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Verzenios ® (abemaciklib)
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Patient-reported outcomes were measured using paper versions of 4 self-administered questionnaires across MONARCH 3 and MONARCH 2.1 The questionnaires are summarized in Table 1.
The analysis for each scale included all treated patients who completed the baseline assessment followed by at least 1 postbaseline assessment. The reason and number of missing or incomplete questionnaires were collected and summarized for each study.1
Table 1. Patient-Reported Outcomes Questionnaires Administered in MONARCH 3 and MONARCH 21
Abbreviation |
Definition |
Description |
MONARCH 3 |
MONARCH 2 |
mBPI-sf |
Modified Brief Pain Inventory – short form |
Pain intensity and pain assessment |
NA |
X |
EORTC-QLQ-C30 |
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 |
Health-related quality of life for general cancer |
X |
X |
EORTC-QLQ-BR23 |
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Breast 23 |
Health-related quality of life for breast cancer |
X |
X |
EQ-5D-5L |
EuroQol 5-Dimension 5 Level |
Self-reported health status |
X |
X |
Abbreviation: NA = not applicable.
Phase 3 Study of Anastrozole or Letrozole Plus Abemaciclib or Placebo in MBC (MONARCH 3)
MONARCH 3 was a randomized, double-blind, placebo-controlled, phase 3 study of abemaciclib or placebo with an NSAI (anastrozole or letrozole) in 493 postmenopausal women with HR+, HER2- advanced or MBC with no prior systemic treatment in this setting.2
Patient-reported outcomes were collected at
baseline
every second cycle starting with cycle 2 through 19
every third cycle after cycle 19, and
Patient compliance rate for scheduled PROs was high and balanced between treatment arms with completion rates of
≥96% at baseline
≥88% for the duration of abemaciclib treatment, and
≥70% at follow-up.3
The most common reason for noncompletion during treatment was "study site failed to administer."3
The prespecified threshold for clinical meaningfulness was set at a difference of ≥10 points on a 0 to 100 scale. Patient-reported outcome scores for diarrhea in the abemaciclib arm showed a clinically (18.68 points) and statistically significant (p<.001) increase. However, diarrhea scores returned to near-baseline levels post therapy.3
Statistically, but not clinically, significant differences were seen in
fatigue (4.96 ± 1.72; p=.004)
systemic therapy side effects (4.48 ± 1.20; p<.001)
appetite loss (4.03 ± 1.89; p=.03), and
nausea/vomiting (2.77 ± 1.12; p=.01).3
Differences deemed to be clinically meaningful in terms of global health status or functional scores were not observed. These results were consistent with the investigator-reported TEAEs.3
Phase 3 Study of Fulvestrant With or Without Abemaciclib in MBC (MONARCH 2)
MONARCH 2 was a randomized, double-blind, placebo-controlled, phase 3 trial of abemaciclib or placebo plus fulvestrant in 669 women with HR+, HER2- advanced breast cancer with disease progression following ET.4
Patient-reported outcomes were assessed at
baseline
cycle 2
every second cycle starting with cycle 3 through 13
every third cycle after cycle 13, and
once 30 days postdiscontinuation.5
Patient compliance rate for PROs was high and balanced between treatment arms with completion rates
≥95% at baseline
≥85% on-therapy, and
≥77% at follow-up.5
The most common reason for noncompletion throughout treatment was “study site failed to administer questionnaire.”5
A prespecified analysis of time to worsening of pain, indicated by ≥2 point increase of “worst pain” or ≥1 level increase of WHO analgesic class, showed a numerically but not statistically significant benefit for abemaciclib plus fulvestrant compared with placebo plus fulvestrant (16.8 vs 11.9 months; HR=0.900; p=.400), based on mBPI-sf data.5
Most of the symptom and function scores (EORTC QLQ-C30 and EORTC-BR23) and mBPI-sf were stable and similar between the 2 treatment arms during the on-therapy and short-term follow-up study periods with no observed statistical or clinical significance. Four outcomes statistically (p<.001) favored the placebo plus fulvestrant arm over time including
appetite loss
nausea and/or vomiting
diarrhea, and
systemic therapy side effects.5
The diarrhea score was the only clinically meaningful (>10 points on a 100 scale) difference in the abemaciclib plus fulvestrant arm.5
These health-related QoL results are consistent with the previously disclosed safety profile. For all symptoms, the burden was reported during early study visits and returned to baseline or near-baseline levels for most patients.5
1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2. Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646. https://doi.org/10.1200/jco.2017.75.6155
3. Goetz MP, Martin M, Tokunaga E, et al. Health-related quality of life in MONARCH 3: abemaciclib plus an aromatase inhibitor as initial therapy in HR+, HER2- advanced breast cancer. Oncologist. 2020;25(9):e1346-e1354. https://doi.org/10.1634/theoncologist.2020-0084
4. Sledge GW, Toi M, Neven P, et al. MONARCH 2: Abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875-2884. http://dx.doi.org/10.1200/JCO.2017.73.7585
5. Kaufman PA, Toi M, Neven P, et al. Health-related quality of life in MONARCH 2: abemaciclib plus fulvestrant in hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy. Oncologist. 2020;25(2):e243-e251. https://doi.org/10.1634/theoncologist.2019-0551
Glossary
EORTC = European Organisation for Research and Treatment of Cancer
EORTC QLQ-BR23 = European Organisation for Research and Treatment of Cancer quality of life questionnaire – Breast 23
EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer quality-of-life questionnaire
ET = endocrine therapy
HER2- = human epidermal growth factor receptor 2-negative
HR = hazard ratio
HR+ = hormone receptor-positive
MBC = metastatic breast cancer
mBPI-sf = Modified Brief Pain Inventory – short form
NSAI = nonsteroidal aromatase inhibitor
PD = progressive disease
PR = partial response
PRO = patient-reported outcome
QoL = quality of life
SD = stable disease
TEAE = treatment-emergent adverse event
WHO = World Health Organization
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Datum fӧr senaste ӧversyn 2021 M01 04