1.Impact of Extra-Corporeal Membrane Oxygenation and Blood Purification Therapy on Early Mobilization in the Intensive Care Unit: Retrospective Cohort Study
Shinichi WATANABE ; Yuki IIDA ; Jun HIRASAWA ; Yuji NAITO ; Motoki MIZUTANI ; Akihiro UEMURA ; Shogo NISHIMURA ; Keisuke SUZUKI ; Yasunari MORITA
Annals of Rehabilitation Medicine 2023;47(3):173-181
Objective:
To investigate the effect on early mobilization in patients undergoing extra-corporeal membrane oxygenation (ECMO) and acute blood purification therapy in the intensive care unit (ICU).
Methods:
We conducted this multicenter retrospective cohort study by collecting data from six ICUs in Japan. Consecutive patients who were admitted to the ICU, aged ≥18 years, and received mechanical ventilation for >48 hours were eligible. The analyzed were divided into two groups: ECMO/blood purification or control group. Clinical outcomes; time to first mobilization, number of total ICU rehabilitations, mean and highest ICU mobility scale (IMS); and daily barrier changes were also investigated.
Results:
A total of 204 patients were included in the analysis, 43 in the ECMO/blood purification group and 161 in the control group. In comparison of clinical outcome, the ECMO/blood purification group had a significantly longer time to first mobilization: ECMO/blood purification group 6 vs. control group 4 (p=0.003), higher number of total ICU rehabilitations: 6 vs. 5 (p=0.042), lower mean: 0 vs. 1 (p=0.043) and highest IMS: 2 vs. 3 (p=0.039) during ICU stay. Circulatory factor were most frequently described as barriers to early mobilization on days 1 (51%), 2 (47%), and 3 (26%). On days 4 to 7, the most frequently described barrier was consciousness factors (21%, 16%, 19%, and 21%, respectively)
Conclusion
The results of this study comparing the ECMO/blood purification group and the untreated group in the ICU showed that the ECMO/blood purification group had significantly longer days to mobilization and significantly lower mean and highest IMS.
2.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.