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1.
Respir Res ; 22(1): 245, 2021 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-34526033

RESUMO

BACKGROUND: We performed a multicenter, randomized open-label trial in patients with moderate to severe Covid-19 treated with a range of possible treatment regimens. METHODS: Patients were randomly assigned to one of three regimen groups at a ratio of 1:1:1. The primary outcome of this study was admission to the intensive care unit. Secondary outcomes were intubation, in-hospital mortality, time to clinical recovery, and length of hospital stay (LOS). Between April 13 and August 9, 2020, a total of 336 patients were randomly assigned to receive one of the 3 treatment regimens including group I (hydroxychloroquine stat, prednisolone, azithromycin and naproxen; 120 patients), group II (hydroxychloroquine stat, azithromycin and naproxen; 116 patients), and group III (hydroxychloroquine and lopinavir/ritonavir (116 patients). The mean LOS in patients receiving prednisolone was 5.5 in the modified intention-to-treat (mITT) population and 4.4 days in the per-protocol (PP) population compared with 6.4 days (mITT population) and 5.8 days (PP population) in patients treated with Lopinavir/Ritonavir. RESULTS: The mean LOS was significantly lower in the mITT and PP populations who received prednisolone compared with populations treated with Lopinavir/Ritonavir (p = 0.028; p = 0.0007). We observed no significant differences in the number of deaths, ICU admission, and need for mechanical ventilation between the Modified ITT and per-protocol populations treated with prednisolone and Lopinavir/Ritonavir, although these outcomes were better in the arm treated with prednisolone. The time to clinical recovery was similar in the modified ITT and per-protocol populations treated with prednisolone, lopinavir/ritonavir, and azithromycin (P = 0.335; P = 0.055; p = 0.291; p = 0.098). CONCLUSION: The results of the present study show that therapeutic regimen (regimen I) with low dose prednisolone was superior to other regimens in shortening the length of hospital stay in patients with moderate to severe COVID-19. The steroid sparing effect may be utilized to increase the effectiveness of corticosteroids in the management of diabetic patients by decreasing the dosage.


Assuntos
COVID-19/tratamento farmacológico , Glucocorticoides/uso terapêutico , Prednisolona/uso terapêutico , Adulto , Idoso , Antivirais/uso terapêutico , COVID-19/diagnóstico , COVID-19/mortalidade , COVID-19/virologia , Quimioterapia Combinada , Feminino , Glucocorticoides/efeitos adversos , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva , Intubação Intratraqueal , Irã (Geográfico) , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Prednisolona/efeitos adversos , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
2.
Trials ; 22(1): 442, 2021 Jul 12.
Artigo em Inglês | MEDLINE | ID: mdl-34247632

RESUMO

BACKGROUND: Minimal change nephropathy (MCN) is a common cause of nephrotic syndrome in both adults and children. International guidelines recommend treatment with prednisolone 1 mg/kg/day to adults. This dose is derived from an empirically established dose in children, although children generally attain remission faster and relapse more rapidly than adults. Prednisolone is associated with multiple and serious adverse events. Activated vitamin D has been shown to reduce albuminuria in other glomerular renal diseases with a minimum of adverse events. This study tests the hypothesis that a new treatment regimen in MCN combining reduced dose prednisolone and active vitamin D is as efficient in inducing remission and has fewer and less severe adverse events than standard prednisolone. Furthermore, we aim to establish models allowing for more personalized medicine based on assessment of the individual's prednisolone metabolism. METHODS: A randomised controlled multicentre non-inferior unblinded trial including 96 adult, incident patients with biopsy-proven MCN, albuminuria > 3 g/day, and an estimated glomerular filtration rate (eGFR) > 30 ml/min from renal departments in Denmark. Patients are randomised to standard prednisolone (1 mg/kg/day) or reduced prednisolone (0.5 mg/kg/day) and alfacalcidol (0.5 µg/day). The primary outcome is the rate of remissions after 16 weeks and the time from diagnosis to remission. The study will include a saliva test to characterise prednisolone pharmacokinetics and compare them to genetic variations in specific liver enzymes responsible for prednisolone metabolism. DISCUSSION: Reducing the prednisolone dose is expected to reduce the number of severe adverse events. This study will examine if reduced prednisolone dose with active vitamin D but without additional immunosuppression is feasible in the treatment of MCN and will reduce the number of adverse events. The findings can potentially change current guidelines for treatment of MCN in adults. Additional outcomes on inter-individual pharmacokinetic and metabolic variations may allow for a more personalised treatment strategy. TRIAL REGISTRATION: EudraCT 2017-001206-16, ClinicalTrials.gov NCT03210688 . Registered on June 3, 2017.


Assuntos
Nefropatias , Nefrose Lipoide , Adulto , Criança , Humanos , Rim , Nefrose Lipoide/diagnóstico , Nefrose Lipoide/tratamento farmacológico , Prednisolona/efeitos adversos , Resultado do Tratamento , Vitamina D/efeitos adversos
3.
Medicine (Baltimore) ; 100(20): e25955, 2021 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-34011077

RESUMO

RATIONALE: Mucous membrane pemphigoid (MMP) is a rare, autoimmune bullous disease that affects mucosal surfaces and skin. Early and aggressive treatment initiation may be warranted due to the risks of serious complications. However, it can be challenging to make an initial diagnosis. Viral infection such as hepatitis B virus (HBV) infection has been found to be associated with the formation of autoimmune bullous diseases. PATIENT CONCERNS: The patient was a 43-year-old male with gingivitis and recurrent swelling over the neck, cheeks, lips, and eyelids. The patient presented at oral medicine, otolaryngology, plastic surgery, and ophthalmology sequentially, and was later referred to the rheumatology, dermatology, and family medicine departments. Recurrent hemorrhagic bullae on oral mucosa and skin scarring occurred 2 years after the onset of the initial symptoms. DIAGNOSIS: Skin biopsy with direct immunofluorescence was performed under the suspicion of MMP. Lesional hematoxylin and eosin stain and perilesional direct immunofluorescence were consistent with MMP. INTERVENTIONS: Systemic Prednisolone and topical corticosteroid were used to control the disease. OUTCOMES: A flare-up of hepatitis B developed as a result of systemic prednisolone use. The disease went through relapses and remissions. The patient is on low-dose prednisolone (5 mg/day) with a monthly outpatient visit in the family medicine department. LESSONS: It would be useful for medical practitioners in different specialties to be alert of the heterogeneous presentations of MMP. Chronic HBV infection might be a risk factor for MMP. In patients with chronic HBV infection, treatment of MMP must be closely monitored for the risk of reactivation of HBV.


Assuntos
Hepatite B Crônica/complicações , Penfigoide Mucomembranoso Benigno/diagnóstico , Prednisolona/administração & dosagem , Adulto , Biópsia , Relação Dose-Resposta a Droga , Hepatite B Crônica/diagnóstico , Hepatite B Crônica/imunologia , Humanos , Masculino , Mucosa Bucal/imunologia , Mucosa Bucal/patologia , Penfigoide Mucomembranoso Benigno/tratamento farmacológico , Penfigoide Mucomembranoso Benigno/imunologia , Penfigoide Mucomembranoso Benigno/patologia , Prednisolona/efeitos adversos , Pele/imunologia , Pele/patologia , Exacerbação dos Sintomas
4.
Int J Hematol ; 114(2): 246-251, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33864237

RESUMO

Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL) are common subtypes of T-cell lymphoma. Although CHOP is a standard regimen for T-cell lymphoma, it has unsatisfactory outcomes. Pirarubicin is an anthracycline antibiotic with lower cardiotoxicity than doxorubicin. THP-COP (pirarubicin, cyclophosphamide, vincristine, and prednisone) is sometimes used for elderly patients with non-Hodgkin's lymphoma in Japan. We performed a retrospective analysis using data from the population-based Osaka Cancer Registry as well as administrative data from 2010 to 2015. Of 82 enrolled patients, 51 received CHOP and 31 received THP-COP. The median age was 65 years in the CHOP group and 75 years in the THP-COP group. The probability of 3-year overall survival (OS) was 49.0% in the CHOP group and 44.9% in the THP-COP group. In the propensity score-adjusted analysis, there was no significant difference between the THP-COP and CHOP groups in the OS of the total sample [hazard ratio (HR) 0.46, 95% CI 0.14-1.55, P = 0.2]. Although our study was limited by its retrospective nature, it showed that clinical outcomes with the THP-COP regimen were comparable to those with the CHOP regimen in PTCL-NOS and AITL. Our findings should be re-assessed in larger studies in the future.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Doxorrubicina/análogos & derivados , Linfoma de Células T Periférico/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Ciclofosfamida/efeitos adversos , Ciclofosfamida/uso terapêutico , Gerenciamento Clínico , Doxorrubicina/efeitos adversos , Doxorrubicina/uso terapêutico , Feminino , Pesquisas sobre Serviços de Saúde , Hospitalização , Humanos , Japão/epidemiologia , Linfoma de Células T Periférico/diagnóstico , Linfoma de Células T Periférico/epidemiologia , Masculino , Pessoa de Meia-Idade , Prednisolona/efeitos adversos , Prednisolona/uso terapêutico , Prednisona/efeitos adversos , Prednisona/uso terapêutico , Prognóstico , Sistema de Registros , Estudos Retrospectivos , Resultado do Tratamento , Vincristina/efeitos adversos , Vincristina/uso terapêutico
6.
Ned Tijdschr Geneeskd ; 1652021 04 08.
Artigo em Holandês | MEDLINE | ID: mdl-33914434

RESUMO

Glucocorticoids are important for treatment of (auto-)immune diseases. Prolonged use of high dose glucocorticoids increases the cardiovascular disease risk. Underlying mechanisms have not been fully elucidated but increased incidence of traditional cardiovascular risk factors and enhanced (V)LDL-cholesterol synthesis are important contributors. If and to what extent this also holds for low-dose corticosteroids (< 7.5mg prednisolone/day) is still unknown. The current evidence is based on observational studies which are often dominated by 'confounding by indication', as disease activity itself is an independent cardiovascular risk factor, and particularly patients with active disease are more likely to receive higher doses of glucocorticoids. Future studies (preferably RCT's) with disease activity data and medication use are required to solve this issue. Obviously, we must always remain critical regarding the use of glucocorticoids and aim for the lowest possible adequate dose and shortest treatment duration.


Assuntos
Doenças Cardiovasculares/induzido quimicamente , Glucocorticoides/efeitos adversos , Fatores de Risco de Doenças Cardíacas , Corticosteroides/efeitos adversos , Arritmias Cardíacas/induzido quimicamente , Doenças Cardiovasculares/prevenção & controle , Relação Dose-Resposta a Droga , Glucocorticoides/uso terapêutico , Humanos , Incidência , Estudos Observacionais como Assunto , Prednisolona/efeitos adversos , Fatores de Risco
7.
Intern Med ; 60(17): 2853-2858, 2021 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-33746170

RESUMO

Lymphoproliferative diseases have been associated with various autoimmune diseases. We experienced a case of non-chronic lymphocytic leukemia type monoclonal B-cell lymphocytosis (MBL) that was exacerbated by increasing prednisolone for dermatomyositis and then improved by decreasing the dosage. Because MBL is difficult to diagnose, cases like ours may not be rare. These findings will facilitate our understanding of the mechanism underlying lymphoproliferative diseases and autoimmune diseases.


Assuntos
Dermatomiosite , Leucemia Linfocítica Crônica de Células B , Linfocitose , Linfócitos B , Dermatomiosite/induzido quimicamente , Dermatomiosite/diagnóstico , Dermatomiosite/tratamento farmacológico , Humanos , Leucemia Linfocítica Crônica de Células B/tratamento farmacológico , Linfocitose/induzido quimicamente , Linfocitose/diagnóstico , Prednisolona/efeitos adversos
8.
Ann Thorac Surg ; 112(4): e237-e239, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33592182

RESUMO

Spontaneous pneumothorax can be classified into primary and secondary variants. A 58-year-old patient presented with a 7-week history of severe coughing and chest pain. He noticed progressive swelling of the face and the upper part of the body. His medical history revealed osteoporosis and severe rheumatoid arthritis treated with steroids and disease-modifying antirheumatic drugs. Computed tomography of the thorax revealed complete rupture of the thoracic wall through costae 9 and 10 with lung herniation. The defect was closed using dual mesh and the pneumothorax was treated. Two weeks after surgery, the subcutaneous emphysema resolved and the patient was discharged from the hospital.


Assuntos
Glucocorticoides/efeitos adversos , Doenças Musculares/induzido quimicamente , Pneumotórax/diagnóstico , Pneumotórax/etiologia , Prednisolona/efeitos adversos , Parede Torácica , Artrite Reumatoide/tratamento farmacológico , Glucocorticoides/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Musculares/complicações , Pneumotórax/terapia , Prednisolona/administração & dosagem , Músculos Respiratórios , Ruptura Espontânea
9.
Int J Hematol ; 113(6): 893-902, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33641058

RESUMO

Approximately 90% of pediatric acute lymphoblastic leukemia (ALL) cases are curable with intensified chemotherapy, but very high-risk patients may require hematopoietic stem cell transplantation (HSCT). A suitable indication for HSCT in the first complete remission (CR1) should be defined to protect patients from long-term complications. We report the outcomes of HSCT in CR1 from the Japan Association of Childhood Leukemia Study (JACLS) ALL-02 study and reassess indications for HSCT. Of 1114 patients, 71 (6.4%) received HSCT in CR1. Indications included high-risk cytogenetic abnormalities and non-CR on day 33. Patients with B-cell precursor (BCP) ALL and a prednisolone poor response (PPR) received HSCT when leukocyte antigen-matched siblings were available. The 4-year overall survival (OS) of transplanted patients was 78.8% (confidence interval 67.3-86.6). Multivariate analysis revealed that cord blood transplantation was associated with poor OS. For BCP-ALL patients with PPR who achieved CR1 after induction therapy, HSCT in CR1 showed excellent outcomes (4-year OS 90.9%) but demonstrated no survival advantage as the outcome with chemotherapy was also excellent (4-year OS 97.0%). This study suggests that in BCP-ALL patients PPR is not an indication for HSCT in CR1. Precise evaluation of treatment responses would increase sophistication of indications for HSCT in CR1.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Leucemia-Linfoma Linfoblástico de Células Precursoras B/mortalidade , Leucemia-Linfoma Linfoblástico de Células Precursoras B/terapia , Prednisolona/administração & dosagem , Adolescente , Aloenxertos , Criança , Pré-Escolar , Intervalo Livre de Doença , Feminino , Humanos , Lactente , Masculino , Prednisolona/efeitos adversos , Indução de Remissão , Taxa de Sobrevida
10.
Medicine (Baltimore) ; 100(7): e24789, 2021 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-33607834

RESUMO

RATIONALE: Granulomatosis with polyangiitis (GPA) is a rare systemic autoimmune disease of unknown etiology. GPA affects multiple ocular tissues, most commonly the orbit, conjunctiva, cornea, and sclera. Retinal and choroidal manifestations are rare in GPA, but they often include choroidal neovascularization (CNV). PATIENT CONCERNS: A 36-year-old man was diagnosed with GPA. He had been taking oral steroid treatment for 8 years. He experienced disease recurrence and the dose of oral prednisolone was increased after steroid pulse therapy. Fundus examination showed small retinal pigment epithelial detachment and serous retinal detachment (SRD). Optical coherence tomography (OCT) revealed a protruded lesion inside the SRD. Fluorescein angiography (FA) showed a small, dot-shaped fluorescein leakage in the SRD, and indocyanine green fluorescein fundus angiography showed choroidal vascular hyperpermeability that was consistent with the hyperfluorescence seen with FA. We had to determine whether the protruded lesion inside the SRD was CNV secondary to the inflammation due to GPA or whether it was central serous chorioretinopathy (CSC)-like condition caused by high-dose steroid treatment. DIAGNOSES: We confirmed that the SRD was due to CSC but not CNV because the protruded lesion examined by B-scan OCT angiography (OCTA) showed no blood flow. INTERVENTIONS: We decided to reduce the dose of steroid. OUTCOMES: Since the reduction of steroids, no sign of worsening in the protruded lesions with SRD has been observed. LESSONS: We therefore propose the effectiveness of this advanced function of OCTA for the examination of blood flow signal images to detect CNV.


Assuntos
Coriorretinopatia Serosa Central/etiologia , Glucocorticoides/efeitos adversos , Granulomatose com Poliangiite/tratamento farmacológico , Prednisolona/efeitos adversos , Descolamento Retiniano/etiologia , Administração Oral , Adulto , Progressão da Doença , Angiofluoresceinografia , Granulomatose com Poliangiite/complicações , Humanos , Masculino , Prednisolona/administração & dosagem , Tomografia de Coerência Óptica
11.
Eur J Cancer ; 145: 245-254, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33419647

RESUMO

INTRODUCTION: We analysed patients with advanced non-small cell lung cancer (NSCLC) who were treated with immune-checkpoint inhibitors (ICIs) to address the effect of the timeline and reason for corticosteroid administration on survival outcomes. METHODS: We retrospectively collected clinical data of non-oncogenic driven, advanced NSCLC patients treated with ICIs at Karolinska University Hospital, including the timeline and reason for steroid administration. Steroid administration was defined as > 10 mg prednisolone equivalent for ≥10 days. We subcategorized patients based on the aetiology of steroid administration into three subgroups: a) steroids for supportive reasons but not for cancer palliation; b) steroids for the palliation of cancer-related symptoms; c) steroids for the management of immune-related adverse events (irAEs). Furthermore, to analyse the timeline, patients were categorised into two groups; those who received corticosteroids within 2 weeks before until 2 days after ICI initiation and those who received steroids later during their treatment course. RESULTS: Analysed data from 196 patients showed 46.3% of patients received corticosteroids. Steroid administration due to irAEs did not affect overall survival (OS) (p = 0.38) compared with the steroid naïve group. Only steroid administration for the palliation of cancer-related symptoms was an independent predictor for shorter OS (HR = 2.7; 95% CI, 1.5-4.9). The timeline of steroid administration did not affect OS (p = 0.456) in our cohort. CONCLUSIONS: Steroids due to irAEs do not appear to hamper ICI efficacy. However, the administration of high-dose steroids to palliate malignancy-associated symptoms might reflect the dismal prognosis of this patient group.


Assuntos
Corticosteroides/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Inibidores de Checkpoint Imunológico/uso terapêutico , Neoplasias Pulmonares/tratamento farmacológico , Prednisolona/uso terapêutico , Corticosteroides/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/imunologia , Carcinoma Pulmonar de Células não Pequenas/patologia , Progressão da Doença , Feminino , Humanos , Inibidores de Checkpoint Imunológico/efeitos adversos , Neoplasias Pulmonares/imunologia , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Prednisolona/efeitos adversos , Intervalo Livre de Progressão , Estudos Retrospectivos , Fatores de Tempo
12.
Osteoporos Int ; 32(7): 1441-1449, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33464392

RESUMO

In this study, no difference in bone loss was observed between patients with early RA initially treated with COmbinatietherapie Bij Reumatoide Artritis (COBRA) (including initially 60 mg/day prednisolone) and patients treated with COBRA-light (including initially 30 mg/day prednisolone) during 4-year observation. PURPOSE: To assess changes in bone mineral density (BMD) after 4 years in early rheumatoid arthritis (RA) patients initially treated with COBRA-light or COBRA therapy. METHODS: In a 1 year, open-label, randomised, non-inferiority trial, patients were assigned to COBRA-light (methotrexate 25 mg/week plus initially prednisolone 30 mg/day) or COBRA (methotrexate 7.5 mg/week, sulfasalazine 2 g/day plus initially prednisolone 60 mg/day) therapy. After 1 year, antirheumatic treatment was at the discretion of treating rheumatologists. BMD was measured at baseline and after 1, 2 and 4 years at hips and lumbar spine with dual-energy X-ray absorptiometry. BMD changes between treatment strategies on average over time were compared with GEE analysis. RESULTS: Data from 155 out of 162 patients could be analysed: 68% were female with a mean age of 52 (SD 13) years. Both COBRA-light and COBRA therapy showed declines in BMD at the total hip of -3.3% and -1.7%, respectively (p = 0.12), and the femoral neck, -3.7% and -3.0%, respectively (p = 0.95). At the lumbar spine, both treatment groups showed minor decline in BMD over 4 years: -0.5% and -1.0%, respectively (p = 0.10). CONCLUSION: In a treat-to-target design in early RA, over 4 years, no differences between groups were found in change in BMD at total hip, femoral neck and the lumbar spine. At the hip, bone loss was around 3% in both groups, while mild bone loss was observed at lumbar spine, both in patients starting prednisolone 60 and 30 mg/day. These data suggest that the well-known negative effects of prednisolone can be modulated by modern treatment of RA.


Assuntos
Antirreumáticos , Artrite Reumatoide , Absorciometria de Fóton , Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Densidade Óssea , Quimioterapia Combinada , Feminino , Humanos , Masculino , Metotrexato/uso terapêutico , Pessoa de Meia-Idade , Prednisolona/efeitos adversos
13.
Br J Haematol ; 192(3): 531-541, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-32583431

RESUMO

We conducted a randomised phase II study to determine the optimal dose and schedule of melphalan, prednisone, and bortezomib (MPB) (jRCTs031180097). Transplant-ineligible untreated multiple myeloma patients were randomised to Arm A (twice weekly bortezomib in one six-week cycle followed by eight five-week cycles of four times once weekly bortezomib with melphalan and prednisolone on days 1-4) or Arm B (nine four-week cycles of three times once weekly bortezomib with melphalan and prednisolone on days 1-4). The primary end-point was complete response (CR) rate. Of 91 patients randomised to two arms, 88 were eligible. The median cumulative bortezomib doses were 45·8 and 35·1 mg/m2 , CR rate was 18·6% [95% confidence interval (CI) 8·4-33·4] and 6·7% (95% CI 1·4-18·3), and the median progression-free survival (PFS) was 2·5 and 1·4 years in Arms A and B [hazard ratio (HR) 1·93 (95% CI 1·09-3·42)], respectively. Frequent grade ≥3 haematologic toxicities in Arms A and B were neutropenia (64·4% vs. 28·3%) and thrombocytopenia (35·6% vs. 10·9%). Grade 2/3 peripheral neuropathy was observed in 24·4/2·2% in Arm A and 8·7/0% in Arm B. In conclusion, Arm A was the more promising regimen, suggesting that the twice weekly schedule of bortezomib in the first cycle and higher cumulative dose of both bortezomib and melphalan influences the efficacy of modified MPB.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Bortezomib/uso terapêutico , Melfalan/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Prednisolona/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Bortezomib/administração & dosagem , Bortezomib/efeitos adversos , Feminino , Humanos , Masculino , Melfalan/administração & dosagem , Melfalan/efeitos adversos , Prednisolona/administração & dosagem , Prednisolona/efeitos adversos , Análise de Sobrevida , Resultado do Tratamento
15.
Minerva Med ; 112(2): 310-312, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-31317691
16.
Ann Palliat Med ; 10(2): 1438-1444, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33081478

RESUMO

BACKGROUND: Prostate cancer is the most common type of malignancy in elderly men. Although elderly patients are commonly encountered in clinical practice, few studies have focused on the value of chemotherapy in elderly patients. In this study, we reviewed the use of docetaxel with prednisolone in elderly men (aged ≥80 years) with metastatic castration-resistant prostate cancer (mCRPC) at Ningbo First Hospital with a focus on efficacy and toxicity. METHODS: A retrospective study including a series of men aged ≥80 years with mCRPC and received docetaxel plus prednisone chemotherapy between August 2011 and May 2019. All these cases were selected from the Ningbo First Hospital prostate cancer database located in Zhejiang Province, China. RESULTS: Sixteen patients were identified, with a mean age of 82 years (range, 80 to 87 years). All patients have received a median of four and half cycles (range, 1-10) of 3-week (60-75 mg/m2 ) docetaxel regimens and 5 mg prednisone twice per day. Seven (43.75%) patients completed more than six cycles. Ten (62.50%) patients had a good prostate-specific antigen (PSA) response of ≥50% decline. Eight (50.00%) patients had ostealgia before receiving docetaxel treatment and six of them (75.00%) experienced reduced pain after the treatment. Hematologic toxicity was observed in six (37.50%) patients with neutropenia, one of which was diagnosed with agranulocytosis and had to be admitted for the same reason. Other adverse reactions such as fever, debilitation, and alopecia were also observed. CONCLUSIONS: Very elderly patients (aged ≥80 years) with mCRPC are easy to be neglected and infrequently involved in clinical trials. Our study demonstrates that docetaxel chemotherapy plus prednisone is tolerable and effective among Chinese elderly patients (≥80 years) with mCRPC. Docetaxel chemotherapy may be given under careful surveillance even in frail elderly patients.


Assuntos
Neoplasias de Próstata Resistentes à Castração , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , China , Docetaxel/efeitos adversos , Humanos , Masculino , Prednisolona/efeitos adversos , Prednisona/efeitos adversos , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Estudos Retrospectivos , Resultado do Tratamento
17.
Pediatr Blood Cancer ; 68(2): e28763, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33047887

RESUMO

BACKGROUND: Adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL) are more likely to have chemotherapy-related complications than children. In addition, several reports have shown that infections account for most of the therapy-related mortality during cancer treatment in AYAs. Thus, we hypothesized that chemotherapy-induced myelosuppression is more severe in AYAs than in children, and the state of neutropenia was compared between children and AYAs using the D-index, a numerical value calculated from the duration and depth of neutropenia. PROCEDURE: This study retrospectively analyzed 95 patients newly diagnosed with ALL at our institution between 2007 and 2019. Of these, 81 were children (<15 years old) and 14 were AYAs (≥15 years old). The D-index and duration of neutropenia during induction chemotherapy for ALL were compared between children and AYAs. RESULTS: The median D-index of children was significantly higher than that of AYAs (8187 vs 6446, respectively, P = .017). Moreover, the median duration of neutropenia was also significantly longer in children than in AYAs (24.0 days vs 11.5 days, respectively, P = .007). CONCLUSION: Contrary to our expectations, myelosuppressive toxicity during induction chemotherapy for ALL was more severe in children than in AYAs.


Assuntos
Antineoplásicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Imunossupressão/efeitos adversos , Quimioterapia de Indução/efeitos adversos , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Adolescente , Antineoplásicos/uso terapêutico , Asparaginase/efeitos adversos , Asparaginase/uso terapêutico , Bacteriemia/microbiologia , Criança , Pré-Escolar , Ciclofosfamida/efeitos adversos , Ciclofosfamida/uso terapêutico , Daunorrubicina/efeitos adversos , Daunorrubicina/uso terapêutico , Feminino , Humanos , Quimioterapia de Indução/métodos , Lactente , Injeções Espinhais , Masculino , Neutropenia/microbiologia , Prednisolona/efeitos adversos , Prednisolona/uso terapêutico , Indução de Remissão , Estudos Retrospectivos , Vincristina/efeitos adversos , Vincristina/uso terapêutico , Adulto Jovem
18.
Am J Ophthalmol ; 222: 382-387, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33045216

RESUMO

PURPOSE: To assess whether prophylactic use of netarsudil 0.02% ophthalmic solution reduces the risk of intraocular pressure (IOP) elevation associated with prolonged use of topical corticosteroids to prevent cornea transplantation rejection. DESIGN: Prospective, randomized clinical trial. METHODS: In this study, 120 subjects were randomized to use netarsudil (off-label) or placebo once daily for 9 months after Descemet membrane endothelial keratoplasty, and 71 fellow eyes were enrolled and assigned to the opposite treatment arm. Participants concurrently used topical prednisolone acetate 1% 4× daily for 3 months, 3× daily for a month, twice daily for a month, and once daily for 4 months. The main outcome was IOP elevation (defined as IOP ≥24 mm Hg or an increase of ≥10 mm Hg over baseline) assessed by Kaplan-Meier and proportional hazards analyses, taking loss to follow-up into consideration. RESULTS: Overall, 95 eyes were assigned to netarsudil and 96 to placebo; 15 eyes (16%) were withdrawn early from the netarsudil arm because of ocular irritation. The rate of IOP elevation was 14% with netarsudil and 21% with placebo (relative risk: 0.6; 95% confidence interval: 0.3-1.3; P = .23). IOP was >30 mm Hg in 7.8% assigned to netarsudil versus 7.4% assigned to placebo (P = .84). Median 6-month central endothelial cell loss was 31% versus 29% with netarsudil versus placebo, respectively (P = .49). CONCLUSIONS: Netarsudil did not produce a statistically significant reduction in the risk of steroid-induced IOP elevation after corneal transplantation relative to placebo.


Assuntos
Benzoatos/administração & dosagem , Pressão Intraocular/efeitos dos fármacos , Hipertensão Ocular/prevenção & controle , Prednisolona/análogos & derivados , beta-Alanina/análogos & derivados , Adulto , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Feminino , Seguimentos , Glucocorticoides/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Hipertensão Ocular/induzido quimicamente , Hipertensão Ocular/fisiopatologia , Soluções Oftálmicas/administração & dosagem , Prednisolona/efeitos adversos , Estudos Prospectivos , beta-Alanina/administração & dosagem
19.
J Clin Oncol ; 39(3): 190-201, 2021 01 20.
Artigo em Inglês | MEDLINE | ID: mdl-33326257

RESUMO

PURPOSE: Capivasertib is a pan-AKT inhibitor. Preclinical data indicate activity in metastatic castration-resistant prostate cancer (mCRPC) and synergism with docetaxel. PATIENTS AND METHODS: ProCAID was a placebo controlled randomized phase II trial in mCRPC. Patients received up to ten 21-day cycles of docetaxel (75 mg/m2 intravenous, day 1) and prednisolone (5 mg twice daily, oral, day 1-21) and were randomly assigned (1:1) to oral capivasertib (320 mg twice daily, 4 days on/3 days off, from day 2 each cycle), or placebo, until disease progression. Treatment allocation used minimization factors: bone metastases; visceral metastases; investigational site; and prior abiraterone or enzalutamide. The primary objective, by intention to treat, determined if the addition of capivasertib prolonged a composite progression-free survival (cPFS) end point that included prostate-specific antigen progression events. cPFS and overall survival (OS) were also assessed by composite biomarker subgroup for PI3K/AKT/PTEN pathway activation status. RESULTS: One hundred and fifty patients were enrolled. Median cPFS was 7.03 (95% CI, 6.28 to 8.25) and 6.70 months (95% CI, 5.52 to 7.36) with capivasertib and placebo respectively (hazard ratio [HR], 0.92; 80% CI, 0.73 to 1.16; one-sided P = .32). Median OS was 31.15 (95% CI, 20.07 to not reached) and 20.27 months (95% CI, 17.51 to 24.18), respectively (HR, 0.54; 95% CI, 0.34 to 0.88; two-sided P = .01). cPFS and OS results were consistent irrespective of PI3K/AKT/PTEN pathway activation status. Grade III-IV adverse events were equivalent between arms (62.2%). The most common adverse events of any grade deemed related to capivasertib were diarrhea, fatigue, nausea, and rash. CONCLUSION: The addition of capivasertib to chemotherapy did not extend cPFS in mCRPC irrespective of PI3K/AKT/PTEN pathway activation status. The observed OS result (a secondary end point) will require prospective validation in future studies to address potential for bias.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Docetaxel/uso terapêutico , Prednisolona/uso terapêutico , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Inibidores de Proteínas Quinases/uso terapêutico , Proteínas Proto-Oncogênicas c-akt/antagonistas & inibidores , Pirimidinas/uso terapêutico , Pirróis/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Progressão da Doença , Docetaxel/efeitos adversos , Método Duplo-Cego , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Prednisolona/efeitos adversos , Intervalo Livre de Progressão , Neoplasias de Próstata Resistentes à Castração/enzimologia , Neoplasias de Próstata Resistentes à Castração/mortalidade , Neoplasias de Próstata Resistentes à Castração/patologia , Inibidores de Proteínas Quinases/efeitos adversos , Proteínas Proto-Oncogênicas c-akt/metabolismo , Pirimidinas/efeitos adversos , Pirróis/efeitos adversos , Fatores de Tempo , Reino Unido
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