1.Laparoscopic versus open partial hepatectomy for hepatocellular carcinoma in F4 cirrhosis: A propensity score-matched study of perioperative safety
Hiroaki SUGITA ; Shinichi NAKANUMA ; Tomokazu TOKORO ; Ryohei TAKEI ; Mitsuyoshi OKAZAKI ; Kaichiro KATO ; Satoshi TAKADA ; Isamu MAKINO ; Shintaro YAGI
Annals of Hepato-Biliary-Pancreatic Surgery 2026;30(2):178-185
Background:
s/Aims: Patients with hepatocellular carcinoma (HCC) and histologically confirmed F4 cirrhosis often have limited hepatic reserve, making major hepatectomy difficult. Although laparoscopic liver resection is increasingly performed, its perioperative safety in this setting remains unclear. This study compared laparoscopic and open partial hepatectomy in these patients using propensity score matching (PSM).
Methods:
Among 298 patients who underwent hepatectomy for HCC between 2006 and 2023, 112 with histologically confirmed F4 cirrhosis who underwent partial hepatectomy were included (laparoscopic, n = 60; open, n = 52). PSM was performed using previous liver resection, difficulty score, tumor size, tumor number, and platelet count, yielding 32 matched pairs. Outcomes included operative time, blood loss, transfusion requirements, complications, hospital stay, posthepatectomy liver failure (PHLF), R0 resection rate, and 30-day mortality.
Results:
After matching, intraoperative blood loss was significantly lower in the laparoscopic group than in the open group (50 mL vs. 295 mL, p < 0.001). Operative time, transfusion rate, complication rate, R0 resection rate, and 30-day mortality were comparable between groups. Hospital stay was significantly shorter in the laparoscopic group (13 vs. 22 days, p < 0.001). Grade A PHLF occurred in one patient in the open group, with no significant between-group difference.
Conclusions
In patients with HCC and histologically confirmed F4 cirrhosis, laparoscopic partial hepatectomy was associated with less blood loss and shorter hospital stay than open surgery, without increasing perioperative morbidity. It may be a safe option in carefully selected patients undergoing limited liver resection.
2.Two Cases of Insomnia Using the Kampo Medicine in which the Therapeutic Effect was Confirmed by Sleep test
Sachie ARIMA ; Takeshi SUGIURA ; Rina KATO ; Sachiyo KATSUMI ; Shinichi ESAKI ; Shintaro SATO ; Shinichi IWASAKI
Kampo Medicine 2024;75(1):66-74
We report two cases in which insomnia successfully treated with sansoninto alone or in combination and the effectiveness could be objectively evaluated with the portable sleep test. Case 1 was 40-year-old man who had suffered from arousal during sleep and daytime fatigue for several years. After taking sansoninto with ninjinto, his symptoms improved. Case 2 was 60-year-old woman who had suffered from a lack of deep sleep and daytime sleepiness. After taking sansoninto, she could get a deep sleep and could have less daytime sleepiness. In this report, we present that portable sleep test conducted before and after treatment confirmed that sleep quality improved. Sansoninto is one of the curative medicines for insomnia, but we believe this is the first report showing objective therapeutic effects using portable sleep test.
3.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.
4.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.
5.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.
7.Factors Affecting Incomplete L5/S Posterior Lumbar Interbody Fusion, Including Spinopelvic Sagittal Parameters
Shinichi KATO ; Nobuki TERADA ; Osamu NIWA ; Mitsuko YAMADA
Asian Spine Journal 2022;16(4):526-533
Methods:
We observed 141 patients (61 men, 80 women; average age, 65.8 years) who had undergone PLIF and checked for the presence of L5/S interbody fusion. We investigated factors such as age, gender, the presence of diffuse idiopathic skeletal hyperostosis (DISH), fusion level, and grade 2 osteotomy, as well as pre-, post-, and post−preoperative L5/S disk height and angle, lumbar lordosis, Visual Analog Scale (VAS) score, Japanese Orthopaedic Association (JOA) score, and pelvic incidence (PI), comparing those with and without L5/S interbody fusion. In addition, we analyzed the patients classified into short-level (n=111) and multi-level fusion groups (n=30).
Results:
Overall, the L5/S interbody fusion rate was 70% (short-level, 78%; multi-level, 40%). Age and pre- and post−preoperative L5/S disk angle were significantly different in each fusion level group. DISH presence, grade 2 osteotomy, and postoperative VAS and JOA scores were significantly different in the short-level fusion group, whereas PI was significantly different in the multi-level fusion group.
Conclusions
Incomplete union after L5/S PLIF correlates with advanced age, many fusion levels, and a large value of preoperative and a small value of post−preoperative L5/S disk angles.
8.Risk Factors Affecting Cage Retropulsion into the Spinal Canal Following Posterior Lumbar Interbody Fusion: Association with Diffuse Idiopathic Skeletal Hyperostosis
Shinichi KATO ; Nobuki TERADA ; Osamu NIWA ; Mitsuko YAMADA
Asian Spine Journal 2021;15(6):840-848
Methods:
A total of 400 patients (175 men, 225 women) who underwent PLIF were observed for >1 year. Factors investigated included the frequency of cage retropulsion and surgical revision. In addition, physical (age, sex, disease), surgical (fusion and PLIF levels, cage number, grade 2 osteotomy), and comorbid (DISH, existing vertebral fracture) factors were compared between patients with and without cage retropulsion. Factors related to surgical revision during the observation period were also considered.
Results:
Cage retropulsion occurred in 15 patients and surgical revision was performed in 11. Revisions included the replacement of pedicle screws (PSs) with larger screws in all patients and supplementary implants in 10. Among the patients with cage retropulsion, the average PLIF level was 2.7, with DISH present in nine patients and existing vertebral fractures in six. Factors affecting cage retropulsion were diagnoses of osteoporotic vertebral fracture, multilevel fusion, single-cage insertion, grade 2 osteotomy, presence of DISH, and existing vertebral fracture. Multivariable analysis indicated that retropulsion of a fusion cage occurred significantly more frequently in patients with DISH and multilevel PLIF.
Conclusions
DISH and multilevel PLIF were significant risk factors affecting cage retropulsion. Revision surgery for cage retropulsion revealed PS loosening, suggesting that implant replacement was necessary to prevent repeat cage retropulsion after revision.
9.Tailored-dose chemotherapy with gemcitabine and irinotecan in patients with platinum-refractory/resistant ovarian or primary peritoneal cancer: a phase II trial
Shinichi TATE ; Kyoko NISHIKIMI ; Ayumu MATSUOKA ; Satoyo OTSUKA ; Kazuyoshi KATO ; Yutaka TAKAHASHI ; Makio SHOZU
Journal of Gynecologic Oncology 2021;32(1):e8-
Objective:
We investigated the efficacy and toxicity of tailored-dose chemotherapy with gemcitabine and irinotecan for platinum-refractory/resistant ovarian or primary peritoneal cancer.
Methods:
We enrolled patients with ovarian or primary peritoneal cancer who received ≥2 previous chemotherapeutic regimens but developed progressive disease during platinumbased chemotherapy or within 6 months post-treatment. All patients received gemcitabine (500 mg/m 2 ) and irinotecan (50 mg/m 2 ) on days 1 and 8 every 21 days at the starting dose. The dose was increased or decreased by 4 levels in subsequent cycles based on hematological or non-hematological toxicities observed. The primary endpoint was progression-free survival (PFS), and secondary endpoints were disease control rate (DCR), overall survival (OS), and adverse events.
Results:
We investigated 25 patients who received 267 cycles (median 8 cycles/patient) between October 2008 and May 2011. Tailored-dose gemcitabine was administered up to the 5th cycle as follows: 1,000 mg/m 2 in 1 (4%), 750 mg/m 2 in 16 (64%), 500 mg/m 2 in 6 (24%), and 250 mg/m 2 in 2 patients (8%). The median PFS and OS were 6.2 months (95% confidence interval [CI]=2.7–10.7) and 16.8 months (95% CI=9.4–30.7), respectively. The DCR was 76%, and PFS was >6 months in 12 of 25 patients (48%). Grade 3 hematological toxicities included leukopenia (9.4%), neutropenia (11.2%), anemia (9.8%), and thrombocytopenia (1.1%).Grade 3/4 non-hematological toxicities did not occur except for fatigue in one patient.
Conclusions
Tailored-dose chemotherapy with gemcitabine and irinotecan was effective and well tolerated in patients with platinum-refractory/resistant ovarian or primary peritoneal cancer.


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