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Objective@#We used paclitaxel and cisplatin, known to be effective in intraperitoneal chemotherapy, in a novel prototype of rotational intraperitoneal pressurized aerosol chemotherapy (RIPAC) and evaluated the pharmacokinetics, tissue concentrations, and toxicities in a pig model. @*Methods@#We developed RIPAC, including the nozzle with the conical pendulum motion, and used 10% of intravenous doses of paclitaxel and cisplatin. We used high-performance liquid chromatography followed by tandem mass spectrometry to analyze serum and tissue concentrations. We applied a non-compartment model to study pharmacokinetics to analyze the time-dependent serum concentrations measured before RIPAC to 48 hours. We evaluated the difference in tissue concentrations between twelve peritoneal regions by the modified peritoneal cancer index. For evaluating toxicities, we observed hepatic and renal function until 4 days after RIPAC. @*Results@#Six pigs underwent RIPAC using paclitaxel (n=3) and cisplatin (n=3). The peak serum concentration (Cmax) and the area under the curve were higher for cisplatin, while the time to the peak serum concentration (Tmax) was longer for paclitaxel. Moreover, the parietal peritoneum showed higher tissue concentrations than the visceral peritoneum, and the ratio of tissue to serum concentrations using Cmax was higher for paclitaxel (172.2–6,237.9) than for cisplatin (0.1–9.3). However, there were no renal and hepatic toxicities after RIPAC with paclitaxel or cisplatin. @*Conclusion@#Delayed absorption of paclitaxel sprayed by RIPAC into the peritoneum to the bloodstream may lead to higher tissue concentrations at different regions and lower serum concentrations than cisplatin.
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Objective@#To investigate the health-related quality of life (HRQOL) related to hyperthermic intraperitoneal chemotherapy (HIPEC) following primary or interval cytoreductive surgery for primary ovarian cancer. @*Methods@#Between 2010 and 2016, a total of 184 patients were randomly assigned to receive cytoreductive surgery with HIPEC (n=92) or without HIPEC (n=92). Quality of life (QOL) assessment was evaluated at baseline (before surgery); on postoperative day 7; after the 3rd and 6th cycle of adjuvant chemotherapy; and at 3, 6, 9, and 12 months after randomization. Patient-reported QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (EORTC-QLQ-C30), ovarian cancer questionnaire modules (QLQ-OV28), and the MD Anderson Symptoms Inventory (MDASI). @*Results@#Of the 184 patients enrolled, 165 (83/92 in the HIPEC group and 82/92 in the control group) participated in the baseline QOL assessment. There were no statistically significant differences in functional scales and symptom scales in QLQ-C30; symptom scales, including gastrointestinal symptoms QLQ-OV28; and severity and impact score in MDASI between the 2 treatment groups until 12 months after randomization. @*Conclusion@#HIPEC with cytoreductive surgery showed no statistically significant difference in HRQOL outcomes. Thus, implementation of HIPEC during either primary or interval cytoreductive surgery does not impair HRQOL.
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OBJECTIVE@#To evaluate the effectiveness and safety of the combination of pegylated liposomal doxorubicin with carboplatin (CD) compared with those of carboplatin and paclitaxel (CP) for platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer in a real-world setting in Korea.@*METHODS@#We enrolled relevant patients from 9 institutions. All patients received CD or CP as the second- or third-line chemotherapy in routine clinical practice during 2013–2018. The primary endpoints were progression-free survival (PFS) and toxicity. The secondary endpoint included the objective response rate (ORR).@*RESULTS@#Overall, 432 patients (224 and 208 in the CD and CP groups, respectively) were included. With a median follow-up of 18.9 months, the median PFS was not different between the groups (12.7 vs. 13.6 months; hazard ratio, 1.161; 95% confidence interval, 0.923–1.460; p=0.202). The ORR was 74.6% and 80.1% in the CD and CP group, respectively (p=0.556). Age and surgery at relapse were independent prognostic factors. More patients in the CD group significantly experienced a grade 3 to 4 hematologic toxicity and hand-foot syndrome (13.8% vs. 6.3%), whereas grade 2 or more alopecia (6.2% vs. 36.1%), peripheral neuropathy (4.4% vs. 11.4%), and allergic/hypersensitivity reaction (0.4% vs. 8.5%) developed more often in the CP group.@*CONCLUSIONS@#The safety and effectiveness of chemotherapy with CD in a real-world setting were consistent with the results from a randomized controlled study. The different toxicity profiles between the 2 chemotherapy (CD and CP) regimens should be considered in the clinical practice.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03562533
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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.
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OBJECTIVE: To evaluate the effectiveness and safety of the combination of pegylated liposomal doxorubicin with carboplatin (CD) compared with those of carboplatin and paclitaxel (CP) for platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer in a real-world setting in Korea.METHODS: We enrolled relevant patients from 9 institutions. All patients received CD or CP as the second- or third-line chemotherapy in routine clinical practice during 2013–2018. The primary endpoints were progression-free survival (PFS) and toxicity. The secondary endpoint included the objective response rate (ORR).RESULTS: Overall, 432 patients (224 and 208 in the CD and CP groups, respectively) were included. With a median follow-up of 18.9 months, the median PFS was not different between the groups (12.7 vs. 13.6 months; hazard ratio, 1.161; 95% confidence interval, 0.923–1.460; p=0.202). The ORR was 74.6% and 80.1% in the CD and CP group, respectively (p=0.556). Age and surgery at relapse were independent prognostic factors. More patients in the CD group significantly experienced a grade 3 to 4 hematologic toxicity and hand-foot syndrome (13.8% vs. 6.3%), whereas grade 2 or more alopecia (6.2% vs. 36.1%), peripheral neuropathy (4.4% vs. 11.4%), and allergic/hypersensitivity reaction (0.4% vs. 8.5%) developed more often in the CP group.CONCLUSIONS: The safety and effectiveness of chemotherapy with CD in a real-world setting were consistent with the results from a randomized controlled study. The different toxicity profiles between the 2 chemotherapy (CD and CP) regimens should be considered in the clinical practice.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03562533
Subject(s)
Humans , Alopecia , Carboplatin , Cohort Studies , Disease-Free Survival , Doxorubicin , Drug Therapy , Follow-Up Studies , Hand-Foot Syndrome , Korea , Ovarian Neoplasms , Paclitaxel , Peripheral Nervous System Diseases , Platinum , Prognosis , Recurrence , Retrospective StudiesABSTRACT
Subject(s)
Humans , Colpotomy , Disease-Free Survival , Gynecology , Hysterectomy , Magnetic Resonance Imaging , Minimally Invasive Surgical Procedures , Obstetrics , Patient Selection , Recurrence , Uterine Cervical NeoplasmsABSTRACT
OBJECTIVE: This study aimed to analyze the clinical features of clear cell carcinoma in relation to endometriosis and to determine an appropriate surveillance strategy for the early detection of malignant transformation of endometrioma in asymptomatic patients. METHODS: We retrospectively reviewed the clinicopathologic data of 50 patients with ovarian clear cell carcinoma. Clinicopathologic characteristics, treatment outcomes, and the association between endometriosis and the risk of malignant transformation were analyzed. RESULTS: Ten (20%) patients had been diagnosed with endometrioma before the diagnosis of clear cell carcinoma. The median period from the diagnosis of endometrioma to clear cell carcinoma diagnosis was 50 months (range, 12–213 months). After complete staging surgery, histological confirmation of endometriosis was possible in 35 (70%) patients. Of the 50 patients, 39 (78%) had not undergone any gynecologic surveillance until the onset of symptoms, at which time many of them presented with a rapidly growing pelvic mass (median 10 cm, range 4.6–25 cm). With the exception of 2 patients, all cancer diagnoses were made when the patients were in their late thirties, and median tumor size was found to increase along with age. Asymptomatic patients (n=11) who had regular gynecologic examinations were found to have a relatively smaller tumor size, lesser extent of tumor spread, and lower recurrence rate (P=0.011, 0.283, and 0.064, respectively). The presence of endometriosis was not related to the prognosis. CONCLUSION: Considering the duration of malignant transformation and the timing of cancer diagnosis, active surveillance might be considered from the age of the mid-thirties, with at least a 1-year interval, in patients with asymptomatic endometrioma.
Subject(s)
Female , Humans , Cell Transformation, Neoplastic , Diagnosis , Endometriosis , Prognosis , Recurrence , Retrospective StudiesABSTRACT
OBJECTIVE: To compare the survival outcomes of adjuvant radiotherapy and chemotherapy in women with uterine-confined endometrial cancer with uterine papillary serous carcinoma (UPSC) or clear cell carcinoma (CCC). METHODS: Medical records of 80 women who underwent surgical staging for endometrial cancer were retrospectively reviewed. Stage I UPSC and CCC were pathologically confirmed after surgery. Survival outcomes were compared between the adjuvant radiotherapy and chemotherapy groups. RESULTS: Fifty-four (67.5%) and 26 (32.5%) women had UPSC and CCC, respectively. Adjuvant therapy was administered to 59/80 (73.8%) women (25 radiotherapy and 34 chemotherapy). High preoperative serum cancer antigen-125 level (25.1±20.2 vs. 11.5±6.5 IU/mL, p 0.999) and overall survival (77.5% vs. 87.8%, p=0.373) rates were similar between the groups. Neither radiotherapy (hazard ratio [HR]=1.810; 95% confidence interval [CI]=0.297–11.027; p=0.520) nor chemotherapy (HR=1.638; 95% CI=0.288–9.321; p=0.578) after surgery was independently associated with disease recurrence. CONCLUSION: Our findings showed similar survival outcomes for adjuvant radiotherapy and chemotherapy in stage I UPSC and CCC of the endometrium. Further large study with analysis stratified by MI or LVSI is required.
Subject(s)
Female , Humans , Adenocarcinoma, Clear Cell , Adenocarcinoma, Papillary , Chemotherapy, Adjuvant , Disease-Free Survival , Drug Therapy , Endometrial Neoplasms , Endometrium , Medical Records , Radiotherapy , Radiotherapy, Adjuvant , Recurrence , Retrospective StudiesABSTRACT
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.
Subject(s)
Female , Humans , Male , Appointments and Schedules , Korea , Papillomavirus Vaccines , VaccinationABSTRACT
The Asian Society of Gynecologic Oncology International Workshop 2018 on gynecologic oncology was held in the Ajou University Hospital, Suwon, Korea on the 24th to 25th August 2018. The workshop was an opportunity for Asian doctors to discuss the latest findings of gynecologic cancer, including cervical, ovarian, and endometrial cancers, as well as the future of fertility-sparing treatments, minimally invasive/radical/debulking surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy. Clinical guidelines and position statement of Asian countries were presented by experts. Asian clinical trials for gynecologic cancers were reviewed and experts emphasized the point that original Asian study is beneficial for Asian patients. In Junior session, young gynecologic oncologists presented their latest research on gynecologic cancers.
Subject(s)
Female , Humans , Antineoplastic Agents , Asian People , Drug Therapy , Education , Endometrial Neoplasms , Immunotherapy , Korea , Ovarian Neoplasms , Radiotherapy , Uterine Cervical NeoplasmsABSTRACT
Since after 2006 when the first edition of practice guidelines for gynecologic oncologic cancer treatment was released, the Korean Society of Gynecologic Oncology (KSGO) has published the following editions on a regular basis to suggest the best possible standard care considering updated scientific evidence as well as medical environment including insurance coverage. The Guidelines Revision Committee was summoned to revise the second edition of KSGO practice guidelines, which was published in July 2010, and develop the third edition. The current guidelines cover strategies for diagnosis and treatment of primary and recurrent ovarian cancer. In this edition, we introduced an advanced format based on evidence-based medicine, collecting up-to-date data mainly from MEDLINE, EMBASE, and Cochrane Library CENTRAL, and conducting a meta-analysis with systematic review. Eight key questions were raised by the committee members. For every key question, recommendations were developed by the consensus meetings and provided with evidence level and strength of the recommendation.
Subject(s)
Committee Membership , Consensus , Diagnosis , Drug Therapy , Evidence-Based Medicine , Insurance Coverage , Korea , Ovarian NeoplasmsABSTRACT
The Surgery Treatment Modality Committee of the Korean Gynecologic Oncologic Group (KGOG) has determined to develop a surgical manual to facilitate clinical trials and to improve communication between investigators by standardizing and precisely describing operating procedures. The literature on anatomic terminology, identification of surgical components, and surgical techniques were reviewed and discussed in depth to develop a surgical manual for gynecologic oncology. The surgical procedures provided here represent the minimum requirements for participating in a clinical trial. These procedures should be described in the operation record form, and the pathologic findings obtained from the procedures should be recorded in the pathologic report form. Here, we focused on radical hysterectomy and lymphadenectomy, and we developed a KGOG classification for those conditions.
Subject(s)
Female , Humans , Classification , Gynecologic Surgical Procedures , Hysterectomy , Lymph Node Excision , Manuals as Topic , Research PersonnelABSTRACT
The Surgery Treatment Modality Committee of the Korean Gynecologic Oncology Group has determined to develop a surgical manual to facilitate clinical trials and to improve communication between investigators by standardizing and precisely describing operating procedures. The literature on anatomic terminology, identification of surgical components, and surgical techniques were reviewed and discussed in depth to develop a surgical manual for gynecologic oncology. The surgical procedures provided here represent the minimum requirements for participating in a clinical trial. These procedures should be described in the operation record form, and the pathologic findings obtained from the procedures should be recorded in the pathologic report form. Here, we describe surgical procedure for ovarian, fallopian tubal, and peritoneal cancers.
Subject(s)
Female , Humans , Gynecologic Surgical Procedures , Manuals as Topic , Ovarian Neoplasms , Research PersonnelABSTRACT
Ovarian cancer is the most lethal of the gynecologic cancers worldwide because most patients present with advanced stage disease at the time of diagnosis. Although multiple therapeutic modalities are employed in the management of ovarian cancer, and despite advances in chemotherapeutic and biologic agents, primary surgery followed by adjuvant chemotherapy remains the cornerstone treatment of this disease. Adequate, comprehensive surgical staging in women with early stage ovarian cancer has been shown to improve oncologic outcomes. Complete surgical cytoreduction leaving no gross residual disease is known to be the only physician-driven prognostic factor for patients with advanced disease. This review describes the rationale and surgical steps for full surgical staging for women with early ovarian cancer, and outlines the cytoreductive surgical procedures required to achieve optimal cytoreduction in patients with advanced ovarian cancer. In addition, the impact of radical surgery (as part of maximal tumor debulking) on the amount of residual tumor and on survival rates will be discussed.
Subject(s)
Female , Humans , Biological Factors , Chemotherapy, Adjuvant , Diagnosis , Neoplasm Staging , Neoplasm, Residual , Ovarian Neoplasms , Survival RateABSTRACT
No abstract available.
Subject(s)
Female , Humans , Fallopian Tube Neoplasms/genetics , Genes, BRCA1 , Genes, BRCA2 , Genetic Testing , Mutation , Ovarian Neoplasms/genetics , Peritoneal Neoplasms/genetics , Republic of Korea , Societies, MedicalABSTRACT
No abstract available.
Subject(s)
Female , Humans , Fallopian Tube Neoplasms/genetics , Genes, BRCA1 , Genes, BRCA2 , Genetic Testing , Mutation , Ovarian Neoplasms/genetics , Peritoneal Neoplasms/genetics , Republic of Korea , Societies, MedicalABSTRACT
OBJECTIVE: To evaluate risk factors for massive lymphatic ascites after laparoscopic retroperitoneal lymphadenectomy in gynecologic cancer and the feasibility of treatments using intranodal lymphangiography (INLAG) with glue embolization. METHODS: A retrospective analysis of 234 patients with gynecologic cancer who received laparoscopic retroperitonal lymphadenectomy between April 2006 and November 2015 was done. In June 2014, INLAG with glue embolization was initiated to manage massive lymphatic ascites. All possible clinicopathologic factors related to massive lymphatic ascites were determined in the pre-INLAG group (n=163). Clinical courses between pre-INLAG group and post-INLAG group (n=71) were compared. RESULTS: In the pre-INLAG group (n=163), four patients (2.5%) developed massive lymphatic ascites postoperatively. Postoperative lymphatic ascites was associated with liver cirrhosis (three cirrhotic patients, p<0.001). In the post-INLAG group, one patient with massive lymphatic ascites had a congestive heart failure and first received INLAG with glue embolization. She had pelvic drain removed within 7 days after INLAG. The mean duration of pelvic drain and hospital stay decreased after the introduction of INLAG (13.2 days vs. 10.9 days, p=0.001; 15.2 days vs. 12.6 days, p=0.001). There was no evidence of recurrence after this procedure. CONCLUSION: Underlying medical conditions related to the reduced effective circulating volume, such as liver cirrhosis and heart failure, may be associated with massive lymphatic ascites after retroperitoneal lymphadenectomy. INLAG with glue embolization can be an alternative treatment options to treat leaking lymphatic channels in patients with massive lymphatic leakage.
Subject(s)
Adult , Aged , Female , Humans , Middle Aged , Ascites/etiology , Embolization, Therapeutic/methods , Genital Neoplasms, Female/surgery , Lymph Node Excision/adverse effects , Lymphography , Postoperative Complications/etiology , Retrospective StudiesABSTRACT
OBJECTIVE: To evaluate risk factors for massive lymphatic ascites after laparoscopic retroperitoneal lymphadenectomy in gynecologic cancer and the feasibility of treatments using intranodal lymphangiography (INLAG) with glue embolization. METHODS: A retrospective analysis of 234 patients with gynecologic cancer who received laparoscopic retroperitonal lymphadenectomy between April 2006 and November 2015 was done. In June 2014, INLAG with glue embolization was initiated to manage massive lymphatic ascites. All possible clinicopathologic factors related to massive lymphatic ascites were determined in the pre-INLAG group (n=163). Clinical courses between pre-INLAG group and post-INLAG group (n=71) were compared. RESULTS: In the pre-INLAG group (n=163), four patients (2.5%) developed massive lymphatic ascites postoperatively. Postoperative lymphatic ascites was associated with liver cirrhosis (three cirrhotic patients, p<0.001). In the post-INLAG group, one patient with massive lymphatic ascites had a congestive heart failure and first received INLAG with glue embolization. She had pelvic drain removed within 7 days after INLAG. The mean duration of pelvic drain and hospital stay decreased after the introduction of INLAG (13.2 days vs. 10.9 days, p=0.001; 15.2 days vs. 12.6 days, p=0.001). There was no evidence of recurrence after this procedure. CONCLUSION: Underlying medical conditions related to the reduced effective circulating volume, such as liver cirrhosis and heart failure, may be associated with massive lymphatic ascites after retroperitoneal lymphadenectomy. INLAG with glue embolization can be an alternative treatment options to treat leaking lymphatic channels in patients with massive lymphatic leakage.
Subject(s)
Adult , Aged , Female , Humans , Middle Aged , Ascites/etiology , Embolization, Therapeutic/methods , Genital Neoplasms, Female/surgery , Lymph Node Excision/adverse effects , Lymphography , Postoperative Complications/etiology , Retrospective StudiesABSTRACT
OBJECTIVE: The aim of this paper was to describe the operative details for en bloc removal of the adnexal tumor, uterus, pelvic peritoneum, and rectosigmoid colon with colorectal anastomosis in advanced epithelial ovarian cancer patients with widespread pelvic involvement. METHODS: The patient presented with good performance status and huge pelvic tumor extensively infiltrating into adjacent pelvic organs and obliterating the cul-de-sac. The patient underwent en bloc pelvic resection as primary cytoreductive surgery. En bloc pelvic resection procedure is initiated by carrying a circumscribing peritoneal incision to include all pan-pelvic disease within this incision. After retroperitoneal pelvic dissection, the round ligaments and infundibulopelvic ligaments are divided. The ureters are dissected and mobilized from the peritoneum. After dissecting off the anterior pelvic peritoneum overlying the bladder with its tumor nodules, the bladder is mobilized caudally and the vesicovaginal space is developed. The uterine vessels are divided at the level of the ureters, and the paracervical tissues (or parametria) are divided. The proximal sigmoid colon is divided above the most proximal extent of gross tumor using a ligating and dividing stapling device. The sigmoid mesentery is ligated and divided including the superior rectal vessels. The pararectal and retrorectal spaces are further developed and dissected down to the level of the pelvic floor. The posterior dissection is progressed and moves to the right and then to the left of the rectum. The rectal pillars including the middle rectal vessels are ligated and divided. Hysterectomy is completed in a retrograde fashion. The distal rectum is divided using a linear stapler. The specimen is removed en bloc with the uterus, adnexa, pelvic peritoneum, rectosigmoid colon, and tumor masses leaving a macroscopically tumor-free pelvis. Colorectal anastomosis was completed using stapling device. RESULTS: En bloc pelvic resection was performed by total abdominal hysterectomy, bilateral salpingo-oophorectomy, pelvic peritonectomy, and rectosigmoid colectomy with colorectal anastomosis using a stapling device. Complete clearance of pelvic disease leaving no gross residual disease was possible using en bloc pelvic resection. CONCLUSION: En bloc pelvic resection is effective for achieving maximal cytoreduction with the elimination of the pelvic disease in advanced primary ovarian cancer patients with extensive pelvic organ involvement.