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1.
Support Care Cancer ; 32(5): 280, 2024 Apr 10.
Artigo em Inglês | MEDLINE | ID: mdl-38594320

RESUMO

Chemotherapy-induced nausea and vomiting (CINV) is a common toxicity that may impair the quality of life of patients with various malignancies ranging from early to end stages. In light of frequent changes to the guidelines for optimal management of CINV, we undertook this narrative review to compare the most recent guidelines published by ASCO (2020), NCCN (2023), MASCC/ESMO (2023), and CCO (2019). The processes undertaken by each organization to evaluate existing literature were also described. Although ASCO, NCCN, MASCC/ESMO, and CCO guidelines for the treatment and prevention of CINV share many fundamental similarities, the literature surrounding low and minimal emetic risk regimens is lacking. Current data regarding adherence to these guidelines is poor and warrants further investigation to improve care.


Assuntos
Antieméticos , Antineoplásicos , Neoplasias , Humanos , Antieméticos/farmacologia , Qualidade de Vida , Vômito/induzido quimicamente , Vômito/prevenção & controle , Vômito/tratamento farmacológico , Náusea/induzido quimicamente , Náusea/prevenção & controle , Náusea/tratamento farmacológico , Neoplasias/tratamento farmacológico , Antineoplásicos/efeitos adversos
2.
J Oncol Pharm Pract ; 28(1): 5-16, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33215563

RESUMO

INTRODUCTION: Cancer patients receiving myelosuppressive chemotherapy are vulnerable to febrile neutropenia (FN) which contributes to poor treatment outcomes. The use of granulocyte colony-stimulating factors is administered to prevent chemotherapy-induced neutropenia. The introduction of biosimilars has allowed for greater cost-savings while maintaining safety and efficacy. This retrospective study assessed the incidence of FN and related treatment outcomes and the cost minimization of a pegfilgrastim biosimilar and its reference. METHODS: A retrospective chart review of breast cancer patients receiving (neo) adjuvant chemotherapy from February 2017 to May 2020 was conducted. The endpoints included the incidence of FN, the occurrence of dose reduction (DR), dose delay (DD) and pain. A cost minimization analysis was performed from a third-party payer perspective. RESULTS: One hundred Neulasta® and 74 Lapelga® patients were included in the first-cycle analysis. The rate of FN in cycle 1 for Neulasta® and Lapelga® was 2/100 and 4/74, respectively; risk difference (RD) = 3.4%; 95% CI: -2.4 to 9.2%. Eighty-three Neulasta® and 59 Lapelga® patients were included in the all-cycle analyses, where DR was reported in 76 (15%) Neulasta® cycles vs 33 (10%) Lapelga® cycles (RD = -3.6, 95% CI: -10.2 to 2.9). DD was reported in 20 (4%) Neulasta® cycles vs. 11 (3.5%) Lapelga® cycles (RD = -0.3; 95% CI: -2.7 to 2.0). Adverse events were similar between groups. Cost minimization using a cohort of 20,000 patients translated into an incremental savings of $21,606,800 CAD for each cycle. CONCLUSION: The biosimilar pegfilgrastim was non-inferior to the reference biologic based on FN incidence in addition to related outcomes including DR and DD.


Assuntos
Medicamentos Biossimilares , Neoplasias da Mama , Protocolos de Quimioterapia Combinada Antineoplásica , Medicamentos Biossimilares/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Feminino , Filgrastim/uso terapêutico , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Humanos , Polietilenoglicóis/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Estudos Retrospectivos
3.
Support Care Cancer ; 29(8): 4269-4275, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33409724

RESUMO

PURPOSE: Olanzapine-containing regimens have been reported to be effective in preventing CINV following highly emetogenic chemotherapy (HEC), but it is unsure whether it is cost-effective. There has been no cost-effectiveness analysis conducted for olanzapine using costs from the USA. The aim of this study is to determine whether olanzapine-containing antiemetic regimens are cost-effective in patients receiving HEC. METHODS: A decision tree model was constructed to evaluate the cost and health outcomes associated with olanzapine-containing antiemetic regimens and otherwise-identical regimens. One-way sensitivity analyses were conducted to individually investigate the effect of (i) lower complete response (CR) rates of olanzapine, closer to non-olanzapine-containing regimens; (ii) higher FLIE scores for patients who achieved no/incomplete response, closer to FLIE scores of patients achieving a complete response; (iii) differing costs of olanzapine to reflect different costs per hospitals, globally, due to different insurance systems and drug costs; and (iv) varying costs for uncontrolled CINV, to account for varying durations of chemotherapy and accompanying uncontrolled CINV. RESULTS: Olanzapine regimens have an expected cost of $325.24, compared with $551.23 for non-olanzapine regimens. Meanwhile, olanzapine regimens have an expected utility/index of 0.89, relative to 0.87 for non-olanzapine regimens. Olanzapine-containing regimens dominate non-olanzapine-containing regimens even if CR of olanzapine-containing regimens fall to 0.63. Only when CR is between 0.60 and 0.62 is olanzapine both more effective and more costly. CONCLUSION: Olanzapine-containing regimens are both cheaper and more effective in the prophylaxis of CINV in HEC patients, compared with non-olanzapine-containing regimens. Future CINV trial resources should be allocated to understand newer antiemetics and compare them to olanzapine-containing regimens as the control arm. Further analysis should use nationally representative data to examine medication costs by payer type.


Assuntos
Antieméticos/uso terapêutico , Análise Custo-Benefício/métodos , Náusea/induzido quimicamente , Olanzapina/uso terapêutico , Vômito/induzido quimicamente , Antieméticos/farmacologia , Feminino , Humanos , Masculino , Olanzapina/farmacologia
4.
Support Care Cancer ; 29(7): 3439-3459, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33442782

RESUMO

INTRODUCTION: The aim of this study is to rigorously review the efficacy and safety of olanzapine in defined hematology oncology settings including (1) the setting of highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC) settings (2) at 5 mg and 10 mg doses, and (3) for response rates for use in the acute, delayed, and overall settings post-MEC and HEC. METHODS: Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched through April 23, 2020. The primary efficacy endpoints were the rate of complete response, in the acute (0-24 h post-chemotherapy), delayed (24-120 h post-chemotherapy), and overall (0-120 h post-chemotherapy) phases. The secondary efficacy endpoints were the rates of no nausea and no emesis, for each phase. Safety endpoints were the rate of no serious adverse events (i.e., no grade 3 or 4 toxicities), as assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria. The Mantel-Haenszel, random-effects analysis model was used to compute risk ratios and accompanying 95% confidence intervals for each endpoint. For endpoints that statistically favored one arm, absolute risk differences were computed to assess whether there is a 10% or greater difference, used as the threshold for clinical significance by MASCC/ESMO. Fragility indices were also calculated for each statistically significant endpoint, to quantitatively assess the robustness of the summary estimate. A cumulative meta-analysis was conducted for each efficacy meta-analysis with more than 5 studies, also using the Mantel-Haenszel random-effects analysis model. RESULTS: Three studies reported on olanzapine for the rescue of breakthrough chemotherapy-induced nausea and vomiting (CINV); 22 studies reported on olanzapine in the prophylactic setting. For studies reporting on HEC patients, olanzapine-containing regimens were statistically and clinically superior in seven of nine efficacy endpoints in the prophylaxis setting. When olanzapine is administered at a 10-mg dose, it is statistically and clinically superior to control patients in eight of nine endpoints among adults. Olanzapine may be effective in the MEC setting and when administered at 5-mg doses, but the paucity of data leads to notable uncertainty. CONCLUSION: Further RCTs are needed in the setting of MEC patients and administration of olanzapine at a lower 5-mg dose, which may be given to reduce the sedative effect of olanzapine at 10 mg.


Assuntos
Antieméticos/uso terapêutico , Antineoplásicos/efeitos adversos , Náusea/tratamento farmacológico , Olanzapina/uso terapêutico , Vômito/tratamento farmacológico , Adolescente , Adulto , Idoso , Antieméticos/farmacologia , Humanos , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Olanzapina/farmacologia , Vômito/induzido quimicamente , Adulto Jovem
5.
Support Care Cancer ; 29(1): 155-167, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32323002

RESUMO

PURPOSE: Breast cancer patients receiving radiotherapy (RT) commonly report pain, contributing to physical and emotional distress, and potentially resulting in poor quality of life. This study prospectively identified trends and risk factors in patient-reported pain associated with breast irradiation using the Edmonton Symptom Assessment Scale (ESAS) and a study-specific Skin Symptom Assessment (SSA). METHODS: Before RT and once per week during RT, patients completed the ESAS and SSA. Upon RT completion, patients were contacted via telephone to complete both assessments weekly for 6 weeks, and a final assessment was conducted 1-3 months post-RT. Only data from patients who had completed both assessments before, at least once during, and at least once after RT were included in our analysis. RESULTS: A total of 426 patients provided data for the analysis. Overall acute pain increased significantly at week 1-2 (p < 0.0001), week 5 (p = 0.0011), and at 1-3 months (p < 0.0001) post-RT compared with baseline, and acute breast pain increased significantly at week 1 (p < 0.001) and week 2 (p = 0.0002) post-RT compared with baseline. Previous chemotherapy (adjuvant or neoadjuvant) in mastectomy patients was associated with increased overall pain compared with mastectomy patients without previous chemotherapy (p = 0.017). Younger patients (40-49 or 50-59 years of age) reported more overall pain (p = 0.0001, p = 0.038) and breast pain (p = 0.0003, p = 0.0038) compared with patients ≥ 60 years of age. CONCLUSIONS: Patient-reported pain associated with breast irradiation peaked 1 week after RT completion. Our findings provide support for closer monitoring of acute pain associated with breast RT in younger patients.


Assuntos
Neoplasias da Mama/radioterapia , Dor/diagnóstico , Qualidade de Vida/psicologia , Radioterapia Adjuvante/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Mama/patologia , Mama/cirurgia , Neoplasias da Mama/tratamento farmacológico , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Autorrelato , Inquéritos e Questionários , Avaliação de Sintomas/métodos
6.
J Oncol Pharm Pract ; 27(3): 650-657, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33554738

RESUMO

Virtual methods have been innovatively utilized to provide clinical and supportive care to patients with cancer. Oncology pharmacists have been actively involved in this movement, in order to minimize patient contact and decrease the risk of viral transmission for this high-risk group. In response to COVID-19 restrictions, the Odette Cancer Centre pharmacy modified the delivery of clinical pharmacy services (CPS), including medication histories and patient education/counseling, to a remote telephone-based model. Process maps were created to visualize workflow before and after the pandemic. Process metrics were tracked over a 6-week period. From March 25th to May 1st, 2020, 202 best-possible medication histories and baseline assessments were completed; 149 of these (74%) were completed remotely. For medication therapy counsels, 72 of 199 were completed remotely (36%). Despite workflow disruptions caused by the pandemic, these results demonstrate that clinical pharmacy service levels could be maintained by incorporating remote delivery approaches without significant investment in resources. Challenges included acceptance by patients and lack of technology to support system-level processes. Further research to develop, refine, and individualize virtual clinical pharmacy care models will help to consolidate the role of these approaches in the post-COVID-19 era.


Assuntos
COVID-19/epidemiologia , Neoplasias/tratamento farmacológico , Serviço de Farmácia Hospitalar , SARS-CoV-2 , Telemedicina , Atenção à Saúde , Humanos , Educação de Pacientes como Assunto
7.
Pain Manag Nurs ; 22(3): 402-407, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33485785

RESUMO

BACKGROUND: Patients who receive radiation treatment (RT) for breast cancer often report pain, which contributes negatively to quality of life (QoL). AIMS: To identify demographic, treatment, and disease characteristics associated with pain and changes in pain before and after RT using the Edmonton Symptom Assessment Scale (ESAS). DESIGN: Retrospective study. SETTINGS: Odette Cancer Centre. PARTICIPANTS: Patients diagnosed with nonmetastatic breast cancer from January 2011-June 2017 with at least one ESAS completed pre-RT and one completed post-RT. METHODS: Data on systemic treatment, radiation, patient demographics, and disease stage were extracted. To identify factors associated with pain before and after RT and changes in pain, univariate and multivariate general linear regression analysis were conducted. p < .05 was considered statistically significant. RESULTS: This study included 1,222 female patients with a mean age of 59 years. ESAS was completed an average of 28 days before RT (baseline) and 142 days after RT, respectively. In multivariable analysis, higher baseline pain scores were associated with having recently completed adjuvant chemotherapy (p = .002) and eventual receipt of locoregional (p = .026) or chest wall (p = .003) radiation. Adjuvant chemotherapy (p = .002) and chest wall radiation (p = .03), were associated with a significant reduction in pain score after radiotherapy, while locoregional RT was associated with a higher pain score after RT (p < .001). CONCLUSIONS: Patients with locoregional RT had higher baseline pain that remained elevated after RT completion and should be screened for pain and provided with pain management and support when necessary.


Assuntos
Neoplasias da Mama , Qualidade de Vida , Neoplasias da Mama/complicações , Neoplasias da Mama/radioterapia , Feminino , Humanos , Pessoa de Meia-Idade , Dor/etiologia , Medidas de Resultados Relatados pelo Paciente , Estudos Retrospectivos
8.
Support Care Cancer ; 28(10): 4933-4942, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32020357

RESUMO

BACKGROUND: The use of patient-reported outcomes (PROs) for routine cancer distress screening is endorsed globally as a quality-care standard. However, there is little research on the integration of PROs in "real-world" oncology practices using implementation science methods. The Improving Patient Experience and Health Outcome Collaborative (iPEHOC) intervention was established at multisite disease clinics to facilitate the use of PRO data by clinicians for precision symptom care. The aim of this study was to examine if patients exposed to the intervention differed in their healthcare utilization compared with contemporaneous controls in the same time frame. METHODS: We used a PRE- and DURING-intervention population cohort comparison study design to estimate the effects of the iPEHOC intervention on the difference in difference (DID) for relative rates (RR) for emergency department (ED) visits, hospitalizations, psychosocial oncology (PSO), palliative care visits, and prescription rates for opioids and antidepressants compared with controls. RESULTS: A small significantly lower Difference in Difference (DID) (- 0.223) in the RR for ED visits was noted for the intervention compared with controls over time (0.947, CI 0.900-0.996); and a DID (- 0.0329) for patients meeting ESAS symptom thresholds (0.927, CI 0.869-0.990). A lower DID in palliative care visits (- 0.0097), psychosocial oncology visits (- 0.0248), antidepressant prescriptions (- 0.0260) and an increase in opioid prescriptions (0.0456) in the exposed population compared with controls was also noted. A similar pattern was shown for ESAS as a secondary exposure variable. CONCLUSION: Facilitating uptake of PROs data may impact healthcare utilization but requires examination in larger scale "real-world" trials.


Assuntos
Oncologia/métodos , Neoplasias/terapia , Medicina de Precisão/métodos , Idoso , Estudos de Coortes , Detecção Precoce de Câncer , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/diagnóstico , Neoplasias/epidemiologia , Ontário/epidemiologia , Cuidados Paliativos/métodos , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Medidas de Resultados Relatados pelo Paciente , Qualidade da Assistência à Saúde
9.
Support Care Cancer ; 28(1): 87-98, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30982093

RESUMO

PURPOSE: Dyspnea is frequently experienced in advanced cancer patients and is associated with poor prognosis and functional decline. This study used the Edmonton Symptom Assessment System (ESAS) to characterize the relationship between dyspnea and concurrent symptoms experienced by advanced cancer patients. METHODS: A prospective database was collected and analyzed to extract patient demographics and ESAS scores. Logistic regression analysis and generalized estimating equations (GEE) identified correlations of other ESAS symptoms in three categories: severity of dyspnea (none, mild, moderate, severe), moderate/severe dyspnea (ESAS ≥ 4), and presence of dyspnea (ESAS ≥ 1), at patients' first visit and over time, respectively. RESULTS: Multivariable analysis revealed drowsiness (p = 0.001), and anxiety (p = 0.01) and appetite loss (p = 0.02) were associated with increased severity of dyspnea at first visit. Over time, tiredness (p = 0.02), drowsiness (p = 0.04), nausea (p = 0.02), and anxiety (p = 0.0006) were more likely to experience increased dyspnea severity. Tiredness (p = 0.0003), depression (p = 0.03), and appetite loss (p = 0.003) were significant for moderate/severe dyspnea at first visit. Over multiple visits, tiredness (p < 0.0001), anxiety (p = 0.0008), and appetite loss (p = 0.0008) had higher probabilities of moderate/severe dyspnea. For the presence of dyspnea at the first visit, anxiety (p = 0.03) and drowsiness (p = 0.002) were significantly correlated with an increased frequency of dyspnea. Over time, anxiety (p < 0.0001) and drowsiness (p < 0.0001) remained significant with the addition of nausea (p = 0.0007). CONCLUSIONS: The highly interactive relationship between dyspnea and other common cancer symptoms necessitates the development of comprehensive symptom assessments and utilization of multimodal management approaches that consider concurrent symptoms for improved identification and treatment of dyspnea.


Assuntos
Dispneia/diagnóstico , Dispneia/etiologia , Neoplasias/complicações , Neoplasias/patologia , Avaliação de Sintomas/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Progressão da Doença , Dispneia/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/diagnóstico , Neoplasias/terapia , Cuidados Paliativos/métodos , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Doente Terminal , Adulto Jovem
10.
Support Care Cancer ; 28(3): 979-1010, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31813021

RESUMO

INTRODUCTION: Weight loss in cancer patients is a worrisome constitutional change predicting disease progression and shortened survival time. A logical approach to counter some of the weight loss is to provide nutritional support, administered through enteral nutrition (EN) or parenteral nutrition (PN). The aim of this paper was to update the original systematic review and meta-analysis previously published by Chow et al., while also assessing publication quality and effect of randomized controlled trials (RCTs) on the meta-conclusion over time. METHODS: A literature search was carried out; screening was conducted for RCTs published in January 2015 up until December 2018. The primary endpoints were the percentage of patients achieving no infection and no nutrition support complications. Secondary endpoints included proportion of patients achieving no major complications and no mortality. Review Manager (RevMan 5.3) by Cochrane IMS and Comprehensive Meta-Analysis (version 3) by Biostat were used for meta-analyses of endpoints and assessment of publication quality. RESULTS: An additional seven studies were identified since our prior publication, leading to 43 papers included in our review. The results echo those previously published; EN and PN are equivalent in all endpoints except for infection. Subgroup analyses of studies only containing adults indicate identical risks across all endpoints. Cumulative meta-analysis suggests that meta-conclusions have remained the same since the beginning of publication time for all endpoints except for the endpoint of infection, which changed from not favoring to favoring EN after studies published in 1997. There was low risk of bias, as determined by assessment tool and visual inspection of funnel plots. CONCLUSIONS: The results support the current European Society of Clinical Nutrition and Metabolism guidelines recommending enteral over parenteral nutrition, when oral nutrition is inadequate, in adult patients. Further studies comparing EN and PN for these critical endpoints appear unnecessary, given the lack of change in meta-conclusion and low publication bias over the past decades.


Assuntos
Nutrição Enteral/métodos , Neoplasias/dietoterapia , Nutrição Parenteral/métodos , Nutrição Enteral/efeitos adversos , Nutrição Enteral/mortalidade , Humanos , Infecções/epidemiologia , Neoplasias/metabolismo , Neoplasias/microbiologia , Neoplasias/mortalidade , Estado Nutricional , Nutrição Parenteral/efeitos adversos , Nutrição Parenteral/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Redução de Peso
12.
J Pharm Pharm Sci ; 23: 177-199, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32407285

RESUMO

PURPOSE: Bioluminescent imaging (BLI) is a versatile technique that offers non-invasive and real-time monitoring of tumor development in preclinical cancer research. However, the technique may be limited by several factors that can lead to misinterpretation of the data. This review aimed to investigate the validity of current BLI tumor models and provide recommendations for future model development. METHODS: Two major databases, MedLine and EMBASE, were searched from inception to July 2018 inclusively. Studies utilizing mouse xenograft models with demonstration of linear correlations between bioluminescent signal and tumor burden were included. Coefficients of correlation and determination were extracted along with data relating to animal model parameters. RESULTS: 116 studies were included for analysis. It was found that the majority of models demonstrate good correlation regardless of the model type. Selection of a single cell clone with highest luciferase expression resulted in a significantly better correlation. Lastly, appropriate tumor measurement techniques should be utilized when validating the BLI model. CONCLUSIONS: In general, BLI remains a valid tool for pre-clinical assessment of tumor burden. While no single factor may be identified as a general limitation, data should be interpreted with caution.


Assuntos
Modelos Animais de Doenças , Imagem Óptica , Animais , Camundongos , Neoplasias Experimentais/diagnóstico por imagem
13.
Oncologist ; 24(4): 537-548, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30842244

RESUMO

Biosimilar filgrastims are primarily indicated for chemotherapy-induced neutropenia prevention. They are less expensive formulations of branded filgrastim, and biosimilar filgrastim was the first biosimilar oncology drug administered in European Union (EU) countries, Japan, and the U.S. Fourteen biosimilar filgrastims have been marketed in EU countries, Japan, the U.S., and Canada since 2008, 2012, 2015, and 2016, respectively. We reviewed experiences and policies for biosimilar filgrastim markets in EU countries and Japan, where uptake has been rapid, and in the U.S. and Canada, where experience is rapidly emerging. U.S. regulations for designating biosimilar interchangeability are under development, and such regulations have not been developed in most other countries. Pharmaceutical substitution is allowed for new filgrastim starts in some EU countries and in Canada, but not Japan and the U.S. In EU countries, biosimilar adoption is facilitated with favorable hospital tender offers. U.S. adoption is reportedly 24%, while the second filgrastim biosimilar is priced 30% lower than branded filgrastim and 20% lower than the first biosimilar filgrastim approved by the U.S. Food and Drug Administration. Utilization is about 60% in EU countries, where biosimilar filgrastim is marketed at a 30%-40% discount. In Japan, biosimilar filgrastim utilization is 45%, primarily because of 35% discounts negotiated by Central Insurance and hospital-only markets. Overall, biosimilar filgrastim adoption barriers are small in many EU countries and Japan and are diminishing in Canada in the U.S. Policies facilitating improved U.S. adoption of biosimilar filgrastim, based on positive experiences in EU countries and Japan, including favorable insurance coverage; larger price discount relative to reference filgrastim pricing; closing of the "rebate trap" with transparent pricing information; formal educational efforts of patients, physicians, caregivers, and providers; and allowance of pharmaceutical substitution of biosimilar versus reference filgrastim, should be considered. IMPLICATIONS FOR PRACTICE: We reviewed experiences and policies for biosimilar filgrastims in Europe, Japan, Canada, and the U.S. Postmarketing harmonization of regulatory policies for biosimilar filgrastims has not occurred. Acceptance of biosimilar filgrastims for branded filgrastim, increasing in the U.S. and in Canada, is commonplace in Japan and Europe. In the U.S., some factors, accepted in Europe or Japan, could improve uptake, including acceptance of biosimilars as safe and effective; larger cost savings, decreasing "rebate traps" where pharmaceutical benefit managers support branded filgrastim, decreased use of patent litigation/challenges, and allowing pharmacists to routinely substitute biosimilar for branded filgrastim.


Assuntos
Antineoplásicos/efeitos adversos , Medicamentos Biossimilares/uso terapêutico , Redução de Custos/estatística & dados numéricos , Custos de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Filgrastim/uso terapêutico , Neutropenia/tratamento farmacológico , Medicamentos Biossimilares/economia , Canadá/epidemiologia , Europa (Continente)/epidemiologia , Filgrastim/economia , Fármacos Hematológicos/economia , Fármacos Hematológicos/uso terapêutico , Humanos , Incidência , Japão/epidemiologia , Neoplasias/tratamento farmacológico , Neutropenia/induzido quimicamente , Neutropenia/epidemiologia , Estados Unidos/epidemiologia , United States Food and Drug Administration
14.
Support Care Cancer ; 27(1): 87-95, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30284039

RESUMO

Chemotherapy-induced nausea and vomiting (CINV) is a common toxicity that may impair the quality of life of patients with a variety of early- and end-stage malignancies. In light of recent changes in the optimal management of CINV, we undertook this narrative review to compare the latest guidelines published by ASCO (2017), NCCN (2018), and MASCC/ESMO (2016). The processes undertaken by each organization to evaluate existing literature were also described. Although ASCO, NCCN, and MASCC/ESMO guidelines for the treatment and prevention of CINV share many fundamental similarities, literature surrounding low and minimal emetic risk regimens is lacking. Data regarding the use of complementary alternative medicine for CINV is particularly scarce and in need of further investigation.


Assuntos
Antieméticos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Náusea/induzido quimicamente , Náusea/terapia , Guias de Prática Clínica como Assunto , Vômito/induzido quimicamente , Vômito/terapia , Adulto , Humanos , Neoplasias/tratamento farmacológico , Padrões de Prática Médica/normas , Qualidade de Vida , Sociedades Médicas/normas
15.
Support Care Cancer ; 27(9): 3245-3252, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31119459

RESUMO

PURPOSE: Radiation-induced nausea and vomiting (RINV) is a common side effect of radiotherapy and can affect up to 50-80% of patients, potentially causing detrimental effects to physical health, clinical efficacy, and patient quality of life. Antiemetic drugs act on receptors involved in the emesis pathway to block the uptake of neurotransmitters and inhibit stimulation of vomiting centers in the brain to prevent and treat RINV. The most commonly prescribed antiemetics for RINV are 5-hydroxytryptamine receptor antagonists (5-HT3 RA). Guidelines describing the optimal management of RINV are produced by the Multinational Association for Supportive Care in Cancer, the European Society of Medical Oncology, the American Society of Clinical Oncology, and the National Comprehensive Cancer Network. This review will present findings from research on antiemetic management for RINV conducted at our center. METHODS: A selective review of research conducted in a palliative outpatient radiotherapy clinic relating to antiemetic management for RINV was performed. RESULTS: Several studies investigating the efficacy of different routes of administration, new antiemetic drug types, and novel combinations of antiemetics have been tested at our clinic to elucidate which approach provides the best response. These include studies on the use of ondansetron rapidly dissolving film, palonosetron, and the addition of a neurokinin-1 receptor antagonist to traditional 5-HT3 RA regimens. CONCLUSIONS: These studies provide a framework for future research and could potentially inform changes to future guidelines to include the use of these novel regimens and techniques.


Assuntos
Antieméticos/uso terapêutico , Náusea/prevenção & controle , Antagonistas dos Receptores de Neurocinina-1/uso terapêutico , Radioterapia/efeitos adversos , Agonistas do Receptor 5-HT3 de Serotonina/uso terapêutico , Vômito/prevenção & controle , Adulto , Instituições de Assistência Ambulatorial , Humanos , Oncologia , Pessoa de Meia-Idade , Neoplasias/radioterapia , Ondansetron/uso terapêutico , Pacientes Ambulatoriais , Palonossetrom/uso terapêutico , Qualidade de Vida/psicologia , Antagonistas da Serotonina/uso terapêutico
16.
Support Care Cancer ; 27(6): 2131-2134, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30246224

RESUMO

INTRODUCTION: The Rapid Response Radiotherapy Program (RRRP) is an outpatient radiotherapy clinic for palliative cancer patients where consultation, planning, and radiation treatment can take place in 1 day, allowing for rapid access to care. The objective of this study was to compare the patient population and overall survival of patients seen in the RRRP from 2014 to 2017 to that of patients seen in 1999. METHOD: Patient characteristics including sex, primary cancer site, sites of metastases, and Karnofsky Performance Status (KPS) were recorded at each clinic visit. Date of death (DOD) was retrieved from the Patient Care System (PCS) and Excelicare. To show overall survival from the first clinic visit, a Kaplan-Meier overall survival curve was generated in all patients from 2014 to 2017. RESULTS: Five hundred ninety-six patients were included in the final analysis. Most patients were male (n = 347) with a primary cancer site of the lung (n = 165) and metastases to the bone (n = 475). Actuarial median overall survival was 15.3 months. In 1999, 395 patients were analyzed, in which a primary of the lung (n = 143) and metastases to the bone (n = 277) were the most prevalent. An additional 72 patients in this population had brain metastases. The actuarial median survival of the 1999 population was 4.5 months. CONCLUSION: The changing patient population in the RRRP has resulted in visible changes in survival. This may reflect differences in the proportion of patients with specific primaries and sites of metastases, as well as improvements in the availability of palliative radiation over the last two decades.


Assuntos
Neoplasias/radioterapia , Cuidados Paliativos/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/mortalidade , Neoplasias/patologia , Análise de Sobrevida , Fatores de Tempo
17.
Support Care Cancer ; 27(3): 783-791, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30607675

RESUMO

PURPOSE: Radiation-induced nausea and vomiting (RINV) can affect 50-80% of patients undergoing radiotherapy and negatively impacts quality of life. This review aimed to compare the most recent RINV antiemetic guidelines produced by the Multinational Association for Supportive Care in Cancer (MASCC), the European Society of Clinical Oncology (ESMO), the American Society of Clinical Oncology (ASCO), and the National Comprehensive Cancer Network (NCCN). Future improvements to the guidelines and the need for further research in RINV were also discussed. METHODS: Antiemetic guidelines produced by MASCC/ESMO, ASCO, and NCCN were examined to identify similarities, differences, and inadequacies within the guidelines. RESULTS: Areas of dissension within the guidelines include the addition of dexamethasone to moderate-risk antiemetic regimens, the prophylactic treatment of RINV in the low-risk categories, and the appropriate treatment for breakthrough emesis. The guidelines are in accordance that high-risk radiotherapy regimens should be treated prophylactically with a serotonin receptor antagonist and for those undergoing concurrent chemotherapy and radiotherapy, antiemetic treatment should be prescribed according to the emetic risk associated with their respective chemotherapy regimen. Low- and minimal-risk recommendations are based on low-level evidence and informal consensus. CONCLUSION: RINV is a frequent and distressing side effect of radiotherapy and requires further research to establish effective antiemetic guidelines and ensure optimal treatment outcomes.


Assuntos
Antieméticos/uso terapêutico , Eméticos/uso terapêutico , Náusea/prevenção & controle , Neoplasias/radioterapia , Guias de Prática Clínica como Assunto , Vômito/prevenção & controle , Consenso , Dexametasona/uso terapêutico , Humanos , Náusea/etiologia , Qualidade de Vida , Radioterapia/efeitos adversos , Pesquisa , Fatores de Risco , Antagonistas da Serotonina/uso terapêutico , Vômito/etiologia
18.
Support Care Cancer ; 26(8): 2519-2549, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29796708

RESUMO

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) continues to be a common side effect of systemic anticancer therapy, decreasing quality of life and increasing resource utilization. The aim of this meta-analysis was to investigate the comparative efficacy and safety of palonosetron relative to other 5-HT3RAs. METHODS: A literature search was carried out in Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. Full-text references were then screened and included in this meta-analysis if they were an RCT and had adequate data regarding one of the five primary endpoints-complete response (CR), complete control (CC), no emesis, no nausea, or no rescue medications. RESULTS: A total of 24 RCTs were included in this review. Palonosetron was statistically superior to other 5-HT3RAs for 10 of the 19 assessed endpoints. Only one endpoint-emesis in the overall phase-had noticeable more favorable data for palonosetron to the point that it approached the 10% risk difference (RD) threshold as specified by the MASCC/ESMO antiemetic panel; another two endpoints (CR in the overall phase and nausea in the delayed phase) approached the 10% threshold. CONCLUSIONS: Palonosetron seems to be more efficacious and safe than other 5-HT3RAs-statistically superior in 10 of 19 endpoints. It is, however, only clinically significant in one endpoint and approached clinically significant difference in another two endpoints. Within the limits of this meta-analysis, our results indicate that palonosetron may not be as superior in efficacy and safety as reported in a previous meta-analysis, and supports the recent MASCC/ESMO, ASCO, and NCCN guidelines in not generally indicating palonosetron as the 5-HT3RA of choice.


Assuntos
Antieméticos/uso terapêutico , Náusea/tratamento farmacológico , Palonossetrom/uso terapêutico , Qualidade de Vida/psicologia , Antagonistas do Receptor 5-HT3 de Serotonina/uso terapêutico , Vômito/tratamento farmacológico , Antieméticos/farmacologia , Antineoplásicos/efeitos adversos , Humanos , Náusea/induzido quimicamente , Palonossetrom/farmacologia , Indução de Remissão , Antagonistas do Receptor 5-HT3 de Serotonina/farmacologia , Vômito/induzido quimicamente
19.
Support Care Cancer ; 26(11): 3959-3966, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29808378

RESUMO

PURPOSE: Radiotherapy-induced nausea and vomiting is a common side effect of radiotherapy. It is well-established that nausea and vomiting have a negative impact on quality of life, but the relative influence of each of symptom is infrequently reported. This study aimed to compare the effects of nausea and vomiting on quality of life in cancer patients receiving palliative radiotherapy. METHODS: The Functional Living Index-Emesis (FLIE) is a quality of life questionnaire developed in the chemotherapy-induced nausea and vomiting setting. The FLIE consists of 18 questions, half of which address nausea and half of which address vomiting. Three prospective studies on the efficacy of various anti-emetic medications conducted at our center used the FLIE to assess radiotherapy-induced nausea and vomiting at various time points during and after palliative radiotherapy. FLIE data from these three studies were combined for the present analysis. Univariate and multivariate analyses were conducted to assess the relationships between nausea and vomiting, time of FLIE completion, and patient-reported quality of life. RESULTS: Nausea and vomiting scores both decreased patients' quality of life. Multivariate modeling showed that both symptoms significantly influenced patients' ability to enjoy meals. Nausea was also associated with increased hardship for the patient, while vomiting imposed more difficulty on the patients' loved ones. CONCLUSIONS: Nausea and vomiting both significantly influence quality of life. Nausea seems to impact the patient more directly, whereas vomiting affects those closest to the patient.


Assuntos
Náusea/epidemiologia , Náusea/etiologia , Neoplasias/tratamento farmacológico , Qualidade de Vida , Lesões por Radiação/epidemiologia , Vômito/epidemiologia , Vômito/etiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antieméticos/uso terapêutico , Feminino , Humanos , Quimioterapia de Indução/efeitos adversos , Masculino , Pessoa de Meia-Idade , Náusea/psicologia , Neoplasias/epidemiologia , Estudos Prospectivos , Lesões por Radiação/psicologia , Inquéritos e Questionários , Vômito/psicologia
20.
Support Care Cancer ; 26(1): 203-211, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-28733699

RESUMO

PURPOSE: To investigate the natural history of taxane-associated acute pain syndrome (TAPS) in a docetaxel patient cohort and to examine the long-term manifestation of TAPS. PATIENTS AND METHODS: For three consecutive treatment cycles, taxane-naive breast cancer patients completed diaries on days 1-7, 14, and 21 and telephone questionnaires 1, 3, 6, 9, and 12 months following treatment. Questionnaires to assess pain and interference were adapted from the Brief Pain Inventory. To examine the experience of arthralgia and myalgia as one syndrome, information on patient experiences with arthralgia or myalgia was elicited separately in order to determine how closely experiences of each toxicity correlated with each other. A ≥2 point increase from baseline was defined as an arthralgia or myalgia "pain flare," and only those with "flare" were included in calculations of incidence. RESULTS: A total of 278 patients were accrued. Thirty-eight patients were omitted due to missing information, and 24 patients were omitted due to metastatic disease, for a total of 216 patients overall and 188 in the docetaxel cohort. A total of 74.5% of docetaxel patients experienced joint pain flare, and 78.2% experienced muscle pain flare at some point in the overall course of three treatment cycles. Joint and muscle pain peaked on days 4-5 for each cycle, and median pain severity for both joint and muscle pain was 4/10 during the 21-day period. Median onset of joint pain flare was 3 days for cycle 1 and 4 days for cycles 2 and 3, with an average median duration of 4 days. Median onset of muscle pain flare was 4 days for all three cycles, with a median duration of 4 days for cycles 1 and 2, and 5 days for cycle 3. Both joint and muscle pain persisted 1 year after treatment in approximately half of responding patients. CONCLUSION: This study documents the significant incidence of TAPS in patients treated with docetaxel chemotherapy and shows a long-term persistence of the syndrome.


Assuntos
Artralgia/induzido quimicamente , Neoplasias da Mama/tratamento farmacológico , Mialgia/induzido quimicamente , Taxoides/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Dor do Câncer/induzido quimicamente , Docetaxel , Feminino , Humanos , Incidência , Pessoa de Meia-Idade , Estudos Prospectivos , Inquéritos e Questionários , Taxoides/administração & dosagem
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