1.Results of a Survey on Clinical Competence to Be Evaluated by the National Physicians' License Examination.
Takao MORITA ; Masahiko HATAO ; Takeshi Aso ; Kensuke HARADA ; Nobuya HASHIMOTO ; Kimitaka KAGA ; Shunzo KOIZUMI ; Kei MATSUEDA ; Makiko OSAWA ; Toshikazu SAITO ; Hiroyuki TOYOKAWA ; Tsukasa TSUDA ; Motokazu HORI
Medical Education 1999;30(6):405-412
The clinical competence needed by every beginning resident and the present status of such competencewere examined in August 1998 through questionnaires distributed to clinical educators and the nursing staff of university hospitals and clinical training hospitals designated by the Ministry of Health and Welfare. Completed questionnaires were returned by 576 (65.9%) of clinical educators and nursing staff. With a cluster analysis of the necessity and the present status of clinical competence, 21 items for clinical competence were identified as those most requiring evaluation by the national examination. These 21 items included 11 items for clinical competence in the cognitive domain, 8 items in the psychomotor domain, and 2 in the affective domain. In about half of the direct answers obtained from clinical educators, evaluations were considered necessary for 15 items of clinical competence, of which 13 belonged to the cognitive domain. These results were consistent with the present status. However, practical examinations have also attracted increasing attention, as the results included strong demands that the national examination evaluate some basic clinical skills, such as physical examination and measurement of vital signs. However, about 30 % of authorities governing the national examination thought no changes are needed in the national examination.
2.A phase II, open-labeled, single-arm study of dose-dense paclitaxel plus carboplatin in advanced or recurrent uterine endometrial cancer treatment: a KCOG-G1303, DOENCA trial
Kensuke HORI ; Shin NISHIO ; Kimio USHIJIMA ; Yuka KASAMATSU ; Eiji KONDO ; Kazuhiro TAKEHARA ; Kimihiko ITO
Journal of Gynecologic Oncology 2021;32(4):e64-
Objective:
To determine the safety and efficacy of dose-dense (dd) paclitaxel (PTX) and carboplatin (CBDCA) in treating advanced or recurrent endometrial cancer.
Methods:
Women aged 20–75 years with histologically confirmed endometrial cancer, the International Federation of Gynecology and Obstetrics (FIGO) stage III disease with some residual tumor, FIGO stage IV disease, recurrence after front-line curative treatment, or recurrence after second-line chemotherapy or radiotherapy were enrolled in this study. PTX (80 mg/m2) was administered intravenously (IV) to every participant on days 1, 8, and 15, and CBDCA (area under the curve of 5) was administered IV on day 1 once every 3 weeks until the disease progressed, unacceptable adverse events occurred, or consent was withdrawn. The primary endpoint was the response rate (RR), while the secondary endpoints were progression-free survival, overall survival, and adverse effects.
Results:
Forty-eight participants were enrolled, and 46 were eligible to receive treatment. The patients' median age was 61 years (range, 43–76 years). Twenty-two participants had experienced recurrence, and the remaining patients had primary advanced endometrial cancer. There were 10 cases of serous carcinoma, 3 cases of endometrioid carcinoma G3, 2 cases of carcinosarcoma, and 2 cases of clear-cell carcinoma according to histology. Twenty-nine participants (63.0%) received ≥6 cycles of chemotherapy. The RR (complete, 13 cases; partial, 20 cases) was 71.3% (95% confidence interval: 59.0%–84.5%).
Conclusion
The dd PTX with CBDCA is feasible and available as a treatment option for advanced or recurrent endometrial cancer.
3.Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer
Aikou OKAMOTO ; Eiji KONDO ; Toshiaki NAKAMURA ; Satoshi YANAGIDA ; Junzo HAMANISHI ; Kenichi HARANO ; Kosei HASEGAWA ; Takeshi HIRASAWA ; Kensuke HORI ; Shinichi KOMIYAMA ; Motoki MATSUURA ; Hidekatsu NAKAI ; Hiroko NAKAMURA ; Jun SAKATA ; Tsutomu TABATA ; Kazuhiro TAKEHARA ; Munetaka TAKEKUMA ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Junpei SOEDA ; Ajit SURI ; Daisuke AOKI ; Toru SUGIYAMA
Journal of Gynecologic Oncology 2021;32(2):e16-
Objective:
To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer.
Methods:
This Phase 2 open-label, single-arm study enrolled Japanese women with homologous recombination deficiency-positive relapsed, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-emergent adverse events (TEAEs), including serious TEAEs.
Results:
Twenty women were enrolled and the confirmed ORR in the full analysis set (FAS) was 35.0% (7/20), consisting of 1 complete response and 6 partial responses. Disease control rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) were anemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leading to discontinuation of niraparib whereas reductions or interruptions were reported in 14 (70.0%) and 15 (75.0%) patients, respectively. The median dose intensity (202.9 mg daily) corresponded to a relative dose intensity of 67.6%.
Conclusion
Efficacy and safety of niraparib in heavily pretreated Japanese women was comparable to that seen in an equivalent population of non-Japanese women. No new safety signals were identified.