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1.
Anaesthesia ; 79(6): 593-602, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38353045

RESUMEN

Cancellations within 24 h of planned elective surgical procedures reduce operating theatre efficiency, add unnecessary costs and negatively affect patient experience. We implemented a bundle intervention that aimed to reduce same-day case cancellations. This consisted of communication tools to improve patient engagement and new screening instruments (automated estimation of ASA physical status and case cancellation risk score plus four screening questions) to identify patients in advance (ideally before case booking) who needed comprehensive pre-operative risk stratification. We studied patients scheduled for ambulatory surgery with the otorhinolaryngology service at a single centre from April 2021 to December 2022. Multivariable logistic regression and interrupted time-series analyses were used to analyse the effects of this intervention on case cancellations within 24 h and costs. We analysed 1548 consecutive scheduled cases. Cancellation within 24 h occurred in 114 of 929 (12.3%) cases pre-intervention and 52 of 619 (8.4%) cases post-intervention. The cancellation rate decreased by 2.7% (95%CI 1.6-3.7%, p < 0.01) during the first month, followed by a monthly decrease of 0.2% (95%CI 0.1-0.4%, p < 0.01). This resulted in an estimated $150,200 (£118,755; €138,370) or 35.3% cost saving (p < 0.01). Median (IQR [range]) number of days between case scheduling and day of surgery decreased from 34 (21-61 [0-288]) pre-intervention to 31 (20-51 [1-250]) post-intervention (p < 0.01). Patient engagement via the electronic health record patient portal or text messaging increased from 75.9% at baseline to 90.8% (p < 0.01) post-intervention. The primary reason for case cancellation was patients' missed appointment on the day of surgery, which decreased from 7.2% pre-intervention to 4.5% post-intervention (p = 0.03). An anaesthetist-driven, clinical informatics-based bundle intervention decreases same-day case cancellation rate and associated costs in patients scheduled for ambulatory otorhinolaryngology surgery.


Asunto(s)
Procedimientos Quirúrgicos Ambulatorios , Citas y Horarios , Procedimientos Quirúrgicos Otorrinolaringológicos , Humanos , Procedimientos Quirúrgicos Ambulatorios/economía , Masculino , Persona de Mediana Edad , Femenino , Adulto , Anciano , Procedimientos Quirúrgicos Otorrinolaringológicos/economía , Paquetes de Atención al Paciente/economía , Paquetes de Atención al Paciente/métodos , Procedimientos Quirúrgicos Electivos/economía , Análisis de Series de Tiempo Interrumpido
2.
Support Care Cancer ; 32(1): 36, 2023 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-38105286

RESUMEN

PURPOSE: This review is an update of the MASCC/ESMO 2015 recommendations for the prophylaxis of acute and delayed nausea and vomiting induced by multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting. METHODS: A systematic literature search was conducted using PubMed from June 1, 2015, through February 1, 2023. RESULTS: We identified 56 references (16 were duplications or invalid), leaving 40 manuscripts for this search. The panel classified level I evidence (three manuscripts) and level II evidence (14 manuscripts). High-dose chemotherapy and stem cell transplant were discussed in four of these manuscripts, and multiple-day chemotherapy treatment in 15. Some manuscripts covered both topics. Additionally, a search for breakthrough nausea and vomiting resulted in 12 "hits." No new relevant studies were identified. CONCLUSIONS: The recommendations for patients receiving high-dose chemotherapy with stem cell transplants and patients undergoing multiple-day cisplatin were updated. For patients receiving high-dose chemotherapy for stem cell transplant, a combination of a 5-HT3 receptor antagonist with dexamethasone and aprepitant is recommended. Olanzapine could be considered part of the antiemetic regimen. Patients receiving multiple-day cisplatin should receive a 5-HT3 receptor antagonist plus dexamethasone plus aprepitant plus olanzapine. For patients experiencing breakthrough nausea and vomiting, the available evidence suggests using a single dose of olanzapine daily for 3 days.


Asunto(s)
Antieméticos , Antineoplásicos , Humanos , Aprepitant/uso terapéutico , Olanzapina/uso terapéutico , Cisplatino/efectos adversos , Consenso , Serotonina/efectos adversos , Antineoplásicos/uso terapéutico , Vómitos/inducido químicamente , Vómitos/prevención & control , Vómitos/tratamiento farmacológico , Náusea/inducido químicamente , Náusea/prevención & control , Náusea/tratamiento farmacológico , Antieméticos/uso terapéutico , Dexametasona/uso terapéutico
3.
Support Care Cancer ; 31(12): 654, 2023 Oct 25.
Artículo en Inglés | MEDLINE | ID: mdl-37878086

RESUMEN

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV)'s impact on work loss remains poorly described. We evaluated associations between the duration of CINV episodes, CINV-related work loss (CINV-WL), and CINV-related activity impairment (CINV-AI) in patients with breast cancer receiving highly emetogenic chemotherapy. METHODS: We analyzed data from a prospective CINV prophylaxis trial of netupitant/palonestron and dexamethasone for patients receiving an anthracycline and cyclophosphamide (AC) for breast cancer (NCT0340371). Over the observed CINV duration (0-5 days), we analyzed patient-reported CINV-WL and CINV-AI for the first two chemotherapy cycles. We categorized patients as having either extended (≥ 3 days) or short (1-2 days) CINV duration and quantified its impact on work using the Work Productivity and Activity Impairment Questionnaire (WPAI). RESULTS: Overall, we captured data for 792 cycles in 402 women, including 136 (33.8%) employed patients with 35.3% reporting CINV. Of those with CINV, patients reported CINV-WL in 26 cycles and CINV-AI in 142 cycles. Of those with CINV, 55.3% of extended CINV cycles experienced CINV-WL compared to 16.7% of short CINV cycles (p < 0.001). The relative risk of CINV-WL between extended and short CINV was 3.32 (p < 0.01) for employed patients. The mean difference in CINV-AI scores (higher = worse) between extended and short duration CINV was 5.0 vs. 3.0 (p < 0.001). CONCLUSION: Extended (≥ 3 days) CINV was associated with more than triple the risk of CINV-WL and higher CINV-AI compared with short CINV.


Asunto(s)
Neoplasias de la Mama , Humanos , Femenino , Neoplasias de la Mama/tratamiento farmacológico , Estudios Prospectivos , Vómitos/inducido químicamente , Vómitos/prevención & control , Náusea/inducido químicamente , Náusea/prevención & control , Antraciclinas
4.
Oncologist ; 28(8): 722-729, 2023 08 03.
Artículo en Inglés | MEDLINE | ID: mdl-37284847

RESUMEN

PURPOSE: A protocol was developed to evaluate the value of an NK-1 receptor antagonist for preventing nausea and vomiting resulting from highly emetogenic chemotherapy when an olanzapine-based antiemetogenic regimen was used. MATERIALS AND METHODS: A221602, a prospective double-blind, placebo-controlled clinical trial, was developed to compare 2 -olanzapine-containing antiemetic regimens, one with an NK-1 receptor antagonist (aprepitant or fosaprepitant) and one without. Trial patients had a malignant disease for which they received intravenous highly emetogenic chemotherapy (single day cisplatin ≥ 70 mg/m2 or doxorubicin plus cyclophosphamide on 1 day). Patients on both arms received commonly administered doses of a 5-HT3 receptor antagonist, dexamethasone, and olanzapine. Additionally, patients were randomized to receive an NK-1 receptor antagonist (fosaprepitant 150 mg IV or aprepitant 130 mg IV) or a corresponding placebo. The primary objective was to compare the proportion of patients with no nausea for 5 days following chemotherapy between the 2 study arms. This trial was designed to test for the noninferiority of deleting the NK-1 receptor antagonist, with noninferiority defined as a decrease in freedom from nausea by less than 10%. RESULTS: A total of 690 patients were entered on this trial, 50% on each arm. The proportion of patients without nausea for the complete 5-day study period was 7.4% lower (upper limit of the one-sided 95% confidence interval was 13.5%) in the arm without an NK-1 receptor antagonist compared with the arm with an NK-1 receptor antagonist. CONCLUSION: This trial did not provide sufficient evidence to support that deletion of the NK-1 receptor antagonist was as good as keeping it, as a part of a 4-drug antiemetic regimen for highly emetogenic chemotherapy (ClinicalTrials.gov Identifier: NCT03578081).


Asunto(s)
Antieméticos , Antineoplásicos , Humanos , Antieméticos/farmacología , Antieméticos/uso terapéutico , Olanzapina , Aprepitant/uso terapéutico , Estudios Prospectivos , Receptores de Neuroquinina-1/uso terapéutico , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Vómitos/prevención & control , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Náusea/prevención & control , Antineoplásicos/uso terapéutico , Método Doble Ciego , Dexametasona/uso terapéutico
5.
Adv Ther ; 40(7): 3217-3226, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37245189

RESUMEN

INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) is a recognized adverse outcome among patients with cancer. This retrospective study aimed to quantify the treatment outcomes, resource utilization, and costs associated with antiemetic use to prevent CINV in a broad US population who received cisplatin-based chemotherapy. METHODS: Data from the STATinMED RWD Insights Database was collected from January 1, 2015 to December 31, 2020. Cohorts included any patients that had at least one claim for fosnetupitant + palonosetron (NEPA) or fosaprepitant + palonosetron (APPA) and evidence of initiating cisplatin-based chemotherapy. Logistic regression was used to evaluate nausea and vomiting visits within 14 days after chemotherapy, and generalized linear models were used to examine all-cause and CINV-related healthcare resource utilization (HCRU) and costs. RESULTS: NEPA was associated with significantly lower rates of nausea and vomiting visits after chemotherapy (p = 0.0001), including 86% greater odds of nausea and vomiting events for APPA during the second week after chemotherapy (odds ratio [OR] = 1.86; p = 0.0003). The mean numbers of all-cause inpatient visits (p = 0.0195) and CINV-related inpatient and outpatient visits were lower among NEPA patients (p < 0.0001). These differences corresponded to 57% of NEPA patients and 67% of APPA patients having one or more inpatient visits (p = 0.0002). All-cause outpatient costs and CINV-related inpatient costs were also significantly lower for NEPA (p < 0.0001). The mean number of all-cause outpatient visits, all-cause inpatient costs, and CINV-related outpatient costs was not significantly different between groups (p > 0.05). CONCLUSION: In this retrospective study based on claims data, NEPA was associated with lower rates of nausea and vomiting and lower CINV-related HCRU and costs compared to APPA following cisplatin-based chemotherapy. These results complement clinical trial data and published economic models supporting the use of NEPA as a safe, effective, and cost-saving antiemetic for patients undergoing chemotherapy.


Asunto(s)
Antieméticos , Antineoplásicos , Neoplasias , Humanos , Antieméticos/uso terapéutico , Cisplatino/efectos adversos , Palonosetrón/uso terapéutico , Palonosetrón/farmacología , Estudios Retrospectivos , Náusea/inducido químicamente , Náusea/prevención & control , Náusea/tratamiento farmacológico , Vómitos/inducido químicamente , Vómitos/prevención & control , Vómitos/tratamiento farmacológico , Neoplasias/complicaciones , Neoplasias/tratamiento farmacológico , Quinuclidinas/uso terapéutico , Resultado del Tratamiento , Fármacos Gastrointestinales/uso terapéutico , Atención a la Salud , Antineoplásicos/efectos adversos
7.
Future Oncol ; 17(23): 3027-3035, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-33878896

RESUMEN

Aim: In the absence of comparative studies, guidelines consider neurokinin 1 receptor antagonists (RAs) as interchangeable. We evaluated the pooled efficacy from three cisplatin registration trials, each with arms containing netupitant/palonosetron (NEPA), a fixed neurokinin 1 RA (netupitant)/serotonin Type 3 (5-HT3) RA (palonosetron) combination, and an aprepitant (APR) regimen. Materials & methods: Efficacy data were pooled for rates of complete response (CR: no emesis/no rescue medication), complete protection (CR + no significant nausea), total control (CR + no nausea) and no significant nausea during acute (0-24 h), delayed (>24-120 h) and overall (0-120 h) phases post chemotherapy. Results: Among 621 NEPA and 576 APR patients, response rates were similar for the acute phase, and generally favored NEPA during delayed and overall phases. CR rates for NEPA versus APR were 88.4 versus 89.2%, 81.8 versus 76.9% (p < 0.05) and 78.4 versus 75.0% during the acute, delayed and overall phases, respectively. Conclusion: Oral NEPA administered on day 1 was more effective than a 3-day APR regimen in preventing delayed nausea and vomiting associated with cisplatin.


Lay abstract Oral netupitant/palonosetron (NEPA) is an innovative product that combines two drugs (netupitant and palonosetron) in a single capsule to prevent nausea and vomiting associated with certain types of chemotherapy. In this paper we pooled together the results of three studies comparing the efficacy of NEPA to two drugs from the same classes administered separately (aprepitant regimen) in patients with various solid tumors receiving cisplatin, a type of chemotherapy with a high likelihood of causing nausea and vomiting. In summary, NEPA was more effective than the aprepitant regimen in preventing nausea and vomiting in the later days (days 3­5) following chemotherapy.


Asunto(s)
Antieméticos/administración & dosificación , Antineoplásicos/efectos adversos , Náusea/epidemiología , Neoplasias/tratamiento farmacológico , Vómitos/epidemiología , Administración Oral , Adulto , Aprepitant/administración & dosificación , Cisplatino/efectos adversos , Ensayos Clínicos Fase II como Asunto , Ensayos Clínicos Fase III como Asunto , Esquema de Medicación , Combinación de Medicamentos , Femenino , Humanos , Isoquinolinas/administración & dosificación , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Náusea/inducido químicamente , Náusea/prevención & control , Piridinas/administración & dosificación , Quinuclidinas/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Vómitos/inducido químicamente , Vómitos/prevención & control
8.
Support Care Cancer ; 29(8): 4269-4275, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-33409724

RESUMEN

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


Asunto(s)
Antieméticos/uso terapéutico , Análisis Costo-Beneficio/métodos , Náusea/inducido químicamente , Olanzapina/uso terapéutico , Vómitos/inducido químicamente , Antieméticos/farmacología , Femenino , Humanos , Masculino , Olanzapina/farmacología
9.
Support Care Cancer ; 29(7): 3439-3459, 2021 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-33442782

RESUMEN

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


Asunto(s)
Antieméticos/uso terapéutico , Antineoplásicos/efectos adversos , Náusea/tratamiento farmacológico , Olanzapina/uso terapéutico , Vómitos/tratamiento farmacológico , Adolescente , Adulto , Anciano , Antieméticos/farmacología , Humanos , Persona de Mediana Edad , Náusea/inducido químicamente , Olanzapina/farmacología , Vómitos/inducido químicamente , Adulto Joven
10.
Crit Rev Oncol Hematol ; 157: 103143, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33260048

RESUMEN

This paper presents an overview of the efficacy of intravenous (IV) NEPA (fixed combination of the NK1RA, fosnetupitant, and 5-HT3RA, palonosetron) relative to oral NEPA and also to historical data for other NK1RA regimens. Data is compiled from 5 pivotal NEPA studies in adult chemotherapy-naïve patients with solid tumors undergoing either cisplatin- or anthracycline cyclophosphamide (AC)-based chemotherapy. Additionally, data was reviewed from 10 pivotal Phase 3 studies utilizing other NK1RA regimens approved for clinical use. The overall (0-120 h) complete response (no emesis, no rescue use), no emesis, and no significant nausea rates for IV NEPA were similar to that of oral NEPA and were consistently numerically higher than historical NK1RA regimens. As a single-dose prophylactic antiemetic combination given with dexamethasone, IV NEPA is a highly effective and convenient guideline-compliant antiemetic agent which may offer a safety benefit over other IV NK1RA regimens due to its lack of associated hypersensitivity and injection-site reactions.


Asunto(s)
Antieméticos , Cisplatino , Adulto , Antraciclinas , Cisplatino/efectos adversos , Ensayos Clínicos Fase III como Asunto , Ciclofosfamida/efectos adversos , Método Doble Ciego , Humanos , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Náusea/prevención & control , Serotonina , Vómitos/prevención & control
11.
Oncologist ; 26(4): 325-331, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33289268

RESUMEN

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) contributes to avoidable acute care, a metric now tracked in Medicare's oncology outcome measure. CINV is preventable, yet guidelines are often not followed. We sought to quantify acute care involving CINV and other avoidable toxicities after highly emetogenic chemotherapy (HEC) to identify excess risk and assess clinician adherence to antiemesis guidelines for HEC. MATERIALS AND METHODS: We retrospectively evaluated U.S. electronic health records (2012-2018) using Medicare's OP-35 outcome measure to identify avoidable acute care involving any of 10 toxicities, including CINV, after HEC regimens relative to non-HEC. Antiemetic guideline adherence was defined as use ofneurokinin-1 (NKl) receptor antagonists Q5 (RAs) plus 5-hydroxytryptamine type 3 RA+ dexamethasone at HEC initiation. RESULTS: Among 17,609 patients receiving HEC, acute care rates associated with HEC chemotherapy included 32% cisplatin, 31% carboplatin, and 21% anthracycline/cyclosphospharnide (AC), with 76% meeting the criteria as avoidable events. Oxaliplatin rates were 29%. Avoidable acute care occurred 1.83 times (95% confidence interval, 1.76-1.91, p < .0001) as often after HEC versus non-HEC excluding oxaliplatin; CINV-related acute care occurred 2.29 times as often. Nonadherence to antiemesis guidelines occurred in 34% and 24% of cisplatin and AC courses, respectively, because of omission of a NKl RA. CONCLUSIONS: Patients treated with HEC regimens experienced high avoidable acute care use, 1.8 times the risk seen for other chemotherapy. Nonadherence to guideline-directed antiemetic prophylaxis highlights the need to ensure adherence to antiemetic guidelines, including the use of NKl RA in HEC. IMPLICATIONS FOR PRACTICE: After survival, perhaps the most important goal in oncology is limiting avoidable acute care, a goal now used by Medicare to impact cancer reimbursement. This study found that patients treated with highly emetogenic chemotherapy (HEC) regimens had high rates of avoidable acute care use, 1.8 times the risk seen for other chemotherapy. A substantial proportion of the avoidable acute care involved chemotherapy-induced nausea and vomiting. Results showed that incomplete adherence to national antiemetic guidelines for HEC regimens primarily driven by omission of upfront neurokinin-1 receptor antagonist use, suggesting that improved adherence can meaningfully resolve this gap in quality and cost of care.


Asunto(s)
Antieméticos , Antineoplásicos , Neoplasias , Anciano , Antieméticos/uso terapéutico , Antineoplásicos/efectos adversos , Humanos , Medicare , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Náusea/prevención & control , Neoplasias/tratamiento farmacológico , Oxaliplatino/uso terapéutico , Estudios Retrospectivos , Estados Unidos , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Vómitos/prevención & control
13.
Future Oncol ; 16(24): 1863-1872, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32543309

RESUMEN

Breakthrough chemotherapy-induced nausea and vomiting (CINV) is nausea and/or vomiting occurring within 5 days of chemotherapy administration despite using guideline-directed prophylactic antiemetic agents. It is highly prevalent (30-40%), usually requiring immediate treatment or "rescue" medication. If breakthrough CINV occurs, antiemetic guidelines recommend using an antiemetic agent from a different class not used in prophylaxis, along with intravenous hydration and/or dexamethasone. Data supporting these guideline recommendations are limited. Importantly, costs associated with breakthrough CINV can be substantial (i.e., unscheduled hydrations). Two retrospective analyses evaluating guideline-adherent CINV prophylaxis suggest that the initial antiemetic selection may decrease breakthrough CINV. Here we review optimal CINV prophylactic strategies and introduce unscheduled hydration as a potential important surrogate for breakthrough CINV aligning with cost-effective cancer care.


Asunto(s)
Antineoplásicos/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Fluidoterapia , Náusea/etiología , Náusea/terapia , Vómitos/etiología , Vómitos/terapia , Antieméticos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Toma de Decisiones Clínicas , Ensayos Clínicos Fase III como Asunto , Manejo de la Enfermedad , Humanos , Náusea/prevención & control , Resultado del Tratamiento , Vómitos/prevención & control
14.
J Natl Compr Canc Netw ; 18(6): 676-681, 2020 06.
Artículo en Inglés | MEDLINE | ID: mdl-32502985

RESUMEN

BACKGROUND: Clinician adherence to antiemetic guidelines for preventing chemotherapy-induced nausea and vomiting (CINV) caused by highly emetogenic chemotherapy (HEC) remains poorly characterized. The primary aim of this study was to evaluate individual clinician adherence to HEC antiemetic guidelines. PATIENTS AND METHODS: A retrospective analysis of patients receiving HEC was conducted using the IBM Watson Explorys Electronic Health Record Database (2012-2018). HEC antiemetic guideline adherence was defined as prescription of triple prophylaxis (neurokinin-1 receptor antagonist [NK1 RA], serotonin type-3 receptor antagonist, dexamethasone) at initiation of cisplatin or anthracycline + cyclophosphamide (AC). Clinicians who prescribed ≥5 HEC courses were included and individual guideline adherence was assessed, noting the number of prescribing clinicians with >90% adherence. RESULTS: A total of 217 clinicians were identified who prescribed 2,543 cisplatin and 1,490 AC courses. Patients (N=4,033) were primarily women (63.3%) and chemotherapy-naïve (92%) with a mean age of 58.6 years. Breast (36%) and thoracic (19%) cancers were the most common tumor types. Guideline adherence rates of >90% were achieved by 35% and 58% of clinicians using cisplatin or AC, respectively. Omission of an NK1 RA was the most common practice of nonadherence. Variation in prophylaxis guideline adherence was considerable for cisplatin (mean, 71%; SD, 29%; coefficient of variation [CV], 0.40) and AC (mean, 84%; SD, 26%; CV, 0.31). CONCLUSIONS: Findings showed substantial gaps in clinician adherence to HEC CINV guidelines, including a high variability across clinicians. Clinicians should review their individual clinical practices and ensure adherence to evidence-based CINV guidelines to optimize patient care.


Asunto(s)
Antieméticos/uso terapéutico , Adhesión a Directriz/normas , Náusea/tratamiento farmacológico , Vómitos/tratamiento farmacológico , Antieméticos/farmacología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
15.
JAMA Oncol ; 6(6): 895-899, 2020 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-32379269

RESUMEN

Importance: Nausea and vomiting, unrelated to chemotherapy, can be substantial symptoms in patients with advanced cancer. Objective: To evaluate the utility of olanzapine for treating chronic nausea/vomiting, unrelated to chemotherapy, in patients with advanced cancer. Design, Setting, and Participants: This study is a double-line, placebo-controlled, randomized clinical trial conducted from July 2017 through April 2019, with analysis conducted in 2019. Eligible participants were outpatients with advanced cancer who had persistent nausea/vomiting without having had chemotherapy or radiotherapy in the prior 14 days. Chronic nausea was present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale). Interventions: Patients received olanzapine (5 mg) or a placebo, orally, daily for 7 days. Main Outcomes and Measures: Patient-reported outcomes were used for study end points. Data were collected at baseline and daily for 7 more days. The primary study end point (the change in nausea numeric rating scores from baseline to the last treatment day) and the study hypothesis were both identified prior to data collection. Results: A total of 30 patients (15 per arm) were enrolled; these included 16 women and 14 men who had a mean (range) age of 63 (39-79) years. Baseline median nausea scores, in all patients, were 9 out of 10 (range, 8-10). After 1 day and 1 week, the median nausea scores in the placebo arm were 9 out of 10 (range, 8-10) on both days, compared with the olanzapine arm scores of 2 out of 10 (range, 2-3) after day 1 and 1 out of 10 (range, 0-3) after 1 week. After 1 week of treatment, the reduction in nausea scores in the olanzapine arm was 8 points (95% CI, 7-8) higher than that of the placebo arm. The primary 2-sided end point P value was <.001. Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being. One patient, on the placebo, stopped treatment early owing to lack of perceived benefit. No patients receiving olanzapine reported excess sedation or any other adverse event. Conclusions and Relevance: Olanzapine, at 5 mg/d, appeared to be effective in controlling nausea and emesis and in improving other symptoms and quality-of-life parameters in the study population. Trial Registration: ClinicalTrials.gov Identifier: NCT03137121.


Asunto(s)
Antieméticos/uso terapéutico , Náusea/tratamiento farmacológico , Olanzapina/uso terapéutico , Vómitos/tratamiento farmacológico , Adulto , Anciano , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Neoplasias/tratamiento farmacológico , Proyectos Piloto , Vómitos/inducido químicamente
16.
Curr Treat Options Oncol ; 21(2): 14, 2020 02 05.
Artículo en Inglés | MEDLINE | ID: mdl-32025954

RESUMEN

OPINION STATEMENT: Nausea and vomiting is a common clinical issue in the advanced cancer patient. The etiology may be related to treatment (chemotherapy, radiation, surgery) or non-treatment clinical issues related to the advanced cancer. A very detailed initial assessment of nausea/vomiting is indicated including frequency, duration, intensity, associated activities, and the presence of anorexia or cachexia and is necessary in order to determine a specific etiology which may allow a potentially specific successful intervention. Various international antiemetic guidelines have been developed for the successful prevention of chemotherapy- and radiotherapy-induced nausea and emesis but the treatment of post-chemotherapy nausea/vomiting and of radiation-induced nausea/vomiting has been less successful. Chronic nausea/vomiting in the advanced cancer patient unrelated to treatment remains a significant clinical problem with few successful treatments and interventions. NCCN and ASCO palliative care guidelines provide various treatment suggestions but these are based on empiric evidence with very few clinical trials available to provide demonstrated effective treatments. Recent randomized clinical trials have demonstrated that olanzapine may be an effective agent for the prevention and treatment of chemotherapy-induced nausea and emesis as well as treatment of chronic nausea and vomiting unrelated to treatment.


Asunto(s)
Susceptibilidad a Enfermedades , Náusea/etiología , Neoplasias/complicaciones , Vómitos/etiología , Antieméticos/administración & dosificación , Antieméticos/efectos adversos , Antieméticos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Toma de Decisiones Clínicas , Terapias Complementarias/efectos adversos , Terapias Complementarias/métodos , Manejo de la Enfermedad , Humanos , Náusea/diagnóstico , Náusea/terapia , Estadificación de Neoplasias , Neoplasias/patología , Neoplasias/terapia , Radioterapia/efectos adversos , Radioterapia/métodos , Vómitos/diagnóstico , Vómitos/terapia
17.
Sci Rep ; 10(1): 3398, 2020 02 25.
Artículo en Inglés | MEDLINE | ID: mdl-32099001

RESUMEN

Lymphatic spread determines treatment decisions in prostate cancer (PCa) patients. 68Ga-PSMA-PET/CT can be performed, although cost remains high and availability is limited. Therefore, computed tomography (CT) continues to be the most used modality for PCa staging. We assessed if convolutional neural networks (CNNs) can be trained to determine 68Ga-PSMA-PET/CT-lymph node status from CT alone. In 549 patients with 68Ga-PSMA PET/CT imaging, 2616 lymph nodes were segmented. Using PET as a reference standard, three CNNs were trained. Training sets balanced for infiltration status, lymph node location and additionally, masked images, were used for training. CNNs were evaluated using a separate test set and performance was compared to radiologists' assessments and random forest classifiers. Heatmaps maps were used to identify the performance determining image regions. The CNNs performed with an Area-Under-the-Curve of 0.95 (status balanced) and 0.86 (location balanced, masked), compared to an AUC of 0.81 of experienced radiologists. Interestingly, CNNs used anatomical surroundings to increase their performance, "learning" the infiltration probabilities of anatomical locations. In conclusion, CNNs have the potential to build a well performing CT-based biomarker for lymph node metastases in PCa, with different types of class balancing strongly affecting CNN performance.


Asunto(s)
Aprendizaje Profundo , Glicoproteínas de Membrana/administración & dosificación , Compuestos Organometálicos/administración & dosificación , Tomografía Computarizada por Tomografía de Emisión de Positrones , Neoplasias de la Próstata/diagnóstico por imagen , Tomografía Computarizada por Rayos X , Anciano , Isótopos de Galio , Radioisótopos de Galio , Humanos , Metástasis Linfática , Masculino , Neoplasias de la Próstata/patología , Estudios Retrospectivos
18.
Expert Opin Drug Saf ; 19(2): 205-210, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-31709853

RESUMEN

Objectives: HTX-019 (Cinvanti®) is a novel injectable emulsion formulation of the neurokinin 1 receptor antagonist (RA) aprepitant, approved (as 30-min infusion and 2-min injection) for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV). This retrospective analysis evaluated the safety of HTX-019 administered by 2-min injection in patients with cancer.Methods: At a single center, HTX-019 was evaluated as a 2-min injection within a guideline-recommended three-drug regimen for CINV prophylaxis in patients receiving highly (HEC) or moderately emetogenic chemotherapy (MEC). Treatment-emergent adverse events (TEAEs) were assessed 0-60 minutes following initiation of HTX-019 administration, focusing on infusion-site adverse events and hypersensitivity reactions.Results: Among 600 patients (78 MEC, 522 HEC), the most common diagnoses were lung (172) and breast (129) cancer. Patients received a 2-min injection of HTX-019, followed by a 5-hydroxytryptamine type 3 RA intravenously (IV) (palonosetron or ondansetron), dexamethasone IV, and chemotherapy regimen (most common was cisplatin-containing) via a central (76%) and peripheral line (24%). No TEAEs occurred within 60 min after start of HTX-019 administration.Conclusion: HTX-019 administered by 2-min injection has a tolerable safety profile in patients with cancer, representing a viable method of HTX-019 administration for CINV prevention.


Asunto(s)
Antieméticos/administración & dosificación , Aprepitant/administración & dosificación , Antagonistas del Receptor de Neuroquinina-1/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Antieméticos/efectos adversos , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Aprepitant/efectos adversos , Dexametasona/administración & dosificación , Quimioterapia Combinada , Femenino , Humanos , Infusiones Intravenosas , Inyecciones Intravenosas , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Náusea/prevención & control , Neoplasias/tratamiento farmacológico , Antagonistas del Receptor de Neuroquinina-1/efectos adversos , Ondansetrón/administración & dosificación , Palonosetrón/administración & dosificación , Estudios Retrospectivos , Vómitos/inducido químicamente , Vómitos/prevención & control
19.
JCO Oncol Pract ; 16(2): e132-e138, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31800352

RESUMEN

PURPOSE: After ASCO and National Comprehensive Cancer Network guideline recommendations for triple antiemetic prophylaxis for carboplatin area under the curve (AUC) ≥ 4, and the publication of studies documenting avoidable acute care after chemotherapy involving nausea and vomiting (NV) and other toxicities, we studied clinician adherence to the guideline change and assessed avoidable acute-care use. METHODS: Using a large electronic health record database, we evaluated antiemetic prophylaxis as recommended in the guidelines and post-chemotherapy avoidable acute-care use (defined as involving any of NV or 8 other toxicities) for patients initiating carboplatin or other chemotherapy from October 2012 to August 2018. RESULTS: We identified 11,554 carboplatin courses. After the guideline change adding neurokinin-1 receptor antagonists (RAs) for carboplatin AUC ≥ 4, its use rose to 20% of courses from the prior average of 16%; virtually all courses also included a 5-HT3 RA plus dexamethasone. We found avoidable acute care in 23% of courses; one quarter of these events were associated with NV. Acute care rates after carboplatin mirrored those after other highly emetogenic chemotherapy or oxaliplatin and exceeded those after other chemotherapy regimens. The > 80% shortfall in adherence may have been caused by low awareness or acceptance of the guideline change and/or by poor awareness of avoidable acute-care use after carboplatin. CONCLUSION: Neurokinin-1 RA prophylaxis for carboplatin AUC ≥ 4 remains low and largely unchanged despite National Comprehensive Cancer Network and ASCO 2017 recommendations for inclusion. NV and avoidable acute care involving NV seen after carboplatin were consistent with other highly emetogenic chemotherapy. Clinician action is required to remediate incomplete prophylaxis and to no longer place patient outcomes, resources for cancer treatment, and clinician reimbursement at risk.


Asunto(s)
Antieméticos , Área Bajo la Curva , Carboplatino/efectos adversos , Humanos , Náusea/inducido químicamente , Náusea/tratamiento farmacológico , Náusea/prevención & control , Calidad de la Atención de Salud , Vómitos/inducido químicamente , Vómitos/tratamiento farmacológico , Vómitos/prevención & control
20.
J Geriatr Oncol ; 11(2): 270-273, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-31005648

RESUMEN

BACKGROUND: Integrating Geriatric Assessment (GA) in the management of older adults with cancer is recommended, yet rarely practiced in routine oncologic care. Our objective was to assess the feasibility of integrating routine GA in the management of older adults with gastrointestinal (GI) malignancies and characterize impairments in this population. METHODS: Patients ≥60yo referred for consultation to the GI Oncology clinic were asked to complete the Cancer and Aging Resilience Evaluation (CARE) on their first visit. CARE was adapted from the Cancer and Aging Research Group GA with modifications to create a completely patient-reported version of the GA. Feasibility was defined as completion of CARE by ≥80% of eligible patients during the initial consultation. RESULTS: Of the eligible 354 new patients seen in the GI Oncology Clinic, 323 (91.2%) completed the CARE survey. Most patients (83.1%) felt the length of time to complete was appropriate (median time of 10 min [IQR 10-15.7 min]). GA impairments were prevalent: 54.7% reported dependence in Instrumental Activities of Daily Living, 15.5% reported dependence in Activities of Daily Living, 20.9% reported ≥1 fall, 35.9% reported a performance status ≥2, 55.7% were limited in walking one block, 74.0% reported polypharmacy (≥4 medications), and 36.4% had ≥3 comorbidities. CONCLUSIONS: Performing a GA in the routine care of older adults with GI malignancies is feasible, and GA impairments are common among this population. A fully patient-reported GA such as the CARE may facilitate broader incorporation of GA in the routine clinic work flow.


Asunto(s)
Neoplasias Gastrointestinales , Neoplasias , Actividades Cotidianas , Anciano , Envejecimiento , Neoplasias Gastrointestinales/terapia , Evaluación Geriátrica , Humanos , Neoplasias/terapia , Derivación y Consulta
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