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Objective: This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2)., Methods: We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women. In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load., Results: A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (-98.61%; 95% confidence interval=-99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed., Conclusion: The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads., Trial Registration: ClinicalTrials.gov Identifier: NCT02139267., 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.)

We aimed to determine whether pretreatment squamous cell carcinoma antigen (SCC-Ag) levels and the average logarithmic change in SCC-Ag levels ( Δ log SCC-Ag Δ time ) after concurrent chemoradiotherapy (CCRT) could predict treatment outcomes in patients with stage IIIC1 cervical squamous cell carcinoma (SCC). We analyzed 168 patients with stage IIIC1 cervical SCC who underwent primary CCRT and collected data on age, local extension, treatment details, hematological parameters, and tumor markers such as SCC-Ag and carcinoembryonic antigen 21-1 (Cyfra). Predictive performances of pretreatment SCC-Ag levels and Δ log SCC-Ag Δ time were assessed using receiver operating characteristic curves. Survival analysis was performed using the Cox regression model and Kaplan-Meier plots. The combination of pretreatment SCC-Ag levels and Δ log SCC-Ag Δ time showed higher area under the curve values than pretreatment SCC-Ag levels alone (area under the curve; 95% confidence interval [CI] 0.708 [0.581-0.836] vs. 0.666 [0.528-0.804], respectively). Pretreatment SCC-Ag (≥ 5 ng/ml and Cyfra levels (≥ 3.15 ng/ml) and Δ log SCC-Ag Δ time (≥ - 1.575) were significant predictors of disease-specific survival. The 5-year disease-specific survival rates significantly differed among the low-, intermediate-, and high-risk groups. Risk stratification using both pretreatment SCC-Ag levels and Δ log SCC-Ag Δ time may predict treatment outcomes of patients with stage IIIC1 SCC., (© 2024. The Author(s).)

Objective: To identify clinicopathological factors associated with disease recurrence for patients with 2018 FIGO stage IA with lymphovascular invasion to IB1 cervical cancer treated with minimally invasive surgery (MIS)., Methods: A total of 722 patients with cervical cancer between January 2010 and February 2021 were identified. Clinicopathological factors related to disease recurrence were analyzed. Disease-free survival (DFS) and overall survival (OS) rates were estimated using the Kaplan-Meier method. To determine prognostic factors for DFS, a Cox proportional hazard regression model was used., Results: Of 722 patients, 49 (6.8%) experienced disease recurrence (37 pelvis, 1 para-aortic lymph node, and 11 peritoneum). Five-year DFS and OS rates were 90.7% and 98.1%, respectively. In multivariate analysis, risk factors associated with disease recurrence were residual disease in the remaining cervix (OR, 3.122; 95% CI, 1.152-8.461; p = 0.025), intracorporeal colpotomy (OR, 3.252; 95% CI, 1.507-7.017; p = 0.003), and positive resection margin (OR, 3.078; 95% CI, 1.031-9.193; p = 0.044). The non-conization group had a higher percentage of stage IB1 (77.4% vs. 64.6%; p = 0.004) and larger tumor (10 mm vs. 7 mm; p < 0.001) than the conization group. Intracorporeal colpotomy and residual disease in the remaining cervix were independent variables associated with disease recurrence in patients undergoing MIS following conization., Conclusion: During MIS, patients with cervical cancer ≤2 cm in size can be vulnerable to peritoneal recurrences. Patients diagnosed with invasive cancer through conization often have low-risk pathological features, which may affect their survival outcomes., Competing Interests: Declaration of Competing Interest All the authors declare no conflict of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To analyze peritoneal spillage and displacement of indocyanine green (ICG)-stained tissues from uterine cervix to pelvis during intracorporeal/vaginal colpotomy in laparoscopic-assisted hysterectomy., Materials and Methods: Eleven patients undergoing laparoscopic-assisted hysterectomy were included. One patient with an incidental diagnosis of endometrial cancer was excluded. Of the 10 patients, five underwent intracorporeal colpotomy (IC) and five received vaginal colpotomy (VC) during laparoscopic-assisted hysterectomy. Approximately 5 cm of resected round ligament from each patient was stained with ICG and cut to 1.0 × 1.0 cm in size. Four to five fragments of ICG-stained tissues were placed and sutured on the uterine cervix before colpotomy. During and after colpotomy, serial pictures under white and fluorescence light were taken to document peritoneal spillage and displacement of ICG-stained tissues to the pelvic peritoneum., Results: Peritoneal spillage of ICG occurred in the entire IC group. Displacement of ICG-stained tissues from uterine cervix to pelvic peritoneum were visualized in three (60%) patients undergoing IC. In the five patients who received VC, peritoneal spillage of ICG and displacement of ICG-stained tissue to pelvic peritoneum did not occur. There were no perioperative complications., Conclusions: IC in minimally invasive radical hysterectomy should not be performed because peritoneal spillage of ICG and displacement of ICG-stained tissues from uterine cervix to pelvis frequently occurs during IC. Therefore, specific measures to prevent tumor exposure during colpotomy should be implemented in cervical cancer patients., (Copyright © 2023. Published by Elsevier B.V.)

We conducted a prospective phase II study on whether extended-field irradiation (EFI) confers survival benefits depending on hypoxic markers in locally advanced uterine cervical cancer (LAUCC). RNA-seq was performed to identify immune and hypoxic gene signatures. A total of 288 patients were randomized to either EFI or pelvic radiotherapy (PRT). All patients completed chemoradiotherapy. Overall, significantly higher 5-year para-aortic recurrence free survival (PARFS) rate occurred in EFI (97.6%) than in PRT group (87.2%), with marginal tendency to improve disease-free survival (DFS; 78% vs 70%, P = .066). Subgroup analyses were performed based on carbonic anhydrase 9 (CA9)-only positive, CA9/hypoxia-inducible factor (HIF) double positive and CA9 negative. In the CA9-only positive, EFI successfully increased 5-year PARFS (100% vs 76.4%, P = .010), resulting in significantly improved long-term DFS (85.7% vs 54.7%, P = .023) compared to the PRT, while there was no such benefit of EFI in the CA9/HIFs double positive. RNA-seq analysis identified distinct immune high subgroup with negative correlation with hypoxia gene signatures (R = -.37, P < .01), which showed a higher 5-year DFS than the immune low (P = .032). Hypoxia-related genes were upregulated in the CA9/HIFs double positive compared to CA9 negative (P < .05). Only 17.4% of patients in CA9-negative group showed immune low signatures, while 40.0% of patients in the double-positive group exhibited immune low signatures. In conclusion, EFI improved PARFS significantly in all patients, but therapeutic efficacy of EFI in terms of improved DFS was solely observed in CA9-only positive LAUCC, and not in CA9/HIFs double-positive subgroup. RNA-seq analysis suggested that hypoxia-induced immunosuppression may be related to treatment resistance in LAUCC., (© 2022 UICC.)

Background: This study aims to evaluate the incidence of and identify risk factors for gastrointestinal (GI) and genitourinary (GU) fistula or perforation formation with or without bevacizumab in patients with recurrent cervical cancer who underwent pelvic radiation therapy (RT)., Methods: Medical records of patients with recurrent cervical cancer who previously underwent pelvic RT between 2007 and 2020 were retrospectively reviewed. Clinicopathological factors were compared between groups that are stratified according to: 1) fistula/perforation (+) versus (-); and 2) bevacizumab plus conventional chemotherapy (BC) versus chemotherapy alone (C). Univariate and multivariate regression analyses were performed to identify risk factors for fistula/perforation. Overall survival (OS) was compared between the different groups., Results: Of 219 participants, fistula/perforation of any grade occurred in 36 patients (16.4%); 27 fistulas and 9 perforations. Bevacizumab was more frequently used in Bevacizumab was more frequently used ( +) group than fistula/perforation (-) group (p = 0.015). Multivariate analysis showed that bevacizumab administration was the only independent risk factor for fistula or perforation (HR, 3.27; 95% CI, 1.18-9.10; P = 0.023). F/P was observed more frequently in women receiving BC (n = 144) than those receiving C (n = 75) (20.8% vs. 8.0%; P = 0.019). During median follow-up of 33.7 months (1.2-185.6 months), no significant OS difference was observed between fistula/perforation ( +) vs. (-) (hazards ratio [HR], 1.78; median 84.2 months [95% CI, 59.3-109.0] vs. 129.5 months [95% CI, 114.1-144.9]; P = 0.065) or BC vs. C (HR, 1.03; median 119.8 months [95% CI, 97.3-142.3] vs. 115.7 months [95% CI, 96.0-135.4]; P = 0.928)., Conclusions: This study suggests that incorporation of bevacizumab in chemotherapy regimens for treating recurrent cervical cancer in patients who underwent pelvic RT incurs considerable risk for GI/GU fistula or perforation. There were no other independent risk factors for developing GI/GU fistula or perforation in this study population., (© 2022. The Author(s).)

Background: The Laparoscopic Approach to Cervical Cancer trial and Surveillance, Epidemiology, and End Results program database study demonstrated that minimally invasive radical hysterectomy was inferior to abdominal radical hysterectomy in terms of disease recurrence and survival. Among risk factors related to poor prognosis after minimally invasive surgery (MIS), tumour spillage during intracorporeal colpotomy became a significant issue. Thus, we designed this trial to evaluate the efficacy and safety of minimally invasive radical hysterectomy using an endoscopic stapler for early-stage cervical cancer., Methods: This trial is a prospective, multi-centre, open-label, single-arm, non-inferiority phase II study. The nine organisations will participate in this trial after the approval of the institutional review board. Major eligibility criteria include women aged 20 years or older with cervical cancer stage IB1 squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma according to the revised 2009 FIGO staging system who will undergo type B2 or C hysterectomy by MIS. The primary endpoint is the 4.5-year disease-free survival (DFS) rate between abdominal radical hysterectomy and MIS using an endoscopic stapler. For calculating the sample size, we hypothesised that the 4.5-year DFS rate after MIS using an endoscopic stapler is assumed to be the same after abdominal radical hysterectomy at 90.9%, and the non-inferiority margin was 7.2%. When we consider a three-year accrual and 4.5-year follow-up, at least 13 events must happen, requiring a total of 111 patients assuming a statistical power of 80% and the one-tailed test of 5% significance. A total of 124 patients is needed, considering a drop-out rate of 10%., Discussion: We expect intracorporeal colpotomy using an endoscopic stapler may prevent tumour spillage during MIS for stage IB1 cervical cancer, showing a comparable prognosis with abdominal radical surgery., Trial Registration: ClinicalTrials.gov ; NCT04370496 ; registration date, May 2020., (© 2022. The Author(s).)

Gynecologic oncologists had originally preferred minimally invasive surgery (MIS) over laparotomic surgery for patients with early-stage cervical cancer until the Laparoscopic Approach to Cervical Cancer (LACC) trial reported a worse prognosis and more loco-regional recurrence in patients treated with MIS. Although some controversy remains, experts suggested that tumor cell spillage and aggravation may have been caused by intra-corporeal colpotomy, usage of uterine elevators, maintenance of Trendelenburg position, and tumor irritation by capnoperitoneum during surgery. Thus, we introduce a surgical procedure with some steps added to the conventional MIS radical hysterectomy for preventing tumor spillage during the surgery, which is currently being evaluated in terms of safety and efficacy through a prospective, multicenter, single-arm, phase II study, entitled "Safety of laparoscopic or robotic radical surgery using endoscopic stapler for inhibiting tumor spillage of cervical neoplasms (SOLUTION trial: NCT04370496)"., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

Objective: The aim of this study was to evaluate the clinicopathologic factors influencing pelvic, extra-pelvic, and intraperitonal recurrences and survival in patients with lymph node-negative early-stage cervical cancer treated with abdominal/laparoscopic/robotic radical hysterectomy (ARH/LRH/RRH)., Study Design: We retrospectively reviewed clinicopathologic data of 342 patients with FIGO stage IB-IIA cervical cancer (2018 FIGO staging) treated with RH and retroperitonal lymphadenectomy between February 2000 and November 2018. Several clinicopathologic factors such as surgical methods including LRH/RRH-vaginal colpotomy (VC) and LRH/RRH-intracorporeal colpotomy (IC), surgical resection margin, and parametrial/endomyometrial infiltration were selected. Univariate and multivariate Cox proportional hazard regression and logistic regression models were used to determine prognostic factors., Results: The median follow-up time was 54 months (range, 6-202 months). In multivariate analysis, positive endomyometrial infiltration (HR, 13.576; 95 % CI, 2.917-63.179; P = 0.001), positive parametrial resection margin (HR, 32.648; 95 % CI, 2.774-384.181; P = 0.006), and LRH/RRH-IC (HR, 4.752; 95 % CI, 1.154-19.578; P = 0.031) were significantly related to overall survival. Six (26.3 %) out of 21 patients with endomyometrial infiltration showed extra-pelvic recurrences associated with lung, liver, and brain. Three (50.0 %) out of 6 patients with positive parametrial margin showed both pelvic and extra-pelvic metastases, such as pelvis and supraclavicular/paratracheal lymph nodes. Five (62.5 %) out of the eight relapsed patients who received LRH/RRH-IC showed intraperitoneal recurrences including omentum, liver surface, colon serosa, and splenic hilum., Conclusions: Three risk factors including parametrial margin, endomyometrial infiltration, and laparoscopic IC appear to be involved in pelvic, extra-pelvic, and intraperitoneal recurrences in node-negative early-stage cervical cancer patients following RH. In particular, endomyometrial infiltration may be one of the strongest independent prognostic factors for extra-pelvic recurrence. Adjuvant systemic therapy may be indicated for lymph node-negative early-stage cervical cancer patients with endomyometrial infiltration., Competing Interests: Declaration of Competing Interest The authors (Tae-Wook Kong, Joo-Hyuk Son, Jiheum Paek, Suk-Joon Chang, Hee-Sug Ryu) declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objective: To evaluate oncologic outcomes of minimally invasive radical hysterectomy (RH) in early cervical cancer before and after the application of parametrial invasion (PMI) criterion on magnetic resonance imaging (MRI) and vaginal colpotomy (VC)., Methods: A total of 216 International Federation of Gynecology and Obstetrics stage IB-IIA cervical cancer patients who underwent minimally invasive RH was identified between April 2006 and October 2018. Patients were classified into the pre-PMI intracorporeal or VC (IVC) (n=117) and post-PMI VC groups (n=99). In the pre-PMI IVC group, PMI criterion (intact stromal ring) on MRI was not applied and the patients received IVC. In the post-PMI VC group, surgical candidates were selected using the PMI criterion on MRI and all patients received VC only. Oncologic outcomes and prognostic factors associated with disease recurrence were analyzed., Results: The rate of positive vaginal cuff margins in the pre-PMI IVC group was higher than that in the post-PMI VC group (11.1% vs. 1.0%, p=0.003). Two-year disease-free survival was different between the 2 groups (84.5% in pre-PMI IVC vs. 98.0% in post-PMI VC groups, p=0.005). Disrupted stromal ring on MRI (hazard ratio [HR]=20.321; 95% confidence interval [CI]=4.903-84.218; p<0.001) and intracorporeal colpotomy (HR=3.059; 95% CI=1.176-7.958; p=0.022) were associated with recurrence., Conclusion: The intact cervical stromal ring on MRI might identify the low-risk group of patients in terms of PMI and lymphovascular/stromal invasion in early cervical cancer. Minimally invasive RH should be performed in optimal candidates with an intact stromal ring on MRI, using VC., 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/aim: This study evaluated whether the lymphocyte tolerance factor (LTF) was an indicator of radiation tolerance of lymphocytes (RTL) using the relative lymphocyte count (RLC), and considering clinical outcomes., Patients and Methods: A total of 92 cervical cancer patients treated with concurrent chemoradiotherapy (CCRT) were analysed. RLC0 was pre-treatment RLC, and RLC1, and RLC2 were at the first and second week of CCRT, respectively. LTF1 was RLC1:RLC2. LTF2 was the dimension of the convex or concave shape comprising the three RLC vertexes. Patients were divided into three groups: good RTL group, low LTF1; moderate RTL group, high LTF1 and low LTF2; and poor RTL group, high LTF1 and high LTF2., Results: Patients with good tumour response to radiotherapy were mostly included in the good RTL group than in the other groups. The poor RTL group had lower 3-year progression-free survival (57.1% vs. 83.8% and 82%, p=0.01) and 5-year disease-specific survival (71.8% vs. 90.4% and 94.9%, p=0.062) rates than the moderate and good RTL groups. Multivariate analyses showed that poor RTL was a significant survival predictor., Conclusion: The poor RTL group according to LTF is a potential predictor of clinical outcome., (Copyright© 2019, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Aims: The most frequent cancers among women worldwide. The mortality of cervical cancer has declined significantly primarily due to the widespread use of Pap smear tests as a screening test and therapeutic vaccination. However, cervical cancer still remains a severe disease among the female population, as the prognosis of metastatic cervical cancer is very poor., Key Methods: In this study, we performed 2D-DIGE and MALDI-TOF/TOF MS to analyze differentially expressed proteins between HeLa and invasive HeLa-I5 cells.., Key Findings: According to our proteomics data, 68 differentially expressed proteins between the HeLa and HeLa-I5 cells were identified. One of these differentially expressed proteins, Progesterone receptor membrane component 1 (PGRMC1), was selected as a candidate for further studies. To correlate the role of PGRMC1 with cellular migration and cancer progression, small interfering RNA (siRNA) was used to knockdown the expression of PGRMC1. Similar function of PGRMC1 was also observed in two other cervical cancer lines, CaSki and ME-180., Significance: PGRMC1 plays an essential role in regulating cancer progression and metastasis of cervical cancer cells, thus serving as a potential therapeutic target for cervical cancer., (Copyright © 2019 Elsevier Inc. All rights reserved.)

In 2016, 9-valent human papillomavirus (HPV) vaccine has been newly introduced in Korea, thus the need to develop recommendations for the vaccine has raised. Until we decide to develop a guideline, no further studies on the bi-valent or quadri-valent HPV vaccine have been announced. We searched and reviewed the literatures focused on the efficacy of 9-valent HPV vaccine, the ideal age of 3-dose schedule vaccination, the efficacy of 9-valent HPV vaccine in middle-aged women, the efficacy of the 2-dose schedule vaccination, the safety of 9-valent HPV vaccine, the possibility of additional 9-valent HPV vaccination, and cross-vaccination of 9-valent HPV vaccine. So, Korean Society of Gynecologic Oncology (KSGO) developed a guideline only for 9-valent HPV vaccine., Competing Interests: No potential conflict of interest relevant to this article was reported., (Copyright © 2019. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology.)

Radioresistance often leads to poor survival in concurrent chemoradiotherapy-treated cervical squamous cell carcinoma, and reliable biomarkers can improve prognosis. We compared the prognostic potential of hemoglobin, absolute neutrophil count, and absolute lymphocyte count with that of squamous cell carcinoma antigen in concurrent chemoradiotherapy-treated squamous cell carcinoma. We analyzed 152 patients with concurrent chemoradiotherapy and high-dose-rate intracavitary brachytherapy-treated cervical squamous cell carcinoma. Hemoglobin, absolute neutrophil count, absolute lymphocyte count, and squamous cell carcinoma antigen were quantitated and correlated with survival, using Cox regression, receiver operating characteristic curve analysis, and Kaplan-Meier plots. Both hemoglobin and absolute lymphocyte count in the second week of concurrent chemoradiotherapy (Hb2 and ALC2) and squamous cell carcinoma antigen in the third week of concurrent chemoradiotherapy (mid-squamous cell carcinoma antigen) correlated significantly with disease-specific survival and progression-free survival. The ratio of high-dose-rate intracavitary brachytherapy dose to total dose (high-dose-rate intracavitary brachytherapy ratio) correlated significantly with progression-free survival. Patients with both low Hb2 (≤11 g/dL) and ALC2 (≤639 cells/µL) showed a lower 5-year disease-specific survival rate than those with high Hb2 and/or ALC2, regardless of mid-squamous cell carcinoma antigen (mid-squamous cell carcinoma antigen: ≤4.7 ng/mL; 5-year disease-specific survival rate: 85.5% vs 94.6%, p = 0.0096, and mid-squamous cell carcinoma antigen: >4.7 ng/mL; 5-year disease-specific survival rate: 43.8% vs 66.7%, p = 0.192). When both Hb2 and ALC2 were low, the low high-dose-rate intracavitary brachytherapy ratio (≤0.43) subgroup displayed significantly lower 5-year disease-specific survival rate compared to the subgroup high high-dose-rate intracavitary brachytherapy ratio (>0.43) (62.5% vs 88.2%, p = 0.0067). Patients with both anemia and lymphopenia during concurrent chemoradiotherapy showed poor survival, independent of mid-squamous cell carcinoma antigen, and escalating high-dose-rate intracavitary brachytherapy ratio might improve survival.

Purpose: Treatment outcomes of patients with pelvic recurrence after hysterectomy alone for uterine cervical cancer who received salvage radiotherapy (RT) with or without concurrent chemotherapy were investigated., Methods: Salvage RT for recurrent cervical cancer confined to the pelvic cavity after hysterectomy alone was received by 33 patients. The median interval between initial hysterectomy and recurrence was 26 months. Whole-pelvic irradiation was delivered to median dose of 45 Gy, followed by a boost with a median dose of 16 Gy to the gross tumor volume. Cisplatin-based concurrent chemotherapy was administered to 29 patients., Results: The median follow-up period was 53 months for surviving patients. Most patients (97.0%) completed salvage RT of ≥45 Gy. Complete response (CR) was achieved in 23 patients (69.7%). Pelvic sidewall involvement and evaluation with positron-emission tomography-computed tomography were significantly associated with CR. The 5‑year progression-free survival (PFS), local control (LC), distant metastasis-free survival (DMFS), and overall survival (OS) rates were 62.7, 79.5, 72.5, and 60.1%, respectively. Initial International Federation of Gynecology and Obstetrics stage, pelvic sidewall involvement, and CR status were significant factors for PFS and OS rates in multivariate analysis. The incidence of severe acute and late toxicities (≥grade 3) was 12.1 and 3.0%, respectively., Conclusion: Aggressive salvage RT with or without concurrent chemotherapy for recurrent cervical cancer confined to the pelvic cavity was feasible, with promising treatment outcomes and acceptable toxicities. However, even more intensive novel treatment strategies should be investigated for patients with unfavorable prognostic factors.

Background: The aim of the present study was to investigate the long-term survival outcomes and toxicities associated with our experienced early administration of adjuvant concurrent chemoradiotherapy (CCRT)., Methods: Ninety-eight patients with pelvic lymph node metastasis, positive resection margin, and/or parametrial invasion who received adjuvant CCRT between 1995 and 2011 were analyzed retrospectively. The first cycle of platinum-based adjuvant chemotherapy was initiated within 2-3 weeks after surgery (median, 12 days) and continued every 4 weeks for a total of 4 cycles. Adjuvant radiotherapy was performed during the second and third cycles of chemotherapy., Results: After a median follow-up period of 119 months for survivors, 13 patients (13.3%) experienced recurrence and 11 patients died of cancer during the follow-up period. The 5-year recurrence-free survival and cancer specific survival rates were 87.6% and 90.6%, respectively. Ninety-four patients (95.9%) received ≥3 cycles of chemotherapy. Total radiation dose of ≥45 Gy was delivered in 91 patients (92.9%). Grade 3-4 hematologic and gastrointestinal toxicities developed in 37 (37.8%) and 14 (14.3%) patients during CCRT, respectively., Conclusion: The present study confirmed the long-term safety and encouraging survival outcomes of early administration of adjuvant CCRT, suggesting the benefits of early time to initiation of adjuvant treatments.

We hypothesized that hemoglobin levels, absolute neutrophil count, and absolute lymphocyte count were associated with radiotherapy response and cancer progression and that they might reflect tumor repopulation during concurrent chemoradiotherapy. This study aimed to investigate these hematological parameters as prognosticators of cervical cancer. We analyzed 105 stage IIB cervical cancer patients treated with concurrent chemoradiotherapy, using log-rank tests and multivariate analyses. Hazard ratios were calculated weekly to evaluate changes in hemoglobin, absolute neutrophil count, and absolute lymphocyte count that were associated with disease-specific survival. Patients were categorized into the high hematological risk (patients with low hemoglobin plus high absolute neutrophil count and/or low absolute lymphocyte count) and the low hematological risk (others) groups according to the median cutoff values. During the second week of concurrent chemoradiotherapy, hematological factors were significantly associated with survival. In multivariate analysis, hematological risk was independently associated with disease-specific survival and progression-free survival. The 5-year disease-specific survival and progression-free survival rates in the high hematological risk group were significantly lower compared with those in the low hematological risk group (81.6% vs 92.6%, p = 0.0297; 73.7% vs 89.3%, p = 0.0163, respectively). During the second week of concurrent chemoradiotherapy, the hematological parameters could predict treatment outcome in stage IIB cervical cancer.

Background/aim: To investigate whether high-dose-rate (HDR) intracavitary brachytherapy (IBT) dose ratios can predict treatment outcomes in patients with stage IIB cervical cancer., Patients and Methods: Ninety-three patients treated with weekly cisplatin-based concurrent chemoradiotherapy and HDR IBT were analyzed. Potential prognostic factors and treatment outcomes were compared between low-HDR-IBT-ratio (≤0.43) and high-HDR-IBT-ratio (>0.43) groups, and univariate and multivariate analyses were performed., Results: Five-year disease-specific survival (DSS) and progression-free survival (PFS) rates were significantly shorter in the low-compared to the high-HDR-IBT-ratio group. A high HDR IBT ratio was confirmed as an independent prognostic factor for DSS and PFS., Conclusion: A high HDR IBT dose ratio improves DSS and PFS in patients with stage IIB cervical cancer. Therefore, active administration of HDR IBT beyond previously accepted levels may be necessary for the treatment of locally advanced cervical cancer., (Copyright© 2017 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.)

Objective: The aim of this study was to compare treatment outcomes of primary concurrent chemoradiation therapy (CCRT) versus radical hysterectomy (RH) followed by adjuvant RT or CCRT in patients with FIGO stage IB-IIA cervical cancer with focal disruption of the cervical stromal ring on magnetic resonance imaging (MRI)., Methods: We retrospectively analyzed the clinicopathological data of 156 patients with FIGO stage IB-IIA cervical cancer showing a focal disruption of the stromal ring on MRI between March 2000 and March 2015. Treatment outcomes were compared between the RT-based (n=54) group and RH-based group (n=54) after propensity score matching of each of the patients using a logistic regression model, including age, tumor size on MRI, pelvic lymph node enlargement on MRI, and histology., Results: Five-year disease-free survival rate was 83.1% for the RT-based group and 77.4% for the RH-based group (p=0.228). Five-year disease-specific survival rate was 84.3% for the RT-based group and 83.5% for the RH-based group (p=0.434). Incidence rates of late grade 3 genitourinary adverse reactions (14.8% vs. 0.0%, p=0.006) were significantly higher in the RH-based group than those in the RT-based group., Conclusions: Primary CCRT might be the preferred treatment for FIGO stage IB-IIA cervical cancer patients with focal disruption of cervical stromal ring on MRI given that no difference in patient's survival was found, but higher incidence of treatment-related complications was observed in the RH-based group. Also, primary radical surgery should be done more cautiously in these patients., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: This study aimed to establish a nomogram to predict microscopic parametrial infiltration (PMI) by combining preoperative clinicopathologic factors in FIGO stage IB cervical cancer patients treated by radical hysterectomy (RH)., Methods: We retrospectively analyzed clinicopathologic data of 298 patients with FIGO stage IB cervical cancer treated by RH between February 2000 and March 2015. The nomogram was developed based on multivariate logistic regression analysis of preoperative clinicopathologic data. The accuracy and discriminative ability of the nomogram were evaluated by a concordance index and calibration curve. The low-risk group was predefined as having a predicted probability of PMI <10%., Results: Multivariate analysis identified diameter-based tumor volume and disruption of the cervical stromal ring on magnetic resonance imaging, serum squamous cell carcinoma antigen level, and menopausal status as independent prognostic factors associated with PMI. The concordance index of the nomogram was 0.940 (95% CI, 0.908-0.967), and calibration plots revealed good agreement between the observed probabilities and nomogram-predicted probabilities (Hosmer Lemeshow test, p=0.574). The nomogram classified 200 out of 298 patients (67.1%) as low risk. In the low-risk group, the predicted probability of PMI was 3.5% and the actual PMI rate was 2.5% (5 out of 200)., Conclusions: We developed a preoperative nomogram predicting microscopic PMI in surgically treated FIGO stage IB cervical cancer patients. The probabilities derived from this nomogram may have the potential to provide valuable guidance for physicians regarding the primary management of FIGO stage IB cervical cancer patients., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Aim: To investigate whether common terminology criteria for adverse events (CTCAE) grade 4 lymphopenia (<200 cells/μl) during concurrent chemoradiotherapy (CCRT) is relevant to poor survival., Patients and Methods: We analyzed 124 patients with newly diagnosed Federation of Gynecology and Obstetrics (FIGO) stage I-III cervical cancer who received weekly cisplatin-based CCRT and brachytherapy using Kaplan-Meier curves and the Cox proportional hazard models., Results: Grade 4 lymphopenia significantly predicted disease-specific survival (DSS) and progression-free survival (PFS) (adjusted hazard ratio (95% confidence interval (CI))=3.6 (1.37-9.44), p=0.009 and 3.28 (1.27-8.48), p=0.014, respectively). The 5-year DSS and 3-year PFS were significantly higher among patients with grade 2-3 lymphopenia (≥200 cells/μl) than among those with grade 4 lymphopenia (84.8% vs. 50.4%, p<0.001, and 80.7% vs. 50%, p=0.002, respectively)., Conclusion: Severe lymphopenia during CCRT could predict poor survival., (Copyright© 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.)

Aim: This study investigates the pattern of disease recurrence and identifies the clinicopathologic prognostic factors for patients with International Federation of Gynecology and Obstetrics (FIGO) stage IB and IIA cervical carcinoma treated with laparoscopic/robotic radical hysterectomy (LRH/RRH)., Methods: We conducted a retrospective analysis of 128 patients with FIGO stage IB and IIA cervical cancer. Preoperative examination did not uncover definitive evidence of parametrial invasion or lymph node metastasis in any of the patients; therefore, all patients underwent LRH/RRH with retroperitoneal lymphadenectomy between April 2006 and December 2013. Sites of disease recurrence and all possible clinicopathologic factors related to the risk of disease recurrence were determined., Results: Multivariate analysis demonstrated that laparoscopic intracorporeal colpotomy (P < 0.041, odds ratio 7.038, 95% confidence interval 1.059-15.183) represented a strong prognostic factor related to disease recurrence. We categorized the minimally invasive surgery group into LRH through vaginal colpotomy (LRH-VC; 79 patients) and LRH/RRH through intracorporeal colpotomy (LRH/RRH-IC; 49 patients) according to the colpotomic approaches. Disease recurrence was higher in the LRH/RRH-IC group than in the LRH-VC group (16.3% vs 5.1%, P = 0.057), with five patients in the LRH/RRH-IC group experiencing intraperitoneal spreads., Conclusions: Total laparoscopic/robotic intracorporeal colpotomy under CO2 pneumoperitoneum may carry a risk of positive vaginal cuff margin, as well as intraperitoneal tumor spreads in patients with early-stage cervical cancer treated with LRH/RRH., (© 2015 Japan Society of Obstetrics and Gynecology.)

Objective: The aim of this study was to preoperatively identify high- and low-risk subgroups of patients with parametrial involvement in those with FIGO (International Federation of Gynecology and Obstetrics) stage IB cervical cancer treated with radical hysterectomy according to menopause., Materials and Methods: We retrospectively reviewed data of 197 patients with FIGO stage IB cervical cancer. None of the patients had definite evidence of parametrial invasion in a preoperative examination and underwent type III radical hysterectomy between February 2006 and March 2015. Preoperative risk criteria predicting parametrial involvement were identified in premenopausal and postmenopausal women, respectively., Results: Tumor size on magnetic resonance imaging (MRI) more than 4 cm (odds ratio [OR], 10.029; 95% confidence interval [95% CI], 2.300-43.741; P = 0.002) and serum squamous cell carcinoma-antigen level of 3.60 ng/mL or more (OR, 4.132; 95% CI, 1.086-5.723; P = 0.037) were independent factors for parametrial invasion in premenopausal women. Significant factors associated with parametrial involvement in postmenopausal women were tumor size on MRI more than 3 cm (OR, 11.353; 95% CI, 2.614-49.306; P = 0.001) and Cyfra 21-1 level of 2.40 ng/mL or more (OR, 8.048; 95% CI, 1.240-52.221; P = 0.029). Patients were categorized into low- and high-risk groups according to risk criteria. Significant differences in the rates of parametrial invasion were observed between the groups (2.3% vs 38.6% in the premenopausal group, P < 0.001; 11.1% vs 77.3% in the postmenopausal group, P < 0.001)., Conclusions: A model using preoperative tumor size on MRI, serum squamous cell carcinoma-antigen, and Cyfra 21-1 level was highly predictive of parametrial invasion in patients with FIGO stage IB cervical cancer. In particular, postmenopausal women were likely to have microscopic parametrial invasion, even among tumors 3 cm or less. Therefore, individualized approaches considering several preoperative factors are needed.

Objective: To determine whether pretreatment CYFRA 21-1 levels can be a useful prognostic indicator in cervical cancer with reference to squamous cell carcinoma-antigen (SCC-Ag)., Methods: We retrospectively analyzed data on 506 consecutive cervical cancer patients who were treated by radical hysterectomy or primary concurrent chemoradiation therapy. The pretreatment serum SCC-Ag and serum CYFRA 21-1 levels were measured in these patients. A multivariate analysis using Cox's proportional hazard model was performed to evaluate the prognostic significance of pretreatment variables., Results: In patients who underwent radical hysterectomy, there was a significant correlation between pretreatment serum SCC-Ag/CYFRA 21-1 levels and patient age, advanced FIGO stage, large tumor size, lymph node metastasis, and deep stromal invasion. In the stepwise Cox regression analysis, large tumor size >4cm was an independent prognostic factor for disease-free survival (OR, 3.110; [95% CI, 1.588-6.093], P=0.001) and overall survival (OR, 8.497; [95% CI, 1.797-40.184], P=0.007) in patients with squamous cell carcinoma, while pretreatment CYFRA 21-1 (P=0.010) serum levels had a significant independent effect on overall survival. Likewise, pretreatment CYFRA 21-1 (P<0.001 and P=0.006) serum levels were the only independent prognostic factor for disease-free survival and overall survival in patients with non-squamous cell carcinoma., Conclusion: Pretreatment CYFRA 21-1 levels may be considered as a useful prognostic indicator in cervical cancer with reference to SCC-Ag., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to analyze clinico-pathologic factors and the optimal cut-off value of high-risk human papillomavirus (HR-HPV) viral load for predicting high-grade residual/recurrent disease after the conization in cervical intraepithelial neoplasia (CIN 2-3), adenocarcinoma in situ (AIS), and microinvasive carcinoma of the uterine cervix (MICA)., Methods: We retrospectively reviewed data from 701 patients with CIN 2-3, AIS, and MICA who underwent conization between September 2003 and June 2012. Receiver-operating characteristic curve analysis was used to find out the cut-off value of HR-HPV viral load for predicting residual/recurrent disease. Clinico-pathologic variables, including resection margin and HR-HPV status, were evaluated as possible predictors of residual/recurrent disease., Results: At a cut-off value of 1.16 RLU/CO for post-cone HR-HPV viral load, the sensitivity was 88.2% and the specificity was 98.3%. Multivariate analysis demonstrated that post-cone cytology (p=0.001, OR=83.808, 95% CI=6.688-1050.232), endocervical margin status (p<0.001, OR=80.478, 95% CI=7.421-872.732), and post-cone HR-HPV status (p<0.001, OR=79.660, 95% CI=8.539-743.129) were significantly associated with residual/recurrent disease. The post-cone HR-HPV positivity was observed more in the patients who showed positive endocervical margin than in the patients with positive ectocervical margin (32.6% vs. 5.3%, p=0.002)., Conclusions: Follow-up using liquid based cytology in combination with HR-HPV test at 12 months after the conization, and not the early HR-HPV test, might be acceptable. Post-cone endocervical margin status combined with post-cone HR-HPV test is critical for predicting residual/recurrent disease and clinical management., (Copyright © 2014. Published by Elsevier Inc.)

Objectives: To evaluate the long-term outcomes and risk factors for recurrence after fertility-sparing laparoscopic radical trachelectomy (LRT) in young women with early-stage cervical cancer., Methods: Eighty-eight consecutive patients from four tertiary cancer centers in Korea who had attempted fertility-sparing LRT for early-stage cervical cancer were included in this study., Results: Seventy-nine patients completed LRT. The mean age and tumor size were 31 years (range, 20-40 years) and 1.8 cm (range, 0.4-7 cm), respectively. Twenty-nine patients had a tumor size greater than 2 cm, 22 had deep stromal invasion greater than 50%, and twelve had lymphovascular space invasion. After a median follow-up time of 44 months (range, 3-105 months), nine patients had recurrence and one had died of disease. A tumor size greater than 2 cm (P = 0.039) and a depth of stromal invasion greater than 50% (P = 0.016) were significant risk factors for recurrence., Conclusions: This is the largest series on fertility-sparing LRT in young women with early cervical cancer. LRT is a feasible and safe fertility-sparing alternative to radical hysterectomy in these women. A tumor size greater than 2 cm and a depth of stromal invasion greater than 50% were risk factors for recurrence., (© 2014 Wiley Periodicals, Inc.)

Neuroendocrine cervical cancer is an aggressive but rare form of cervical cancer. The majority of neuroendocrine cervical cancer patients present with advanced-stage diseases. However, the limited numbers of neuroendocrine tumor markers are insufficient for clinical purposes. Thus, we used a proteomic approach combining lysine labeling 2D-DIGE and MALDI-TOF MS to investigate the biomarkers for neuroendocrine cervical cancer. By analyzing the global proteome alteration between the neuroendocrine cervical cancer line (HM-1) and non-neuroendocrine cervical cancer lines (CaSki cells, ME-180 cells, and Hela cells), we identified 82 proteins exhibiting marked changes between HM-1 and CaSki cells, and between ME-180 and Hela cells. Several proteins involved in protein folding, cytoskeleton, transcription control, signal transduction, glycolysis, and redox regulation exhibited significant changes in abundance. Proteomic and immunoblot analyses indicated respective 49.88-fold and 25-fold increased levels of transgelin in HM-1 cells compared with that in other non-neuroendocrine cervical cancer cell lines, implying that transgelin is a biomarker for neuroendocrine cervical cancer. In summary, we used a comprehensive neuroendocrine/non-neuroendocrine cervical cancer model based proteomic approach for identifying neuroendocrine cervical cancer markers, which might contribute to the prognosis and diagnosis of neuroendocrine cervical cancer., (© 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Objective: There have been many comparative reports on laparoscopic radical hysterectomy (LRH) versus abdominal radical hysterectomy (ARH) for early-stage cervical cancer. However, most of these studies included patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA2 and small (tumor diameter ≤2 or 3 cm) IB1 disease. The purpose of this study was to compare the feasibility, morbidity, and recurrence rate of LRH and ARH for FIGO stage IB and IIA cervical cancer with tumor diameter of 3 cm or greater., Materials and Methods: We conducted a retrospective analysis of 88 patients with FIGO stage IB and IIA cervical cancer with tumor diameter of 3 cm or greater. All patients had no evidence of parametrial invasion and lymph node metastasis in preoperative gynecologic examination, pelvic magnetic resonance imaging, and positron emission tomography-computed tomography, and they all underwent LRH or ARH between February 2006 and March 2013., Results: Among 88 patients, 40 patients received LRH whereas 48 underwent ARH. The mean estimated blood loss was 588.0 mL for the ARH group compared with 449.1 mL for the LRH group (P < 0.001). The mean operating time was similar in both groups (246.0 minutes in the ARH vs 254.5 minutes in the LRH group, P = 0.589). Return of bowel motility was observed earlier after LRH (1.8 vs 2.2 days, P = 0.042). The mean hospital stay was significantly shorter for the LRH group (14.8 vs 18.0 days, P = 0.044). There were no differences in histopathologic characteristics between the 2 groups. The mean tumor diameter was 44.4 mm in the LRH and 45.3 mm in the ARH group. Disease-free survival rates were 97.9% in the ARH and 97.5% in the LRH group (P = 0.818)., Conclusions: Laparoscopic radical hysterectomy might be a feasible therapeutic procedure for the management of FIGO stage IB and IIA cervical cancer with tumor diameter of 3 cm or greater. Further randomized studies that could support this approach are necessary to evaluate long-term clinical outcome.

Objective: The objective of this study was to evaluate the potential risk factors associated with parametrial invasion and to identify preoperatively a subgroup of patients at low risk for parametrial involvement who could be appropriate candidates for less radical surgery in FIGO stage IB1 cervical cancer., Methods: We retrospectively reviewed the medical records of 317 FIGO stage IB1 cervical cancer patients undergoing class III radical hysterectomy and bilateral pelvic lymphadenectomy. Clinocopathologic factors associated with parametrial invasion were analyzed and the risk criteria predicting parametrial involvement were calculated using a logistic regression model., Results: Of 317 patients, 17 patients (5.4%) had parametrial involvement. Tumor size >3 cm (OR, 3.80; [95% CI, 1.19-12.06]; p=0.02) and pelvic lymph node metastasis (OR, 3.02; [95% CI, 1.04-8.79]; p=0.04) were independent pathologic factors for parametrial invasion on multivariate analysis. Significant preoperative factors associated with parametrial involvement were tumor size >3 cm (OR, 4.29; [95% CI, 1.43-12.89]; p<0.01) and serum SCC Ag level >1.40 ng/mL (OR, 3.27; [95% CI, 1.11-9.69]; p=0.03). We identified 185 low-risk (tumor size ≤ 3 cm and SCC ≤ 1.4 ng/mL) and 132 high-risk (tumor size>3 cm and/or SCC>1.4 ng/mL) patients. The rates of parametrial involvement in low- and high-risk patients were 1.1% and 11.4%, respectively (p<0.01)., Conclusions: In this dataset, a model using tumor size and SCC Ag level is highly predictive of parametrial involvement in patients with stage IB1 cervical cancer and may identify candidates for less radical parametrial resection., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: To determine the safe criteria for less radical trachelectomy to treat patients with early-stage cervical cancer., Methods: We reviewed medical records and pathologic slides of 65 patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA-IB1 cervical cancer. The safe criteria for less radical trachelectomy were determined by using three factors such as tumor size ≤ 1 cm, stromal invasion ≤ 5 mm, and no lymphovascular space invasion (LVSI) for minimizing parametrial involvement, lymph node metastasis (LNM), and the need of adjuvant radiotherapy. The diagnostic values were investigated by calculating specificity, negative predictive value for no parametrial involvement, no LNM, and no need of adjuvant radiotherapy., Results: The median age was 32 years (range 22-44 years), and the median duration of follow-up was 26 months (range 2-103 months). Among seven single or combined factors for the safe criteria, (1) tumor size ≤ 1 cm, (2) tumor size ≤ 1 cm and stromal invasion ≤ 5 mm, (3) tumor size ≤ 1 cm and no LVSI, (4) tumor size ≤ 1 cm, stromal invasion ≤ 5 mm, and no LVSI did not show parametrial involvement, LNM, and the need of adjuvant radiotherapy. In particular, tumor size ≤ 1 cm showed the highest specificity (28.1-29.5%) and negative predictive value (100%). In spite of no difference in progression-free survival (PFS) between tumor size ≤ 1 cm and >1 cm (P = 0.22), tumor size ≤ 1 cm showed better PFS without disease recurrence than tumor size >1 cm (2-year PFS, 100% vs. 90%)., Conclusions: Less radical trachelectomy may be safe in patients with early-stage cervical cancer who have tumor size ≤ 1 cm.

Objective: To find out whether a negative finding on magnetic resonance imaging (MRI) can rule out bladder or rectum mucosal invasion safely without cystoscopy or sigmoidoscopy., Study Design: We retrospectively reviewed the medical records of patients with cervical cancer between January 2005 and December 2009. MRI findings on bladder or rectum were classified as follows: (1) definite evidence of mucosal invasion, (2) suggestive of mucosal invasion or (3) no evidence of mucosal invasion. We correlated MRI findings with the cystoscopy and sigmoidoscopy findings., Results: A total of 257 patients were enrolled in this study. Sixteen patients had at least suspicious bladder invasion, and 1 patient had definite rectal invasion on MRI. Of these 17 patients, 6 patients had actual bladder mucosa invasion, and 1 patient had rectal mucosa invasion. The remaining 240 had negative MRI, cystoscopy and sigmoidoscopy findings. The MRI sensitivity, specificity, positive predictive value, negative predictive value and accuracy of bladder or rectum mucosal invasion were 100%, 96.0%, 41.25%, 100% and 96.1%, respectively., Conclusion: Skipping cystoscopy or sigmoidoscopy based on the absence of invasion on MRI is safe enough without concern for understaging.

Aim: The aim of this study was to assess various treatment options in stage IB2 cervical cancer patients., Methods: Between January 1995 and May 2007, 63 patients with stage IB2 were treated by radical hysterectomy (n = 28), primary concurrent chemoradiation (CCRT, n = 16) or radiation therapy (RT, n = 19). Disease-free survival (DFS) and overall survival (OS) were compared between these treatment modalities., Results: The 3-year DFS of the surgical approach group was 67.5% compared to 70.3% of the primary RT/CCRT group (p = 0.603). The 5-year OS of all patients was 75.9%. The 5-year OS of the surgical approach group was 81.6% compared to 76.2% of the primary RT/CCRT group (p = 0.578). Twelve (42.8%) of 28 surgically treated patients had high-risk pathologic factors. Out of 20 premenopausal patients who underwent the surgical approach, ovarian preservation was possible in 13 patients without adjuvant CCRT. Of these 13 patients, 7 patients did not experience disease recurrence and continued normal ovarian function., Conclusion: Both radical hysterectomy and primary RT/CCRT are effective treatment options in IB2 cervical cancer. In addition, the surgical approach can be considered for preserving ovarian function in premenopausal IB2 cervical cancer patients., (Copyright © 2010 S. Karger AG, Basel.)

Background: Sarcomatoid squamous cell carcinoma of the uterine cervix is a rare tumor with uncertain pathogenesis. The rarity of this neoplasm makes it difficult to diagnose and manage, and it seems to be an aggressive tumor with a short disease-free survival. To date, < 20 cases have been reported. We report the first case of sarcomatoid carcinoma successfully treated by laparoscopic radical hysterectomy., Case: A 26-year-old woman presented with postcoital spotting. Gynecologic examination revealed an approximately 2.5-cm-diameter mass on the posterior lip of the cervix, and biopsy revealed a sarcomatoid carcinoma. After the baseline study for cervical cancer, the patient was found to have International Federation of Obstetricians and Gynecologists stage IB1 disease. The patient underwent laparoscopic radical hysterectomy with bilateral pelvic and paraaortic lymphadenectomy. Histopathologic examination showed no evidence of parametrial tumor extension or lymph node metastasis, and no adjuvant treatment was given., Conclusion: This report entails the first description of laparoscopic surgery for sarcomatoid carcinoma of the cervix. Despite short-term follow-up, it seems that early-stage disease could be successfully treated by laparoscopic radical hysterectomy.

Objective: To evaluate the efficacy of cold knife conization with electrocauterization and the feasibility of conservative management in patients with stage IA1 carcinoma of the cervix according to margin status after conization., Methods: Medical and histopathological records of 108 patients with stage IA1 cervical carcinoma were reviewed retrospectively. Patients underwent cold knife conization with electrocauterization or conization followed by hysterectomy. Disease recurrence was defined as a histologic diagnosis of cervical intraepithelial neoplasia (CIN) 2 or higher grade lesion., Results: Forty patients underwent conization followed by hysterectomy; of 27 women with positive margins, 14 (35%) had a residual lesion. Sixty-eight patients underwent conization without further surgical intervention. Forty patients had a negative resection margin without recurrence, while 28 had a positive resection margin: positive exocervical (n=11), positive endocervical (n=17). Among these, there were 7 cases of recurrence: positive exocervical (n=1); positive endocervical (n=6)., Conclusion: Cold knife conization with electrocauterization appears to be a safe treatment option for patients with stage IA1 cervical carcinoma if careful follow-up is guaranteed for patients with CIN 3 exocervical resection margins. However, patients with CIN 3 endocervical resection margins should be managed surgically with repeat conization or hysterectomy., (Crown Copyright 2009. Published by Elsevier Ireland Ltd. All rights reserved.)

Objective: The aim of this study was to verify whether the Gynecologic Oncology Group (GOG) criteria are valid in a different cohort of patients and to investigate simplified new criteria tailoring adjuvant radiation therapy in patients with intermediate-risk factors after radical hysterectomy., Study Design: We analyzed the data of 332 patients with FIGO stage IB cervical cancer who underwent radical hysterectomy between 1994 and 2007. Two hundred and twenty-five patients without high-risk factors (lymph node metastasis, parametrial invasion, or positive surgical margins) were identified and were classified into low-risk and high-risk groups according to the GOG criteria and new criteria based on combinations of intermediate-risk factors (large tumor size, deep stromal invasion, lymph-vascular space invasion). We evaluated the prognostic significance of both criteria., Results: We identified 140 low-risk patients and 85 high-risk patients in the application of the GOG criteria. Low-risk patients had significantly better disease-free survival (DFS) (P=0.001) and overall survival (OS) (P=0.013) than high-risk patients. There were 145 low-risk patients and 80 high-risk patients on applying the new criteria. Low-risk patients had significantly better DFS (P=0.001) and OS (P=0.013) than high-risk patients. The receiver operating characteristic (ROC) curves showed that both criteria had similar performance for predicting which patients would have help from adjuvant therapy., Conclusion: This study demonstrated that the GOG criteria were still valid in the different population, the simplified new criteria were convenient to apply in practice, and the performance of the new criteria was as good as the GOGs.

Objectives: Our aim was to know preoperative magnetic resonance imaging (MRI) can accurately predict lymph node metastasis (LNM) and deep myometrial invasion (DMI, > or = 50%) in patients with uterine cancer., Methods: From January 1997 to December 2006, 99 patients who were diagnosed with uterine cancer and surgically staged at our institution were retrospectively analyzed. Preoperative clinicopathologic characteristics and MRI findings were reviewed and compared with LNM status and DMI observed in the final pathology., Results: The sensitivity, specificity, positive predictive value (PPV), and negative predictive values (NPV) for MRI in determination of pelvic LNM were 77.7%, 85.6%, 35.0%, and 94.7%, respectively. MRI failed to detect the presence of paraaortic LNM in all of the three patients with positive paraaortic lymph nodes. The sensitivity, specificity, PPV, and NPV for MRI in determining DMI were 46.6%, 84.5%, 35%, and 89.8%, respectively., Conclusion: Preoperative evaluation of uterine cancer by MRI does not accurately predict the LNM and DMI.

Objective: The purpose of this study was to determine if HPV DNA testing improves the accuracy of detecting possible high-grade cervical lesions in women with atypical squamous cells of undetermined significance (ASC-US)., Methods: Cervical cytology and Hybrid Capture II (HCII) assay for HPV DNA detection was performed in 10,526 women from July 2005 to July 2007. Two hundred and sixty women with ASC-US underwent colposcopy-directed biopsy to determine the final histologic diagnosis. They were divided into two groups according to the positivity of the HPV DNA test, and the respective biopsy results were compared., Results: Positive HCII was significantly more associated with CIN 2, CIN 3, and invasive cancer than negative HCII (p < 0.001). The odds ratio of positive HPV DNA testing in detecting high-grade lesions was 7.0 (95% CI; 2.8-17.7)., Conclusion: The HPV DNA test is useful for predicting the severity of lesions of the uterine cervix and formulating decisions with regard to treatment plans.

Objective: To investigate the objective response rate to and tolerance of biweekly Lipo-Dox (TTY Biopharm Co. Ltd., Taipei, Taiwan) at a dosage of 20 mg/m(2) in previously treated patients with recurrent cervical cancer., Materials and Methods: This study was performed as a Simons two-stage phase II clinical trial. Ten patients with recurrent cervical cancer were enrolled between April 2003 and December 2005 at the Mackay Memorial Hospital. Lipo-Dox (20 mg/m(2) intravenous) diluted in 250 mL of 5% dextrose solution was administered at 2-weekly intervals., Results: The mean age of the patients was 51 +/- 11.1 years. The mean number of cycles of Lipo-Dox injection was 4.6 (range, 1-12 cycles). Nine patients (90%) had disease progression. Only one patient (10%) achieved a partial response, and this was also the only patient who experienced WHO grade 2 palmar-plantar erythrodysesthesia, which led to treatment delay for 2 months. The median survival time was 2 months (range, 2-6 months). The majority of patients experienced grade 1 or 2 anemia (30%), leukopenia (20%) or thrombocytopenia (20%), and others exhibited symptoms of nausea and vomiting (30%)., Conclusion: Salvage chemotherapy with Lipo-Dox at a dose of 20 mg/m(2) administered at 2-weekly intervals produced limited responses in patients with recurrent cervical cancer. This trial will not proceed to the second stage. These results may discourage the management of recurrent cervical cancer with single-agent Lipo-Dox in future clinical trials.