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Objective: This study compared the outcomes of laparotomic radical hysterectomy (LRH) and minimally invasive radical hysterectomy (MISRH) in patients with early-stage cervical cancer., Methods: The clinical data of patients with early-stage cervical cancer who underwent LRH or MISRH (laparoscopic/robotic) at Chang Gung Memorial Hospital, Linkou Branch, from 2002 to 2017 were retrospectively reviewed. The surgical safety (operation time, blood loss, blood transfusion rate, length of postoperative stay, and perioperative complications), overall survival (OS), disease-free survival (DFS), and recurrence pattern were analyzed. Propensity score matching (PSM) at a 3:1 ratio was performed to balance prognostic variables., Results: Of the 760 patients (entire cohort), 614 underwent LRH and 146 underwent MISRH. After PSM, 394 and 140 patients were included in the LRH and MISRH groups, respectively. The 5-year OS rate was significantly lower in the MISRH group than in the LRH group (85.6% vs. 93.2%, p=0.043), and the 5-year DFS rate (p=0.21) did not differ significantly. After PSM, the 5-year OS rates did not differ significantly between the MISRH and LRH groups (87.1% vs. 92.1%, p=0.393). The MISRH group had a significantly shorter operation time (p<0.001), lower intraoperative blood loss (p<0.001), lower blood transfusion rate (p<0.001), and shorter postoperative stay (p<0.001) but a significantly higher rate of intraoperative bladder injury (p<0.001) than the LRH group., Conclusion: After PSM, MISRH is associated with nonsignificantly lower OS but a significantly higher risk of intraoperative urological complications than LRH., Competing Interests: No potential conflict of interest relevant to this article was reported., (© 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.)

Objectives: To evaluate content validity and psychometric properties of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) to determine its suitability in inflammatory bowel disease (IBD) clinical trials., Methods: Content validity of PROMIS-29 was evaluated using qualitative interviews, including concept elicitation and cognitive debriefing, among patients living with Crohn's disease (Crohn's disease n = 20) or ulcerative colitis (UC, n = 19). PROMIS-29 validity, reliability, and responsiveness were assessed using data from phase II clinical trials of Crohn's disease (N = 360) and UC (N = 518)., Results: Common (≥74%) symptoms reported in qualitative interviews were increased stool frequency, fatigue, abdominal pain/cramping, blood/mucus in stool, bowel urgency, and diarrhea. Disease impact aligned with PROMIS-29 content (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles/activities). Cognitive debriefing indicated that PROMIS-29 instructions were easily understood, items were relevant, and the recall period was appropriate. Psychometric evaluations demonstrated that PROMIS-29 scores indicating worse symptoms/functioning were associated with lower health-related quality of life and greater disease activity and severity. PROMIS-29 domain scores correlated (r s ≥ 0.40) with IBD Questionnaire domains and EuroQol-5-Dimension-5-Level dimensions measuring similar concepts. Test-retest reliability among patients with stable disease was moderate-to-excellent (0.64-0.94) for nearly all domains in all studies. PROMIS-29 was responsive to change in disease status from baseline to week 12. Thresholds for clinically meaningful improvement ranged from ≥3 to ≥8, depending on domain., Conclusions: PROMIS-29 is valid, reliable, and responsive for assessing general health-related quality of life and treatment response in IBD clinical trials., Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section., (Copyright © 2024. Published by Elsevier Inc.)

A case of a 32-year-old patient who presented with vaginal bleeding 2 years after undergoing laparoscopic radical trachelectomy and vaginal cerclage was noted to have Mersilene tape erosion. Subsequent management includes the removal of displaced Mersilene tape and a repeat cerclage through a new technique of laparoscopic abdominal cerclage to avoid repeat tape erosion. The novel technique of laparoscopic abdominal cerclage to lower the incidence of preterm delivery among pregnant patients who underwent laparoscopic radical trachelectomy for early-stage cervical cancer is described., Competing Interests: This study was financially supported by Prof. Chyi-Long Lee, Editor-in-Chief of Gynecology and Minimally Invasive Therapy, had no role in the peer-review process or decision to publish this article. The other authors declared no conflicts of interest in writing this paper., (Copyright: © 2024 Gynecology and Minimally Invasive Therapy.)

Cervical cancer is a significant public health concern, particularly in low- and middle-income countries where resources for prevention and treatment are limited. Routine screening, such as the Papanicolaou test (Pap smears) and human papillomavirus (HPV) testing, plays a crucial role in the early detection and prevention of cervical cancer. However, the participation rate in cervical cancer screening programs remains below optimal levels due to various factors. This study aimed to evaluate the reliability and acceptability of the HygeiaTouch Self Sampling Kit for Women in collecting vaginal samples for HPV typing, comparing the results with samples collected by physicians. The study included 1210 women aged 21-65 from three medical centers in Taiwan. The findings indicated that the self-sampling kit was as effective as physician-collected specimens in terms of obtaining valid samples and identifying HPV. The agreement between the two methods was 88%, with a κ value of 0.75. Furthermore, the study assessed the mechanical characteristics of the self-sampling applicator through tensile, bending, and torque tests, and determined that it was safe for intravaginal use. Additionally, the study evaluated the safety and satisfaction of self-sampling and found a low rate of adverse events (0.7%) and high levels of satisfaction (over 90%) among participants. Overall, we demonstrated that the HygeiaTouch Self Sampling Kit for Women is a reliable and acceptable device for HPV testing and cervical screening, providing a convenient, safe, and effective alternative for women., Competing Interests: Chung‐Yao Yang is employed by Hygeia Touch Inc. in Taiwan. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 The Authors. Bioengineering & Translational Medicine published by Wiley Periodicals LLC on behalf of American Institute of Chemical Engineers.)

With the rising need for accessible cervical cancer screening, self-sampling methods offer a promising alternative to traditional physician-led sampling. This study aims to evaluate the efficacy of the HygeiaTouch Self Sampling Kit for Women in detecting human papillomavirus (HPV) types and predicting cervical lesions. We studied the concordance in identifying high-risk HPV (hrHPV) types between samples collected by physicians and those self-collected by women using a self-sampling kit for validation. Women aged 21-65, fitting into specific categories based on their cervical health history were eligible. Cohen's kappa coefficient to gauge concordance between the two specimen types and relative accuracy metrics in identifying cervical intraepithelial neoplasia (CIN) were also calculated, with physician-sampled specimens serving as a reference. A total of 1210 participants from three institutes were involved. The self-sampling kit closely matched the physician-led method in terms of collecting valid specimens (100% vs. 100%), identifying hrHPV types (kappa: 0.75, 95% confidence interval [95% CI]: 0.72-0.79; agreement: 87.7%, 95% CI: 85.8-89.6) and predicting CIN grade 2 or worse (CIN2+) (relative sensitivity: 0.949, relative accuracy: 0.959). Kappa values varied between 0.71 and 0.83 for different hrHPV types and combinations, with an overall value 0.75 (95% CI: 0.72-0.79) signifying robust compatibility between the two methods. Our study underscores the potential of the HygeiaTouch Self Sampling Kit as a reliable, efficient, and user-friendly alternative to traditional sampling methods. This suggests that self-sampling could be pivotal in expanding cervical cancer screening accessibility and enhancing detection rates., (© 2024 Wiley Periodicals LLC.)

Competing Interests: Prof. Chyi-Long Lee and Prof. Kuan-Gen Huang, the editorial board members at Gynecology and Minimally Invasive Therapy, had no roles in the peer review process of or decision to publish this article. The other author declared no conflicts of interest in writing this paper.

Although the incidence of most cancers increases with age, a considerable number of patients receive a diagnosis of cancer during their reproductive years. Young women wishing to get pregnant after cancer treatment should be provided consultation for fertility preservation and possible options. In patients with cervical cancer, hysterectomy is often inevitable because the uterus is located too close to the cervix. For young patients with cervical cancer who desire to get pregnant and whose lesion is confined to the cervix, sparing the uterus and, partially, the cervix should be prioritized as much as possible, while simultaneously ensuring favorable oncologic outcomes. In this review, we explore how to choose an adequate fertility-preserving procedure to achieve a balance between favorable oncologic outcomes and fertility and management during pregnancy after a radical trachelectomy in women with early-stage cervical cancer. For patients who require hysterectomy or radiation, evaluation of the ovarian condition and laparoscopic ovarian transposition followed by the use of artificial reproduction techniques and pregnancy by surrogacy should be discussed as options to achieve a successful pregnancy., Competing Interests: Prof. Kuan-Gen Huang, an editorial board member at Gynecology and Minimally Invasive Therapy, had no role in the peer review process of or decision to publish this article. The other authors declared no conflicts of interest in writing this paper., (Copyright: © 2023 Gynecology and Minimally Invasive Therapy.)

Competing Interests: There are no conflicts of interest.

Background & Aims: The QUASAR Phase 2b Induction Study evaluated the efficacy and safety of guselkumab, an interleukin-23p19 subunit antagonist, in patients with moderately to severely active ulcerative colitis (UC) with prior inadequate response and/or intolerance to corticosteroids, immunosuppressants, and/or advanced therapy., Methods: In this double-blind, placebo-controlled, dose-ranging, induction study, patients were randomized (1:1:1) to receive intravenous guselkumab 200 or 400 mg or placebo at weeks 0/4/8. The primary endpoint was clinical response (compared with baseline, modified Mayo score decrease ≥30% and ≥2 points, rectal bleeding subscore ≥1-point decrease or subscore of 0/1) at week 12. Guselkumab and placebo week-12 clinical nonresponders received subcutaneous or intravenous guselkumab 200 mg, respectively, at weeks 12/16/20 (uncontrolled study period)., Results: The primary analysis population included patients with baseline modified Mayo scores ≥5 and ≤9 (intravenous guselkumab 200 mg, n = 101; 400 mg, n = 107; placebo, n = 105). Week-12 clinical response percentage was greater with guselkumab 200 mg (61.4%) and 400 mg (60.7%) vs placebo (27.6%; both P < .001). Greater proportions of guselkumab-treated vs placebo-treated patients achieved all major secondary endpoints (clinical remission, symptomatic remission, endoscopic improvement, histo-endoscopic mucosal improvement, and endoscopic normalization) at week 12. Among guselkumab week-12 clinical nonresponders, 54.3% and 50.0% of patients in the 200- and 400-mg groups, respectively, achieved clinical response at week 24. Safety was similar among guselkumab and placebo groups., Conclusions: Guselkumab intravenous induction was effective vs placebo in patients with moderately to severely active UC. Guselkumab was safe, and efficacy and safety were similar between guselkumab dose groups., Clinicaltrials: gov number: NCT04033445., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: This study evaluated the content validity and psychometric properties of the Patient-Reported Outcomes Measurement Information System® (PROMIS)-Fatigue Short Form 7a (SF-7a) v1.0 scale to determine its suitability in clinical trials to assess fatigue in patients with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC)., Methods: A qualitative interview assessed patients' experience living with CD (N = 20) and UC (N = 19). The contents of the SF-7a scale were cognitively debriefed to evaluate content validity. A psychometric evaluation was performed using data from clinical trials of patients with CD (N = 360) and UC (N = 214). Correlations with Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Disease Activity Index (CDAI; CD only), and Mayo score (UC only) determined validity. The Patient Global Impression of Change (PGIC) was used to evaluate reliability and responsiveness to change. Using PGIC as an anchor, a preliminary threshold for clinically meaningful change was identified to define fatigue response in both CD and UC patients., Results: All patients reported fatigue as a common symptom. Patients confirmed SF-7a items were relevant to assessing fatigue, instructions and response options were clear, and its 7-day recall period was appropriate. Higher SF-7a scores were associated with higher disease activity (CDAI and Mayo score) and lower health-related quality of life (IBDQ), confirming known groups validity. The correlation of the SF-7a scale was higher with fatigue-related items. (r s ≥ -0.70) than with items not directly associated with fatigue. Test-retest reliability was moderate to good (0.54-0.89) among patients with stable disease, and responsiveness to change in disease severity was demonstrated from baseline to Week 12. A ≥7point decrease was identified as a reasonable threshold to define clinically meaningful improvement., Conclusion: The SF-7a scale is a valid, reliable, and sensitive measure of fatigue in patients with moderately to severely active IBD and can be used to evaluate treatment response., (© 2023. The Author(s).)

Background: We investigated whether mutations in plasma circulating tumor DNA (ctDNA) can provide prognostic insight in patients with different histological types of ovarian carcinoma. We also examined the concordance of mutations detected in ctDNA samples with those identified in the corresponding formalin-fixed paraffin-embedded (FFPE) tumor specimens., Methods: Between July 2016 and December 2017, 29 patients with ovarian carcinoma were prospectively enrolled. FFPE tumor specimens were obtained from all participants. A total of 187 blood samples for ctDNA analysis were collected before surgery (C0), immediate after surgery before adjuvant chemotherapy (C1), and at six-month intervals. Progression-free survival (PFS) and overall survival (OS) served as the main outcome measures., Results: The study cohort consisted of 13 (44.8%) patients with high-grade serous carcinomas (HGSC), 9 (31.0%) with clear cell carcinoma, 2 (6.9%) with mucinous carcinomas, 4 (13.8%) with low-grade serous carcinomas, and 1 (3.4%) with endometrioid carcinoma. Twenty-four (82.8%) patients had at least one detectable ctDNA variant. The concordance rate between mutations identified in pretreatment ctDNA and corresponding FFPE tumor specimens was 92.3% for patients with HGSC and 58.6% for the entire cohort. The median follow-up time was 33.15 months (range: 0.79-46.13 months). Patients with an advanced stage disease more likely had detectable ctDNA mutations before surgery (C0) and after surgery at C1, while those with HGSC more likely had ctDNA mutations detected before surgery. The presence of ctDNA mutations at C1 was an independent predictor of worse OS with a hazard ratio of 6.56 (95% confidence interval, (1.07-40.17) for detectable versus undetectable C1 ctDNA variants, p = 0.042)., Conclusions: ctDNA mutations are common in patients with ovarian carcinoma. The presence of ctDNA mutations after surgery was an independent predictor of less favorable PFS and OS., Competing Interests: Conflicts of interest Shu-Jen Chen, Hua-Chien Chen, Wen Hsiao, and Kien-Thiam Tan are employees of ACT Genomics, Co. Ltd., (Copyright © 2022 Chang Gung University. Published by Elsevier B.V. All rights reserved.)

Introduction: One target of rheumatoid arthritis (RA) treatment is to achieve early sustained remission; over the long term, patients in sustained remission have less structural joint damage and physical disability. We evaluated Simplified Disease Activity Index (SDAI) remission with abatacept + methotrexate versus abatacept placebo + methotrexate and impact of de-escalation (DE) in anti-citrullinated protein antibody (ACPA)-positive patients with early RA., Methods: The phase IIIb, randomized, AVERT-2 two-stage study (NCT02504268) evaluated weekly abatacept + methotrexate versus abatacept placebo + methotrexate., Primary Endpoint: SDAI remission (≤ 3.3) at week 24. Pre-planned exploratory endpoint: maintenance of remission in patients with sustained remission (weeks 40 and 52) who, from week 56 for 48 weeks (DE period), (1) continued combination abatacept + methotrexate, (2) tapered abatacept to every other week (EOW) + methotrexate for 24 weeks with subsequent abatacept withdrawal (abatacept placebo + methotrexate), or (3) withdrew methotrexate (abatacept monotherapy)., Results: Primary study endpoint was not met: 21.3% (48/225) of patients in the combination and 16.0% (24/150) in the abatacept placebo + methotrexate arm achieved SDAI remission at week 24 (p = 0.2359). There were numerical differences favoring combination therapy in clinical assessments, patient-reported outcomes (PROs) and week 52 radiographic non-progression. After week 56, 147 patients in sustained remission with abatacept + methotrexate were randomized (combination, n = 50; DE/withdrawal, n = 50; abatacept monotherapy, n = 47) and entered DE. At DE week 48, SDAI remission (74%) and PRO improvements were mostly maintained with continued combination therapy; lower remission rates were observed with abatacept placebo + methotrexate (48.0%) and with abatacept monotherapy (57.4%). Before withdrawal, de-escalating to abatacept EOW + methotrexate preserved remission., Conclusions: The stringent primary endpoint was not met. However, in patients achieving sustained SDAI remission, numerically more maintained remission with continued abatacept + methotrexate versus abatacept monotherapy or withdrawal., Trial Registration: ClinicalTrials.gov identifier, NCT02504268. Video abstract (MP4 62241 KB)., (© 2023. The Author(s).)

Competing Interests: Prof. Kuan-Gen Huang and Prof. Chyi-Long Lee, the editorial board members at Gynecology and Minimally Invasive Therapy, had no roles in the peer review process of or decision to publish this article. The other authors declared no conflicts of interest in writing this paper.

Competing Interests: Prof. Kuan-Gen Huang and Dr. Chyi-Long Lee, the editorial board members at Gynecology and Minimally Invasive Therapy, had no roles in the peer review process of or decision to publish this article. The other authors declared no conflicts of interest in writing this paper.

Background: AVERT-2 (a phase IIIb, two-stage study) evaluated abatacept + methotrexate versus methotrexate alone, in methotrexate-naive, anti-citrullinated protein antibody-positive patients with early (≤ 6 months), active RA. This subanalysis investigated whether individual patients who achieved the week 24 Simplified Disease Activity Index (SDAI) remission primary endpoint could sustain remission to 1 year and then maintain it following changes in therapy., Methods: During the 56-week induction period (IP), patients were randomized to weekly subcutaneous abatacept 125 mg + methotrexate or abatacept placebo + methotrexate. Patients completing the IP who achieved SDAI remission (≤ 3.3) at weeks 40 and 52 entered a 48-week de-escalation (DE) period. Patients treated with abatacept + methotrexate were re-randomized to continue weekly abatacept + methotrexate, or de-escalate and then withdraw abatacept (after 24 weeks), or receive abatacept monotherapy. Proportions of patients achieving sustained SDAI and Boolean remission, and Disease Activity Score in 28 joints using C-reactive protein (DAS28 [CRP]) < 2.6, were assessed. For patients achieving early sustained SDAI remission at weeks 24/40/52, flow between disease activity categories and individual trajectories was evaluated; flow was also evaluated for later remitters (weeks 40/52 but not week 24)., Results: Among patients treated with abatacept + methotrexate (n/N = 451/752) at IP week 24, 22% achieved SDAI remission, 17% achieved Boolean remission, and 42% achieved DAS28 (CRP) < 2.6; of these, 56%, 58%, and 74%, respectively, sustained a response throughout IP weeks 40/52. Among patients with a sustained response at IP weeks 24/40/52, 82% (14/17) on weekly abatacept + methotrexate, 81% (13/16) on abatacept monotherapy, 63% (12/19) who de-escalated/withdrew abatacept, and 65% (11/17) on abatacept placebo + methotrexate were in SDAI remission at end of the DE period; rates were higher than for later remitters in all arms except abatacept placebo + methotrexate., Conclusions: A high proportion of individual patients achieving clinical endpoints at IP week 24 with abatacept + methotrexate sustained their responses through week 52. Of patients achieving early and sustained SDAI remission through 52 weeks, numerically more maintained remission during the DE period if weekly abatacept treatment continued., Trial Registration: NCT02504268 (ClinicalTrials.gov), registered July 21, 2015., (© 2023. Crown.)

Competing Interests: Prof. Chyi-Long Lee and Prof. Kuan-Gen Huang, editorial board members at Gynecology and Minimally Invasive Therapy, had no roles in the peer review process of or decision to publish this article. The other author declared no conflicts of interest in writing this paper.

Objective: Laparoscopic box simulation training is widely recognized as an assessment tool to facilitate psychomotor skills especially for novice surgeons. However, current commercialized training modules including pegs, gauze, clips, pins etc. are generally costly and relatively inaccessible. We introduce a simple and pioneer surgical training drill, the Origami Box Folding Exercise (OBFE), based on the validated evaluating system of objective structured assessment of technical skills (OSATS) constructed with the scoring system of procedure-specific checklist (PSC) and global rating scale (GRS)., Materials and Methods: Face and content validation of the OBFE and OSATS are evaluated by five endoscopic experts from two medical centers in Taiwan. This is a prospective observational study analyzing the pre-test/post-test result of OBFE from 37 participants in two individual workshops as training and evaluating method for laparoscopic psychomotor skills. Both the pre and post tests are video recorded with a time limit of 5 min graded by two independent evaluators based on the OSATS scoring system., Results: The reliability of PSC, GRS, and intergroup value between PSC and GRS were 0.923, 0.926 and 0.933, respectively. Inter-rater reliability of PSC, GRS, and both were 0.985, 0.932 and 0.977, respectively. Construct validity of PSC and GRS were statistically significant, with p-value 0.006 and 0.001, respectively., Conclusion: OBFE enhances laparoscopic psychomotor skills with requirement of a single piece of paper. The associated OSATS tool for a 5-min OBFE test was validated. OBFE training is an efficient training and assessment system to promote psychomotor skills in laparoscopic box simulation drill which requires simple and economical preparation., Competing Interests: Declaration of competing interest Hsin-Hong Kuo, MD has a consultancy to Huaprac. Chih-Feng Yen, MD, PhD, Wei-Li Lin, MD, Hung-Hsueh Chou, MD, PhD, Kuan-Gen Huang, MD, PhD, Chyi-Long Lee, MD, PhD, Kung-Liahng Wang, MD and Ming-Ju Hsieh, MD have no conflicts of interest or financial ties to disclose., (Copyright © 2023. Published by Elsevier B.V.)

Background: Combined cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) to treat peritoneal surface malignancy (PSM) has gained a positive result compared with palliative chemotherapy alone in several cancer types. However, its postoperative care could be challenging. We aimed to develop a predicting model on early mortality., Methods: We retrospectively reviewed 132 PSM patients who had received CRS-HIPEC. The optimal cut-off value of the neutrophil-to-lymphocyte ratio (NLR) was determined as 4.4 by using the receiver operating characteristic curve analysis with an area under the curve (AUC) of 0.75. The impact of NLR on survival was elucidated by comparing the pre-operative low (NLR≤ 4.4, n = 101) and high (NLR> 4.4, n = 31) groups using the Kaplan-Meier method. The significant variables selected in multivariate analysis on early mortality were used in prediction model development., Results: Multivariate analysis showed that incomplete CRS, major postoperative complications, higher pre-operative NLR, and dynamic NLR changes were significant predictors of early mortality. Our perioperative prediction of prognosis (triple P) model contained four independent risks, and the AUC after classification was 0.860 (95% confidence interval [CI]: 0.773-0.947). External validation confirmed positive discrimination ability (AUC: 0.808, 95% CI: 0.666-0.950)., Conclusion: In conclusion, our triple P model provides great determination in outcomes prediction and it is easily obtained, reliable, and applicable in routine practice., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to declare. Corresponding author contact information: Correspondence to Ting-Jung Wu, MD. PhD, 5, Fusing st., Gueishan Dist., Taoyuan County 333, Taiwan, Tel: +886-3-3281200 ext 3366, Fax: +886-3-3285818 E-mail: wutj5056@gmail.com; wutj5056@adm.cgmh.org.tw., (Copyright © 2022 Asian Surgical Association and Taiwan Robotic Surgery Association. Published by Elsevier B.V. All rights reserved.)

Background: To investigate outcomes and morbidity of patients undergoing secondary cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in recurrent ovarian cancer., Materials and Methods: Between April 2014 and January 2019, a total of 51 recurrent ovarian cancer patients receiving secondary CRS and HIPEC were retrospectively reviewed., Results: Among the 51 patients, median peritoneal cancer index score was 13 (range 3-34), and completeness of cytoreduction (CC) score of 0/1 was achieved in 41 patients (78.8%). Regimen of HIPEC included cisplatin and paclitaxel in 39 (75%) cases. The median follow-up duration of survivors was 20.2 months. Sixteen (30.8%) patients remained free of recurrence after HIPEC. The median progression-free survival (PFS) and overall survival (OS) were 11.8 months and 34.5 months respectively. Multivariate analysis showed previous chemotherapy &lt;2 lines (HR 0.24, 0.11-0.52; p = 0.001), chemotherapy-free interval ≥6 months (HR 0.19, 0.09-0.37; p &lt; 0.001) and CA125 &lt; 35 U/mL before HIPEC (HR 0.133, 0.021-0.0832; p = 0.031) were good prognostic factors for PFS. CC0/1 was not significant in multivariate analysis. The most common grade 3/4 toxicity was anemia (17.3%), pleural effusion (11.5%) and renal insufficiency (5.7%). Patients with age ≥50, peritoneal carcinomatosis index (PCI) ≥ 11, operation time ≥10 h and diaphragm surgery had significantly higher incidence of pleural effusion., Conclusions: The current study showed adding HIPEC to secondary CRS might prolong PFS especially in patients with previous chemotherapy &lt;2 lines, chemotherapy-free interval ≥6 months and CA125 &lt; 35 U/mL before HIPEC., Competing Interests: Conflicts of interest The authors declare that they have no competing interests., (Copyright © 2021 Chang Gung University. Published by Elsevier B.V. All rights reserved.)

Objective: This study aims to describe the feasibility of treating early-stage endometrial cancer with hysterectomy, bilateral salpingo-oophorectomy, sentinel lymph node biopsy, and bilateral pelvic lymphadenectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES)., Materials and Methods: A longitudinal study of prospectively registered patients was conducted at an academic tertiary care center. 15 patients who underwent vNOTES surgical staging of early endometrial carcinoma between January 2014 and December 2020 were included in the study., Results: 15 patients between 20 and 80yrs of age with histologically proven Stage1 Gr1-2 endometrial cancer underwent vNOTES surgical staging. The mean age of the study population was 52.8 years (Standard Deviation [SD] 6.8) and the mean BMI was 27.8 kg/m 2 (SD 6.4). The average operative time was 231.4 min (SD 41.0) with the mean estimated blood loss of 122.0 mL (SD 104.4). A total of 12 (80%) patients underwent SNL biopsy with ICG guided system, whereas 3 (20%) had pelvic lymph node dissection. There was one case with the surgical complication of bladder injury requiring conversion to conventional laparoscopy., Conclusion: With this study, we studied the feasibility of vNOTES surgery for early-stage endometrial cancer with minimal complications and the best long-term surgical outcome. The surgeries were performed by a single skilled endoscopist surgeon with previous experience with vNOTES surgery for adnexal tumors and hysterectomy. Our results showed the practicality of vNOTES in staging surgery for early-stage endometrial cancer. However, application to a larger cohort is required for more extensive surgical outcome studies., Competing Interests: Declaration of competing interest The authors have no conflict of interests to disclose., (Copyright © 2022. Published by Elsevier B.V.)

Competing Interests: Dr. Kuan-Gen Huang, an editorial board member at Gynecology and Minimally Invasive Therapy, had no role in the peer review process of or decision to publish this article. The other authors declared no conflicts of interest in writing this paper.

Background: Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) is a therapeutic approach used to achieve curative treatment in intra-abdominal malignancy with peritoneal carcinomatosis (PC). However, it is a complicated procedure with high post-operative complication rates. Thus, we analyzed our preliminary data to establish whether multidisciplinary teamwork (MDT) implementation is beneficial for CRS-HIPEC outcomes., Method: A series of 132 consecutive patients with synchronous or recurrent PC secondary to gastrointestinal or gynecologic cancer who received CRS-HIPEC operation between May 2015 and September 2017 were included. Ninety-nine patients were categorized into the MDT group, with the 33 other patients into the non-MDT group., Results: The mean PCI score was 16.3 ± 8.8. Patients in the MDT group more often presented a higher PCI score ( p value = 0.038). Regarding CRS completeness (CCR 0-1), it was distributed 81.8% and 57.6% in the MDT and the non-MDT group, respectively ( p value = 0.005). Although post-operative complications were common ( n = 62, 47.0%), post-operative complication rates did not differ between the two groups. The cumulative OS survival rate at the first year was 75.5%. Older age ( p = 0.030, HR = 4.58, 95% CI = 1.16-18.10), ECOG 2 ( p = 0.030, HR = 6.41, 95% CI = 1.20-34.14), and incomplete cytoreduction ( p = 0.048, HR = 2.79, 95% CI = 1.04-8.27) were independent prognostic factors for survival., Conclusions: Our experience suggests that the CRS-HIPEC performed under MDT cooperation may result in higher complete cytoreduction rates without increasing post-operative complications and hospital mortalities.

Objective: The objective of this study is to evaluate the safety and efficacy of adding bevacizumab to dose-dense adjuvant chemotherapy with bevacizumab maintenance after neoadjuvant chemotherapy (NAC) and interval debulking surgery (IDS) for stage III/IV ovarian, tubal, and primary peritoneal cancer., Study Design: This phase II clinical trial using Simon's minimax two-stage design was conducted. At the first stage, 13 subjects were enrolled, and the trial would proceed to second stage if ≤3 subjects discontinued treatment for study-defined significant adverse events (AEs). Patients with stage III/IV ovarian, tubal, and primary peritoneal cancer deemed not feasible for primary cytoreductive surgery were enrolled after 3-4 cycles of NAC and IDS without disease progression. NAC could be either weekly paclitaxel (80 mg/m 2 ) (dose-dense) plus 3-weekly carboplatin (AUC5-6) or 3-weekly conventional schedule. After IDS, postoperative dose-dense adjuvant chemotherapy for 3 cycles at least (best to 6 cycles), and 3-weekly bevacizumab 15 mg/kg was given since postoperative cycle 2. Further 3-weekly maintenance bevacizumab 15 mg/kg was given intravenously for 17 cycles., Results: Of the 22 enrolled subjects, 13 (59.1 %) had no gross lesion after IDS. Of the 13 subjects enrolled on the 1 st stage, one study-defined significant AE occurred, therefore the trial proceeded to the 2nd stage (n = 9). The median progression-free survival (PFS) was 22.1 months (95 % confidence interval [CI], 13.7-30.5), and the median overall survival (OS) was 49.2 months (95 % CI, 33.8-64.6). Peritoneal Cancer Index score at entering abdomen during IDS was significant for PFS (>12 vs ≤ 12: p = 0.003). One of the 22 subjects did not receive any study treatment. In the safety analysis (n = 21), grade 3/4 AEs included thrombocytopenia of 38.1 %, neutropenia 71.4 %, and anemia 28.6 %. Study-defined significant AEs of bowel perforation, poor-healing wound, and hypertension were found in 1 case each, respectively., Conclusion: This phase II trial demonstrated adding bevacizumab to dose-dense adjuvant chemotherapy with bevacizumab maintenance after NAC was feasible with tolerable toxicity and comparable PFS/OS as compared to other studies using bevacizumab in the NAC phase or dose-dense scheduling throughout., Competing Interests: Declaration of Competing Interest Lai CH, Lin H and Qiu JT report free bevacizumab supply from Roche for this trial. Lai CH reports honorarium from ACT Genomics., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objective: Minimally invasive radical hysterectomy has been shown to be associated with poorer outcome in an influential prospective, randomized trial. However, many centers worldwide performing minimally invasive radical hysterectomy have data and experience that prove otherwise. We aim to review surgical and oncologic outcomes of patients operated by Laparoscopic Radical Hysterectomy in a tertiary hospital, by experienced surgeons and standardization in radicality, for cervical carcinoma Stage 1A1-1B1 from January 2009 to May 2014., Materials & Methods: Standardised surgical technique with Parametrium & Paracolpium resection approach was adopted by qualified and experienced Gynecologic/Gyne-Oncologic Endoscopic & Minimally Invasive Surgeons in performing Laparoscopic Radical Hysterectomy for Cervical Cancer stage 1A1-1B1 from January 2009-May 2014, involving 53 patients. Electronic Medical Record system (EMR) Of Chang Gung Memorial Hospital(Tertiary Referral Centre), Department of Obstetrics & Gynecology was accessed for surgical and oncologic outcomes., Results: Fifty-Three patients operated from January 2009 to May 2014 were followed up for an average of 96.7 months with longest follow-up at 127 months. There were no cases of recurrence or death reported. 5 Year - Survival Rate and 5 Year Disease-Free Survival Rate were 100%. Two patients received post-operative pelvic radiation concurrent with chemotherapy using Cisplatin due to greater than 1/3 cervical stromal invasion., Conclusion: It is vital to standardize minimally invasive surgical techniques for early stage cervical cancer, with focus on adequate radicality and resection which may contribute to excellent survival outcomes. Further international multi-center randomized trial (Minimally Invasive Therapy Versus Open Radical Hysterectomy In Cervical Cancer) will provide justification for continued practice of MIS in early stage cervical cancer., Competing Interests: Declaration of competing interest Drs. Chyi-Long LEE, Kuan-Gen HUANG, Peng Teng CHUA, Marie Christine Valerie R. MENDOZA, Siew Yen LAI has no Conflict of interest or funding/financial ties to disclose. Ms. Pei San LEE has no Conflict of interest or funding/financial ties to disclose., (Copyright © 2021. Published by Elsevier B.V.)

Human papillomavirus (HPV) is the well-established etiologic factor for cervical neoplasia. Cervical conization constitutes an effective treatment for high-grade cervical intraepithelial neoplasia (HG-CIN). We conducted an observational study for long-term outcomes and HPV genotype changes after conization for HG-CIN. Between 2008 and 2014, patients with newly diagnosed HG-CIN before conization (surveillance new [SN] group) and those who had undergone conization without hysterectomy (surveillance previous [SP] group) were enrolled. HPV testing and Pap smear were performed periodically for the SN and SP (collectively S) groups. All other patients receiving conization for HG-CIN during the study period were identified from our hospital database. Those eligible but not enrolled into our study were assigned to the non-surveillance (non-S) group. For the S group (n = 493), the median follow-up period was 74.3 months. Eighty-four cases had recurrent CIN Grade 2 or worse (CIN2+) (5-year cumulative rate: 14.8%), of which six had invasive cancer. Among the 84 patients, 65 (77.4%) exhibited type-specific persistence in the paired HPV results, whereas only 7 (8.3%) harbored new HPV types that belonged to the 9-valent vaccine types. Among the 7397 non-S patients, 789 demonstrated recurrent CIN2+, of which 57 had invasive cancer. The stages distribution of those progressed to invasive cancer in the non-S group were more advanced than the S group (P = .033). Active surveillance might reduce the severity of those progressed to cancer. Because a majority of the patients with recurrent CIN2+ had persistent type-specific HPV infections, effective therapeutic vaccines are an unmet medical need., (© 2020 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of Union for International Cancer Control.)

The molecular underpinnings of seromucinous borderline tumor (SMBT) - an uncommon ovarian epithelial neoplasm characterized by association with endometriosis, frequent bilateral ovarian involvement, and occasional progression to invasive carcinoma - remain poorly understood. Here, we sought to comprehensively characterize the mutational landscape of SMBT and elucidate the clonal relationship between bilateral ovarian SMBTs. We also compared the mutational profiles between SMBTs and concurrent invasive carcinomas. Formalin-fixed, paraffin-embedded tissue specimens were retrieved from 28 patients diagnosed with SMBT. Massively parallel sequencing of 409 cancer-related genes was conducted to identify somatic mutations in 33 SMBT samples and four concurrent invasive carcinoma specimens. TERT promoter mutations were assessed by Sanger sequencing, whereas immunohistochemistry was used as a surrogate tool for detecting deletions or epigenetic silencing of relevant tumor suppressor genes. Twenty-six (92.9%) of the 28 patients were diagnosed with stage I SMBTs. Seven (25%) cases showed bilateral ovarian involvement and 13 (46%) had concomitant endometriosis. Concurrent ovarian carcinomas were identified in three patients, whereas one case had a synchronous endometrial carcinoma. Somatic mutations in the KRAS, PIK3CA, and ARID1A genes were identified in 100, 60.7, and 14.3% of SMBT samples, respectively. In contrast, TERT promoter mutations and DNA mismatch repair deficiencies were absent. Sequencing of paired specimens from patients with bilateral SMBT revealed the presence of at least two shared somatic mutations, suggestive of a clonal relationship. Similarly, we identified shared somatic mutations between SMBT samples and concurrent ovarian carcinoma specimens. Taken together, these findings demonstrated a distinct mutational landscape of SMBT in which (1) KRAS is invariably mutated, (2) PIK3CA is frequently mutated, and (3) TERT promoter mutations and DNA mismatch repair deficiencies are absent. Our findings represent the first extensive characterization of this rare ovarian neoplasm, with potential implications for disease classification and molecular diagnostics.

Objective: Sexual dysfunction has been reported in women following treatment for gynecological cancer. However, the actual sexual activities adopted by these women are not well understood. The aims of this study were to (1) explore a relatively new concept, diversity of sexual activities (DSA), and (2) identify factors associated with DSA in women with gynecological cancer., Methods: This cross-sectional study included 136 Taiwanese long-term partnered women with gynecologic cancer treated in a large medical center. DSA was measured with the Diversity of Sexual Activities Scale, which assesses the number of sexual activities adopted in the past 6 months. Covariates included sexual knowledge and sexual attitudes, perceived changes in relationships of intimacy since treatment, and demographic and clinical factors., Results: The mean age of participants was 51.2 years (SD = 8.66); cancer diagnoses were cervical (50.7%), endometrial (31.6%), and ovarian (17.6%). The mean number of sexual activities was 2.88 (SD = 2.63); 29.4% of participants had no physical contact with their partners after treatment. The participants reported a significantly decreased overall satisfaction toward adopted sexual activities after cancer treatment. Lower DSA was associated with older age and receiving a combination of chemotherapy and radiotherapy., Conclusions: Cancer treatment has a significant impact on sexual activity in women with gynecological cancer. Around 30% of participants reported not having any physical contact with their partners since receiving cancer treatment. Sexual rehabilitation counseling that emphasizes alternative forms of sexual expression is suggested., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Competing Interests: There are no conflicts of interest.

This review aimed to evaluate the short term and long-term outcomes of laparoscopic radical hysterectomy (LRH) versus abdominal radical hysterectomy (ARH) for early-stage cervical cancer. A search of PubMed, Medline and Scopus databased from 2000 to 2018 was conducted. Thirty studies were retrieved including 22 retrospective cohort studies and 8 prospective cohort studies. LRH was comparable with ARH in 5-year overall survival (RR = 1.0. 95%CI 0.98-1.03; p = 0.33) and 5-year disease-free survival (RR = 1.02 95%CI 0.97-1.06; p = 0.98). The majority of included studies reported the negative cancer factors which drive adjuvant therapy were similar between two approaches. LRH was associated with lower blood loss and blood transfusion, less postoperative complication, shorter hospital stays and similar intraoperative complication rate compared to ARH. Our data suggested LRH for early-stage cervical cancer was as safe and effective in terms of long-term outcomes, but with lower surgical morbidities., (Copyright © 2020. Published by Elsevier B.V.)

Objective: The characteristics of patients with metachronous breast and ovarian malignancies and the pathogenic role of BRCA1/2 mutations remain poorly understood. We investigated these issues through a review of hospital records and nationwide Taiwanese registry data, followed by BRCA1/2 mutation analysis in hospital-based cases., Methods: We retrospectively retrieved consecutive clinical records of Taiwanese patients who presented with these malignancies to our hospital between 2001 and 2017. We also collected information from the Data Science Center of the Taiwan Cancer Registry (TCR) between 2007 and 2015. Next-generation sequencing and multiplex ligation-dependent probe amplification were used to identify BRCA1/2 mutations and large genomic rearrangements, respectively. When BRCA1/2 mutations were identified in index cases, pedigrees were reconstructed and genetic testing was offered to family members., Results: A total of 12,769 patients with breast cancer and 1,537 with ovarian cancer were retrieved from our hospital records. Of them, 28 had metachronous breast and ovarian malignancies. We also identified 113 cases from the TCR dataset. Eighteen hospital-based cases underwent BRCA1/2 sequencing and germline pathogenic mutations were detected in 7 patients (38.9%, 5 in BRCA1 and 2 in BRCA2 ). All BRCA1/2 mutation carriers had ovarian high-grade serous carcinomas. Of the 12 patients who were alive at the time of analysis, 5 were BRCA1/2 mutation carriers. All of them had family members with BRCA1/2 -associated malignancies., Conclusions: Our results provide pilot evidence that BRCA1/2 mutations are common in Taiwanese patients with metachronous breast and ovarian malignancies, supporting the clinical utility of genetic counseling., Competing Interests: No potential conflict of interest relevant to this article was reported., (Copyright © 2020. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology.)

Background: Vaginal cuff dehiscence is a rare but potentially grave complication after total hysterectomy. Abdominal or pelvic contents are at risk of evisceration through the vaginal opening. It is associated with significant risk for patient morbidity, such as peritonitis, bowel injury, and sepsis., Case Presentation: We report a case of vaginal cuff dehiscence in a 45-year-old multiparous Taiwanese woman who had undergone abdominal total hysterectomy and presented with vaginal cuff dehiscence precipitated by sexual intercourse. Immediate laparoscopic repair was done. Few authors have reported the utilization of the laparoscopic approach. It allows thorough inspection, visualization, and irrigation of the abdominal cavity. It is also associated with fewer intraoperative and postoperative complications., Conclusion: Laparoscopic repair is a safe treatment option to manage vaginal cuff dehiscence after total hysterectomy.

Objectives: An Asian Gynecologic Oncology Group phase III randomized trial was conducted to determine whether maintenance chemotherapy could improve progression-free survival (PFS) in stages III/IV ovarian cancer., Methods: Between 2007 and 2014, 45 newly-diagnosed ovarian cancer patients were enrolled after complete remission and randomized (1:1) to arm A (4-weekly carboplatin area under the curve 4 and pegylated liposomal doxorubicin [PLD] 30 mg/m², n=24) for 6 cycles or arm B (observation, n=21). The primary end-point was PFS. A post hoc translational study was conducted to deep sequence BRCA /homologous recombination deficiency (HRD) genes, because BRCA /HRD mutations ( BRCA /HRD m ) are known to be associated with better prognosis., Results: Enrollment was slow, accrual was closed when 7+ years had passed. With a median follow-up of 88.9 months, the median PFS was significantly better in arm A (55.5 months) than arm B (9.2 months) (hazard ratio [HR]=0.40; 95% confidence interval [CI]=0.19-0.87; p=0.020), yet the median overall survival was not significantly different in arm A (not reached) than arm B (95.1 months) (p=0.148). Overall grade 3/4 adverse events were more frequent in arm A than arm B (60.9% vs 0.0%) (p<0.001). Quality of life was generally not significantly different. Distribution of BRCA1/2m or BRCA /HRD m was not significantly biased between the two arms. Wild-type BRCA /non-HRD subgroup seemed to fare better with maintenance therapy (HR=0.35; 95% CI=0.11-1.18; p=0.091)., Conclusions: Despite limitations in small sample size, it suggests that maintenance carboplatin-PLD chemotherapy could improve PFS in advanced ovarian cancer., Competing Interests: No potential conflict of interest relevant to this article was reported., (Copyright © 2020. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology.)

Competing Interests: There are no conflicts of interest.

Differences among hosts, resulting from genetic variation in the immune system or heterogeneity in drug treatment, can impact within-host pathogen evolution. Genetic association studies can potentially identify such interactions. However, extensive and correlated genetic population structure in hosts and pathogens presents a substantial risk of confounding analyses. Moreover, the multiple testing burden of interaction scanning can potentially limit power. We present a Bayesian approach for detecting host influences on pathogen evolution that exploits vast existing data sets of pathogen diversity to improve power and control for stratification. The approach models key processes, including recombination and selection, and identifies regions of the pathogen genome affected by host factors. Our simulations and empirical analysis of drug-induced selection on the HIV-1 genome show that the method recovers known associations and has superior precision-recall characteristics compared to other approaches. We build a high-resolution map of HLA-induced selection in the HIV-1 genome, identifying novel epitope-allele combinations.

We conduct a 3-y study involving 11,662 respondents to map cultural tightness-the degree to which a society is characterized by rules and norms and the extent to which people are punished or sanctioned when they deviate from these rules and norms-across 31 provinces in China. Consistent with prior research, we find that culturally tight provinces are associated with increased governmental control, constraints in daily life, religious practices, and exposure to threats. Departing from previous findings that tighter states are more rural, conservative, less creative, and less happy, cultural tightness in China is associated with urbanization, economic growth, better health, greater tolerance toward the LGBT (lesbian, gay, bisexual, and transgender) community, and gender equality. Further, analyzing about 3.85 million granted patents in China (1990-2013), we find that provinces with tighter cultures have lower rates of substantive/radical innovations yet higher rates of incremental innovations; individuals from culturally tighter provinces reported higher levels of experienced happiness., Competing Interests: The authors declare no conflict of interest., (Copyright © 2019 the Author(s). Published by PNAS.)

Competing Interests: None