研究者詳細 - 長島　健悟

論文 - 長島　健悟

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Correlation between immune-related adverse events and prognosis in patients with gastric cancer treated with nivolumab

Masuda K, Shoji H, Nagashima K, Yamamoto S, Imazeki H, Aoki M, Miyamoto T, Hirano H, Honma Y, Iwasa S, Okita N, Takashima A, Kato K, Boku N

BMC Cancer 19 （ 1 ） 1 - 10 2019年10月

研究論文（学術雑誌）, 共著, 査読有り

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Gastric mucosal injury and hemorrhage after definitive chemoradiotherapy for locally advanced esophageal cancer

Monma S, Kato K, Shouji H, Okita N, Takashima A, Honma Y, Iwasa S, Hamaguchi T, Yamada Y, Shimada Y, Boku N, Nagashima K, Ito Y, Itami J

Esophagus 16 （ 4 ） 402 - 407 2019年10月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 16129059

Background: Definitive chemoradiotherapy is one of the treatment options for locally advanced esophageal cancer with curative intent. Esophagitis and pharyngitis are well-known adverse events that occur during chemoradiotherapy, but gastric mucosal injury has been less frequently reported compared to mucositis. Importantly, gastric mucosal injury is not well known, hard to manage, and sometimes fatal. Hence, we examined the clinical characteristics and the incidence of gastric mucosal injury after CRT for esophageal cancer. Methods: The medical records of patients who received definitive chemoradiotherapy combined with 5-fluorouracil and cisplatin for stage II/III (nonT4) esophageal squamous cell carcinoma from January 2001 to December 2010 at our institute were reviewed retrospectively. Results: We investigated 256 patients in whom, data for endoscopic abdomen examinations were both before and after CRT were available. Gastric mucosal damage was observed in 90 patients (35%) (grade 1/2/3 = 69/18/3). One of the possible risk factors identified in this study was the irradiation dose to abdomen. Compared to patients with cervical esophagus–upper thoracic esophagus tumor location, patients with middle thoracic esophagus–abdominal esophagus tumor location were more likely to develop gastric mucosal damage, although there was no statistically significant difference. Conclusions: It is important to consider gastric mucosal injury in patients who receive CRT, particularly when the irradiation field includes stomach.

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Inequality within a community at the neighborhood level and the incidence of mood disorders in Japan: a multilevel analysis

Fujita M, Nagashima K, Takahashi S, Hata A

Social Psychiatry and Psychiatric Epidemiology 54 （ 9 ） 1125 - 1131 2019年09月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 09337954

Purpose: This study analyzes whether income inequality within a community at the neighborhood level is associated with incidence of mood disorder in Japan. Methods: A retrospective cohort study was performed using the data of 116,658 National Health Insurance beneficiaries aged between 20 and 69 in Chiba City, Japan. To evaluate income inequality within a community, the Gini coefficient within a 30-min walking distance from an individual’s residence was calculated using income distribution estimated by the National Census and the Housing and Land Survey 2013. Incidence of mood disorder was determined through insurance claims submitted from April 1, 2013, to March 31, 2016. A multilevel logistic analysis with three levels—the individual, household, and residential district—was performed to evaluate the association. Results: Income inequality within a community at the neighborhood level was not associated with incidence of mood disorder in the models with and without equivalent household income (p for trend = 0.856 and 0.947, respectively). No difference was observed in the impact of the Gini coefficient among income levels, lower versus higher income groups (p for interaction between Gini coefficient and household income = 0.967). In contrast, lower equivalent income at the household level was significantly associated with higher incidence of mood disorder (p for trend < 0.001). Conclusions: While we confirmed that lower income at the household level itself had an adverse effect on mental health, income inequality within a community at the neighborhood level was not a significant factor for incidence of mood disorder in Japan.

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Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type 2 diabetes treated with sitagliptin: A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study (PRIME-V study)

Koshizaka M, Ishikawa K, Ishibashi R, Maezawa Y, Sakamoto K, Uchida D, Nakamura S, Yamaga M, Yokoh H, Kobayashi A, Onishi S, Kobayashi K, Ogino J, Hashimoto N, Tokuyama H, Shimada F, Ohara E, Ishikawa T, Shoji M, Ide S, Ide K, Baba Y, Hattori A, Kitamoto T, Horikoshi T, Shimofusa R, Takahashi S, Nagashima K, Sato Y, Takemoto M, Newby LK, Yokote K, On behalf of the PRIME-V study group

Diabetes, Obesity and Metabolism （Diabetes, Obesity and Metabolism） 21 （ 8 ） 1990 - 1995 2019年08月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 14628902

A prospective, multicentre, open-label, blinded-endpoint, randomized controlled study was conducted to evaluate the efficacy of treatment with ipragliflozin (sodium-dependent glucose transporter-2 inhibitor) versus metformin for visceral fat reduction and glycaemic control among Japanese patients with type 2 diabetes treated with sitagliptin, HbA1c levels of 7%-10%, and body mass index (BMI) ≥ 22 kg/m . Patients were randomly assigned (1:1) to receive ipragliflozin 50 mg or metformin 1000-1500 mg daily. The primary outcome was change in visceral fat area as measured by computed tomography after 24 weeks of therapy. The secondary outcomes were effects on glucose metabolism and lipid metabolism. Mean percentage reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group (−12.06% vs. −3.65%, P = 0.040). Ipragliflozin also significantly reduced BMI, subcutaneous fat area, waist circumference, fasting insulin, and homeostatic model assessment (HOMA)-resistance, and increased HDL-cholesterol levels. Metformin significantly reduced HbA1c and LDL-cholesterol levels and increased HOMA-beta. There were no severe adverse events. The use of ipragliflozin or metformin in combination with dipeptidyl peptidase-4 inhibitors, widely used in Japan, may have beneficial effects in ameliorating multiple cardiovascular risk factors. 2

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Prognostic significance of early changes in serum biomarker levels in patients with newly diagnosed metastatic prostate cancer

Narita S, Nomura K, Hatakeyama S, Takahashi M, Sakurai T, Kawamura S, Hoshi S, Ishida M, Kawaguchi T, Ishidoya S, Shimoda J, Sato H, Mitsuzuka K, Tochigi T, Tsuchiya N, Ohyama C, Arai Y, Nagashima K, Habuchi T

Scientific Reports 9 （ 1 ） 12071 2019年08月

研究論文（学術雑誌）, 共著, 査読有り

We evaluated the impact of early changes in serum biomarker levels on the survival of patients with metastatic hormone-sensitive prostate cancer (mHSPC) who were initially treated with androgen deprivation therapy (ADT). We retrospectively investigated 330 patients with mHSPC whose serum maker levels were at baseline and at 2–4 months. An optimal Cox regression model was established with the highest optimism-corrected concordance index based on 10-fold cross-validation. The median cancer-specific survival (CSS) and overall survival (OS) were 7.08 and 6.47 years (median follow-up, 2.53 years), respectively. In the final optimal Cox model with serum biomarker levels treated as time-varying covariates, prostate-specific antigen (PSA), hemoglobin (Hb), and alkaline phosphatase (ALP) significantly increased the risk of poor survival in the context of both CSS and OS. Kaplan–Meier curves stratified by the three risk factors of high PSA, low Hb and high ALP desmondtated that median OS were not reached with none of these factors, 6.47 years with one or two factors, and 1.76 years with all three factors.Early changes in serum biomarker levels after ADT may be good prognostic markers for the survival of patients with mHSPC.

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Prognostic factors in patients who received end-of-life chemotherapy for advanced cancer

Hiramoto S, Tamaki T, Nagashima K, Hori T, Kikuchi A, Yoshioka A, Inoue A

International Journal of Clinical Oncology 24 （ 4 ） 454 - 459 2019年04月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 13419625

Background: Clinical efficacy of aggressive end-of-life (EOL) chemotherapy remains unclear. Method: Medical records of patients with advanced cancer between August 2011 and August 2016 were retrospectively analyzed. The primary endpoint was to identify prognostic factors at the last administration of chemotherapy. The secondary endpoint was to analyze the relationship between EOL symptoms and EOL treatment details. Results: Among 300 evaluated patients, the number of patients who died within 14 and 30 days from the last administration of chemotherapy were 16 (5.3%) and 50 (16.7%), respectively. Multivariate analysis revealed that ECOG-PS (OR 3.698, p < 0.001) and GPS2 (OR 3.791, p = 0.028) were significant prognostic factors. The MST of patients with both PS 2–4 and GPS2 (+) was 38 days, while that in patients with both PS 0–1 and GPS2 (−) was 134.5 days. The prevalence rate of nausea and vomiting (25.0%) and the mean hydration volume (0.50 L/day) in patients who died within 30 days from the chemotherapy was significantly higher than others (7.4%) (0.20 L/day). Conclusion: ECOG-PS and GPS were significant prognostic factors for aggressive EOL chemotherapy. Information on these factors may aid clinical decision-making in terms of risk–benefit balance, particularly in patients with poor prognosis.

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Single-use suvorexant for treating insomnia during overnight polysomnography in patients with suspected obstructive sleep apnea: a single-center experience

Matsumura T, Terada J, Yoshimura C, Koshikawa K, Kinoshita T, Yahaba M, Nagashima K, Sakao S, Tatsumi K

Drug Design, Development and Therapy 13 809 - 816 2019年02月

研究論文（学術雑誌）, 共著, 査読有り

Purpose: Although patients with suspected obstructive sleep apnea (OSA) might suffer difficulty in falling asleep during overnight polysomnography (PSG), standard hypnotics to obtain sleep during PSG have not been established. The aim of this study was to investigate the safety and efficacy of a new hypnotic agent, suvorexant, a dual orexin receptor antagonist, for insomnia in suspected OSA patients during in-laboratory PSG. Patients and methods: An observational study was conducted during PSG for 149 patients with suspected OSA who had no insomnia at home. Patients with difficulty in falling asleep during PSG were optionally permitted to take single-use suvorexant. Patients with residual severe insomnia (>1 hour) after taking suvorexant were permitted to take an add-on use zolpidem. Clinical data and sleep questionnaire results were analyzed between a no insomnia group (without hypnotics) and an insomnia group (treated with suvorexant). Results: Among 84 patients who experienced insomnia during PSG and required hypnotics (the insomnia group; treated with suvorexant), 44 (52.4%) achieved sufficient subjective sleep with single-use of suvorexant, while the other 40 (47.6%) required suvorexant plus zolpidem. An apnea hypopnea index (AHI) of ≥5 was observed in 144 out of 149 patients with predominantly obstructive respiratory events. Among those patients, 70.8% in the no insomnia group and 63.1% in the insomnia group had severe OSA. Regarding both subjective sleep time and morning mood, significant differences between the no insomnia group and the insomnia group were not observed. No patient taking suvorexant had an adverse event, such as delirium or falling. Conclusion: Single-use suvorexant seems to be a safe and effective (but mild) hypnotic agent for suspected OSA patients with insomnia during in-laboratory PSG.

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Hyperprogressive disease during nivolumab or irinotecan treatment in patients with advanced gastric cancer

Aoki M, Shoji H, Nagashima K, Imazeki H, Miyamoto T, Hirano H, Honma Y, Iwasa S, Okita N, Takashima A, Kato K, Higuchi K, Boku N

ESMO Open 4 （ 3 ） e000488 2019年01月

研究論文（学術雑誌）, 共著, 査読有り

Background Nivolumab showed a survival benefit for advanced gastric cancer (AGC). However, an acceleration of tumour growth during immunotherapy, (hyperprogressive disease, HPD) has been reported in various cancers. This study reviewed the HPD in patients with AGC treated with nivolumab or irinotecan. Methods The subjects of this retrospective study were patients with AGC with measurable lesions, and their tumour growth rates (TGR) during nivolumab or irinotecan were compared with those during prior therapy. HPD was defined as an increase in TGR more than twofold. Results 34 and 66 patients received nivolumab and irinotecan in third or later line between June 2009 and September 2018 at our hospital; 22 patients receiving nivolumab had prior treatment with irinotecan, and one patient received irinotecan after nivolumab. Nivolumab and irinotecan showed no differences in disease control rates (38.2% and 34.8%) and in progression-free survival (PFS) (HR 1.1, 95% CI 0.7 to 1.6, p=0.802). The incidence of HPD was slightly higher after nivolumab (29.4%) than after irinotecan (13.5%) (p=0.0656), showing no differences in background between the patients with and without HPD. Compared between HPD and PD other than HPD after nivolumab, the HRs for PFS and overall survival (OS) were 1.1 (95% CI 0.5 to 2.7; p=0.756), and 2.1 (95% CI 0.7 to 5.8; p=0.168), but such clear difference in OS was not observed after irinotecan. Conclusions HPD was observed more frequently after nivolumab compared with irinotecan, which was associated with a poor prognosis after nivolumab but not so clearly after irinotecan.

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Phase II feasibility study of preoperative concurrent chemoradiotherapy with cisplatin plus 5-fluorouracil and elective lymph node irradiation for clinical stage II/III esophageal squamous cell carcinoma

Hashimoto J, Kato K, Ito Y, Kojima T, Akimoto T, Daiko H, Hamamoto Y, Matsushita H, Katano S, Hara H, Tanaka Y, Saito Y, Nagashima K, Igaki H

International Journal of Clinical Oncology （International Journal of Clinical Oncology） 24 （ 1 ） 60 - 67 2019年01月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 13419625

Background: Preoperative chemoradiotherapy (CRT) is a standard treatment for stage II/III esophageal cancer. Preoperative chemotherapy is also considered a standard treatment for stage II/III esophageal squamous cell carcinoma (ESCC) in patients who undergo radical lymph node dissection. We conducted a feasibility study of preoperative CRT with cisplatin plus 5-fluorouracil (CF) and elective lymph node irradiation followed by esophagectomy with radical lymph node dissection in patients with stage II/III ESCC. Methods: Patients with clinical stage II/III, excluding T4, ESCC (International Union Against Cancer TNM classification system, 6th edition) were eligible. Chemotherapy comprised two courses of CF infusion repeated after 4-weeks. Radiation therapy was concurrently administered to the primary tumor, metastatic lymph nodes, and regional lymph nodes at a dose of 41.4 Gy. After the completion of CRT, transthoracic esophagectomy with 2–3 fields lymphadenectomy was performed. The primary endpoint was the completion rate of protocol treatment with R0 resection. Results: Thirty-one eligible patients were enrolled. During CRT, the most common grade 3 or 4 toxicities were leukopenia (65%), neutropenia (65%), anemia (13%), thrombocytopenia (13%), febrile neutropenia (13%), anorexia (16%), esophagitis (16%) and hyponatremia (16%). Thirty patients (96.8%) underwent surgery. One patient received palliative chemotherapy because of appearance of lung metastasis during CRT. The completion rate of protocol treatment was 93.5% (29/31). There was one treatment-related death after surgery. Pathological complete response was achieved in 42% (13/30). Conclusion: Preoperative CRT with CF and elective lymph node irradiation showed an acceptable toxicity and promising activity especially in ESCC.

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加藤直広, 野間久史, 長島健悟

計算機統計学 32 （ 2 ） 105 - 117 2019年01月

研究論文（学術雑誌）, 共著, 査読有り

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Intravenous nicorandil versus adenosine for fractional flow reserve measurement: a crossover, randomized study

Nishi T, Kitahara H, Fujimoto Y, Nakayama T, Nagashima K, Hanaoka H, Kobayashi Y

Heart and Vessels 33 （ 12 ） 1570 - 1575 2018年12月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 09108327

Nicorandil has vasodilatory effects on both the epicardial coronary arteries and the coronary microvasculature, thereby increasing coronary blood flow. The objective of the present study was to investigate the effectiveness of intravenous (IV) nicorandil infusion for fractional flow reserve (FFR) measurement. In this crossover randomized study, 49 patients underwent FFR measurement with a consecutive randomized order of patient-blind infusions of continuous IV adenosine administration and a single bolus IV administration of nicorandil. The primary endpoint was the difference between the FFR by nicorandil and the FFR by adenosine, as assessed by the Bland–Altman method. The mean FFR value measured by nicorandil was not significantly different from that measured by adenosine [0.8125 ± 0.1349 vs. 0.7978 ± 0.124; mean difference, 0.0147 (95% confidence interval − 0.0373, 0.0667); P = 0.58]. There was no clinically significant diagnostic discordance, with the FFR by nicorandil > 0.80 and that by adenosine < 0.75. Hyperemia was achieved earlier using nicorandil than adenosine (34 ± 13 vs. 58 ± 15, P < 0.001). The duration of hyperemia after IV nicorandil was variable (6–570 s, mean 89 ± 98 s). IV nicorandil decreased systolic blood pressure by 32 ± 16 mm Hg (24 ± 10%) from baseline. Linear regression analysis showed that the average FFR value and the difference in systolic blood pressure were significantly associated with the bias in the FFR value between the two drugs. In conclusions, the results of the present study suggest that IV nicorandil can achieve maximal hyperemia easily and rapidly, providing an acceptable diagnostic performance for FFR assessment. However, a wide range of variation in hyperemic plateau and a decrease in blood pressure are the major limitations of this method.

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終末期進行がん患者における長期入院の予測因子と終末期症状・治療との関連

菊地綾子, 平本秀二, 堀哲雄, 吉岡亮, 長島健悟

Palliative Care Research 13 （ 4 ） 335 - 340 2018年12月

研究論文（学術雑誌）, 共著, 査読有り

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Hepatitis B virus reactivation in patients with rheumatoid arthritis: analysis of the National Database of Japan

Fujita M, Sugiyama M, Sato Y, Nagashima K, Takahashi S, Mizogami M, Hata A

Journal of Viral Hepatitis 25 （ 11 ） 1312 - 1320 2018年11月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 13520504

This study aimed to determine the incidence and risk factors for hepatitis B virus (HBV) reactivation in patients with rheumatoid arthritis (RA) undergoing immunosuppressive therapy. The National Database of Japan, in which insurance claim data have been comprehensively accumulated, was utilized. The subjects were 76 641 RA patients who were plausibly initiated on immunosuppressive therapy from April 2013 to March 2014. Laboratory tests of the hepatitis B surface antigen, anti-hepatitis B virus surface antibody, and anti-hepatitis B virus core antibody were performed in 28.23%, 12.52% and 14.63% of patients, respectively, when the therapy was initiated. We found that HBV reactivation and fulminant hepatitis occurred in both the patients with and without HBV DNA monitoring, indicating insufficient monitoring in Japan during the study. The cumulative incidence of HBV reactivation over 24 months was 1.57% (95% confidence interval [CI] = 1.28%-1.92%) in the monitoring group, which consisted of those with resolved HBV infection. Glucocorticoid administration was a potent risk factor for HBV reactivation (hazard ratio [HR] = 1.70, 95% CI = 1.26-2.29, P =.001 in all subjects, and HR = 1.82, 95% CI = 1.18-2.81, P =.007 in the nonmonitoring group), although it was not statistically significant in the monitoring group (HR = 1.49, 95% CI = 0.99-2.26 and P =.057). No significant risk difference was observed between single administration of methotrexate and biological drugs.

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Altered cerebral blood flow in the anterior cingulate cortex is associated with neuropathic pain

Watanabe K, Hirano S, Kojima K, Nagashima K, Mukai H, Sato T, Takemoto M, Matsumoto K, Iimori T, Isose S, Omori S, Shibuya K, Sekiguchi Y, Beppu M, Amino H, Suichi T, Yokote K, Uno T, Kuwabara S, Misawa S

Journal of Neurology, Neurosurgery and Psychiatry 89 （ 10 ） 1082 - 1087 2018年10月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 00223050

Objective To assess the cerebral blood flow (CBF) in patients with diabetic neuropathic pain, and its changes after duloxetine therapy. Methods Using iodine-123-N-isopropyl-p-iodoamphetamine single-photon emission computed tomography (IMP-SPECT), we performed a cross-sectional study of 44 patients with diabetes, and compared CBF in those with (n = 24) and without neuropathic pain (n = 20). In patients with neuropathic pain, we also longitudinally assessed changes in CBF 3 months after treatment with duloxetine. Results IMP-SPECT with voxel-based analyses showed a significant increase in cerebral blood flow in the right anterior cingulate cortex and a decrease in the left ventral striatum in patients with neuropathic pain, compared with those without pain. After duloxetine treatment, volume of interest analyses revealed a decrease in cerebral blood flow in the anterior cingulate cortex in patients with significant pain relief but not in non-responders. Furthermore, voxel-based whole brain correlation analyses demonstrated that greater baseline CBF in the anterior cingulate cortex was associated with better pain relief on the numerical rating scale. Conclusions Our results suggest that the development of neuropathic pain is associated with increased activity in the anterior cingulate cortex, and greater baseline activation of this region may predict treatment responsiveness to pharmacological intervention. Trial registration number UMIN000017130;Results.

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Imaging peritoneal metastasis of gastric cancer with 18F-fluorothymidine positron emission tomography/computed tomography: a proof-of-concept study

Honma Y, Terauchi T, Tateishi U, Kano D, Nagashima K, Iwasa S, Takashima A, Kato K, Hamaguchi T, Boku N, Shimada Y, Yamada Y

British Journal of Radiology 91 （ 1089 ） 20180259 2018年09月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 00071285

objective: Peritoneal metastasis (PM) is the most frequent form of metastasis in gastric cancer (GC). The sensitivity of detecting PM by pre-operative imaging modalities is low. Utility of positron emission tomography (PET) with F-fluodeoxyglucose (FDG) for GC is limited, because diffuse-type tumors are not FDG-avid. F-fluothymidine ([F-18]FLT) is a radiotracer that reflects cellular proliferation and the utility of [F-18] FLT-PET in GC has been reported. In this proof-of-concept study, we explored the ability of [F-18]FLT-PET/CT to detect PM of GC previously identified by other imaging modalities. methods: The key eligibility criteria were as follows; (i) histologically proven gastric adenocarcinoma; (ii) evident PM detected by CT performed within 4 weeks prior to registration; (iii) no prior treatment of PM within 4 weeks before registration. [F-18]FLT-PET/CT was performed at National Cancer Center Hospital, and [F-18]FLT-PET/CT images were evaluated independently by two radiologists. Safety assessments were carried out before and after [F-18]FLT-PET/CT. The primary end point was the detection sensitivity of PM. results: A total of 19 eligible patients were analyzed, of which 15 (78.9%) had diffuse-type histology. Detection sensitivity of PM, primary lesion, and lymph node metastasis were 73.7% [maximum standardized uptake value (SUVmax): 1.697-13.21], 100% (SUVmax: 2.71-22.01), and 72.7% (SUVmax: 2.079-12.61), respectively. No patients experienced adverse events during or after [F-18] FLT-PET/CT. conclusion: This proof-of-concept study shows that [F-18]FLT-PET/CT is a sensitive method for detecting PM in GC, and paves the way for future studies investigating the clinical utility of this approach for the detection of clinically non-evident PM in GC. 18 18

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Medical costs attributable to overweight and obesity in Japanese individuals

Fujita M, Sato Y, Nagashima K, Takahashi S, Hata A

Obesity Research and Clinical Practice 12 （ 5 ） 479 - 484 2018年09月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 1871403X

Objective: We aimed to reveal the association between body mass index (BMI) and medical costs in the current Japanese population, and to estimate the population attributable fraction (PAF) of medical costs due to overweight and obesity. Methods: A generalized linear mixed model with log link function and gamma distribution was used to evaluate the association between BMI and medical costs in 34,537 beneficiaries of the National Health Insurance aged 40–69 years in Chiba City. Medical cost data were obtained from insurance claims submitted between April 2012 and March 2016. PAFs due to overweight (BMI ≥25.0 and <30.0 kg/m ) and obesity (BMI ≥30.0 kg/m ) were calculated. Results: Overweight and obesity were significant predictors of excessive medical costs in all age and sex groups. PAF due to overweight and obesity was estimated to be 9.62% (95% confidence interval, 8.52–10.73%). Additionally, PAFs in 40–59-year-old individuals (12.76% in men and 11.63% in women) were greater than those in 60–69-year-old subjects (6.55% in men and 7.80% in women) for both sexes. Conclusions: In the Japanese population, overweight and obesity are an excessive financial burden with an estimated PAF of 9.62% of total medical costs. 2 2

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The first multicenter, randomized, controlled trial of home telemonitoring for Japanese patients with heart failure: home telemonitoring study for patients with heart failure (HOMES-HF)

Kotooka N, Kitakaze M, Nagashima K, Asaka M, Kinugasa Y, Nochioka K, Mizuno A, Nagatomo D, Mine D, Yamada Y, Kuratomi A, Okada N, Fujimatsu D, Kuwahata S, Toyoda S, Hirotani S-i, Komori T, Eguchi K, Kario K, Inomata T, Sugi K, Yamamoto K, Tsutsui H, Masuyama T, Shimokawa H, Momomura S-i, Seino Y, Sato Y, Inoue T, Node K, On behalf of the HOMES-HF study investigators

Heart and Vessels 33 （ 8 ） 866 - 876 2018年08月

研究論文（学術雑誌）, 共著, 査読有り

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Type of second primary malignancy after achieving complete response by definitive chemoradiation therapy in patients with esophageal squamous cell carcinoma

Yamaguchi T, Kato K, Nagashima K, Iwasa S, Honma Y, Takashima A, Hamaguchi T, Ito Y, Itami J, Boku N, Higuchi K

International Journal of Clinical Oncology 23 （ 4 ） 652 - 658 2018年08月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 13419625

Background: While the standard treatment for stage II–III (non-T4) esophageal squamous cell carcinoma (ESCC) is neoadjuvant therapy followed by esophagectomy, definitive chemoradiation therapy (dCRT) is an option to treat ESCC patients who reject or may not tolerate surgical treatment. Second primary malignancy (SPM) is a problem for long-term survivors after achieving complete response (CR) by dCRT. Methods: The source of the subjects in this study was the patients with stage II/III (excluding T4 disease) ESCC (UICC6th) who underwent dCRT from 2000 to 2011 at the National Cancer Center Hospital, Japan. SPM, defined as malignancy newly detected at different site from the initial disease, was checked in patients who achieved CR by the initial dCRT. Results: Among the 285 patients with stage II/III (excluding T4 disease) ESCC who underwent dCRT, 185 patients achieved CR. SPM was detected in 49 patients (median time to developing SPM, 41.5 months), accounting for 19.3% (95% CI 0.137–0.257) as the 5-year cumulative risk of SPM. SPMs were head and neck cancer (n = 12), gastric cancer (n = 12), esophageal cancer (n = 7), lung cancer (n = 5), colon cancer (n = 4), diffuse large B-cell lymphoma (n = 3), bladder cancer (n = 2), small intestinal cancer (n = 1), cholangiocarcinoma (n = 1), malignant melanoma (n = 1), and breast cancer (n = 1). There were no significant differences in baseline characteristics between the patients who developed SPM (n = 49) and others (n = 136). Conclusions: Because second primary malignancy developed often after achieving CR by dCRT for ESCC, it should be followed carefully.

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Safety and efficacy of eculizumab in Guillain-Barré syndrome: a multicentre, double-blind, randomised phase 2 trial

Misawa S, Kuwabara S, Sato Y, Yamaguchi N, Nagashima K, Katayama K, Sekiguchi Y, Iwai Y, Amino H, Suichi T, Yokota T, Nishida Y, Kanouchi T, Kohara N, Kawamoto M, Ishii J, Kuwahara M, Suzuki H, Hirata K, Kokubun N, Masuda R, Kaneko J, Yabe I, Sasaki H, Kaida K-i, Takazaki H, Suzuki N, Suzuki S, Nodera H, Matsui N, Tsuji S, Koike H, Yamasaki R, Kusunoki S, for the Japanese Eculizumab Trial for GBS (JET-GBS) Study Group

The Lancet Neurology 17 （ 6 ） 519 - 529 2018年06月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 14744422

Background: Despite the introduction of plasmapheresis and immunoglobulin therapy, many patients with Guillain-Barré syndrome still have an incomplete recovery. Evidence from pathogenesis studies suggests the involvement of complement-mediated peripheral nerve damage. We aimed to investigate the safety and efficacy of eculizumab, a humanised monoclonal antibody against the complement protein C5, in patients with severe Guillain-Barré syndrome. Methods: This study was a 24 week, multicentre, double-blind, placebo-controlled, randomised phase 2 trial done at 13 hospitals in Japan. Eligible patients with Guillain-Barré syndrome were aged 18 years or older and could not walk independently (Guillain-Barré syndrome functional grade 3–5). Patients were randomly assigned (2:1) to receive 4 weeks of intravenous immunoglobulin plus either eculizumab (900 mg) or placebo; randomisation was done via a computer-generated process and web response system with minimisation for functional grade and age. The study had a parallel non-comparative single-arm outcome measure. The primary outcomes were efficacy (the proportion of patients with restored ability to walk independently [functional grade ≤2] at week 4) in the eculizumab group and safety in the full analysis set. For the efficacy endpoint, we predefined a response rate threshold of the lower 90% CI boundary exceeding 50%. This trial is registered with ClinicalTrials.gov, number, NCT02493725. Findings: Between Aug 10, 2015, and April 21, 2016, 34 patients were assigned to receive either eculizumab (n=23) or placebo (n=11). At week 4, the proportion of the patients able to walk independently (functional grade ≤2) was 61% (90% CI 42–78; n=14) in the eculizumab group, and 45% (20–73; n=5) in the placebo group. Adverse events occurred in all 34 patients. Three patients had serious adverse events: two in the eculizumab group (anaphylaxis in one patient and intracranial haemorrhage and abscess in another patient) and one in the placebo group (depression). The possibility that anaphylaxis and intracranial abscess were related to eculizumab could not be excluded. No deaths or meningococcal infections occurred. Interpretation: The primary outcome measure did not reach the predefined response rate. However, because this is a small study without statistical comparison with the placebo group, the efficacy and safety of eculizumab could be investigated in larger, randomised controlled trials. Funding: The Japan Agency for Medical Research and Development, Ministry of Health, Labor and Welfare, and Alexion Pharmaceuticals.

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A phase II study of combination therapy with oral S-1 and cisplatin in elderly patients with advanced gastric cancer

Sasaki Y, Iwasa S, Okazaki S, Goto M, Kojima Y, Naganuma A, Nagashima K, Nagai Y, Hirano H, Honma Y, Takashima A, Kato K, Hamaguchi T

Gastric Cancer 21 （ 3 ） 439 - 445 2018年05月

研究論文（学術雑誌）, 共著, 査読有り, ISSN 14363291

Background: A combination of S-1 and cisplatin is recognized as one of the standard first-line chemotherapy regimens for patients with advanced gastric cancer. However, demographic analyses of pivotal phase III studies have showed that only a minority of treated patients were aged 76 years or older. The purpose of this phase II study was to evaluate the safety and efficacy of combination therapy with S-1 and cisplatin in elderly patients with chemotherapy-naive advanced gastric cancer. Methods: Patients aged 76 years or older received S-1 40 mg/m orally twice daily for 21 days and cisplatin 60 mg/m intravenously infused at day 8 of each 35-day cycle. Dose modification was performed according to creatinine clearance. The primary endpoint was overall survival (OS). Secondary endpoints included response rate, progression-free survival (PFS), time to treatment failure (TTF), and adverse events. Results: A total of 40 patients were enrolled. Median OS was 12.3 months, PFS was 7.8 months, and TTF was 4.3 months. The response rate was 54%. The most common grade 3–4 adverse events were anorexia (25%), neutropenia (23%), hyponatremia (20%), anemia (18%), and febrile neutropenia (8%). No treatment-related death occurred. Conclusions: Combination chemotherapy with S-1 and cisplatin is an effective and well-tolerated regimen for elderly patients with advanced gastric cancer when the dose is adjusted according to renal function. 2 2

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