Verzenio® (Abemaciclib)

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Abemaciclib: Incidence of Diarrhea in Elderly Population

While diarrhea (any grade) occurred with similar incidence in abemaciclib-treated patients across age groups, clinically relevant diarrhea was higher in the elderly.

MX_cFAQ_ABE070_ELDERLY_DIARRHEA
MX_cFAQ_ABE070_ELDERLY_DIARRHEA
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Detailed Information

Of the 900 patients who received abemaciclib in MONARCH 1, MONARCH 2, and MONARCH 3, 38% were 65 years of age or older and 10% were 75 years of age or older.1 No overall differences in safety or effectiveness of abemaciclib were observed between these patients and younger patients.1-3

Age-Specific Subgroup Analysis of MONARCH 2 and MONARCH 3 Trials

An exploratory subgroup analysis of MONARCH 2 and MONARCH 3 was performed for 3 age groups (women aged <65, 65-74, and ≥75 years). Using pooled safety data, age-specific subgroup analyses were performed for the most common TEAEs associated with either ET or ET plus abemaciclib.4

Pooled safety data were available for 1152 patients treated in MONARCH 2 and 3 trials including

  • 688 (59.7%) patients <65 years
  • 331 (28.7%) patients between 65 and 74 years, and
  • 133 (11.5%) patients ≥75 years.4

Of those patients, 768 women received abemaciclib plus ET and 384 women received placebo plus ET.4

The most frequent TEAE was diarrhea and the most common grade ≥3 TEAE was neutropenia. Diarrhea (any grade) occurred with similar incidence in abemaciclib-treated patients across age groups (~85%). Clinically relevant diarrhea (grade 2/3) was higher in the 2 older age groups in the abemaciclib + ET arm. In the placebo + ET arm, grade 2/3 diarrhea was more common in the ≥75 group compared to the <65 group. Diarrhea was the most common AE leading to study treatment discontinuation in all age groups, which was notably higher in the 2 older subgroups.4

Incidence of diarrhea by age group in MONARCH 2 and MONARCH 3 can be seen in Incidence of Diarrhea by Age Group in MONARCH 2 and MONARCH 3.

Incidence of Diarrhea by Age Group in MONARCH 2 and MONARCH 34

 

Abemaciclib + ET

Placebo + ET

Diarrhea, n (%)

<65 Years
n=466

65-74 Years
n=219

≥75 Years
n=83

<65 Years
n=222

65-74 Years
n=112

≥75 Years
n=50

Any grade

396 (85.0)

183 (83.6)

71 (85.5)

57 (25.7)

33 (29.5)

17 (34.0)

Grade 2/3

184 (39.5)

99 (45.2)

46 (55.4)

15 (6.8)

5 (4.5)

8 (16.0)

Grade 3a

46 (9.9)

28 (12.8)

16 (19.3)

1 (0.5)

0 (0.0)

2 (4.0)

Abbreviation: ET = endocrine therapy.

aThere were no Grade 4 diarrhea events.

Elderly patients receiving abemaciclib needed more dose adjustments to manage AEs, including diarrhea, as seen in Pooled Analysis of Diarrhea Management in Abemaciclib-Treated Patients in MONARCH 2 and MONARCH 3 by Age Group.5

Pooled Analysis of Diarrhea Management in Abemaciclib-Treated Patients in MONARCH 2 and MONARCH 3 by Age Group5

 

<65 Years
n=466

65-74 Years
n=219

≥75 Years
n=83

Dose omissions, n (%)

59 (12.7)

49 (22.4)

25 (30.1)

Dose reductions, n (%)

68 (14.6)

41 (18.7)

19 (22.9)

Study treatment discontinuation, n (%)

2 (0.4)

4 (1.8)

4 (4.8)

Concomitant antidiarrheals, n (%)

342 (73.4)

157 (71.7)

60 (72.3)

Abemaciclib in combination with ET demonstrates a generally tolerable safety profile and consistent efficacy results across all age subgroups examined, supporting the use of this combination in elderly patient populations.4

Despite the limited number of patients in the ≥75 group with potentially confounding comorbidities, the safety data suggest that appropriate management of toxicities, including dose adjustments and use of supportive medication for GI toxicities, could maximize the tolerability of abemaciclib in the elderly.4

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Sledge GW Jr, 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. https://doi.org/10.1200/JCO.2017.73.7585

3Goetz 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

4Goetz MP, Okera M, Wildiers H, et al. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021;186(2):417-428. https://doi.org/10.1007/s10549-020-06029-y

5Goetz MP, Okera M, Wildiers H, et al. Safety and efficacy of abemaciclib plus endocrine therapy (ET) in elderly patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+, HER2-) advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Poster presented at: 42nd Annual San Antonio Breast Cancer Symposium (SABCS); December 10-14, 2019; San Antonio, TX. Accessed April 22, 2021. https://www.abstractsonline.com/pp8/#!/7946/presentation/562

Glossary

AE = adverse event

ET = endocrine therapy

GI = gastrointestinal

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2021 M04 22


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