TriangleNCT02574455 · OUTCOME
Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
What was measured
DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions.
Analysis population: Participants in the BM-ve Population with objective response 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 | Source count |
|---|---|
| Sacituzumab Govitecan | 82 |
| Treatment of Physician's Choice (TPC) | 15 |
Reported measurements
IRC Assessment
| Group | Source count |
|---|---|
| Sacituzumab Govitecan | 82 |
| Treatment of Physician's Choice (TPC) | 11 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sacituzumab Govitecan | 6.3 | Not reported | 5.5 | 7.9 | Not reported |
| Treatment of Physician's Choice (TPC) | 3.6 | Not reported | 2.8 | NA | Due to smaller number of participants with an event, upper limit of 95% confidence interval (CI) could not be calculated. |
Investigator Assessment
| Group | Source count |
|---|---|
| Sacituzumab Govitecan | 78 |
| Treatment of Physician's Choice (TPC) | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sacituzumab Govitecan | 6.9 | Not reported | 5.6 | 7.9 | Not reported |
| Treatment of Physician's Choice (TPC) | 3.0 | Not reported | 2.8 | 4.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.150
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.107
- group Description
- DOR by IRC Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0683
- p Value Comment
- Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.407
- statistical Method
- Log Rank
- ci Lower Limit
- 0.103
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.435
- group Description
- DOR by Investigator Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- p Value Comment
- Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.212
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.150
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.107
- group Description
- DOR by IRC Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0683
- p Value Comment
- Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.407
- statistical Method
- Log Rank
- ci Lower Limit
- 0.103
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.435
- group Description
- DOR by Investigator Assessment
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- p Value Comment
- Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.212
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 7.9
- value
- 6.3
- comment
- Due to smaller number of participants with an event, upper limit of 95% confidence interval (CI) could not be calculated.
- group Id
- OG001
- lower Limit
- 2.8
- upper Limit
- NA
- value
- 3.6
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- IRC Assessment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 7.9
- value
- 6.9
- group Id
- OG001
- lower Limit
- 2.8
- upper Limit
- 4.3
- value
- 3.0
- denoms
- counts
- group Id
- OG000
- value
- 78
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Investigator Assessment
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- Participants in the BM-ve Population with objective response were analyzed.
- reporting Status
- POSTED
- time Frame
- From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
- title
- Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice