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1.
Breast Cancer ; 31(2): 234-242, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38079066

RESUMO

BACKGROUND: The Chemotherapy-induced Alopecia Distress Scale (CADS) is a patient-reported outcome measure for assessing distress associated with Chemotherapy-induced alopecia (CIA). This study aimed to confirm the psychometric validity of the Japanese version of the CADS (CADS-J). METHODS: A total of 132 patients with breast cancer who developed CIA were asked to complete the CADS-J twice at 2 week intervals to confirm test-retest reliability. The body image domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) breast cancer-specific module, the self-esteem scale from the Rosenberg Self-Esteem Scale, and the emotional domain of the EORTC QLQ Core 30 were used to confirm the convergent validity of the CADS-J. The overall quality of life and physical domains of the EORTC QLQ Core 30 were used to confirm the discriminant validity of the CADS-J. RESULTS: In total, 125 participants provided valid responses. The mean age was 52.2 years. The overall Cronbach's alpha for the CADS-J was 0.903. The intraclass correlation coefficients of the first and second responses were r = 0.874, r = 0.952, r = 0.911, and r = 0.959 for the physical domain, emotional domain, activity domain, and relationship domain, respectively. In terms of convergent validity, the total CADS-J score was moderately correlated with body image (r = - 0.63), self-esteem (r = - 0.48), and the emotional domain (r = - 0.61). Regarding discriminant validity, the total CADS-J score was weakly correlated with the overall quality of life (r = - 0.34) and physical domain (r = - 0.24). CONCLUSIONS: The CADS-J is psychometrically reliable and valid for evaluating the distress caused by CIA. It is expected to be used in daily practice and as an endpoint in various studies.


Assuntos
Antineoplásicos , Neoplasias da Mama , Humanos , Pessoa de Meia-Idade , Feminino , Qualidade de Vida , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/psicologia , Reprodutibilidade dos Testes , Japão , Alopecia/induzido quimicamente , Alopecia/diagnóstico , Alopecia/psicologia , Psicometria/métodos , Antineoplásicos/efeitos adversos , Inquéritos e Questionários
2.
Breast Cancer ; 30(4): 637-646, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37020090

RESUMO

BACKGROUND: Invasive lobular carcinoma (ILC) grows diffusely in a single-cell fashion, sometimes presenting only subtle changes in preoperative imaging; therefore, axillary lymph node (ALN) metastases of ILC are difficult to detect using magnetic resonance imaging (MRI). Preoperative underestimation of nodal burden occurs more frequently in ILC than in invasive ductal carcinoma (IDC), however, the morphological assessment for metastatic ALNs of ILC have not fully been investigated. We hypothesized that the high false-negative rate in ILC is caused by the discrepancy in the MRI findings of ALN metastases between ILC and IDC and aimed to identify the MRI finding with a strong correlation with ALN metastasis of ILC. METHOD: This retrospective analysis included 120 female patients (mean ± standard deviation age, 57.2 ± 11.2 years) who underwent upfront surgery for ILC at a single center between April 2011 and June 2022. Of the 120 patients, 35 (29%) had ALN metastasis. Using logistic regression, we constructed prediction models based on MRI findings: primary tumor size, focal cortical thickening (FCT), cortical thickness, long-axis diameter (LAD), and loss of hilum (LOH). RESULTS: The area under the curves were 0.917 (95% confidence interval [CI] 0.869-0.968), 0.827 (95% CI 0.758-0.896), 0.754 (95% CI 0.671-0.837), and 0.621 (95% CI 0.531-0.711) for the FCT, cortical thickness, LAD, and LOH models, respectively. CONCLUSIONS: FCT may be the most relevant MRI finding for ALN metastasis of ILC, and although its prediction model may lead to less underestimation of the nodal burden, rigorous external validation is required.


Assuntos
Neoplasias da Mama , Carcinoma Ductal de Mama , Carcinoma Lobular , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Neoplasias da Mama/patologia , Metástase Linfática/diagnóstico por imagem , Metástase Linfática/patologia , Carcinoma Lobular/diagnóstico por imagem , Carcinoma Lobular/cirurgia , Carcinoma Lobular/patologia , Estudos Retrospectivos , Carcinoma Ductal de Mama/patologia , Linfonodos/patologia , Imageamento por Ressonância Magnética
3.
Jpn J Clin Oncol ; 53(7): 562-571, 2023 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-37057634

RESUMO

OBJECTIVE: We occasionally observed internal mammary lymph node metastases of breast cancer in a clinical setting. However, unlike a standard treatment in axillary metastasis, surgical resection for internal mammary lymph node metastasis is not prevalent because of unclear safety and benefits. Thus, we aimed to evaluate the diagnostic ability and clinical outcomes of positron emission tomography/computed tomography and video-assisted thoracoscopic surgery. METHODS: We retrospectively investigated 34 patients with breast cancer with abnormal 18F-fluorodeoxyglucose uptake in internal mammary lymph nodes, at a single centre, between January 2015 and June 2022 and identified 11 female patients (mean age ± SD, 51.5 ± 12.9 years) who underwent video-assisted thoracoscopic surgery resection. Positron emission tomography/computed tomography was used to determine the clinical stage. We reviewed the surgical pathology of eleven and two patients who underwent direct-view internal mammary lymph node resection to calculate the positive predictive value of positron emission tomography/computed tomography. RESULTS: Ipsilateral fluorodeoxyglucose accumulation was observed, with an average maximum standardized uptake value of 8.9 (range, 3.1-24.0). No perioperative complications occurred, and all patients who underwent video-assisted thoracoscopic surgery alone were discharged from the hospital on post-operative day 2 or 3. The estimated positive predictive value was 80%. All patients were alive, and seven of nine patients with metastasis were relapse-free, at a mean follow-up period of 17.9 months (range, 1-51). However, two patients had recurrence at 16 and 14 months after surgery for internal mammary lymph node relapse. CONCLUSIONS: Radiotherapy is the standard treatment for suspected internal mammary lymph node metastasis detected using positron emission tomography/computed tomography; however, we could safely perform minimally invasive video-assisted thoracoscopic surgery resection, leading to a definite pathological diagnosis.


Assuntos
Neoplasias da Mama , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Humanos , Feminino , Cirurgia Torácica Vídeoassistida , Metástase Linfática/patologia , Estudos Retrospectivos , Tomografia por Emissão de Pósitrons/métodos , Recidiva Local de Neoplasia/patologia , Linfonodos/diagnóstico por imagem , Linfonodos/cirurgia , Linfonodos/patologia , Fluordesoxiglucose F18 , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/cirurgia , Compostos Radiofarmacêuticos
4.
Breast Cancer Res Treat ; 197(3): 593-602, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36494460

RESUMO

PURPOSE: Male breast cancer (MBC) is a rare cancer accounting for only 1% of all male cancers and is, therefore, poorly studied. We aimed to characterize the subtypes of MBC in Japanese patients based on genetic profiling, the presence of tumor-infiltrating cells, and the expression of immunohistochemical markers. METHODS: This retrospective study included 103 patients with MBC diagnosed between January 2009 and December 2019 at various hospitals in Japan. Clinicopathological patient characteristics were obtained from medical records, and formalin-fixed paraffin-embedded tissue specimens were analyzed for histological markers, mutations of 126 genes, BRCA1 methylation, and stromal tumor-infiltrating lymphocytes. RESULTS: The median patient age was 71 (range 31-92) years. T1-stage tumors were the most frequent (47.6%), and most were node negative (77.7%). The majority of tumors were positive for estrogen receptor (98.1%), progesterone receptor (95.1%), and androgen receptor (96.1%), and BRCA2 was the most frequently mutated gene (12.6%). The most common treatment was surgery (99.0%), either total mastectomy (91.1%) or partial mastectomy (7.0%). Survival analysis showed a 5-year recurrence-free survival rate of 64.4% (95% confidence interval [CI] 46.7-88.8) and a 5-year overall survival rate of 54.3% (95% CI 24.1-100.0). CONCLUSION: Japanese MBC is characterized by a high rate of hormonal receptor positivity and BRCA2 somatic mutation. Due to the observed clinicopathological differences in MBC between the Western countries and Japan, further prospective studies are needed to evaluate the most suitable treatment strategies.


Assuntos
Neoplasias da Mama Masculina , Neoplasias da Mama , Adulto , Idoso , Idoso de 80 Anos ou mais , Humanos , Masculino , Pessoa de Meia-Idade , Proteína BRCA1/genética , Proteína BRCA1/metabolismo , Neoplasias da Mama/patologia , Neoplasias da Mama Masculina/patologia , População do Leste Asiático , Mastectomia , Metilação , Mutação , Estudos Retrospectivos
5.
Medicine (Baltimore) ; 101(50): e32199, 2022 Dec 16.
Artigo em Inglês | MEDLINE | ID: mdl-36550858

RESUMO

BACKGROUND: Solitary fibrous tumors (SFT) are uncommon mesenchymal neoplasms which can arise in any anatomical location. Pleural SFTs have been most frequently documented; however, breast SFT is an exceedingly rare entity and seldom present in male breast, with only 8 previously reported cases. Recently, STAT6 immunostaining was considered to be a definitive marker of SFT, however, no case of the male breast SFT showing STAT6 positivity preoperatively has been reported. METHODS AND RESULTS: We describe a case of breast SFT in a 73-year-old male patient with a 12-month history of a palpable breast mass. The only associated clinical symptom was bilateral gynecomastia. An ultrasound scan examination revealed an oval, well-circumscribed and hypoechoic mass with hypervascularity. A core-needle biopsy was performed, and microscopic examination with immunohistochemistry confirmed the diagnosis of SFT. He underwent a complete surgical resection with clear margins, and there were no signs of high cellularity, remarkable mitotic activity, pleomorphism, hemorrhage or necrosis. CONCLUSION: A perioperative immunohistochemical evaluation for diffuse and intense nuclear expression of STAT6 was helpful to distinguish SFT from myofibroblastoma. We, herein, describe the first case of SFT in a male breast, confirmed by STAT6 immunostaining positivity. We also conducted a literature review of all previous cases of breast SFTs.


Assuntos
Hemangiopericitoma , Febre Grave com Síndrome de Trombocitopenia , Tumores Fibrosos Solitários , Humanos , Masculino , Idoso , Tumores Fibrosos Solitários/diagnóstico por imagem , Tumores Fibrosos Solitários/cirurgia , Hemangiopericitoma/patologia , Ultrassonografia , Mama/patologia , Biomarcadores Tumorais
6.
Front Oncol ; 12: 989650, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36176414

RESUMO

Purpose: Positron emission tomography/computed tomography (PET/CT) and magnetic resonance imaging (MRI) are useful for detecting axillary lymph node (ALN) metastasis in invasive ductal breast cancer (IDC); however, there is limited clinical evidence to demonstrate the effectiveness of the combination of PET/CT plus MRI. Further axillary surgery is not recommended against ALN micrometastasis (lesion ≤2 mm) seen in sentinel lymph nodes, especially for patients who received proper adjuvant therapy. We aimed to evaluate the efficacy of a prediction model based on PET/CT plus MRI for ALN macrometastasis (lesion >2 mm) and explore the possibility of risk stratification of patients using the preoperative PET/CT plus MRI and biopsy findings. Materials and methods: We retrospectively investigated 361 female patients (370 axillae; mean age, 56 years ± 12 [standard deviation]) who underwent surgery for primary IDC at a single center between April 2017 and March 2020. We constructed a prediction model with logistic regression. Patients were divided into low-risk and high-risk groups using a simple integer risk score, and the false negative rate for ALN macrometastasis was calculated to assess the validity. Internal validation was also achieved using a 5-fold cross-validation. Results: The PET/CT plus MRI model included five predictor variables: maximum standardized uptake value of primary tumor and ALN, primary tumor size, ALN cortical thickness, and histological grade. In the derivation (296 axillae) and validation (74 axillae) cohorts, 54% and 61% of patients, respectively, were classified as low-risk, with a false-negative rate of 11%. Five-fold cross-validation yielded an accuracy of 0.875. Conclusions: Our findings demonstrate the validity of the PET/CT plus MRI prediction model for ALN macrometastases. This model may aid the preoperative identification of low-risk patients for ALN macrometastasis and provide helpful information for PET/MRI interpretation.

7.
Jpn J Clin Oncol ; 51(9): 1471-1474, 2021 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-34215870

RESUMO

The standard first-line treatment for patients with human epidermal growth factor 2-positive metastatic breast cancer is a combination therapy of trastuzumab, pertuzumab and docetaxel, and the standard second-line treatment is trastuzumab emtansine. However, it may be difficult for the elderly to maintain sufficient intensity of treatment due to severe adverse events of trastuzumab, pertuzumab and docetaxel. The aim of this trial is to confirm the non-inferiority of trastuzumab emtansine over trastuzumab, pertuzumab and docetaxel in terms of overall survival in elderly (65-year-old or more) patients with human epidermal growth factor 2-positive metastatic breast cancer. If improved overall survival and fewer toxicities are observed, trastuzumab emtansine may be a feasible new standard first-line treatment for elderly patients with human epidermal growth factor 2-positive metastatic breast cancer. A planned total 330 patients will be enrolled from 45 institutions over 6.5 years. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000030783 [http://www.umin.ac.jp/ctr/index.htm].


Assuntos
Ado-Trastuzumab Emtansina/uso terapêutico , Neoplasias da Mama , Idoso , Anticorpos Monoclonais Humanizados , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias da Mama/tratamento farmacológico , Docetaxel/uso terapêutico , Feminino , Humanos , Japão , Receptor ErbB-2 , Trastuzumab/uso terapêutico
9.
Breast Cancer ; 28(4): 896-903, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33599914

RESUMO

BACKGROUND: We conducted a prospective study with the intention to omit surgery for patients with ductal carcinoma in situ (DCIS) of the breast. We aimed to identify clinicopathological predictors of postoperative upstaging to invasive ductal carcinoma (IDC) in patients preoperatively diagnosed with DCIS. PATIENTS AND METHODS: We retrospectively analyzed patients with DCIS diagnosed through biopsy between April 1, 2010 and December 31, 2014, from 16 institutions. Clinical, radiological, and histological variables were collected from medical records. RESULTS: We identified 2,293 patients diagnosed with DCIS through biopsy, including 1,663 DCIS (72.5%) cases and 630 IDC (27.5%) cases. In multivariate analysis, the presence of a palpable mass (odds ratio [OR] 1.8; 95% confidence interval [CI] 1.2-2.6), mammography findings (≥ category 4; OR 1.8; 95% CI 1.2-2.6), mass formations on ultrasonography (OR 1.8; 95% CI 1.2-2.5), and tumor size on MRI (> 20 mm; OR 1.7; 95% CI 1.2-2.4) were independent predictors of IDC. Among patients with a tumor size on MRI of ≤ 20 mm, the possibility of postoperative upstaging to IDC was 22.1%. Among the 258 patients with non-palpable mass, nuclear grade 1/2, and positive for estrogen receptor, the possibility was 18.1%, even if the upper limit of the tumor size on MRI was raised to ≤ 40 mm. CONCLUSION: We identified four independent predictive factors of upstaging to IDC after surgery among patients with DCIS diagnosed by biopsy. The combined use of various predictors of IDC reduces the possibility of postoperative upstaging to IDC, even if the tumor size on MRI is larger than 20 mm.


Assuntos
Neoplasias da Mama/patologia , Carcinoma Ductal de Mama/patologia , Carcinoma Intraductal não Infiltrante/patologia , Neoplasias da Mama/diagnóstico , Carcinoma Ductal de Mama/diagnóstico , Carcinoma Intraductal não Infiltrante/diagnóstico , Feminino , Humanos , Mamografia/métodos , Pessoa de Meia-Idade , Período Pós-Operatório , Estudos Retrospectivos
10.
Oncologist ; 26(4): e686-e693, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33321004

RESUMO

BACKGROUND: Advance care planning (ACP) is a process that supports adults in understanding and sharing their personal values, life goals, and preferences regarding future medical care. We examined the current status of ACP and end-of-life (EOL) communication between oncologists and patients with metastatic breast cancer. MATERIALS AND METHODS: We conducted a survey among 41 institutions that specialize in oncology by using an online tool in October 2019. Participants (118 physicians) from 38 institutions completed a 39-item questionnaire that measured facility type and function; physicians' background and clinical approach, education about EOL communication, and understanding about ACP; and the current situation of ACP and EOL discussions. RESULTS: Ninety-eight responses concerning physicians' engagement in ACP with patients were obtained. Seventy-one (72%) answered that they had engaged in ACP. Among these, 23 (33%) physicians used a structured format to facilitate the conversation in their institutions, and only 6 (8%) settled triggers or sentinel events for the initiation of ACP. In the multivariable analysis, only the opportunity to learn communication skills was associated with physicians' engagement with ACP (odds ratio: 2.8, 95% confidence interval: 1.1-7.0). The frequency and timing of communication about ACP and EOL care with patients substantially varied among the oncologists. Communication about patients' life expectancy was less frequent compared with other topics. CONCLUSION: The opportunity to improve EOL communication skills promoted physicians' engagement with ACP among patients with metastatic/advanced breast cancer. However, there were still substantial variabilities in the method, frequency, and timing of ACP and EOL communication among the oncologists. IMPLICATIONS FOR PRACTICE: This study found that the opportunity to improve end-of-life (EOL) communication skills promoted physicians' engagement in advance care planning (ACP) among patients with metastatic/advanced breast cancer. All oncologists who treat said patients are encouraged to participate in effective education programs concerning EOL communication skills. In clinical practice, there are substantial variabilities in the method, frequency, and timing of ACP and EOL communication among oncologists. As recommended in several clinical guidelines, the authors suggest a system that identifies patients who require conversations about their care goals, a structured format to facilitate the conversations, and continuous measurement for improving EOL care and treatment.


Assuntos
Planejamento Antecipado de Cuidados , Neoplasias da Mama , Assistência Terminal , Adulto , Neoplasias da Mama/terapia , Comunicação , Morte , Feminino , Humanos
11.
Jpn J Clin Oncol ; 51(2): 185-191, 2021 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-33157551

RESUMO

BACKGROUND: Improvements in early detection and treatment have resulted in an increasing number of long-term survivors of colorectal cancer (CRC). For the survivors, second primary cancer and recurrence are important issues; however, evidence for an appropriate surveillance strategy remains limited.This study aimed to investigate the frequency and timing of second primary cancer in patients after surgery for exploring an appropriate surveillance strategy by using an integrated analysis of three large-scale randomized controlled trials in Japan. METHODS: The eligibility criteria of three trials included histologically confirmed CRC and having received surgery. The timing, site and frequency of second primary cancers and recurrence were investigated. Risk factors associated with second primary cancers were also examined. The standardized incidence ratio (SIR) of second primary cancers compared with the national database of the Japan Cancer Registry was estimated. RESULTS: A total of 2824 patients were included in this study. The cumulative incidence of second primary cancer increased over time. The SIR of any second primary cancer was 1.07 (95% CI: 0.94-1.21). The SIR for second primary cancers of colon was 1.09 (95% CI: 0.79-1.47). The cumulative incidence of recurrence almost reached plateau at 3 years. CONCLUSIONS: A common surveillance strategy for the general population can be applied even for curatively resected CRC patients, as the risk of second primary cancers was almost the same as that of the general population.


Assuntos
Ensaios Clínicos como Assunto , Neoplasias Colorretais/cirurgia , Oncologia , Recidiva Local de Neoplasia/patologia , Segunda Neoplasia Primária/epidemiologia , Adulto , Idoso , Neoplasias Colorretais/patologia , Feminino , Humanos , Incidência , Japão , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Adulto Jovem
12.
Jpn J Clin Oncol ; 50(9): 1076-1079, 2020 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-32548619

RESUMO

The standard treatment for the patients with surgically resectable early non-small cell lung cancer (NSCLC) is lung lobectomy. However, if patients have idiopathic pulmonary fibrosis combined with early stage lung cancer, there is no standard treatment for this population. Patients with idiopathic pulmonary fibrosis have chronic progressive decline in respiratory function; thus, the preservation of respiratory function is essential. The aim of this trial is to confirm the clinical effectiveness of sublobar resection such as wedge resection or segmentectomy for early NSCLC with idiopathic pulmonary fibrosis compared with lobectomy in a randomized phase III trial. The primary endpoint is overall survival. If the non-inferiority of overall survival and minimal invasiveness are proven, it can be a new standard treatment for early NSCLC with idiopathic pulmonary fibrosis. A planned total 430 patients will be enrolled from 50 institutions over 5 years. This trial has been registered in the UMIN Clinical Trials Registry with code UMIN000032696 [http://www.umin.ac.jp/ctr/index.htm].


Assuntos
Carcinoma Pulmonar de Células não Pequenas/cirurgia , Fibrose Pulmonar Idiopática/cirurgia , Neoplasias Pulmonares/cirurgia , Pneumonectomia/métodos , Adulto , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/patologia , Feminino , Humanos , Fibrose Pulmonar Idiopática/mortalidade , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Masculino , Estadiamento de Neoplasias , Análise de Sobrevida
13.
Future Oncol ; 16(4): 31-38, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31920105

RESUMO

Background: Although surgical resection is necessary to cure the locally advanced gastric cancer, it is sometimes difficult for extensive nodal metastasis such as para-aortic nodal disease or bulky nodal metastasis around the major gastric branched arteries. We had conducted several Phase II studies and clarified preoperative chemotherapy with doublet regimen followed by surgery markedly improved the survival for this disease. Recently, preoperative chemotherapy with docetaxel, oxaliplatin and S-1 (DOS) showed promising efficacy and acceptable feasibility for resectable advanced gastric cancer. Aim: To describe the design and rationale for the multi-institutional, single-arm, Phase II trial of systemic chemotherapy with DOS followed by surgery in advanced gastric cancer with extensive lymph node metastasis (JCOG1704). If efficacy and safety of DOS can be shown, we will conduct a Phase III trial comparing preoperative DOS and current standard cisplatin and S-1. Trial registration: jRCTs031180028.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos Clínicos , Cuidados Pré-Operatórios , Neoplasias Gástricas/tratamento farmacológico , Neoplasias Gástricas/patologia , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Quimioterapia Adjuvante , Docetaxel/administração & dosagem , Combinação de Medicamentos , Feminino , Humanos , Metástase Linfática , Masculino , Estadiamento de Neoplasias , Oxaliplatina/administração & dosagem , Ácido Oxônico/administração & dosagem , Cuidados Pós-Operatórios , Neoplasias Gástricas/mortalidade , Tegafur/administração & dosagem
14.
BMC Cancer ; 19(1): 1002, 2019 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-31653251

RESUMO

BACKGROUND: Amputation is the standard of care even for early-stage subungual melanomas (SUMs), known as nail apparatus melanoma, because the nail bed and nail matrix are close to the distal phalanx. However, a recent study demonstrated that not all patients with SUMs had histologic invasion of the underlying distal phalanx. As most SUMs occur in the thumb or big toe, amputation of either the thumb or big toe substantially interferes with activities of daily living, including poor cosmesis, loss of function, and phantom pain. Non-amputative digit preservation surgery can thus be applied in such cases without compromising patient prognosis. METHODS: We are conducting a multi-institutional single-arm trial to confirm the safety and efficacy of non-amputative digit preservation surgery. We will compare our results with those reported in the Japanese Melanoma Study, in which patients underwent amputation for SUMs as a traditional standard of care. Patients aged between 20 and 80 years with stage I, II, or III without evidence of tumor invasion to the underlying distal phalanx on preoperative radiograph are included in the study. The primary endpoint is major relapse-free survival (major RFS), which does not include local recurrence as an event; secondary endpoints include overall survival, digit-preservation survival, relapse-free survival, local relapse-free survival, partial relapse-free survival, and incidence of adverse events. A total of 85 patients from 21 Japanese institutions will be recruited within 5.5 years, and the follow-up period will last at least 5 years. The Japan Clinical Oncology Group Protocol Review Committee approved this study protocol in August 2017, and patient enrollment began in November 2017. Ethical approval was obtained from each institution's Institutional Review Board prior to patient enrollment. DISCUSSION: This is the first prospective trial to confirm the safety and efficacy of non-amputative digit preservation surgery for SUM without distant metastasis or bony invasion. The results of this trial could provide evidence to support this less-invasive surgery as a new standard of care to preserve adequately functioning digits. TRIAL REGISTRATION: Registry number: UMIN000029997 . Date of Registration: 16/Nov/2017. Date of First Participant Enrollment: 12/Dec/2017.


Assuntos
Melanoma/epidemiologia , Melanoma/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Doenças da Unha/epidemiologia , Doenças da Unha/cirurgia , Atividades Cotidianas , Adulto , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica/efeitos adversos , Amputação Cirúrgica/métodos , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Incidência , Japão/epidemiologia , Masculino , Oncologia/métodos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Prognóstico , Estudos Prospectivos , Polegar/patologia , Polegar/cirurgia , Dedos do Pé/patologia , Dedos do Pé/cirurgia , Adulto Jovem
15.
Jpn J Clin Oncol ; 48(12): 1096-1100, 2018 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-30295796

RESUMO

A randomized controlled trial has been initiated to compare chemotherapy containing dose-dense paclitaxel plus carboplatin with or without bevacizumab to a conventional regimen containing tri-weekly paclitaxel plus carboplatin with or without bevacizumab. Eligible patients are those with stage IVB, recurrent or persistent cervical carcinoma not amenable to curative treatment with local therapy. Patients are randomly assigned to either the conventional or dose-dense regimen. However, patients who are at increased risk of adverse events following bevacizumab administration will not receive this drug. The primary endpoint of phase II part is response rate. If the response rate of the dose-dense regimen is better than that of conventional regimen, this study will proceed to phase III, where the primary endpoint is overall survival. Secondary endpoints in phase III part are progression-free survival, response rates, adverse events, serious adverse events and the proportion of non-hospitalization periods compared with planned treatment periods.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Bevacizumab/uso terapêutico , Carboplatina/uso terapêutico , Paclitaxel/uso terapêutico , Neoplasias do Colo do Útero/tratamento farmacológico , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/farmacologia , Bevacizumab/administração & dosagem , Bevacizumab/farmacologia , Carboplatina/administração & dosagem , Carboplatina/farmacologia , Feminino , Humanos , Japão , Pessoa de Meia-Idade , Metástase Neoplásica , Estadiamento de Neoplasias , Paclitaxel/administração & dosagem , Paclitaxel/farmacologia , Neoplasias do Colo do Útero/patologia
16.
Jpn J Clin Oncol ; 48(12): 1105-1108, 2018 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-30346569

RESUMO

For stage I/II tongue cancer patients, it is controversial whether prophylactic neck dissection should be performed with partial glossectomy. Based on the evidence of the primary tumor's depth of invasion as a predictive factor of occult lymph node metastases and a prognostic factor of disease-free survival, randomized phase III trial was initiated in November 2017 to evaluate the omission value for prophylactic neck dissection for stage I/II tongue cancer with 3-10 mm of depth of invasion. In 5 years, 440 patients will be accrued from 28 institutions. The primary end point of the study is the overall survival, whereas the secondary end points are relapse-free survival, local relapse-free survival, proportion of unresectable relapse and of cervical lymph node relapse, post-operative function (paralysis of the accessory and facial nerves and subjective symptoms) and adverse events. This trial has been registered with the UMIN Clinical Trials Registry (registration number: UMIN000030098; http://www.umin.ac.jp/ctr/index.htm).


Assuntos
Metástase Linfática/patologia , Neoplasias da Língua/cirurgia , Adulto , Idoso , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Esvaziamento Cervical , Estadiamento de Neoplasias , Neoplasias da Língua/patologia
17.
Gan To Kagaku Ryoho ; 43(12): 2035-2037, 2016 Nov.
Artigo em Japonês | MEDLINE | ID: mdl-28133213

RESUMO

We report a case of recurrent breast cancer with involvement of the right adrenal grand, which was resected using laparoscopic surgery. The patient was a 41-year-old woman who underwent duct-lobular segmentectomy for ductal carcinoma in situ. Histopathology showed microinvasion, and tested positive for ER and PR, but negative for HER2, so we applied radiation to the remaining breast and administered tamoxifen. After 9 months, local recurrence was detected and quadrantectomy with axillary lymph node dissection was performed. One year and 10 months later, local recurrence was again detected and a tumorectomy was performed. The adjuvant therapy was changed to an LH-RH analog plus anastrozole and it was administered effectively for 5 years. Left ileal metastasis appeared in the 2nd month after completion of the adjuvant chemotherapy, so radiation was applied and an LH-RH analog plus exemestane administration was started. Three years passed without recurrence, but a right adrenal tumor appeared on computed tomography. The tumor grew over 6 months, so laparoscopic right adrenalectomy was performed. Histopathologically, the tumor tested positive for ER and PR, and negative for HER2 so we diagnosed metastasis of breast cancer, and administered an LH-RH analog plus exemestane. The patient's disease has not progressed in the 3 months since surgery.


Assuntos
Neoplasias das Glândulas Suprarrenais/cirurgia , Neoplasias da Mama/patologia , Neoplasias das Glândulas Suprarrenais/secundário , Adrenalectomia , Adulto , Neoplasias da Mama/cirurgia , Feminino , Humanos , Laparoscopia , Mastectomia Segmentar , Recidiva , Resultado do Tratamento
18.
Gan To Kagaku Ryoho ; 42(12): 1594-6, 2015 Nov.
Artigo em Japonês | MEDLINE | ID: mdl-26805107

RESUMO

We report the case of a patient with a postoperative recurrence of colon cancer who received XELOX plus bevacizumab chemotherapy whilst undergoing hemodialysis. A 73-year-old man had been receiving maintenance hemodialysis for 9 years due to chronic renal failure. At 64 years old, a Hartmann's operation and a posterior segment and segment 3 partial liver resection were performed for sigmoid colon cancer and metastatic liver cancer. Three years 1 months after surgery, local recurrence at the liver invading into the right lung was detected. XELOX plus bevacizumab chemotherapy was administered. After 16 courses of treatment, tumor control was achieved. Chemotherapy with molecular target drugs is currently recommended for advanced/metastatic colorectal cancer; however, a standardized strategy for hemodialysis patients is not established. As the number of hemodialysis patients receiving chemotherapy for some cancers is likely to increase in the future, it will be necessary to consider chemotherapy strategies for hemodialysis patients.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Falência Renal Crônica/complicações , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias do Colo Sigmoide/tratamento farmacológico , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Bevacizumab/administração & dosagem , Capecitabina , Colectomia , Terapia Combinada , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Fluoruracila/administração & dosagem , Fluoruracila/análogos & derivados , Hepatectomia , Humanos , Neoplasias Hepáticas/complicações , Neoplasias Hepáticas/secundário , Neoplasias Hepáticas/cirurgia , Masculino , Oxaloacetatos , Recidiva , Diálise Renal , Neoplasias do Colo Sigmoide/complicações , Neoplasias do Colo Sigmoide/patologia , Neoplasias do Colo Sigmoide/cirurgia
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