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1.
Eur J Haematol ; 113(5): 564-575, 2024 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-39074908

RESUMEN

INTRODUCTION: This systematic review, adhering to PRISMA guidelines, aimed to evaluate the efficacy and safety of antiemetic prophylaxis in haematological patients undergoing high-dose chemotherapy as part of their hematopoietic stem cell transplantation (HSCT) conditioning regimens. METHODS: We performed a comprehensive search in PubMed, EMBASE, ClinicalTrials.gov and the Cochrane database to identify randomised controlled trials (RCTs) and systematic reviews of antiemetic prophylaxis. Studies in English, French, Italian or Spanish were included. This review is registered with PROSPERO, ID CRD42023406380. RESULTS: Eight RCTs were analysed. The antiemetic regimens evaluated ranged from monotherapy with 5-Hydroxytryptamine Receptor 3 antagonists (5-HT3RAs) to complex combinations including olanzapine, neurokinin-1 receptor antagonists, 5-HT3RAs and corticosteroids. Complete response rates for triplet or quadruple regimens varied between 23.5% and 81.9%. Although no significant adverse effects were observed, minor symptoms such as diarrhoea, constipation, sedation and headaches were reported. CONCLUSION: Existing evidence on HSCT antiemetic therapy highlights its benefits but fails to provide clear clinical directions. The choice between triplet and quadruplet therapies for different patient scenarios is still uncertain. Until more detailed research is available, healthcare providers must rely on the latest guidelines and their judgement to customise antiemetic care for each patient's specific needs and risks.


Asunto(s)
Antieméticos , Neoplasias Hematológicas , Trasplante de Células Madre Hematopoyéticas , Vómitos , Humanos , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Antieméticos/uso terapéutico , Antieméticos/administración & dosificación , Neoplasias Hematológicas/terapia , Vómitos/prevención & control , Vómitos/etiología , Nivel de Atención , Náusea/etiología , Náusea/prevención & control , Resultado del Tratamiento , Acondicionamiento Pretrasplante/métodos
2.
Front Oncol ; 14: 1374547, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38529378

RESUMEN

Background: Nausea and vomiting are common side effects of Trastuzumab Deruxtecan (T-DXd), but guidelines for optimal management were not initially available. This retrospective single-center study aimed at evaluating the efficacy of two antiemetic regimens in patients receiving T-DXd. Methods: Data from metastatic breast cancer patients receiving T-DXd were collected. Two groups were defined: patients treated with 5-HT3 receptor antagonists (RA) ± dexamethasone (5-HT3-group) and patients treated with a fixed oral combination of netupitant (NK1RA) and palonosetron ± dexamethasone (NK1 group). Physicians preferentially offered the NK1 regimen to patients at higher risk of nausea and vomiting based on internal recommendations. Only nausea and vomiting during cycles 1 and 2 were considered. Comparisons of nausea and vomiting by the antiemetic prophylaxis group were assessed using chi-square. Results: A total of 53 patients were included in the analysis. At cycle 1, 72% and 28% of patients received the 5-HT3 and NK1 prophylaxis, respectively. Overall, 58% reported nausea, with no differences between groups (58% vs. 60%; p = 0.832), but with a trend for lower grade in the NK1 group (33.3% G1; 26.7% G2) compared to the 5-HT3 group (23.7% G1; 31.6% G2; 2.6% G3). Vomiting was reported by 21% and 0% of patients in the 5-HT3 and the NK1 group, respectively (p = 0.054). Among the 15 patients in the 5-HT3 group with nausea at cycle 1 who escalated to NK1 at cycle 2, nausea decreased from 100% to 53% (p = 0.022) and vomiting decreased from 47% to 13% (p = 0.046). Conclusions: The NK1 regimen improved vomiting control at cycle 1 and, when introduced at cycle 2, significantly improved both nausea and vomiting. The biased NK1 selection for higher-risk patients may have dampened the differences between groups at cycle 1. These findings support enhanced control of T-DXd-related nausea and vomiting with NK1RA.

3.
Surg Endosc ; 37(8): 5999-6007, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37095234

RESUMEN

BACKGROUND: The use of multimodal pharmacological prophylactic regimes has decreased postoperative nausea and vomiting (PONV) in general but it still occurs in over 60% of female patients after bariatric surgery. This study aimed to evaluate the efficacy of ST36 acupoint injection with anisodamine in prevention of PONV among female patients after bariatric surgery. METHODS: Ninety patients undergoing laparoscopic sleeve gastrectomy were randomly allocated to anisodamine or control group at the ratio of 2:1. Anisodamine or normal saline was injected into Zusanli (ST36) bilaterally after induction of general anesthesia. The incidence and severity of PONV were assessed during the first 3 postoperative days and at 3 months. The quality of early recovery of anesthesia, gastrointestinal function, sleep quality, anxiety, depression, and complications were also evaluated. RESULTS: Baseline and perioperative characteristics were comparable between two groups. In the anisodamine group, 25 patients (42.4%) experienced vomiting within postoperative 24 h compared with 21 (72.4%) in the control group (relative risk 0.59; 95% confidence interval 0.40-0.85). Time to first rescue antiemetic was 6.5 h in anisodamine group, and 1.7 h in the control group (P = 0.011). Less rescue antiemetic was required during the first 24 h in the anisodamine group (P = 0.024). There were no differences in either postoperative nausea or other recovery characteristics. CONCLUSIONS: The addition of ST36 acupoint injection with anisodamine significantly reduced postoperative vomiting without affecting nausea in female patients with obesity undergoing laparoscopic sleeve gastrectomy.


Asunto(s)
Antieméticos , Cirugía Bariátrica , Laparoscopía , Humanos , Femenino , Náusea y Vómito Posoperatorios/prevención & control , Náusea y Vómito Posoperatorios/tratamiento farmacológico , Antieméticos/uso terapéutico , Puntos de Acupuntura , Estudios Prospectivos , Cirugía Bariátrica/efectos adversos
4.
Curr Med Res Opin ; 37(12): 2035-2042, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34515599

RESUMEN

OBJECTIVES: Inhalative anesthesia is of common use, but is generally known to potentiate postoperative nausea and vomiting (PONV). With an internal change of anesthesia regimen from total intravenous anesthesia (TIVA) to isoflurane (in terms of myocardial protection) in cardiac anesthesia a higher incidence of PONV was to be expected. Therefore, we evaluated the incidence of PONV after the simultaneous implementation of PONV prophylaxis. METHODS: The incidence of PONV, prospectively assessed in 197 cardiac surgery patients (68 y ± 10.4, 66.5% male) having isoflurane plus dual PONV prophylaxis with dexamethasone and droperidol, was compared with previous data of 190 controls (67 y ± 9.6, 71% male) having TIVA without and with single or dual PONV prophylaxis (n = 64 dexamethasone and droperidol, n = 25 dexamethasone, n = 101 only TIVA), and the Apfel-scoring (0-4 depending on PONV-risk). DRKS00014275. Statistics: Chi2-test, p < .05 (Bonferroni). RESULTS: The incidence of PONV under isoflurane with antiemetic prophylaxis was 20.8% (95% confidence interval (CI) 15.4; 27.4) compared to 30.5% (95%CI 24; 37.6) under TIVA (p = .029; dexamethasone and droperidol 23.4% (95%CI 13.8; 35.7); dexamethasone 32% (95%CI 14.9; 53.5); only TIVA 34.7% (95%CI 25.5; 44.8)), but was not lower in high-risk patients than predicted according to Apfel-scoring 4 (71.4 vs. 78%). CONCLUSION: In cardiac anesthesia, the use of isoflurane is not at the expense of PONV when using a risk-independent two-drug-prophylaxis. It is even beneficial resulting surprisingly in a lower incidence of PONV than under TIVA unless with and without prophylaxis. Patients with the highest risk for PONV and receiving isoflurane should receive a third antiemetic prophylactic drug.


Asunto(s)
Anestesia en Procedimientos Quirúrgicos Cardíacos , Antieméticos , Isoflurano , Propofol , Anestesia General , Antieméticos/uso terapéutico , Femenino , Humanos , Isoflurano/efectos adversos , Masculino , Náusea y Vómito Posoperatorios/tratamiento farmacológico , Náusea y Vómito Posoperatorios/epidemiología , Náusea y Vómito Posoperatorios/prevención & control
5.
Int J Surg Protoc ; 25(1): 98-107, 2021 Jun 03.
Artículo en Inglés | MEDLINE | ID: mdl-34131606

RESUMEN

BACKGROUND: The practice of antiemetic prophylaxis within the prevention and management of postoperative nausea and vomiting is important for optimal care of surgical patients. The poor practice of antiemetic prophylaxis on postoperative nausea and vomiting prevention come up with complications, reduce patient satisfaction, and increase overall costs. This study aims to assess practice and associated factors of antiemetic prophylaxis among health professionals in referral hospitals of Northwest Ethiopia. METHOD AND MATERIALS: Institutional based cross-sectional study was conducted on 407 health professionals from February 27 to March 30, 2019, in referral Hospitals of Northwest Ethiopia. A stratified random sampling technique was used to select the study participants. A structured questionnaire was used to collect data. Bivariable and multivariable logistic regression was used to identify factors associated with the antiemetic prophylaxis practice level of health professionals on postoperative nausea and vomiting prevention and management. The p-values of < 0.05 were considered statistically significant. RESULTS: In this study 153 (37.6%) of health professionals were practicing antiemetic prophylaxis. The multivariable logistic regression analysis showed that anesthetists were (AOR: 8.11; 95% CI: 3.27, 20.08) and physicians (AOR: 4.78; 95% CI: 2.46, 9.30) were more likely to give anti-emetic prophylaxis as compared with midwives. Learning in academic classes (AOR: 3.83; 95% CI: 1.46, 10.09), took training (AOR: 6.97; 95% CI: 2.208, 22.021), professionals who said that there are enough anti-emetic drugs available (AOR: 3.10; 95% CI: 1.67, 5.77), professionals, who respond that patients can afford to buy antiemetic's (AOR: 3.56; 95% CI: 1.23, 10.32) were more likely to give anti-emetic prophylaxis as compared to their counterparts. CONCLUSIONS: Less than fifty percent (37.6%) of health Professionals practice antiemetic prophylaxis. Type of Profession, learning, training, availability, and cost of antiemetic drugs were factors significantly affecting the practice of antiemetic prophylaxis. HIGHLIGHTS: Less than fifty percent of health Professionals practice antiemetic prophylaxis.The availability, drugs affects the practice of antiemetic prophylaxis.The cost of anti-emetics affects the practice of antiemetic prophylaxis.

6.
Bull Cancer ; 108(5): 449-454, 2021 May.
Artículo en Inglés | MEDLINE | ID: mdl-33814187

RESUMEN

INTRODUCTION: Swallowing difficulties in patients with advanced head and neck cancer (HNC) represent an obstacle to adequate antiemetic prophylaxis before chemotherapy. We aim to assess chemotherapy-induced nausea and vomiting (CINV) risk in HNC patients in our center, with a specific focus among patients who could not receive appropriate NK1 receptor antagonist (NK1-RA) prophylaxis. MATERIALS AND METHODS: Prospective observational monocentric study. CINV were evaluated with the MASCC Antiemesis Tool self-questionnaire (MAT) for all patients treated by platinum-based chemotherapy for advanced HNC (January-April 2019), thereafter, only for patients without NK1-RA prophylaxis due to swallowing difficulties were included (May-October 2019). RESULTS: Sixty-one patients were included (82% male, 49.2% reccurent/metastatic disease), 18 did not received NK1-RA prophylaxis due to swallowing difficulties. Among 52 patients included from January to April 2019, 17.3% reported swallowing difficulties. The chemotherapy regimen was highly and moderately emetic for 40 (65.6%) and 21 patients (34.4%), respectively. CINV was associated with both cisplatin-based chemotherapy (OR 10.66, 95% CI [2.17-52.08]) and exclusive chemotherapy (OR 7.76, 95% CI [1.79-33.78]). Patients who did not receive anti-NK1 prophylaxis had no more CINV than patients with adequate CINV prophylaxis. DISCUSSION: CINV remains frequent in patients treated by platinum-based chemotherapy for HNC. Oral NK1-RA prophylaxis can be unavailable because of swallowing difficulties, without an increased risk of CINV.


Asunto(s)
Antineoplásicos/efectos adversos , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Náusea/inducido químicamente , Antagonistas del Receptor de Neuroquinina-1/uso terapéutico , Compuestos de Platino/efectos adversos , Vómitos/inducido químicamente , Anciano , Carboplatino/efectos adversos , Cisplatino/efectos adversos , Trastornos de Deglución/complicaciones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Náusea/prevención & control , Estudios Prospectivos , Vómitos/prevención & control
7.
Drug Des Devel Ther ; 14: 3915-3927, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33061297

RESUMEN

BACKGROUND: High-dose myeloablative conditioning prior to autologous hematopoietic stem cell transplantation (autoHSCT) in pediatric patients is usually highly emetogenic. The antiemetic neurokinin-1 receptor antagonist fosaprepitant was safe and effective in children receiving highly emetogenic chemotherapy. Data on fosaprepitant during autoHSCT in children are currently not available. METHODS: A total of 35 consecutive pediatric patients, who received an antiemetic prophylaxis with fosaprepitant (4 mg/kg; single dose, max. 1 x 150 mg/kg BW) and ondansetron (24-hours continuous infusion; 8-32 mg/24h) or granisetron (2 x 40 µg/kg∙d-1) during highly emetogenic conditioning chemotherapy before autoHSCT were retrospectively analyzed, and their results were compared with a control group comprising 35 consecutive pediatric patients, who received granisetron or ondansetron only. The antiemetic efficacy and the safety of the two prophylaxis regimens were compared with respect to three time periods after the first chemotherapy administration (0-24h, >24-120h, >120-240h). RESULTS: Clinical adverse events and clinically relevant increases/decreases of laboratory markers were similarly low and did not significantly differ between the two study groups (p>0.05). The registered number of vomiting events was significantly higher in the control group in the time periods of 0-24h (64 vs 22 events; p<0.01), >24-120h (135 vs 78 events; p<0.0001), >120-240h (268 vs 105 events; p<0.0001), and the whole observation period 0-240h (467 vs 205 events; p<0.0001). The percentage of patients experiencing vomiting was higher in the control group during the time period of >24-120h (100% vs 74.3%) but not the other analyzed time periods (p>0.05). CONCLUSION: The fosaprepitant-based antiemetic prophylaxis was safe, well tolerated and significantly reduced vomiting in children undergoing highly emetogenic chemotherapy prior to autoHSCT. Prospective randomized trials are necessary to confirm these results.


Asunto(s)
Profilaxis Antibiótica , Antieméticos/uso terapéutico , Trasplante de Células Madre Hematopoyéticas , Morfolinas/uso terapéutico , Neoplasias/terapia , Antagonistas del Receptor de Serotonina 5-HT3/uso terapéutico , Adolescente , Antieméticos/administración & dosificación , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Morfolinas/administración & dosificación , Estudios Retrospectivos , Antagonistas del Receptor de Serotonina 5-HT3/administración & dosificación , Trasplante Autólogo
8.
J Oncol Pharm Pract ; 26(6): 1482-1485, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-32507102

RESUMEN

The ongoing pandemic caused by severe acute respiratory syndrome (SARS) coronavirus type 2 (SARS-CoV-2, also known as COVID-19) has caused unprecedented strain on the global healthcare system, causing thousands of deaths worldwide. Patients with underlying conditions such as cancer are at substantial risk of acquiring and dying from this novel coronavirus. Numerous reports have shown that infection with SARS-CoV-2 causes depletion of B- and T-lymphocytes, including CD4 and CD8 T-cells, and is associated with severe illness and death and that patients with higher lymphocyte levels may have better outcomes. Dexamethasone, a widely prescribed antiemetic for acute and delayed nausea and vomiting from a variety of cancer drugs, causes B and T cell depletion, which may augment immunosuppression. Since it seems that lymphocytes are vital in the immune response to novel coronavirus, oncologists should reconsider the routine use of prophylactic dexamethasone in uninfected patients, to avoid inducing lymphopenia, which may increase risk of infection or lead to inferior outcomes if a cancer patient subsequently becomes infected. Since many cancer drugs and malignant diseases inherently cause lymphopenia, further reduction of lymphocytes with dexamethasone should be avoided if possible and if safe and effective alternative antiemetics are available during the COVID-19 crisis.


Asunto(s)
Antieméticos/administración & dosificación , Infecciones por Coronavirus/epidemiología , Dexametasona/administración & dosificación , Neumonía Viral/epidemiología , COVID-19 , Femenino , Humanos , Pandemias , Linfocitos T/inmunología
10.
Ann Hematol ; 99(4): 867-875, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32036421

RESUMEN

A survey within hematopoietic stem cell transplant (HSCT) centers of the Gruppo Italiano Trapianto Midollo Osseo (GITMO) was performed in order to describe current antiemetic prophylaxis in patients undergoing HSCT. The multicenter survey was performed by a questionnaire, covering the main areas on chemotherapy-induced nausea and vomiting (CINV): antiemetic prophylaxis guidelines used, antiemetic prophylaxis in different conditioning regimens, and methods of CINV evaluation. The survey was carried out in November 2016, and it was repeated 6 months after the publication of the Multinational Association of Supportive Care in Cancer (MASCC)/European Society for Medical Oncology (ESMO) specific guidelines on antiemetic prophylaxis in HSCT. The results show a remarkable heterogeneity of prophylaxis among the various centers and a significant difference between the guidelines and the clinical practice. In the main conditioning regimens, the combination of a serotonin3 receptor antagonist (5-HT3-RA) with dexamethasone and neurokin1 receptor antagonist (NK1-RA), as recommended by MASCC/ESMO guidelines, increased from 0 to 15% (before the publication of the guidelines) to 9-30% (after the publication of the guidelines). This study shows a lack of compliance with specific antiemetic guidelines, resulting mainly in under-prophylaxis. Concerted strategies are required to improve the current CINV prophylaxis, to draft shared common guidelines, and to increase the knowledge and the adherence to the current recommendations for CINV prophylaxis in the specific field of HSCT.


Asunto(s)
Antieméticos/uso terapéutico , Trasplante de Células Madre Hematopoyéticas , Náusea/prevención & control , Acondicionamiento Pretrasplante/efectos adversos , Vómitos/prevención & control , Aloinjertos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Adhesión a Directriz , Encuestas de Atención de la Salud , Humanos , Italia , Agonistas Mieloablativos/efectos adversos , Agonistas Mieloablativos/uso terapéutico , Náusea/inducido químicamente , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en Medicina/estadística & datos numéricos , Trasplante Autólogo , Vómitos/inducido químicamente
11.
J Cancer Res Clin Oncol ; 146(4): 1089-1100, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32056007

RESUMEN

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) is a severe and distressing complication during allogeneic hematopoietic stem cell transplantation (alloHSCT). The antiemetic fosaprepitant has shown favorable results in pediatric and adult patients receiving chemotherapy. Data on fosaprepitant in children and adolescents undergoing alloHSCT are missing. METHODS: In this non-interventional observation study, 120 children and adolescents with a median age of 11.8 years undergoing alloHSCT after a moderately or highly emetogenic conditioning (MEC or HEC) were analyzed. They received an antiemetic prophylaxis with granisetron (2 × 40 µg/kg d-1) with or without fosaprepitant (4 mg/kg; single dose, max. 1 × 150 mg/kg BW), and were analyzed in the control (CG; n = 60) or fosaprepitant group (FG; n = 60). The efficacy and safety of the two antiemetic prophylaxis regimens were analyzed and compared with respect to the acute (0-24 h) and the delayed (> 24-120 h) CINV phase and > 120-240 h after MEC or HEC administration. RESULTS: During MEC, significantly more patients in the CG experienced vomiting during the first 0-24 h (58.6 vs. 25.0%; p = 0.0156) and during > 24-120 h (93.1% vs. 57.1%; p = 0.0020), compared with the FG. Likewise, significantly more vomiting events (269 vs. 136; p < 0.0001) were registered in the CG. During HEC, significantly more patients in the CG experienced vomiting during the first 0-24 h (32.3 vs. 9.4%; p = 0.0319) compared with the FG. Significantly more vomiting events (241 vs. 99; p < 0.0001) were registered in the CG. Laboratory and clinical adverse events were not significantly different between the two groups (p > 0.05). CONCLUSIONS: Antiemetic prophylaxis with fosaprepitant and granisetron was well tolerated, safe, and effective in pediatric patients undergoing alloHSCT. However, larger prospective trials are necessary to evaluate these findings.


Asunto(s)
Antieméticos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Granisetrón/administración & dosificación , Neoplasias Hematológicas/terapia , Trasplante de Células Madre Hematopoyéticas/métodos , Morfolinas/administración & dosificación , Adolescente , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Niño , Preescolar , Femenino , Neoplasias Hematológicas/tratamiento farmacológico , Humanos , Lactante , Masculino , Náusea/inducido químicamente , Náusea/prevención & control , Acondicionamiento Pretrasplante/efectos adversos , Acondicionamiento Pretrasplante/métodos , Vómitos/inducido químicamente , Vómitos/prevención & control
12.
J Altern Complement Med ; 26(1): 67-71, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31580707

RESUMEN

Introduction: Postoperative nausea and vomiting (PONV) are frequent in patients undergoing laparoscopic cholecystectomy. The aim of this study is to evaluate the effectiveness of intraoperative laser acupuncture stimulation of Pericardium 6 (PC6) and Large Intestine 4 (LI4) acupoints combined with antiemetic drug prophylaxis on PONV. Methods: A total of 88 patients, scheduled for laparoscopic cholecystectomy, were assigned into 2 groups. Group I received bilateral laser acupuncture on PC6 and LI4 acupoints after induction of anesthesia and also received antiemetic drug (metoclopramide) prophylaxis. Patients in Group II received only antiemetic drug prophylaxis. Nausea and vomiting frequencies and need for rescue antiemetic drug (ondansetron) were recorded after extubation, at 30th minute at recovery room and at 6th hour at ward. Results: The incidence of nausea and rescue antiemetic drug need was higher at postoperative 6th hour in Group II. Vomiting was not different in groups at any time. Conclusion: Intraoperative laser acupuncture stimulation of PC6 and LI4 acupoints combined with antiemetic drug prophylaxis decreases nausea and rescue antiemetic drug need in late postoperative period in patients undergoing laparoscopic cholecystectomy.


Asunto(s)
Terapia por Acupuntura , Antieméticos , Cuidados Intraoperatorios/métodos , Náusea y Vómito Posoperatorios/prevención & control , Adulto , Anestesia General , Antieméticos/administración & dosificación , Antieméticos/uso terapéutico , Colecistectomía Laparoscópica/efectos adversos , Femenino , Humanos , Terapia por Láser , Masculino , Persona de Mediana Edad , Náusea y Vómito Posoperatorios/terapia
13.
BMC Cancer ; 19(1): 1118, 2019 Nov 15.
Artículo en Inglés | MEDLINE | ID: mdl-31730451

RESUMEN

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) belong among the most burdensome side effects in hemato-oncology. Mostly, a combination of ondansetron and dexamethasone is used as antiemetic prophylaxis in pediatric patients undergoing emetogenic chemotherapy. However, dexamethasone is prohibited in different pediatric chemotherapy protocols. Currently, data on the use of ondansetron with the new antiemetic agent fosaprepitant without dexamethasone is not available for pediatric patients. METHODS: In this non-interventional observation study, 79 pediatric patients with a median age of 8.0 years (range 0.5-17.9 years) who received a CINV prophylaxis regimen with either fosaprepitant (4 mg/kg; maximum 150 mg) and ondansetron (as 24-h continuous infusion) (n = 40; fosaprepitant group/FG) or ondansetron only (n = 39; control group/CG) during moderately or highly emetogenic chemotherapy were analyzed. The groups were analyzed and compared for frequency of vomiting, administered doses of on-demand antiemetic dimenhydrinate and adverse events during the acute (0-24 h after chemotherapy administration) and delayed (> 24 h-120 h) CINV phases. RESULTS: A total of 112 and 116 chemotherapy blocks were analyzed in the fosaprepitant and the control group, respectively. The emetogenic potential of the administered chemotherapy did not significantly differ (p = 0.8812) between the two cohorts. In the acute CINV phase, the percentage of patients experiencing vomiting (n = 26 patients) and the vomiting events were significantly higher (p = 0.0005 and p < 0.0001, respectively) in the CG (n = 26 patients (66.7%); 88 events) compared with the FG (n = 10 patients (25.0%); 37 events). In the delayed CINV phase, the percentage of patients experiencing vomiting and the vomiting events were also significantly higher (p = 0.0017 and p < 0.0001, respectively) in the CG (n = 31 patients (79.5%); 164 events) compared with the FG (n = 17 patients (42.5%); 103 events). Additionally, significantly more dimenhydrinate doses were administered in the CG compared with the FG patients (n = 322/n = 198; p < 0.0001). The occurrence of adverse events did not significantly differ between the two groups (p > 0.05). CONCLUSION: Fosaprepitant (4.0 mg/kg) in addition to ondansetron, without application of dexamethasone, was well tolerated, safe, effective and superior to ondansetron only as CINV prophylaxis in pediatric patients during moderately and highly emetogenic chemotherapy.


Asunto(s)
Antieméticos/uso terapéutico , Antineoplásicos/efectos adversos , Morfolinas/uso terapéutico , Náusea/prevención & control , Neoplasias/tratamiento farmacológico , Vómitos/prevención & control , Adolescente , Antieméticos/efectos adversos , Antineoplásicos/administración & dosificación , Estudios de Casos y Controles , Niño , Preescolar , Estudios de Factibilidad , Femenino , Humanos , Lactante , Masculino , Morfolinas/efectos adversos , Náusea/inducido químicamente , Neoplasias/patología , Ondansetrón/efectos adversos , Ondansetrón/uso terapéutico , Seguridad del Paciente , Resultado del Tratamiento , Vómitos/inducido químicamente
14.
Drug Des Devel Ther ; 13: 3439-3451, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31686784

RESUMEN

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) are a major burden for patients undergoing emetogenic chemotherapy. International guidelines recommend an antiemetic prophylaxis with corticosteroids, 5-HT3R-antagonists and NK1R-antagonists. The NK1R-antagonist fosaprepitant has shown favorable results in pediatric and adult patients. There is little pediatric experience with fosaprepitant. METHODS: This non-interventional observation study analyzed 303 chemotherapy courses administered to 83 pediatric patients with a median age of 9 years (2-17 years), who received antiemetic prophylaxis either with fosaprepitant and granisetron with or without dexamethasone (fosaprepitant group/FG; n=41), or granisetron with or without dexamethasone (control group/CG; n=42), during moderately (CINV risk 30-90%) or highly (CINV risk>90%) emetogenic chemotherapy. The two groups' results were compared with respect to the safety and efficacy of the antiemetic prophylaxis during the acute (0-24hrs after chemotherapy), delayed (>24-120hrs after chemotherapy) and both CINV phases. Laboratory and clinical adverse events were compared between the two cohorts. RESULTS: Adverse events were not significantly different in the two groups (p>0.05). Significantly fewer vomiting events occurred during antiemetic prophylaxis with fosaprepitant in the acute (23 vs 142 events; p<0.0001) and the delayed (71 vs 255 events; p<0.0001) CINV phase. In the control group, the percentage of chemotherapy courses with vomiting was significantly higher during the acute (24%/FG vs 45%/CG; p<0.0001) and delayed CINV phase (28%/FG vs 47%/CG; p=0.0004). Dimenhydrinate (rescue medication) was administered significantly more often in the CG, compared to the FG (114/FG vs 320/CG doses; p<0.0001). Likewise, in the control group, dimenhydrinate was administered in significantly more (p<0.0001) chemotherapy courses during the acute and delayed CINV phases (79 of 150; 52.7%), compared to the fosaprepitant group (45 of 153; 29.4%). CONCLUSION: Antiemetic prophylaxis with fosaprepitant and granisetron with or without dexamethasone was well tolerated, safe and effective in pediatric patients. However, larger prospective trials are needed to evaluate these findings.


Asunto(s)
Antieméticos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Dexametasona/uso terapéutico , Granisetrón/uso terapéutico , Morfolinas/uso terapéutico , Náusea/tratamiento farmacológico , Vómitos/tratamiento farmacológico , Adolescente , Antieméticos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Niño , Preescolar , Estudios de Cohortes , Dexametasona/administración & dosificación , Quimioterapia Combinada , Femenino , Granisetrón/administración & dosificación , Humanos , Masculino , Morfolinas/administración & dosificación , Náusea/inducido químicamente , Vómitos/inducido químicamente
15.
J Clin Diagn Res ; 11(5): FC10-FC14, 2017 May.
Artículo en Inglés | MEDLINE | ID: mdl-28658796

RESUMEN

INTRODUCTION: Chemotherapy Induced Nausea and Vomiting (CINV) is the most distressing side effect of cancer chemotherapy. It can seriously produce an impact on patient's quality of life. Prevention of CINV is far more effective than treatment of an established CINV. If the patient receives an optimal antiemetic regimen during the initial course of chemotherapy, the likelihood of developing emesis is greatly reduced. Although, all first generation 5HT3 antagonists demonstrate reasonable efficacy in preventing acute CINV, delayed CINV still remains a problem. AIM: To compare the effectiveness and safety of palonosetron versus ondansetron as an antiemetic agent in patients receiving cancer chemotherapy. MATERIALS AND METHODS: A prospective observational study was conducted in 106 patients in each treatment arm. Study duration was 12 months from January 2013 to January 2014. Consecutive patients diagnosed with cancer satisfying inclusion criteria, who were about to receive moderately or highly emetogenic chemotherapy were enrolled into the study after getting informed written consent. Each patient received either Intravenous (IV) palonosetron 0.25 mg or ondansetron 8 mg half an hour before chemotherapy as antiemetic. Patients were followed up for a period of five days following chemotherapy. Number of episodes, severity of vomiting and nausea and antiemetic rescue given if any were recorded. The data were graded using NCI-CTCAE (VERSION 3.0). Proportion of patients with nausea and vomiting during acute (0-24 hours), delayed (24-120 hours) and overall period (0-120 hours) in both the study groups were compared. Outcome was assessed in terms of symptom control and response. Data were analysed using SPSS-16.0 statistical software (IBM). Chi-square test was used to compare the difference in clinical response. RESULTS: Complete response during acute phase in ondansetron group was 80.2%, while for palonosetron it was 89.6%. During delayed phase, ondansetron and palonosetron produced complete response in 70.8% and 86.8% respectively. A total of 65.1% and 82.1% of subjects experienced complete response during the overall period in the ondansetron and palonosetron groups respectively. The difference in the response to antiemetic prophylaxis was statistically significant between the two groups for delayed (p-value = 0.006) and overall phase (p-value = 0.008). CONCLUSION: Palonosetron is clinically more efficacious than ondansetron in controlling CINV especially in delayed phase and overall period of emesis.

16.
Support Care Cancer ; 25(8): 2505-2513, 2017 08.
Artículo en Inglés | MEDLINE | ID: mdl-28281050

RESUMEN

PURPOSE: We assessed the cost-effectiveness of a risk model-guided (RMG) antiemetic prophylaxis strategy compared with the physician's choice (PC) strategy in patients receiving chemotherapy for early-stage breast cancer. METHODS: We conducted a cost-utility analysis based on a published randomized controlled trial of 324 patients with early-stage breast cancer undergoing chemotherapy at two Canadian cancer centers. Patients were randomized to receive their antiemetic treatments according to either predefined risk scores or the treating physician's preference. Effectiveness was measured as quality-adjusted life years (QALYs) gained. Cost and utility data were obtained from the Canadian published literature. We used generalized estimating equations to estimate the incremental cost-effectiveness ratios (ICERs) and 95% confidence intervals (CIs) over a range of willingness-to-pay values. The lower and upper bounds of the 95% CIs were used to characterize the statistical uncertainty for the cost-effectiveness estimates and construct cost-effectiveness acceptability curves. RESULTS: From the health care system's perspective, the RMG strategy was associated with greater QALYs gained (0.0016, 95% CI 0.0009, 0.0022) and higher cost ($49.19, 95% CI $24.87, $73.08) than the PC strategy, resulting in an ICER of $30,864.28 (95% CI $14,718.98, $62,789.04). At the commonly used threshold of $50,000/QALY, the probability that RMG prophylaxis is cost-effective was >94%; this probability increased with greater willingness-to-pay values. CONCLUSION: The risk-guided antiemetic prophylaxis is an economically attractive option for patients receiving chemotherapy for early-stage breast cancer. This information supports the implementation of risk prediction models to guide chemotherapy-induced nausea and vomiting prophylaxis in clinical practices.


Asunto(s)
Antieméticos/uso terapéutico , Neoplasias de la Mama/economía , Conducta de Elección/efectos de los fármacos , Análisis Costo-Beneficio/métodos , Neoplasias de la Mama/tratamiento farmacológico , Femenino , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Médicos , Riesgo
17.
Expert Opin Pharmacother ; 17(12): 1623-9, 2016 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-27322893

RESUMEN

INTRODUCTION: Antiemetic prophylaxis for the prevention of chemotherapy-induced nausea and vomiting, and the development of new antiemetic drugs are expanding areas of research. However, studies of antiemetic prophylaxis in chemoradiotherapy have not been prioritised, and little is known about the proper timing, duration, and combination of antiemetic drugs for the prevention of chemoradiotherapy-induced nausea and vomiting (C-RINV). AREAS COVERED: The article summarises the available antiemetic studies, the evidence for antiemetic prophylaxis of C-RINV, and the future perspectives for antiemetic research in chemoradiotherapy. EXPERT OPINION: Antiemetic prophylaxis for patients receiving concomitant chemoradiotherapy has, for many years, been an orphan research area. The distinction between acute and delayed nausea and vomiting does not apply to fractionated radiotherapy, and prophylaxis should be considered to cover the entire course of treatment and not only the acute and delayed chemotherapy-induced nausea and vomiting. The best prophylaxis in women receiving fractionated radiotherapy and concomitant weekly cisplatin is a combination of the neurokinin receptor antagonist fosaprepitant with palonosetron and dexamethasone. Even with this three-drug combination nausea is a significant problem and the effect of multi-receptor targeting antiemetics such as olanzapine and amisulpride should be explored in this setting.


Asunto(s)
Antieméticos/uso terapéutico , Antineoplásicos/efectos adversos , Náusea/tratamiento farmacológico , Vómitos/tratamiento farmacológico , Antineoplásicos/uso terapéutico , Cisplatino/efectos adversos , Cisplatino/uso terapéutico , Quimioterapia Combinada , Humanos , Isoquinolinas/efectos adversos , Isoquinolinas/uso terapéutico , Morfolinas/efectos adversos , Morfolinas/uso terapéutico , Náusea/etiología , Neoplasias/tratamiento farmacológico , Palonosetrón , Quinuclidinas/efectos adversos , Quinuclidinas/uso terapéutico , Receptores de Serotonina 5-HT3/química , Receptores de Serotonina 5-HT3/metabolismo , Vómitos/etiología
18.
J Anaesthesiol Clin Pharmacol ; 29(4): 526-9, 2013 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-24249992

RESUMEN

CONTEXT: Postoperative nausea and vomiting (PONV) is common after ambulatory surgery performed under general anesthesia. Anecdotal evidence suggests that caffeine may be useful in preventing PONV. AIMS: The aim of the study was to determine efficacy of intravenous (IV) caffeine given prior to surgery is effective prophylaxis against PONV. SETTINGS AND DESIGN: We conducted a prospective, randomized, double-blind, placebo-controlled study. SUBJECT AND METHODS: Patients at moderate or high risk of PONV were randomized to receive IV caffeine (500 mg) or saline placebo during general anesthesia; all patients received dexamethasone and dolasetron. STATISTICAL ANALYSIS: Statistical comparisons were tested using bivariable linear and logistic regression for each outcome and then adjusted for high/low risk. RESULTS: Nausea in the postanesthesia care unit (PACU) was more common in the caffeine (16 of 62 patients) than the placebo group (seven of 69; P = 0.02). There were no significant differences in the use of rescue antiemetics in the PACU, in the incidence of nausea or vomiting over 24 h postoperatively, nor in other outcomes (headache, fatigue, or overall satisfaction) either in the PACU or at 24 h; time-to-discharge was similar for both groups. CONCLUSION: Caffeine was not effective in the prevention of PONV or headache, and did not improve time-to-discharge or patient satisfaction.

19.
Bull Cancer ; 100(9): 799-810, 2013 Sep.
Artículo en Francés | MEDLINE | ID: mdl-23917624

RESUMEN

Current chemotherapy-induced nausea and vomiting management guidelines recommend taking into account the emetogenic potential of the chemotherapy employed as well as individual risk factors to such effects. We performed an interventional prospective study to assess the impact of an innovating therapeutic optimization strategy. The latter combines current guidelines application to a specific consultation in order to individualize the treatment. This study included 170 patients and covered a total of 1,746 days of various chemotherapies. Among these patients, 86.5% never vomited and 53.8% never had any nausea or vomiting. These results seem generally better than the ones found in the literature with all kinds of chemotherapies. Regarding them, we have attempted to highlight the determining criteria for a successful antiemetic treatment.


Asunto(s)
Antieméticos/uso terapéutico , Náusea/prevención & control , Vómitos/prevención & control , Adulto , Anciano , Anciano de 80 o más Años , Antieméticos/administración & dosificación , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Ansiedad/diagnóstico , Protocolos Clínicos , Esquema de Medicación , Femenino , Adhesión a Directriz , Humanos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Medicina de Precisión/métodos , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Vómitos/inducido químicamente
20.
Artículo en Inglés | WPRIM (Pacífico Occidental) | ID: wpr-176595

RESUMEN

It was previously reported that the Korean predictive model could be used to identify patients at high risk of postoperative nausea and vomiting (PONV). This study investigated whether PONV in the high-risk and very high-risk patients identified by the Korean predictive model could be prevented by multiple prophylactic antiemetics. A total of 2,456 patients were selected from our previous PONV study and assigned to the control group, and 374 new patients were recruited consecutively to the treatment group. Patients in each group were subdivided into two risk groups according to the Korean predictive model: high-risk group and very high-risk group. Patients in the treatment group received an antiemetic combination of dexamethasone 5 mg (minutes after induction) and ondansetron 4 mg (30 min before the end of surgery). The incidences of PONV were examined at two hours after the surgery in the postanesthetic care unit and, additionally, at 24 hr after the surgery in the ward, and were analyzed for any differences between the control and treatment groups. The overall incidence of PONV decreased significantly from 52.1% to 23.0% (p< or =0.001) after antiemetic prophylaxis. Specifically, the incidence decreased from 47.3% to 19.4% (p< or =0.001) in the high-risk group and from 61.3% to 28.3% (p< or =0.001) in the very high-risk group. Both groups showed a similar degree of relative risk reductions: 59.0% vs. 53.8% in the high-risk and very high-risk groups, respectively. The results of our study showed that the antiemetic prophylaxis with the combination of dexamethasone and ondansetron was effective in reducing the occurrence of PONV in both high-risk and very high-risk patients.


Asunto(s)
Adulto , Femenino , Humanos , Persona de Mediana Edad , Anestésicos/efectos adversos , Antieméticos/farmacología , Dexametasona/administración & dosificación , Incidencia , Corea (Geográfico) , Ondansetrón/administración & dosificación , Complicaciones Posoperatorias/prevención & control , Náusea y Vómito Posoperatorios/prevención & control , Periodo Posoperatorio , Riesgo , Factores de Riesgo , Resultado del Tratamiento
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