scholarly journals LBA63 Placebo-controlled, double-blinded phase Ⅲ study comparing dexamethasone on day 1 with dexamethasone on days 1 to 4, with combined neurokinin-1 receptor antagonist, palonosetron, and olanzapine in patients receiving cisplatin-containing highly emetogenic chemotherapy: SPARED trial

2021 ◽  
Vol 32 ◽  
pp. S1339-S1340
Author(s):  
K. Shimomura ◽  
H. Minatogawa ◽  
T. Mashiko ◽  
H. Arioka ◽  
H. Iihara ◽  
...  
Keyword(s):  
Receptor Antagonist ◽  
Emetogenic Chemotherapy ◽  
Highly Emetogenic Chemotherapy ◽  
Neurokinin 1 Receptor ◽  
Neurokinin 1 ◽  
Double Blinded

Placebo-Controlled, Double-Blinded Phase III Study Comparing Dexamethasone on Day 1 With Dexamethasone on Days 1 to 3 With Combined Neurokinin-1 Receptor Antagonist and Palonosetron in High-Emetogenic Chemotherapy

2018 ◽  
Vol 36 (10) ◽  
pp. 1000-1006 ◽  
Author(s):  
Yuka Ito ◽  
Takashi Tsuda ◽  
Hiroko Minatogawa ◽  
Sayaka Kano ◽  
Kentaro Sakamaki ◽  
...  
Keyword(s):  
Receptor Antagonist ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Phase Iii ◽  
Neurokinin 1 Receptor ◽  
Phase Iii Study ◽  
Neurokinin 1 ◽  
Double Blinded ◽  
To Receive

Purpose We evaluated the noninferiority of dexamethasone (DEX) on day 1, with sparing on days 2 and 3, combined with neurokinin-1 receptor antagonist (NK1-RA) and palonosetron (Palo) compared with the 3-day use of DEX in highly-emetogenic chemotherapy (HEC). Patients and Methods Patients who were scheduled to receive HEC (cisplatin ≥ 50 mg/m2 or anthracycline plus cyclophosphamide) were randomly assigned to receive either DEX on days 1 to 3 (Arm D3) or DEX on day 1 and placebo on days 2 and 3 (Arm D1) combined with NK1-RA and Palo. The primary end point was complete response (CR), defined as no emesis and no rescue medications during the overall (0 to 120 h) phase. The noninferiority margin was set at −15.0% (Arm D1 − Arm D3). Results A total of 396 patients—196 and 200 patients in Arms D3 and D1, respectively—were evaluated. CR rates during the overall period were 46.9% for Arm D3 and 44.0% for Arm D1 (95% CI, −12.6% to 6.8%; P = .007). CR rates during the acute (0 to 24 h) phase were 63.3% and 64.5% for Arms D3 and D1, respectively (95% CI, −8.1% to 10.6%; P < .001), and they were 56.6% and 51.5%, respectively, during the delayed (24 to 120 h) phase (95% CI, −14.8% to 4.6%; P = .023). Hot flushes and tremors were observed more frequently as DEX-related adverse events on days 4 and 5 in Arm D3, whereas anorexia, depression, and fatigue were observed more frequently on days 2 and 3 in Arm D1. As an indication of quality of life, global health status was similar in both arms. Conclusion Antiemetic DEX administration on days 2 and 3 can be spared when combined with NK1-RA and Palo in HEC.

scholarly journals What the HEC? Clinician Adherence to Evidence-Based Antiemetic Prophylaxis for Highly Emetogenic Chemotherapy

2020 ◽  
Vol 18 (6) ◽  
pp. 676-681
Author(s):  
Eric J. Roeland ◽  
Kathryn J. Ruddy ◽  
Thomas W. LeBlanc ◽  
Ryan D. Nipp ◽  
Gary Binder ◽  
...  
Keyword(s):  
Receptor Antagonist ◽  
Guideline Adherence ◽  
Emetogenic Chemotherapy ◽  
Evidence Based ◽  
Clinical Practices ◽  
Highly Emetogenic Chemotherapy ◽  
Antiemetic Prophylaxis ◽  
Antiemetic Guidelines ◽  
Ibm Watson ◽  
Neurokinin 1

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.

Factors associated with neurokinin-1 receptor antagonist use among commercially insured cancer patients receiving highly emetogenic chemotherapy.

2017 ◽  
Vol 35 (5_suppl) ◽  
pp. 24-24
Author(s):  
Maika Onishi ◽  
Sowmya Vasan ◽  
Melissa Kate Accordino ◽  
Grace Hillyer ◽  
Alfred I. Neugut ◽  
...  
Keyword(s):  
Retrospective Cohort ◽  
Insurance Coverage ◽  
Emetogenic Chemotherapy ◽  
Highly Emetogenic Chemotherapy ◽  
Neurokinin 1 Receptor ◽  
Factors Associated ◽  
Preferred Provider Organizations ◽  
Comprehensive Benefit ◽  
Male Patients ◽  
Neurokinin 1

24 Background: Neurokinin-1 receptor antagonists (NK1RA) reduce chemotherapy-induced nausea/vomiting (CINV) among patients undergoing highly emetogenic chemotherapy (HEC). We evaluated factors associated with the use of NK1RA in patients treated with HEC. Methods: We performed a retrospective cohort study using Truven Health Marketscan to identify subjects who initiated HEC (doxorubicin or cisplatin) between 2009 and 2013, and concurrently received a NK1RA. Multivariable logistic regression was used, to determine the association of clinical and demographic factors and NK1RA use. Results: Of 32,004 subjects with cancer who were treated with either doxorubicin or cisplatin-containing regimens, 11,325 (33.3%) did not receive an NK1RA. From 2009 to 2013, NK1RA use increased from 53.2% to 73.5% (p < 0.0001). Compared to non-users, NK1RA users were more frequently treated with cisplatin-based regimens (67.9% vs. 32.1%, p < 0.0001), had in-network claims (66.7% vs. 33.3%, p < 0.0001), were younger, and without other comorbidities. Multivariate analysis demonstrated that NK1RA use was more likely with cisplatin compared to doxorubicin (OR = 1.71, 95% CI 1.62-1.81) and with female compared to male patients (OR = 1.75, 95% CI 1.65-1.84). In-network claims (OR 1.26, 95% CI 1.16-1.36) and comprehensive benefit plans (OR = 1.14, 95% CI 1.04-1.25) were associated with increased NK1RA use, compared to out-of network claims and preferred provider organizations (PPO), respectively. Age ≥ 65 years (OR = 0.64, 95% CI 0.5-0.69) and increased comorbidities (comorbidity score of 1: OR 0.88, 95% CI 0.83-0.94; score of 2- OR 0.61, 95% CI 0.56-0.67) versus a score of 0 were associated with decreased NK1RA use. Conclusions: A substantial proportion of patients receiving HEC do not receive NK1RA, and type of insurance coverage was associated with receipt.

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