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1.
Ann Hematol ; 103(6): 2021-2031, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38280061

RESUMEN

Secondary central nervous system involvement (sCNSi) in diffuse large B-cell lymphoma (DLBCL) is fatal. However, its features in patients with sCNSi who are categorized as lower risk by international prognostic index (IPI) or CNS-IPI are not yet fully understood. In the present analysis, we evaluated DLBCL patients who developed sCNSi at their first progression and who participated in JCOG0601, most of whom were lower risk by IPI. Of 409 patients, 21 (5.1%) developed sCNSi during a median follow-up of 4.9 years. Five-year cumulative incidence of sCNSi were 5.1%; and 4.0%, 5.3%, and 11.5% at low, intermediate, and high risk of CNS-IPI, respectively. The most common locations of extranodal lesions at the time of registration in patients with sCNSi were the stomach (n = 4), paranasal cavity (n = 3), and bone marrow (n = 2). In univariable analysis, paranasal cavity lesion was a high-risk factor for sCNSi (subdistribution hazard ratio, 4.34 [95% confidence interval 1.28-14.73]). Median overall survival after sCNSi was 1.3 years, with a 2-year overall survival rate of 39.3%. The incidence of sCNSi in DLBCL patients at lower risk of CNS-IPI was low, as previously reported, but paranasal cavity lesion might indicate high risk for organ involvement. CLINICAL TRIAL REGISTRATION: JCOG0601 was registered in the UMIN Clinical Trials Registry (UMIN000000929, date of registration; December 04, 2007) and the Japan Registry of Clinical Trials (jRCTs031180139, date of registration; February 20, 2019).


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias del Sistema Nervioso Central , Ciclofosfamida , Doxorrubicina , Linfoma de Células B Grandes Difuso , Prednisona , Rituximab , Vincristina , Humanos , Linfoma de Células B Grandes Difuso/tratamiento farmacológico , Linfoma de Células B Grandes Difuso/epidemiología , Rituximab/uso terapéutico , Masculino , Femenino , Vincristina/uso terapéutico , Vincristina/administración & dosificación , Persona de Mediana Edad , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Anciano , Doxorrubicina/uso terapéutico , Ciclofosfamida/uso terapéutico , Ciclofosfamida/administración & dosificación , Neoplasias del Sistema Nervioso Central/tratamiento farmacológico , Adulto , Prednisona/uso terapéutico , Prednisona/administración & dosificación , Anciano de 80 o más Años , Estudios de Seguimiento , Tasa de Supervivencia
2.
Jpn J Clin Oncol ; 53(3): 195-202, 2023 Mar 07.
Artículo en Inglés | MEDLINE | ID: mdl-36702740

RESUMEN

Assessments of patient-reported outcomes and health-related quality of life in cancer clinical trials have been increasingly emphasized recently because patient and public involvement in cancer treatment development has been promoted by regulatory authorities and academic societies. To assess patient experiences during and after cancer treatment, there is interest in implementing patient-reported outcome and health-related quality of life assessments into cancer clinical trials. The Japan Clinical Oncology Group quality of life ad hoc committee previously created a version of the Quality of Life Assessment Policy in 2006. Recently, there has been increasing demand from Japan Clinical Oncology Group researchers to assess patient-reported outcome/health-related quality of life in clinical trials. Although guidelines are available regarding planning and reporting clinical trials that include patient-reported outcome/health-related quality of life as an endpoint, there are still issues regarding the lack of consensus on standardized methods for analysing and interpreting the results. Hence, it was considered necessary to reorganize the Japan Clinical Oncology Group patient-reported outcome/quality of life research committee and to revise the former patient-reported outcome/quality of life research policy to promote patient-reported outcome/health-related quality of life research in future Japan Clinical Oncology Group trials. The purpose of this Japan Clinical Oncology Group patient-reported outcome/quality of life research policy is to define patient-reported outcome/health-related quality of life research and provide guidelines for including patient-reported outcome/health-related quality of life as an endpoint in Japan Clinical Oncology Group trials.


Asunto(s)
Neoplasias , Calidad de Vida , Humanos , Japón , Oncología Médica , Neoplasias/terapia , Políticas
3.
Int J Clin Oncol ; 28(10): 1411-1420, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37526805

RESUMEN

BACKGROUND: Ovarian serous borderline tumors (SBT) are typically unilateral and are primarily treated using hysterectomy and bilateral salpingooophorectomy (SO). However, most young patients prefer fertility-sparing surgeries (FSS) with tumorectomy or unilateral SO. Micropapillary morphology and invasive implants have been designated as histopathological risk indicators for recurrence or metastasis, but their clinical impact remains controversial because of limitations like diagnostic inconsistency and incomplete surgical staging. METHODS: A nationwide multi-institutional population-based retrospective surveillance was conducted with a thorough central pathology review to reveal the clinical features of SBT. Of 313 SBT patients enrolled in the Japanese Society of Clinical Oncology's Surveillance of Gynecologic Rare Tumors, 289 patient records were reviewed for clinical outcomes. The glass slides of patients at stage II-IV or with recurrence or death were re-evaluated by three gynecological pathologists. RESULT: The 10-year overall and progression-free survival (PFS) rates were 98.6% and 92.3%. The median recurrence period was 40 months and 77.0% was observed in the contralateral ovary within 60 months. Patients aged ≤ 35 years underwent FSS more frequently and relapsed more (p < .001). A clinic-pathological analysis revealed diagnosis during pregnancy, FSS, and treatment at non-university institutes as well as advanced stage and large diameter were independent risk factors of recurrence. Among patients having pathologically confirmed SBTs, PFS was not influenced by the presence of micropapillary pattern or invasive implants. CONCLUSION: The recurrence rate was lower in this cohort than previous reports, but the clinical impacts of incomplete resection and misclassification of the tumor were still significant on the treatment of SBT.

4.
J Appl Clin Med Phys ; 24(6): e14040, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37191875

RESUMEN

PURPOSE: The Medical Physics Working Group of the Radiation Therapy Study Group at the Japan Clinical Oncology Group is currently developing a virtual audit system for intensity-modulated radiation therapy dosimetry credentialing. The target dosimeters include films and array detectors, such as ArcCHECK (Sun Nuclear Corporation, Melbourne, Florida, USA) and Delta4 (ScandiDos, Uppsala, Sweden). This pilot study investigated the feasibility of our virtual audit system using previously acquired data. METHODS: We analyzed 46 films (32 and 14 in the axial and coronal planes, respectively) from 29 institutions. Global gamma analysis between measured and planned dose distributions used the following settings: 3%/3 mm criteria (the dose denominator was 2 Gy), 30% threshold dose, no scaling of the datasets, and 90% tolerance level. In addition, 21 datasets from nine institutions were obtained for array evaluation. Five institutions used ArcCHECK, while the others used Delta4. Global gamma analysis was performed with 3%/2 mm criteria (the dose denominator was the maximum calculated dose), 10% threshold dose, and 95% tolerance level. The film calibration and gamma analysis were conducted with in-house software developed using Python (version 3.9.2). RESULTS: The means ± standard deviations of the gamma passing rates were 99.4 ± 1.5% (range, 92.8%-100%) and 99.2 ± 1.0% (range, 97.0%-100%) in the film and array evaluations, respectively. CONCLUSION: This pilot study demonstrated the feasibility of virtual audits. The proposed virtual audit system will contribute to more efficient, cheaper, and more rapid trial credentialing than on-site and postal audits; however, the limitations should be considered when operating our virtual audit system.


Asunto(s)
Planificación de la Radioterapia Asistida por Computador , Radioterapia de Intensidad Modulada , Humanos , Proyectos Piloto , Japón , Habilitación Profesional , Radiometría , Dosificación Radioterapéutica , Oncología Médica , Fantasmas de Imagen
5.
Int J Clin Oncol ; 26(2): 429-437, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33111205

RESUMEN

BACKGROUND: [18F] fluorodeoxyglucose-positron emission tomography is incorporated in response criteria currently used for lymphoma; however, the primary endpoint in earlier phase study is an overall response, which includes the partial response of 50% shrinkage in two dimensions. Therefore, the measurement of target lesions is still prerequisite to determine the destiny of new, promising agents. Since required is calculating the sum of the product of bidimensional diameters of maximal six target lesions, the International Workshop Criteria (IWC) used as response evaluation in lymphoma is more time-consuming than the Response Evaluation Criteria in Solid Tumors (RECIST). This study aimed to examine whether the RECIST could replace the IWC using data from a phase II/III study of R-CHOP-21 versus R-CHOP-14 for advanced-stage indolent B-cell lymphoma, JCOG0203. METHODS: To evaluate the degree of agreement between them, the Kappa coefficient (KC) was calculated. Excluding patients without target lesions for the RECIST following central pathological review, 269 patients were evaluable. We determined which criterion was more predictive for progression-free survival. The criterion showing the lower point estimate of the hazard ratio (HR) of a complete response (CR) vs. a non-CR was defined as more useful. RESULTS: The KC between them was 0.34 (95% confidence interval [CI] 0.26-0.42); namely, indicating poor agreement. The HR of the IWC (0.47: 95% CI 0.33-0.68, log-rank test p < 0.001) was lower than that of the RECIST (0.64: 95% CI 0.45-0.89, p = 0.0075). CONCLUSION: We conclude that unidimensional measurements cannot be substituted for the bidimensional ones for indolent lymphoma.


Asunto(s)
Linfoma de Células B , Humanos , Linfoma de Células B/diagnóstico por imagen , Linfoma de Células B/tratamiento farmacológico , Tomografía de Emisión de Positrones , Criterios de Evaluación de Respuesta en Tumores Sólidos , Resultado del Tratamiento
6.
Cancer Sci ; 111(10): 3770-3779, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32767806

RESUMEN

The efficiency of upfront consolidation with high-dose chemotherapy/autologous stem-cell transplantation (HDCT/ASCT) for newly diagnosed high-risk diffuse large B-cell lymphoma (DLBCL) may be influenced by induction chemotherapy. To select better induction chemotherapy regimens for HDCT/ASCT, a randomized phase II study was conducted in high-risk DLBCL patients having an age-adjusted International Prognostic Index (aaIPI) score of 2 or 3. As induction chemotherapy, 6 cycles of R-CHOP-14 (arm A) or 3 cycles of R-CHOP-14 followed by 3 cycles of CHASER (arm B) were planned, and patients who responded proceeded to HDCT with LEED and ASCT. The primary endpoint was 2-y progression-free survival (PFS), and the main secondary endpoints included overall survival, overall response rate, and adverse events (AEs). In total, 71 patients were enrolled. With a median follow-up of 40.3 mo, 2-y PFS in arms A and B were 68.6% (95% confidence interval [CI], 50.5%-81.2%) and 66.7% (95% CI: 48.8%-79.5%), respectively. Overall survival at 2 y in arms A and B was 74.3% (95% CI: 56.4%-85.7%) and 83.3% (95% CI: 66.6%-92.1%). Overall response rates were 82.9% in arm A and 69.4% in arm B. During induction chemotherapy, 45.7% and 75.0% of patients in arms A and B, respectively, had grade ≥ 3 non-hematologic toxicities. One patient in arm A and 6 in arm B discontinued induction chemotherapy due to AEs. In conclusion, R-CHOP-14 showed higher 2-y PFS and less toxicity compared with R-CHOP-14/CHASER in patients with high-risk DLBCL, suggesting the former to be a more promising induction regimen for further investigations (UMIN-CTR, UMIN000003823).


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Trasplante de Células Madre Hematopoyéticas/métodos , Quimioterapia de Inducción/métodos , Linfoma de Células B Grandes Difuso/terapia , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Terapia Combinada , Ciclofosfamida/administración & dosificación , Ciclofosfamida/efectos adversos , Doxorrubicina/administración & dosificación , Doxorrubicina/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prednisona/administración & dosificación , Prednisona/efectos adversos , Supervivencia sin Progresión , Rituximab/administración & dosificación , Rituximab/efectos adversos , Trasplante Autólogo/efectos adversos , Vincristina/administración & dosificación , Vincristina/efectos adversos , Adulto Joven
7.
Jpn J Clin Oncol ; 50(4): 379-386, 2020 Apr 07.
Artículo en Inglés | MEDLINE | ID: mdl-32083282

RESUMEN

Primary debulking surgery followed by platinum-based chemotherapy remains the standard treatment of patients with stage III-IV epithelial ovarian cancer. Neoadjuvant chemotherapy is an alternative treatment regimen that can be considered in selected patients. Complete cytoreduction, both through primary debulking surgery and interval debulking surgery, has a major positive effect on survival and should be the goal, even if this requires extensive surgery. When thorough assessment of tumor spread and performance status of the patient indicates that complete primary cytoreduction is not feasible without unacceptable morbidity, then alternative therapeutic strategies, such as neoadjuvant chemotherapy, must be considered. Such patients can be offered the option of interval debulking surgery after checking their response to neoadjuvant chemotherapy and resolution of the initial obstacles for primary debulking surgery (i.e. complete response of irresectable disease and improvement of the performance status). Current evidence suggests that a selected group of patients with International Federation of Gynecology and Obstetrics stage III-IV ovarian cancer will benefit from NAC-IDS. Research is ongoing to identify patients who might derive the greatest benefit from neoadjuvant chemotherapy followed by interval debulking surgery, instead of primary debulking surgery, on the basis of radiological, genetic, pathological, and immunological variables. In this review, we discuss current knowledge about the clinical significance of primary debulking surgery and neoadjuvant chemotherapy in advanced ovarian cancer and discuss unanswered questions in the field.


Asunto(s)
Procedimientos Quirúrgicos de Citorreducción , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/cirugía , Quimioterapia Adyuvante , Femenino , Humanos , Estadificación de Neoplasias , Neoplasias Ováricas/patología , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
8.
Jpn J Clin Oncol ; 50(5): 502-511, 2020 May 05.
Artículo en Inglés | MEDLINE | ID: mdl-32115625

RESUMEN

The Japan Clinical Oncology Group Lung Cancer Study Group has been carrying out clinical studies, exploring new strategies of treatment, supportive therapies (antiemetics, etc.), etc., for a variety of cancers, including not only small cell lung cancer and non-small cell lung cancer but also rare chest tumours (represented by thymoma) and cancer-associated conditions (cancerous pericarditis, cancerous pleuritis, etc.). In this review, an overview of all studies conducted from 1985 to 2019 is provided.


Asunto(s)
Neoplasias Pulmonares/historia , Oncología Médica/historia , Carcinoma de Pulmón de Células no Pequeñas/historia , Carcinoma de Pulmón de Células no Pequeñas/terapia , Historia del Siglo XX , Historia del Siglo XXI , Humanos , Japón , Neoplasias Pulmonares/terapia , Carcinoma Pulmonar de Células Pequeñas/historia , Carcinoma Pulmonar de Células Pequeñas/terapia
9.
Jpn J Clin Oncol ; 49(10): 901-910, 2019 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-31565730

RESUMEN

Due to the rapid aging of Japan's population, clinical research focusing on older patients with cancer is urgently needed. The Japan Clinical Oncology Group (JCOG) has conducted several such clinical trials, but there has been no formal policy for geriatric research. We have therefore established a JCOG policy for geriatric cancer research. We defined the patient selection policy based on treatment tolerance and chronological age. Older patients are categorized into three conceptual groups: 'fit patients' who can undergo the same standard treatment given to younger patients, 'frail patients' for whom best supportive or palliative care is indicated and 'vulnerable patients' who fall between the fit and frail categories. Unmet needs often exist for vulnerable patients. The policy recommends that study endpoints include not only survival but also other endpoints such as physical and cognitive function because the objective of therapy in older patients is not only extended life expectancy but also maintenance of the patient's general condition. In this viewpoint, co-primary or composite endpoints that incorporate geriatric assessment in the study design are often applicable. Study design will differ depending on the study population, clinical question, and treatment. Even for older patients, a randomized clinical trial is still the gold standard when the clinical question asks which treatment is better. An observational study of a broader population is applicable for investigating actual conditions of older patients. This JCOG Geriatric Research Policy includes several practical solutions for various issues in geriatric research. We plan to revise this policy periodically to guide future geriatric research.


Asunto(s)
Investigación Biomédica , Evaluación Geriátrica , Política de Salud , Oncología Médica , Anciano , Determinación de Punto Final , Humanos , Japón , Ensayos Clínicos Controlados Aleatorios como Asunto
10.
Jpn J Clin Oncol ; 49(8): 727-733, 2019 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-31329908

RESUMEN

BACKGROUND: New Japanese ethical guidelines for medical researches and the Clinical Trials Act have come into effect and monitoring is mandated for intervention studies. Methods of monitoring can be modified according to a study risk, but there is no established method in Japan regarding how to assess a study risk. EORTC assesses a study risk using their own study risk calculator and classifies their trials into three categories. For each category, different levels of monitoring are applied. This project is aimed to assess the study risks of JCOG trials using the EORTC calculator. METHODS: We selected clinical trials open to patient recruitment in JCOG as of Nov 2014. Each trial was scored based on the EORTC study risk calculator and classified into three risk categories; low, medium and high. RESULTS: A total of 40 studies were included in the assessment. Twenty-seven studies (67.5%) were classified into low risk group, 12 (30%) in medium risk group, and only 1 (2.5%) in high risk group. Clinical trials evaluating multimodality therapy and/or using unapproved drugs tended to be scored higher and most of them were classified into medium or high risk group. CONCLUSIONS: JCOG conducts central monitoring and site visit audit with sampling source data verification for every trial, which are almost compatible with the way in EORTC for the medium risk group. Because most of the JCOG studies were classified into low or medium risk group, the intensity of monitoring and audit in JCOG was considered as reasonable even from the EORTC perspective.


Asunto(s)
Investigación Biomédica , Ensayos Clínicos como Asunto , Oncología Médica , Neoplasias/terapia , Medición de Riesgo , Terapia Combinada , Humanos , Japón , Factores de Riesgo
11.
Cancer Sci ; 109(7): 2286-2293, 2018 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-29772611

RESUMEN

Aggressive adult T-cell leukemia/lymphoma (ATL) has an extremely poor prognosis and is hyperendemic in Okinawa, Japan. This study evaluated two prognostic indices (PIs) for aggressive ATL, the ATL-PI and Japan Clinical Oncology Group (JCOG)-PI, in a cohort from Okinawa. The PIs were originally developed using two different Japanese cohorts that included few patients from Okinawa. The endpoint was overall survival (OS). Multivariable Cox regression analyses in the cohort of 433 patients revealed that all seven factors for calculating each PI were statistically significant prognostic predictors. Three-year OS rates for ATL-PI were 35.9% (low-risk, n = 66), 10.4% (intermediate-risk, n = 256), and 1.6% (high-risk, n = 111), and those for JCOG-PI were 22.4% (moderate-risk, n = 176) and 5.3% (high-risk, n = 257). The JCOG-PI moderate-risk group included both the ATL-PI low- and intermediate-risk groups. ATL-PI more clearly identified the low-risk patient subgroup than JCOG-PI. To evaluate the external validity of the two PIs, we also assessed prognostic discriminability among 159 patients who loosely met the eligibility criteria of a previous clinical trial. Three-year OS rates for ATL-PI were 34.5% (low-risk, n = 42), 9.2% (intermediate-risk, n = 109), and 12.5% (high-risk, n = 8). Those for JCOG-PI were 22.4% (moderate-risk, n = 95) and 7.6% (high-risk, n = 64). The low-risk ATL-PI group had a better prognosis than the JCOG-PI moderate-risk group, suggesting that ATL-PI would be more useful than JCOG-PI for establishing and examining novel treatment strategies for ATL patients with a better prognosis. In addition, strongyloidiasis, previously suggested to be associated with ATL-related deaths in Okinawa, was not a prognostic factor in this study.


Asunto(s)
Enfermedades Endémicas , Leucemia-Linfoma de Células T del Adulto/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Humanos , Japón/epidemiología , Masculino , Persona de Mediana Edad , Pronóstico , Modelos de Riesgos Proporcionales , Tasa de Supervivencia
12.
Gastric Cancer ; 20(5): 904-912, 2017 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-28150070

RESUMEN

The role of multidisciplinary treatment including surgery for liver metastases from gastric cancer (LMGC) is controversial. Studies to answer this clinical question are increasing in number, but all published data thus far are based on retrospective analyses with limited sample sizes. Thus, the European Organisation for Research and Treatment of Cancer (EORTC) Gastrointestinal Tract Cancer Group (GITCG) and the Japan Clinical Oncology Group (JCOG) Stomach Cancer Study Group (SCSG) initiated a collaboration to develop an optimal treatment strategy for LMGC. Before planning a prospective study, a questionnaire was sent out to the network members of both groups in June 2016 to clarify current common practice in each region. Sixty-seven sites from 17 countries in the EORTC network and 55 sites from Japan responded. According to the survey, for patients with resectable LMGC without extrahepatic metastases, preoperative chemotherapy followed by resection of both primary (if still in place) and liver lesions was the preferred option for both the synchronous and the metachronous setting. For patients with unresectable LMGC, most of the sites recommended chemotherapy only. In this article, the detailed results of this survey are reported, shedding light on current community practice, and a joint EORTC-JCOG strategy of investigation is delineated.


Asunto(s)
Antineoplásicos/administración & dosificación , Neoplasias Hepáticas/terapia , Neoplasias Gástricas/terapia , Terapia Combinada , Encuestas de Atención de la Salud , Humanos , Cooperación Internacional , Neoplasias Hepáticas/secundario , Neoplasias Primarias Múltiples/patología , Neoplasias Primarias Múltiples/terapia , Neoplasias Primarias Secundarias/patología , Neoplasias Primarias Secundarias/terapia , Neoplasias Gástricas/patología
13.
Surg Today ; 46(6): 668-85, 2016 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-26289837

RESUMEN

PURPOSE: Prior to publication of the Clavien-Dindo classification in 2004, there were no grading definitions for surgical complications in either clinical practice or surgical trials. This report establishes supplementary criteria for this classification to standardize the evaluation of postoperative complications in clinical trials. METHODS: The Japan Clinical Oncology Group (JCOG) commissioned a committee. Members from nine surgical study groups (gastric, esophageal, colorectal, lung, breast, gynecologic, urologic, bone and soft tissue, and brain) specified postoperative complications experienced commonly in their fields and defined more detailed grading criteria for each complication in accordance with the general grading rules of the Clavien-Dindo classification. RESULTS: We listed 72 surgical complications experienced commonly in surgical trials, focusing on 17 gastroenterologic complications, 13 infectious complications, six thoracic complications, and several other complications. The grading criteria were defined simply and were optimized for surgical complications. CONCLUSIONS: The JCOG postoperative complications criteria (JCOG PC criteria) aim to standardize the terms used to define adverse events (AEs) and provide detailed grading guidelines based on the Clavien-Dindo classification. We believe that the JCOG PC criteria will allow for more precise comparisons of the frequency of postoperative complications among trials across many different surgical fields.


Asunto(s)
Clasificación/métodos , Oncología Médica/organización & administración , Complicaciones Posoperatorias/clasificación , Miembro de Comité , Humanos , Japón , Estándares de Referencia
14.
Oral Oncol ; 157: 106976, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-39111143

RESUMEN

BACKGROUND AND PURPOSE: Hypothyroidism is a recognized late adverse event following radiotherapy for head and neck cancer (HNC). In the JCOG1008 trial, we treated patients with high-risk HNC with postoperative chemoradiotherapy. We aimed to elucidate factors associated with hypothyroidism by analyzing the JCOG1008 data. MATERIALS AND METHODS: In 2012-2018, 261 patients from 28 institutions were enrolled in JCOG1008. Thyroid function tests were conducted to assess hypothyroidism, including free thyroxine (FT4) and thyroid-stimulating hormone assays. Hypothyroidism was defined as Grade 2 or higher in CTCAE v4.0. Various clinical and dosimetric parameters were analyzed. In radiotherapy, there were no dose constraints for the thyroid. Multivariable analysis was conducted on these variables to identify predictive factors for hypothyroidism. RESULTS: The analysis included 162 patients (57 with 3D-CRT and 105 with IMRT), with a median follow-up of 4.7 years (0.3-9.3 years). Among these, 27 (16.7 %) developed hypothyroidism within 2 years after radiotherapy. In a multivariable analysis, the weekly cisplatin [OR=7.700 (CI: 1.632-36.343, p = 0.010)] and baseline FT4 [OR=0.009 (CI: <0.001-0.313, p = 0.010)] were significantly associated with hypothyroidism in the IMRT group. Regarding dosimetric characteristics, V60Gy [OR=1.069 (CI: 0.999-1.143, p = 0.054)] was potentially associated with the development of hypothyroidism. CONCLUSION: The study revealed that the incidence of hypothyroidism within 2 years after postoperative chemoradiotherapy for high-risk HNC was 16.7 % based on analytical results from prospective clinical trials.


Asunto(s)
Neoplasias de Cabeza y Cuello , Hipotiroidismo , Humanos , Hipotiroidismo/etiología , Hipotiroidismo/epidemiología , Masculino , Femenino , Persona de Mediana Edad , Neoplasias de Cabeza y Cuello/radioterapia , Neoplasias de Cabeza y Cuello/terapia , Factores de Riesgo , Incidencia , Anciano , Quimioradioterapia/efectos adversos , Adulto
15.
Ann Gastroenterol Surg ; 7(6): 856-862, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37927916

RESUMEN

Treatment strategy for locally advanced gastric cancer differs worldwide. Neoadjuvant chemotherapy (NAC) is considered one of the promising treatment options for locally advanced gastric cancer, even in Japan, and clinical trials have been conducted or are ongoing. A consensus meeting was organized at the 77th general meeting of the Japanese Society of Gastroenterological Surgery in 2022, in which the current status and future prospects of NAC for locally advanced gastric cancer were discussed. Participants at the meeting looked forward to the results of the JCOG1509 trial, providing solid evidence regarding NAC. The optimal indications and regimens for NAC were also debated. Patients with cStage III gastric cancer are the main targets of NAC in Japan, and a doublet regimen of S-1 and oxaliplatin was preferred by the participants. However, the feasibility of a triplet regimen with S-1, oxaliplatin, and docetaxel, and that with 5-FU, leucovorin, oxaliplatin, and docetaxel has been demonstrated, and these could become treatment options in Japan. Other points of discussion include perioperative chemotherapy to avoid peritoneal recurrence and for patients with dMMR/MSI-high tumors. The panel regarded NAC as a promising treatment option, and NAC will become the standard treatment for cStage III gastric cancer in Japan if an ongoing clinical trial successfully demonstrates its efficacy.

17.
Front Pharmacol ; 13: 991982, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36313371

RESUMEN

Background: Alzheimer's disease (AD) is a progressive neurodegeneration and is the most prevalent form of dementia. Intervention at an early stage is imperative. Although three acetylcholinesterase inhibitors (AChEIs) are currently approved for the treatment of mild AD, they are not sufficiently effective. Novel treatments for mild AD are of utmost importance. Objective: To assess the effectiveness of hachimijiogan (HJG), a traditional Japanese herbal medicine (Kampo), in the treatment of mild AD. Methods: This exploratory, open-label, randomized, multicenter trial enrolled patients with mild AD whose score on the Mini Mental State Examination (MMSE) was over 21points. All participants had been taking the same dosage of AChEI for more than 3 months. The participants were randomly assigned to an HJG group taking HJG extract 7.5 g/day in addition to AChEI or to a control group treated only with AChEI. The primary outcome was the change from baseline to 6 months post treatment initiation on the Alzheimer's Disease Assessment Scale-cognitive component- Japanese version(ADAS-Jcog). The secondary outcomes were change from baseline of the Instrumental Activity of Daily Life (IADL), Apathy scale, and Neuropsychiatric Inventory (NPI) -Q score. Results: Among the 77 enrollees, the data of 69(34 HJG and 35 control)were available for analysis. The difference in the change of ADAS-Jcog from baseline to 6 months of the HJG and control groups was 1.29 (90% Confidence interval (CI), -0.74 to 3.32 p = 0.293). In the subgroup analysis, the differences in the change from baseline to 3 and 6 months for women were 3.70 (90% CI ,0.50 to 6.91, p = 0.059) and 2.90 (90% CI,0.09 to 5.71, p = 0.090), respectively. For patients over 65 years, the difference at 3 months was 2.35 (90%CI, 0.01 to 4.68 p = 0.099). No significant differences were found between the HJG and control groups in IADL score, Apathy scale, or NPI-Q score. Conclusion: Although not conclusive, our data indicate that HJG has an adjuvant effect for acetylcholinesterase inhibitors and that it delays the deterioration of the cognitive dysfunction of mild Altzheimer's disease patients. Clinical Trial Registration: http://clinicaltrials.gov Japan Registry of clinical trials, identifier jRCTs 071190018.

18.
Front Surg ; 9: 968199, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36248370

RESUMEN

Background: An increasing number of lung ground-glass nodules (GGNs) have been detected ever since low-dose computer tomography started growing in popularity. Three-dimensional (3D) reconstruction technology plays a critical role in lung resection, especially in segmentectomy. In this study, we explore the role of 3D reconstruction in thoracoscopic complex segmentectomy of lower lung lobe. Methods: A total of 97 patients who underwent complex segmentectomy of lower lung lobe from January 2021 to March 2022 were retrospectively analyzed. We divided these patients into a 3D group (n = 42) and a routine group (n = 55) based on preoperative 3D reconstruction or without this procedure. The demographics of patients and GGNs were collected and perioperative outcomes were compared between the two groups. Results: All of the baseline characteristics between the groups were comparable (all P > 0.05). There was no 30-day postoperative mortality and conversion in the two groups. The operation time of the 3D group was significantly shorter than that of the routine group (111.4 ± 20.8 min vs. 127.1 ± 32.3 min, P = 0.007). The number of stapler reloads during surgery in the 3D group was less than that in the routine group (9.0 ± 2.2 vs. 10.4 ± 2.6, P = 0.009). The rate of air leakage on postoperative days 1-3 was lower in the 3D group (11.9% vs. 30.9%, P = 0.027). In addition, the resection margins of all patients in the 3D group were adequate, while four patients in the routine group had inadequate resection margins, although there was no statistically significant difference (P = 0.131). Intraoperative blood loss, postoperative drainage, postoperative hospital stay, pneumonia/atelectasis, and hemoptysis were similar between the two groups. Conclusions: For performing complex segmentectomy of the lower lung lobe, the procedure of 3D reconstruction may shorten the operation time, decrease the number of stapler reloads, prevent postoperative air leakage, and guarantee a safe surgical margin. Therefore, 3D reconstruction is recommended for complex segmentectomy of the lower lung lobe.

19.
Diagnostics (Basel) ; 12(4)2022 Apr 14.
Artículo en Inglés | MEDLINE | ID: mdl-35454036

RESUMEN

Primary debulking surgery (PDS) has remained the only treatment of ovarian cancer with survival advantage since its development in the 1970s. However, survival advantage is only observed in patients who are optimally resected. Neoadjuvant chemotherapy (NACT) has emerged as an alternative for patients in whom optimal resection is unlikely and/or patients with comorbidities at high risk for perioperative complications. The purpose of this review is to summarize the evidence to date for PDS and NACT in the treatment of stage III/IV ovarian carcinoma. We systematically searched the PubMed database for relevant articles. Prior to 2010, NACT was reserved for non-surgical candidates. After publication of EORTC 55971, the first randomized trial demonstrating non-inferiority of NACT followed by interval debulking surgery, NACT was considered in a wider breadth of patients. Since EORTC 55971, 3 randomized trials-CHORUS, JCOG0602, and SCORPION-have studied NACT versus PDS. While CHORUS supported EORTC 55971, JCOG0602 failed to demonstrate non-inferiority and SCORPION failed to demonstrate superiority of NACT. Despite conflicting data, a subset of patients would benefit from NACT while preserving survival including poor surgical candidates and inoperable disease. Further randomized trials are needed to assess the role of NACT.

20.
Front Psychiatry ; 12: 685451, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34987422

RESUMEN

Research on elderly financial exploitation has mostly focused on financial abuse that occurs in families and other types of trusted relationships. As such, little is known about financial frauds and scams perpetrated by strangers. Financial fraud and scam prevention activities for older adults must be promoted, for which the correlation between the psychological, social, and cognitive characteristics of their vulnerability needs to be determined. The present study aimed to determine whether cognitive decline is a risk factor for scam vulnerability in older adults. Thus, we created a scam vulnerability scale for older adults with cognitive decline and analyzed the data to reveal the correlation between them, including inhibition and executive function. We conducted an interview survey with 50 older adults with cognitive decline (average age: 79.42 years, SD: 5.44) and 51 older adults without cognitive decline (average age: 76.12 years, SD: 5.82). The interview survey included the scam vulnerability scale, psychosocial questionnaires, and neuropsychological tests. The scale included six items with a four-point Likert scale based on a previous study. Hierarchical multiple regression analysis revealed that lower scores on the Japanese version of the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Jcog; indicating higher general cognitive function) correlated with higher scam vulnerability in the cognitive decline group (ß = -0.46, p < 0.001). In addition, men were found to be more vulnerable in both groups (cognitive decline group: ß = -0.29, p = 0.015, cognitive non-decline group; ß = -0.32, p = 0.018). Inhibition and executive function were found not to correlate significantly with scam vulnerability. These results suggest that mild cognitive decline correlates with higher scam vulnerability, whereas moderate to severe cognitive decline correlates with lower vulnerability, possibly because it makes understanding the scam attempt itself difficult. Older adults with mild cognitive decline and their families, particularly those visiting elderly care or outpatient facilities, should be notified of the scam vulnerability of older clients using the ADAS-Jcog score as an index to help them avoid victimization.

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