Verzenio® (Abemaciclib)

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What real-world evidence is available regarding the use of abemaciclib?

Several publications have evaluated the use of abemaciclib in a real-world setting, including comparing efficacy outcomes and determining prognostic factors.

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Detailed Information

This medical response may not completely match the information in the current local labeling for ABEMACICLIB. Please see local labeling for approved label information.

Real-World Survival Comparison to MONARCH 1 Results

A real-world retrospective cohort utilizing patient data from the Flatiron Health electronic health record (EHR) database compared overall survival (OS) in patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). Patients were selected in accordance with the original key eligibility criteria from MONARCH 1. A population of 281 patients who received single-agent chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine) following 1 to 2 prior chemotherapy regimens in the metastatic setting and had not previously received a cyclin-dependent kinase (CDK) 4 and CDK6 inhibitor was identified and compared with the 132 participants of MONARCH 1.1

Overall survival results were adjusted using 2 methods (Mahalanobis distance matching and entropy balancing with bootstrapping) to account for baseline demographic and clinical differences between the real-world and trial cohorts.1

The median OS for the abemaciclib arm was 22.3 months compared with 13.6 months seen in the matched cohort (hazard ratio [HR]=0.54; 95% CI: 0.37-0.77). The sensitivity analysis utilizing entropy balancing corroborated these results, noting a median OS of 12.7 months, when compared with the abemaciclib arm, resulted in a HR of 0.56 (95% CI from bootstrapping 0.44-0.78).1

These exploratory results suggest a survival advantage and adequately place the clinical benefit of abemaciclib monotherapy in clinical context.1

Real-World Treatment Patterns and Outcomes in MBC Patients Treated With Abemaciclib

A real-world retrospective observational study utilizing data from the Flatiron Health EHR database described baseline characteristics, treatment patterns, and outcomes among 118 female MBC patients treated with abemaciclib in the United States (US).2

Using technology-enabled abstraction, real-world tumor response assessments were collected to calculate real-world best response which was defined as real-world complete response or real-world partial response. Time to first response was estimated using the Kaplan-Meier method.2

Baseline Characteristics in Real-World Study of Abemaciclib Treatment Patterns2

Characteristic

Abemaciclib
N=118
%

Racea

White

63.6

Black or African American

9.3

Asian

2.5

Other race

8.5

Stage at initial diagnosisa

I

11.9

II

16.1

III

28.8

IV

34.7

Tumor grade at initial diagnosisa

Grade 1

9.3

Grade 2

45.8

Grade 3

22.9

Menopausal statusb

Postmenopausal

66.1

Premenopausal

33.9

Presence of lung metastases

34.7

Presence of liver metastases

22.9

Presence of brain metastases

7.6

ECOG PSac

0

31.4

1

27.1

2

8.5

3

3.4

4

0

Line of treatment receiving abemaciclib

First line

28.8

Second line

21.2

Third line

20.3

Later lines

29.7

Concomitant therapy

Fulvestrant

59.3

Aromatase inhibitor

22.9

Other treatment

5.1

Prior treatment with a different CDK4/6 inhibitor

25.0

Abbreviation: CDK = cyclin-dependent kinase; ECOG PS = Eastern Cooperative Oncology Group performance status.

aValues may not add to 100 due to unknown, missing, or undocumented data.

bAge was used as a proxy for menopausal status, where premenopausal was defined as ≤60 years of age and postmenopausal was defined as >60 years of age.

cECOG PS may have been recorded up to 45 days prior to or up to 14 days after the index date, whichever was closest to the index date. If there were multiple ECOG PS values at the same absolute distance from the index date, priority was given to the ECOG PS preceding the index date. If there were multiple ECOG PS values recorded on the same day, the highest numerical value was selected.

Most patients (80.5%) had a starting dose of abemaciclib 150 mg twice daily. Of these patients, abemaciclib was most frequently administered in combination with fulvestrant (63.2%) or an aromatase inhibitor (AI) (25.3%). Other twice daily starting doses of abemaciclib included

  • 200 mg (7.6%)
  • 100 mg (4.2%), and
  • 50 mg (3.4%).2

The remaining patients in the cohort for whom a starting dose of abemaciclib was known began treatment with a dose of either 150 mg (0.8%) or 200 mg (0.8%), once daily.2

Among patients treated in this cohort

  • 37.3% had a dose hold
  • 6.8% had a dose reduction, and
  • 21.2% had a schedule change.

Of the patients with a schedule change (n=25), 72% changed from twice to once daily.2

Among all abemaciclib patients who had at least 1 real-world tumor response assessment (n=68), 41.2% had a real-world best response; 5.9% had a real-world complete response and 35.3% had a real-world partial response. Although not statistically significant, there was a trend toward higher rates of real-world best response in first line (65.0%) as compared with

  • second line (37.4%)
  • third line (35.7%), and
  • later lines (22.3%).2

Median real-world time to first response was 3.6 months (95% CI: 3.5-5.2).2

The incidence of diarrhea was lower in the real-world than in clinical trials (67% versus ~85%, respectively), with a median time-to-onset of 27 days compared to 6-8 days in clinical trials. Use of anti-diarrheal medication was consistent with use in clinical trials while the rate of discontinuation due to diarrhea was higher than in clinical trials.2

The incidence of any grade and grade ≥3 neutropenia was lower in the real-world than in clinical trials (36% and 8% versus 44-46% and 24-27%, respectively) while the incidence of venous thromboembolisms was consistent with clinical trial results.2

The authors concluded that there is evidence to support clinical benefit with abemaciclib in the real-world, and that these results complement those seen in clinical trials. Future research will be needed as treatment patterns evolve and longer follow-up periods are available to further describe patient outcomes.2

Prognostic Factors in HR+, HER2- Advanced Breast Cancer

Patients Treated With CDK4 and 6 Inhibitors

Utilizing the Flatiron Health EHR database, a retrospective analysis compared outcomes (time to treatment discontinuation, real-world progression-free survival [rwPFS], and OS) with and without select clinical factors among a cohort of HR+/HER2- MBC patients treated with a CDK4 and 6 inhibitors in a first- and second-line setting. Of the 518 patients included, median age at diagnosis of MBC was 66 years old (interquartile [IQR] range 59-73 years) and 11.4% of patients were progesterone receptor-negative (PR-).3

At baseline, 20.5%, 46.3%, and 65.8% of patients had liver, visceral (defined as liver and/or lung), and non-bone only metastases.3

Of 207 patients who received CDK4 and 6 inhibitors as initial therapy in the metastatic setting

  • 1.4% received monotherapy
  • 69.1% received it in combination with an AI, and
  • 29.5% received it in combination with fulvestrant.3

The median rwPFS from the start of the first line of therapy was not reached (95% CI: 10.7 months to not available). The presence of liver metastases was correlated with higher risk of progression or death compared with no liver metastases (HR=2.04; 95% CI: 1.13-3.68). The presence of non-bone only metastases (HR=2.23; 95% CI: 1.20-4.15) also correlated with a higher level of risk. Visceral metastases and progesterone receptor (PR) status were not shown to lead to a statistically significant effect in first-line rwPFS when examined via univariate analysis. Analyses of other lines of therapy are ongoing.3

All Patients With HR+, HER2- MBC

Retrospective Studies – Overall Survival and Patient Characteristics

A retrospective analysis of US EHR data from Vector Oncology’s data warehouse examined OS and patient characteristics in order to determine common poor prognostic factors. Data was collected from the initiation of therapy for first, second, and third lines of therapy.4

Of 378 women starting a first line of therapy, 17.2% and 39.2% of patients experienced an OS event prior to starting second or third lines of therapy, respectively. Patients with liver metastases were generally younger (mean age 57.2; SD 13.8 vs 61.2, 13.1; p=.016) and more likely to have a grade 3 tumor (36.1% vs 24.7%; p=.039). Higher mortality was also observed in patients with liver metastases across lines of therapy, with OS events occurring in 66.2% vs 56.9% of patients with the first line of therapy. Sample size and selection criteria may limit generalizability of these results.4

Liver metastases positive patients had a poorer prognosis as they were more likely to have an OS event across first to third line compared with liver metastases negative patients. For all 3 lines, median OS for liver metastases positive patients was shorter than the liver metastases negative median OS.4

Median OS in first line was 14 months shorter in liver metastases positive patients compared with liver metastases negative patients. Other potential indicators of poor prognosis, such as high tumor grade, are being explored.4

A retrospective observational study analyzed medical and pharmacy claims data from the IBM® MarketScan® Research Databases between January 2007 to January 2020 to describe patient characteristics, real-world utilization patterns, and outcomes in a US cohort of patients ≥18 years of age who newly initiated abemaciclib treatment for HR+, HER2- MBC between 1-Sept-2017 to 31-Oct-2019.5

Patients were stratified by prior CDK4 and 6 inhibitor use (yes/no) and were grouped by concomitant therapy of

  • +aromatase inhibitor (+AI)
  • +fulvestrant (+F)
  • 200 mg abemaciclib monotherapy (200mgMono), or
  • +other.5

There were 454 patients included in the analysis with a mean age of 57.7 years and 98.9% female.5 Patient characteristics, real-world utilization patterns, and outcomes can be seen in Patient Characteristics, Real-World Utilization Patterns, and Outcomes in a US Patient Cohort Upon Initiation of Abemaciclib for HR+, HER2- MBC.

Prior CDK4 and 6 inhibitors use within each regimen ranged from 37.6% (+AI) to 60.0% (+other). Nearly 75% (n=331) of all abemaciclib initiators began treatment with a 150 mg dose and the median length of follow-up was 321 days (IQR 195-482).5

Patient Characteristics, Real-World Utilization Patterns, and Outcomes in a US Patient Cohort Upon Initiation of Abemaciclib for HR+, HER2- MBC5

Concomitant Therapy Group

 

+AI
n=133

+F
n=159

200mgMono
n=47

+Other
n=115

Prevalence of new abemaciclib initiators, %a

29.3

35.0

10.4

25.3

Visceral metastases, %

50.4

49.7

55.3

47.8

Chemotherapy use in the 6-month pre-index period, %

18.8

21.4

51.1

21.7

Median time-to-discontinuation without prior CDK4 and 6 inhibitors (days)

NR
(95% CI, 430 days-NR)

531
(95% CI, 281-NR)

141
(95% CI, 80-NR)

392
(95% CI, 300-NR)

Median time-to-discontinuation with prior CDK4 and 6 inhibitors (days)

196
(95% CI, 125-NR)

146
(95% CI, 93-225)

140
(95% CI, 86-NR)

191
(95% CI, 113-280)

Abbreviations: 200mgMono = 200 mg abemaciclib monotherapy; +AI = +aromatase inhibitor; CDK = cyclin-dependent kinase; +F = +fulvestrant; HR+ = hormone receptor-positive; HER2- = human epidermal growth factor receptor 2-negative; MBC = metastatic breast cancer; NR = not reached.

aPercent of each concomitant therapy group is calculated out of the total 454 patients.

This real-world data complements pivotal abemaciclib clinical trial results by examining abemaciclib use among a more heterogeneous patient population in a clinical practice setting. The number of patients with prior CDK4/6 inhibitor use, visceral metastases, and prior chemotherapy at abemaciclib initiation suggests many patients had advanced disease and were in later stages of their treatment.5

Retrospective Study – Multiple Prognostic Factor Index

A retrospective study utilized US EHR data from Vector Oncology’s data warehouse from January 1, 2008 through April 30, 2017 to assess the effect of multiple clinical prognostic factors collectively including

  • liver metastases
  • primary endocrine resistance
  • negative progesterone receptor status, and
  • high tumor grade.6

Eligibility included HR+, HER2- MBC diagnosis in 2008 or later and prior systemic therapy for MBC.6

Patients were grouped based on the number of prognostic factors present at MBC diagnosis: 0, 1, and 2+. Differences in rwPFS and OS from start of first-line therapy were evaluated by Kaplan-Meier method and multivariable Cox proportional hazards regression.6

Eligible patients (n=378) had a mean age of 60.3 years. Among these

  • 57.1% were white
  • 36.5% were de novo metastatic
  • 22% had liver metastases
  • 27.2% had high tumor grade, and
  • 27.1% were PR- at baseline.6

Among all patients

  • 170 (45%) had received endocrine therapy (ET) as first-line treatment
  • followed by chemotherapy (28%)
  • CDK4 and 6 inhibitors (17%), or
  • other anticancer treatment (9%).6

After adjustment, rwPFS and OS were significantly (p<.05) shorter in patients with 1 and 2+ clinical prognostic factors compared with patients with none as shown in Real-World PFS and OS Based on Prognostic Factors in Patients With HR+, HER2- MBC.6

Real-World PFS and OS Based on Prognostic Factors in Patients With HR+, HER2- MBC6

 

Number of Prognostic Factors

 

0 (n=110)

1 (n=136)

2+ (n=132)

Median rwPFS (months)
HR (95% CI)

21.32
1.0 (Ref)

9.59
2.16 (1.52-3.08)

5.09
3.97 (2.79-5.66)

Median OS (months)
HR (95% CI)

43.01
1.0 (Ref)

32.20
1.60 (1.06-2.42)

21.75
2.39 (1.58-3.61)

Abbreviations: HER2- = human epidermal growth factor receptor 2-negative; HR = hazard ratio; HR+ = hormone receptor-positive; MBC = metastatic breast cancer; OS = overall survival; PFS = progression free survival; Ref = reference; rwPFS = real-world progression free survival.

These data demonstrate the heterogeneity in patient survival outcomes depending on the presence and number of prognostic factors.6

Next Generation Sequencing

Next generation sequencing (NGS) results of tumor and liquid biopsies obtained between January 2008 and September 2016 from 130 patients with estrogen receptor positive (ER+)/progesterone receptor-positive (PR+)/HER2- MBC were analyzed in an effort to describe the basis of sensitivity and resistance.7

All patients received a CDK4 and 6 inhibitor for MBC at a community cancer network with NGS results available pre- and/or post-CDK4 and 6 inhibitor therapy.7

Samples were classified as

  • sensitive (n=69; duration of therapy ≥6 months), or
  • resistant (n=61; duration of therapy <6 months).7

The frequency of genomic alterations with likely or known significance were characterized including

  • short variants
  • indels
  • copy number variants, and
  • fusions.7

Alterations in 215 unique genes were identified from the NGS results. The most frequently altered genes were

  • phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)
  • gene encoding tumor protein 53 (TP53)
  • estrogen receptor gene (ESR1)
  • cyclin D1 (CCND1), and
  • fibroblast growth factor receptor 1 (FGFR1).7

Select alterations in ESR1 and RAD21 homolog (RAD21) were more frequent after exposure to CDK4 and 6 inhibitors.7

In NGS obtained before exposure to CDK4 and 6 inhibitors, alterations in select genes including retinoblastoma 1 (RB1), murine double minute 2 (MDM2), aurora kinase A (AURKA), and v-myc avian myelocytomatosis viral oncogene homolog (MYC) were more frequent in the resistant samples, whereas AT-rich interaction domain 1A (ARID1A) alterations were more frequent in sensitive samples.7

Of the 6 patients with paired NGS samples pre- and post-CDK4 and 6 inhibitor treatment, alterations in MYC, cyclin dependent kinase inhibitor 2A (CDKN2A), PIK3CA, breast cancer susceptibility gene 1 (BRCA1), or RB1 were acquired in 3 patients.7

Based on real-world data, this study describes the genomic landscape of ER+/PR+/HER2- MBC tumors from patients treated with CDK4 and 6 inhibitors and identifies potential mechanisms underlying sensitivity and resistance to this new class of drugs.7

Characteristics of Patients with Metastatic Breast Cancer Following Progression on a CDK4 and 6 Inhibitor

A retrospective study in the US compared two cohorts of patients diagnosed with HR+, HER2- MBC since January 2011. The first cohort, CohortPost, underwent biopsy following progression on a CDK4 and 6 inhibitors with or without ET. The second cohort, CohortPre, underwent biopsy with no evidence of having already received a CDK4 and 6 inhibitors.8

Tumor tissue was analyzed for genomic alterations using the Tempus xT NGS assay to query 595 cancer-related genes.8

Chi-square or Fisher's exact test was used as appropriate for categorical variables including mutation frequency, with significance at false discovery rate <0.2.8

Demographic and clinical characteristics were largely similar between cohorts as seen in Demographics and Clinical Characteristics of MBC Patients. Post progression patients had higher occurrences of liver metastases, multiple metastatic sites (≥3), and more frequently received endocrine therapy.8

Demographics and Clinical Characteristics of MBC Patients8

Characteristic

CohortPre 
n=117

CohortPost
n=169

Age at MBC diagnosis, mean (SD)

60 (12.83)

55 (11.41)

Female, n (%)

173 (97.74)

190 (98.95)

Race, n (%)

Asian

7 (3.95)

4 (2.08)

Black or African American

17 (9.6)

10 (5.2)

White

96 (54.23)

103 (53.64)

FU, median (IQR)

8.2 (1.3-21.2)

36 (23.4-60.4)

CCI ≥1, n (%)

29 (24.79)

28 (16.57)

Initial stage at diagnosis, n (%)

Stage 1

6 (5.12)

7 (4.14)

Stage 2

11 (9.4)

24 (14.2)

Stage 3

9 (7.69)

16 (9.46)

Stage 4 (De novo MBC)

40 (34.18)

41 (24.26)

Biopsy site

Liver

25 (21.36)

90 (53.25)

Non-Liver

92 (78.63)

79 (46.74)

≥3 metastatic sites at biopsy, n (%)

17 (14.52)

73 (43.19)

Prior treatment, n (%)

Chemotherapy

30 (25.64)

49 (28.99)

ET

21 (17.94)

63 (37.27)

Abbreviations: CCI = Charlson Comorbidity Index; ET = endocrine therapy; FU = follow-up length from metastasis diagnosis; IQR = interquartile range; MBC = metastatic breast cancer.

Genomic alterations in both cohorts were analyzed using a combination of 3 Tempus xT panels with the majority of patient data generated from xT.v2. There was no significant difference between the tumor purity of CohortPre and CohortPost.8

The xT assay results indicated that patients in CohortPost had significantly higher tumor mutation burden (TMB) compared to patients in CohortPre (median 2.92 vs 2.08, p<.0001). Additionally, a subset of patients with liver metastases across both cohorts (n=115) showed a similar, but nonsignificant trend for having a greater TMB (median 2.92 vs 2.08, p=.0991).8

Genomic results suggest a higher TMB as well as higher frequency of ESR1 alterations and Chr:12q15 related changes (MDM2, YEATS domain containing 4 [YEATS4], factor receptor substrate 2 [FRS2]) in CohortPost, with fewer differences noted for PIK3CA, TP53, GATA binding protein 3 (GATA3), CCND1, and FGFR1 between CohortPre and CohortPost.8

Real-World Evidence in Early Breast Cancer

Genomic Testing in Early Breast Cancer (EBC) and Geographic Variability

From July 2019 through October 2019, 320 physicians in the EU5 (France, Germany, Italy, Spain, and United Kingdom [UK]), US, and Japan completed patient record forms for HR+, HER2- EBC patients that had received adjuvant therapy in the previous 12 months.9

There were 2447 patient records. The frequency of neoadjuvant and adjuvant therapy varied by region. The rate of genomic testing in patients who had received neoadjuvant therapy was

  • 15.8% in the EU5
  • 26.5% in the US, and
  • 18.3% in Japan.9

Genomic testing patterns also varied according to therapy received and geographic region, as summarized in Genomic Tests and Assays Utilized by Geographic Region and Treatment Received in EBC.9

 

Genomic Tests and Assays Utilized by Geographic Region and Treatment Received in EBC9

Testa, n (%)

EU5b
Neoadjuvantc
n=293

EU5b
Adjuvant only
n=1566

United States
Neoadjuvantc
n=92

United States
Adjuvant only
n=255

Japan
Neoadjuvantc
n=44

Japan
Adjuvant only
n=197

BRCA1

100 (34.1)

236 (15.1)

42 (45.7)

96 (37.6)

8 (18.2)

13 (6.6)

BRCA2

91 (31.1)

209 (13.3)

31 (33.7)

87 (34.1)

2 (4.5)

3 (1.5)

Ki-67

195 (66.6)

1121 (71.6)

31 (33.7)

73 (28.6)

9 (20.5)

85 (43.1)

OncotypeDx

57 (19.5)

223 (14.2)

31 (33.7)

125 (49)

13 (29.5)

30 (15.2)

MammaPrint

16 (5.5)

74 (4.7)

10 (10.9)

15 (5.9)

10 (22.7)

9 (4.6)

Adjuvant! Online

23 (7.8)

120 (7.7)

2 (2.2)

7 (2.7)

1 (2.3)

26 (13.2)

Abbreviations: BRCA = breast cancer susceptibility gene; EBC = early breast cancer; EU = European Union.

aEndoPredict, Breast Cancer Index, Mammostrat, PAM50 omitted (% use <10%).

bIncludes France, Germany, Italy, Spain, and United Kingdom.

cExcludes nonendocrine therapy.

A cross-sectional observational study in France, Germany, Italy, Spain, UK, US, and Japan surveyed 765 physicians on use of genomic assays to assess risk of recurrence. In each country, 20 to 64 physicians also completed patient record forms from March 2019 through September 2019, for up to 8 eligible patients with HR+, HER2- EBC.10

Physicians in US (n=176), UK (n=52) and Spain (n=100) reported the highest use of genomic assays and Japan (n=134) reported the lowest use. Patients were categorized from

  • low to intermediate risk of recurrence (US 61%; Spain 57%; UK 65%; Japan 13%), and
  • intermediate to high risk of recurrence (US 64%; Spain 67%; UK 65%; Japan 20%).10

Patient record forms were completed for 2447 patients with 98% female and mean age of 59.6 years. Of the 765 physicians surveyed, 729 assessed some or all of their patients with EBC for risk of recurrence. Of those, Oncotype DX was the most frequently used genomic assay, making up 67% of genomic assays used to assess risk of recurrence. Frequency of Oncotype DX testing varied by

Additionally, Oncotype DX testing was less frequent in node positive patients with testing in 14% of 733 node positive patients, compared with 23% of 1593 node negative patients (p<.0001).10

Frequency of Oncotype DX Testing in HR+, HER2- EBC Patients10

Frequency of Oncotype DX Testing

 

n (%)

P value

Stagea

I

194/755 (26)

<.0001

II

221/1130 (20)

III

56/505 (11)

Tumor gradeb

grade 1

100/484 (21)

<.0001

grade 2

203/908 (22)

grade 3

44/384 (12)

Tumor sizec

<2 cm

161/865 (19)

.0503

2-5 cm

254/1265 (20)

>5 cm

11/105 (11)

Aged

≤50 years

161/657 (25)

.0003

>50 years

318/1790 (18)

Abbreviations: EBC = early breast cancer; HER2- = human epidermal growth factor receptor 2-negative; HR+ = hormone receptor-positive.

aFrequency of testing was less in stage 3 patients. Similar patterns were seen across most countries, but often not statistically significant. Germany had similar use across stages (~20%).

bFrequency of testing was less in patients with grade 3 tumors. Similar patterns were seen across countries except UK and Spain where testing was less in patients with grade 1 tumor, but not statistically significant.

cFrequency of testing was less in patients with large tumors. Similar patterns were seen across countries except Italy, but generally not significant.

dFrequency of testing was less in patients >50 years. Similar patterns were seen across countries, and significant in Germany (p=.0029) and Italy (p<.0001), except for US and Japan where testing was very similar between age groups.

Similar patterns of Oncotype DX testing were seen in most countries, but often were not statistically significant.

Key differences included

  • Germany had consistent use (~20%) across all stages
  • UK and Spain had less frequent testing in patients with grade 1 tumors
  • Italy had different testing patterns based on tumor size
  • US and Japan had similar levels of testing between age groups, and
  • Germany and Japan used Oncotype DX testing more often for node positive patients than node negative patients.10

Use of Ki-67 Testing in EBC

Adult patients with HR+, HER2- EBC treated in community practices were included in an observational, retrospective cohort study to evaluate the use of Ki-67 testing and scoring.11

In this sample, 555 of 567 patients received systemic therapy for EBC. Initial tumor stages for the overall population included

  • stage I (n=63)
  • stage II (n=370)
  • stage III (n=121), and
  • unknown (n=13).11

Of the 555 patients, 91 (16%) patients received neoadjuvant therapy and 525 (95%) had received adjuvant therapy. Adjuvant regimens included

  • ET-containing regimen (82%)
  • chemotherapy (53%), and
  • chemotherapy followed by ET (33%).11

Among patients with 1 to 3 positive nodes (n=258), 61 (24%) were tested for Ki-67 expression, of which, 33 (54%) had scores ≥20%.11

Following Ki-67 testing,

  • 59% of all tested patients received chemotherapy, while
  • 67% of patients with Ki-67 ≥20% received chemotherapy.11

Analyses showed that clinical or pathological factors were not predictors of Ki-67 testing; however, individuals without insurance were less likely to receive Ki-67 testing (p<.0003).11

Of those tested (n=130), grade 2 (p=.0027) and grade 3 (p<.001) tumors were predictors of Ki-67 scores ≥20%. Overall, Ki-67 scores ≥20% were common among those with grade 2 (64%) and grade 3 (94%) tumors; however, 28% of patients with grade 1 tumors also had Ki-67 ≥20%.11

References

1Rugo HS, Dieras V, Cortes J, et al. Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2-metastatic breast cancer receiving single-agent chemotherapy–a comparison with MONARCH 1. Breast Cancer Res Treat. 2020;184(1):161-172. https://doi.org/10.1007/s10549-020-05838-5

2Carter GC, Sheffield KM, Gossai A, et al. Real-world treatment patterns and outcomes of abemaciclib for the treatment of HR+, HER2- metastatic breast cancer. Curr Med Res Opin. 2021;37(7):1179-1187. https://doi.org/10.1080/03007995.2021.1923468

3Saverno KR, Carter GC, Li L, et al. Influence of prognostic factors on outcomes among metastatic breast cancer patients treated with CDK4 & 6 inhibitors in routine clinical practice. Poster presented at: 41st Annual San Antonio Breast Cancer Symposium (SABCS); December 4-8, 2018; San Antonio, TX. Accessed November 2, 2020. https://sabcs18.posterview.com/nosl/i/P2-08-38

4Saverno K, Carter GC, Dufour R, et al. Outcomes among metastatic breast cancer patients with characteristics that confer a less favorable prognosis. Poster presented at: 41st Annual San Antonio Breast Cancer Symposium (SABCS); December 4-8, 2018; San Antonio, TX. Accessed November 2, 2020. https://sabcs18.posterview.com/nosl/i/P2-08-66

5Saverno KR, Beyrer J, Smyth EN, et al. Real-world patient characteristics, utilization patterns, and outcomes of US patients with HR+/HER2- metastatic breast cancer treated with abemaciclib. Poster presented at: 43rd Annual San Antonio Breast Cancer Symposium (SABCS); December 8-11, 2020; San Antonio, TX. Accessed May 17, 2021. https://www.abstractsonline.com/pp8/#!/9223/presentation/1379

6Vidal GA, Carter GC, Gilligan A, et al. Risk stratification based on a prognostic factor index among patients with HR+, HER2- MBC. J Clin Oncol. 2019;37(15 suppl):e12516. American Society of Clinical Oncology abstract e12516. http://dx.doi.org/10.1200/JCO.2019.37.15_suppl.e12516

7Hamilton EP, Jansen VM, Nash Smyth EN, et al. Next-generation sequencing (NGS) results among hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) patients treated with a CDK4 & 6 inhibitor: a retrospective observational study based on real‑world data. Poster presented at: 55th Annual Meeting of the American Society of Clinical Oncology (ASCO); May 31-June 4, 2019; Chicago, IL. Accessed November 2, 2020. https://meetinglibrary.asco.org/record/175977/abstract

8Andre F, Aggarwal A, Rao X, et al. Characterizing demographics, clinical, and genomic characteristics for US patients with HR+, HER2- metastatic breast cancer following progression on a CDK4 and 6 inhibitor. Poster presented at: 57th Annual Meeting of the American Society of Clinical Oncology (ASCO Virtual); June 4-8, 2021. Accessed June 4, 2021. https://lillyscience.lilly.com/congress/AmOncMtgJun2021

9Method M, Rider A, Williams R, Brown J. Genomic testing, biomarkers and treatment patterns in early breast cancer. Poster presented at: Annual Meeting of the European Society for Medical Oncology (ESMO Virtual); September 19-21, 2020. Accessed September 15, 2020. https://cslide.ctimeetingtech.com/esmo2020/attendee/confcal_2/presentation/list?q=174P

10Brown J, Williams R, Rider A, et al. Multi-country study of the use of genomic assays in HR+, HER2- early breast cancer and characteristics of patients tested. Poster presented at: 43rd Annual San Antonio Breast Cancer Symposium (SABCS); December 8-11, 2020; San Antonio, TX. Accessed May 17, 2021. https://www.abstractsonline.com/pp8/#!/9223/presentation/1021

11Brown J, Scardo S, Method M, et al. The use of Ki67 testing and scoring in HR+, HER2- early breast cancer. Poster presented at: Annual Meeting of the European Society for Medical Oncology (ESMO Virtual); September 19-21, 2020. Accessed September 15, 2020. https://cslide.ctimeetingtech.com/esmo2020/attendee/confcal_2/presentation/list?q=181p

Fecha de la última revisión: 2021 M08 04


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