Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline
Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) · Source last updated 2022-06-15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
First dose date up to last follow-up (maximum up to 30.8 months)
What was measured
Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported.
Analysis population: Participants in the Safety analysis set were analyzed.
Groups in this outcome
Sacituzumab Govitecan
Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Treatment of Physician's Choice (TPC)
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively).
Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.
Gemcitabine 800 to 1200 mg/m\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.
Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Sacituzumab Govitecan
258
Treatment of Physician's Choice (TPC)
224
Reported measurements
Anemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
8.9
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
5.4
Not reported
Not reported
Not reported
Not reported
Lymphocyte Count Decreased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
33.3
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
25.0
Not reported
Not reported
Not reported
Not reported
Neutrophil Count Decreased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
48.8
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
35.3
Not reported
Not reported
Not reported
Not reported
Platelet Count Decreased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
1.2
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
2.7
Not reported
Not reported
Not reported
Not reported
White Blood Cell Decreased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
41.1
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
25.4
Not reported
Not reported
Not reported
Not reported
Alanine Aminotransferase Increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
1.2
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
2.2
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphatase Increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
3.1
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
3.6
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase Increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
3.5
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
2.2
Not reported
Not reported
Not reported
Not reported
Blood Bilirubin Increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
1.9
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
2.7
Not reported
Not reported
Not reported
Not reported
Creatinine Increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
0.4
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
0
Not reported
Not reported
Not reported
Not reported
Hypercalcemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
0
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
0.4
Not reported
Not reported
Not reported
Not reported
Hyperglycemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
3.1
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
3.1
Not reported
Not reported
Not reported
Not reported
Hyperkalemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
0.8
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
0
Not reported
Not reported
Not reported
Not reported
Hypermagnesemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
0.4
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
0.4
Not reported
Not reported
Not reported
Not reported
Hypernatremia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
0
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
0
Not reported
Not reported
Not reported
Not reported
Hypoalbumenemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
0.8
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
1.3
Not reported
Not reported
Not reported
Not reported
Hypocalcemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
1.6
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
1.3
Not reported
Not reported
Not reported
Not reported
Hypoglycemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
0.4
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
0
Not reported
Not reported
Not reported
Not reported
Hypokalemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
4.3
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
0.9
Not reported
Not reported
Not reported
Not reported
Hypomagnesemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
0.8
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
0
Not reported
Not reported
Not reported
Not reported
Hyponatremia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
3.9
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
3.6
Not reported
Not reported
Not reported
Not reported
Hypophosphatemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Sacituzumab Govitecan
8.1
Not reported
Not reported
Not reported
Not reported
Treatment of Physician's Choice (TPC)
3.6
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
8.9
group Id
OG001
value
5.4
title
Anemia
categories
measurements
group Id
OG000
value
33.3
group Id
OG001
value
25.0
title
Lymphocyte Count Decreased
categories
measurements
group Id
OG000
value
48.8
group Id
OG001
value
35.3
title
Neutrophil Count Decreased
categories
measurements
group Id
OG000
value
1.2
group Id
OG001
value
2.7
title
Platelet Count Decreased
categories
measurements
group Id
OG000
value
41.1
group Id
OG001
value
25.4
title
White Blood Cell Decreased
categories
measurements
group Id
OG000
value
1.2
group Id
OG001
value
2.2
title
Alanine Aminotransferase Increased
categories
measurements
group Id
OG000
value
3.1
group Id
OG001
value
3.6
title
Alkaline Phosphatase Increased
categories
measurements
group Id
OG000
value
3.5
group Id
OG001
value
2.2
title
Aspartate Aminotransferase Increased
categories
measurements
group Id
OG000
value
1.9
group Id
OG001
value
2.7
title
Blood Bilirubin Increased
categories
measurements
group Id
OG000
value
0.4
group Id
OG001
value
0
title
Creatinine Increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0.4
title
Hypercalcemia
categories
measurements
group Id
OG000
value
3.1
group Id
OG001
value
3.1
title
Hyperglycemia
denoms
counts
group Id
OG000
value
258
group Id
OG001
value
224
units
Participants
description
Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported.
groups
description
Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
id
OG000
title
Sacituzumab Govitecan
description
Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively).
Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.
Gemcitabine 800 to 1200 mg/m\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.
Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
id
OG001
title
Treatment of Physician's Choice (TPC)
param Type
NUMBER
population Description
Participants in the Safety analysis set were analyzed.
reporting Status
POSTED
time Frame
First dose date up to last follow-up (maximum up to 30.8 months)
title
Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline