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Objective: Few studies have been conducted on the relationship between metabolic syndrome (MetS) and persistent human papillomavirus (HPV) infection. We investigated whether MetS and associated factors can predict the persistence of HPV infection., Patients and Methods: We performed a retrospective cohort study of 80,993 female cases undergoing general medical screenings at Samsung Medical Center and 51,140 cases were included in final analysis. MetS and associated factors were used to develop a model predicting the persistence of HPV infection which was defined as HPV positivity for at least one year. The performance of the model was internally validated using bootstrapping and externally validated by testing the risk score against the test set., Results: Of the 51,140 cases, there were 5833 (11.4%) cases diagnosed with MetS and 7682 (15.0%) cases diagnosed with HPV infection at baseline. The 12- to 24-month persistence rates of HPV were 50.0% (2846/5691). MetS (OR 1.34, 95% CI 1.04-1.71), globulin (by quintile; OR 1.70, 95% CI 1.25-2.30), fibrinogen (x100 value by quintile; OR 1.07, 95% CI 1.02-1.14), total protein (by quintile; OR 0.91, 95% CI 0.84-0.99) and prothrombin time (by quintile; OR 0.94, 95% CI 0.89-0.99) were significantly associated with the persistence of HPV in multivariate analysis. For validation, a prediction model showed good performance for a range of risk scores and categorized cases into low-, intermediate- and high-risk, which were also correlated with HPV persistence (45.8%, 51.9%, and 60.2% respectively, P < 0.001)., Conclusion: MetS and associated factors were associated with an increased risk of persistent HPV infection., Competing Interests: Declaration of Competing Interest The authors report no conflict of interest., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Secondary cytoreductive surgery (SCS) is possible in selected patients with recurrent epithelial ovarian cancer (EOC). The goal of SCS is complete resection, although chemotherapy is always followed. Delayed intervals between primary debulking surgery and adjuvant chemotherapy was reported to be associated with poorer survivals, however, the role of intervals in recurrent disease is still unknown., Materials and Methods: This retrospective cohort study reviewed data from electronic medical records of women with recurrent EOC treated at Samsung Medical Centre, Seoul, Korea, between January 1, 2002, and December 31, 2015. Patients who underwent SCS with adjuvant chemotherapy for recurrent EOC were eligible. We defined intervals as the period between the day of SCS and the first cycle of adjuvant chemotherapy., Results: Seventy-nine patients were eligible for this study. Their median age was 48 (range, 18-69) years and median interval between the date of SCS and initiation of adjuvant chemotherapy was 10 (range, 4-115) days. The rate of complete resection was 72.2% (57/79). Division of the patients by interval (Group 1, interval ≤ 10 days; Group 2, interval > 10 days) revealed no difference in clinical parameters. No gross residual disease after SCS (no vs. any gross residual, p = 0.002) and longer platinum-free survival (over 12 vs. 6-12 months, p = 0.023) were independent favorable prognostic factors in Cox model; however, the intervals did not affect survival., Conclusions: Delayed intervals to adjuvant chemotherapy after secondary cytoreductive surgery is not associated with decreased survivals. It is important to identify recurrent EOC patients who might have no gross residual disease following SCS. Moreover, surgeons should strive for complete resection.

Since after 2006 when the first edition of practice guidelines for gynecologic oncologic cancer treatment was released, the Korean Society of Gynecologic Oncology (KSGO) has published the following editions on a regular basis to suggest the best possible standard care considering updated scientific evidence as well as medical environment including insurance coverage. The Guidelines Revision Committee was summoned to revise the second edition of KSGO practice guidelines, which was published in July 2010, and develop the third edition. The current guidelines cover strategies for diagnosis and treatment of primary and recurrent ovarian cancer. In this edition, we introduced an advanced format based on evidence-based medicine, collecting up-to-date data mainly from MEDLINE, EMBASE, and Cochrane Library CENTRAL, and conducting a meta-analysis with systematic review. Eight key questions were raised by the committee members. For every key question, recommendations were developed by the consensus meetings and provided with evidence level and strength of the recommendation., Competing Interests: Dong Hoon Suh, Suk-Joon Chang, Taejong Song, Sung Jong Lee, and Jae-Weon Kim serve as editors of the Journal of Gynecologic Oncology (JGO), but have no role in the decision to publish this article. No other conflict of interest relevant to this article was reported., (Copyright © 2018. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology.)

Objective: The aim of this investigation is to compare outcomes of patients according to the presence of cancer arising from endometriosis in ovarian clear cell carcinoma (CCC) and endometrioid carcinoma (EC)., Methods: This study retrospectively investigated 224 CCC and EC patients treated in Samsung Medical Center from 2001 to 2015 to identify cancer arising from endometriosis according to Sampson and Scott criteria. Propensity score matching was performed to compare patients arising from endometriosis to patients without endometriosis (ratio 1:1) according to stage, age, lymph node metastasis (LNM), cancer antigen (CA)-125 level, and residual status after debulking surgery., Results: Forty-five cases arising from endometriosis were compared with 179 cases without endometriosis. CCC and EC arising from endometriosis tended to present with early age (mean, 45.2 vs. 49.2 years; p=0.003), early-stage (stages I and II, 92.7% vs. 62.3%; p<0.001), lower CA-125 level (mean, 307.1 vs. 556.7; p=0.041), higher percentages of no gross residual disease after surgery (87.8% vs.56.8%; p=0.001), and higher percentages of negative LNM (82.9% vs. 59.0%; p=0.008) compared to cases without endometriosis. Kaplan-Meier curves for progression-free survival (PFS) and overall survival (OS) showed better outcomes for groups with cancer arising from endometriosis (p=0.014 for PFS; and p=0.010 for OS). However, the association with endometriosis was not significant in multivariate analysis. Also, after propensity score matching, survival differences between the 2 groups were not significant., Conclusion: CCC and EC arising from endometriosis are diagnosed at an earlier age and stage. However, cancer arising from endometriosis was not a significant prognostic factor., Competing Interests: No potential conflict of interest relevant to this article was reported., (Copyright © 2018. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology)

Objectives: This study aimed to investigate the current management of endometrial hyperplasia (EH) in Korea., Materials and Methods: This was an electronic survey, which included 40 questions, that was distributed to the members of the Korean Gynecologic Oncology Group in 2014., Results: In total, 50 (69%) of 72 members responded to the survey. The oral progestogens were the most popular choices for managing EH without atypia (simple hyperplasia(SH), 64%; complex hyperplasia (CH), 52%). In the case of CH with atypia, most of the gynecologist respondents would perform hysterectomy (95.9%). For fertility preservation, the oral progestogens were the most popular choices (SH, 75.5%; CH, 56.3%), followed by the levonorgestrel-releasing intrauterine system (LNG-IUS). More than 70% of the respondents reported use of dilatation and curettage as a follow-up method., Conclusions: Our survey results show that most of Korean gynecologic oncologists still prefer oral progestogens for conservative management of EH, notwithstanding the many successful reports on the LNG-IUS. As a follow-up evaluation method, dilatation and curettage is mostly used. To identify the optimum therapy, a randomized controlled trial comparing the LNG-IUS with continuous oral progestogens is required. Furthermore, a large-scale prospective study to confirm the most reliable technique for follow-up evaluation is necessary.

Objective: To demonstrate the survival impact of intraoperative tumor rupture in women with stage I clear cell carcinoma (CCC) of the ovary., Methods: A total of 193 patients with stage I CCC of the ovary who had undergone a complete staging operation followed by ≥three cycles of adjuvant platinum-based chemotherapy, were retrospectively reviewed. Survival analysis was performed and compared between three stage groups: IA/IB, IC1, and IC2/IC3., Results: There were 70, 51, and 72 women with ovarian CCC in stages IA/IB, IC1, and IC2/IC3, respectively. Intraoperative tumor rupture occurred in 69 (35.8%) patients. Gross endometriosis (p=0.020) and significant peritumoral adhesion (p<0.001) were associated with intraoperative tumor rupture. However, neither laparoscopic approach nor large tumor size >10cm were associated with intraoperative tumor rupture. Patients with stage IC2/IC3 compared to those with stage IC1, had poorer progression-free survival (PFS) (5-year PFS, 68.5% versus 91.7%; p=0.010) and overall survival (OS) (5-year OS, 81.1% versus 95.4%; p=0.027). However, there was no significant difference between patients with stages IA/IB and IC1 CCC in PFS (5-year PFS 88.8% versus 91.7%; p=0.291) and OS (5-year OS 94.6% versus 95.4%; p=0.444). Stage IC2/IC3 was the only independent poor prognostic factor for OS (hazard ratio, 3.50; 95% confidence interval, 1.31 to 9.36)., Conclusion: Surgical spillage of tumor cells does not appear to have a negative impact on survival outcomes of women with stage I ovarian CCC who received ≥three cycles of adjuvant platinum-based chemotherapy., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to determine the prognostic factors in women with synchronous endometrial and ovarian cancers., Methods: Medical records of 3240 patients with endometrial cancer who had undergone primary surgery were collected from 7 institutions and were retrospectively reviewed. The progression-free survival (PFS) and overall survival (OS) curves and rates were calculated using the Kaplan-Meier method. Multivariate analysis to determine independent prognostic factors was performed using the Cox regression model., Results: The incidence of synchronous endometrial/ovarian cancer was 3.8% (123/3240 women). During the median follow-up period of 66 months, 33.3% and 26.1% of women developed recurrences and reported cancer-related deaths. The 5-year PFS and 5-year OS for all 123 women were 66.9% and 80.0%, respectively. In multivariate analysis, pretreatment CA-125 and tumor stage of the ovary showed prognostic significance about PFS (P = 0.043 and P = 0.027) and OS (P = 0.047 and P = 0.031), respectively., Conclusions: Pretreatment CA-125 and tumor stage of the ovary were independent prognostic factors for recurrence and survival.

Objectives: This study aimed to describe the clinicopathologic characteristics and outcomes and to assess the predictors associated with prognosis in endometrial carcinoma that developed bone metastasis., Methods: A retrospective review of medical records was performed to identify the patients with endometrial carcinoma who developed bone metastasis between October 1994 and May 2012., Results: Of the 1185 patients with endometrial carcinoma, 22 (1.8%) were identified with bone metastasis, and 21 patients were analyzed in the study. Seventeen (80.9%) patients had advanced-stage disease (2009 International Federation of Gynecologists and Obstetricians stages III-IV). Four (19.0%) patients had a bone lesion at the diagnosis of endometrial cancer. The median time of recurrence to the bone in 17 patients was 9 months (range, 2-43 months). The median overall survival (OS) and survival after bone metastasis of the entire cohort were 33 months (range, 9-57 months) and 15 months (range, 12-17 months), respectively. The patients with bone metastasis at recurrence had significantly longer OS than those patients with bone metastasis at diagnosis of endometrial cancer (36 vs 13 months; P = 0.042). Metastasis to extrapelvic bone was significantly associated with longer OS (46 vs 19 months; P = 0.001) and longer survival after bone metastasis (25 vs 12 months; P = 0.002). Isolated bone recurrence without extraosseous metastases and extrapelvic bone metastasis revealed independent predictors for survival after bone metastasis (hazard ratio, 0.09; 95% confidence interval, 0.01-0.67; P = 0.019 and hazard ratio, 0.07; 95% confidence interval, 0.01-0.53; P = 0.01)., Conclusions: In endometrial carcinoma that develops bone metastasis, isolated bone recurrence and extrapelvic bone metastasis are significant predictors of prolonged survival after the diagnosis of bone metastasis. Further researches on the optimal treatment modality and factors that have the clinical implications are warranted.

Objective: Some authors have recommended the use of diagnostic laparoscopy as a pretreatment assessment step for conservative hormonal treatment in young women with endometrial cancer. The aim of this study was to determine the incidence of synchronous primary cancer of the endometrium and ovary in young women., Methods: The medical records of 3240 patients with endometrial cancer who underwent primary surgery between 1995 and 2010 were collected from 7 institutions and were retrospectively reviewed. Low-risk endometrial cancer was defined as tumors without myometrial invasion; normal or benign-looking ovaries; normal CA-125; grade 1 endometrioid histology; and early stage endometrial cancer on pretreatment assessment., Results: Fifteen percent (471/3240) were younger than 40 years of age. The incidence of synchronous ovarian cancer in young women with endometrial cancer was 4.5% (21/471). In patients with low-risk endometrial cancer, synchronous cancers were not identified., Conclusion: The incidence of synchronous ovarian malignancies in young women with endometrial cancer was quiet low (4.5%), unlike previous studies have revealed (11-29%). Therefore, diagnostic laparoscopy is not mandatory in patients with low-risk early stage endometrial cancer selected for conservative treatment to confirm the absence of ovarian malignancy., (© 2013.)

Objective: To present 515 LESS surgeries and report the perioperative outcomes and late complications according to the Clavien-Dindo classification., Study Design: We performed a prospective single-center study (Canadian Task Force classification II-2). One surgeon trained in minimally invasive surgery performed 515 cases of LESS surgery from May 2008 to September 2011., Results: LESS gynecological surgery was performed on 515 patients (274 total hysterectomies; 26 subtotal hysterectomies; 87 adnexectomies including oophorectomy, salpingectomy, and salpingo-oophorectomy; 100 ovarian cystectomies; 17 myomectomies; 11 others). The median age and body mass index of the patients were 45 years and 22.6 kg/m², respectively. LESS surgery was successfully completed in 493 patients (95.7%) without the need for one or more ancillary ports or conversion to laparotomy. Twenty patients needed one or more additional ports and two cases were converted to laparotomy. One or more additional ports were required most frequently in ovarian cystectomy procedures (12/100, 12%). Thirty-six patients (7.0%) required intraoperative and/or postoperative transfusions. Each of these patients underwent hysterectomy (33/274, 12.0%) or subtotal hysterectomy (3/26, 11.5%). Perioperative complications (<30 postoperative days), excluding transfusions, occurred in 8 patients (1.6%) and included one case each of vault bleeding, vault abscess, stump watery discharge, rectal injury, and vesicovaginal fistula, and three cases of urinary tract injury. Late complications occurred in three patients (0.6%) and included two umbilical hernias and one vault evisceration. The overall complication rate, excluding transfusions, was 2.1% (11/515)., Conclusion: The rate of late postoperative complications, including umbilical port site hernia and vault evisceration, was not increased in this study, as compared to previous reports of single-port and conventional laparoscopic surgeries., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Objective: To assess the incidence and management of accidental rectal injury during gynecologic laparoscopic surgery., Design: A retrospective study with review of outcomes (Canadian Task Force classification II-3)., Setting: A tertiary care/research/university hospital., Patients: Patients with colon injury during laparoscopy for gynecologic diseases at Samsung Medical Center, Seoul, Korea, from January 2000 to April 2012., Intervention: Use of absorbable suture or staples in primary repair of injured colon., Measurements and Main Results: From January 2000 to April 2012, 12 354 patients underwent laparoscopic surgery. Rectal injury occurred in 15 women (0.12%). Their median age was 42.5 years (30-49), and the median length of injury was 3 cm (0.7-7). Among 13 patients with rectal injuries recognized during surgery, 10 patient injuries were repaired primarily with interrupted absorbable sutures without converting laparotomy, 1 patient underwent laparoscopic low anterior resection with Endo-GIA, 1 underwent open primary repair, and 1 underwent open low anterior resection. Two rectal injuries were detected after surgery. One of these patients underwent primary repair under laparotomy at day 4 after surgery. The other patient had development of a rectovaginal fistula requiring open segmental resection 30 days after primary laparoscopy despite conservative management, including percutaneous drainage and prophylactic antibiotics., Conclusion: Rectal injury during laparoscopy in the gynecologic field can be repaired successfully without the need for a colostomy regardless of mechanism of injury and the size of injury if adequate rectal tissue is available and recognized during surgery., (Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.)

Objective: Dynamin 2, which plays a role in endocytosis, is known to be required for HPV infection on host cells. We investigated dynamin 2 as a biomarker in grading of cervical intraepithelial neoplasia (CIN) by comparing with Ki-67 expression and the type of HPV infection (low-risk vs. high-risk)., Study Design: We performed immunohistochemical stains of dynamin 2 and Ki-67 on tumor samples of patients with CIN and the type of HPV infection was investigated., Results: All the patients with reactive changes (n=7) or normal (n=4) did not show dynamin 2 expression. There were 33, 14, and 12 cases with CIN I, II, and III, respectively, and there was a negative correlation between the degree of dynamin 2 expression and the severity of CIN lesions with statistical significance (P<0.001). Negative expression of dynamin 2 was more sensitive for the detection of CIN II/III than high expression (2+) of Ki-67 (96.2% vs. 73.1%, P=0.041). Among patients in whom HPV infection was detected, the degrees of dynamin 2 expression were not associated with the type of HPV infection (low-risk vs. high-risk). Overall, there was a negative correlation between the expression patterns of Ki-67 and dynamin 2., Conclusion: We found that dynamin 2 may be a helpful biomarker in grading of CIN lesions and a candidate biomarker for detecting low grade CIN with high sensitivity., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Gliomatosis peritonei (GP) is commonly associated with ovarian teratoma and is not thought to have an adverse prognostic effect. However, the prognostic impact and characteristics of GP remain to be clarified. In this study, we investigated the clinicopathologic features of ovarian teratoma associated with GP, and we further compared ovarian immature teratoma (IT) with GP to ovarian IT without GP. During the study period, there were a total of 16 ovarian teratomas associated with GP. Among them, 15 cases were ovarian ITs of various grades. When ovarian IT with GP (n = 15) was compared to ovarian IT without GP (n = 27), it was found that ovarian IT patients with GP had larger tumor size (median, 19 vs. 13 cm; P < 0.001), more frequent recurrence (40 %, 6/15 vs. 3.7 %, 1/27; P = 0.005), and frequently elevated preoperative CA-125 level (100 %, 12/12 vs. 50 %, 10/20; P = 0.004). All recurrences occurred within 2 years of the initial surgery. Survival curves indicated that ovarian IT patients with GP had significantly shorter recurrence-free survival compared to those without GP (P = 0.002). The 2-year recurrence-free survival rates were 59.3 and 96.3 % in IT with GP and IT without GP, respectively. However, all but one case of IT with GP are currently alive. In conclusion, GP is an adverse prognostic factor characterized by frequent recurrence in patients with ovarian IT.

Introduction: Approximately 15% of all cervical cancers are found in women under the age of 40. Sexual function is a matter of great importance for these women. However, the impact of the surgical radicality for cervical cancer on sexual function has not been established., Aims: The aim of this study is to estimate the difference in postoperative sexual function in women with surgically treated early-stage cervical cancer according to the extent of surgical radicality., Methods: One hundred and five women with early-stage cervical cancer treated by cervical conization (CC), radical trachelectomy (RT), and radical hysterectomy (RH) between January 2006 and December 2009 were asked to answer a validated questionnaire, the Female Sexual Function Index (FSFI)., Main Outcome Measure: FSFI score., Results: Eighty-one completed questionnaires from 39 (48.2%) women in the CC group, 18 (22.2%) in the RT group, and 24 (29.6%) in the RH group were studied. The FSFI total score for the CC group was 30.72 ± 3.39, suggesting no sexual dysfunctioning. The FSFI total score for the RT and RH groups (21.78 ± 4.17 and 22.40 ± 4.09, respectively) demonstrated a globally compromised sexuality, based on a FSFI total score of 26.55 as the clinical cut-off for sexual dysfunction. The FSFI total scores in the RT and RH groups were significantly decreased compared to the CC group (P < 0.001). However, there were no significant differences between the RT and RH groups., Conclusions: The RT and RH groups, unlike the CC group, had compromised sexual function after the treatment of early-stage cervical cancer., (© 2012 International Society for Sexual Medicine.)

Aim: To evaluate prognostic factors in Korean patients with endometrial cancer., Methods: A retrospective analysis was conducted on 248 patients who were staged surgically at the Samsung Medical Center between 1995 and 2004. Survival data were analyzed using Kaplan-Meier estimates, and multivariate analysis was performed using the Cox regression method., Results: The median age was 51 years (range 21-75), which was younger than in previous studies in Western patients, and the age of 50 years was the cutoff to predict survival. More than half (55.6%) were normal weight or underweight (BMI <25). Multivariate analysis revealed that age, Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) stage, and histopathology were independent predictors of disease-free survival, and FIGO stage and p53 mutation were independent prognostic factors for disease-specific survival (DSS). The 5-year DSS for patients with stage I, II, III and IV disease was 95.6, 93.8, 69.8 and 50%, respectively. The 5-year DSS rate for patients with a p53 mutation was 84.4%, compared with 97.1% for patients without., Conclusions: Korean patients with endometrial cancer were younger and had a lower BMI than previously reported. Furthermore, age greater than 50 years was predictive of a poor outcome. Age, FIGO stage, histopathology and a p53 mutation were independent prognostic factors for survival., (Copyright © 2012 S. Karger AG, Basel.)

Objective: Single-port access (SPA) surgery is a rapidly advancing technique in laparoscopic surgery. Currently, there is limited evidence on the learning curve and complications of performing SPA laparoscopic-assisted vaginal hysterectomies (LAVHs)., Study Design: One hundred patients who initially planned to undergo a SPA-LAVH for benign indications between May 2008 and October 2009 were enrolled. All operative data were prospectively collected. Patients were arranged in order based on the date of surgery and the outcomes were compared between quartiles (cases 1-25, 26-50, 51-75, and 76-100). Proficiency was defined as the point at which the slope of the curve becomes less steep for operative time. Plateau was defined as the point at which the slope is zero. A comparison of the data on a quartile was performed. Locally weighted regression generated smoothed lines that represent operative time over the sequence of the operations., Results: Most SPA-LAVHs were successful, but additional ports were needed in 5 patients because of pelvic adhesions (n=3) and large uterine size (n=2). There were 3 cases with post-operative complications (hemorrhage, 1; vesicovaginal fistula, 1; and cuff abscess, 1), who were managed without sequelae. Without increased operative morbidities, the operative time decreased from a median of 133.0 min (interquartile range, 107.5-162.5 min) in the first quartile to a median of 100.0 min (interquartile range, 85.0-117.5 min) for the last quartile (p=0.011). The proficiency and plateau were determined after approximately 25 and 75 cases, respectively., Conclusions: The SPA-LAVH was safe, effective, and reproducible after training, and with the current technique, had a low rate of complications., (Copyright © 2011. Published by Elsevier Ireland Ltd.)

Objective: To evaluate the oncologic safety and reproductive outcomes in patients with advanced-stage borderline ovarian tumors (BOTs)., Study Design: The medical records of patients with advanced-stage BOTs who were treated between 1997 and 2009 were reviewed retrospectively. Reproductive outcomes were assessed by telephone interviews., Results: Six (24%) and 19 patients (76%) had stages II and III disease, respectively. Twenty patients (80%) were treated by radical surgery and five patients (20%) underwent fertility-sparing surgery. Five patients (20%) had invasive implants and 20 patients (80%) had non-invasive implants. The median follow-up time was 71.4 months (range, 10-135 months). Four patients relapsed after a median interval of 40 months (range, 16-77 months) following primary treatment. Of these four patients, two who initially had invasive implants relapsed in the form of invasive ovarian carcinoma. Patients with invasive implants (2 of 5 [40%]) tend to relapse more frequently than patients with non-invasive implants (2 of 20 [10%]). Among five women who underwent fertility-sparing surgery, four attempted to conceive and five singleton pregnancies occurred., Conclusion: Patients with advanced-stage BOTs with non-invasive implants have an excellent prognosis. Fertility-sparing surgery should be considered if there are no invasive implants. Indeed, reproductive outcomes after fertility-sparing surgery with non-invasive implants are promising., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

The human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine has been demonstrated to be highly efficacious and immunogenic with a favorable safety profile. This study assessed the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Korean girls aged 10-14 yr. This multi-center, observer-blind trial randomly assigned 321 healthy girls to receive three doses (0, 1, 6-month schedule) of HPV-16/18 AS04-adjuvanted vaccine or hepatitis A vaccine. Immunogenicity against vaccine antigens was assessed one month post-Dose 3. Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded. In the according-to-protocol analysis, all initially seronegative subjects vaccinated with the HPV-16/18 AS04-adjuvanted vaccine had seroconverted at Month 7, with a peak geometric mean titer (GMT) that was 600-fold higher than the natural infection titer of 29.8 EU/mL for HPV-16 and a peak GMT that was 400-fold higher than the natural infection titer of 22.6 EU/mL for HPV-18. The vaccine was well tolerated with no increase in reactogenicity with subsequent doses and no reports of vaccine-related SAEs. In conclusion, the HPV-16/18 AS04-adjuvanted vaccine is shown to be highly immunogenic and generally well-tolerated in Korean girls aged 10-14 yr.