Chemotherapy-Induced Nausea and Vomiting
Conditions
Brief summary
This Canadian, multi-centre, prospective, observational real-world study is designed to collect patient-reported outcome data on the use of Akynzeo® (netupitant/palonosetron) for the prevention of nausea and vomiting in oncology patients receiving highly emetogenic chemotherapy (HEC).
Detailed description
The study will assess quality of life using the Functional Living Index of Emesis (FLIE) questionnaire and generate Real World Evidence in support of existing clinical trial data, including effectiveness and safety of Akynzeo® in the real world setting for the prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC).
Interventions
DRUG300mg netupitant/0.5mg palonosetron hydrochloride
Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)
Sponsors
Purdue Pharma, Canada
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must satisfy the following criteria to be enrolled in the study: 1. Patient scheduled to receive a highly emetogenic chemotherapy (HEC). 2. Patient scheduled to receive antiemetic prevention with Akynzeo® according to the approved Canadian Product Monograph as deemed medically necessary by the participating physician independently from this study. 3. Age ≥ 18 years. 4. Women of childbearing potential must use effective contraception during therapy and up to one month after treatment with Akynzeo®. 5. Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent prior to or at the screening visit. 6. Patient is able and willing to comply with the study protocol for the entire length of the study and will follow all study requirements, procedures and complete all visits as required. 7. Patient is participating in another clinical trial where antiemetic treatment is not pre-specified by the study protocol.
Exclusion criteria
1. Women of child bearing potential who are pregnant, planning on becoming pregnant or breast feeding. 2. Hypersensitivity to active substances, excipients or other ingredients of Akynzeo®. 3. Concomitant use of pimozide, terfenadine, astemizole, or cisapride. 4. Patient currently enrolled in another clinical trial where antiemetic treatment is pre-specified by the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Functional Living Index-Emesis (FLIE) Score at Cycle 1 | Day 5 of cycle 1 | The Functional Living Index - Emesis questionnaire is a validated patient reported outcome with the objective of assessing the impact of chemotherapy-induced nausea and vomiting on patient's daily function. Questionnaire consists of a nausea domain and a vomiting domain of nine items each where the patient should rate how much nausea and vomiting have affected the quality of life. For each question the patient will rate how much nausea (or vomiting) has affected an aspect of his quality of life during the past five days. Each question uses a visual analogue scale (100 mm) and an ordinal scale (where 1= no emesis-7=a great deal). The minimum total score is 18 and the maximum total score is 126. Higher scores indicate less impairment on daily life as a result of nausea or vomiting. A FLIE total score \> 108 indicates no impairment on daily life as a result of nausea or vomiting. Assessed by patient following day 5 of each cycle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days | No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5) |
| Severity of Nausea on Day 5 (Change From Day 1) | Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days | Question 1 of the daily evaluation of the Patient Diary (How much nausea did you experience on average during the last 24 hours?). Data was collected on a visual analogue scale. Scale ranges from 0 mm (no nausea) to 100 mm (always severe nausea). |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited from cancer treatment centers based on physician review of medical charts from the recruiting physicians clinical practice and referral from other physicians.
Participants by arm
| Arm | Count |
|---|---|
| Modified Intent-to-Treat Population 300mg netupitant/0.5mg palonosetron hydrochloride | 197 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 12 |
| Overall Study | Chemotherapy discontinued | 4 |
| Overall Study | Death | 8 |
| Overall Study | Disease progression | 5 |
| Overall Study | Non-compliance | 1 |
| Overall Study | Patient Received Cisplatin days 1-3 q 3 weeks | 1 |
| Overall Study | Patient stopped treatment | 2 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Received only 3 HEC cycles | 4 |
| Overall Study | Screen Failure | 3 |
| Overall Study | Switched to non-HEC | 5 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Modified Intent-to-Treat Population |
|---|---|
| Age, Continuous | 60.0 years |
| Age, Customized Mean (SD) | 58.3 years STANDARD_DEVIATION 12.2 |
| Race/Ethnicity, Customized Aboriginal | 2 Participants |
| Race/Ethnicity, Customized Asian | 14 Participants |
| Race/Ethnicity, Customized Black | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 168 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Race/Ethnicity, Customized other | 5 Participants |
| Region of Enrollment Canada | 197 Participants |
| Sex: Female, Male Female | 161 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 197 |
| other Total, other adverse events | 178 / 197 |
| serious Total, serious adverse events | 39 / 197 |
Outcome results
Primary
Total Functional Living Index-Emesis (FLIE) Score at Cycle 1
The Functional Living Index - Emesis questionnaire is a validated patient reported outcome with the objective of assessing the impact of chemotherapy-induced nausea and vomiting on patient's daily function. Questionnaire consists of a nausea domain and a vomiting domain of nine items each where the patient should rate how much nausea and vomiting have affected the quality of life. For each question the patient will rate how much nausea (or vomiting) has affected an aspect of his quality of life during the past five days. Each question uses a visual analogue scale (100 mm) and an ordinal scale (where 1= no emesis-7=a great deal). The minimum total score is 18 and the maximum total score is 126. Higher scores indicate less impairment on daily life as a result of nausea or vomiting. A FLIE total score \> 108 indicates no impairment on daily life as a result of nausea or vomiting. Assessed by patient following day 5 of each cycle.
Time frame: Day 5 of cycle 1
Population: mITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Total Functional Living Index-Emesis (FLIE) Score at Cycle 1 | 109.2 score on a scale | Standard Deviation 17.7 |
Secondary
Complete Response
No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5)
Time frame: Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | Complete Response | Missing Data | 16 Participants |
| Treatment | Complete Response | Complete Response: Yes | 84 Participants |
| Treatment | Complete Response | Complete Response: No | 96 Participants |
| Cycle 2 | Complete Response | Complete Response: No | 78 Participants |
| Cycle 2 | Complete Response | Complete Response: Yes | 97 Participants |
| Cycle 2 | Complete Response | Missing Data | 9 Participants |
| Cycle 3 | Complete Response | Complete Response: No | 62 Participants |
| Cycle 3 | Complete Response | Complete Response: Yes | 104 Participants |
| Cycle 3 | Complete Response | Missing Data | 9 Participants |
| Cycle 4 | Complete Response | Complete Response: Yes | 101 Participants |
| Cycle 4 | Complete Response | Missing Data | 6 Participants |
| Cycle 4 | Complete Response | Complete Response: No | 44 Participants |
Secondary
Severity of Nausea on Day 5 (Change From Day 1)
Question 1 of the daily evaluation of the Patient Diary (How much nausea did you experience on average during the last 24 hours?). Data was collected on a visual analogue scale. Scale ranges from 0 mm (no nausea) to 100 mm (always severe nausea).
Time frame: Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days
Population: mITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Severity of Nausea on Day 5 (Change From Day 1) | -7.1 mm | Standard Deviation 23.8 |
| Cycle 2 | Severity of Nausea on Day 5 (Change From Day 1) | -3.3 mm | Standard Deviation 21.6 |
| Cycle 3 | Severity of Nausea on Day 5 (Change From Day 1) | -1.4 mm | Standard Deviation 15.4 |
| Cycle 4 | Severity of Nausea on Day 5 (Change From Day 1) | -1.5 mm | Standard Deviation 10.7 |