Ovarian surveillance including endometrial cytology for patients with hereditary breast and ovarian cancer before risk-reducing salpingo-oophorectomy: A retrospective analysis.

AIM: Ovarian surveillance in women with hereditary breast and ovarian cancer who do not undergo risk-reducing salpingo-oophorectomy has been controversial. Therefore, this study aimed to demonstrate the clinical features of ovarian surveillance at our institution using a technique that combines serum cancer antigen 125 measurements, transvaginal ultrasonography, and uterine endometrial cytology. METHODS: We retrospectively examined 65 women, who had not undergone risk-reducing salpingo-oophorectomy diagnosed with hereditary breast and ovarian cancer between 2000 and 2021 at our hospital. Clinical information was obtained and analyzed through a chart review. The details of the treatment course were reviewed for patients who had developed ovarian cancer. RESULTS: Overall, 5 of the 65 women were diagnosed with ovarian cancer based on abnormal findings during periodic surveillance. All patients who developed ovarian cancer were asymptomatic, even if the cancer was at an advanced stage. Two of the 65 patients had endometrial cytology abnormalities, both of whom had ovarian cancer. All patients who developed ovarian cancer underwent primary debulking surgery, and complete gross resection was achieved. None of the patients experienced ovarian cancer recurrence. CONCLUSIONS: The ovarian surveillance strategy at our institution for women with hereditary breast and ovarian cancer who do not undergo risk-reducing salpingo-oophorectomy can identify asymptomatic ovarian cancer and contribute to achieving complete gross resection during primary surgery. Ovarian surveillance may contribute to a reduction in ovarian cancer mortality.

Paclitaxel-carboplatin and bevacizumab combination with maintenance bevacizumab therapy for metastatic, recurrent, and persistent uterine cervical cancer: An open-label multicenter phase II trial (JGOG1079).

OBJECTIVE: This multicenter, open-label, phase II study aimed to evaluate the efficacy and safety of paclitaxel-carboplatin, bevacizumab, and bevacizumab-based maintenance therapy for metastatic, recurrent, and persistent uterine cervical cancer. METHODS: Patients with measurable diseases that were not adapted to regional therapies, such as surgery or radiotherapy, and were systematic chemotherapy-naïve were eligible. The participants received paclitaxel (175 mg/m2), carboplatin (AUC 5), and bevacizumab (15 mg/m2) every three weeks until disease progression or unacceptable adverse events occurred. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall response rate (ORR), overall survival (OS), safety, and time to treatment failure. RESULTS: Sixty-nine patients were analyzed using our protocol. The median paclitaxel- carboplatin therapy duration was six cycles; 40% of patients received bevacizumab maintenance therapy. The median PFS was 11.3 months. The median OS was not reached; the median time to treatment failure was 5.9 months. The ORR was 79.7% [95% confidence interval (CI) 63.8-88.4]; 16 patients (23.2%) showed complete response (CR) and 39 patients (56.5%) showed partial response (PR). The median PFS was 14.3 months (95% CI 7.3-17 months) for the 25 patients who received maintenance therapy and 7.4 months (95% CI 6.1-11 months) for nonrecipients (p = 0.0449). Gastrointestinal perforation/fistulas occurred in four patients (5.6%), all of whom had a history of radiation therapy. CONCLUSIONS: Paclitaxel-carboplatin and bevacizumab therapy is an acceptable and tolerable treatment for advanced or recurrent cervical cancer.

Indocyanine green-guided sentinel lymph node mapping during laparoscopic surgery with vaginal cuff closure but no uterine manipulator for cervical cancer.

BACKGROUND: Lymph node metastasis is a critical prognostic factor in cervical cancer. Considering the potential complications of lymphadenectomy and desirability of avoiding systemic lymphadenectomy, accurate intraoperative prediction of the existence of lymph node metastasis is important in patients undergoing surgery for cervical cancer. We evaluated the feasibility and value of indocyanine green (ICG) use for sentinel lymph node (SLN) mapping during laparoscopic surgery performed for cervical cancer. METHODS: This single-center cohort study included 77 patients undergoing a new laparoscopic radical surgery method with pelvic lymphadenectomy for early-stage cervical cancer. The surgery, performed without using a uterine manipulator, included creation of a vaginal cuff. Bilateral ICG-guided SLN mapping and rapid histopathological examination were performed, and results were analyzed in relation to final histopathologic diagnoses. RESULTS: The SLN pelvic side-specific detection rate was 93.5%, sensitivity (SLN-positive cases/SLN-detected pelvic lymph node-positive cases) was 100%, intraoperative negative predictive value (NPV) was 97.8%, and final pathological NPV was 100%. The detection rate was significantly lower for tumors ≥ 2 cm in diameter than for tumors < 2 cm in diameter. Micrometastases were missed by intraoperative examination in 3 cases. CONCLUSION: The high NPV suggests the feasibility and usefulness of ICG-based SLN mapping plus rapid intraoperative examination for identification of metastatic SLNs. Use of ICG-based mapping for intraoperative identification of SLNs in patients undergoing this new laparoscopic surgery method for early-stage cervical cancer was particularly effective for tumors < 2 cm in diameter. However, incorporating a search for micrometastases into rapid intraoperative histopathologic examination may be necessary.

Laparoscopic pelvic exenteration and laterally extended endopelvic resection for postradiation recurrent cervical carcinoma: Technical feasibility and short-term oncologic outcome.

OBJECTIVE: Surgery is the only treatment for cervical cancer recurrence in a previously irradiated field. Pelvic exenteration (PE) and laterally extended endopelvic resection (LEER) are indicated for select patients; however, morbidity and mortality rates remain high, and new treatment modalities are required. Laparoscopy optimizes visualization and allows meticulous dissection while also reducing intraoperative blood loss and postoperative complications without worsening the outcomes. We aimed to clarify the feasibility and outcomes of laparoscopic PE and LEER for previously irradiated recurrent cervical cancer. METHODS: We prospectively investigated the outcomes of laparoscopic PE and LEER in 28 patients with recurrent cervical carcinoma after radiotherapy. RESULTS: Seventeen laparoscopic PEs for central recurrences and 11 laparoscopic LEERs for lateral recurrences were performed. The median operation time and blood loss were 454mins and 285 mL in the PE group, and 562mins and 325 mL in the LEER group, respectively, with no conversions to laparotomy. R0 resection was achieved in all patients in the PE group and 73% in the LEER group. The morbidity and mortality rates were 41% and 0% in PE group, and 55% and 0% in LEER group, respectively. The 2-year disease-free survival and overall survival were 68.9% and 76% in the PE group, and 27.3% and 29.6% in the LEER group, respectively. CONCLUSION: Laparoscopic PE is feasible for previously irradiated central recurrent cervical cancer and has acceptable outcomes. Laparoscopic LEER is also feasible for lateral recurrence, but oncologic outcome may be modest in this limited preliminary study. Further studies using a larger sample size with a longer follow-up period is warranted to determine the indications for laparoscopic LEER.

Clinical and pathological outcomes of risk-reducing salpingo-oophorectomy for Japanese women with hereditary breast and ovarian cancer.

BACKGROUND: To clarify the clinical as well as pathological outcomes in Japanese women with germline pathogenic BRCA1/2 variants who underwent risk-reducing salpingo-oophorectomy (RRSO). METHODS: This prospective study examined the rate of occult cancer and primary peritoneal cancer after RRSO at our institution in the period from 2011 to 2020. Clinical records of genetically confirmed patients with germline pathogenic BRCA1/2 variants who desired to undergo RRSO were reviewed. Specimens obtained during RRSO were pathologically diagnosed as per SEE-FIM protocol. All the participants underwent magnetic resonance imaging (MRI) about 1 month preoperatively. RESULTS: One hundred and seventeen women underwent RRSO during this period. Of these, the numbers of women with germline pathogenic BRCA1 and BRCA2 variants were 72 and 45, respectively. The mean observational time after RRSO was 35.8 months. Despite negative preoperative screening results, three (2.6%) serous tubal intraepithelial carcinoma and three (2.6%) invasive carcinomas were identified. Of the three invasive carcinomas cases, two were International Federation of Gynecology and Obstetrics (FIGO) stage I primary fallopian tube cancer, and the third case was double cancer (ovarian cancer and fallopian tube cancer) with FIGO stage IC3. CONCLUSIONS: The rate of occult neoplasms was similar to those reported by studies performed in other countries. Although women with occult cancer were diagnosed with FIGO stage I, the MRI performed 1 month preoperatively did not show any such malignant findings. Thus, RRSO is the only promising method that can improve the prognosis in women with germline pathogenic BRCA1/2 variants.

Early oral feeding is safe and useful after rectosigmoid resection with anastomosis during cytoreductive surgery for primary ovarian cancer.

BACKGROUND: The aim of this study was to investigate the safety and clinical usefulness of early oral feeding (EOF) after rectosigmoid resection with anastomosis for the treatment of primary ovarian cancer. METHODS: We performed a retrospective review of all consecutive patients who had undergone rectosigmoid resection with anastomosis for primary ovarian, tubal, or peritoneal cancer between April 2012 and March 2019 in a single institution. Patient-related, disease-related, and surgery-related data including the incidence of anastomotic leakage and postoperative hospital stay were collected. EOF was introduced as a postoperative oral feeding protocol in September 2016. Before the introduction of EOF, conventional oral feeding (COF) had been used. RESULTS: Two hundred and one patients who underwent rectosigmoid resection with anastomosis, comprised of 95 patients in the COF group and 106 patients in the EOF group, were included in this study. The median number of postoperative days until the start of diet intake was 5 (range 2-8) in the COF group and 2 (range 2-8) in the EOF group (P < 0.001). Postoperative morbidity was equivalent between the groups. The incidence of anastomotic leakage was similar (1%) in both groups. The median length of the postoperative hospital stay was reduced by 6 days for the EOF group: 17 (range 9-67) days for the COF group versus 11 (8-49) days for the EOF group (P < 0.001). CONCLUSION: EOF provides a significant reduction in the length of the postoperative hospital stay without an increased complication risk after rectosigmoid resection with anastomosis as a part of cytoreductive surgery for primary ovarian cancer.

Positive surgical margin is an independent predictor of overall survival of patients with vulvar squamous cell carcinoma.

AIM: It is uncertain whether curative surgical treatment or a less radical surgery with adjuvant treatment should be provided to preserve function in patients with vulvar squamous cell carcinoma (SCC) that is adjacent to the urethra, anus, and vagina. The aim of this study was to investigate the surgical margin in patients with vulvar SCC with regard to local recurrence and overall survival. METHODS: Thirty-four patients were identified as having a diagnosis of vulvar SCC without distant metastasis. They had been treated surgically with curative intent at the Cancer Institute Hospital. Clinical data were analyzed retrospectively. RESULTS: Rates of 5-year local recurrence-free survival among patients with positive, <3-mm, <5-mm, <8-mm, and ≥8-mm surgical margins were 32%, 30.3%, 42.5%, 55.5%, and 73%, respectively. Rates of 5-year overall survival of patients with positive, <3-mm, <5-mm, <8-mm, and ≥8-mm surgical margins were 15.5%, 53.8%, 58.8%, 67.6%, and 83.3%, respectively. In the multivariable analysis, a tumor size of more than 2-cm (hazard ratio [HR] = 17.7, 95% confidence interval [CI] = 1.39-226) and a positive surgical margin (HR = 0.0092, 95% CI = 0.011-0.53) were risk factors for local recurrence, and a lymph node involvement (HR = 1.41, 95% CI = 0.31-6.43) and a positive surgical margin (HR = 0.0046, 95% CI = 0.011-0.53) were significant risk factors for overall mortality. CONCLUSIONS: To improve the prognosis, thorough resection with an adequate surgical margin is needed. But narrow surgical margin may be acceptable, particularly to preserve the function of adjacent organs.

Surgical outcomes of early-stage primary vaginal nonsquamous cell carcinoma.

OBJECTIVE: Definitive radiation therapy (RT), using external beam RT and/or brachytherapy, is a standard treatment option for primary vaginal carcinoma. However, this treatment has poor prognosis when applied to vaginal nonsquamous cell carcinoma (non-SCC). We aimed to clarify treatment outcome and surgical safety in early-stage primary vaginal non-SCC. METHODS: After receiving approval from the institutional review board, we retrospectively reviewed the clinical records and pathological samples of patients treated at our hospital between 1991 and 2018. Among 49 patients with primary vaginal carcinoma, 12 with histologically confirmed early-stage primary vaginal non-SCC were included in this study. RESULTS: In total, 40% of patients with primary vaginal carcinoma treated at our hospital had primary vaginal non-SCC. The average observation time was 34 months (median 53.3 months). Three patients had local recurrence: 2 in pelvic lymph nodes and 1 in the vagina. Furthermore, 2 patients died of their disease. Five-year local control rate of stage I and stage II non-SCC was 75% and 100%, respectively. Disease-specific survival rate of stage I and stage II non-SCC was 81.8% and 100%, respectively. No major morbidity was observed. Three patients required allogeneic blood transfusion, whereas 1 underwent autotransfusion. None of the 12 patients were discharged with self-catheterization. CONCLUSION: Five-year local control and disease-specific survival rates of patients surgically treated for vaginal non-SCC were favorable. Therefore, surgery could be a safe and reasonable option for early-stage primary vaginal non-SCC.

En Bloc Resection of an Aggressive Angiomyxoma by a Novel Combination Laparoscopic and Open Perineal Approach.

STUDY OBJECTIVE: To show a novel combination laparoscopic and open perineal approach to complete resection of aggressive angiomyxoma. DESIGN: Step-by-step video demonstration of the combination approach (Canadian Task Force classification III). SETTING: Combined laparoscopic and open perineal approach was performed in the tertiary center. PATIENT: A 46-year-old woman presented with an 8-cm vulvar mass, diagnosed as an aggressive angiomyxoma. The patient, who strongly desired to preserve her uterus and ovaries, provided informed consent for resection of the tumor by our combination approach, also approved by our Institutional Review Board. INTERVENTION: Combined laparoscopic and open perineal approach. MEASUREMENTS AND MAIN RESULTS: Aggressive angiomyxoma is a rare mesenchymal neoplasm that occurs most often in the female pelviperineal region [1]. Aggressive angiomyxoma is locally infiltrative, and high postoperative local recurrence rates (36%-72%) due to incomplete resection have been reported [2]. Therefore, until recently, wide surgical excision with tumor-free margins have been the most commonly accepted treatment. However, aggressive angiomyxoma is a benign, slow-growing tumor, and because extensive surgical resection, which is associated with high operative morbidity rates, has not been shown to have a significant effect on prognosis, a more conservative procedure may be preferable [3]. The mass was located mainly at the left ischiorectal fossa, but it extended above the pelvic diaphragm and was attached to internal obturator muscle, vagina, bladder, urethra, and rectum. We excised the tumor completely and without complications by a combined laparoscopic and open perineal approach. Twelve months have passed since the surgery, and there has been no adjuvant treatment and no sign of recurrence. CONCLUSION: Our combination approach to aggressive angiomyxoma in the pelviperineal region is technically feasible, and the good visualization and meticulous dissection provided during the laparoscopic portion of the surgery contribute to complete resection.

Laparoscopic Anterior Pelvic Exenteration with Super Radical Parametrectomy for a Recurrent Low-Grade Endometrial Sarcoma That is Resistant to Hormone Therapy and Chemotherapy.

STUDY OBJECTIVE: To show total laparoscopic complete resection of a recurrent low-grade endometrial sarcoma. DESIGN: Step-by-step demonstration of the technique of laparoscopic anterior pelvic exenteration with super radical parametrectomy, including the explanation of detailed pelvic anatomy (Canadian Task Force classification III). SETTING: Low-grade endometrial stromal sarcoma (LGESS) is a rare malignancy that makes up around 0.2% of all uterine malignancies [1]. Total abdominal hysterectomy and bilateral salpingo-oophorectomy is a standard treatment; however, the recurrence risk is quite high [2]. For a recurrent LGESS that is resistant to hormone therapy and chemotherapy, complete resection with negative surgical margins (R0 resection) can be the most promising method [3]. PATIENT: The patient had undergone total abdominal hysterectomy and bilateral salpingo-oophorectomy because of a LGESS. Almost 20 years later, a recurrent LGESS was detected at the vaginal stump, and the patient underwent several rounds of chemotherapy and hormonal therapy. These treatments were inefficacious, and the recurrent tumor progressed. An abdominal computed tomographic scan revealed that the recurrent tumor occupied the vaginal stump, involved the bladder and the left ureter, and extended to the left pelvic sidewall. INTERVENTIONS: Anterior pelvic exenteration with super radical parametrectomy was performed laparoscopically with no blood transfusion. R0 resection could be achieved without any intraoperative and postoperative complications. Without any adjuvant treatment, there has been no sign of recurrence during the 12 months that have passed since the surgery. This video obtained institutional review board approval through our local ethics committee in the Cancer Institutional Hospital (institutional review board number 2016-1007). CONCLUSION: The good visualization and meticulous dissection provided during laparoscopic surgery can make the approach advantageous and may contribute to R0 achievement.

Comparison of the Technical Feasibility and Safety of Three Contained Morcellation Techniques: A Pilot Study in an Animal Model.

STUDY OBJECTIVE: To compare 3 laparoscopic contained morcellation techniques in terms of feasibility and safety. DESIGN: Pilot study in an animal model (Canadian Task Force classification II-1). SETTING: Gynecologic oncology department at a cancer institute in Japan. PATIENTS: Porcine model. INTERVENTIONS: Three contained morcellation techniques were tested, each multiple times in 1 of 3 anesthetized female pigs: manual morcellation (8 times), dual-site power morcellation (8 times), and single-site power morcellation (6 times). All were tested on beef tongue introduced abdominally. MEASUREMENTS AND MAIN RESULTS: The following variables were compared: bag insertion time, morcellation time, bag removal time, total in-bag morcellation time, and the volume of pneumoperitoneum CO2 consumed. Bag rupture was evaluated ex vivo on completion of the procedure. Bag insertion time (in minutes) was significantly greater for dual-site morcellation (10.91 ± 3.38) than for manual (4.58 ± 2.47, p = .003) or single-site power (7.25 ± .77, p = .014) morcellation. Bag removal time (in minutes) was also significantly greater for dual-site morcellation (.85 ± .11 vs .27 ± .14, p<.001, vs .33 ± .59, p = .001). Total in-bag morcellation time, although greatest for manual morcellation at 21.4 ± 10.2 minutes, did not differ significantly between techniques. CO2 consumption was significantly low for manual morcellation. Visual inspection revealed no bag damage when manual morcellation was performed, but bag damage occurred in 3 dual-site cases and in 1 single-site case. CONCLUSION: Considering preventing specimen leakage as the main aim of contained morcellation, the bag used for power morcellation needs improvement. Although manual morcellation requires an umbilical wound of about 25 mm, the absence of bag damage, acceptable total morcellation time, relatively low CO2 consumption, and nonuse of a power device, which translate to an economic benefit, lead us to conclude that manual morcellation will remain advantageous into the future.

Clinical management of the status of atypical endometrial cells using the descriptive reporting format for endometrial cytology.

OBJECTIVE: We aimed to develop and reinforce a clinical management regimen for atypical endometrial cell (ATEC) categories within the descriptive reporting format for endometrial cytology. METHODS: Between January 2013 and December 2014, 215 samples, for which histological examination was performed immediately or within 3 months after cytology, were cytologically diagnosed as ATEC. For these samples, the medical records were retrospectively reviewed to identify risk factors for malignancy. RESULTS: Among 152 samples diagnosed as ATEC, of undetermined significance, 19 (12.5%) were malignant. In the younger group (age <55 years), the χ2 values of body mass index (BMI) ≥25 kg/m2 (5.85), gravidity (5.64) and parity (5.15) were relatively high, suggesting that these were risk factors for malignancy. Of the nulligravida patients, those with BMI ≥25 kg/m2 , 28% were diagnosed with malignant disease. In the older group (≥55 years), endometrial thickening (6.84), atypical genital bleeding (6.43) and BMI ≥25 kg/m2 (3.79) were found to be risk factors for malignancy. Of the patients with endometrial thickening and atypical genital bleeding, 67% were diagnosed with malignant disease. Among 63 samples diagnosed as ATEC, cannot exclude atypical endometrial hyperplasia or more, 35 (55.6%) samples were positive for malignancy. CONCLUSIONS: High-risk patients diagnosed with ATEC, of undetermined significance were identified. Endometrial biopsy should be considered for nulligravida patients aged <55 years with a BMI ≥25 kg/m2 .

Maintenance hormonal therapy after treatment with medroxyprogesterone acetate for patients with atypical polypoid adenomyoma.

BACKGROUND: As atypical polypoid adenomyoma (APA) has been reported to be a hormone-related tumor, we aimed to analyze the efficacy and safety of maintenance hormonal therapy after fertility-preserving treatment of these patients with medroxyprogesterone acetate (MPA). METHODS: Data were retrospectively analyzed from patients with APA who were treated with a fertility-preserving regimen including MPA between October 2001 and December 2011. Eighteen patients were treated with MPA and 14 (77.8%) achieved either a complete or a partial response after the planned treatment. Five patients took progestin for maintenance therapy. RESULTS: Eighteen patients were treated for a mean observation period of 96.7 months. While taking the maintenance therapy, no patient had APA relapse. One patient developed well-differentiated endometrioid adenocarcinoma 18 months after she stopped taking maintenance progestin. Eleven patients without maintenance therapy underwent hysterectomy, andnine of them developed well-differentiated endometrial cancer. Through univariate analysis, there was a significant difference in time to hysterectomy between patients with and without maintenance therapy (P = 0.015). Through multivariate analysis, body mass index (BMI), menstrual status before protocol therapy, maintenance treatment, and pregnancy were found to be significantly associated with a lower risk of hysterectomy. No patient had a recurrence of APA after hysterectomy during the observation period (median, 54 months; range, 2-148 months). CONCLUSION: No patient showed progression while receiving hormonal therapy, including initial protocol therapy. Maintenance hormonal therapy after treatment with MPA was highly effective and safe, particularly in patients with BMI ≧24 kg/m2 and irregular menstruation cycle.

Long-term outcomes of fertility-sparing treatment of atypical polypoid adenomyoma with medroxyprogesterone acetate.

PURPOSE: Our objective was to analyze the long-term oncologic outcomes of fertility-preserving hormonal treatment with medroxyprogesterone acetate (MPA) in patients with APA. METHODS: In a retrospective chart review, we identified patients with APA who were treated with MPA for fertility preservation at our hospital between 2001 and 2011. Eighteen patients with histologically diagnosed APA were identified. Clinical data including treatment, obstetrical, and oncologic outcomes were recorded. RESULTS: The mean observation period was 77.6 months (median 73.5, range 22-142), and the mean age was 33.6 years. Four patients also developed well-differentiated endometrial carcinoma. After the treatment, 14 patients (77.8 %) achieved either a complete response or partial response. Eight patients experienced recurrence, while four experienced persistent disease. Ten patients (55.6 %) eventually underwent hysterectomy. The median time to hysterectomy was 40.3 months (range 24-68). Nine patients progressed to endometrial cancer, and one experienced persistent APA. Among younger patients (<35 years of age), four out of five patients who were married could have children. Seven patients (38.9 %) showed no evidence of the disease during the observation period (median 60 months, range 22-117 months). No one died because of the disease during the observation period. CONCLUSIONS: MPA yields a high response rate in APA, and if only younger patients are considered, a favorable pregnancy rate can be obtained. However, because recurrence rate is high, long-term follow-up under supervision of a trained gynecologic oncologist is required. To confirm MPA's utility, multi-center collaboration would be warranted.

Clinical usefulness of the oral chemotherapy agent S-1 in heavily pre-treated patients with advanced or recurrent cervical cancer.

PURPOSE: Our aim was to evaluate the efficacy and safety of S-1 in heavily pre-treated patients with advanced (FIGO stage IVB) or recurrent cervical cancer. METHODS: The Institutional Review Board of our hospital approved the protocol for this retrospective phase II study. Patients with measurable disease received two oral doses of S-1 (35 mg/m(2)) daily for 4 weeks of a 6-week cycle or 2 weeks of a 3-week cycle. The antitumor effect, time to progression, overall survival, and adverse events were investigated. RESULTS: We retrospectively analyzed relevant data of 28 patients with advanced or recurrent cervical cancer. Twenty-two patients had prior chemotherapy (not including chemoradiotherapy) and 27 had prior radiotherapy. The median number of prior chemotherapy regimens and cycles was 2 (range 0-4) and 7 (range 0-35), respectively. Two patients (7.1%) had partial response, and 10 patients (35.7%) had stable disease. Ten patients (35.7%) discontinued the therapy because of progressive disease. The response in 5 patients could not be evaluated because of termination of treatment in the middle of the first cycle. The disease control rate was 42.8%. After a median follow-up duration of 7.5 months, the median time to progression was 4.2 months (95% CI 2.7-5.4) and the median overall survival was 9.92 months (95% CI 9.20-NA). The two patients with partial response had received less prior chemotherapy. CONCLUSIONS: Oral S-1 in palliative chemotherapy is a useful and well-tolerated treatment in heavily pre-treated patients with advanced or recurrent uterine cervical cancer.

Platinum-free interval in second-line chemotherapy for recurrent cervical cancer.

OBJECTIVE: The purpose of this study was to determine whether the platinum-free interval (PFI) was a predictive indicator in second-line treatment of cervical cancer in patients who had undergone prior platinum-based chemotherapy. The role of the PFI in selecting the second-line regimen in other gynecologic malignancies is also discussed. METHODS: In this retrospective study, we examined the clinical records of patients with recurrent or metastatic cervical cancer who had received platinum-containing combination regimens as second-line chemotherapy. All patients had received prior platinum-containing chemotherapy or concurrent chemoradiotherapy. RESULTS: The overall response rate to second-line chemotherapy was 25.8%; 7 patients achieved a complete response and 17 a partial response. The median progression-free survival (PFS) was 5.1 months and median overall survival (OS) was 13.5 months. The response rate was 12.5%, 14.2%, 20.0%, 22.2%, and 55.0%; median PFS was 4.0, 5.1, 4.4, 5.8, and 7.4 months; and median OS was 10.2, 14.4, 11.9, 16.3, and 19.7 months when PFI was within 3, 3 to 5, 6 to 11, 12 to 23, and more than 24 months, respectively. Age (>50 years), size (>3 cm), prior radiotherapy, and PFI (>24 months) were identified as prognostic factors in the multivariate analysis for PFS and OS. CONCLUSIONS: The results indicate that a PFI of more than 24 months is the discriminating point between platinum-sensitive and platinum-resistance cervical cancer. This indicates that PFI offers a useful tool in selecting agents for second-line chemotherapy in a wide range of gynecologic malignancies.

Efficacy of intra-abdominal cytoreductive surgery in advanced endometrial cancer with distant metastasis.

OBJECTIVE: The efficacy of intra-abdominal cytoreductive surgery in patients with endometrial cancer and distant metastasis is equivocal. We investigated the effectiveness of such surgical treatment and whether it should be performed before or after chemotherapy (CT). METHODS: This study included patients with an International Federation of Gynecology and Obstetrics stage IVB endometrial cancer who received initial treatment at our hospital between January 2006 and December 2017. RESULTS: We retrospectively reviewed 67 patients with stage IVB endometrial cancer with distant metastases and classified them into preceding surgery (PS, n=23), chemotherapy followed by a surgery (CS, n=27), and CT (n=17) groups. We examined the achievement of resection with [R (1)] or without [R (0)] intra-abdominal macroscopic residue and survival. The median survival time for R (0) was 44 (95% confidence interval [CI]=9-not available [NA]) months in the PS group and 27 (95% CI=11-NA) months in the CS group. The median survival time for R (1) was 9 (95% CI=0-24) months in the PS group and 12 (95% CI=7-19) months in the CS group. The similar prognosis in both groups was worse with R (1) than with R (0). The survival curve for R (1) in the resection groups was similar to that of the CT group. CONCLUSION: Achieving resection without intra-abdominal macroscopic residue for endometrial cancer with distant metastases, whether before or after CT, could extend patients' survival.

Transperineal endoscopic approach with GelPOINT V-path in laparoscopic pelvic exenteration for postirradiated recurrent cervical cancer.

Pelvic exenteration (PE) is a highly invasive procedure associated with high morbidity and mortality rates. Laparoscopy is a promising option to reduce this invasiveness, and laparoscopic PE significantly reduces blood loss and shortens hospital stays. In the case of a large tumor with invasion to the surrounding organs, laparoscopic dissection around the pelvic floor is sometimes problematic owing to restrictions on handling instruments. To overcome these limitations, we performed a transperineal endoscopic approach using the GelPOINT V-path in addition to laparoscopic PE. This approach enabled dissection around the pelvic floor without the abovementioned obstacles under magnified visualization. As a result, we could dissect the pelvic floor precisely with a reduction of the dead pelvic space, which might contribute to reduced rates of postoperative complications while ensuring oncologic outcomes.

An attempt to establish real-world databases of poly(ADP-ribose) polymerase inhibitors for advanced or recurrent epithelial ovarian cancer: the Japanese Gynecologic Oncology Group.

The development of new treatments for gynecological malignancies has been conducted mainly through collaborative international phase III trials led by the United States and Europe. The survival outcomes of many gynecological malignancies have greatly improved as a result. Recent large-scale genome-wide association studies have revealed that drug efficacy and adverse event profiles are not always uniform. Thus, it is important to validate new treatment options in each country to safely and efficiently provide newly developed treatment options to patients with gynecological malignancies. The Japanese Gynecologic Oncology Group (JGOG) is conducting 5 cohort studies (JGOG 3026, 3027, 3028, 3030, and 3031) to establish real-world data (RWD) of poly(ADP-ribose) polymerase (PARP) inhibitor use in patients with advanced or recurrent epithelial ovarian cancer. The RWD constructed will be used to provide newly developed PARP inhibitors for women with advanced or recurrent ovarian cancer in a safer and more efficient manner as well as to develop further treatment options. In 2022, The JGOG, Korean Gynecologic Oncology Group, Chinese Gynecologic Cancer Society, and Taiwanese Gynecologic Oncology Group established the East Asian Gynecologic Oncology Trial Group to collaborate with East Asian countries in clinical research on gynecologic malignancies and disseminate new knowledge on gynecologic malignancies from Asia. The JGOG will conduct a collaborative integrated analysis of the RWD generated from Asian countries and disseminate real-world clinical knowledge regarding new treatment options that have been clinically implemented.

Impact of the coverage of risk-reducing salpingo-oophorectomy by the national insurance system for women with BRCA pathogenic variants in Japan.

To determine the impact of the coverage of risk-reducing salpingo-oophorectomy (RRSO) and mastectomy (RRM) as well as genetic testing for BRCA pathogenic variants by the national insurance system in Japan. We compared the clinical background of women who underwent RRSO at our institution before and after its coverage by the national insurance system. Those who underwent RRSO between January 2017 and December 2019 and between April 2020 and March 2022 were classified as Period. A and B, respectively. Overall, 134 women underwent RRSO during the study period. In Period A and B, 45 and 89 women underwent RRSO for the study period was 36 and 24 months, respectively. Compared with Period A, the number of women who underwent RRSO per month increased by threefold in Period B (p < 0.01). In addition, the number of women who underwent surgery for breast cancer along with RRSO increased in Period B (p < 0.01). Although the number of women who underwent concurrent RRM with RRSO in Period B increased, the difference was not statistically significant. Compared with Period A, the number of women diagnosed with BRCA pathogenic variant increased by 3.9-fold, and the proportion of women who underwent concurrent hysterectomy at the time of RRSO decreased from 66 to 7.9% in Period B (p < 0.01). Owing to the introduction of the national insurance system, the number of women who underwent RRSO and concurrent surgery for breast cancer at the time of RRSO increased in Japan.