1.Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for newly diagnosed advanced or recurrent endometrial cancer: Japan subset from the phase III DUO-E trial
Shin NISHIO ; Tadaaki NISHIKAWA ; Masahiko MORI ; Shoji KAMIURA ; Toshiyuki SUMI ; Mayu YUNOKAWA ; Yuichi IMAI ; Eiji KONDO ; Kazuhiro TAKEHARA ; Hirokuni TAKANO ; Wataru KUDAKA ; Nobuhiro KADO ; Wataru YAMAGAMI ; Hidenori KATO ; Koji NISHINO ; Tomoka USAMI ; Junzo HAMANISHI ; Masahiro NII ; Itsumi TAKAYA ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2025;36(4):e118-
Objective:
DUO-E/GOG-3041/ENGOT-EN10 (NCT04269200) demonstrated statistically significant and clinically meaningful progression-free survival (PFS) improvement with durvalumab plus carboplatin/paclitaxel, followed by durvalumab with or without olaparib, vs. carboplatin/paclitaxel alone (intention-to-treat [ITT] population) in patients with newly diagnosed advanced or recurrent endometrial cancer. We evaluated efficacy and safety in the Japan subset of DUO-E.
Methods:
Patients with newly diagnosed International Federation of Gynecology and Obstetrics stage III/IV or recurrent endometrial cancer were randomized 1:1:1 to control arm (carboplatin/paclitaxel + durvalumab placebo [6 cycles] followed by durvalumab placebo + olaparib placebo), durvalumab arm (carboplatin/paclitaxel + durvalumab [1,120 mg every 3 weeks] [6 cycles] followed by durvalumab [1,500 mg every 4 weeks] + olaparib placebo), or durvalumab + olaparib arm (carboplatin/paclitaxel + durvalumab [6 cycles] followed by durvalumab + olaparib [300 mg twice a day]). Dual primary endpoints were investigatorassessed PFS for durvalumab and durvalumab + olaparib arms vs. control. This prespecified exploratory analysis evaluated PFS and safety in the Japan subset.
Results:
In the Japan subset (n=88) PFS favored durvalumab (hazard ratio=0.61, 95% confidence interval [CI]=0.32–1.12) and durvalumab + olaparib (0.44, 95% CI=0.22–0.85) vs. control; median PFS was 9.9 and 15.1 vs. 9.5 months, and the 18-month PFS rate was 37.0% and 42.1% vs. 22.2%, respectively. The safety profile in the Japan subset was generally consistent with the full safety analysis set and the established profiles of the individual agents.
Conclusion
Efficacy and safety in the Japan subset were generally consistent with outcomes in the DUO-E ITT population. This Japanese subset analysis of DUO-E supports carboplatin/ paclitaxel + durvalumab followed by durvalumab with or without olaparib as new treatment options in patients with advanced or recurrent endometrial cancer and is the first to report on these regimens in Japanese patients alone.
2.The post-progression survival of patients with recurrent or persistent ovarian clear cell carcinoma: results from a randomized phase III study in JGOG3017/GCIG
Eiji KONDO ; Tsutomu TABATA ; Nao SUZUKI ; Daisuke AOKI ; Hideaki YAHATA ; Yoshio KOTERA ; Osamu TOKUYAMA ; Keiichi FUJIWARA ; Eizo KIMURA ; Fumitoshi TERAUCHI ; Toshiyuki SUMI ; Aikou OKAMOTO ; Nobuo YAEGASHI ; Takayuki ENOMOTO ; Toru SUGIYAMA
Journal of Gynecologic Oncology 2020;31(6):e94-
Objective:
In this study we sought to investigate the clinical factors that affect postprogression survival (PPS) in patients with recurrent or persistent clear cell carcinoma (CCC).We utilized the JGOG3017/Gynecological Cancer InterGroup data to compare paclitaxel plus carboplatin (TC) and irinotecan plus cisplatin (CPT-P) in the treatment of stages I to IV CCC.
Methods:
We enrolled 166 patients with recurrent or persistent CCC and assessed the impact of variables, including platinum sensitivity, treatment arm, crossover chemotherapy, primary stage, residual tumor at primary surgery, performance status, ethnicity, and tumor reduction surgery at recurrence on the median of PPS in patients with recurrent or persistent CCC.
Results:
A total of 77 patients received TC, and 89 patients received CPT-P. The median PPS for patients with platinum-resistant disease was 10.9 months, compared with 18.8 months for patients with platinum-sensitive disease (hazard ratio [HR]=1.88; 95% confidence interval [CI]=1.30–2.72; log-rank p<0.001). In the multivariate analysis, the platinum sensitivity (resistant vs. sensitivity; HR=1.60; p=0.027) and primary stage (p=0.009) were identified as independent predictors of prognosis factors for PPS in recurrent or persistent CCC.
Conclusions
Our findings revealed that platinum sensitivity and primary stage are clinical factors that significantly affect PPS in patients with recurrent or persistent CCC as wellas other histologic subtypes of ovarian cancer. PPS in patients with recurrent CCC should establish the basis for future clinical trials in this population.
3.Lung Metastasis of Renal Cell Carcinoma Extended into the Left Atrium
Shun Nakaji ; Koji Hashizume ; Tsuneo Ariyoshi ; Yoichi Hisada ; Kazuyoshi Tanigawa ; Takashi Miura ; Seiji Matsukuma ; Mizuki Sumi ; Toshiyuki Nakayama ; Kiyoyuki Eishi
Japanese Journal of Cardiovascular Surgery 2013;42(2):145-147
We report an extremely rare case of renal cell carcinoma (RCC) extending into the left atrium through the pulmonary vein next to lung metastasis. The patient was a 76-year-old man. Extirpation of the RCC in the right kidney was carried out. Metastasis to the lungs, mediastinal lymph nodes and the pubis were diagnosed and 4 years later, a myxoma-like tumor was formed in the left atrium by echocardiography. We extirpated of the tumor. During surgery, continuity with the metastatic lesion in the right lung, right inferior pulmonary vein and the left atrium was suggested. Histopathologic examination showed the same histopathology as seen in the RCC.


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