1.Prognostic impact of the number of resected pelvic nodes in endometrial cancer: Japanese Gynecologic Oncology Group Study JGOG2043 post hoc analysis
Yosuke KONNO ; Michinori MAYAMA ; Kazuhiro TAKEHARA ; Yoshihito YOKOYAMA ; Jiro SUZUKI ; Nobuyuki SUSUMU ; Kenichi HARANO ; Satoshi NAKAGAWA ; Toru NAKANISHI ; Wataru YAMAGAMI ; Kosuke YOSHIHARA ; Hiroyuki NOMURA ; Aikou OKAMOTO ; Daisuke AOKI ; Hidemichi WATARI
Journal of Gynecologic Oncology 2025;36(1):e3-
Objective:
This study aimed to determine whether the number of resected pelvic lymph nodes (PLNs) affects the prognosis of endometrial cancer (EC) patients at post-operative risk of recurrence.
Methods:
JGOG2043 was a randomized controlled trial to assess the efficacy of three chemotherapeutic regimens as adjuvant therapy in EC patients with post-operative recurrent risk. A retrospective analysis was conducted on 250 patients who underwent pelvic lymphadenectomy alone in JGOG2043. The number of resected and positive nodes and other clinicopathologic risk factors for survival were retrieved.
Results:
There were 83 patients in the group with less than 20 PLNs removed (group A), while 167 patients had 20 or more PLNs removed (group B). There was no significant difference in patients’ backgrounds between the two groups, and the rate of lymph node metastasis was not significantly different. There was a trend toward fewer pelvic recurrences in group B compared with group A (3.5% vs. 9.6%; p=0.050). Although Kaplan-Meier analysis showed no statistically significant difference in survival rates between the two groups (5-year overall survival [OS]=90.3% vs. 84.3%; p=0.199), multivariate analysis revealed that resection of 20 or more nodes is one of the independent prognostic factors (hazard ratio=0.49; 95% confidence interval=0.24–0.99; p=0.048), as well as surgical stage, high-risk histology, and advanced age for OS.
Conclusion
Resection of 20 or more PLNs was associated with improved pelvic control and better survival outcomes in EC patients at risk of recurrence who underwent pelvic lymphadenectomy alone and were treated with adjuvant chemotherapy.
2.Prognostic impact of the number of resected pelvic nodes in endometrial cancer: Japanese Gynecologic Oncology Group Study JGOG2043 post hoc analysis
Yosuke KONNO ; Michinori MAYAMA ; Kazuhiro TAKEHARA ; Yoshihito YOKOYAMA ; Jiro SUZUKI ; Nobuyuki SUSUMU ; Kenichi HARANO ; Satoshi NAKAGAWA ; Toru NAKANISHI ; Wataru YAMAGAMI ; Kosuke YOSHIHARA ; Hiroyuki NOMURA ; Aikou OKAMOTO ; Daisuke AOKI ; Hidemichi WATARI
Journal of Gynecologic Oncology 2025;36(1):e3-
Objective:
This study aimed to determine whether the number of resected pelvic lymph nodes (PLNs) affects the prognosis of endometrial cancer (EC) patients at post-operative risk of recurrence.
Methods:
JGOG2043 was a randomized controlled trial to assess the efficacy of three chemotherapeutic regimens as adjuvant therapy in EC patients with post-operative recurrent risk. A retrospective analysis was conducted on 250 patients who underwent pelvic lymphadenectomy alone in JGOG2043. The number of resected and positive nodes and other clinicopathologic risk factors for survival were retrieved.
Results:
There were 83 patients in the group with less than 20 PLNs removed (group A), while 167 patients had 20 or more PLNs removed (group B). There was no significant difference in patients’ backgrounds between the two groups, and the rate of lymph node metastasis was not significantly different. There was a trend toward fewer pelvic recurrences in group B compared with group A (3.5% vs. 9.6%; p=0.050). Although Kaplan-Meier analysis showed no statistically significant difference in survival rates between the two groups (5-year overall survival [OS]=90.3% vs. 84.3%; p=0.199), multivariate analysis revealed that resection of 20 or more nodes is one of the independent prognostic factors (hazard ratio=0.49; 95% confidence interval=0.24–0.99; p=0.048), as well as surgical stage, high-risk histology, and advanced age for OS.
Conclusion
Resection of 20 or more PLNs was associated with improved pelvic control and better survival outcomes in EC patients at risk of recurrence who underwent pelvic lymphadenectomy alone and were treated with adjuvant chemotherapy.
3.Prognostic impact of the number of resected pelvic nodes in endometrial cancer: Japanese Gynecologic Oncology Group Study JGOG2043 post hoc analysis
Yosuke KONNO ; Michinori MAYAMA ; Kazuhiro TAKEHARA ; Yoshihito YOKOYAMA ; Jiro SUZUKI ; Nobuyuki SUSUMU ; Kenichi HARANO ; Satoshi NAKAGAWA ; Toru NAKANISHI ; Wataru YAMAGAMI ; Kosuke YOSHIHARA ; Hiroyuki NOMURA ; Aikou OKAMOTO ; Daisuke AOKI ; Hidemichi WATARI
Journal of Gynecologic Oncology 2025;36(1):e3-
Objective:
This study aimed to determine whether the number of resected pelvic lymph nodes (PLNs) affects the prognosis of endometrial cancer (EC) patients at post-operative risk of recurrence.
Methods:
JGOG2043 was a randomized controlled trial to assess the efficacy of three chemotherapeutic regimens as adjuvant therapy in EC patients with post-operative recurrent risk. A retrospective analysis was conducted on 250 patients who underwent pelvic lymphadenectomy alone in JGOG2043. The number of resected and positive nodes and other clinicopathologic risk factors for survival were retrieved.
Results:
There were 83 patients in the group with less than 20 PLNs removed (group A), while 167 patients had 20 or more PLNs removed (group B). There was no significant difference in patients’ backgrounds between the two groups, and the rate of lymph node metastasis was not significantly different. There was a trend toward fewer pelvic recurrences in group B compared with group A (3.5% vs. 9.6%; p=0.050). Although Kaplan-Meier analysis showed no statistically significant difference in survival rates between the two groups (5-year overall survival [OS]=90.3% vs. 84.3%; p=0.199), multivariate analysis revealed that resection of 20 or more nodes is one of the independent prognostic factors (hazard ratio=0.49; 95% confidence interval=0.24–0.99; p=0.048), as well as surgical stage, high-risk histology, and advanced age for OS.
Conclusion
Resection of 20 or more PLNs was associated with improved pelvic control and better survival outcomes in EC patients at risk of recurrence who underwent pelvic lymphadenectomy alone and were treated with adjuvant chemotherapy.
4.Current treatment strategies for ovarian cancer in the East Asian Gynecologic Oncology Trial Group (EAGOT)
Yusuke KOBAYASHI ; Muneaki SHIMADA ; Masato TAMATE ; Hyun Woong CHO ; Jun ZHU ; Hung-Hsueh CHOU ; Hiroaki KAJIYAMA ; Aikou OKAMOTO ; Daisuke AOKI ; Sokbom KANG ; Jeong-Won LEE ; Jae-Weon KIM ; Jae-Hoon KIM ; Zhongqiu LIN ; Jihong LIN ; Xiaohua WU ; Hung-Cheng LAI ; Ting-Chang CHANG ; Chyong-Huey LAI ; Yong Man KIM ; Takayuki ENOMOTO
Journal of Gynecologic Oncology 2024;35(3):e87-
Ovarian cancer, notable for its severe prognosis among gynecologic cancers, has seen substantial progress in treatment approaches recently. Enhanced protocols in chemotherapy and the introduction of poly (ADP-ribose) polymerase (PARP) inhibitors for maintenance therapy have markedly improved outcomes for patients with specific genetic profiles, such as those positive for BRCA mutations or exhibiting homologous recombination deficiency (HRD). Additionally, the method of intraperitoneal chemotherapy administration has emerged as a valuable alternative to traditional transvenous routes, showing promise for wider clinical adoption. The field of surgery has also evolved, with increasing exploration into the benefits and feasibility of laparoscopic methods over more invasive traditional surgeries, aiming for complete tumor removal but with reduced patient impact. The hereditary nature of ovarian cancer underscores the importance of genetic testing, which has become integral in tailoring treatment strategies, particularly in determining suitability for PARP inhibitors.The formation of the East Asian Gynecologic Oncology Trial Group (EAGOT) aims to optimize treatment across Japan, Korea, China, and Taiwan. The ovarian cancer committee of EAGOT shared the current policies, focusing on 5 topics: 1) strategies for maintenance therapy after initial surgery and chemotherapy, 2) drug regimens for platinum-sensitive and platinum-resistant recurrence, 3) intraperitoneal chemotherapy, 4) laparoscopic surgery as an alternative to laparotomy, and 5) current status of genetic testing (BRCA, HRD, and panel tests) for ovarian cancer and its prospects. EAGOT’s multi-national trials aim to harmonize these evolving treatment strategies, ensuring that the latest and most effective protocols are accessible across the region, thereby significantly impacting patient outcomes in East Asia.
5.A phase II trial evaluating the efficacy and safety of repeated high dose medroxyprogesterone acetate (MPA) therapy for patients with recurrent early-stage endometrial cancer or atypical endometrial hyperplasia:Japanese Gynecologic Oncology Group study (JGOG2051/KGOG2031, REMPA trial)
Kensuke SAKAI ; Wataru YAMAGAMI ; Yasunori SATO ; Nobuyuki SUSUMU ; Yoshihito YOKOYAMA ; Kazuhiro TAKEHARA ; Masaki MANDAI ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e106-
Background:
Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy.
Methods
This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years.
6.A retrospective study of dose-dense paclitaxel and carboplatin plus bevacizumab as first-line treatment of advanced epithelial ovarian cancer
Hiromi KOMAZAKI ; Kazuaki TAKAHASHI ; Hiroshi TANABE ; Yuichi SHOBURU ; Misato KAMII ; Akina TSUDA ; Motoaki SAITO ; Kyosuke YAMADA ; Hirokuni TAKANO ; Hirofumi MICHIMAE ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e76-
Objective:
This study compared the effectiveness, safety, and tolerability of dose-dense paclitaxel and carboplatin plus bevacizumab (ddTC+Bev) with ddTC for advanced ovarian cancer.
Methods:
We retrospectively analyzed the clinical records of 134 patients who received ddTC+Bev or ddTC as first-line chemotherapy for stage III–IV ovarian cancer. Progressionfree survival as primary endpoint of this study was compared using the log-rank test. Cox proportional hazards model and propensity score matching (PSM) were used to analyze prognostic factors, and the frequency of adverse events was examined using the χ 2 test.
Results:
We categorized 134 patients in the ddTC+Bev (n=57) and ddTC (n=77) groups who started treatment at four related institutions from November 2013 to December 2017.No patients used poly (ADP-ribose) polymerase inhibitors as the first line maintenance therapy. The progression-free survival (PFS) of the ddTC+Bev group had a significantly better prognosis than that of the ddTC group (hazard ratio [HR]=0.50; 95% confidence interval [CI]=0.32–0.79; p<0.003). Multivariate analysis showed that ddTC+Bev regimen was a prognostic factor. However, intergroup comparison using PSM revealed that the PFS of the ddTC+Bev group had a nonsignificantly better prognosis than that of the ddTC group (HR=0.70; 95% CI=0.41–1.20; p=0.189). Few adverse events above G3 were noted for ddTC+Bev, which were sufficiently tolerable.
Conclusion
This study could not demonstrate that adding Bev to ddTC improves prognosis.Further studies with more cases are warranted.
7.Niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer: final results of a multicenter phase 2 study
Daisuke AOKI ; Tsutomu TABATA ; Satoshi YANAGIDA ; Toshiaki NAKAMURA ; Eiji KONDO ; Junzo HAMANISHI ; Kenichi HARANO ; Kosei HASEGAWA ; Takeshi HIRASAWA ; Kensuke HORI ; Shinichi KOMIYAMA ; Motoki MATSUURA ; Hidekatsu NAKAI ; Hiroko NAKAMURA ; Jun SAKATA ; Kazuhiro TAKEHARA ; Munetaka TAKEKUMA ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Junpei SOEDA ; Ai KATO ; Ajit SURI ; Aikou OKAMOTO ; Toru SUGIYAMA
Journal of Gynecologic Oncology 2024;35(5):e114-
Objective:
To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer.
Methods:
This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs).
Results:
20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively.
Conclusion
The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.
8.Cost-effectiveness analysis of hospital treatment volume and survival outcomes in endometrial cancer in Japan
Hiroko MACHIDA ; Koji MATSUO ; Takahiro HIGASHI ; Daisuke AOKI ; Takayuki ENOMOTO ; Aikou OKAMOTO ; Hidetaka KATABUCHI ; Satoru NAGASE ; Masaki MANDAI ; Nobuo YAEGASHI ; Wataru YAMAGAMI ; Mikio MIKAMI
Journal of Gynecologic Oncology 2024;35(5):e61-
Objective:
Hospital treatment volume affects survival in patients with endometrial cancer;notably, initial treatment at high-volume centers improves survival outcomes. Our study assessed the effect of hospital treatment volume on cost-effectiveness and survival outcomes in patients with endometrial cancer in Japan.
Methods:
A decision-analytic model was evaluated using the following variables and their impact on cost-effectiveness: 1) hospital treatment volume (low-, intermediate-, and highvolume centers) and 2) postoperative recurrent risk factors based on pathological findings (high- and intermediate-risk or low-risk). Data were obtained from the Japan Society of Obstetrics and Gynecology database, systematic literature searches, and the Japanese Diagnosis Procedure Combination database. Quality-adjusted life years (QALY) was used as a measure of effectiveness. The model was built from a public healthcare perspective and the impact of uncertainty was assessed using sensitivity analyses.
Results:
A base-case analysis showed that the incremental cost-effectiveness ratio at high-volume centers was below a willingness-to-pay (WTP) threshold of ¥5,000,000with a maximum of ¥3,777,830/4.28 QALY for the high- and intermediate-risk group, and ¥2,316,695/4.57 QALY for the low-risk group. Treatment at the high-volume centers showed better efficiency and cost-effectiveness in both strategies compared to intermediate- or lowvolume centers. Sensitivity analyses showed that the model outcome was robust to changes in input values. With the WTP threshold, treatment at high-volume centers remained cost-effective in at least 73.6% and 78.2% of iterations for high- and intermediate-risk, and lowrisk groups, respectively.
Conclusion
Treatment at high-volume centers is the most cost-effective strategy for guiding treatment centralization in patients with endometrial cancer.
9.Current treatment strategies for ovarian cancer in the East Asian Gynecologic Oncology Trial Group (EAGOT)
Yusuke KOBAYASHI ; Muneaki SHIMADA ; Masato TAMATE ; Hyun Woong CHO ; Jun ZHU ; Hung-Hsueh CHOU ; Hiroaki KAJIYAMA ; Aikou OKAMOTO ; Daisuke AOKI ; Sokbom KANG ; Jeong-Won LEE ; Jae-Weon KIM ; Jae-Hoon KIM ; Zhongqiu LIN ; Jihong LIN ; Xiaohua WU ; Hung-Cheng LAI ; Ting-Chang CHANG ; Chyong-Huey LAI ; Yong Man KIM ; Takayuki ENOMOTO
Journal of Gynecologic Oncology 2024;35(3):e87-
Ovarian cancer, notable for its severe prognosis among gynecologic cancers, has seen substantial progress in treatment approaches recently. Enhanced protocols in chemotherapy and the introduction of poly (ADP-ribose) polymerase (PARP) inhibitors for maintenance therapy have markedly improved outcomes for patients with specific genetic profiles, such as those positive for BRCA mutations or exhibiting homologous recombination deficiency (HRD). Additionally, the method of intraperitoneal chemotherapy administration has emerged as a valuable alternative to traditional transvenous routes, showing promise for wider clinical adoption. The field of surgery has also evolved, with increasing exploration into the benefits and feasibility of laparoscopic methods over more invasive traditional surgeries, aiming for complete tumor removal but with reduced patient impact. The hereditary nature of ovarian cancer underscores the importance of genetic testing, which has become integral in tailoring treatment strategies, particularly in determining suitability for PARP inhibitors.The formation of the East Asian Gynecologic Oncology Trial Group (EAGOT) aims to optimize treatment across Japan, Korea, China, and Taiwan. The ovarian cancer committee of EAGOT shared the current policies, focusing on 5 topics: 1) strategies for maintenance therapy after initial surgery and chemotherapy, 2) drug regimens for platinum-sensitive and platinum-resistant recurrence, 3) intraperitoneal chemotherapy, 4) laparoscopic surgery as an alternative to laparotomy, and 5) current status of genetic testing (BRCA, HRD, and panel tests) for ovarian cancer and its prospects. EAGOT’s multi-national trials aim to harmonize these evolving treatment strategies, ensuring that the latest and most effective protocols are accessible across the region, thereby significantly impacting patient outcomes in East Asia.
10.A phase II trial evaluating the efficacy and safety of repeated high dose medroxyprogesterone acetate (MPA) therapy for patients with recurrent early-stage endometrial cancer or atypical endometrial hyperplasia:Japanese Gynecologic Oncology Group study (JGOG2051/KGOG2031, REMPA trial)
Kensuke SAKAI ; Wataru YAMAGAMI ; Yasunori SATO ; Nobuyuki SUSUMU ; Yoshihito YOKOYAMA ; Kazuhiro TAKEHARA ; Masaki MANDAI ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e106-
Background:
Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy.
Methods
This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years.

Result Analysis
Print
Save
E-mail