The fluorescence imaging for laparoscopic and laparotomic endometrial sentinel lymph node biopsy (FILLES) trial: Siriraj gynecologic sentinel node of endometrial cancer (SiGN-En) study.

BACKGROUND AND OBJECTIVES: The objective of this study is to establish the detection rate of sentinel lymph node (SLN) biopsies and to determine the sensitivity and false-negative rate of SLN biopsies compared with those of systematic pelvic and para-aortic lymphadenectomies in endometrial cancer. METHODS: This prospective cohort study enrolled patients with endometrial cancer who were scheduled for surgical staging. Patients with a history of chemotherapy or radiotherapy, an abnormal liver function test, or an allergy to indocyanine green (ICG) were excluded. All patients underwent surgical staging with an ICG injection at the cervix. SLNs were identified by a near-infrared fluorescent camera. All SLNs were sent to a pathologist for ultrastaging. RESULTS: From November 2019 to June 2023, 142 patients underwent SLN mapping and surgical staging. SLNs were not detected bilaterally in 8 patients. The detection rate of the SLN biopsies in this study was 91.2%. Thus, the accuracy of the SLN biopsies was 97.6%. The sensitivity for finding metastatic SLNs was 84.2%, with a negative predictive value of 97.22%. CONCLUSIONS: A SLN biopsy in endometrial cancer has a high detection rate and high accuracy. However, surgical expertise and a learning curve are required.

Combined analysis of clinical features, human chorionic gonadotropin (hCG) value, and hCG ratios for early prediction of postmolar gestational trophoblastic neoplasia.

PURPOSE: To investigate factors predicting postmolar gestational trophoblastic neoplasia (GTN) by combined analysis of clinical features, human chorionic gonadotropin (hCG) value, and hCG ratios. METHODS: This retrospective study enrolled patients with histopathologically proven molar pregnancy. Patients lost to follow-up before remission or developing postmolar GTN were excluded. Demographic and clinical characteristics and hCG data obtained before and after molar evacuation were collected. Area under the receiver operating characteristic curve (AUC) analysis was used to identify the hCG and hCG ratio cutoff values that predict postmolar GTN. Multivariate analysis was employed to identify independent predictors of GTN. RESULTS: There were 113 complete moles, 11 partial moles, and 52 unspecified moles included in the final analysis. Of the 176 cases, 90 achieved remission and 86 developed post-molar GTN. The incidence of postmolar GTN was 48.9%, with a median time to GTN development of 5 weeks. Univariate analysis showed age, molar evacuation performed elsewhere, pre-evacuation hCG, hCG at 2nd week post-evacuation, and ratio of hCG at 2nd week post-evacuation to post-evacuation hCG significantly predict GTN. Multivariate analysis revealed an hCG value ≥ 1400 IU/L at 2nd week post-evacuation (AUC: 0.92, aOR: 6.51, 95% CI 1.28-33.16; p = 0.024) and a ratio of hCG at 2nd week post-evacuation to post-evacuation hCG of ≥ 0.02 (AUC: 0.88, aOR: 12.27, 95% CI 2.15-70.13; p = 0.005) to independently predict GTN. CONCLUSIONS: An hCG value ≥ 1400 IU/L at 2nd week post-evacuation and a ratio of hCG at 2nd week post-evacuation to post-evacuation hCG of ≥ 0.02 independently and reliably predict postmolar GTN.

Human papillomavirus genotype distribution in low-grade squamous intraepithelial lesion cytology, and its immediate risk for high-grade cervical lesion or cancer: a single-center, cross-sectional study.

OBJECTIVE: To investigate the distribution of human papillomavirus (HPV) genotypes in low-grade squamous intraepithelial lesion (LSIL) cytology and the immediate risk of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) lesions. METHODS: This prospective cross-sectional study enrolled women aged ≥21 years that were diagnosed with LSIL cytology at Siriraj Hospital (Bangkok, Thailand) during 2017-2019. Anyplex II HPV testing was performed to detect 14 high-risk HPV cases prior to colposcopy-directed biopsy. RESULTS: In total, 318 patients were included in the final analysis. Of those, 24 (7.5%), 241 (75.8%), 53 (16.7%) were aged 21- 25 years, 25-50 years, and ≥50 years, respectively. Eighty-two patients (25.8%) had abnormal screening results within the previous 5 years. High-risk HPV infection was found in 188 patients (59.1%) with 127 (39.9%) having single and 61 (19.2%) having multiple infections. The five most common HPV genotypes were HPV 66 (18.6%), HPV51 (9.7%), HPV58 (9.4%), HPV16 (9.1%), and HPV56 (8.2%). The immediate risk of CIN2+ was 6% in LSIL, regardless of the HPV status, 8% in high-risk HPV-positive LSIL, and 3.1% in high-risk HPV-negative LSIL. When using 6% as the threshold risk for colposcopy, performing reflex HPV testing in LSIL cytology can decrease the number of colposcopies by 40.9%, with an area under the receiver operating characteristic curve of 0.6 (95% confidence interval, 0.5-0.7). CONCLUSION: The study findings support the idea that geographic variations affect the HPV genotype. Reflex HPV testing may decrease the number of colposcopies in cytology-based screening regions with a high prevalence of low-carcinogenic HPV.

Efficacy of Siriraj, in-house-developed, frozen gloves for cold therapy reduction of chemotherapy-induced peripheral neuropathy in gynecological cancer patients: randomized controlled trial.

OBJECTIVES: The primary objective of this study was to investigate the efficacy of cold therapy in reducing paclitaxel-based, chemotherapy-induced, peripheral neuropathy (CIPN). The secondary objective was to establish the incidence of CIPN arising from paclitaxel administration. MATERIALS AND METHODS: The study enrolled gynecological cancer patients who were aged over 18 years and receiving chemotherapy which included paclitaxel (175 mg/m2 every 3 weeks). The patients were allocated to control and cold-therapy groups by computer randomization. During paclitaxel administration, frozen gloves developed in-house by Siriraj Hospital were worn-with a cold pack inside-on both hands and both feet by the cold-therapy patients. The CIPN incidence was evaluated by FACT/GOG-Ntx (version 4) at each chemotherapy cycle and at the 1-month follow-up after treatment completion. RESULTS: There were 79 patients (control arm, 40; study arm, 39). The CIPN incidences in the control and cold-therapy groups were 100% and 48.7%, respectively. CIPN was significantly decreased in the intervention group between the first cycle and the 1 month follow-up after chemotherapy cessation (P value < 0.001). Four patients discontinued the cold therapy due to pain, but there were no serious adverse effects due to the therapy. CONCLUSION: The Siriraj Hospital, in-house-developed, frozen gloves can reduce CIPN effectively as part of cold therapy for paclitaxel-based chemotherapy. The benefits of using the gloves are apparent from the first chemotherapy cycle to the 1-month, post-treatment follow-up assessment.

A comparison of high-risk human papillomavirus DNA detection between urine and cervical sample testing in women with abnormal Pap smears.

AIMS: To compare the clinical performance of high-risk human papillomavirus (hrHPV) DNA detection between urine and cervical samples collected from the same patient for the detection of CIN2+ lesions (high-grade squamous intraepithelial lesions or cervical cancer lesions). The secondary objectives were to evaluate agreement among hrHPV genotypes and to compare patient satisfaction between urine and cervical sample collection. METHODS: This prospective cross-sectional study enrolled 96 women with abnormal cervical cytology who attended the colposcopy clinic at Siriraj Hospital (Bangkok, Thailand) between July 2016 and January 2017. Self-collected random-voiding and first stream urine samples were collected into a universal sterile urine container and immediately mixing with preservative before the pelvic examination. Cervical tissue sampling was performed according to standard treatment guidelines. Both specimens were sent for extraction and detection of hrHPV by Anyplex II HPV high-risk testing. Study patients were surveyed to compare patient satisfaction between urine and cervical sample collection. RESULTS: Carcinogenic hrHPV positive rate was 73% in urine samples and 81% in cervical samples. The sensitivity for HPV in the detection CIN2+ was high in both the urine and cervical groups at 86.2% and 94.8%, respectively. Agreement between the urine and cervical groups for HPV 16 or 18 detection was high, with kappa values of 0.86 for subtypes 16/18. Urine specimen collection had significantly higher satisfaction and acceptability than cervical specimen collection. CONCLUSION: Urine hrHPV testing by real-time polymerase chain reaction demonstrated high sensitivity and accuracy for the detection of CIN2+ lesions, with very good agreement when compared with cervical sample testing.

Sexual dysfunction in Thai gynecologic malignancies survivors: A single-institutional cross-sectional observational survey.

OBJECTIVE: To examine the prevalence of female sexual dysfunction (FSD) in gynecologic cancer survivors. METHODS: A cross-sectional observation survey recruited women aged 18-65 years old who were diagnosed with gynecologic cancers and underwent surgery, radiation, chemotherapy, or combined modalities. Data were collected from September 2019 to March 2020 by the Thai version of the female sexual function index questionnaire to define FSD. The survey contained six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. RESULTS: Of the 98 women included in the study, the mean age was 48.7 ± 10.6 years old. Two-third (67.3%) of the participants was premenopausal, had been diagnosed with ovarian cancer, and had early-stage gynecologic cancers. Fifty-eight of 98 (59.2%) participants were sexually active in the past 4 weeks before the survey. Among those, 89.6% had FSD. The median scores in the FSD group were significantly lower than those in the non-FSD group in all six domains, namely, desire, arousal, lubrication, orgasm, satisfaction, and pain (p < 0.05). There was no statistically significant difference observed between participants with and without FSD in terms of age group, cancer-related data, or sexual behavior data, except participants who had good/excellent relationships with their partners, which impacted FSD (p = 0.01). CONCLUSIONS: This study discovered the high prevalence (89.6%) of hidden issue of "female sexual dysfunction" in Thai gynecologic cancer survivors. The good/excellent relationships with their partners affected the FSD who were sexually active in the past 4 weeks before the survey.

An application of ERBB2 receptor inhibitors in a rare case of S310F somatic ERBB2 mutation of primary signet-ring cell adenocarcinoma of vagina: A case report and review literature of S310F somatic ERBB2 mutation in breast and gynecologic cancers.

•The extremely uncommon subtype of epithelial vaginal cancer.•Comprehensive genomic sequencing of the rare subtype vaginal cancer.•Incorporated of the actionable targeted drugs in the treatment of uncommon cancer based on the comprehensive genomic profile.•A promising response of uncommon disease after the actionable targeted therapy.

Effects of pregabalin on postoperative pain after hysterectomy under spinal anesthesia with intrathecal morphine: a randomized controlled trial.

PURPOSE: To determine if preoperative pregabalin could decrease 24-h postoperative morphine consumption after spinal anesthesia with intrathecal morphine compared with placebo. METHODS: A randomized, double-blind, controlled trial was performed in the tertiary care center. Patients aged between 18 and 65 years who were American Society of Anesthesiologists class I-II and scheduled for abdominal hysterectomy with or without salpingo-oophorectomy were randomly allocated to a placebo or a pregabalin group. Patients received pregabalin 150 mg or placebo 1 h prior to anesthesia. Spinal anesthesia was achieved with 0.5% hyperbaric bupivacaine with morphine 0.2 mg. Intravenous patient-controlled analgesia morphine was provided postoperatively. Postoperative morphine consumption at 6, 12, and 24 h, time to first analgesic rescue, pain scores, adverse effects, and patient satisfaction were evaluated at 24 h after the operation. RESULTS: One hundred twenty-five patients were recruited and 119 patients (placebo N = 58, pregabalin N = 61) were included in the analysis. Forty-seven (81.0%) patients in the placebo group and 53 (86.9%) patients in the pregabalin group required morphine in the first 24 h. Median [IQR] 24-h morphine consumption was 4.0 [1.8, 10.0] mg in the placebo group and 5.0 [2.0, 11.0] mg in the prebagalin group, p = 0.60. There were no differences in cumulative morphine consumption at 6, 12, and 24 h postoperatively. The two groups also did not differ in time to first analgesic rescue, pain scores at rest and on movement, and side effects. CONCLUSION: A single preoperative dose of pregabalin 150 mg did not reduce 24-h postoperative morphine consumption or pain scores or prolong the time to first analgesic rescue in spinal anesthesia with intrathecal morphine.

Utilization of a Scored Patient-Generated Subjective Global Assessment in Detecting a Malnourished Status in Gynecologic Cancer Patients.

PURPOSE: To assess the prevalence of malnutrition in gynecologic cancer patients using the Scored Patient- Generated Subjective Global Assessment (PG-SGA) questionnaire. MATERIALS AND METHODS: A total of 97 gynecologic cancer patients who never had any treatment but were planned for surgery were enrolled. The patients were asked to complete the scored PG-SGA form before the treatment was started. Attending physicians were also asked to complete other information in the PG-SGA form. Total scores were calculated and the patients were classified into 3 nutritional status levels. RESULTS: Mean age was 54 years. Postoperative diagnoses were endometrial cancer in 42 cases (43.2%), ovarian cancer in 29 cases (29.9%), and cervical cancer in 26 cases (26.8%). Mean PG-SGA score was 5.2+4.7. Malnutrition (PG-SGA B and C) was found in 52 patients (53.6%, 95% CI 43.7% - 63.2%). Preoperative BMI, hemoglobin, serum albumin, and cancer stage were not significantly associated with nutritional status. Malnutrition was significantly more common among patients diagnosed with ovarian cancer, compared to other types of cancer (79.3% vs. 42.6%, p 0.004). CONCLUSIONS: Prevalence of malnutrition among gynecologic cancer patients was 53.5%, according to the scored PG-SGA. Malnutrition was significantly more common among patients with ovarian cancer.

Clinical outcomes of stage I endometrial carcinoma patients treated with surgery alone: Siriraj Hospital experiences.

OBJECTIVE: To evaluate the recurrence rates and patterns of failure in patients with stage I endometrial carcinoma after surgical staging without adjuvant therapy. METHODS: Medical records of 229 patients with stage I endometrial carcinoma, treated with surgery alone between 2002 and 2010 at Siriraj Hospital were retrospectively reviewed. The primary objective of this study was recurrence rates. The secondary objectives were patterns of failure, disease-free survival, overall survival, and prognostic factors related to outcomes. RESULTS: During median follow-up time of 53.3 months, 11 recurrences (4.8%) occurred with a median time to recurrence of 21.2 months (range, 7.7 to 77.8 months). Vaginal recurrence was the most common pattern of failure (8/11 patients, 72.7%). Other recurrences were pelvic, abdominal and multiple metastases. Factors that appeared to be prognostic factors on univariate analyses were age and having high intermediate risk (HIR) (Gynecologic Oncology Group [GOG] 99 criteria), none of which showed significance in multivariate analysis. The recurrence rates were higher in the patients with HIR criteria (22.2% vs. 4.1%, p=0.013) or patients with stage IB, grade 2 endometrioid carcinoma (9.4% vs. 4.3%, p=0.199). Five-year disease-free survival and 5-year overall survival were 93.9% (95% CI, 89.9 to 5.86) and 99.5% (95% CI, 97.0 to 99.9), respectively. CONCLUSION: The patients with low risk stage I endometrial carcinoma had excellent outcomes with surgery alone. Our study showed that no single factor was demonstrated to be an independent predictor for recurrence.

Inflammatory Breast Cancer from Metastatic Ovarian Cancer.

Metastases to the breast from tumors other than breast carcinomas are extremely rare and represent only 0.2-1.3% of all diagnosed malignant breast tumors. Furthermore, while the most common sites for advanced ovarian cancer metastases are the liver, lung, and pleura, metastasis to the breast from a primary ovarian cancer is uncommon and has only been reported in 0.03-0.6% of all breast cancers. Here we describe a case report of a 50-year-old female patient with a rare case of breast metastases from an advanced ovarian cancer, presenting as inflammatory breast cancer. Our observations emphasize the clinical importance of distinguishing between primary and metastatic breast cancer during diagnosis for the purpose of appropriate prognosis and treatment.

Prevalence and incidence of anemia in Thai patients with gynecologic cancer.

This prospective, single institute, 6-month observational survey aimed to evaluate the prevalence, incidence, frequency, treatment of anemia, and trigger hemoglobin (Hb) level for initiating transfusion in patients with gynecologic malignancy. One hundred and eighty-six consecutive patients with gynecologic malignancy were analyzed between June and December 2009. Hb level data were collected for up to six data points or 6 months of scheduled visits. Tumor type, disease status, cancer treatment and anemia treatment as well as trigger Hb level for starting treatment were evaluated. The mean age of patients was 51 years. Prevalence of anemia at enrollment was 66.1% (123/186), with 36 of 186 patients (19.4%) having moderate to severe anemia (Hb < 10.0 g/dl). The highest prevalence was found among patients with endometrial cancer (72.2%) and ovarian cancer (72%), newly-diagnosed/receiving treatment (70.9%) and those receiving radiotherapy (75%). The incidence of anemia was 85.7% (54/63). Ovarian cancer had the highest association (87%). For disease status and cancer treatment, the incidence was highest in patients with persistent/recurrent disease (95.2%) and those who received radiotherapy (100%). One hundred and seventy-seven of 186 patients (95.2%) were ever anemic during the survey. Anemia was frequently reported in patients with all tumor types (93-100%), persistent/recurrent disease (98.3%) and those who received radiotherapy (100%) and 80.8% of patients who were ever anemic received treatment (oral iron, 42.9%; transfusion, 37.3%; and erythropoietic agent, 0.6%). In conclusion, the mean Hb trigger level for initiating transfusion as treatment of anemia was 8.6g/dL. The prevalence, incidence, and frequency of anemia are very high among patients with gynecologic malignancy; especially those with ovarian cancer, persistent/recurrent disease, and those receiving treatment.

Relieving perineal pain after perineorrhaphy by diclofenac rectal suppositories: a randomized double-blinded placebo controlled trial.

BACKGROUND: Perineal pain after episiotomy is a common problem following vaginal birth. The pain affects either physical or mental function negatively. There are many methods in perineal pain relief such as local ice pack and a bath, ultrasound, oral anesthesia, and intravenous anesthesia. Analgesic rectal suppository is one of various methods in pain relief especially in drowsy patients, or when oral preparation causes gastric discomfort, nausea or vomiting. OBJECTIVE: To assess the effectiveness of diclofenac rectal suppositories for relief perineal pain after perineorrhaphy. DESIGN: A randomized double-blinded placebo controlled trial. MATERIAL AND METHOD: Seventy-two term, singleton, pregnant women who gave vaginal birth with second to third degree episiotomy tears were randomized with envelop concealment to either diclofenac or placebo rectal suppositories group. Each group received two tablets of 50 mg diclofenac or two tablets of look-alike placebo rectal suppositories. Visual analogue scale was used for scaling pain score before administration of the medications, and at 30 minutes, 1, 2, 12, and 24 hours after administration. RESULTS: No differences were found in the median pain scores before administration of medications and at 30 min, 1 hour and 2 hour after administration (p > 0.05), while the median pain scores were significantly reduced in the diclofenac group at 12 and 24 hours after administration compared to the control group (4.5 vs. 0.0; p < 0.001 and 2.0 vs. 0.0; p = 0.02 for 12 hours and 24 hours, consecutively). CONCLUSION: The present study suggested that diclofenac suppository was effective on reducing perineal pain after episiotomy, especially at 12 and 24 hours after administration.