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

Brief summary public domain (ClinicalTrials.gov)

This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia. Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL

Detailed description public domain (ClinicalTrials.gov)

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 patients receiving a specific agent in a drug class.

Arm public domain (ClinicalTrials.gov)

Cohort 1: Darbepoetin alfa (): Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.

Arm public domain (ClinicalTrials.gov)

Cohort 2: Any 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.

Primary outcome public domain (ClinicalTrials.gov)

Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL. 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). Time frame: 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..

Secondary outcome public domain (ClinicalTrials.gov)

Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL. Time frame: Baseline to Week 9.

Secondary outcome public domain (ClinicalTrials.gov)

Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points. Time frame: Baseline and Week 9.

Secondary outcome public domain (ClinicalTrials.gov)

Time to First Increase in Hemoglobin. Time frame: From Baseline until Week 9.

Secondary outcome public domain (ClinicalTrials.gov)

Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time. Time frame: From Baseline to Week 13.

Secondary outcome public domain (ClinicalTrials.gov)

Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time. Time frame: From Baseline to Week 13.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * Diagnosed with breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric cancer * Expected to receive at least 8 additional weeks of a given regimen of myelosuppressive chemotherapy after enrolment * Starting treatment with either darbepoetin alfa (in Cohort 1 countries) or any ESA (in Cohort 2 countries) as per European Summary of Product Characteristics (SPC) for symptomatic anaemia. Exclusion Criteria: * Received any ESA treatment or Red Blood Cell (RBC) transfusion within 28 days prior to enrolment * Known primary benign or malignant haematologic disorder which can cause anaemia * Known hypersensitivity to ESAs

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 1262 participants (actual).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL [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.]. Number, percentage of participants (95% Confidence Interval). Darbepoetin Alfa (n=510): 31.8 (27.7 to 35.8).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL [Baseline to Week 9]. Number, percentage of participants (95% Confidence Interval). Breast cancer (N=152): Darbepoetin Alfa (n=510): 38.8 (31.1 to 46.6). Prostate cancer (N=39): Darbepoetin Alfa (n=510): 28.2 (14.1 to 42.3). Small cell lung cancer (N=12): Darbepoetin Alfa (n=510): 16.7 (0.0 to 37.8). Non-small cell lung cancer (N=70): Darbepoetin Alfa (n=510): 28.6 (18.0 to 39.2). Colorectal cancer (N=71): Darbepoetin Alfa (n=510): 31.0 (20.2 to 41.7). Ovarian cancer (N=79): Darbepoetin Alfa (n=510): 38.0 (27.3 to 48.7). Bladder cancer (N=16): Darbepoetin Alfa (n=510): 0.0 (NA to NA) [Confidence interval could not be calculated since there were no participants with both PPF improvement and hemoglobin increase.]. Endometrial cancer (N=12): Darbepoetin Alfa (n=510): 8.3 (0.0 to 24.0). Renal cancer (N=10): Darbepoetin Alfa (n=510): 10.0 (0.0 to 28.6). Pancreatic cancer (N=31): Darbepoetin Alfa (n=510): 35.5 (18.6 to 52.3). Esophogeal cancer (N=3): Darbepoetin Alfa (n=510): 33.3 (0.0 to 86.7). Gastric cancer (N=15): Darbepoetin Alfa (n=510): 26.7 (4.3 to 49.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points [Baseline and Week 9]. Mean, units on a scale (Standard Deviation). Darbepoetin Alfa (n=44): 3.5 (5.5).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to First Increase in Hemoglobin [From Baseline until Week 9]. Median, days (95% Confidence Interval). Darbepoetin Alfa (n=510): 36.5 (30.0 to 43.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time [From Baseline to Week 13]. Number, percentage of participants. Darbepoetin Alfa (n=510): 70.0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time [From Baseline to Week 13]. Number, percentage of participants. Darbepoetin Alfa (n=510): 75.7.