Verzenios ® (abemaciklib)

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Verzenios® ▼ (abemaciclib): Patientrapporterade resultat

De flesta symptom- och funktionspoäng i M2 var likartade mellan studiearmarna. Inga kliniskt betydelsefulla skillnader i hälsotillstånd eller funktionspoäng observerades i M3.

Detailed Information

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

  • day 1 of every second cycle starting with cycle 3 through 19

  • every third cycle after cycle 19, and

  • short-term postdiscontinuation follow-up.2,3

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 posttherapy.3

Statistically, but not clinically, significant differences were seen in

  • fatigue (4.96; p=.004)

  • systemic therapy side effects (4.48; p<.001)

  • appetite loss (4.03; p=.03), and

  • nausea/vomiting (2.77; 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. 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

References

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. Published online June 14, 2020. 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 2020 M07 27


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