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Aim: To assess real-world occurrence of common clinical trial-reported adverse events (AE) among patients with recurrent ovarian cancer initiating niraparib 200 mg/day. Materials & methods: This retrospective observational study used physician-extracted anonymized medical record data of eligible patients initiating niraparib 200 mg/day after platinum-based chemotherapy. Results: Of 153 patients, 57 (37%) experienced ≥1 of the three most common all-grade AEs within 3 months after niraparib initiation: nausea (16%; grade 3/4: 2%), thrombocytopenia (14%; grade 3/4: 3%) and fatigue (24%; grade 3/4: 3%). In the ENGOT-OV16/NOVA trial, these respective AEs occurred in 74, 61 and 59% of patients. Conclusion: Incidence of common clinical trial-reported AEs was lower among patients initiating niraparib 200 mg/day in real-world practice versus patients initiating niraparib 300 mg/day in ENGOT-OV16/NOVA.
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Antineoplásicos/uso terapêutico , Indazóis/uso terapêutico , Neoplasias Ovarianas/tratamento farmacológico , Piperidinas/uso terapêutico , Inibidores de Poli(ADP-Ribose) Polimerases/uso terapêutico , Adulto , Idoso , Antineoplásicos/administração & dosagem , Antineoplásicos/efeitos adversos , Feminino , Humanos , Indazóis/administração & dosagem , Indazóis/efeitos adversos , Quimioterapia de Manutenção , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Ovarianas/diagnóstico , Piperidinas/administração & dosagem , Piperidinas/efeitos adversos , Inibidores de Poli(ADP-Ribose) Polimerases/administração & dosagem , Inibidores de Poli(ADP-Ribose) Polimerases/efeitos adversos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
PURPOSE: The aim of this study was to assess the use of immediate postoperative instillation of intravesical chemotherapy (IPOIC) after transurethral resection of bladder tumour (TURBT) of nonmuscle invasive bladder cancer (NMIBC) in Europe. METHODS: Urologists based in five European Union nations were asked to extract information from the records of patients with NMIBC-urothelial carcinoma who received at least one TURBT. Multivariate logistic regression models were developed to determine the significant predictors of IPOIC usage. Data were weighted to control for country-to-country and other differences. RESULTS: Overall, 324 urologists (58 France, 72 Germany, 62 Italy, 65 Spain, 67 United Kingdom) were involved; the participation rate was 55 %. Overall, 771 patients received 954 TURBTs (mean-1.2/patient), of which 413 of the TURBTs (43.3 %) were administered IPOIC . Sixty-six of the 413 IPOICs (16.0 %) were for a recurrent tumour. Five of the tested variables were significantly associated with a patient's likelihood of receiving IPOIC after TURBT. Variables in the order of significance are as follows: (1) country (United Kingdom, patients most likely to receive IPOIC; France, least likely); (2) progression risk (physician assessed) [lower-risk conditions (no CIS, tumour < 3 cm) or intermediate risk-more likely]; (3) whether urologist completed a uro-oncology fellowship (completed-more likely); (4) recurrence risk (physician assessed) [higher-risk conditions (≥T2, ≥3 cm, CIS)-more likely]; and (5) physician's NMIBC patients volume (higher volume-more likely). CONCLUSIONS: This study revealed wide practice variation and substantial noncompliance with European Association of Urology Guidelines on the use of IPOIC after TURBT for NMIBC.
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Carcinoma de Células de Transição/tratamento farmacológico , Quimioterapia Adjuvante/métodos , Padrões de Prática Médica/estatística & dados numéricos , Neoplasias da Bexiga Urinária/tratamento farmacológico , Urologia , Administração Intravesical , Idoso , Carcinoma de Células de Transição/cirurgia , Cistectomia/métodos , Escolaridade , Feminino , França , Alemanha , Humanos , Itália , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Músculo Liso/patologia , Invasividade Neoplásica/patologia , Espanha , Reino Unido , Bexiga Urinária/patologia , Neoplasias da Bexiga Urinária/patologia , Neoplasias da Bexiga Urinária/cirurgiaRESUMO
INTRODUCTION: The incidence and prevalence of nontuberculous mycobacterial pulmonary disease (NTM-PD) are increasing globally. Approximately 80% of NTM-PD cases in Japan and five countries within Europe (Eur5; France, Germany, Italy, Spain, and the UK) are caused by Mycobacterium avium complex (MAC). This study describes the clinical decision-making process associated with the management of patients with NTM-PD in Japan and the Eur5. METHODS: We analyzed data from a survey conducted between July 2013 and October 2013 among physicians treating patients with NTM-PD in clinical practice to compare the healthcare settings, clinical presentation, and patient management in Japan and the Eur5. RESULTS: Overall, 619 physicians (Japan, 173; Eur5, 446) participated in the survey. Most patients in Japan (85%) and the Eur5 (79%) were diagnosed with MAC-PD. Patients were managed generally in hospital-based outpatient clinics (117/173, 68%) in Japan and research/teaching hospitals affiliated with medical schools (140/446, 31%) in the Eur5. The most common reason for delaying treatment was the patient's symptoms not being considered serious enough for treatment (55/128, 43%) in Japan and awaiting results of antimicrobial susceptibility testing (44/151, 29%) in the Eur5. Culture negativity was less commonly achieved after treatment in patients in Japan versus those in the Eur5 (31% [73/238] vs. 70% [300/426], p < 0.0001). In treatment phases that were either completed or discontinued, the primary goal was symptomatic improvement, followed by achieving culture conversion, in both Japan and the Eur5. Overall, 19% (16/85) of physicians in Japan and 43% (220/511) in the Eur5 were "entirely satisfied" with their patients' treatment outcomes. CONCLUSIONS: Similarities and differences exist in the healthcare settings, clinical presentation, and management of patients with NTM-PD in Japan and the Eur5. Insufficient consideration of culture status by physicians, delayed treatment initiation, and symptom-based cessation emphasize the need for educational efforts on the guideline-based strategies.
Mycobacteria are microorganisms that cause a disease in the lungs known as nontuberculous mycobacterial pulmonary disease (NTM-PD). The number of people with NTM-PD is increasing globally. This study was a survey of doctors who treated people with NTM-PD in Japan and Europe and aimed to understand geographical similarities and differences in the management, treatment, and health of people with NTM-PD. In the survey, treatment for NTM-PD was found to be often delayed or not started. In Japan, this was most commonly because the individual's symptoms were not thought to be serious enough and in Europe because of delays in laboratory testing needed to decide which antibiotic treatment should be used. The most common treatment goal in both Japan and Europe was improvement in the individual's symptoms. Clinical guidelines recommend continuing treatment for at least 12 months after the person with NTM-PD has tested negative for mycobacteria. There were similarities and differences in the healthcare settings, clinical presentation, and management of people with NTM-PD between Japan and Europe. It is important to ensure uniform implementation of the treatment guidelines for NTM-PD in each clinical setting so that people with NTM-PD experience better health outcomes.
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PURPOSE: We assessed the use of intravesical postoperative chemotherapy among United States urologists in patients with nonmuscle invasive bladder cancer. MATERIALS AND METHODS: A national sample of United States based urologists (259) retrospectively assessed their practice patterns involving intravesical postoperative chemotherapy after transurethral resection in patients with nonmuscle invasive bladder cancer. These urologists reviewed the medical records of their last 4 patients with nonmuscle invasive bladder cancer, and completed a case report form for specific demographic, pathological and treatment information. Selection criteria included the pathological and patient factors of histologically confirmed diagnosis of nonmuscle invasive bladder cancer-transitional cell carcinoma, completion of initial treatment plan with ongoing observation, candidate for or recipient of intravesical therapy, and no ongoing initial intravesical induction therapy. RESULTS: Overall the participation rate among those sampled was 61%. Of the 1,010 eligible patients with nonmuscle invasive bladder cancer 59.6% received instillation therapy during the initial treatment, of whom 28.4% (16.9% of patients overall) received intravesical postoperative chemotherapy. Primary, low risk patients most often received intravesical postoperative chemotherapy and 90.4% of the time patients received immediate instillation within 12 hours of surgery. However, of the urologists surveyed 66% never used intravesical postoperative chemotherapy, 17% used intravesical postoperative chemotherapy half (50%) of the time and only 2% used intravesical postoperative chemotherapy all (100%) of the time. CONCLUSIONS: Wide variation in the use of intravesical postoperative chemotherapy exists among urologists in the United States. The reason for the great diversity in the use of intravesical postoperative chemotherapy is speculative. However, physician awareness, physician bias, recurrence risk, and local pharmacy and hospital practice factors are all likely contributing factors.
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Carcinoma de Células de Transição/tratamento farmacológico , Carcinoma de Células de Transição/cirurgia , Recidiva Local de Neoplasia/prevenção & controle , Padrões de Prática Médica , Neoplasias da Bexiga Urinária/tratamento farmacológico , Neoplasias da Bexiga Urinária/cirurgia , Administração Intravesical , Idoso , Terapia Combinada , Feminino , Humanos , Masculino , Período Pós-Operatório , Recidiva , Estados Unidos , Urologia/normasRESUMO
INTRODUCTION: Repository corticotropin injection (RCI) has immune-modulatory and anti-inflammatory effects and is approved for multiple indications, including severe and acute chronic allergic and inflammatory processes involving the eye and adnexa. This study describes patient characteristics, treatment patterns, and physicians' assessments of patients with uveitis treated with RCI. METHODS: This was a retrospective medical record review of US patients. Eligible patients had a diagnosis of uveitis, received RCI in the past 12 months, and had completed or were receiving RCI treatment at the time of data collection. Baseline characteristics and after-treatment clinical data are descriptively reported. RESULTS: The study included 91 patients (mean age 41 years, 62% female, and mean time since diagnosis 3.98 years). Most patients had moderate (n = 48, 53%) to severe (n = 21, 23%) visual impairment, and none was blind before RCI therapy. Patients used an average of 2.5 medications before RCI. Initial RCI dosing regimens, dose adjustments, and treatment durations were different for each patient. Concomitant medication use and dosages were reduced during RCI; 76 patients (84%) improved, 15 patients (16%) stayed the same, and none worsened; 86% of patients had improvements in vision. CONCLUSIONS: Physicians individualized RCI therapy among patients who suffered uveitis for several years and when previous therapies were inadequate. Most patients improved after initiating RCI, most commonly in vision. The findings support use of RCI for uveitis and provide a better understanding of patient characteristics and practice patterns to guide appropriate use.
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Hormônio Adrenocorticotrópico/uso terapêutico , Inflamação/tratamento farmacológico , Prontuários Médicos , Uveíte/tratamento farmacológico , Administração Tópica , Adolescente , Hormônio Adrenocorticotrópico/administração & dosagem , Adulto , Idoso , Criança , Relação Dose-Resposta a Droga , Feminino , Humanos , Inflamação/diagnóstico , Injeções Intraoculares , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estados Unidos , Uveíte/diagnóstico , Adulto JovemRESUMO
BACKGROUND: Repository corticotropin injection (RCI) has regulatory approval for many indications, including symptomatic sarcoidosis. This large case series of patients with advanced symptomatic sarcoidosis treated with RCI describes patient characteristics, RCI utilization patterns, concomitant therapies, and physicians' assessments of treatment response. METHODS: Patients ⩾18 years with symptomatic sarcoidosis, treated with RCI in the previous 36 months, who had completed a course of RCI or received RCI for ⩾6 months at the time of data collection were included. RESULTS: The study included 302 patients (mean age, 51 years; 52%, women) with a mean 4.8 years since initial diagnosis of sarcoidosis. Most patients (76%) had extrapulmonary involvement, primarily in the skin (28%), joints (25%), heart (22%), and eyes (22%); 34% had multiple (⩾2) organ involvement. The mean duration of RCI treatment was 32.5 weeks, with 61.6% of patients continuing RCI therapy for ⩾6 months. The RCI utilization pattern indicated an individualized approach to therapy, with a higher starting dose associated with a shorter duration of therapy compared with a lower starting dose. The percentage of patients who used corticosteroids decreased from 61.3% during the 3 months before initiation of RCI to 12.9% 3 months after RCI therapy; the mean daily dose of corticosteroid decreased from 18.2 mg to 9.9 mg. The proportion of patients given <10 mg/day of prednisone increased from 21% before RCI use to 47% 3 months after RCI use. According to physicians' assessments of change in patients' health status after RCI therapy, overall status improved in 95% of patients, overall symptoms in 73%, lung function in 38%, and inflammation in 33%. CONCLUSIONS: The findings suggest that RCI is a viable treatment option for patients with advanced symptomatic sarcoidosis and provide insights on patient characteristics and practice patterns to help clinicians determine appropriate use. The reviews of this paper are available via the supplemental material section.
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Hormônio Adrenocorticotrópico/administração & dosagem , Glucocorticoides/administração & dosagem , Prednisona/administração & dosagem , Sarcoidose/tratamento farmacológico , Adolescente , Adulto , Idoso , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Sarcoidose/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
Objective In 2017, the Society for Maternal-Fetal Medicine (SMFM) Guideline Committee reaffirmed that 17 α -hydroxyprogesterone caproate (17-OHPC) to prevent preterm birth (PTB) is underutilized. We sought to determine what drove progestogen treatment choice of obstetricians managing pregnant women with histories of 1+ singleton spontaneous PTBs (< 37 weeks) who then delivered singleton gestations within the previous 12 months. Subjects We recruited a nationally representative random sample of obstetricians to abstract medical records of study-qualified patients. Of the 423 study-qualified physicians contacted, 358 (85%) participated; 56 (16%) maternal fetal medicine specialists and 302 (84%) general obstetrician/gynecologists (OB/GYNs) extracted data from 991 eligible patient charts. Results Almost three-fourths of patients (73.6%) were treated with 17-OHPC; 18.6% received vaginal progesterone, and 11.8% were not treated. Key drivers of physicians' choice to (1) prescribe branded 17-OHPC were "FDA (Food and Drug Administration) approval" (52% relative influence [RI]) and "SMFM guidelines" (24% RI); (2) prescribe vaginal progesterone were "ease of administration" (32% RI) and "shortened cervix" (16% RI); and (3) not provide prophylaxis were "patient not informed of risk" (35% RI) and "no shortened cervix" (29% RI). Conclusion Study findings support SMFM's contention of continued 17-OHPC underutilization to prevent PTB. Need for additional physician education merits assessment along with appropriate follow-up actions.
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INTRODUCTION: Repository corticotropin injection (RCI) has anti-inflammatory and immune-modulatory effects and is approved for multiple indications, including several rheumatologic conditions. The aims of this nationally representative, retrospective, observational study were to describe patient characteristics, RCI treatment patterns, and barriers to RCI use in patients with rheumatologic disease, and to compare medical resource use (MRU) before and after RCI therapy. METHODS: A random sample of US physicians was recruited to abstract the medical records of deidentified patients with a diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA), dermatomyositis/polymyositis (DM/PM), or systemic lupus erythematosus (SLE) who had been treated with RCI in the previous 24 months. Patient characteristics and patterns of RCI use were identified. Mean MRU in the 3 months before and after RCI therapy was compared using paired-samples t tests. RESULTS: A total of 449 physicians abstracted the medical records of 217 RA, 190 PsA, 254 DM/PM, and 95 SLE patients. In all groups combined, patients had received a mean of 3.3 treatment medications before initiating RCI. Most patients (75%-94%) were receiving RCI for the first time, indicating that repeated courses of RCI were uncommon. RCI was used as bridge therapy in 18% of patients. Approximately 24% of patients encountered an obstacle in accessing RCI, primarily insurance-related. After RCI therapy, the number of hospitalizations and hospital days were significantly reduced for all cohorts (all P < 0.05), and the number of outpatient visits was significantly lower for all cohorts (P < 0.05) except the SLE cohort (P = 0.3230). Study limitations include potentially incomplete data in the medical records and a relatively short duration for capturing MRU changes. CONCLUSIONS: RCI was used primarily as late-line therapy in patients with rheumatologic diseases. Medical resource use was significantly lower in the 3 months after therapy compared with 3 months prior. This finding suggests that RCI may improve disease control and warrants further evaluation. FUNDING: Mallinckrodt Pharmaceuticals.
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OBJECTIVES: Actinic keratoses (AKs) are common skin lesions with the potential to progress to squamous cell carcinoma. Many effective treatment alternatives exist, yet the reasons for treatment choice have not been explored. This study examined which AK therapy was preferred among dermatologists and primary care physicians (PCPs), as well as potential determinants of therapeutic selection. METHODS: A random national sample of 534 dermatologists and PCPs selected from the American Medical Association database completed AK questionnaires. The final sample included 1184 AK patients treated by dermatologists and 559 AK patients treated and/or referred by PCPs. All analyses were weighted using the survey sampling weights. RESULTS: Patients who had new and recurring lesions as well as patients who had a mean duration of more than a year since the last AK episode treatment (all p<0.05) were more likely to receive pharmacotherapy. Patients being treated by a dermatologist, receiving pharmacotherapy treatment only, and having both new and recurring lesions (all p<0.05) were less likely to have a complete treatment success. CONCLUSIONS: This study identifies several patient and physician factors associated with treatment preference and related outcomes in patients being treated for AK.
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Dermatologia , Ceratose/terapia , Avaliação de Resultados em Cuidados de Saúde , Padrões de Prática Médica/estatística & dados numéricos , Atenção Primária à Saúde , Neoplasias Cutâneas/terapia , Idoso , Crioterapia/estatística & dados numéricos , Uso de Medicamentos/estatística & dados numéricos , Feminino , Pesquisas sobre Atenção à Saúde , Humanos , Ceratolíticos/uso terapêutico , Ceratose/tratamento farmacológico , Ceratose/patologia , Masculino , Estudos Retrospectivos , Neoplasias Cutâneas/tratamento farmacológico , Neoplasias Cutâneas/patologia , Inquéritos e Questionários , Estados UnidosRESUMO
INTRODUCTION: The 17-gene Oncotype DX® prostate cancer assay (Genomic Health Inc., Redwood City, California) is a validated, biopsy based gene expression assay that reports the Genomic Prostate Score. Combined with clinical risk features, Genomic Prostate Score provides an individualized estimation of disease aggressiveness at diagnosis. With this retrospective chart review we assessed the impact of incorporating the Oncotype DX Genomic Prostate Score on treatment recommendations and decisions for men with newly diagnosed low risk prostate cancer in community urology practices. METHODS: A total of 24 urologists who ordered the Oncotype DX prostate cancer assay soon after launch (May 2013) were invited to participate in the study. Clinicopathological data, Genomic Prostate Score results and treatment related information were retrieved from medical records. Data also were collected for a pre-Genomic Prostate Score baseline group diagnosed from May 2012 to April 2013. Descriptive analyses were performed to evaluate the proportion of men for whom active surveillance was recommended and used before and after the availability of Genomic Prostate Score. RESULTS: Overall 15 physicians contributing 211 patients (Genomic Prostate Score group 124, baseline group 87) participated in the chart review. Patients in the Genomic Prostate Score and baseline groups had comparable risk based on traditional clinical pathological features, with 82% with NCCN® very low or low risk disease. With Genomic Prostate Score the relative increase in active surveillance recommended was 22% (baseline 50% and Genomic Prostate Score 61%, absolute increase of 11%) and the relative increase in use of active surveillance was 56% (baseline 43% and Genomic Prostate Score 67%, absolute increase of 24%). Treatment recommendations for active surveillance were directionally consistent with assay reported risk. CONCLUSIONS: Genomic Prostate Score testing was associated with greater physician recommendation of and use of active surveillance in community clinical practices.