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Keiichi Fujiwara,Hiroyuki Fujiwara,Hiroyuki Yoshida,Toyomi Satoh,Kan Yonemori,Shoji Nagao,Takashi Matsumoto,Hiroaki Kobayashi,Hughes Bourgeois,Philipp Harter,Anna Maria Mosconi,Isabel Palacio Vazquez 대한부인종양학회 2021 Journal of Gynecologic Oncology Vol.32 No.5
Objective: The addition of maintenance olaparib to bevacizumab demonstrated a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1/ENGOT-ov25 trial (NCT02477644). We evaluated maintenance olaparib plus bevacizumab in the Japan subset of PAOLA-1. Methods: PAOLA-1 was a randomized, double-blind, phase III trial. Patients received maintenance olaparib tablets 300 mg twice daily or placebo twice daily for up to 24 months, plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total. This prespecified subgroup analysis evaluated investigator-assessed PFS (primary endpoint). Results: Of 24 randomized Japanese patients, 15 were assigned to olaparib and 9 to placebo. After a median follow-up for PFS of 27.7 months for olaparib plus bevacizumab and 24.0 months for placebo plus bevacizumab, median PFS was 27.4 versus 19.4 months, respectively (hazard ratio [HR]=0.34; 95% confidence interval [CI]=0.11–1.00). In patients with tumors positive for homologous recombination deficiency, the HR for PFS was 0.57 (95% CI=0.16–2.09). Adverse events in the Japan subset were generally consistent with those of the PAOLA-1 overall population and with the established safety and tolerability profiles of olaparib and bevacizumab. Conclusion: Results in the Japan subset of PAOLA-1 support the overall conclusion of the PAOLA-1 trial demonstrating that the addition of maintenance olaparib to bevacizumab provides a PFS benefit in patients with newly diagnosed, advanced ovarian cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02477644
Kan Yonemori,Keiichi Fujiwara,Kosei Hasegawa,Mayu Yunokawa,Kimio Ushijima,Shiro Suzuki,Ayumi Shikama,Shinichiro Minobe,Tomoka Usami,김재원,김병기,Peng-Hui Wang,Ting-Chang Chang,Keiko Yamamoto,Shirong Han,Jo 대한부인종양학회 2024 Journal of Gynecologic Oncology Vol.35 No.2
Objective: In the global phase 3 Study 309/KEYNOTE-775 (NCT03517449) at the first interimanalysis, lenvatinib+pembrolizumab significantly improved progression-free sur vival (PFS),overall sur vival (OS), and objective response rate (ORR) versus treatment of physician’schoice chemotherapy (TPC) in patients with previously treated advanced/recurrentendometrial cancer (EC). This explorator y analysis evaluated outcomes in patients enrolledin East Asia at the time of prespecified final analysis. Methods: Women ≥18 years with histologically confirmed advanced, recurrent, or metastaticEC with progressive disease after 1 platinum-based chemotherapy (2 if 1 given in neoadjuvant/adjuvant setting) were enrolled. Patients were randomized 1:1 to lenvatinib 20 mg orallyonce daily plus pembrolizumab 200 mg intravenously ever y 3 weeks (≤35 cycles) or TPC(doxorubicin or paclitaxel). Primar y endpoints were PFS per RECIST v1.1 by blindedindependent central review and OS. No alpha was assigned for this subgroup analysis. Results: Among 155 East Asian patients (lenvatinib+pembrolizumab, n=77; TPC, n=78),median follow-up time (data cutoff: March 1, 2022) was 34.3 (range, 25.1–43.0) months. Hazard ratios (HRs) with 95% confidence inter vals (CIs) for PFS (lenvatinib+pembrolizumabvs. TPC) were 0.74 (0.49–1.10) and 0.64 (0.44–0.94) in the mismatch repair proficient(pMMR) and all-comer populations, respectively. HRs (95% CI) for OS were 0.68 (0.45–1.02)and 0.61 (0.41–0.90), respectively. ORRs were 36% with lenvatinib+pembrolizumab and 22%with TPC (pMMR) and 39% and 21%, respectively (all-comers). Treatment-related adverseevents occurred in 97% and 96% (grade 3–5, 74% and 72%), respectively. Conclusion: Lenvatinib+pembrolizumab provided clinically meaningful benefit withmanageable safety compared with TPC, supporting its use in East Asian patients withpreviously treated advanced/recurrent EC. Trial Registration: ClinicalTrials.gov Identifier: NCT03517449
Multi-step Metamagnetic Processes of PrPd2Si2 Single Crystal
Toru Shigeoka,Tetsuya Fujiwara,Keiichi Koyama,Shojiro Kimura,Kazuo Watanabe 한국물리학회 2013 THE JOURNAL OF THE KOREAN PHYSICAL SOCIETY Vol.63 No.3
Magnetic studies were performed on PrPd2Si2 single crystals which crystallize in the tetragonalThCr2Si2-type structure. The temperature dependence of the magnetic susceptibility indicates thatthe compound orders antiferromagnetically at temperatures below TN = 3.2 K. The transition wasconfirmed by specific heat measurements. Magnetization measurements at fields up to 18 T showthat the easy magnetization direction is the [100] direction in the basal plane. In the magnetizationprocess, five or four metamagnetic transitions appear; the process is a five (four)-step metamagneticone. The [110] magnetization process is a three-step one. A strong magnetic anisotropy betweenthe [100] and [110] directions is observed within the basal plane for high magnetic fields. Alongthe hard magnetization direction of the c-axis, a metamagnetic transition appears. The B[100] − Tphase diagram was constructed. A magnetic anisotropy between the [100] and [001] directions isalso strong. These behaviors are discussed based on an analysis of crystalline field effects.
Aiko Ogasawara,Taro Hihara,Daisuke Shintani,Akira Yabuno,Yuji Ikeda,Kenji Tai,Keiichi Fujiwara,Keisuke Watanabe,Kosei Hasegawa 대한암학회 2020 Cancer Research and Treatment Vol.52 No.4
Purpose Circulating tumor DNA (ctDNA) is an attractive source for liquid biopsy to understand molecular phenotypes of a tumor non-invasively, which is also expected to be both a diagnostic and prognostic marker. PIK3CA and KRAS are among the most frequently mutated genes in epithelial ovarian cancer (EOC). In addition, their hotspot mutations have already been identified and are ready for a highly sensitive analysis. Our aim is to clarify the significance of PIK3CA and KRAS mutations in the plasma of EOC patients as tumor-informed ctDNA. Materials and Methods We screened 306 patients with ovarian tumors for somatic PIK3CA or KRAS mutations. A total of 85 EOC patients had somatic PIK3CA and/or KRAS mutations, and the correspon-ding mutations were subsequently analyzed using a droplet digital polymerase chain reaction in their plasma. Results The detection rates for ctDNA were 27% in EOC patients. Advanced stage and positive peritoneal cytology were associated with higher frequency of ctDNA detection. Preoperative ctDNA detection was found to be an indicator of outcomes, and multivariate analysis revealed that ctDNA remained an independent risk factor for recurrence (p=0.010). Moreover, we assessed the mutation frequency in matched plasma before surgery and at recurrence from 17 patients, and found six patients had higher mutation rates in cell-free DNA at recurrence compared to that at primary diagnosis. Conclusion The presence of ctDNA at diagnosis was an indicator for recurrence, which suggests potential tumor spread even when tumors were localized at the time of diagnosis.
Takashi Motohashi,Akira Yabuno,Hiroshi Michimae,Tetsuro Ohishi,Miwa Nonaka,Masashi Takano,Shin Nishio,Hiroyuki Fujiwara,Keiichi Fujiwara,Eiji Kondo,Toru Sugiyama,Tsutomu Tabata 대한부인종양학회 2021 Journal of Gynecologic Oncology Vol.32 No.1
Objective: The standard dose for pegylated liposomal doxorubicin (PLD) is 50 mg/m2every 4weeks. While 40 mg/m2has recently been used in clinical practice, evidence supporting thisuse remains lacking. Methods: This phase III randomized, non-inferiority study compared progression free survival (PFS) for patients with platinum-resistant ovarian carcinoma between anexperimental arm (40 mg/m2PLD) and a standard arm (50 mg/m2PLD) until 10 courses,disease progression or unacceptable toxicity. Eligible patients had received ≤2 prior lines. Stratification was by performance status and PFS of prior chemotherapy (<3 months versus ≥3months). The primary endpoint was PFS and secondary endpoints were overall survival (OS),toxicity profile, clinical response and tolerability. The total number of patients was 470. Results: The trial was prematurely closed due to slow recruitment, with 272 patients randomizedto the experimental arm (n=137) and standard arm (n=135). Final analysis was performed with234 deaths and 269 events for PFS. In the experimental arm vs. standard arm, median PFS was4.0 months vs. 4.0 months (hazard ratio [HR]=1.065; 95% confidence interval [CI]=0.830–1.366)and median OS was 14.0 months vs. 14.0 months (HR=1.078; 95% CI=0.831–1.397). Hematologictoxicity and oral cavity mucositis (≥grade 2) were more frequent in the standard arm than in theexperimental arm, but no difference was seen in ≥grade 2 hand-foot skin reaction. Conclusion: Non-inferiority of 2 PLD dosing schedule was not confirmed because the trialwas closed prematurely. However, recommendation of dose reduction of PLD should bebased both on efficacy and safety. Trial Registration: UMIN Clinical Trials Registry Identifier: UMIN000003130