A Phase 4 interventional study of NEPA (300mg netupitant/0.5mg palonosetron) and Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV) in Chemotherapy-induced Nausea and Vomiting, sponsored by Helsinn Healthcare SA. Completed at 19 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Helsinn Healthcare SA · Phase 4, Interventional, and Supportive care
MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high risk of developing CINV based on a prediction tool. A multinational and multicenter study.
Antiemetic guidelines recommendations are based on the emetogenic potential of the chemotherapy. Chemotherapy (CT) agents are divided in Highly, Moderately, Low and Minimally Emetogenic potential.
In addition to type of chemotherapy, several patient-related risk factors can increase the risk of CINV (chemotherapy-induced nausea and vomiting). Currently, there is limited consensus surrounding the most relevant patient risk factors that may predict the risk of CINV. Based on a recent study by Dranitsaris et al. (Dranitsaris et al. Ann Oncol. 2017 Jun 1; 28(6):1260-1267.), eight (8) predictive factors have been identified and an algorithm has been developed to incorporate these factors into the optimal selection of prophylactic antiemetics:
The clinical application of this prediction tool has the potential to be an important resource for clinicians and may help to enhance patient care by optimizing the use of the antiemetics in a proactive manner.
Antiemetic guideline recommendations are based on the emetogenic potential of chemotherapy and involve 4 levels of classification of intravenous chemotherapy agents, i.e., high, moderate, low and minimal; these have been accepted by major organisations. Moderate emetogenic chemotherapy (MEC) results in acute vomiting in 30% to 90% of cancer patients in the absence of antiemetic therapy. In addition to the chemotherapy type, several patient-related risk factors and clinical characteristics can increase CINV risk. These can include use of antiemetics inconsistent with international guidelines, younger age, prechemotherapy nausea, no complete CINV response in an earlier cycle, history of nausea/vomiting, (trait) anxiety, fatigue experience, and expectations of nausea/vomiting. Other studies have largely confirmed some of the key risk factors for CINV (history of vomiting during pregnancy, history of motion sickness, age, gender) and added other factors such as (chronic) alcohol consumption, body surface area, fewer hours slept the night prior to infusion, or advanced stage cancer. Currently, there is a limited consensus surrounding the most relevant patient risk factors that may predict CINV risk. Based on a recent study by Dranitsaris et al. eight predictive factors have been identified, and an algorithm has been developed to combine these patient-related risk factors into the optimal treatment of prophylactic antiemetics. These include:
Akynzeo®, an oral combination of the neurokinin 1 receptor antagonists (NK1 RA), netupitant and the 5-hydroxytryptamine (HT3) receptor antagonists (5-HT3 RA), palonosetron, is recommended by guidelines for the prevention of CINV. Akynzeo® has been evaluated in a multicentre, randomised, double-blind, double-dummy phase II clinical trial at various dose ranges among 694 cisplatin-treated cancer patients from 44 sites (two countries); each NEPA (netupitant-palonosetron) dose significantly improves CINV prevention in cancer patients. Similar results were obtained in another international, randomised, double-blind and parallel group phase III clinical trial; NEPA prevented CINV in patients receiving MEC.
The current study primarily aimed to evaluate whether Akynzeo® leads to a higher response rate compared with standard care in MEC regimen-treated patients who are identified to be at high risk based on the algorithm.
Exclusion Criteria:
Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle. Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
Drug: NEPA (300mg netupitant/0.5mg palonosetron) · Drug: Dexamethasone, 8 mg (oral) or equivalent IV dose
Dexamethasone (or equivalent corticosteroids) 8 mg administered by the oral route (or equivalent IV dose) on Day 1, approximately 1 hour before chemotherapy and one of the 5-HT3-RAs recommended by European Society for Medical Oncology (ESMO) and Multinational Association of Supportive Care in Cancer (MASCC) guidelines (standard of care), i.e. either: Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV)
Drug: Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV) · Drug: Dexamethasone, 8 mg (oral) or equivalent IV dose
Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Also known as: Akynzeo® capsules
Standard of care will be administered on Day 1 of each cycle.
Also known as: 5-HT3 RA
Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
Also known as: corticosteroid
The Probability of Complete Responses Over Three Cycles of Chemotherapy After the Start of the MEC Administration
To evaluate if the use of NEPA (netupitant and palonosetron) in patients treated with IV moderately emetogenic chemotherapy and at high risk of CINV is more effective in preventing CINV than a standard of care antiemetics over three cycles of chemotherapy. The primary endpoint is the probability of complete responses (no emetic episode and no rescue medication), during the overall phase (0-120h), after the start of the MEC administration over three cycles of chemotherapy. This endpoint is evaluated in patients with at least one reported cycle assessment. The model-based statistics of generalized linear model were used to calculate the difference in the probability to experience a "per cycle" CINV Indicators between the treatment arms.
Time frame: At the end of all three chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy
Probability of: * No emetic episode during the acute, delayed, and overall phase and daily in each cycle * No rescue medication during the acute, delayed, and overall phase and daily in each cycle * No significant nausea (maximum MAT scale = 2) during the acute, delayed, and overall phase and daily in each cycle; * No nausea (MAT scale = 0) during the acute, delayed, and overall phase and daily in each cycle; * Complete protection (no emetic episode, no rescue medication, and no significant nausea) during the acute, delayed, and overall phase and daily in each cycle Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles. The model-based statistics of generalized linear model were used to calculate the difference in the probability to experience a "per cycle" CINV Indicators between the treatment arms.
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of the Predictive Role of Potential Risk Factors in the Development of CINV Over Three Cycles of Chemotherapy
Analysis of the development of CINV as a dependent variable will be performed to identify additional potential risk factors of CINV thought to be increasing the risk of CINV in patients receiving MEC. The outcome measure is the development of CINV, defined as any occurrence of nausea or a vomiting episode. The data on the development of CINV will be taken from data collection tools, patients' diaries and MASCC Antiemesis Tool (MAT).
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE)
An overall summary of adverse events (AE) will be presented, including the frequency of patients with: * Any treatment-emergent adverse event * Any treatment-emergent adverse event related to a study drug * Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions * Any treatment-emergent serious adverse event All AEs will be summarized by their: * Severity * Seriousness * Relationship to a drug
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events
An overall summary of adverse events (AE) will be presented, including the percentage of patients with: * Any treatment-emergent adverse event * Any treatment-emergent adverse event related to a study drug * Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions * Any treatment-emergent serious adverse event All AEs will be summarized by their: * Severity * Seriousness * Relationship to a drug
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Number of Participants With Discontinuations Due to Adverse Events
The frequency of discontinuations due to adverse events (AE) will be presented.
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Percentage of Participants With Discontinuations Due to Adverse Events
The percentage of patients with discontinuations due to adverse events (AE) will be presented.
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Number of Participants With Death Due to Adverse Events
The frequency of on treatment deaths due to adverse events (AE) will be presented.
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Percentage of Participants With Death Due to Adverse Events
The percentage of patients with on treatment death due to adverse events (AE) will be presented. All AEs leading to on treatment death will be summarized by their: * Severity * Seriousness * Relationship to a drug
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Exploration of the Effect of CINV on Daily Activities and Quality of Life in Patients Receiving Moderately-emetogenic Chemotherapy Over Three Cycles of Chemotherapy
Evaluation of the effect of CINV on daily activities and quality of life that will be measured by using the Functional Living Index-Emesis (FLIE) questionnaire, a validated, nausea and vomiting specific, patient-reported outcome instrument. The Functional Living Index-Emesis (FLIE) has 18 questions. These questions are divided into two domains: Nausea (questions 1-9) and Vomiting (questions 10-18). The minimum score for any question is 0 and the maximum score is 100. Higher scores indicate less impairment on daily life as a result of nausea or vomiting. The model-based statistics of generalized linear model were used to calculate the difference in the score "per cycle" between the treatment arms.
Time frame: At the end of chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of Resource Utilization and Health Economic Outcome - Number of Days With Rescue Medication Administered for the Treatment of CINV
Health economic endpoint, the number of days with rescue medication administered for the treatment of CINV, will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of Resource Utilization and Health Economic Outcome - Daily Doses of Rescue Medication Administered for the Treatment of CINV
Health economic endpoint, the daily doses of rescue medication administered for the treatment of CINV, will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags
Health economic endpoint, the number of re-hydration bags given for at least grade 2 vomiting (more details below), will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations
Health economic endpoint, the number of days of unplanned hospitalizations related to CINV, will be evaluated during the study cycles All hospitalizations will be summarized according to the department of hospitalization (type of ward)
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Outpatient Physician Visits
Health economic endpoint, the number of outpatient physician visits and health care consultations due to CINV (e.g., general practitioner), will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Unplanned Laboratory Test
Health economic endpoint, the number of unplanned laboratory test including those at unplanned hospitalizations due to CINV, will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV
Health economic endpoint, the number of discontinuations of chemotherapy treatment due to CINV, will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Delays of Chemotherapy Administration Due to CINV
Health economic endpoint, the number of delays of chemotherapy administration due to CINV, will be evaluated during the study cycles. Delays will be observed after the first administration of Cycle 1 for Cycles 2 and 3.
Time frame: At the start of cycles 2 and 3. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of Resource Utilization and Health Economic Outcome - the Average Length of Delay of Chemotherapy Administration Due to CINV
Health economic endpoint, the average length of delay (in days) of chemotherapy administration due to CINV, will be evaluated during the study cycles. Delays will be observed after the first administration of Cycle 1 for Cycles 2 and 3.
Time frame: At the start of Cycles 2 and 3. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work
Health economic endpoint, the number of days of absence from work, will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy
Number of vomiting episodes during the acute, delayed, and overall phase in each cycle Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles. The model-based statistics of generalized linear model were used to calculate the difference in the number of vomiting episodes "per cycle" between the treatment arms.
Time frame: At the end of chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
The Full Analysis Set (FAS) consists of 401 (NEPA: 196, SoC: 205) randomised patients to whom study drug was dispensed. It was the primary basis for the analyses of efficacy.
| Milestone | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Started | 206 | 208 |
| Full analysis set (fas) population | 196 | 205 |
| Completed | 154 | 163 |
| Not completed | 52 | 45 |
To evaluate if the use of NEPA (netupitant and palonosetron) in patients treated with IV moderately emetogenic chemotherapy and at high risk of CINV is more effective in preventing CINV than a standard of care antiemetics over three cycles of chemotherapy. The primary endpoint is the probability of complete responses (no emetic episode and no rescue medication), during the overall phase (0-120h), after the start of the MEC administration over three cycles of chemotherapy. This endpoint is evaluated in patients with at least one reported cycle assessment. The model-based statistics of generalized linear model were used to calculate the difference in the probability to experience a "per cycle" CINV Indicators between the treatment arms.
| Probability of complete response | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| The Probability of Complete Responses Over Three Cycles of Chemotherapy After the Start of the MEC Administration | 0.810 | 0.718 |
Probability of: * No emetic episode during the acute, delayed, and overall phase and daily in each cycle * No rescue medication during the acute, delayed, and overall phase and daily in each cycle * No significant nausea (maximum MAT scale = 2) during the acute, delayed, and overall phase and daily in each cycle; * No nausea (MAT scale = 0) during the acute, delayed, and overall phase and daily in each cycle; * Complete protection (no emetic episode, no rescue medication, and no significant nausea) during the acute, delayed, and overall phase and daily in each cycle Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles. The model-based statistics of generalized linear model were used to calculate the difference in the probability to experience a "per cycle" CINV Indicators between the treatment arms.
| Probability | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| No emetic episode - acute phase | 0.983 | 0.951 |
| No emetic episode - delayed phase | 0.966 | 0.881 |
| No emetic - Day 2 | 0.981 | 0.938 |
| No emetic - Day 3 | 0.968 | 0.927 |
| No emetic - Day 4 | 0.977 | 0.938 |
| No emetic - Day 5 | 0.981 | 0.963 |
| No emetic - overall phase | 0.954 | 0.867 |
| No rescue medication - acute phase | 0.896 | 0.897 |
| No rescue medication - delayed phase | 0.848 | 0.785 |
| No rescue medication - Day 2 | 0.893 | 0.880 |
| No rescue medication - Day 3 | 0.905 | 0.872 |
| No rescue medication - Day 4 | 0.905 | 0.877 |
| No rescue medication - Day 5 | 0.910 | 0.915 |
| No rescue medication - overall phase | 0.824 | 0.765 |
| No significant nausea - acute phase | 0.868 | 0.856 |
| No significant nausea - delayed phase | 0.815 | 0.755 |
| No significant nausea - Day 2 | 0.872 | 0.817 |
| No significant nausea - Day 3 | 0.848 | 0.790 |
| No significant nausea - Day 4 | 0.847 | 0.803 |
| No significant nausea - Day 5 | 0.865 | 0.832 |
| No significant nausea - overall phase | 0.775 | 0.727 |
| No nausea - acute phase | 0.777 | 0.744 |
| No nausea - delayed phase | 0.677 | 0.576 |
| No nausea - Day 2 | 0.779 | 0.682 |
| No nausea - Day 3 | 0.749 | 0.655 |
| No nausea - Day 4 | 0.746 | 0.652 |
| No nausea - Day 5 | 0.797 | 0.703 |
| No nausea - overall phase | 0.637 | 0.549 |
| Complete protection - acute phase | 0.832 | 0.798 |
| Complete protection - delayed phase | 0.755 | 0.653 |
| Complete protection - Day 2 | 0.822 | 0.765 |
| Complete protection - Day 3 | 0.816 | 0.740 |
| Complete protection - Day 4 | 0.821 | 0.762 |
| Complete protection - Day 5 | 0.834 | 0.802 |
| Complete protection - overall phase | 0.718 | 0.624 |
Analysis of the development of CINV as a dependent variable will be performed to identify additional potential risk factors of CINV thought to be increasing the risk of CINV in patients receiving MEC. The outcome measure is the development of CINV, defined as any occurrence of nausea or a vomiting episode. The data on the development of CINV will be taken from data collection tools, patients' diaries and MASCC Antiemesis Tool (MAT).
| Participants | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Cycle 1 - Any occurrence of nausea or a vomiting episode | 77 | 97 |
| Cycle 2 - Any occurrence of nausea or a vomiting episode | 71 | 90 |
| Cycle 3 - Any occurrence of nausea or a vomiting episode | 65 | 86 |
An overall summary of adverse events (AE) will be presented, including the frequency of patients with: * Any treatment-emergent adverse event * Any treatment-emergent adverse event related to a study drug * Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions * Any treatment-emergent serious adverse event All AEs will be summarized by their: * Severity * Seriousness * Relationship to a drug
| Participants | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Patients with any TEAE | 150 | 150 |
| Patients with any TEAE related to a study drug | 37 | 38 |
| Patients with any TEAE leading to chemotherapy dose reductions | 6 | 11 |
| Patients with any TEAE leading to treatment discontinuation | 5 | 7 |
| Patients with any serious TEAE | 22 | 23 |
| Patients with any severe TEAE | 26 | 32 |
| Patients with on treatment death due to TEAE | 2 | 2 |
An overall summary of adverse events (AE) will be presented, including the percentage of patients with: * Any treatment-emergent adverse event * Any treatment-emergent adverse event related to a study drug * Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions * Any treatment-emergent serious adverse event All AEs will be summarized by their: * Severity * Seriousness * Relationship to a drug
| percentage of patients | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Patients with any TEAE | 76.5 | 73.2 |
| Patients with any TEAE related to a study drug | 18.9 | 18.5 |
| Patients with any TEAE leading to chemotherapy dose reductions | 3.1 | 5.4 |
| Patients with any TEAE leading to treatment discontinuation | 2.6 | 3.4 |
| Patients with any serious TEAE | 11.2 | 11.2 |
| Patients with any severe TEAE | 13.3 | 15.6 |
| Patients with on treatment death due to TEAE | 1.0 | 1.0 |
The frequency of discontinuations due to adverse events (AE) will be presented.
| Participants | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Number of Participants With Discontinuations Due to Adverse Events | 5 | 7 |
The percentage of patients with discontinuations due to adverse events (AE) will be presented.
| percentage of patients | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Percentage of Participants With Discontinuations Due to Adverse Events | 2.6 | 3.4 |
The frequency of on treatment deaths due to adverse events (AE) will be presented.
| Participants | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Number of Participants With Death Due to Adverse Events | 2 | 2 |
The percentage of patients with on treatment death due to adverse events (AE) will be presented. All AEs leading to on treatment death will be summarized by their: * Severity * Seriousness * Relationship to a drug
| percentage of patients | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Percentage of Participants With Death Due to Adverse Events | 1.0 | 1.0 |
Evaluation of the effect of CINV on daily activities and quality of life that will be measured by using the Functional Living Index-Emesis (FLIE) questionnaire, a validated, nausea and vomiting specific, patient-reported outcome instrument. The Functional Living Index-Emesis (FLIE) has 18 questions. These questions are divided into two domains: Nausea (questions 1-9) and Vomiting (questions 10-18). The minimum score for any question is 0 and the maximum score is 100. Higher scores indicate less impairment on daily life as a result of nausea or vomiting. The model-based statistics of generalized linear model were used to calculate the difference in the score "per cycle" between the treatment arms.
| FLIE score | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| After cycle 1 - FLIE score | 115.14 ± 17.152 | 111.10 ± 21.134 |
| After cycle 2 - FLIE score | 115.78 ± 18.022 | 112.10 ± 19.919 |
| After cycle 3 - FLIE score | 114.74 ± 19.356 | 111.24 ± 21.772 |
Health economic endpoint, the number of days with rescue medication administered for the treatment of CINV, will be evaluated during the study cycles
| Number of days | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| cycle 1 | 0.5 ± 1.20 | 0.5 ± 1.13 |
| Cycle 2 | 0.4 ± 1.20 | 0.6 ± 1.26 |
| Cycle 3 | 0.5 ± 1.28 | 0.5 ± 1.22 |
Health economic endpoint, the daily doses of rescue medication administered for the treatment of CINV, will be evaluated during the study cycles
| Doses of medication per cycle | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Cycle 1 | 16.3 ± 68.53 | 46.3 ± 343.13 |
| Cycle 2 | 13.7 ± 57.0 | 19.9 ± 70.87 |
| Cycle 3 | 24.7 ± 99.48 | 17.5 ± 74.24 |
Health economic endpoint, the number of re-hydration bags given for at least grade 2 vomiting (more details below), will be evaluated during the study cycles
| Number of bags | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Cycle 1 | 0 ± 0.00 | 0 ± 0.20 |
| Cycle 2 | 0 ± 0.00 | 0 ± 0.15 |
| Cycle 3 | 0 ± 0.00 | 0 ± 0.00 |
Health economic endpoint, the number of days of unplanned hospitalizations related to CINV, will be evaluated during the study cycles All hospitalizations will be summarized according to the department of hospitalization (type of ward)
| days of hospitalization | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Cycle 1 | 0 ± 0.07 | 0.1 ± 0.75 |
| Cycle 2 | 0 ± 0.23 | 0 ± 0.30 |
| Cycle 3 | 0 ± 0.00 | 0 ± 0.38 |
Health economic endpoint, the number of outpatient physician visits and health care consultations due to CINV (e.g., general practitioner), will be evaluated during the study cycles
| Number of outpatient visits | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Cycle 1 | 0 ± 0.07 | 0 ± 0.16 |
| Cycle 2 | 0 ± 0.08 | 0 ± 0.15 |
| Cycle 3 | 0 ± 0.00 | 0 ± 0.00 |
Health economic endpoint, the number of unplanned laboratory test including those at unplanned hospitalizations due to CINV, will be evaluated during the study cycles
| Number of unplanned tests | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Cycle 1 | 0 ± 0.07 | 0.1 ± 0.46 |
| Cycle 2 | 0 ± 0.15 | 0 ± 0.16 |
| Cycle 3 | 0 ± 0.00 | 0 ± 0.23 |
Health economic endpoint, the number of discontinuations of chemotherapy treatment due to CINV, will be evaluated during the study cycles
| Participants | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Cycle 1 | 1 | 0 |
| Cycle 2 | 1 | 1 |
| Cycle 3 | 0 | 0 |
Health economic endpoint, the number of delays of chemotherapy administration due to CINV, will be evaluated during the study cycles. Delays will be observed after the first administration of Cycle 1 for Cycles 2 and 3.
| Participants | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Cycle 2 | 0 | 2 |
| Cycle 3 | 0 | 3 |
Health economic endpoint, the average length of delay (in days) of chemotherapy administration due to CINV, will be evaluated during the study cycles. Delays will be observed after the first administration of Cycle 1 for Cycles 2 and 3.
| Days | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Cycle 2 | 0 ± 0 | 7 ± 0.00 |
| Cycle 3 | 0 ± 0 | 7.7 ± 1.15 |
Health economic endpoint, the number of days of absence from work, will be evaluated during the study cycles
| Days | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Cycle 1 | 3 ± 3.08 | 5.7 ± 4.16 |
| Cycle 2 | 1 ± 0.00 | 4.3 ± 3.59 |
| Cycle 3 | 2.4 ± 1.34 | 7.0 ± 2.83 |
Number of vomiting episodes during the acute, delayed, and overall phase in each cycle Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles. The model-based statistics of generalized linear model were used to calculate the difference in the number of vomiting episodes "per cycle" between the treatment arms.
| Number of vomiting episodes | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| Cycle 1 acute phase - Number of vomiting episodes | 0.04 ± 0.300 | 0.09 ± 0.494 |
| Cycle 2 acute phase - Number of vomiting episodes | 0.04 ± 0.316 | 0.10 ± 0.508 |
| Cycle 3 acute phase - Number of vomiting episodes | 0.05 ± 0.422 | 0.11 ± 0.601 |
| Cycle 1 delayed phase - Number of vomiting episodes | 0.08 ± 0.425 | 0.46 ± 1.579 |
| Cycle 2 delayed phase - Number of vomiting episodes | 0.06 ± 0.440 | 0.35 ± 1.424 |
| Cycle 3 delayed phase - Number of vomiting episodes | 0.10 ± 0.701 | 0.36 ± 1.507 |
| Cycle 1 day 2 - Number of vomiting episodes | 0.03 ± 0.230 | 0.19 ± 0.893 |
| Cycle 2 day 2 - Number of vomiting episodes | 0.02 ± 0.177 | 0.10 ± 0.481 |
| Cycle 3 day 2 - Number of vomiting episodes | 0.05 ± 0.422 | 0.18 ± 0.969 |
| Cycle 1 day 3 - Number of vomiting episodes | 0.07 ± 0.433 | 0.20 ± 0.825 |
| Cycle 2 day 3 - Number of vomiting episodes | 0.09 ± 0.690 | 0.11 ± 0.579 |
| Cycle 3 day 3 - Number of vomiting episodes | 0.09 ± 0.543 | 0.17 ± 0.777 |
| Cycle 1 day 4 - Number of vomiting episodes | 0.05 ± 0.449 | 0.14 ± 0.593 |
| Cycle 2 day 4 - Number of vomiting episodes | 0.10 ± 0.670 | 0.11 ± 0.556 |
| Cycle 3 day 4 - Number of vomiting episodes | 0.10 ± 0.594 | 0.17 ± 0.769 |
| Cycle 1 day 5 - Number of vomiting episodes | 0.05 ± 0.431 | 0.07 ± 0.438 |
| Cycle 2 day 5 - Number of vomiting episodes | 0.06 ± 0.480 | 0.10 ± 0.527 |
| Cycle 3 day 5 - Number of vomiting episodes | 0.07 ± 0.506 | 0.15 ± 0.792 |
| Cycle 1 overall phase - Number of vomiting episodes | 0.11 ± 0.516 | 0.55 ± 1.804 |
| Cycle 2 overall phase - Number of vomiting episodes | 0.10 ± 0.585 | 0.45 ± 1.760 |
| Cycle 3 overall phase - Number of vomiting episodes | 0.15 ± 0.837 | 0.47 ± 1.909 |
Collected over Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | 2/196 (1%) | 22/196 (11.2%) | 150/196 (76.5%) |
| Standard of care + Dexamethasone 8 mg | 2/205 (1%) | 23/205 (11.2%) | 150/205 (73.2%) |
| Event | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| neutropeniaBlood and lymphatic system disorders | 6/196 | 5/205 |
| NauseaGastrointestinal disorders | 2/196 | 5/205 |
| DiarrhoeaGastrointestinal disorders | 3/196 | 1/205 |
| PyrexiaGeneral disorders | 3/196 | 1/205 |
| VomitingGastrointestinal disorders | 1/196 | 3/205 |
| DeathGeneral disorders | 2/196 | 2/205 |
| Cerebrovascular accidentNervous system disorders | 2/196 | 1/205 |
| InfectionInfections and infestations | 1/196 | 2/205 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/196 | 2/205 |
| PancytopeniaBlood and lymphatic system disorders | 1/196 | 0/205 |
| Event | NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Standard of care + Dexamethasone 8 mg |
|---|---|---|
| FatigueGeneral disorders | 54/196 | 46/205 |
| DiarrhoeaGastrointestinal disorders | 40/196 | 48/205 |
| ConstipationGastrointestinal disorders | 41/196 | 29/205 |
| ParaesthesiaNervous system disorders | 33/196 | 26/205 |
| Decreased appetiteMetabolism and nutrition disorders | 23/196 | 30/205 |
| AstheniaGeneral disorders | 25/196 | 21/205 |
| DizzinessNervous system disorders | 24/196 | 15/205 |
| Abdominal painGastrointestinal disorders | 19/196 | 25/205 |
| Neuropathy peripheralNervous system disorders | 15/196 | 20/205 |
| HypoaesthesiaNervous system disorders | 11/196 | 20/205 |
| Age, Continuous(year) | NEPA (300mg Netupitant/0.5mg Palonosetron) + Dexamethasone 8 mg | Standard of Care + Dexamethasone 8 mg | Total |
|---|---|---|---|
| Mean | 62.7 ± 11.8 | 62.7 ± 11.3 | 62.7 ± 11.5 |
| Sex: Female, Male(Participants) | NEPA (300mg Netupitant/0.5mg Palonosetron) + Dexamethasone 8 mg | Standard of Care + Dexamethasone 8 mg | Total |
|---|---|---|---|
| Female | 93 | 87 | 180 |
| Male | 103 | 118 | 221 |
| Race and Ethnicity Not Collected(Participants) | NEPA (300mg Netupitant/0.5mg Palonosetron) + Dexamethasone 8 mg | Standard of Care + Dexamethasone 8 mg | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| weight(kg) | NEPA (300mg Netupitant/0.5mg Palonosetron) + Dexamethasone 8 mg | Standard of Care + Dexamethasone 8 mg | Total |
|---|---|---|---|
| Mean | 73.28 ± 16.001 | 74.78 ± 17.285 | 74.05 ± 16.666 |
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