RESUMEN
BACKGROUND: The aim of this study was to evaluate the impact of intravenous palonosetron compared to ondansetron on hypotension induced by spinal anesthesia in women undergoing cesarean section. METHODS: Fifty-four women scheduled for elective cesarean section were, randomly allocated to ondansetron group (n = 27) or palonosetron group (n = 27). Ten minutes prior to the administration of spinal anesthesia, participants received an intravenous injection of either ondansetron or palonosetron. A prophylactic phenylephrine infusion was initiated immediately following the intrathecal administration of bupivacaine and fentanyl. The infusion rate was titrated to maintain adequate blood pressure until the time of fetal delivery. The primary outcome was total dose of phenylephrine administered. The secondary outcomes were nausea or vomiting, the need for rescue antiemetics, hypotension, bradycardia, and shivering. Complete response rate, defined as the absence of postoperative nausea and vomiting and no need for additional antiemetics, were assessed for up to 24 hours post-surgery. RESULTS: No significant differences were observed in the total dose of phenylephrine used between the ondansetron and palonosetron groups (387.5 µg [interquartile range, 291.3-507.8 µg versus 428.0 µg [interquartile range, 305.0-507.0 µg], P = 0.42). Complete response rates also showed no significant differences between the groups both within two hours post-spinal anesthesia (88.9% in the ondansetron group versus 100% in the palonosetron group; P = 0.24) and at 24 hours post-surgery (81.5% in the ondansetron group versus 88.8% in the palonosetron group; P = 0.7). In addition, there was no difference in other secondary outcomes. CONCLUSION: Prophylactic administration of palonosetron did not demonstrate a superior effect over ondansetron in mitigating hemodynamic changes or reducing phenylephrine requirements in patients undergoing spinal anesthesia with bupivacaine and fentanyl for cesarean section.
Asunto(s)
Anestesia Raquidea , Cesárea , Hipotensión , Ondansetrón , Palonosetrón , Humanos , Femenino , Anestesia Raquidea/efectos adversos , Cesárea/efectos adversos , Palonosetrón/administración & dosificación , Palonosetrón/uso terapéutico , Adulto , Hipotensión/tratamiento farmacológico , Hipotensión/prevención & control , Hipotensión/etiología , Embarazo , Ondansetrón/administración & dosificación , Ondansetrón/uso terapéutico , Antieméticos/administración & dosificación , Antieméticos/uso terapéutico , Náusea y Vómito Posoperatorios/prevención & control , Náusea y Vómito Posoperatorios/etiología , Fenilefrina/administración & dosificación , Anestesia Obstétrica/efectos adversos , Anestesia Obstétrica/métodosRESUMEN
Although carboplatin (CBDCA) is classified as a moderately emetogenic agent, the majority of guidelines recommend the use of a neurokinin-1 receptor antagonist in addition to a 5-hydroxytryptamine type 3 receptor antagonist with dexamethasone (DEX) for CBDCA-containing chemotherapy because of its higher emetogenic risk. However, the additional efficacy of aprepitant (APR) in CBDCA-containing treatment remains controversial, and data on multiple-day treatments are limited. Etoposide (ETP) was administered on days 1-3 in the CBDCA + ETP regimen, and it is important to evaluate suitable antiemetic therapy for the regimen. Therefore, we evaluated the efficacy of additional APR in CBDCA + ETP. Patients were divided into two groups and retrospectively evaluated. One was the control group, which was prophylactically administered palonosetron (PALO) and DEX, and the other was the APR group, which received APR orally with PALO and DEX. The primary endpoint was complete response (CR) between the groups. The overall CR rates were 75.0 and 76.4% in the control and APR groups, respectively, with no significant difference (p = 1.00). In the acute phase, it was 88.9 and 97.2%, respectively, and 86.1 and 79.2% in the delayed phase, respectively, without significant differences (p = 0.10 and 0.38, respectively). The incidence and severity of nausea, vomiting, and anorexia were not significantly different between the two groups in the acute and delayed phases. Our findings suggest that combining APR with PALO and DEX does not improve the CR rate in CBDCA + ETP therapy.
Asunto(s)
Antieméticos , Aprepitant , Carboplatino , Dexametasona , Etopósido , Náusea , Palonosetrón , Vómitos , Aprepitant/uso terapéutico , Aprepitant/administración & dosificación , Carboplatino/administración & dosificación , Carboplatino/uso terapéutico , Carboplatino/efectos adversos , Humanos , Dexametasona/administración & dosificación , Dexametasona/uso terapéutico , Palonosetrón/administración & dosificación , Palonosetrón/uso terapéutico , Masculino , Etopósido/administración & dosificación , Etopósido/uso terapéutico , Antieméticos/administración & dosificación , Antieméticos/uso terapéutico , Femenino , Persona de Mediana Edad , Vómitos/inducido químicamente , Vómitos/prevención & control , Anciano , Náusea/inducido químicamente , Náusea/prevención & control , Estudios Retrospectivos , Adulto , Quimioterapia Combinada , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Quinuclidinas/administración & dosificación , Quinuclidinas/uso terapéutico , Morfolinas/administración & dosificación , Morfolinas/uso terapéutico , Antineoplásicos/administración & dosificación , Antineoplásicos/uso terapéutico , Antineoplásicos/efectos adversos , Isoquinolinas/administración & dosificación , Isoquinolinas/uso terapéutico , Resultado del TratamientoRESUMEN
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma, for which cyclophosphamide, doxorubicin, vincristine, and prednisone with rituximab(R-CHOP) is one of the standard regimens. Given that R-CHOP is highly emetogenic, chemotherapy-induced nausea and vomiting (CINV) prevention is clinically important. However, there is a paucity of studies focusing on these patients. This study aimed to ascertain the effectiveness of an oral fixed-dose combination of netupitant and palonosetron (NEPA) in preventing CINV in patients with DLBCL undergoing first-line R-CHOP chemotherapy. Seventy patients were enrolled in this single-center prospective non-comparative study conducted between November 2020 and May 2023 in South Korea. NEPA was administered 1 h prior to chemotherapy initiation on day 1. The primary endpoint of the study was the complete response rate (no emesis, and no rescue medication) during the acute, delayed, and overall phases, which were assessed over a period of 120 h post-chemotherapy. The complete response rates for NEPA were 90.0% [95% CI 80.5, 95.9] for the acute phase, 85.7% [95% CI 75.3, 92.9] for the delayed phase, and 84.3% [95% CI 73.6, 91.9] for the overall phase, with no-emesis rates (acute: 97.1% [95% CI 97.1, 99.7], delayed: 95.7% [95% CI 88.0, 99.1], overall: 92.9% [95% CI 84.1, 97.6]). NEPA was well tolerated with no severe treatment-emergent adverse events. NEPA exhibited substantial efficacy in mitigating CINV in DLBCL patients undergoing R-CHOP chemotherapy, demonstrating high CR and no-emesis rates, and favorable safety profiles.
Asunto(s)
Antieméticos , Protocolos de Quimioterapia Combinada Antineoplásica , Ciclofosfamida , Doxorrubicina , Linfoma de Células B Grandes Difuso , Náusea , Palonosetrón , Prednisona , Rituximab , Vincristina , Vómitos , Humanos , Linfoma de Células B Grandes Difuso/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Doxorrubicina/efectos adversos , Doxorrubicina/administración & dosificación , Ciclofosfamida/efectos adversos , Ciclofosfamida/uso terapéutico , Ciclofosfamida/administración & dosificación , Masculino , Femenino , Persona de Mediana Edad , Vincristina/efectos adversos , Vincristina/uso terapéutico , Vincristina/administración & dosificación , Náusea/prevención & control , Náusea/inducido químicamente , Vómitos/prevención & control , Vómitos/inducido químicamente , Rituximab/efectos adversos , Rituximab/uso terapéutico , Rituximab/administración & dosificación , Prednisona/efectos adversos , Prednisona/administración & dosificación , Prednisona/uso terapéutico , Anciano , Palonosetrón/uso terapéutico , Palonosetrón/administración & dosificación , Adulto , Estudios Prospectivos , Antieméticos/uso terapéutico , Antieméticos/administración & dosificación , Piridinas/efectos adversos , Piridinas/administración & dosificación , Piridinas/uso terapéutico , Resultado del Tratamiento , Combinación de Medicamentos , Isoquinolinas , QuinuclidinasRESUMEN
OBJECTIVE: The aim of this study is to assess the clinical efficacy of a 5 mg dosage of olanzapine in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) among female patients diagnosed with gastrointestinal tract tumors. METHODS: Patients undergoing the oxaliplatin/irinotecan chemotherapy regimen were enrolled in this prospective controlled study. The olanzapine group received a 5 mg dosage of olanzapine along with palonosetron and dexamethasone, while the control group received a standard two-combination regimen consisting of dexamethasone and palonosetron. The primary endpoints included the total protection (TP) rates for the entire age group and the subgroup aged 60 years and above. Secondary endpoints encompassed the total protection rates during the acute and delayed phases within the two age brackets, as well as the total control (TC) rates and complete remission (CR) rates across all three phases (total, acute, and delayed). Additionally, the study involved the assessment of quality of life and the collection of adverse events associated with the interventions. RESULTS: 1) Regarding the primary endpoint, the total phase TP rates within both the entire age group and the age group exceeding 60 years demonstrated superiority in the olanzapine group when compared to the control group (66.7% vs 37.25%, P = 0.003; 68.8% vs 44.4%, P = 0.044). 2) In terms of secondary endpoints, the olanzapine group exhibited superior acute phase TP rates in both age brackets when compared to the control group (P < 0.05). The olanzapine group also demonstrated higher delayed-phase TP rates, TC rates across all three phases, and CR rates within the two age brackets, although the differences were not statistically significant (P > 0.05). Furthermore, the quality of life in the olanzapine group surpassed that of the control group for both age brackets (P < 0.05), characterized by enhanced appetite and a higher incidence of drowsiness in the patients treated with olanzapine when compared to those in the control group (P < 0.05). CONCLUSION: Olanzapine can enhance CINV induced by MEC regimen in female patients across all age groups, including the elderly, and therefore improve the quality of life for these patients. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/index.html , identifier: ChiCTR20000368269, 25/08/2020.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica , Irinotecán , Náusea , Olanzapina , Oxaliplatino , Vómitos , Humanos , Olanzapina/administración & dosificación , Olanzapina/uso terapéutico , Olanzapina/efectos adversos , Femenino , Persona de Mediana Edad , Náusea/inducido químicamente , Náusea/prevención & control , Vómitos/inducido químicamente , Vómitos/prevención & control , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Estudios Prospectivos , Oxaliplatino/efectos adversos , Oxaliplatino/administración & dosificación , Irinotecán/efectos adversos , Irinotecán/administración & dosificación , Anciano , Adulto , Antieméticos/administración & dosificación , Antieméticos/uso terapéutico , Neoplasias Gastrointestinales/tratamiento farmacológico , Palonosetrón/administración & dosificación , Palonosetrón/uso terapéutico , Calidad de Vida , Dexametasona/administración & dosificación , Dexametasona/uso terapéuticoRESUMEN
Lung cancer, a global mortality leader, often necessitates Video-Assisted Thoracoscopic (VATS) surgery. However, post-operative nausea and vomiting (PONV) is common, highlighting a need for effective management and prevention strategies in this context. A retrospective case-control study at Fujian Medical University Union Hospital evaluated patients undergoing VATS radical resection of lung cancer between May and September 2022. Patients were categorized based on PONV prevention methods, and data encompassing demographics, surgical history, and postoperative adverse events s were analyzed to assess the association between prophylactic protocols and PONV incidence. The Netupitant and Palonosetron Hydrochloride (NEPA) group showed a significant reduction in PONV occurrences post-surgery compared to Ondansetron (ONDA) and Control groups, emphasizing NEPA's efficacy in alleviating PONV symptoms (P < 0.05). Furthermore, following VATS radical resection of lung cancer, NEPA markedly reduced the intensity of PONV symptoms in patients. Both univariate and multivariate logistic analyses corroborated that NEPA independently reduces PONV risk, with its protective effect also apparent in susceptible populations like females and non-smokers. NEPA utilization markedly reduced both the incidence and severity of PONV in patients undergoing VATS radical resection of lung cancer, serving as an independent protective factor in mitigating PONV risk post-surgery.
Asunto(s)
Neoplasias Pulmonares , Náusea y Vómito Posoperatorios , Cirugía Torácica Asistida por Video , Humanos , Femenino , Cirugía Torácica Asistida por Video/métodos , Cirugía Torácica Asistida por Video/efectos adversos , Masculino , Neoplasias Pulmonares/cirugía , Náusea y Vómito Posoperatorios/prevención & control , Náusea y Vómito Posoperatorios/etiología , Persona de Mediana Edad , Estudios Retrospectivos , Anciano , Estudios de Casos y Controles , Antieméticos/uso terapéutico , Antieméticos/administración & dosificación , Ondansetrón/uso terapéutico , Ondansetrón/administración & dosificación , Palonosetrón/uso terapéutico , Palonosetrón/administración & dosificaciónRESUMEN
CONTEXTO CLÍNICO: Las náuseas y los vómitos inducidos por la quimioterapia son graves y preocupantes. existen varios tratamientos antieméticos eficaces y bien tolerados por el paciente, no obstante, las náuseas y los vómitos inducidos por la quimioterapia sigue siendo un efecto adverso importante del tratamiento. La emesis se puede medir objetivamente mediante observación directa e independiente. Las náuseas, que a menudo acompañan a la emesis, son una sensación subjetiva que requiere el autoinforme del paciente para cuantificarla. Se han definido tres tipos distintos de náuseas y los vómitos inducidos por la quimioterapia: aguda, tardía y anticipatoria. Reconocer las diferencias entre estos tipos de náuseas y los vómitos inducidos por la quimioterapia tiene implicaciones importantes tanto para la prevención como para el tratamiento. Emesis aguda: la emesis aguda se define como la que ocurre durante las primeras 24 horas después de la quimioterapia. En ausencia de una profilaxis eficaz, lo más habitual es que comience entre una y dos horas después de la quimioterapia y, por lo general, alcanza su punto máximo en las primeras cuatro a seis horas. INFORMACIÓN FARMACOLÓGICA: Palonosetrón es un antagonista del receptor 5-HT 3 con una fuerte afinidad de unión por este receptor y poca o ninguna afinidad por otros receptores. ESTRATEGIAS DE BÚSQUEDA DE INFORMACIÓN: Se realizó una búsqueda en las principales bases de datos bibliográficas Pubmed, términos utilizados náuseas, vómitos, inducidos, quimioterapia, prevención, emesis, altamente emetógena, moderadamente emetógena. Se filtra la búsqueda a Estudios Clínicos fase III, controlados randomizados, Revisiones Sistemáticas, Meta-análisis, Guías de Práctica Clínica, además se limitó la búsqueda estudios en humanos. También se realiza búsqueda manual en otras bases de datos bibliográficas (Cochrane, NIH, TRIP DATABASE), en buscadores genéricos de internet, agencias de evaluación de tecnologías sanitarias y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas, metaanálisis, estudios clínicos aleatorizados y controlados, guías de práctica clínica, evaluaciones de tecnología sanitaria, evaluaciones económicas y políticas de cobertura de otros sistemas de salud. CONCLUSIONES: El agente de segunda generación palonosetrón tiene una afinidad de 30 a 100 veces mayor por el receptor 5-HT3 y una vida media significativamente más larga (40 horas) en comparación con los antagonistas del receptor 5-HT3 de primera generación (29).Las náuseas y los vómitos inducidos por la quimioterapia (CINV) son un efecto adverso importante del tratamiento. El factor más importante que determina la probabilidad de que se desarrolle una emesis aguda o retardada es la emetogenicidad intrínseca de un agente quimioterapéutico en particular. Como agente único, palonosetrón es más eficaz que ondansetrón o dolasetrón para prevenir la emesis debida a agentes quimioterapéuticos de emetogenicidad variable (30). Esto quedó ilustrado por un ensayo multicéntrico en 592 pacientes, la mayoría de los cuales recibieron doxorrubicina y ciclofosfamida para el cáncer de mama; una minoría recibió regímenes de quimioterapia basados en cisplatino y carboplatino. Los sujetos fueron asignados aleatoriamente a una dosis única IV de palonosetrón en uno de dos niveles de dosis (0,25 o 0,75 mg IV) o dolasetrón (100 mg). Más pacientes tratados con palonosetrón (0,25 mg) tuvieron un control completo de la emesis aguda (63 frente a 53 por ciento) y tardía (54 frente a 39 por ciento) en comparación con dolasetrón. La dosis de 0,75 mg no fue significativamente superior en comparación con la de 0,25 mg. Un ensayo diseñado de manera similar también demostró la superioridad del palonosetrón en comparación con el ondansetrón. Cuando se usa en combinación con glucocorticoides, palonosetrón proporciona un control superior de la emesis retardada en comparación con los antagonistas del receptor 5-HT3 de primera generación combinados con glucocorticoides. Las directrices antieméticas actualizadas de la Red Nacional Integral del Cáncer (NCCN) recomiendan palonosetrón como el antagonista 5-HT3 preferido para pacientes que reciben quimioterapia moderadamente emetógena. Por el contrario, las directrices actualizadas de la Asociación Multinacional de Atención de Apoyo en Cáncer (MASCC)/Sociedad Europea de Oncología Médica (ESMO) y la Sociedad Americana de Oncología Clínica (ASCO) no especifican un antagonista 5-HT3 preferido para pacientes que reciben tratamiento emetógeno moderado. Los antagonistas del receptor 5-HT3 son generalmente seguros, con un perfil de efectos secundarios favorable (predominantemente dolor de cabeza leve, malestar general y estreñimiento.
Asunto(s)
Humanos , Quimioterapia Adyuvante/efectos adversos , Quimioterapia Combinada/efectos adversos , Palonosetrón/administración & dosificación , Evaluación en Salud/economía , EficaciaRESUMEN
The triplet antiemetic regimen is administered to prevent chemotherapy-induced nausea and vomiting (CINV) after moderately emetogenic chemotherapy (MEC). However, the superiority of palonosetron over first-generation 5-hydroxytryptamine-3 receptor antagonists in triplet antiemetic therapy remains unclear. In this study, we evaluated the efficacy of palonosetron (PALO) and granisetron (GRA) in triplet antiemetic therapy for CINV. This study included 267 patients who received MEC at our hospital between April 2017 and September 2020. Patients were pretreated with antiemetic therapy comprising PALO or GRA and dexamethasone on day 1 and aprepitant on days 1-3. We evaluated the rate of complete response (CR) (i.e., no vomiting and no use of rescue medication) in the acute phase (0-24 h), delayed phase (24-120 h), and overall phase (0-120 h) after first-cycle chemotherapy. Furthermore, multivariate analysis was conducted to identify risk factors for non-CR. The rate of CR in the overall and delayed phases was significantly higher in the PALO group (91.9 and 91.9%, respectively) than in the GRA group (74.1 and 75.5%, respectively). In the acute phase, the incidence was not different between the GRA and PALO groups (96.5 and 99.2%, respectively). Multivariate analysis revealed that female sex and the use of GRA were risk factors for non-CR. Subgroup analysis revealed the superiority of PALO over GRA in female patients, but not in male patients. In conclusion, PALO was more effective than GRA in triplet antiemetic therapy in preventing CINV during MEC, especially for female patients.
Asunto(s)
Antieméticos/administración & dosificación , Antineoplásicos/efectos adversos , Náusea/epidemiología , Neoplasias/tratamiento farmacológico , Vómitos/epidemiología , Anciano , Aprepitant/administración & dosificación , Quimioterapia Combinada/métodos , Femenino , Granisetrón/administración & dosificación , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Náusea/prevención & control , Palonosetrón/administración & dosificación , Estudios Retrospectivos , Resultado del Tratamiento , Vómitos/inducido químicamente , Vómitos/prevención & controlRESUMEN
OBJECTIVE: The outbreak of coronavirus disease 2019 (COVID-19) has affected the treatment of cancer patients, with particular regard to the management of both chemotherapy and side effects. Chemotherapy-induced nausea and vomiting (CINV) are amongst the most troublesome side effects that impair patients' adherence to treatments and their quality of life (QoL). NEPA (Akynzeo®), is an oral fixed-dose combination of netupitant [a neurokinin-1 receptor antagonist (NK1RA), 300 mg] and palonosetron [(5-hydroxytryptamine (serotonin or 5HT) type3 receptor antagonist (5HT3RA), 0.5 mg] which has been shown to be effective in preventing CINV. PATIENTS AND METHODS: This prospective study started before the outbreak of COVID-19 and was carried out during the pandemic period. The aim was to evaluate the efficacy and safety of a single oral dose NEPA plus 12 mg of dexamethasone (DEX) in patients treated with Folfoxiri plus Bevacizumab and Folfirinox. The patients were diagnosed with advanced colorectal cancer (CRC) or advanced pancreatic ductal adenocarcinoma (PDAC). They were divided into two groups: naïve patients and patients previously treated with serotonin receptor antagonists (5HT3-RA) and neurokin-1 receptor antagonists (NK1-RA). RESULTS: During the overall phase, the complete response (CR) rate was 96.8% in naïve patients treated with Folfoxiri plus Bevacizumab, and 94.6% in patients treated with Folfirinox. During the acute and delayed phases, the CR rate was 92.8% and 94.2%, with Folfoxiri and Bevacizumab, as well as 96.2% and 94.6%, with Folfirinox. There was no adequate control of CINV events in patients on antiemetic prophylaxis with 5HT3-RA or NK1-RA associated with cortisone. During the overall phase, the CR rate was 74.6% with Folfoxiri plus Bevacizumab and 75.8% with Folfirinox. During the acute and delayed phases, the CR rate was 72.5% and 74.8% with Folfoxiri plus Bevacizumab, as well as 75.2% and 74.6% with Folfirinox. CONCLUSIONS: This study has shown the therapeutic benefits of NEPA in the management and prophylaxis of CINV events, both in naive patients and patients previously treated with 5HT3-RA and NK1-RA. In addition, NEPA has been shown to be safe, both before and during the COVID-19 pandemic.
Asunto(s)
Antieméticos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bevacizumab/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Palonosetrón/uso terapéutico , Piridinas/uso terapéutico , Anciano , Antieméticos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Bevacizumab/administración & dosificación , COVID-19 , Femenino , Fluorouracilo/administración & dosificación , Fluorouracilo/uso terapéutico , Humanos , Irinotecán/administración & dosificación , Irinotecán/uso terapéutico , Leucovorina/administración & dosificación , Leucovorina/uso terapéutico , Masculino , Persona de Mediana Edad , Náusea/prevención & control , Oxaliplatino/administración & dosificación , Oxaliplatino/uso terapéutico , Palonosetrón/administración & dosificación , Pandemias , Estudios Prospectivos , Piridinas/administración & dosificación , Vómitos/prevención & controlRESUMEN
PURPOSE: The stability of aprepitant injectable emulsion is evaluated in various admixture bags and solutions, under different storage conditions, and when combined with other antiemetics. METHODS: A volume of 18 mL aprepitant injectable emulsion was added to infusion bags (either non-di-(2-ethylhexyl) phthalate [DEHP], polyvinyl chloride [PVC]-containing bags or non-DEHP, non-PVC bags) containing 100, 130, or 250 mL of 0.9% normal saline solution (NSS) or 5% dextrose in water (D5W). Bags were stored at controlled room temperature (20-25°C) for up to 12 hours or refrigerated (2-8°C) for up to 72 hours. Compatibility/stability was also assessed in admixtures combined with either dexamethasone or palonosetron. At specified time points, bags were tested for appearance, pH, assay for aprepitant (ie, percent label claim of aprepitant) and aprepitant-related substances, Z-average particle size, globule size distribution, particulate matter, and DEHP content (PVC bags). In separate analyses to assess microbial burden, bags containing aprepitant were inoculated with seven different organisms and assessed for microbial growth. RESULTS: There was no detectable impact on the physicochemical properties or potential to promote microbial growth of aprepitant when diluted with various amounts of either NSS or D5W and when admixed with either dexamethasone or palonosetron at room temperature for at least 6 hours or during refrigeration for up to 72 hours in either PVC- or non-PVC-containing bags. CONCLUSION: Aprepitant-containing admixtures are stable under these conditions, a finding that may improve patient and provider convenience and reduce medication wastage.
Asunto(s)
Antieméticos/química , Aprepitant/química , Dexametasona/química , Palonosetrón/química , Antieméticos/administración & dosificación , Aprepitant/administración & dosificación , Dexametasona/administración & dosificación , Dietilhexil Ftalato/química , Combinación de Medicamentos , Incompatibilidad de Medicamentos , Embalaje de Medicamentos , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Emulsiones , Concentración de Iones de Hidrógeno , Palonosetrón/administración & dosificación , Cloruro de Polivinilo/química , Refrigeración , Temperatura , Factores de TiempoRESUMEN
BACKGROUND: Postoperative nausea and vomiting (PONV) is a common complaint in patients following general anesthesia. Various antiemetics, including 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists, are effective but still have limited efficacy. Therefore, combination therapy is preferable to using a single drug alone in high-risk patients. We performed a comparative study on the antiemetic effect of palonosetron, a 5-HT3 receptor antagonist, monotherapy vs palonosetron-midazolam combination therapy for the prevention of PONV. METHODS: A total of 104 female patients scheduled for breast cancer surgery were enrolled. They were randomly divided into 2 groups, a palonosetron monotherapy group (group P) and palonosetron-midazolam combination therapy group (group PM). Both groups received 0.075âmg palonosetron intravenously after induction of anesthesia. Patient-controlled analgesia (PCA) was applied according to the allocated group. Intravenous (IV)-PCA in group P consisted of fentanyl 20âµg/kg plus normal saline (total volume: 100âml); IV-PCA in group PM consisted of fentanyl 20âµg/kg plus midazolam 4âmg plus normal saline (total volume: 100âml). Efficacy parameters were collected during 0 to 1, 1 to 6, 6 to 24, and 24 to 48âhours postoperative time intervals. These measures included complete response (defined as no PONV and no rescue anti-emetic use) rate, incidence of PONV, sedation score, rescue antiemetic use, rescue analgesic use, and numerical rating scale (NRS) for pain. The complete response rate during the 0 to 24âhours interval was analyzed as the primary outcome. RESULTS: Although the complete response rate between 0 and 24âhours was higher in group PM (42.3% and 48.1% in group P and PM, respectively), there was no statistically significant difference (Pâ=â.55). The complete response rates in other time intervals were not different between the 2 groups as well. The sedation score and NRS score also showed no differences between the 2 groups. CONCLUSIONS: The combination therapy of palonosetron with midazolam did not lead to a greater reduction in the incidence of PONV than monotherapy in patients undergoing breast surgery and receiving IV-PCA containing fentanyl.
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Analgesia Controlada por el Paciente/efectos adversos , Neoplasias de la Mama/cirugía , Fentanilo , Midazolam/administración & dosificación , Palonosetrón/administración & dosificación , Náusea y Vómito Posoperatorios , Anestésicos Intravenosos/administración & dosificación , Antieméticos/administración & dosificación , Antieméticos/efectos adversos , Método Doble Ciego , Quimioterapia Combinada/métodos , Femenino , Fentanilo/administración & dosificación , Fentanilo/efectos adversos , Humanos , Mastectomía/efectos adversos , Mastectomía/métodos , Midazolam/efectos adversos , Persona de Mediana Edad , Palonosetrón/efectos adversos , Náusea y Vómito Posoperatorios/etiología , Náusea y Vómito Posoperatorios/prevención & control , Resultado del TratamientoRESUMEN
Nausea, vomiting, and renal injury are the common adverse effects associated with cisplatin. Cisplatin is excreted via the multidrug and toxin release (MATE) transporter, and the involvement of the MATE transporter in cisplatin-induced kidney injury has been reported. The MATE transporter is also involved in the excretion of ondansetron, but the effects of 5-HT3 receptor antagonists used clinically for cisplatin-induced renal injury have not been elucidated. Therefore, the aim of this study was to investigate the effects of 5-HT3 receptor antagonists in a mouse model of cisplatin-induced kidney injury and to validate the results using medical big data analysis of more than 1.4 million reports and a survey of 3000 hospital medical records. The concomitant use of a first-generation 5-HT3 receptor antagonist (ondansetron, granisetron, or ramosetron) significantly increased cisplatin accumulation in the kidneys and worsened renal damage. Conversely, the concomitant use of palonosetron had no effect on renal function compared with the use of cisplatin alone. Furthermore, an analysis of data from the US Food and Drug Administration Adverse Event Reporting System and retrospective medical records revealed that the combination treatment of cisplatin and a first-generation 5-HT3 receptor antagonist significantly increased the number of reported renal adverse events compared with the combination treatment of cisplatin and a second-generation 5-HT3 receptor antagonist. These results suggest that compared with the first-generation antagonists, second-generation 5-HT3 receptor antagonists do not worsen cisplatin-induced acute kidney injury. The findings should be validated in a prospective controlled trial before implementation in clinical practice.
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Lesión Renal Aguda/patología , Cisplatino/efectos adversos , Náusea/tratamiento farmacológico , Antagonistas del Receptor de Serotonina 5-HT3/administración & dosificación , Vómitos/tratamiento farmacológico , Lesión Renal Aguda/inducido químicamente , Anciano , Animales , Bencimidazoles/administración & dosificación , Bencimidazoles/efectos adversos , Cisplatino/administración & dosificación , Modelos Animales de Enfermedad , Femenino , Granisetrón/administración & dosificación , Granisetrón/efectos adversos , Humanos , Riñón/efectos de los fármacos , Riñón/patología , Riñón/fisiopatología , Masculino , Ratones , Persona de Mediana Edad , Náusea/inducido químicamente , Ondansetrón/administración & dosificación , Ondansetrón/efectos adversos , Proteínas de Transporte de Catión Orgánico/metabolismo , Palonosetrón/administración & dosificación , Palonosetrón/efectos adversos , Eliminación Renal/fisiología , Estudios Retrospectivos , Antagonistas del Receptor de Serotonina 5-HT3/efectos adversos , Vómitos/inducido químicamenteRESUMEN
Patients who undergo multiple-day chemotherapy sessions experience hard-to-treat nausea and vomiting. Currently, there is no effective standard treatment for this condition. This study compared the preventive effect of first-generation 5-hydroxytryptamine 3 receptor antagonists (5-HT3 RAs) and second-generation 5-HT3 RAs palonosetron in multiple-day chemotherapy-induced nausea and vomiting. The design of this study was a retrospective case-control study of patients who received a five-day cisplatin-based chemotherapy and were treated with aprepitant, dexamethasone, granisetron, and ramosetron or palonosetron. The patients were divided into two groups: patients given granisetron and ramosetron (the first-generation group), and those given palonosetron (palonosetron group). The percentage of patients with a complete response or total control was assessed. They were divided into three phases: 0-216 h (overall phase), 0-120 h (remedial phase), and 120-216 h (after phase). The remedial phase was further divided into 0-24 h (early phase) and 24-120 h (later phase). Moreover, the nutritional status of each patient was assessed by noting the patients' total calorie-intake per day and total parenteral nutrition. First-generation 5-HT3 RAs and palonosetron were used for treatment in 18 and 28 patients, respectively. The complete response rate and caloric oral intake of the later phase were higher in the palonosetron group than in the first-generation group. We conclude that palonosetron treatment was more effective than first-generation 5-HT3 RAs in controlling multiple-day chemotherapy-induced nausea and vomiting.
Asunto(s)
Antieméticos/administración & dosificación , Bencimidazoles/administración & dosificación , Granisetrón/administración & dosificación , Náusea/tratamiento farmacológico , Palonosetrón/administración & dosificación , Antagonistas del Receptor de Serotonina 5-HT3/administración & dosificación , Vómitos/tratamiento farmacológico , Adulto , Antineoplásicos/efectos adversos , Bleomicina/efectos adversos , Quimioterapia Combinada , Etopósido/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Neoplasias de Células Germinales y Embrionarias/tratamiento farmacológico , Neoplasias Ováricas/tratamiento farmacológico , Compuestos de Platino/efectos adversos , Estudios Retrospectivos , Neoplasias Testiculares/tratamiento farmacológico , Vómitos/inducido químicamenteRESUMEN
INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) may affect adherence to planned chemotherapy treatments and compromise patients' quality of life during the therapy. NEPA is an oral fixed combination of netupitant, a highly-selective NK1-RA and palonosetron, a 5HT3-RA, approved for the prevention of acute and delayed CINV. The aim of this study was to evaluate the efficacy and safety of NEPA with dexamethasone for CINV prophylaxis in the challenging setting of carboplatin and gemcitabine combination chemotherapy, after failure of prophylaxis with 5HT3 receptor antagonist. METHODS: Eligible patients were undergoing carboplatin and gemcitabine combination chemotherapy for metastatic non-small cell lung cancer (NSCLC), ovarian cancer or urothelial cancer and experienced nausea and/or vomiting after the first cycle of chemotherapy, despite an antiemetic prophylaxis with a 5HT3-RA and dexamethasone. Primary efficacy endpoint was complete response (CR: no emesis, no rescue medication) obtained with NEPA, during the overall phase (0-120 h), after the start of chemotherapy. RESULTS: During the first cycle of chemotherapy, 15 out of 30 (50%) patients did not properly control CINV with a 5HT3-RA plus dexamethasone used as primary antiemetic prophylaxis and then were switched to NEPA from the subsequent cycle. During NEPA administration, 13 out of 15 patients (86.7%) achieved an overall CR (no emesis, no rescue medication). Antiemetic treatment with NEPA was very well tolerated with only two patients (13.3%) that experienced a grade 1 TEAE. CONCLUSIONS: Our experience showed that NEPA has proven to be very effective and well tolerated in the prophylaxis of CINV induced by carboplatin-based chemotherapy.
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Antieméticos/administración & dosificación , Dexametasona/administración & dosificación , Quimioterapia Combinada/efectos adversos , Náusea/prevención & control , Profilaxis Pre-Exposición/métodos , Antagonistas del Receptor de Serotonina 5-HT3/administración & dosificación , Vómitos/prevención & control , Adulto , Carboplatino/administración & dosificación , Carboplatino/efectos adversos , Desoxicitidina/administración & dosificación , Desoxicitidina/efectos adversos , Desoxicitidina/análogos & derivados , Femenino , Humanos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Palonosetrón/administración & dosificación , Piridinas/administración & dosificación , Estudios Retrospectivos , Insuficiencia del Tratamiento , Vómitos/inducido químicamente , GemcitabinaRESUMEN
Postoperative nausea and vomiting (PONV) afflict approximately 30% of patients overall and up to 80% of high-risk patients after surgery. Optimal pharmacological prophylaxis of PONV is challenging as it necessitates the consideration of PONV risk, drug efficacy, and potential adverse effects. Despite significant advances in our understanding of the pathophysiology and risk factors of PONV, its incidence has remained largely unchanged. Newer antiemetics have been introduced that may have improved safety profiles, longer duration of action, and better efficacy. This review aims to summarize the recent developments pertaining to these new agents and their potential application toward the management of PONV.
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Antieméticos/administración & dosificación , Manejo de la Enfermedad , Antagonistas de Dopamina/administración & dosificación , Antagonistas del Receptor de Neuroquinina-1/administración & dosificación , Náusea y Vómito Posoperatorios/prevención & control , Antagonistas del Receptor de Serotonina 5-HT3/administración & dosificación , Aprepitant/administración & dosificación , Quimioterapia Combinada , Humanos , Palonosetrón/administración & dosificación , Náusea y Vómito Posoperatorios/fisiopatología , Ensayos Clínicos Controlados Aleatorios como Asunto/métodosRESUMEN
INTRODUCTION AND OBJECTIVES: The incidence of Postoperative Nausea and Vomiting (PONV) after video cholecystectomy is high. Progress in pharmacological PONV prophylaxis includes a new generation of 5-HT3 antagonists. This study aims to assess the effect of the 5-HT3 antagonist in postanesthetic antiemetic management of patients submitted to laparoscopic cholecystectomy with total intravenous anesthesia. METHODS: Sixty individuals who underwent video cholecystectomy were randomized into three groups of 20 individuals according to the treatment administered: 0.125 mg of palonosetron (Group 1); 4 mg of ondansetron associated with 4 mg of dexamethasone (Group 2); 4 mg of dexamethasone (Group 3). General intravenous anesthesia was performed with propofol, remifentanil and rocuronium. The group to which the participant belonged was concealed from the investigator who assessed drug effect. PONV was assessed using the Rhodes Scale at 12 and 24 hours after surgery. Rescue medication was 0.655 to 1.5 mg of droperidol. RESULTS: Group 1 presented a lower incidence of PONV and required less rescue medication in the first postoperative hour. There was no significant difference among the three groups regarding PONV incidence in the first 12 postoperative hours. Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours. Group 1 showed significantly superior nausea control in the first 12 postoperative hours. CONCLUSIONS: The present study showed evidence that palonosetron is superior to the drugs compared regarding a protracted antiemetic effect and less requirement of rescue drugs, mainly related to its ability to completely inhibit the uncomfortable symptom of nausea.
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Anestésicos Intravenosos/administración & dosificación , Antieméticos/administración & dosificación , Colecistectomía Laparoscópica/métodos , Náusea y Vómito Posoperatorios/prevención & control , Adulto , Dexametasona/administración & dosificación , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ondansetrón/administración & dosificación , Palonosetrón/administración & dosificación , Propofol/administración & dosificación , Remifentanilo/administración & dosificación , Rocuronio/administración & dosificación , Adulto JovenRESUMEN
Abstract Introduction and objectives: The incidence of Postoperative Nausea and Vomiting (PONV) after video cholecystectomy is high. Progress in pharmacological PONV prophylaxis includes a new generation of 5-HT3 antagonists. This study aims to assess the effect of the 5-HT3 antagonist in postanesthetic antiemetic management of patients submitted to laparoscopic cholecystectomy with total intravenous anesthesia. Methods: Sixty individuals who underwent video cholecystectomy were randomized into three groups of 20 individuals according to the treatment administered: 0.125 mg of palonosetron (Group 1); 4 mg of ondansetron associated with 4 mg of dexamethasone (Group 2); 4 mg of dexamethasone (Group 3). General intravenous anesthesia was performed with propofol, remifentanil and rocuronium. The group to which the participant belonged was concealed from the investigator who assessed drug effect. PONV was assessed using the Rhodes Scale at 12 and 24 hours after surgery. Rescue medication was 0.655 to 1.5 mg of droperidol. Results: Group 1 presented a lower incidence of PONV and required less rescue medication in the first postoperative hour. There was no significant difference among the three groups regarding PONV incidence in the first 12 postoperative hours. Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours. Group 1 showed significantly superior nausea control in the first 12 postoperative hours. Conclusions: The present study showed evidence that palonosetron is superior to the drugs compared regarding a protracted antiemetic effect and less requirement of rescue drugs, mainly related to its ability to completely inhibit the uncomfortable symptom of nausea.
Resumo Justificativa e objetivo: Náuseas e Vômitos no Pós-Operatório (NVPO) têm alta incidência após videocolecistectomia. Avanços na profilaxia farmacológica de NVPO incluem a nova geração de antagonista 5-HT3. O objetivo deste estudo foi avaliar o efeito do antagonista 5-HT3 no controle antiemético pós-anestésico em videocolecistectomia com anestesia venosa total. Método: Estudo realizado no HC-UFU (Hospital Terciário). Sessenta indivíduos submetidos a videocolecistectomia foram randomizados em três grupos de igual número, sendo administrados 0,125 mg de palonosetrona (Grupo 1); 4 mg de ondasetrona e 4 mg de dexametasona (Grupo 2); ou 4 mg de dexametasona (Grupo 3). A anestesia geral venosa foi realizada com propofol, remifentanil e rocurônio. O avaliador do efeito da droga desconhecia o grupo ao qual o indivíduo pertencia. NVPO foi avaliada aplicando a Escala de Rhodes após 12 e 24 horas do término da cirurgia. Para resgate terapêutico, foi estabelecido 0,655−1,5 mg de droperidol. Resultado: Observou-se no Grupo 1 menor incidência de NVPO e de resgate terapêutico na primeira hora de PO. Não foi observada diferença significativa entre os três grupos com relação a ocorrência de NVPO nas primeiras 12 horas de pós-operatório. Os grupos 1 e 2 foram superiores ao Grupo 3 no que se refere ao controle de NVPO de 12 a 24 horas e após o resgate de 12−24 horas. Observou-se que o controle de náuseas nas primeiras 12 horas de pós-operatório do Grupo 1 foi significantemente superior. Conclusão: O presente estudo mostrou evidências da superioridade da palonosetrona às demais drogas empregadas no que se refere ao efeito antiemético prolongado e menor necessidade de resgate, principalmente na capacidade de inibir completamente o desconfortável sintoma de náusea.
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Humanos , Masculino , Femenino , Adulto , Adulto Joven , Colecistectomía Laparoscópica/métodos , Anestésicos Intravenosos/administración & dosificación , Náusea y Vómito Posoperatorios/prevención & control , Antieméticos/administración & dosificación , Dexametasona/administración & dosificación , Propofol/administración & dosificación , Método Doble Ciego , Ondansetrón/administración & dosificación , Rocuronio/administración & dosificación , Remifentanilo/administración & dosificación , Palonosetrón/administración & dosificación , Persona de Mediana EdadRESUMEN
Abstract Background: Postoperative nausea and vomiting is the second most common complaint in the postoperative period after pain. The incidence of postoperative nausea and vomiting was 60-80% in middle ear surgeries in the absence of antiemetic prophylaxis. Because of this high incidence of postoperative nausea and vomiting, we aimed to assess the effect of palonosetron-dexamethasone and ondansetron-dexamethasone combination for the prevention of postoperative nausea and vomiting in patients of middle ear surgery. Methods: Sixty-four patients, scheduled for middle ear surgery, were randomized into two groups to receive the palonosetron-dexamethasone and ondansetron-dexamethasone combination intravenously before induction of anesthesia. Anesthesia technique was standardized in all patients. Postoperatively, the incidences and severity of nausea and vomiting, the requirement of rescue antiemetic, side effects and patient satisfaction score were recorded. Results: Demographics were similar in the study groups. The incidence difference of nausea was statistically significant between groups O and P at a time interval of 2-6 hours only (p = 0.026). The incidence and severity of vomiting were not statistically significant between groups O and P during the whole study period. The overall incidence of postoperative nausea and vomiting (0-24 hours postoperatively) was 37.5% in group O and 9.4% in group P (p = 0.016). Absolute risk reduction with palonosetron-dexamethasone was 28%, the relative risk reduction was 75%, and the number-needed-to-treat was 4. The patient's satisfaction score was higher in group P than group O (p = 0.016). The frequency of rescue medication was more common in group O than in group P patients (p = 0.026). Conclusion: The combination of palonosetron-dexamethasone is superior to ondansetron-dexamethasone for the prevention of postoperative nausea and vomiting after middle ear surgeries.
Resumo Justificativa: Náusea e vômito no pós-operatório é a segunda queixa pós-operatória mais frequente após a dor. Sem profilaxia antiemética, a incidência de náusea e vômito no pós-operatório foi de 60−80% após cirurgia do ouvido médio. Dada a alta incidência relatada de náusea e vômito no pós-operatório, nosso objetivo foi avaliar o efeito da combinação de palonosetrona-dexametasona e ondansetrona-dexametasona na prevenção de náusea e vômito no pós-operatório em pacientes submetidos a cirurgia do ouvido médio. Método: Sessenta e quatro pacientes programados para cirurgia de ouvido médio foram aleatoriamente divididos em dois grupos. Um recebeu a combinação de palonosetrona-dexametasona (grupo P) e o outro ondansetrona-dexametasona (grupo O) por via intravenosa antes da indução anestésica. A técnica anestésica foi padronizada em todos os pacientes. No pós-operatório, foram registradas incidência e gravidade das náuseas e vômitos, necessidade de antiemético de resgate, efeitos colaterais e índice de satisfação dos pacientes. Resultados: As características demográficas foram semelhantes nos grupos estudados. A diferença na incidência de náusea foi estatisticamente significante entre os grupos O e P apenas no intervalo de tempo entre 2 e 6 horas (p = 0,026). A incidência e gravidade de vômito não foram estatisticamente significantes entre os grupos O e P durante todo o período do estudo. A incidência geral de náusea e vômito no pós-operatório (0−24 horas de pós-operatório) foi de 37,5% no grupo O e de 9,4% no grupo P (p = 0,016). A combinação palonosetrona-dexametasona associou-se com redução do risco absoluto de 28%, redução do risco relativo de 75%, e o número necessário para tratar foi 4. O escore de satisfação do paciente foi maior no grupo P (p = 0,016). A frequência da medicação de resgate foi mais comum no grupo O (p = 0,026). Conclusão: A combinação de palonosetrona-dexametasona é superior à ondansetrona-dexametasona na prevenção da náusea e vômito no pós-operatório após cirurgia de ouvido médio.
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Humanos , Masculino , Femenino , Adulto , Adulto Joven , Dexametasona/administración & dosificación , Ondansetrón/administración & dosificación , Náusea y Vómito Posoperatorios/prevención & control , Palonosetrón/administración & dosificación , Método Doble Ciego , Incidencia , Estudios Prospectivos , Satisfacción del Paciente , Náusea y Vómito Posoperatorios/epidemiología , Quimioterapia Combinada , Oído Medio/cirugía , Persona de Mediana Edad , Antieméticos/administración & dosificaciónRESUMEN
BACKGROUND: Postoperative nausea and vomiting is the second most common complaint in the postoperative period after pain. The incidence of postoperative nausea and vomiting was 60-80% in middle ear surgeries in the absence of antiemetic prophylaxis. Because of this high incidence of postoperative nausea and vomiting, we aimed to assess the effect of palonosetron-dexamethasone and ondansetron-dexamethasone combination for the prevention of postoperative nausea and vomiting in patients of middle ear surgery. METHODS: Sixty-four patients, scheduled for middle ear surgery, were randomized into two groups to receive the palonosetron-dexamethasone and ondansetron-dexamethasone combination intravenously before induction of anesthesia. Anesthesia technique was standardized in all patients. Postoperatively, the incidences and severity of nausea and vomiting, the requirement of rescue antiemetic, side effects and patient satisfaction score were recorded. RESULTS: Demographics were similar in the study groups. The incidence difference of nausea was statistically significant between groups O and P at a time interval of 2-6hours only (p=0.026). The incidence and severity of vomiting were not statistically significant between groups O and P during the whole study period. The overall incidence of postoperative nausea and vomiting (0-24hours postoperatively) was 37.5% in group O and 9.4% in group P (p=0.016). Absolute risk reduction with palonosetron-dexamethasone was 28%, the relative risk reduction was 75%, and the number-needed-to-treat was 4. The patient's satisfaction score was higher in group P than group O (p=0.016). The frequency of rescue medication was more common in group O than in group P patients (p=0.026). CONCLUSION: The combination of palonosetron-dexamethasone is superior to ondansetron-dexamethasone for the prevention of postoperative nausea and vomiting after middle ear surgeries.
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Dexametasona/administración & dosificación , Ondansetrón/administración & dosificación , Palonosetrón/administración & dosificación , Náusea y Vómito Posoperatorios/prevención & control , Adulto , Antieméticos/administración & dosificación , Método Doble Ciego , Quimioterapia Combinada , Oído Medio/cirugía , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Náusea y Vómito Posoperatorios/epidemiología , Estudios Prospectivos , Adulto JovenAsunto(s)
Antieméticos/uso terapéutico , Trasplante de Células Madre Hematopoyéticas , Melfalán/efectos adversos , Mieloma Múltiple/terapia , Náusea/prevención & control , Palonosetrón/uso terapéutico , Piridinas/uso terapéutico , Acondicionamiento Pretrasplante/efectos adversos , Vómitos/prevención & control , Adulto , Anciano , Antieméticos/administración & dosificación , Dexametasona/administración & dosificación , Dexametasona/uso terapéutico , Quimioterapia Combinada , Femenino , Humanos , Quimioterapia de Inducción , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Palonosetrón/administración & dosificación , Estudios Prospectivos , Piridinas/administración & dosificación , Trasplante Autólogo , Vómitos/inducido químicamenteRESUMEN
INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) can be a serious and debilitating adverse effect that is highly feared by cancer patients. For patients receiving moderately emetogenic chemotherapy regimens at our institution in the ambulatory infusion center, palonosetron was selected as the preferred serotonin (5-HT3) antagonist for CINV prophylaxis per the 2016 NCCN Guidelines, when a neurokinin1 antagonist was not included in the prophylactic regimen. The purpose of this study was to evaluate the efficacy of dexamethasone and palonosetron versus granisetron for the prevention of CINV in patients receiving moderately emetogenic chemotherapy regimens. METHODS: This study is an Institutional Review Board-approved, single-center retrospective review of electronic health records including patients who received moderately emetogenic chemotherapy regimens with CINV prophylaxis with dexamethasone and either palonosetron or granisetron. RESULTS: A total of 268 eligible patients were included in the study. Eighty-eight patients received palonosetron and 180 patients received granisetron as their 5-HT3 receptor antagonist between October 31, 2014 and October 31, 2016. There were no statistically significant differences between the two antiemetic groups for the primary outcome of presence of any change in day 1 intravenous prophylactic antiemetics. Nine (10.23%) palonosetron patients and 15 (8.33%) granisetron patients required a change in their day 1 intravenous prophylactic antiemetics (P = 0.610). CONCLUSIONS: Despite palonosetron's better efficacy, longer half-life, and higher binding affinity, the results of this retrospective review demonstrates that the choice of serotonin antagonist, palonosetron or granisetron, did not result in a change in day 1 intravenous prophylactic antiemetics or antiemetic outpatient medications for patients undergoing moderately emetogenic chemotherapy regimens.