1.A Systematic Review and Meta-Analysis of Systemic Corticosteroids for the Palliation of Dyspnea in Patients with Cancer
Kozue SUZUKI ; Hideki KATAYAMA ; Hiroyuki KOHARA ; Yoshinobu MATSUDA ; Sho GOYA ; Jun KAKO ; Yoko KASAHARA ; Masanori MORI ; Takeo NAKAYAMA ; Hiroaki WATANABE ; Takashi YAMAGUCHI
Palliative Care Research 2025;20(2):95-102
Objective: Almost half of all patients with cancer experience dyspnea, which can have various causes. Although systemic corticosteroids are administered to relieve symptoms, their efficacy has not been established. This systematic review aims to determine the efficacy of systemic corticosteroids for dyspnea in patients with cancer. Methods: CENTRAL, MEDLINE, EMBASE, and Ichushi-Web databases were searched for articles published from their inception to September 23, 2019, on studies of systemic corticosteroid administration for dyspnea in patients with cancer. The primary outcome measure was dyspnea intensity, as assessed by patient-reported outcomes. Secondary outcome measures were quality of life, delirium, and severe adverse events. Results: Two RCTs were included in the meta-analysis. With regard to alleviating dyspnea, the systematic corticosteroid group was associated with significantly greater dyspnea relief than the placebo group (mean difference: −0.71 [95% CI: −1.4 to −0.03]). However, a meta-analysis of quality of life and delirium could not be performed due to insufficient data. Analysis of severe adverse events showed no significant difference in their incidence between the corticosteroid and control groups (relative rate: 0.96 [95% CI: 0.19-4.93]). Conclusions: Systemic corticosteroids may be effective in treating dyspnea in patients with cancer, particularly those with lung involvement. Limiting the conditions for which corticosteroids are approved is expected to promote their appropriate use and minimize their adverse effects. However, further investigation is needed to determine the appropriate dosage, and the conditions in which corticosteroids are effective.
2.Prevention of symptomatic pulmonary embolism for gynecologic malignancies with preoperative asymptomatic venous thromboembolism: GOTIC-VTE trial
Yoshifumi TAKAHASHI ; Hiroyuki FUJIWARA ; Kouji YAMAMOTO ; Masashi TAKANO ; Morikazu MIYAMOTO ; Kosei HASEGAWA ; Maiko MIWA ; Toyomi SATOH ; Hiroya ITAGAKI ; Takashi HIRAKAWA ; Mayuyo MORI-UCHINO ; Tomonori NAGAI ; Yoshinobu HAMADA ; Soichi YAMASHITA ; Hiroko YANO ; Tomoyasu KATO ; Keiichi FUJIWARA ; Mitsuaki SUZUKI ; On behalf of the GOTIC-VTE Trial Investigators
Journal of Gynecologic Oncology 2024;35(4):e37-
Objective:
In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression.
Methods:
Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events.
Results:
Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase).
Conclusion
The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124
3.Current Status of Do-not-resuscitate Discussions for Terminal Cancer Patients in Japan
Yosuke MATSUDA ; Sachiko OHDE ; Masanori MORI ; Isseki MAEDA ; Takashi YAMAGUCHI ; Hiroto ISHIKI ; Yutaka HATANO ; Jun HAMANO ; Tatsuya MORITA
Palliative Care Research 2024;19(2):137-147
Purpose: The purpose of this study was to clarify the current status of Do-Not-Resuscitate discussions (DNRd) with terminally ill cancer patients in Japan and the psychological burden on bereaved families depending on whether or not a DNRd is performed. Method: A multicenter prospective observational study of advanced cancer patients admitted to 23 palliative care units (PCUs) in Japan was conducted, and a questionnaire survey of bereaved families was also conducted after patients died. Result: 1,605 patients were included in the analysis, and 71.4% of patients had a DNRd with doctors before PCU admission, 10.8% at admission, and 11.4% during admission. In contrast, 93.3% of family members had a DNRd with doctors before PCU admission, 48.4% at admission, and 52.1% during admission. Conclusion: Although DNRd was performed between patients and physicians in 72.3% of cases at any point throughout the course of time from before PCU admission to death, there was no evidence of psychological burden such as depression or complicated grief in the bereaved families due to patient participation in DNRd.
4.Prevention of symptomatic pulmonary embolism for gynecologic malignancies with preoperative asymptomatic venous thromboembolism: GOTIC-VTE trial
Yoshifumi TAKAHASHI ; Hiroyuki FUJIWARA ; Kouji YAMAMOTO ; Masashi TAKANO ; Morikazu MIYAMOTO ; Kosei HASEGAWA ; Maiko MIWA ; Toyomi SATOH ; Hiroya ITAGAKI ; Takashi HIRAKAWA ; Mayuyo MORI-UCHINO ; Tomonori NAGAI ; Yoshinobu HAMADA ; Soichi YAMASHITA ; Hiroko YANO ; Tomoyasu KATO ; Keiichi FUJIWARA ; Mitsuaki SUZUKI ; On behalf of the GOTIC-VTE Trial Investigators
Journal of Gynecologic Oncology 2024;35(4):e37-
Objective:
In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression.
Methods:
Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events.
Results:
Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase).
Conclusion
The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124
5.Prevention of symptomatic pulmonary embolism for gynecologic malignancies with preoperative asymptomatic venous thromboembolism: GOTIC-VTE trial
Yoshifumi TAKAHASHI ; Hiroyuki FUJIWARA ; Kouji YAMAMOTO ; Masashi TAKANO ; Morikazu MIYAMOTO ; Kosei HASEGAWA ; Maiko MIWA ; Toyomi SATOH ; Hiroya ITAGAKI ; Takashi HIRAKAWA ; Mayuyo MORI-UCHINO ; Tomonori NAGAI ; Yoshinobu HAMADA ; Soichi YAMASHITA ; Hiroko YANO ; Tomoyasu KATO ; Keiichi FUJIWARA ; Mitsuaki SUZUKI ; On behalf of the GOTIC-VTE Trial Investigators
Journal of Gynecologic Oncology 2024;35(4):e37-
Objective:
In Japan, perioperative prophylaxis of pulmonary embolism (PE) in gynecologic cancer patients with preoperative asymptomatic venous thromboembolism (VTE) has not been well established yet. The GOTIC-VTE trial was a prospective, multi-center, single-arm clinical trial to investigate the prevention of postoperative symptomatic PE onset by seamless anticoagulant therapy from the preoperative period to 4 weeks after surgery instead of using intermittent pneumatic compression.
Methods:
Anticoagulant therapy was started immediately after asymptomatic VTE diagnosis and stopped preoperatively according to the rules of each institution. Unfractionated heparin administration was resumed within 12 hours postoperatively, and this was followed by the switch to low-molecular-weight heparin and subsequently, edoxaban; this cycle was continued for 28 days. Primary outcome was the occurrence of symptomatic PE in 28 days postoperatively. Secondary outcomes were the incidence of VTE-related events in 28 days and 6 months postoperatively and protocol-related adverse events.
Results:
Between February 2018 and September 2020, 99 patients were enrolled; of these, 82patients were assessed as the full analysis set, including 58 for ovarian cancer, fallopian tube, or peritoneal cancer; 21 for endometrial cancer; and 3 for cervical cancer. No symptomatic PE was observed within 28 days postoperatively; two patients had bleeding events (major bleeding and clinically relevant nonmajor bleeding) and three had grade 3 adverse events (increased alanine transaminase, aspartate aminotransferase, or gamma-glutamyl transferase).
Conclusion
The multifaceted perioperative management for gynecologic malignancies with asymptomatic VTE effectively prevented postoperative symptomatic PE.Trial Registration: JRCT Identifier: jRCTs031180124
6.Rotatable sphincterotome as a rescue device for endoscopic retrograde cholangiopancreatography cannulation: a single-center experience
Takeshi OKAMOTO ; Takashi SASAKI ; Tsuyoshi TAKEDA ; Takafumi MIE ; Chinatsu MORI ; Takaaki FURUKAWA ; Yuto YAMADA ; Akiyoshi KASUGA ; Masato MATSUYAMA ; Masato OZAKA ; Naoki SASAHIRA
Clinical Endoscopy 2024;57(1):96-104
Background/Aims:
Selective bile duct or pancreatic duct cannulation remains a significant initial hurdle in endoscopic retrograde cholangiopancreatography (ERCP) despite advances in endoscopy and accessories. This study evaluated our experience with a rotatable sphincterotome in cases of difficult cannulation.
Methods:
We retrospectively reviewed ERCP cases using TRUEtome, a rotatable sphincterotome, as a rescue device for cannulation at a cancer institute in Japan from October 2014 to December 2021.
Results:
TRUEtome was used in 88 patients. Duodenoscopes were used for 51 patients, while single-balloon enteroscopes (SBE) were used for 37 patients. TRUEtome was used for biliary and pancreatic duct cannulation (84.1%), intrahepatic bile duct selection (12.5%), and strictures of the afferent limb (3.4%). Cannulation success rates were similar in the duodenoscope and SBE groups (86.3% vs. 75.7%, p=0.213). TRUEtome was more commonly used in cases with steep cannulation angles in the duodenoscope group and in cases requiring cannulation in different directions in the SBE group. There were no significant differences in adverse events between the two groups.
Conclusions
The cannulation sphincterotome was useful for difficult cannulations in both unaltered and surgically altered anatomies. It may be an option to consider before high-risk procedures such as precut and endoscopic ultrasound-guided rendezvous techniques.
7.Risk factors for recurrent stenosis after balloon dilation for benign hepaticojejunostomy anastomotic stricture
Takafumi MIE ; Takashi SASAKI ; Takeshi OKAMOTO ; Tsuyoshi TAKEDA ; Chinatsu MORI ; Yuto YAMADA ; Takaaki FURUKAWA ; Akiyoshi KASUGA ; Masato MATSUYAMA ; Masato OZAKA ; Naoki SASAHIRA
Clinical Endoscopy 2024;57(2):253-262
Background/Aims:
Hepaticojejunostomy anastomotic stricture (HJAS) is a feared adverse event associated with hepatopancreatobiliary surgery. Although balloon dilation for benign HJAS during endoscopic retrograde cholangiopancreatography with balloon-assisted enteroscopy has been reported to be useful, the treatment strategy remains controversial. Therefore, we evaluated the outcomes and risk factors of recurrent stenosis after balloon dilation alone for benign HJAS.
Methods:
We retrospectively analyzed consecutive patients who underwent balloon-assisted enteroscopy–endoscopic retrograde cholangiopancreatography for benign HJAS at our institution between July 2014 and December 2020.
Results:
Forty-six patients were included, 16 of whom had recurrent HJAS after balloon dilation. The patency rates at 1 and 2 years after balloon dilation were 76.8% and 64.2%, respectively. Presence of a residual balloon notch during balloon dilation was an independent predictor of recurrence (hazard ratio, 2.80; 95% confidence interval, 1.01–7.78; p=0.048), whereas HJAS within postoperative 1 year tended to be associated with recurrence (hazard ratio, 2.43; 95% confidence interval, 0.85–6.89; p=0.096). The patency rates in patients without a residual balloon notch were 82.1% and 73.1% after 1 and 2 years, respectively.
Conclusions
Balloon dilation alone may be a viable option for patients with benign HJAS without residual balloon notches on fluoroscopy.
8.Impact of adaptive radiotherapy on survival in locally advanced nasopharyngeal carcinoma treated with concurrent chemoradiotherapy
Yusuke UCHINAMI ; Koichi YASUDA ; Hideki MINATOGAWA ; Yasuhiro DEKURA ; Noboru NISHIKAWA ; Rumiko KINOSHITA ; Kentaro NISHIOKA ; Norio KATOH ; Takashi MORI ; Manami OTSUKA ; Naoki MIYAMOTO ; Ryusuke SUZUKI ; Keiji KOBASHI ; Yasushi SHIMIZU ; Jun TAGUCHI ; Nayuta TSUSHIMA ; Satoshi KANO ; Akihiro HOMMA ; Hidefumi AOYAMA
Radiation Oncology Journal 2024;42(1):74-82
Purpose:
To investigate the clinical significance of adaptive radiotherapy (ART) in locally advanced nasopharyngeal carcinoma treated with intensity-modulated radiotherapy (IMRT).
Materials and Methods:
Eligible patients were treated with concurrent chemoradiotherapy using IMRT. Planning computed tomography in ART was performed during radiotherapy, and replanning was performed. Since ART was started in May 2011 (ART group), patients who were treated without ART up to April 2011 (non-ART group) were used as the historical control. The Kaplan-Meier method was used to calculate overall survival (OS), locoregional recurrence-free survival (LRFS), progression-free survival (PFS), and distant metastasis-free survival (DMFS). LRFS for the primary tumor (LRFS_P) and regional lymph node (LRFS_LN) were also studied for more detailed analysis. Statistical significance was evaluated using the log-rank test for survival.
Results:
The ART group tended to have higher radiation doses. The median follow-up period was 127 months (range, 10 to 211 months) in the non-ART group and 61.5 months (range, 5 to 129 months) in the ART group. Compared to the non-ART group, the ART group showed significantly higher 5-year PFS (53.8% vs. 81.3%, p = 0.015) and LRFS (61.2% vs. 85.3%, p = 0.024), but not OS (80.7% vs. 80.8%, p = 0.941) and DMFS (84.6% vs. 92.7%, p = 0.255). Five-year LRFS_P was higher in the ART group (61.3% vs. 90.6%, p = 0.005), but LRFS_LN did not show a significant difference (91.9% vs. 96.2%, p = 0.541).
Conclusion
Although there were differences in the patient backgrounds between the two groups, this study suggests the potential effectiveness of ART in improving locoregional control, especially in the primary tumor.
9.Survey on the Status of Descriptions regarding Reference Information for Dispensing and Medication Support in the Interview Form
Takashi OMOTO ; Mariko KIKUCHI ; Kaoru MORI ; Kenzo KUDO
Japanese Journal of Drug Informatics 2023;25(3):124-130
Objective: We examined the descriptions of reference information regarding the dispensing process in the interview form (IF). If there was no description, we determined the test data’s availability from the pharmaceutical company.Methods: The survey targeted 78 drugs that complied with the new description IF guidelines, for regular tablets and capsules launched from April 2018 to December 2021. The survey was conducted between March 13th and June 14th, 2022. We investigated the reference information regarding the stability of the medications during the crushing and simple suspension method during dispensing.Results: Regarding the data related to the stability of medications during the crushing process, ten drugs were described as having “data available,” 18 drugs were to be “inquired individually,” 31 drugs had “no applicable data,” and 14 drugs had “no items.” Regarding the status of descriptions on the simple suspension method, ten drugs were described as having “data available,” 18 drugs had data that was to be “inquired individually,” 32 drugs had “no applicable data,” and 14 drugs had “no items.” Regarding the 35 drugs for which both the stability during crushing and the simple suspension method were listed as either “no applicable data” or “no items,” we contacted the pharmaceutical companies to inquire about the test data for the stability during the crushing and simple suspension method. We found that four drugs had “data available” on the stability of medications during the crushing process, while six drugs had “data available” on the simple suspension method.Conclusion: Many IFs that complied with the new description guidelines had items for reference information regarding dispensing. However, the test data’s description was not sufficient. Furthermore, even if there is no description of reference information regarding dispensing in the IF, we confirmed that the pharmaceutical company owns the test data.
10.The Effect of High-flow Nasal Cannula Oxygen for Dyspnea in Patients with Advanced Disease: Systematic Review
Sho GOYA ; Yasushi NAKANO ; Hiroaki TSUKUURA ; Yusuke TAKAGI ; Hiroaki WATANABE ; Yoshinobu MATSUDA ; Jun KAKO ; Yoko KASAHARA ; Hiroyuki KOHARA ; Masanori MORI ; Takeo NAKAYAMA ; Takashi YAMAGUCHI
Palliative Care Research 2023;18(4):261-269
Objective: To evaluate the efficacy of high-flow nasal cannula oxygen (HFNC) for dyspnea in patients with advanced disease. Methods: A literature search was conducted using MEDLINE, Cochrane Library, EMBASE, and Ichu-shi Web. Inclusion criteria were: 1) randomized controlled trials evaluating the effect of HFNC on dyspnea; 2) aged 18 years or older with advanced disease with hypoxemia; 3) control group was conventional oxygen therapy or noninvasive positive pressure ventilation. Exclusion criteria were: 1) patients in intensive care unit, 2) weaning from ventilator. Results: Six studies (4 from database searches, and 2 from hand searches) were included. In the 2 studies evaluating short-term intervention, one showed HFNC was more efficacious, and the other conventional oxygen was more efficacious. In the 2 studies evaluating long-term interventions: one showed HFNC was more efficacious, and the other showed no significant difference. In the 2 studies evaluating the intervention during exercise, one showed HFNC was more efficacious, and the other showed no significant difference. Conclusion: HFNC may be effective for dyspnea in patients with advanced disease associated with hypoxemia.


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