Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 181
Filtrar
Mais filtros

Base de dados
País/Região como assunto
Tipo de documento
Intervalo de ano de publicação
1.
Breast Cancer Res Treat ; 201(3): 409-415, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37480384

RESUMO

PURPOSE: Metastatic breast cancer (MBC) is usually incurable; treatment aims to maximize patients' function and quality of life (QOL). Eribulin is a standard treatment in patients with MBC pretreated with anthracycline and taxane; however, the best administration schedule is unknown. METHODS: In this prospective phase II trial of patients with luminal MBC, we administered biweekly eribulin to patients who completed a three-cycle induction treatment. RESULTS: Sixty patients with hormone-receptor-positive and HER2-negative MBC were enrolled; 40 obtained stable disease (SD) or better efficacy after induction therapy, after which they were switched to biweekly maintenance administration. The median progression-free survival (PFS) in patients who switched to maintenance therapy was 15.21 weeks (95% CI 9.71-22.14), starting on the first day of maintenance therapy. Overall survival (OS) in patients who switched to maintenance therapy was 21.39 months (95% CI 18.89-32.89). PFS and OS in the whole population starting from the registration date were 19.00 weeks (95% CI 17.00-25.00) and 21.52 months (95% CI 16.23-24.25), respectively. PFS from the enrollment date for patients who received maintenance therapy was 25.29 weeks (95% CI 19.14-32.14). Patients who achieved complete response or partial response during induction therapy had significantly longer PFS compared to patients with SD. CONCLUSION: The efficacy of biweekly administration of eribulin at maintenance was nonsignificant. However, less frequent visits are convenient, and reduced dose intensity improves safety. Biweekly administration, besides dose reduction, could be an acceptable option for patients who are unable to maintain a standard regimen.


Assuntos
Neoplasias da Mama , Qualidade de Vida , Humanos , Feminino , Neoplasias da Mama/tratamento farmacológico , Quimioterapia de Indução , Estudos Prospectivos
2.
Breast Cancer Res Treat ; 202(3): 485-496, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37676450

RESUMO

PURPOSE: The Phase III POTENT trial demonstrated the efficacy of adding S-1 to adjuvant endocrine therapy for estrogen receptor-positive, HER2-negative early breast cancer. We investigated the efficacy of S-1 across different recurrence risk subgroups. METHODS: This was a post-hoc exploratory analysis of the POTENT trial. Patients in the endocrine-therapy-only arm were divided into three groups based on composite risk values calculated from multiple prognostic factors. The effects of S-1 were estimated using the Cox model in each risk group. The treatment effects of S-1 in patients meeting the eligibility criteria of the monarchE trial were also estimated. RESULTS: A total of 1,897 patients were divided into three groups: group 1 (≤ lower quartile of the composite values) (N = 677), group 2 (interquartile range) (N = 767), and group 3 (> upper quartile) (N = 453). The addition of S-1 to endocrine therapy resulted in 49% (HR: 0.51, 95% CI: 0.33-0.78) and 29% (HR: 0.71, 95% CI 0.49-1.02) reductions in invasive disease-free survival (iDFS) events in groups 2 and 3, respectively. We could not identify any benefit from the addition of S-1 in group 1. The addition of S-1 showed an improvement in iDFS in patients with one to three positive nodes meeting the monarchE cohort 1 criteria (N = 290) (HR: 0.47, 95% CI: 0.29-0.74). CONCLUSIONS: The benefit of adding adjuvant S-1 was particularly marked in group 2. Further investigations are warranted to explore the optimal usage of adjuvant S-1.

3.
Support Care Cancer ; 31(6): 369, 2023 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-37266722

RESUMO

PURPOSE: Breast cancer is the most common cancer among Japanese women and often yields a better prognosis than other cancers. However, few studies have been conducted on pain control using opioids in Japan. In this study, we aimed to examine actual opioid use among breast cancer patients. METHODS: Breast cancer patients were defined as female patients with a first breast cancer diagnosis during the observational period in an acute care hospital database (April 2008 - February 2020). We examined the percentage of patients prescribed opioids, the opioid amount per patient, and the opioid dosage per day around surgery, bone metastasis diagnosis, or death. RESULTS: Overall, 217,722 breast cancer patients were identified. The percentage of patients prescribed opioids and the average amount of opioids per patient were highest in the month of surgery, 78% and 27 morphine milligram equivalents (MMEs), respectively. The average opioid dosage increased with time after surgery from 19 to 28 MMEs. Around bone metastasis, the percentage of patients prescribed opioids and the average opioid amount per patient peaked one month after the diagnosis, 31% and 371 MMEs, respectively. The average opioid dosage gradually increased from 22 to 35 MMEs in succeeding days after a bone metastasis diagnosis. The percentage of patients prescribed opioids and the average opioid amount per patient increased as the month of death approached. CONCLUSION: We investigated opioid prescription trends around clinical events in breast cancer patients on a large scale in Japan. These results may be useful to control cancer pain among breast cancer patients.


Assuntos
Neoplasias Ósseas , Neoplasias da Mama , Feminino , Humanos , Analgésicos Opioides , Neoplasias Ósseas/secundário , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Prescrições de Medicamentos , População do Leste Asiático , Hospitais , Estudos Longitudinais , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/etiologia , Padrões de Prática Médica , Estudos Retrospectivos
4.
Pathol Int ; 73(9): 413-433, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37378453

RESUMO

Vimentin is a stable mesenchymal immunohistochemical marker and is widely recognized as a major marker of mesenchymal tumors. The purpose of the present study was to investigate if the vimentin expression status might serve as a significant predictor of outcomes in patients with invasive breast carcinoma of no special type (IBC-NST) and to investigate, by comprehensive RNA sequencing analyses, the mechanisms involved in the heightened malignant potential of vimentin-positive IBC-NSTs. This study, conducted using the data of 855 patients with IBC-NST, clearly identified vimentin expression status as a very important independent biological parameter for accurately predicting the outcomes in patients with IBC-NST. RNA sequence analyses clearly demonstrated significant upregulation of coding RNAs known to be closely associated with cell proliferation or cellular senescence, and significant downregulation of coding RNAs known to be closely associated with transmembrane transport in vimentin-positive IBC-NSTs. We conclude that vimentin-positive IBC-NSTs show heightened malignant biological characteristics, possibly attributable to the upregulation of RNAs closely associated with proliferative activity and cellular senescence, and downregulation of RNAs closely associated with transmembrane transport in IBC-NSTs.


Assuntos
Neoplasias da Mama , Humanos , Feminino , Vimentina , Neoplasias da Mama/patologia
5.
Cancer ; 128(8): 1692-1698, 2022 04 15.
Artigo em Inglês | MEDLINE | ID: mdl-35045185

RESUMO

BACKGROUND: Fosnetupitant (FosNTP), an intravenous neurokinin 1 receptor antagonist, demonstrated a favorable safety profile with a potentially low risk of injection site reactions (ISRs) and promising antiemetic efficacy in patients receiving cisplatin-based highly emetogenic chemotherapy in a previous phase 2 study. We conducted a randomized, double-blind safety study to evaluate the safety profile of FosNTP, including ISRs, in patients receiving doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide (AC/EC) chemotherapy. METHODS: Patients scheduled to receive AC/EC were randomized 1:1 to receive 235 mg of FosNTP or 150 mg of fosaprepitant (FosAPR), both in combination with 0.75 mg of intravenous palonosetron and 9.9 mg of dexamethasone on day 1. The stratification factors were age category (<55 vs ≥55 years) and study site. The primary end point was the incidence of treatment-related adverse events (TRAEs) with FosNTP. RESULTS: Overall, 102 patients were randomized to FosNTP (n = 52) or FosAPR (n = 50), and all were treated with the study drug and evaluated for safety. The primary end point, the incidence of TRAEs, was similar with FosNTP (21.2%; 95% confidence interval [CI], 11.1%-34.7%) and FosAPR (22.0%; 95% CI, 11.5%-36.0%), with any-cause ISRs observed in 5.8% and 26.0% of patients, respectively, and treatment-related ISRs observed in 0% and 10.0%, respectively. The overall (0-120 hour) complete response (defined as no emetic event and no rescue medication) rate, standardized by age category in the full analysis set, was 45.9% (23 of 51 patients) with FosNTP and 51.3% (25 of 49 patients) with FosAPR. CONCLUSIONS: FosNTP demonstrated a favorable safety profile with a very low risk of ISRs in the AC/EC setting.


Assuntos
Antieméticos , Antraciclinas/efeitos adversos , Antieméticos/efeitos adversos , Ciclofosfamida/efeitos adversos , Dexametasona/uso terapêutico , Método Duplo-Cego , Humanos , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Náusea/tratamento farmacológico , Vômito/induzido quimicamente , Vômito/tratamento farmacológico
6.
Support Care Cancer ; 30(5): 4327-4336, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35094140

RESUMO

PURPOSE: The Japanese Society of Medical Oncology (JSMO) published a guideline (GL) on febrile neutropenia (FN) in 2017. This study aims to identify promoting factors and disincentives for complying with GL recommendations according to attributes of doctors providing chemotherapy. METHODS: A questionnaire survey was conducted with SurveyMonkey™ for physician members of the Japanese Association of Supportive Care in Cancer and relevant academic organizations. Each question had four options (always do, do in more than half of patients, do in less than half, do not at all) and a free description form. Responses were analyzed according to the respondents' attributes. RESULT: Seven hundred eighty-eight out of retrieved 801 responses were available for analysis. Multivariable analysis demonstrated that the percentage of GL users was higher among women and Japanese Society of Clinical Oncology members. The overall compliance rate was higher among women, JSMO members, and board-certified medical oncologists. Internists emphasized the significance of collecting blood cultures at FN onset, and surgeons stressed the importance of G-CSF prophylaxis. Hematologists were less likely to adhere to recommendations on risk assessment of FN by the Multinational Association of Supportive Care in Cancer score and administration of gammaglobulin products. However, those are acceptable due to the characteristics of their practice. Eight recommendations had no difference in compliance rates between users and non-users, some of whose statements were ambiguous and discretionary. CONCLUSION: Women were more likely to use and adhere to GL. The recommendations should be developed considering the characteristics of specialty and subspecialty and avoiding ambiguity and discretionary statements.


Assuntos
Neutropenia Febril , Hematologia , Neoplasias , Cirurgiões , Neutropenia Febril/induzido quimicamente , Neutropenia Febril/tratamento farmacológico , Neutropenia Febril/prevenção & controle , Feminino , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Humanos , Japão , Masculino , Oncologia , Neoplasias/tratamento farmacológico , Inquéritos e Questionários
7.
Lancet Oncol ; 22(1): 74-84, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33387497

RESUMO

BACKGROUND: Oral fluoropyrimidines, such as S-1, have been shown to have a role in controlling disease progression in metastatic breast cancer. We examined adjuvant treatment with S-1 in patients with oestrogen receptor (ER)-positive and HER2-negative primary breast cancer. METHODS: We did a multicentre, open-label, randomised, controlled, phase 3 trial in 139 sites (137 hospitals and two clinics). Eligible patients were women aged 20-75 years with histologically diagnosed stage I to IIIB invasive breast cancer (intermediate to high risk of recurrence). Patients were temporarily registered at participating institutions and biopsy or surgical samples were collected and sent for central pathological assessment. Patients received 5 years of standard adjuvant endocrine therapy (selective oestrogen receptor modulators with or without ovarian suppression and aromatase inhibitors) with or without 1 year of S-1. Oral S-1 80-120 mg/day was administered twice a day for 14 days with 7 days off. Randomisation (1:1) using the minimisation method was done with six stratification factors (age, axillary lymph node metastasis at surgery or sentinel lymph node biopsy, preoperative or postoperative (neoadjuvant or adjuvant) chemotherapy, preoperative endocrine therapy, proportion of ER-positive cells, and study site). The primary endpoint was invasive disease-free survival, in the full analysis set (all randomly assigned patients, excluding those with significant protocol deviations). The safety analysis set consisted of all patients who received at least one dose of study treatment. Here, we report the results from the interim analysis at the data cutoff date Jan 31, 2019. This trial is registered with Japan Registry of Clinical Trials, jRCTs051180057, and the University hospital Medical Information Network, UMIN000003969. FINDINGS: Between Feb 1, 2012, and Feb 1, 2016, 1930 patients were enrolled in the full analysis set, 957 (50%) received endocrine therapy plus S-1 and 973 (50%) received endocrine therapy alone. Median follow-up was 52·2 months (IQR 42·1-58·9). 155 (16%) patients in the endocrine therapy alone group and in 101 (11%) patients in the endocrine therapy plus S-1 group had invasive disease-free survival events (hazard ratio 0·63, 95% CI 0·49-0·81, p=0·0003). As the primary endpoint was met at interim analysis, the trial was terminated early. The most common grade 3 or worse adverse events were decreased neutrophil count (72 [8%] of 954 patients in the endocrine therapy plus S-1 group vs seven [1%] of 970 patients in the endocrine therapy alone group), diarrhoea (18 [2%] vs none), decreased white blood cells (15 [2%] vs two [<1%]), and fatigue (six [<1%] vs none). Serious adverse events were reported in nine (1%) of 970 patients in the endocrine therapy alone group and 25 (3%) of 954 patients in the endocrine therapy plus S-1 group. There was one (<1%) possible treatment-related death in the endocrine therapy plus S-1 group due to suspected pulmonary artery thrombosis. INTERPRETATION: These data suggest that this combination of S-1 with endocrine therapy could be a potential treatment option for this intermediate and high-risk group of patients with ER-positive, HER2-negative primary breast cancer. FUNDING: Public Health Research Foundation (Japan), Taiho Pharmaceutical.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Inibidores da Aromatase/administração & dosagem , Biomarcadores Tumorais/análise , Neoplasias da Mama/tratamento farmacológico , Ácido Oxônico/administração & dosagem , Receptor ErbB-2/análise , Receptores de Estrogênio/análise , Moduladores Seletivos de Receptor Estrogênico/administração & dosagem , Tegafur/administração & dosagem , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Inibidores da Aromatase/efeitos adversos , Neoplasias da Mama/química , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Intervalo Livre de Doença , Combinação de Medicamentos , Feminino , Humanos , Pessoa de Meia-Idade , Terapia Neoadjuvante , Ácido Oxônico/efeitos adversos , Moduladores Seletivos de Receptor Estrogênico/efeitos adversos , Tegafur/efeitos adversos , Fatores de Tempo , Adulto Jovem
8.
Support Care Cancer ; 29(11): 6831-6839, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34008079

RESUMO

PURPOSE: The Japanese Society of Medical Oncology published a guideline (GL) on febrile neutropenia (FN) in 2017. The study's purpose is to reveal how widely GL penetrated among physicians and surgeons providing chemotherapy. METHODS: A questionnaire survey was conducted with SurveyMonkey™ for members of the Japanese Association of Supportive Care in Cancer and relevant academic organizations. Each question had four options (always do, do in more than half of patients, do in less than half, do not at all) and a free description form. Responses were analyzed with statistical text-analytics. RESULT: A total of 800 responses were retrieved. Major respondents were experts with more than 10-year experience, physicians 54%, and surgeons 46%. Eighty-seven percent of respondents knew and used GL. Forty-eight percent assessed FN with Multinational Association of Supportive Care in Cancer (MASCC) score "always" or "more than half." Eighty-one percent chose beta-lactam monotherapy as primary treatment in high-risk patients. Seventy-seven percent did oral antibacterial therapy in low-risk patients ambulatorily. Seventy-eight percent administered primary prophylactic G-CSF (ppG-CSF) in FN frequency ≥ 20% regimen. Fifty-nine percent did ppG-CSF for high-risk patients in FN frequency 10-20% regimen. Ninety-seven percent did not use ppG-CSF in FN frequency < 10% regimen. The medians of complete and complete plus partial compliance rates were 46.4% (range 7.0-92.8) and 77.8% (range 35.4-98.7). The complete compliance rates were less than 30% in seven recommendations, including the MASCC score assessment. CONCLUSION: GL is estimated to be widely utilized, but some recommendations were not followed, presumably due to a mismatch with actual clinical practices in Japan.


Assuntos
Neutropenia Febril , Hematologia , Neoplasias , Cirurgiões , Neutropenia Febril/tratamento farmacológico , Fator Estimulador de Colônias de Granulócitos , Humanos , Japão , Neoplasias/complicações , Neoplasias/tratamento farmacológico , Inquéritos e Questionários
9.
Int J Clin Oncol ; 26(1): 1-17, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33161452

RESUMO

Patients with cancer should appropriately receive antiemetic therapies against chemotherapy-induced nausea and vomiting (CINV). Antiemetic guidelines play an important role in managing CINV. Accordingly, the first Japanese antiemetic guideline published in 2010 by the Japan Society of Clinical Oncology (JSCO) has considerably aided Japanese medical staff in providing antiemetic therapies across chemotherapy clinics. With the yearly advancements in antiemetic therapies, the Japanese antiemetic guidelines require revisions according to published evidence regarding antiemetic management worldwide. A revised version of the first antiemetic guideline that considered several upcoming evidences had been published online in 2014 (version 1.2), in which several updated descriptions were included. The 2015 JSCO clinical practice guideline for antiemesis (version 2.0) (in Japanese) has addressed clinical antiemetic concerns and includes four major revisions regarding (1) changes in emetogenic risk categorization for anti-cancer agents, (2) olanzapine usage as an antiemetic drug, (3) the steroid-sparing method, and (4) adverse drug reactions of antiemetic agents. We herein present an English update summary for the 2015 JSCO clinical practice guideline for antiemesis (version 2.0).


Assuntos
Antieméticos , Antineoplásicos , Neoplasias , Antieméticos/uso terapêutico , Antineoplásicos/efeitos adversos , Humanos , Japão , Oncologia , Náusea/induzido quimicamente , Náusea/tratamento farmacológico , Neoplasias/tratamento farmacológico , Vômito/induzido quimicamente , Vômito/tratamento farmacológico
10.
Gan To Kagaku Ryoho ; 48(9): 1127-1131, 2021 Sep.
Artigo em Japonês | MEDLINE | ID: mdl-34521790

RESUMO

Occult breast cancer is rare in practice. We studied the clinical outcomes of 5 occult breast cancers, including 2 with Luminal and 3 with non-Luminal subtypes, for which the primary site was not detected in the breast-by-breast MRI. The percentage of occult breast cancers that we encountered at our hospital was 0.11%. The mean age was 54 years. The Ki-67 labeling index value was 30% or higher for all the patients except one. Four patients were administered neoadjuvant chemotherapy and all but one patient received non-mastectomy and axillary dissection plus radiotherapy. We observed recurrent cases in one example each of the Luminal and HER2 subtypes, and both patients were less than 40 years old. The estimates of the probability of 5 year recurrence-free survival and 5 year overall survival were 40.0% and 66.7%, respectively. One recurrence case was a patient negative for ER and positive for HER2 wherein a breast cancer lesion appeared in the breast during post-treatment follow-up. Intrabreast relapse, which is itself rare in occult breast cancer, was observed 4 years postoperatively after standard treatment. Although there was no deviation according to subtype rate, the Ki-67 labeling index value was high and the prognosis was poor in our 5 cases.


Assuntos
Neoplasias da Mama , Adulto , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/terapia , Intervalo Livre de Doença , Feminino , Humanos , Imageamento por Ressonância Magnética , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Prognóstico , Receptor ErbB-2 , Receptores de Estrogênio , Receptores de Progesterona
11.
Cancer Sci ; 111(9): 3313-3326, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32619077

RESUMO

The ongoing, Phase Ib MONALEESASIA study is evaluating the efficacy and safety of ribociclib plus endocrine therapy in Asian patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Eligible patients from Japan, Hong Kong, and Singapore were enrolled in this 2-phase study consisting of a dose-escalation phase to determine the maximum-tolerated dose and the recommended Phase II dose of ribociclib plus letrozole, and a dose-expansion phase to evaluate safety and tolerability of ribociclib plus letrozole, fulvestrant, or tamoxifen. An exploratory biomarker analysis evaluating expression of target genes was also conducted. In the dose-escalation phase, the maximum-tolerated/recommended Phase II doses of ribociclib were lower in Japanese patients (300 mg) than in Asian non-Japanese patients (600 mg). Ribociclib plus endocrine therapy at the recommended Phase II dose had a manageable safety profile, with neutropenia and elevated liver transaminases being the most common adverse events leading to dose modifications or discontinuations, and it demonstrated evidence of clinical activity in both Japanese and Asian non-Japanese patients. Preliminary efficacy in Asian populations is similar to that observed in White populations studied in previous ribociclib (MONALEESA) trials. Biomarker analysis demonstrated suppression of pharmacodynamic biomarker gene expression, indicating inhibition of target genes by ribociclib combined with endocrine therapy. Results from the ongoing study support the use of ribociclib in combination with letrozole in Asian non-Japanese patients at the same dose (600 mg) as White patients. In Japanese patients, a lower dose of ribociclib (300 mg) should be considered. Clinicaltrials.gov: NCT02333370.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Idoso , Idoso de 80 Anos ou mais , Aminopiridinas/administração & dosagem , Antineoplásicos Hormonais/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Povo Asiático , Biomarcadores , Neoplasias da Mama/etiologia , Neoplasias da Mama/mortalidade , Quinase 4 Dependente de Ciclina/antagonistas & inibidores , Quinase 6 Dependente de Ciclina/antagonistas & inibidores , Feminino , Humanos , Japão , Pessoa de Meia-Idade , Gradação de Tumores , Metástase Neoplásica , Estadiamento de Neoplasias , Inibidores de Proteínas Quinases/administração & dosagem , Purinas/administração & dosagem , Resultado do Tratamento
12.
Oncologist ; 25(2): e373-e380, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32043774

RESUMO

BACKGROUND: We previously reported the results of a prospective study of chemotherapy-induced nausea and vomiting (CINV) in a cohort of patients who received carboplatin-based chemotherapy and were selected from a nationwide registry of those scheduled for moderately (MEC) or highly emetogenic chemotherapy (HEC) by the CINV Study Group of Japan. Of 1,910 previously registered patients (HEC: 1,195; MEC: 715), 400 patients received carboplatin-based chemotherapy. The frequency of CINV was determined, and the risk factors for CINV were assessed. MATERIALS AND METHODS: CINV data were collected from 7-day diaries. Risk factors for CINV were identified using logistic regression models. RESULTS: Of 400 patients scheduled for carboplatin-based chemotherapy, 267 patients received two antiemetics (5-hydroxytryptamine-3 receptor antagonist [5-HT3 RA] and dexamethasone [DEX]), 118 patients received three antiemetics (5-HT3 RA, DEX, and neurokinin-1 receptor antagonist [NK1 RA]), and 15 were nonadherent to the treatment. In these patients, the CINV overall, acute, and delayed phase rates of complete response (CR), defined as no vomiting with no rescue medication, were 67.0%, 98.2%, and 67.5%, respectively. The rates of no nausea were 55.6%, 94.0%, and 56.1%, respectively, and those of no vomiting were 81.3%, 99.0%, and 81.8%, respectively. Older age was associated with a decreased non-CR, whereas female sex, history of pregnancy-related emesis, and dual antiemetic therapy were associated with an increased non-CR during the overall period. CONCLUSION: In a clinical practice setting, in patients who received carboplatin-based chemotherapy, adherence is quite high and appropriate antiemetic prophylaxis requires a triple antiemetic regimen including NK1 RA. IMPLICATIONS FOR PRACTICE: For patients receiving carboplatin-based chemotherapy, triple antiemetic therapy with 5-hydroxytryptamine-3 receptor antagonist, dexamethasone, and neurokinin-1 receptor antagonist should be given prophylactically regardless of risk factor status.


Assuntos
Antieméticos , Antineoplásicos , Idoso , Antieméticos/uso terapêutico , Antineoplásicos/efeitos adversos , Carboplatina/efeitos adversos , Feminino , Humanos , Japão/epidemiologia , Náusea/induzido quimicamente , Náusea/tratamento farmacológico , Náusea/epidemiologia , Estudos Prospectivos , Sistema de Registros , Vômito/induzido quimicamente , Vômito/tratamento farmacológico , Vômito/epidemiologia
13.
Gan To Kagaku Ryoho ; 47(11): 1605-1608, 2020 Nov.
Artigo em Japonês | MEDLINE | ID: mdl-33268737

RESUMO

Severe stenosis rarely occurs with radiation esophagitis after irradiation. We report our recent experience of a case of recurrent breast cancer in which the patient developed severe esophageal stenosis after receiving combined bevacizumab (Bev)-paclitaxel(PTX)therapy following radiotherapy for a thoracic vertebral metastasis. A 59-year-old woman with Stage ⅢB left breast cancer had undergone total mastectomy with axillary lymph node dissection after receiving neoadjuvant therapy. Elevated carcinoembryonic antigen levels were observed 23 months postoperatively, and multiple bone metastases were detected on PET-CT. After 5 sessions of irradiation with 20 Gy at the Th8-L1 level, combined Bev and PTX plus zoledronic acid was administered. The patient developed dysphagia at the end of the 4 cycles of combined Bev and PTX therapy, and her condition exacerbated subsequently. Therefore, upper gastrointestinal endoscopy was performed, which revealed a circumferential stenosis 31-37 cm from the incisors. We decided to perform the endoscopic treatment. After 3 balloon dilatations, her condition improved, and oral ingestion was possible. The esophageal stenosis might have been caused by the exacerbation of esophagitis because of the delayed wound healing effect of Bev in addition to radiation.


Assuntos
Neoplasias da Mama , Estenose Esofágica , Esofagite , Radiação , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Bevacizumab/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/cirurgia , Esofagite/induzido quimicamente , Feminino , Humanos , Mastectomia , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Paclitaxel/efeitos adversos , Pacientes , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada
14.
Cancer ; 125(22): 4076-4083, 2019 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-31381152

RESUMO

BACKGROUND: The current randomized, double-blind, phase 2 study assessed the efficacy and safety profile of a single intravenous administration of fosnetupitant, a neurokinin 1 receptor antagonist prodrug, for the prevention of chemotherapy-induced nausea and vomiting in Japanese patients receiving cisplatin-based chemotherapy. METHODS: Patients scheduled to receive cisplatin (at a dose of ≥70 mg/m2 )-based regimens were randomly assigned to receive fosnetupitant at a dose of 81 mg or 235 mg or placebo in combination with palonosetron at a dose of 0.75 mg and dexamethasone. The primary endpoint was complete response (CR; no vomiting and no rescue medication) during the overall phase (0-120 hours). The overall CR rate was compared between each dose of fosnetupitant and the placebo group adjusting for the stratification factors of sex and age class (age <55 years vs age ≥55 years). Safety was assessed, with special attention given to events that potentially were suggestive of infusion site reactions. RESULTS: A total of 594 patients were randomized. Of these, 194 patients, 195 patients, and 195 patients, respectively, in the placebo and fosnetupitant 81-mg and 235-mg dose groups were evaluable for efficacy. The overall CR rate was 54.7% for the placebo group, 63.8% for the fosnetupitant 81-mg dose group (adjusted difference, 9.1%; 95% CI, -0.4% to 18.6% [P = .061]), and 76.8% for the fosnetupitant 235-mg dose group (adjusted difference, 22.0%; 97.5% CI, 11.7% to 32.3% [P < .001]). Safety profiles were comparable between the 3 groups. The incidence of infusion site reactions related to fosnetupitant was ≤1% in each dose group. CONCLUSIONS: Fosnetupitant at a dose of 235 mg provided superior prevention of chemotherapy-induced nausea and vomiting among patients receiving cisplatin-based chemotherapy compared with the control group, and with a satisfactory safety profile.


Assuntos
Antieméticos/uso terapêutico , Antineoplásicos/efeitos adversos , Isoquinolinas/uso terapêutico , Náusea/etiologia , Náusea/prevenção & controle , Neoplasias/complicações , Piridinas/uso terapêutico , Quinuclidinas/uso terapêutico , Vômito/etiologia , Vômito/prevenção & controle , Adulto , Idoso , Antieméticos/administração & dosagem , Antieméticos/farmacocinética , Antineoplásicos/uso terapêutico , Combinação de Medicamentos , Feminino , Humanos , Isoquinolinas/administração & dosagem , Isoquinolinas/farmacocinética , Masculino , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológico , Piridinas/administração & dosagem , Piridinas/farmacocinética , Quinuclidinas/administração & dosagem , Quinuclidinas/farmacocinética , Resultado do Tratamento
15.
Br J Cancer ; 120(5): 475-480, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30745582

RESUMO

BACKGROUND: NK105 is a novel nanoparticle drug delivery formulation that encapsulates paclitaxel (PTX) in polymeric micelles. We conducted an open-label phase III non-inferiority trial to compare the efficacy and safety of NK105 and PTX in metastatic or recurrent breast cancer. METHODS: Patients were randomly assigned in a 1:1 ratio to receive either NK105 (65 mg/m2) or PTX (80 mg/m2) on days 1, 8 and 15 of a 28-day cycle. The primary endpoint was progression-free survival (PFS), with a non-inferiority margin of 1.215. RESULTS: A total of 436 patients were randomised and 211 patients in each group were included in the efficacy analysis. The median PFS was 8.4 and 8.5 months for NK105 and PTX, respectively (adjusted hazard ratio: 1.255; 95% confidence interval: 0.989-1.592). The median overall survival and overall response rates were 31.2 vs. 36.2 months and 31.6% vs. 39.0%, respectively. The two groups exhibited similar safety profiles. The incidence of peripheral sensory neuropathy (PSN) was 1.4% vs. 7.5% (≥Grade 3) for NK105 and PTX, respectively. The patient-reported outcomes of PSN were significantly favourable for NK105 (P < 0.0001). CONCLUSIONS: The primary endpoint was not met, but NK105 had a better PSN toxicity profile than PTX. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT01644890.


Assuntos
Adenocarcinoma/tratamento farmacológico , Antineoplásicos Fitogênicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Paclitaxel/análogos & derivados , Paclitaxel/uso terapêutico , Adenocarcinoma/secundário , Adulto , Idoso , Neoplasias da Mama/patologia , Estudos de Equivalência como Asunto , Feminino , Humanos , Pessoa de Meia-Idade , Metástase Neoplásica , Doenças do Sistema Nervoso Periférico/induzido quimicamente , Intervalo Livre de Progressão , Modelos de Riscos Proporcionais
16.
Jpn J Clin Oncol ; 49(2): 121-129, 2019 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-30576544

RESUMO

OBJECTIVE: Netupitant is a novel, selective neurokinin-1 receptor antagonist used for prevention of chemotherapy-induced nausea and vomiting, a distressing side effect of chemotherapy. This double-blind, randomized, Phase II study investigated the dose-response of oral netupitant in Japanese patients receiving highly emetogenic chemotherapy. METHODS: Chemotherapy-naïve patients were randomized (1:1:1) to a single oral netupitant 30-, 100- or 300-mg dose before chemotherapy initiation. Patients received concomitant palonosetron (0.75 mg intravenously [i.v.] Day 1) and dexamethasone (9.9 mg i.v. Day 1, 8 mg orally Days 2-4). RESULTS: Overall, 402 patients (30 mg: 134; 100 mg: 135; 300 mg: 133) were treated and evaluable for efficacy and safety. The primary endpoint of overall (0-120 h after chemotherapy administration) complete response (CR) rate (no emesis, no rescue medication) was 64.2%, 60.0% and 54.9% in the 30-, 100- and 300-mg arms, respectively, without statistical significance for dose-response. The safety profile of netupitant was comparable in the three arms. The plasma concentrations of netupitant and its metabolites increased with the dose increase from 30 mg to 300 mg. CONCLUSIONS: No dose-response relationship of netupitant in terms of overall CR rate was observed in this study. Netupitant was well tolerated at all doses without clinically harmful safety signals observed. CLINICAL TRIAL REGISTRATION: JapicCTI-142 483.


Assuntos
Antineoplásicos/efeitos adversos , Eméticos/efeitos adversos , Náusea/tratamento farmacológico , Palonossetrom/administração & dosagem , Palonossetrom/uso terapêutico , Piridinas/administração & dosagem , Piridinas/uso terapêutico , Vômito/tratamento farmacológico , Administração Oral , Adulto , Idoso , Aminas , Antieméticos/administração & dosagem , Antieméticos/uso terapêutico , Método Duplo-Cego , Determinação de Ponto Final , Feminino , Humanos , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Náusea/sangue , Náusea/induzido quimicamente , Náusea/prevenção & controle , Palonossetrom/sangue , Palonossetrom/farmacocinética , Piridinas/sangue , Piridinas/farmacocinética , Resultado do Tratamento , Vômito/sangue , Vômito/induzido quimicamente , Vômito/prevenção & controle
17.
Gan To Kagaku Ryoho ; 46(11): 1683-1685, 2019 Nov.
Artigo em Japonês | MEDLINE | ID: mdl-31748472

RESUMO

For anti-emetic therapy, the first guideline was published 2010, following second version was open for public in 2015. The latest guideline for anti-emetic therapy in Japan, version 2.2 was disclosed on web site of Japan Society of Clinical Oncology. The point of new version were included 3 points which were a new categorization of moderately emetic chemotherapy, improvement of olanzapine for anti-emetic drug, and steroid spearing for MEC.


Assuntos
Antieméticos/uso terapêutico , Guias de Prática Clínica como Assunto , Antineoplásicos , Humanos , Japão , Náusea , Vômito
18.
Breast Cancer Res ; 20(1): 107, 2018 09 05.
Artigo em Inglês | MEDLINE | ID: mdl-30185224

RESUMO

After the publication of this article [1], we noticed that in Fig. 2, the survival curve images (C and D, lower panel) were incorrect. The corrected Fig. 2 is presented below. The correction does not affect in any our results and conclusions.

19.
Breast Cancer Res ; 20(1): 78, 2018 07 27.
Artigo em Inglês | MEDLINE | ID: mdl-30053906

RESUMO

BACKGROUND: Hypoxia is a key driver of cancer progression. We evaluated the prognostic impact of 18F-fluoromisonidazole (FMISO) prior to treatment in patients with breast cancer. METHODS: Forty-four patients with stage II/III primary breast cancer underwent positron emission tomography/computed with 18F-fluorodeoxyglucose (FDG-PET/CT) and FMISO. After measurement by FDG-PET/CT, the tissue-to-blood ratio (TBR) was obtained using FMISO-PET/CT. FMISO-TBR was compared for correlation with clinicopathological factors, disease-free survival (DFS), and overall survival (OS). Multiplex cytokines were analyzed for the correlation of FMISO-TBR. RESULTS: Tumors with higher nuclear grade and negativities of estrogen receptor (ER) and progesterone receptor had significantly higher FMISO-TBR than other tumors. Kaplan-Meier survival curves showed that patients with a higher FMISO-TBR (cutoff, 1.48) had a poorer prognosis of DFS (p = 0.0007) and OS (p = 0.04) than those with a lower FMISO-TBR. Multivariate analysis indicated that higher FMISO-TBR and ER negativity were independent predictors of shorter DFS (p = 0.01 and 0.03). Higher FMISO-TBR was associated with higher plasma levels of angiogenic hypoxic markers such as vascular endothelial growth factor, transforming growth factor-α, and interleukin 8. CONCLUSIONS: FMISO-PET/CT is useful for assessing the prognosis of patients with breast cancer, but it should be stratified by ER status. TRIAL REGISTRATION: UMIN Clinical Trials Registry, UMIN000006802 . Registered on 1 December 2011.


Assuntos
Neoplasias da Mama/diagnóstico por imagem , Misonidazol/análogos & derivados , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Compostos Radiofarmacêuticos/administração & dosagem , Adulto , Idoso , Mama/diagnóstico por imagem , Mama/patologia , Neoplasias da Mama/mortalidade , Hipóxia Celular , Intervalo Livre de Doença , Feminino , Fluordesoxiglucose F18/administração & dosagem , Humanos , Pessoa de Meia-Idade , Misonidazol/administração & dosagem , Prognóstico , Receptores de Estrogênio/metabolismo
20.
Future Oncol ; 14(19): 1909-1919, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29482364

RESUMO

Trastuzumab is an anti-HER2 monoclonal antibody indicated for the treatment of HER2-overexpressing breast and gastric cancers. Despite its clinical efficacy, access to the biological drug can be limited due to its relatively high price, especially in low-income countries. CT-P6 (Herzuma®) is a biosimilar candidate of originator or 'reference' trastuzumab, which may offer an alternative, more cost-effective treatment option. This article reviews the unmet needs of patients eligible to receive reference trastuzumab and the potential place of a trastuzumab biosimilar within the market. The review also summarizes the available clinical evidence supporting the biosimilarity of CT-P6 and reference trastuzumab with respect to pharmacokinetics, efficacy, safety and immunogenicity.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias Gástricas/tratamento farmacológico , Trastuzumab/uso terapêutico , Medicamentos Biossimilares/efeitos adversos , Medicamentos Biossimilares/farmacocinética , Neoplasias da Mama/patologia , Feminino , Humanos , Neoplasias Gástricas/patologia , Trastuzumab/efeitos adversos
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA