometrial cancer who underwent preoperative (18)F-FDG PET/CT in the period 2004-2009. METHODS: Clinicopathological data for 84 women with endometrial cancer were reviewed from medical records. Cox proportional hazards modelling identified recurrence predictors. The receiver operating characteristic (ROC) curve was used to determine the cut-off value for predicting recurrence. MAIN OUTCOME MEASURE: Disease-free survival (DFS). RESULTS: The number of patients with International Federation of Gynecology and Obstetrics (FIGO) stages were: I (58); II (11); III (13); and IV (2). The median DFS was 48 (1-85) months. By univariate analysis, DFS was significantly associated with FIGO stage, histology, peritoneal cytology, myometrial invasion, nodal metastasis, serum CA-125, MTV, and TLG. Using multivariate analysis, the MTV (P = 0.010; hazard ratio, HR = 1.010; 95% confidence interval, 95% CI = 1.002-1.018) and TLG (P = 0.024; HR = 1.001; 95% CI = 1.000-1.002) were associated with DFS. The area under the ROC curve was 0.679 (95% CI = 0.505-0.836) after discriminating for recurrence using an MTV cut-off value of 17.15 ml. Regarding TLG, the cut-off value was 56.43 g and the area under the ROC plot was 0.661 (95% CI = 0.501-0.827). Kaplan-Meier survival graphs demonstrated a significant difference in DFS between groups categorised using the cut-off values for MTV and TLG (P < 0.022 for MTV and P < 0.047 for TLG, by log-rank test). CONCLUSIONS: Preoperative MTV and TLG could be independent prognostic factors predicting the recurrence of endometrial cancer.

Preoperative nomogram for the identification of lymph node metastasis in early cervical cancer.

BACKGROUND: The objective of this study is to construct a preoperative nomogram predicting lymph node metastasis (LNM) in early-cervical cancer patients. METHODS: Between 2009 and 2012, 493 early-cervical cancer patients received hysterectomy and pelvic/para-aortic lymphadenectomy. Patients who were diagnosed during 2009-2010 were assigned to a model-development cohort (n=304) and the others were assigned to a validation cohort (n=189). A multivariate logistic model was created from preoperative clinicopathologic data, from which a nomogram was developed and validated. A predicted probability of LNM<5% was defined as low risk. RESULTS: Age, tumour size assessed by magnetic resonance imaging, and LNM assessed by positron emission tomography/computed tomography were independent predictors of nodal metastasis. The nomogram incorporating these three predictors demonstrated good discrimination and calibration (concordance index=0.878; 95% confidence interval (CI), 0.833-0.917). In the validation cohort, the discrimination accuracy was 0.825 (95% CI, 0.736-0.895). In the model-development cohort, 34% of them were classified as low risk and negative predictive value (NPV) was 99.0%. In the validation cohort, 38% were identified as low risk and NPV was 95.8%. Integrating the model-development and validation cohorts, negative likelihood ratio was 0.094 (95% CI, 0.036-0.248). CONCLUSION: A robust nomogram predicting LNM in early cervical cancer was developed. This model may improve clinical trial design and help physicians to decide whether lymphadenectomy should be performed.

Intermediate-risk grouping of cervical cancer patients treated with radical hysterectomy: a Korean Gynecologic Oncology Group study.

BACKGROUND: In this study, we sought to identify a criterion for the intermediate-risk grouping of patients with cervical cancer who exhibit any intermediate-risk factor after radical hysterectomy. METHODS: In total, 2158 patients with pathologically proven stage IB-IIA cervical cancer with any intermediate-risk factor after radical hysterectomy were randomly assigned to two groups, a development group and a validation group, at a ratio of 3 : 1 (1620 patients:538 patients). To predict recurrence, multivariate models were developed using the development group. The ability of the models to discriminate between groups was validated using the log-rank test and receiver operating characteristic (ROC) analysis. RESULTS: Four factors (histology, tumour size, deep stromal invasion (DSI), and lymphovascular space involvement (LVSI)) were significantly associated with disease recurrence and included in the models. Among the nine possible combinations of the four variables, models consisting of any two of the four intermediate-risk factors (tumour size ≥3 cm, DSI of the outer third of the cervix, LVSI, and adenocarcinoma or adenosquamous carcinoma histology) demonstrated the best performance for predicting recurrence. CONCLUSION: This study identified a 'four-factor model' in which the presence of any two factors may be useful for predicting recurrence in patients with cervical cancer treated with radical hysterectomy.

Partial posterior hyaloidectomy for macular disorders.

PURPOSE: To evaluate the effect of partial posterior hyaloidectomy (PPH) in preventing iatrogenic retinal breaks related to the induction of a posterior vitreous detachment (IPVD). METHODS: Fifty-nine patients who necessitated IPVD for an epiretinal membrane or macular hole were included in this prospective, interventional case series. Extensive removal of vitreous gel, close to the retina, was conducted before IPVD under 23 G (gauge)-vitrectomy system. The PPH involved the limited extent of IPVD and limited removal of the outermost vitreous cortex to an area slightly beyond the margin of the temporal major vascular arcade. The incidence of retinal breaks related to the surgery was compared with 57 eyes that had undergone conventional 23-G total vitrectomy accompanied by extensive IPVD using χ(2)-test. RESULTS: Patients were followed-up for a mean of 14.3 months (6-30 months) after the surgery. The incidence of peripheral retinal breaks after the PPH was 3.4% (2/59 eyes), which was significantly lower than that in the eyes that underwent conventional 23 G vitrectomy (15.8%, 9/57 eyes, P=0.023) for the same disorders that required an IPVD. No patient complained of postoperative floaters, postoperatively. CONCLUSIONS: PPH would be an efficient procedure to prevent iatrogenic peripheral retinal breaks related to an IPVD.

Donor evaluation for lung transplantation in Korea.

Lung transplantation for end-stage lung disease results in prolonged survival and improved pulmonary function. However, the shortage of donor lungs has been a major limiting factor in Korea. We sought to investigate the number and utilization of donor lungs by the five institutions performing LTx in Korea, retrospectively reviewing outcomes of organs registered in the Korean Network for Organ Sharing from January to December, 2010. Lungs were offered from 270 brain-dead patients (189 males and 81 females) of mean age of 45.2 ± 14.2 years (range, 12 to 77 years). The most common cause of brain death was hemorrhage (n = 219, 81%). Only 18 (6.7%) donor lungs were used, which was low compared with kidney (93.3%), liver (86.3%), heart (26.7%), and pancreas (11.1%) use. The mean age of donors of transplanted lungs was 35.7 years (range, 14 to 51 years) compared with 45.9 years for other organs (P = .003). The characteristics of utilized donor lungs were: mean partial pressure of oxygen (PaO(2)), 300.9 mm Hg; mean smoking history, as 2.7 pack-years; and mean body mass index, 21.2 kg/m(2). The causes of refusal were medical ineligibility (n = 129) including poor PaO(2), abnormal chest x-ray, long smoking history, older age (n = 46), no properly matched recipient (n = 46), unknown (n = 17), and family withdrawal (n = 14). Only 8 (33.3%) were transplanted from standard criteria and 10 from the lungs that did not satisfy these criteria. An efficient utilization system is needed to improve lung transplantations.

Preliminary study analyzing the methylated genes in the plasma of patients with pancreatic cancer.

BACKGROUND AND AIMS: CpG islands of the promoter region of some genes are methylated in pancreatic cancer tissue and the detection of this methylation has been suggested to be useful in the diagnosis of various cancers. The aim of this study was to investigate whether the detection of methylated CpG islands in plasma can be used in the diagnosis of pancreatic cancer. MATERIAL AND METHODS: Plasma DNA was collected from patients with pancreatic cancer, chronic pancreatitis, and healthy controls. The methylation status of six genes, UCHL1, NPTX2, SARP2, ppENK, p16, and RASSF1A, was checked by methylation-specific PCR and was subsequently confirmed by direct sequencing after bisulfite treatment. RESULTS: CpG island methylation was detectable in 13 of 16 patients (81.3%) with pancreatic cancer, 1 of 29 healthy controls (3.5%), and 8 of 13 patients with chronic pancreatitis (61.5%). The mean number of genes with CpG island methylation was 1.6±1.2 in pancreatic cancer, 0.04±0.19 in healthy controls, and 1.2±1.1 in chronic pancreatitis. Among six genes, p16 was more specifically methylated in pancreatic cancer compared with chronic pancreatitis (p=0.016). The methylation status was not correlated with smoking history, tumor size, or cancer stage. CONCLUSIONS: The detection of methylated genes in the plasma may have a role in differentiating between pancreatic cancers and healthy controls but not between pancreatic cancer and chronic pancreatitis.

Proteins involved in DNA damage response pathways and survival of stage I non-small-cell lung cancer patients.

BACKGROUND: Biological complexity leads to significant variation in the survival of patients with stage I non-small-cell lung cancer (NSCLC). DNA damage response (DDR) pathways play a critical role in maintaining genomic stability and in the progression of NSCLC. Therefore, the development of a prognostic biomarker focusing on DDR pathways is an intriguing issue. PATIENTS AND METHODS: Expression of several proteins (ATM, ATMpS1981, γH2AX, 53BP1, 53BP1pS25, Chk2, Chk2pT68, MDC1, MDC1pS964, BRCA1pS1423, and ERCC1) and overall survival were investigated in 889 pathological stage I NSCLC patients. RESULTS: Low expression of BRCA1pS1423 or ERCC1 was significantly associated with worse survival in the whole cohort of patients. Analysis performed based on histology revealed that low expression of γH2AX, Chk2pT68, or ERCC1 was a poor prognostic factor in squamous cell carcinoma patients [adjusted hazard ratio (aHR), Cox P: 1.544, 0.012 for γH2AX; 1.624, 0.010 for Chk2pT68; 1.569, 0.011 for ERCC1]. The analysis of the interaction between two proteins showed that this effect was more pronounced in squamous cell carcinoma patients. However, these effects were not detected in adenocarcinoma patients. CONCLUSIONS: The proteins involved in DDR pathways exhibited differential expression between squamous cell carcinoma and adenocarcinoma and were important determinants of survival in stage I squamous cell carcinoma patients.

The dynamic healing profile of human periodontal ligament stem cells: histological and immunohistochemical analysis using an ectopic transplantation model.

BACKGROUND AND OBJECTIVE: Human periodontal ligament stem cells (hPDLSCs) have been reported to play the pivotal role in periodontal regeneration. However, the dynamic cellular healing process initiated by hPDLSCs still remains to be elucidated. In the present study, the sequence of regeneration by hPDLSCs was assessed using histological and immunohistochemical observation in an ectopic transplantation model, which is a well-standardized assessment tool that excludes the innate healing factors from the animals. MATERIAL AND METHODS: Human periodontal ligament stem cells that were isolated and characterized from teeth (n=12) extracted for the purpose of orthodontic treatment were transplanted with carriers into ectopic subcutaneous pouches in immunocompromised mice (n=20). Animals were killed after several different healing periods: 3 d (n=4), 1 (n=4), 2 (n=4), 4 (n=4) and 8 wk (n=4). Histological analysis for regenerated tissues formed by hPDLSCs was conducted using hematoxylin and eosin, Masson's trichrome and picrosirius red staining. In addition, immunohistochemical staining was performed to observe the sequential expression of osteogenic/cementogenic and periodontal ligament tissue-specific markers associated with periodontal regeneration. RESULTS: The whole healing process by transplanted hPDLSCs could be broadly divided into four distinctive phases. In the first phase, proliferated hPDLSCs migrated evenly all over the carrier, and collagenous tissues appeared in the form of amorphous collagen matrices. In the second phase, collagen fibers were well arranged among the carriers, and cementoid-like tissues were observed. In the third phase, the formation of mature collagen fibers, resembling Sharpey's fibers, was associated with active mineralization of cementum-like tissues, and in the fourth phase, the maturation of cementum-like tissues was observed on carrier surfaces. Various osteogenic/cementogenic markers related to the regeneration processes were expressed in a well-orchestrated time order. Interestingly, well-organized cementum-like and periodontal ligament fiber-like tissues and cells with early and late osteogenic/cementogenic markers were frequently observed in the secluded area of carrier surfaces. We termed this area the cell-rich zone. CONCLUSION: The results from this study clearly demonstrated the sequential histological changes during periodontal tissue regeneration by hPDLSCs. Understanding of this process would potentially enable us to develop better cell-based treatment techniques.

Laparoscopic versus open radical hysterectomy in early-stage cervical cancer: long-term survival outcomes in a matched cohort study.

BACKGROUND: To compare the long-term survival outcomes between laparoscopic radical hysterectomy (LRH) and open radical hysterectomy (ORH). METHOD: We matched patients with stage IA2 to IIA cervical cancer with known risk factors for recurrence who underwent ORH and LRH. RESULTS: Compared with ORH (n = 263), LRH (n = 263) did not have higher risks of recurrence [hazard ratio (HR) = 1.28; 95% confidence interval (CI) 0.62-2.64] or death (HR = 1.46; 95% CI 0.62-3.43). Even in patients with tumors >2 cm in diameter, the risks of recurrence (HR = 0.82; 95% CI 0.31-2.16) or death (HR = 1.01; 95% CI 0.35-2.95) were not higher for LRH than for ORH. The LRH and ORH group had 5-year recurrence-free survival rates of 92.8% and 94.4%, respectively (P = 0.499). LRH resulted in significantly lower estimated blood loss (379.6 versus 541.1 ml, P < 0.001) and shorter postoperative hospital stay (12.5 versus 20.3 days, P < 0.001). Intraoperative complication rates were similar in the two groups (6.8% versus 5.7%, P = 0.711), but postoperative complication rate was lower in the LRH than in the ORH group (9.2% versus 21%, P < 0.001). CONCLUSION: LRH is an oncologically safe alternative to ORH and was associated with fewer postoperative complication and earlier recovery.

CT scan assessment of the pathway of the true lateral approach for transforaminal endoscopic lumbar discectomy: is It possible?

We performed a prospective study to examine the influence of the patient's position on the location of the abdominal organs, to investigate the possibility of a true lateral approach for transforaminal endoscopic lumbar discectomy. Pre-operative abdominal CT scans were taken in 20 patients who underwent endoscopic lumbar discectomy. Axial images in parallel planes of each intervertebral disc from L1 to L5 were achieved in both supine and prone positions. The most horizontal approach angles possible to avoid injury to the abdominal organs were measured. The results demonstrated that the safe approach angles were significantly less (i.e., more horizontal) in the prone than in the supine position. Obstacles to a more lateral approach were mainly the liver, the spleen and the kidneys at L1/2 (39 of 40, 97.5%) and L2/3 (28 of 40, 70.0%), and the intestines at L3/4 (33 of 40, 82.5%) and L4/5 (30 of 30, 100%). A true lateral approach from each side was possible for 30 of the 40 discs at L3/4 (75%) and 23 of the 30 discs at L4/5 (76.7%). We concluded that a more horizontal approach for transforaminal endoscopic lumbar discectomy is possible in the prone position but not in the supine. Prone abdominal CT is more helpful in determining the trajectory of the endoscope. While a true lateral approach is feasible in many patients, our study shows it is not universally applicable.

Outcomes after radical hysterectomy according to tumor size divided by 2-cm interval in patients with early cervical cancer.

BACKGROUND: this study investigated the outcomes after radical hysterectomy according to tumor size divided by 2-cm interval in patients with International Federation of Obstetrics and Gynecology stage IA2-IIA cervical cancer. PATIENTS AND METHODS: a total of 1415 patients were eligible for participation in the study and were retrospectively analyzed. Patients were divided into four groups according to tumor size (i.e. ≤ 2, 2-4, 4-6 and >6 cm). The relationships between tumor size and other clinicopathologic risk factors, the probability of adjuvant therapy, survival parameters, recurrence-free survival (RFS) and overall survival (OS) were analyzed. RESULTS: the incidence of intermediate- and high-risk factors gradually increased with increasing tumor size. Adjuvant therapy was required in 13.6%, 34.0%, 56.7% and 92.9% of patients with tumor sizes of ≤ 2, 2-4, 4-6 and >6 cm, respectively (P < 0.001). The risks of recurrence and death gradually increased with increasing tumor size, after adjusting for other significant prognostic factors in multivariate analysis (P < 0.001 and < 0.001, respectively). Even in patients with no intermediate- or high-risk factors, tumor size was a significant predictor of RFS and OS (P < 0.001 and < 0.001, respectively). Immediate surgical parameters did not significantly differ according to tumor size. CONCLUSIONS: tumor size divided by a 2-cm interval was an independent prognostic factor and correlated well with other risk factors and with the need for adjuvant therapy.

Surgical management of the esophageal leiomyoma: lessons from a retrospective review.

Esophageal leiomyoma is the most common benign tumor of the esophagus. Although enucleation via thoracotomy has been considered standard treatment, minimally invasive surgery is increasingly used for the treatment of this disease. We analyzed our surgical outcomes by comparing thoracotomy and the thoracoscopic approach. A retrospective review was performed of patients who underwent surgical resection of esophageal leiomyomas at the Seoul National University Hospital. Between 1982 and 2005, 63 patients were identified (male, n= 39; female, n= 24) at a mean age of 44.5 years. Thirty-two patients (51%) were symptomatic. Forty-five patients underwent thoracotomy, and 18 patients were resected using thoracoscopy. There was no mortality. The mean length of hospital stay was 10.3 days in the open group and 8.0 days in thoracoscopy group. Intraoperative mucosal repair was required in eight patients. Preoperative endoscopic mucosal biopsy within 1 month was identified as a risk factor for mucosal injury. Among the 11 patients with tumors less than 1.5 cm in size, thoracoscopic resection was attempted on four patients, and three out of the four cases required conversions to thoracotomy. Minimally invasive surgery for esophageal leiomyoma can be performed with good results. Our results suggest that the thoracoscopic approach should be considered as a standard surgical method for the treatment of esophageal leiomyoma. However, in cases of small tumors less than 1.5 cm in size, localization of the tumor may be difficult, and if asymptomatic, a regular monitoring should be considered as an alternative approach in such small tumors.

Outcomes after radical hysterectomy in patients with early-stage adenocarcinoma of uterine cervix.

BACKGROUND: To determine the prognostic factors and treatment outcomes of patients with early-stage adenocarcinoma (AdCa) of uterine cervix who underwent radical hysterectomy (RH). METHODS: Patients with early-stage squamous cell carcinoma (SCCa) of the uterine cervix who underwent RH were compared with patients with AdCa by multivariate analysis. RESULTS: A total of 1218 patients were eligible, of which 996 (81.8%) had SCCa and 222 (18.2%) had AdCa. In multivariate analysis, parametrial involvement and lymph node metastasis were significant factors for both recurrence-free survival(RFS) and overall survival (OS) of patients with AdCa, whereas age, tumour size, parametrial involvement and lymph node metastasis were significant factors for both RFS and OS of patients with SCCa. After adjusting for significant prognostic factors, patients with AdCa had significantly poorer RFS (odds ratio (OR)=2.07, 95% confidence interval (CI)=1.37-3.12, P=0.001) and OS (OR=2.56, 95% CI=1.65-3.96, P<0.001) than patients with SCCa. Recurrence outside the pelvis was more frequent in AdCa than in those with SCCa (75 vs 57.8%, P=0.084). CONCLUSION(S): Although RH is still acceptable for treatment of patients with AdCa, a more effective systemic adjuvant therapy is required.

Management of occult invasive cervical cancer found after simple hysterectomy.

BACKGROUND: To estimate safety and efficacy of radical parametrectomy (RP) and radiation therapy (RT) or concurrent chemoradiation therapy (CCRT) for patients with occult invasive cervical cancer found after simple hysterectomy. MATERIALS AND METHODS: We retrospectively evaluated outcomes in 147 patients with occult invasive cervical cancer. RESULTS: Forty-eight patients with IA1 lesions (IA1 group) did not receive further treatment. Of the 99 patients with IA2-IIA lesions, 26 received no definitive treatment (observation group), 44 received RT or CCRT (RT/CCRT group), and 29 underwent RP (RP group). After a median follow-up of 116 months (range 3-235 months), recurrent disease was observed in 0%, 34.6%, 6.8%, and 0% of patients in the IA1, observation, RT/CCRT, and RP groups, respectively. In the RT/CCRT group, treatment was delayed due to severe diarrhea in 4 patients (9%) and 12 patients (27%) had late complications related to RT requiring further management (including two surgical interventions). Five patients in the RP group (17%) experienced perioperative complications which were easily managed, intraoperatively or conservatively. Late complications were not observed in the RP group. CONCLUSION: Although RP and RT/CCRT had similar therapeutic efficacy, the lower rate of late complications observed with RP makes it preferable to RT/CCRT.