Trial Outcomes & Findings for Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia (NCT NCT01444456)

Last Updated: 2017-03-20

Results Overview

Improvement in PPF was defined as improvement at Week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \[MID\]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).

Recruitment status

COMPLETED

Target enrollment

1262 participants

Primary outcome timeframe

Baseline to Week 9 (Treatment Day 57). Due to the observational nature of the study and variation in ESA dosing schedules, assessments closest to day 57 and within Days 43 to 70 (inclusive) were used to calculate the Week 9 visit results.

Results posted on

2017-03-20

Participant Flow

Open to patients receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia. First patient enrolled 10 october 2011; last patient enrolled 28 May 2013.

Before enrolling participants, each country was assigned to either cohort 1 (patients receiving only darbepoetin alfa) or cohort 2 (patients receiving any ESA). Cohort 2 was assigned only to those countries in which local regulations did not permit observational study participation by participants receiving a specific agent in a drug class.

Participant milestones

Participant milestones
Measure	Darbepoetin Alfa or Other ESA Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
Overall Study STARTED	1262
Overall Study Received Darbepoetin Alfa or Other ESA	1158
Overall Study Received Darbepoetin Alfa	1134
Overall Study COMPLETED	977
Overall Study NOT COMPLETED	285

Reasons for withdrawal

Reasons for withdrawal
Measure	Darbepoetin Alfa or Other ESA Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
Overall Study Withdrawal by Subject	21
Overall Study Physician Decision	9
Overall Study Lost to Follow-up	37
Overall Study Death	73
Overall Study Ineligibility determined	23
Overall Study Other	18
Overall Study Not treated	104

Baseline Characteristics

Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Darbepoetin Alfa or Other ESA n=1158 Participants Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
Age, Continuous	63.9 years STANDARD_DEVIATION 11.1 • n=93 Participants
Sex: Female, Male Female	691 Participants n=93 Participants
Sex: Female, Male Male	467 Participants n=93 Participants
Fatigue-Visual Analog Scale (VAS) Score	51.2 units on a scale STANDARD_DEVIATION 22.6 • n=93 Participants
Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score	28.4 units on a scale STANDARD_DEVIATION 10.5 • n=93 Participants
Hemoglobin level	9.3 g/dL STANDARD_DEVIATION 0.6 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline to Week 9 (Treatment Day 57). Due to the observational nature of the study and variation in ESA dosing schedules, assessments closest to day 57 and within Days 43 to 70 (inclusive) were used to calculate the Week 9 visit results.

Population: The Primary analysis set consists of enrolled participants who received at least 1 dose of darbepoetin alfa, have baseline assessments for each of Hemoglobin, FACT-F subscale and VAS, and analyzable post-baseline assessments for each of Hemoglobin, FACT-F subscale, and VAS at Week 9.

Outcome measures

Outcome measures
Measure	Darbepoetin Alfa n=510 Participants Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL	31.8 percentage of participants Interval 27.7 to 35.8

SECONDARY outcome

Timeframe: Baseline to Week 9

Population: Primary analysis set

Improvement in PPF was defined as improvement at week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \[MID\]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).

Outcome measures

Outcome measures
Measure	Darbepoetin Alfa n=510 Participants Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Breast cancer (N=152)	38.8 percentage of participants Interval 31.1 to 46.6
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Prostate cancer (N=39)	28.2 percentage of participants Interval 14.1 to 42.3
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Small cell lung cancer (N=12)	16.7 percentage of participants Interval 0.0 to 37.8
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Non-small cell lung cancer (N=70)	28.6 percentage of participants Interval 18.0 to 39.2
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Colorectal cancer (N=71)	31.0 percentage of participants Interval 20.2 to 41.7
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Ovarian cancer (N=79)	38.0 percentage of participants Interval 27.3 to 48.7
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Bladder cancer (N=16)	0.0 percentage of participants Confidence interval could not be calculated since there were no participants with both PPF improvement and hemoglobin increase.
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Endometrial cancer (N=12)	8.3 percentage of participants Interval 0.0 to 24.0
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Renal cancer (N=10)	10.0 percentage of participants Interval 0.0 to 28.6
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Pancreatic cancer (N=31)	35.5 percentage of participants Interval 18.6 to 52.3
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Esophogeal cancer (N=3)	33.3 percentage of participants Interval 0.0 to 86.7
Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL Gastric cancer (N=15)	26.7 percentage of participants Interval 4.3 to 49.0

SECONDARY outcome

Timeframe: Baseline and Week 9

Population: Primary analysis set participants with a fatigue VAS score improvement at Week 9 of 5 ± 3 points from Baseline

The FACT-F subscale consists of 13 fatigue-related items (statements) that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants are asked to indicate how they feel in response to each of the 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale can range from 0 to 52; the higher the score the better the quality of life. A positive change (\>0) from baseline score constitutes an improvement in fatigue between Baseline and Week 9. The fatigue-visual analog scale (VAS) is a 100-point scale where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).

Outcome measures

Outcome measures
Measure	Darbepoetin Alfa n=44 Participants Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points	3.5 units on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: From Baseline until Week 9

Population: Primary analysis set

Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL

Outcome measures

Outcome measures
Measure	Darbepoetin Alfa n=510 Participants Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
Time to First Increase in Hemoglobin	36.5 days Interval 30.0 to 43.0

SECONDARY outcome

Timeframe: From Baseline to Week 13

Population: Primary analysis set

The percentage of participants with iimprovement in PPF at any time from Day 2 until the end-of-study assessment (Week 13). Improvement in PPF was defined as improvement in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference \[MID\]). The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the FACT-An questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for "Not at all" to 4 for "Very much". Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).

Outcome measures

Outcome measures
Measure	Darbepoetin Alfa n=510 Participants Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time	70.0 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 13

Population: Primary analysis set

The percentage of participants with increase in hemoglobin (≥ 1 g/dL) at any time from Day 2 until the end-of-study assessment (Week 13).

Outcome measures

Outcome measures
Measure	Darbepoetin Alfa n=510 Participants Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time	75.7 percentage of participants

Adverse Events

Darbepoetin Alfa or Other ESA

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Darbepoetin Alfa or Other ESA n=1158 participants at risk Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
Cardiac disorders Cardiac arrest	0.09% 1/1158 • Up to 28 days after a participant's last dose date, capped at 17 weeks Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.
Nervous system disorders Cerebrovascular accident	0.09% 1/1158 • Up to 28 days after a participant's last dose date, capped at 17 weeks Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.

Other adverse events

Other adverse events
Measure	Darbepoetin Alfa or Other ESA n=1158 participants at risk Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
Blood and lymphatic system disorders Thrombocytosis	0.09% 1/1158 • Up to 28 days after a participant's last dose date, capped at 17 weeks Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.
Cardiac disorders Arrhythmia	0.09% 1/1158 • Up to 28 days after a participant's last dose date, capped at 17 weeks Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.
Eye disorders Cystoid macular oedema	0.09% 1/1158 • Up to 28 days after a participant's last dose date, capped at 17 weeks Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.
Gastrointestinal disorders Abdominal pain	0.09% 1/1158 • Up to 28 days after a participant's last dose date, capped at 17 weeks Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.
General disorders Injection site pain	0.09% 1/1158 • Up to 28 days after a participant's last dose date, capped at 17 weeks Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.
Immune system disorders Drug hypersensitivity	0.09% 1/1158 • Up to 28 days after a participant's last dose date, capped at 17 weeks Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.
Metabolism and nutrition disorders Hyperglycaemia	0.09% 1/1158 • Up to 28 days after a participant's last dose date, capped at 17 weeks Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.
Skin and subcutaneous tissue disorders Pruritus	0.09% 1/1158 • Up to 28 days after a participant's last dose date, capped at 17 weeks Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.
Skin and subcutaneous tissue disorders Rash	0.09% 1/1158 • Up to 28 days after a participant's last dose date, capped at 17 weeks Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER