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Yasuaki Arai

Publications and source records attributed to Yasuaki Arai.

At least 19 recordsLinked to original sources
PubMed2026

Durvalumab and tremelimumab, with or without lenvatinib, combined with transarterial chemoembolisation in participants with embolisation-eligible hepatocellular carcinoma (EMERALD-3): a global, randomised, open-label, sponsor-blinded, phase 3 study.

BACKGROUND: Transarterial chemoembolisation (TACE), a standard treatment for embolisation-eligible hepatocellular carcinoma (HCC), induces tumour immune responses. Single tremelimumab regular interval durvalumab (STRIDE) is a standard treatment in advanced HCC. In this phase 3 trial, we assessed the efficacy and safety of STRIDE, with or without lenvatinib, plus TACE, in participants with embolisation-eligible HCC. METHODS: EMERALD-3 is a phase 3, randomised, open-label, sponsor-blinded study, conducted at 177 medical sites in 21 countries. Eligible participants were 18 years or older (aged &#x2265;21 years in Egypt or Singapore) at screening and had confirmed HCC (by imaging or histopathologically from biopsy specimen, surgery, or both) not amenable to curative surgery, curative ablation, or transplantation but amenable to TACE. Participants had Child-Pugh class A liver function, an Eastern Cooperative Oncology Group performance status of 0-1, and at least one measurable target intrahepatic lesion per modified Response Evaluation Criteria in Solid Tumours. Participants were randomly allocated in a 1:1:1 ratio to receive STRIDE plus lenvatinib plus TACE, STRIDE plus TACE, or TACE until each group reached its preplanned enrolment target of 175 participants. After the STRIDE plus TACE group reached its enrolment target, randomisation was adjusted to continue in a 1:1 ratio between the STRIDE plus lenvatinib plus TACE group and TACE group until approximately 275 participants were enrolled in each of these two groups. Randomisation used a centrally assigned interactive response technology system, stratified by region, baseline tumour burden, and previous palliative embolisation. In the STRIDE plus lenvatinib plus TACE group, on the first day, participants were given 300 mg tremelimumab intravenously, followed by 1500 mg durvalumab plus oral lenvatinib (8 mg for <60 kg bodyweight or 12 mg for &#x2265;60 kg bodyweight); participants then received 1500 mg durvalumab every 4 weeks plus once-daily lenvatinib for up to 36 cycles. In the STRIDE plus TACE group, participants were given 300 mg tremelimumab and 1500 mg durvalumab intravenously on the first day, followed by 1500 mg durvalumab every 4 weeks. The technique and number of TACE procedures were at the investigators' discretion, with the first procedure administered at least 7 days after the first dose of durvalumab in the two investigation treatment groups and within 7 days of random allocation in the TACE group. The primary endpoint was progression-free survival for STRIDE plus lenvatinib plus TACE versus TACE. Key secondary endpoints were overall survival for STRIDE plus lenvatinib plus TACE versus TACE and progression-free survival and overall survival for STRIDE plus TACE versus TACE. This study was registered with ClinicalTrials.gov (NCT05301842), with enrolment completed. FINDINGS: From March 28, 2022, to Nov 20, 2024, 1124 participants were screened. The full analysis set comprised 760 participants, who were randomly allocated to STRIDE plus lenvatinib plus TACE (n=293), STRIDE plus TACE (n=175), or TACE (n=292). 633 (83%) participants were male and 127 (17%) were female; 548 (72%) were Asian. At the first data cutoff (Sept 2, 2025); the overall median follow-up for progression-free survival was 10&#xb7;0 months (IQR 4&#xb7;6-17&#xb7;2); median follow-up for progression-free survival was 11&#xb7;0 months (IQR 4&#xb7;8-18&#xb7;4) for STRIDE plus lenvatinib plus TACE and 8&#xb7;3 months (4&#xb7;1-15&#xb7;5) for TACE. Median progression-free survival was 13&#xb7;0 months (95% CI 12&#xb7;2-16&#xb7;7) for STRIDE plus lenvatinib plus TACE versus 9&#xb7;8 months (8&#xb7;0-11&#xb7;4) for TACE (HR 0&#xb7;70 [95% CI 0&#xb7;57-0&#xb7;86]; p=0&#xb7;0007). At the second data cutoff (Feb 23, 2026) and a median follow-up for overall survival of 24&#xb7;6 months (IQR 16&#xb7;5-31&#xb7;5) for STRIDE plus lenvatinib plus TACE and 22&#xb7;9 months (14&#xb7;9-30&#xb7;2) for TACE, median overall survival was 39&#xb7;5 months (95% CI 34&#xb7;1-not reached) for STRIDE plus lenvatinib plus TACE and 34&#xb7;7 months (28&#xb7;8-not reached) for TACE (HR 0&#xb7;84 [95% CI 0&#xb7;65-1&#xb7;09]; p=0&#xb7;18). At this data cutoff, median progression-free survival was 12&#xb7;9 months (95% CI 10&#xb7;2-15&#xb7;9) for STRIDE plus TACE and 8&#xb7;1 months (6&#xb7;5-10&#xb7;2) for the first 175 participants randomised to TACE (HR 0&#xb7;71 [95% CI 0&#xb7;56-0&#xb7;91]), with median follow-up of 10&#xb7;3 months (IQR 4&#xb7;6-23&#xb7;7) for STRIDE plus TACE and 7&#xb7;7 months (3&#xb7;0-18&#xb7;5) for the first 175 participants randomly allocated to TACE. The most common adverse events of maximum grade 3 or 4 were hypertension (34 [12%] of 287) for STRIDE plus lenvatinib plus TACE, post-embolisation syndrome and anaemia (ten [6%] of 175 each) for STRIDE plus TACE, and post-embolisation (17 [6%] of 290) for TACE. 184 (64%) participants receiving STRIDE plus lenvatinib plus TACE, 89 (51%) receiving STRIDE plus TACE, and 68 (23%) receiving TACE had serious adverse events. Treatment-related adverse events with an outcome of death during the treatment-emergent period occurred in seven (2%) of 287 participants who received STRIDE plus lenvatinib plus TACE (two for myocarditis; and one each for hepatic failure, haemophagocytic lymphohistiocytosis, septic shock, cardiac failure, and unknown cause), none of 175 participants who received STRIDE plus TACE, and two (1%) of 290 participants who received TACE (one each for acute myocardial infarction and unknown cause). INTERPRETATION: STRIDE plus lenvatinib plus TACE showed a statistically significant progression-free survival improvement versus TACE. These findings support a STRIDE-based regimen as a potential new treatment option for people with embolisation-eligible HCC; additional follow-up is being conducted for final analysis of overall survival across treatment groups. FUNDING: AstraZeneca.

Adult↗
PubMed2006

Distant metastasis of prostate cancer: early detection of recurrent tumor with dual-phase carbon-11 choline positron emission tomography/computed tomography in two cases.

Several types of recurrence may be detected by radiologic assessment after treatment in patients with prostate cancer. However, early detection of distant metastasis using positron emission tomography has so far never been published. We report two patients who underwent hormone therapy or surgical resection for prostate cancer. They developed distant metastases which were detected on whole body [C-11] choline positron emission tomography/computed tomography with significant elevation of serum PSA level. In one patient, recurrent tumor of the supraclavicular node (6 mm) diminished in size after subsequent hormone therapy. Surgical resection of recurrent tumor of the lung (12 mm) was performed in the other patient, the pathology of which confirmed the metastatic adenocarcinoma derived from the prostate. The recurrent tumor can be correctly detected by dual-phase whole body [C-11] choline positron emission tomography/computed tomography.

Adenocarcinoma↗
PubMed2006

A phase II Study of the global dose and schedule of capecitabine in Japanese patients with metastatic colorectal cancer.

BACKGROUND: Although the standard 3-week capecitabine regimen (1250 mg/m(2) twice daily for 2 weeks followed by a 1-week rest) has shown superior activity and improved safety over bolus 5-fluorouracil/leucovorin in two large randomized phase III trials in Europe and in the United States, only a 4-week regimen of capecitabine (828 mg/m(2) twice daily for 3 weeks) has been studied in Japan. Therefore, we performed a phase II study to investigate the 3-week regimen of capecitabine in Japanese patients with metastatic colorectal cancer (MCRC). METHODS: Previously untreated patients with MCRC received oral capecitabine 1250 mg/m(2) twice daily for 2 weeks. Treatment was repeated every 3 weeks. Blood and urine samples were collected for pharmacokinetic analysis. RESULTS: Sixty patients were enrolled. The overall response rate was 35% [95% confidence interval (CI), 23-48%], and 52% of patients had stable disease. The median time to progression was 5.5 months (95% CI, 4.2-6.7 months). The median overall survival was 20.2 months (95% CI, 16.6-27.8 months). The most frequently occurring adverse drug reaction was hand-foot syndrome (all-grade 73%; grade 3 13%). Diarrhea, anorexia, nausea and stomatitis were each seen in 37% of patients. The pharmacokinetic profiles of capecitabine and its metabolites were similar to those reported in Caucasian patients. CONCLUSIONS: The 3-week regimen of capecitabine was effective and well tolerated in Japanese patients with MCRC as well, and could be used as the basic regimen for future combination therapies.

Administration, Oral↗
PubMed2006

Disease activity and 18F-FDG uptake in organising pneumonia: semi-quantitative evaluation using computed tomography and positron emission tomography.

PURPOSE: The present study was conducted to evaluate whether( 18)F-fluorodeoxyglucose positron emission tomography (FDG-PET) in combination with computed tomography (CT) reflects disease activity in patients with organising pneumonia. METHODS: Eighty-eight subjects who were normal (n=66) or who had proven organising pneumonia (n=22) underwent FDG-PET and CT imaging. The subjects included 55 men and 33 women, ranging in age from 24 to 63 years (mean 47 years). PET and CT data sets were digitally fused using a conformational PET/CT fusion algorithm. All scans were evaluated independently by two chest radiologists who were unaware of other clinical data. The visual score, maximal and mean standardised uptake value (SUV), and maximal and mean lesion-to-normal tissue ratio (LNR) were calculated. The imaging results were compared with the laboratory and pulmonary function test results. The inflammatory cells in the lesions were quantified immunohistochemically. RESULTS: The visual score, maximal and mean SUV, and maximal and mean LNR of the patients with organising pneumonia were significantly higher than those of the normal subjects. The patients with air-space consolidation had a significantly higher SUV than those without air-space consolidation (mean+/-SD 3.08+/-0.39 vs 2.35+/-0.56; p<0.05). The number of CD45(+) cells was positively correlated with the maximal SUV (r=0.632, p<0.01) and the maximal LNR (r=0.453, p<0.05). The number of CD8(+) T lymphocytes also showed positive correlations with the maximal SUV (r=0.540, p<0.01) and the maximal LNR (r=0.547, p<0.01). CONCLUSION: Patients with organising pneumonia have an enhanced FDG accumulation which reflects the degree of disease activity.

Adult↗
PubMed2006

CT-guided needle biopsy of lung lesions: a survey of severe complication based on 9783 biopsies in Japan.

PURPOSE: The aim of our study was to update the rate of severe complications following CT-guided needle biopsy in Japan via a mailed survey. MATERIALS AND METHODS: Postal questionnaires regarding CT-guided needle biopsy were sent out to multiple hospitals in Japan. The questions regarded: the total number and duration of CT-guided lung biopsies performed at each hospital, and the complication rates and numbers of pneumothorax, hemothorax, air embolism, tumor seeding, tension pneumothorax and other rare complications. Each severe complication was followed with additional questions. RESULTS: Data from 9783 biopsies was collected from 124 centers. Pneumothorax was the most common complication, and occurred in 2412 (35%) of 6881 cases. A total of 39 (35%) hospitals reported 74 (0.75%) cases with severe complications. There were six cases (0.061%) with air embolism, six cases (0.061%) with tumor seeding at the site of the biopsy route, 10 cases (0.10%) with tension pneumothorax, six cases (0.061%) with severe pulmonary hemorrhage or hemoptysis, nine cases (0.092%) with hemothorax, and 27 cases (0.26%) with others, including heart arrest, shock, and respiratory arrest. From a total of 62 patients with severe complications, 54 patients (0.55%) recovered without sequela, however one patient (0.01%) recovered with hemiplegia due to cerebral infarction, and the remaining seven patients (0.07%) died. CONCLUSIONS: This is the first national study documenting severe complications with respect to CT-guided needle biopsy in Japan. The complication rate in Japan is comparable to internationally published figures. We believe this data will improve both clinicians as well as patients understanding of the risk versus benefit of CT-guided needle biopsy, resulting better decisions.

Biopsy, Needle↗
PubMed2006

Glut-1 expression and enhanced glucose metabolism are associated with tumour grade in bone and soft tissue sarcomas: a prospective evaluation by [18F]fluorodeoxyglucose positron emission tomography.

PURPOSE: This study was conducted to investigate whether( 18)F-fluorodeoxyglucose (FDG) uptake, quantified by positron emission tomography (PET), correlates with histological variables including tumour grade, cell proliferation, cell cycle control integrity and glucose metabolism in patients with bone and soft tissue sarcomas. METHODS: Eighty-two patients clinically suspected of having a bone or soft tissue sarcoma underwent FDG PET within 1 week prior to operation and 63 patients (mean age 48 years, range 18-74 years) were enrolled in the complete analysis. We excluded 17 patients with pathologically confirmed benign tumours and two patients with uncontrolled diabetes or concomitant malignancy from data analysis. Maximum and average standardised uptake values (SUVs) of the primary lesion were compared with histological variables including tumour differentiation, the presence of necrosis, MIB-1 score, mitotic score, p53 overexpression, MIB-1 grade, mitotic grade and GLUT-1 expression. RESULTS: Significant correlations were found between maximal and mean SUVs and MIB-1 grade, mitotic grade, MIB-1 score, tumour differentiation and mitotic score. The mean and maximal SUVs were significantly higher in tumours with p53 overexpression than in those without p53 overexpression (p<0.0001). GLUT-1-positive tumours had significantly higher mean (6.5+/-4.2 vs 1.1+/-0.2, p=0.006) and maximal SUVs (8.8+/-5.4 vs 1.7+/-0.5, p=0.005) than the GLUT-1-negative tumours. GLUT-1 intensity correlated positively with both mean (r=0.500, p<0.0001) and maximal SUVs (r=0.509, p<0.0001). Mu ltiple linear regression analysis showed a significant correlation between maximal SUV and MIB-1 grade (p<0.0001). CONCLUSION: The enhanced glucose metabolism, as determined by SUV, is a strong index of tumour grade in bone and soft tissue sarcomas.

Adolescent↗
PubMed2006

CT and MRI findings in KIT-weak or KIT-negative atypical gastrointestinal stromal tumors.

The large majority of gastrointestinal stromal tumors (GIST) can be diagnosed on the basis of KIT immunoreactivity. However, some atypical tumors show weak or negative KIT expression. We studied the imaging characteristics of atypical GIST, reviewing CT and MRI findings in ten patients (eight men, two women; mean age 59 years) with atypical GIST. Radiological studies were evaluated by two radiologists by consensus and included CT and MR imaging in all patients. Pathological diagnoses were made from surgery and confirmed by the polymerase-chain reaction (PCR) to amplify both exons of the c-kit gene and PDGFRA gene. The CT and MR examinations revealed a heterogeneous mass of the stomach containing cystic regions and soft tissue elements in all cases. All lesions were extraluminal masses and had an exophytic epicenter. On T1-weighted MR images soft tissue elements of the tumors were of homogeneously low- (n=3) or iso-signal intensity (n=7) compared with the liver parenchyma. On fast spin-echo T2-weighted MR images soft tissue elements of all tumors showed cystic regions of significantly high signal intensity interspersed with septumlike structures of low signal intensity. All lesions exhibited homogeneously (n=4) or heterogeneously (n=6) mild to moderate enhancement of soft tissue elements. Despite the relatively small number of patients CT and MRI findings of atypical GIST are a submucosal mass with soft tissue elements and cystic regions.

Aged↗
PubMed2006

A case of ganglioneuroma presenting abnormal FDG uptake.

We report a case of ganglioneuroma with abnormal 18F-fluorodeoxyglucose (FDG) uptake. A 26-year-old woman presented to the hospital with a slowly growing abdominal tumor without symptoms. She was diagnosed with neuroblastoma in childhood and treated by surgery and chemotherapy. Computed tomography (CT) revealed huge retroperitoneal tumors and fused 18F-fluorodeoxyglucose positron emission tomography (FDG-PET)/CT image showed abnormal accumulation of FDG in tumors with maximal standardized uptake value of 2.02. Considering her past history, ganglioneuroma matured from neuroblastoma was considered, the most likely diagnosis. However, a second primary malignant tumor, such as malignant peripheral nerve sheath tumor arising in ganglioneuroma, could not be ruled out. Then, an excisional biopsy was performed and the diagnosis of mature ganglioneuroma was made. Pathological investigation may be needed to differentiate ganglioneuroma from other malignant tumors and, therefore, FDG-PET/CT findings can be helpful for biopsy planning.

Abdominal Neoplasms↗
PubMed2006

Diaphyseal medullary stenosis with pleomorphic malignant fibrous histiocytoma of the bone: 99mTc hydroxymethylenediphosphonate and 201Tl chloride scintigraphy findings.

Diaphyseal medullary stenosis (DMS) is an extremely rare hereditary bone dysplasia, which was first described by Arnold in 1973. DMS has a high incidence of pleomorphic malignant fibrous histiocytoma (MFH). In this paper, we report the imaging findings of DMS with pleomorphic MFH of the bone, mainly describing 99mTc hydroxymethylenediphosphonate (HMDP) and thallium-201 (201Tl) chloride scintigraphy findings. On 99mTc HMDP scintigraphy, focal increased uptake area of the right femur corresponded to the area of bone marrow invasion of the tumor and bone infarction. The mechanism of the uptake of 99mTc HMDP to the extraosseous lesion was not clear. On 201Tl chloride scintigraphy, the increased uptake of the periphery of the mass seemed to reflect the aggressiveness of invasion and the cellularity.

Adult↗
PubMed2006

Omental torsion.

A 65-year-old man presented to the emergency department complaining of right lower abdominal pain. Abdominal computed tomography showed a whirling pattern of fatty streaks and vessels in the greater omentum. From this typical finding, a diagnosis of omental torsion was made immediately, which was confirmed by subsequent surgery. We report a case of surgically and pathologically proven omental torsion that demonstrated a typical appearance on computed tomography and was diagnosed preoperatively.

Abdominal Pain↗
PubMed2006

CT and MRI features of low-grade fibromyxoid sarcoma in the shoulder of a pediatric patient.

We report the computed tomography (CT) and magnetic resonance imaging (MRI) features of a 10-year-old boy with low-grade fibromyxoid sarcoma (LGFMS) in the shoulder and correlate them with the clinicopathological features. LGFMS, a rare soft tissue sarcoma with bland histological features and paradoxically aggressive behavior, tends to occur in superficial regions and in children more than previously recognized. To date, few imaging studies have been reported, particularly in pediatric patients. In this case, precontrast CT showed a low- to isodensity mass and punctate calcification. On contrast-enhanced CT, heterogeneous enhancement was seen. MRI findings correlated well with the pathological features of the tumor. The myxoid area showed high signal intensity on T2-weighted MR images and heterogeneous enhancement after administration of contrast material; the hypercellular area demonstrated lower signal intensity on T2-weighted MR images and slight enhancement.

Child↗
PubMed2006

Pseudo-occlusion of the hepatic artery during hepatic arterial infusion chemotherapy.

Hepatic arterial occlusion (HAO) is frequently encountered in patients receiving hepatic arterial infusion chemotherapy (HAIC) via an implanted port-catheter system. Usually, HAO precludes continuation of HAIC, and treatment for liver metastases is changed to systemic chemotherapy. However, two cases were encountered in which, even though HAO was diagnosed by arteriography via the port, the hepatic artery was actually patent. These cases illustrate that arteriography via the port is insufficient to confirm HAO.

Aged↗
PubMed2006

Staging performance of carbon-11 choline positron emission tomography/computed tomography in patients with bone and soft tissue sarcoma: comparison with conventional imaging.

The present study was conducted to compare the diagnostic accuracy between carbon-11 choline (11C-choline) positron emission tomography (PET)/computed tomography (CT) and conventional imaging for the staging of bone and soft tissue sarcomas. Sixteen patients who underwent 11C-choline PET/CT prior to treatment were evaluated retrospectively for staging accuracy. Conventional imaging methods consisted of 99,mTc-hydroxymethylene diphosphonate bone scintigraphy, chest CT and magnetic resonance imaging of the primary site. The images were reviewed and a consensus was reached by two board-certified radiologists who were unaware of any clinical or radiological information using hard-copy films and multimodality computer platform. Tumor stage was confirmed by histological examination and/or by an obvious progression in number and/or size of the lesions on follow-up examinations. Reviewers examining both 11C-choline PET/CT and conventional imaging classified T stage in all patients. Interpretation based on 11C-choline PET/CT, the Node (N) stage was correctly diagnosed in all patients, whereas the accuracy of conventional imaging in N stage was 63%. Tumor Node Metastasis (TNM) stage was assessed correctly with 11C-choline PET/CT in 15 of 16 patients (94%) and with conventional imaging in eight of 16 patients (50%). The overall TNM staging and N staging accuracy of 11C-choline PET/CT were significantly higher than that of conventional imaging (P < 0.05). 11C-choline PET/CT is more accurate than conventional imaging regarding clinical staging of patients with bone and soft tissue sarcomas. A whole body 11C-choline PET/CT might be acceptable for imaging studies of tumor staging prior to treatment.

Adolescent↗
PubMed2006

Leiomyosarcoma of the renal vein: arterial encasement on contrast-enhanced dynamic computed tomography.

We report a case of leiomyosarcoma of the renal vein, which is a rare tumor with no more than 30 cases found in the published English language literature. This case demonstrates encasement of the renal artery by the tumor mass, a previously unreported manifestation. The present study could be useful in considering this rare tumor in the differential diagnosis of renal hilar tumors.

Aged↗