FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2983415531> ?p ?o ?g. }

• W2983415531 endingPage "1974" @default.
• W2983415531 startingPage "1974" @default.
• W2983415531 abstract "Cancer chemotherapy may be associated with a high incidence of nausea and vomiting (CINV), which may occur acutely within 24 hours after the start of chemotherapy (acute phase) or in the following days (delayed phase). Despite the availability of several antiemetics, clinical findings show that control of nausea and vomiting continue to be a serious concern for hematological patients, mainly for those receiving multiple-day (MD) and high-dose (HD) chemotherapy (CT), for which no specific international recommendations have been formulated, due to the lack of a unanimous consensus between the main international guidelines. NEPA is the first antiemetic developed as an oral fixed dose combination of two drugs that are antagonists of two receptors involved in the control of nausea and vomiting: a new highly selective NK1-RA, netupitant, and a second generation 5HT3-RA, palonosetron, that simplify the antiemetic regimen allowing for a lower number of capsules and days of treatment. In clinical practice, NEPA is administered together with dexamethasone that contributes to CINV prophylaxis by its intrinsic antiemetic properties. However, dexamethasone also exhibits an important immunosuppressive activity, which could lead to several adverse events, such as increasing the risk of serious infections, especially in patients undergoing myeloablative treatment. The rational of this study was to explore the efficacy of multiple doses of NEPA given with an every-other-day regimen without dexamethasone in preventing CINV in patients with non-Hodgkin's lymphoma (NHL) eligible for autologous stem cell transplantation (ASCT) and treated with MD-HD-CT. The chemotherapy regimen (BEAM/FEAM) was administered for 6 days, NEPA was taken on day 1, 3 and 5, and nausea and vomiting were monitored up to day 15. No dexamethasone was given for antiemetic prophylaxis. The primary endpoint was the percentage of patients achieving a Complete Response (CR; no vomiting and no use of rescue medication) during the overall phase, defined as the period from day 1 (first day of chemotherapy) until 2 days after the last dose of chemotherapy. Seventy patients participated to the study. According to the adopted Fleming one-stage design, the primary endpoint of this study was achieved. Indeed, the number of complete responders for the overall phase was 60, which is greater than the predetermined cut-off of 42, representing the minimum frequency of responders for which the treatment is considered effective. In addition to the primary efficacy result, several additional endpoints were evaluated for the study period (Figure 1). The CR values were 87.1% (primary endpoint, overall phase: days 1-8), 88.6% (acute phase: days 1-6) and 98.6% (delayed phase: days 7-8), while the complete control (CR with no more than mild nausea) was 85.7% (overall phase), 88.6% (acute phase) and 95.7% (delayed phase) (Figure 1A). Moreover, the percentages of patients that did not have any emetic episodes were 88.6% (overall phase), 90% (acute phase) and 98.6% (delayed phase) and patients that did not require a rescue therapy for controlling CINV were 94.3% (overall phase), 94.3% (acute phase) and 100% (delayed phase). Daily records taken from day 1 to day 15 showed that values for all these categories were above 85% for all the days of observation (Figure 1B). Patients also documented the grade of their nausea according to the Likert scale. Moderate and severe episodes of nausea were reported by less than 10% for the overall phase and less than 5% in both acute and delayed phase and the daily values of no nausea were above 65% for each day of the treatment (Figure 1C and 1D). Indeed, the mean patient global satisfaction for the antiemetic prophylaxis for the study period was 9.13 ± 1.59 out of 10. Regarding safety, a total of 12 Treatment-Emergent Adverse Events (TEAEs) occurred in 6 (8.6%) subjects enrolled in the study. Among these, only 1 (8.3%, constipation) was evaluated as possibly related to NEPA administration. Moreover, the only two TEAEs classified as SAE (Serious Adverse Event) were two episodes of fever that have been evaluated as not-related to NEPA. Therefore, the safety profile of NEPA was confirmed also in this setting. In conclusion, our study demonstrated that multiple alternate dosing of NEPA without the addition of dexamethasone can effectively prevent nausea and vomiting in a difficult setting, such as MD/HD-CT with a good tolerability profile. Disclosures No relevant conflicts of interest to declare." @default.
• W2983415531 created "2019-11-22" @default.
• W2983415531 creator A5003536375 @default.
• W2983415531 creator A5006314162 @default.
• W2983415531 creator A5011614506 @default.
• W2983415531 creator A5025988073 @default.
• W2983415531 creator A5029736700 @default.
• W2983415531 creator A5031937532 @default.
• W2983415531 creator A5037076561 @default.
• W2983415531 creator A5042424261 @default.
• W2983415531 creator A5050114663 @default.
• W2983415531 creator A5057593886 @default.
• W2983415531 creator A5057806356 @default.
• W2983415531 creator A5066201036 @default.
• W2983415531 creator A5072927664 @default.
• W2983415531 creator A5078063107 @default.
• W2983415531 creator A5079030265 @default.
• W2983415531 creator A5088135888 @default.
• W2983415531 creator A5089924339 @default.
• W2983415531 creator A5090444895 @default.
• W2983415531 date "2019-11-13" @default.
• W2983415531 modified "2023-10-14" @default.
• W2983415531 title "Phase II Multicenter, Not Comparative, Study of Multiple Doses of NEPA (netupitant + palonosetron) in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in Non-Hodgkin Lymphoma Patients Eligible for Autologous Hematopoietic Stem Cell Transplantation Receiving Multiple Days / High Dose Chemotherapy Regimens" @default.
• W2983415531 doi "https://doi.org/10.1182/blood-2019-125071" @default.
• W2983415531 hasPublicationYear "2019" @default.
• W2983415531 type Work @default.
• W2983415531 sameAs 2983415531 @default.
• W2983415531 citedByCount "0" @default.
• W2983415531 crossrefType "journal-article" @default.
• W2983415531 hasAuthorship W2983415531A5003536375 @default.
• W2983415531 hasAuthorship W2983415531A5006314162 @default.
• W2983415531 hasAuthorship W2983415531A5011614506 @default.
• W2983415531 hasAuthorship W2983415531A5025988073 @default.
• W2983415531 hasAuthorship W2983415531A5029736700 @default.
• W2983415531 hasAuthorship W2983415531A5031937532 @default.
• W2983415531 hasAuthorship W2983415531A5037076561 @default.
• W2983415531 hasAuthorship W2983415531A5042424261 @default.
• W2983415531 hasAuthorship W2983415531A5050114663 @default.
• W2983415531 hasAuthorship W2983415531A5057593886 @default.
• W2983415531 hasAuthorship W2983415531A5057806356 @default.
• W2983415531 hasAuthorship W2983415531A5066201036 @default.
• W2983415531 hasAuthorship W2983415531A5072927664 @default.
• W2983415531 hasAuthorship W2983415531A5078063107 @default.
• W2983415531 hasAuthorship W2983415531A5079030265 @default.
• W2983415531 hasAuthorship W2983415531A5088135888 @default.
• W2983415531 hasAuthorship W2983415531A5089924339 @default.
• W2983415531 hasAuthorship W2983415531A5090444895 @default.
• W2983415531 hasConcept C126322002 @default.
• W2983415531 hasConcept C143998085 @default.
• W2983415531 hasConcept C2776694085 @default.
• W2983415531 hasConcept C2776712918 @default.
• W2983415531 hasConcept C2778336483 @default.
• W2983415531 hasConcept C2779924295 @default.
• W2983415531 hasConcept C2780401358 @default.
• W2983415531 hasConcept C2780580376 @default.
• W2983415531 hasConcept C2780852908 @default.
• W2983415531 hasConcept C2780884295 @default.
• W2983415531 hasConcept C2781413609 @default.
• W2983415531 hasConcept C71924100 @default.
• W2983415531 hasConceptScore W2983415531C126322002 @default.
• W2983415531 hasConceptScore W2983415531C143998085 @default.
• W2983415531 hasConceptScore W2983415531C2776694085 @default.
• W2983415531 hasConceptScore W2983415531C2776712918 @default.
• W2983415531 hasConceptScore W2983415531C2778336483 @default.
• W2983415531 hasConceptScore W2983415531C2779924295 @default.
• W2983415531 hasConceptScore W2983415531C2780401358 @default.
• W2983415531 hasConceptScore W2983415531C2780580376 @default.
• W2983415531 hasConceptScore W2983415531C2780852908 @default.
• W2983415531 hasConceptScore W2983415531C2780884295 @default.
• W2983415531 hasConceptScore W2983415531C2781413609 @default.
• W2983415531 hasConceptScore W2983415531C71924100 @default.
• W2983415531 hasIssue "Supplement_1" @default.
• W2983415531 hasLocation W29834155311 @default.
• W2983415531 hasOpenAccess W2983415531 @default.
• W2983415531 hasPrimaryLocation W29834155311 @default.
• W2983415531 hasRelatedWork W160231609 @default.
• W2983415531 hasRelatedWork W2020302560 @default.
• W2983415531 hasRelatedWork W2032692004 @default.
• W2983415531 hasRelatedWork W2037186270 @default.
• W2983415531 hasRelatedWork W2044881681 @default.
• W2983415531 hasRelatedWork W2764326115 @default.
• W2983415531 hasRelatedWork W2892354693 @default.
• W2983415531 hasRelatedWork W3164313245 @default.
• W2983415531 hasRelatedWork W4234294619 @default.
• W2983415531 hasRelatedWork W81655036 @default.
• W2983415531 hasVolume "134" @default.
• W2983415531 isParatext "false" @default.
• W2983415531 isRetracted "false" @default.
• W2983415531 magId "2983415531" @default.
• W2983415531 workType "article" @default.