Relapsed Ovarian Cancer
Conditions
Brief summary
Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug
Interventions
DRUGtrabectedin
Sponsors
PharmaMar
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women aged 18 years or older. * Presence of platinum-sensitive relapsed ovarian cancer. * Treatment and treated indication according to local label SmPC and reimbursement for trabectedin and PLD treatment. * Prior treatment with a minimum of 1 cycle of trabectedin + PLD according to SmPC before inclusion in the study, and no more than 3 previous treatment lines. * Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Progression Free Survival by Prior Antiangiogenic Treatment | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Progression Free Survival by BRCA1/2 Status | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Progression Free Survival by Platinum Sensitivity | From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019) | PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival by BRCA1/2 Status | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. |
| Overall Survival by Platinum Sensitivity | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. |
| Best Tumor Response | From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019) | Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions |
| Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment | Through study completion, up to 4.5 years (Jan 2015 to Sept 2019) | Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead |
| Change From Baseline to Best Post-baseline ECOG Performance Status Score | Through study completion, up to 4.5 years (Jan 2015 to Sept 2019) | Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead |
| Best Response by Prior Antiangiogenic Treatment | From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019) | Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions |
| Overall Survival | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. |
| Overall Survival by Prior Antiangiogenic Treatment | From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019) | Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive. |
Countries
Belgium, France, Germany, Italy, Spain
Participant flow
Recruitment details
A total of 220 patients treated according to standard local clinical practice in 57 sites across Italy, Spain, Germany, France, and Belgium have been enrolled in the study. The first patient was included in the study on 28 July 2015. Data were collected between 26 January 2015, date of first patient trabectedin administration (prior treatment before inclusion in the study) and 18 September 2019, date of last patient last visit.
Participants by arm
| Arm | Count |
|---|---|
| Prior Use of Antiangiogenics Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as antiangiogenic by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | 129 |
| No Prior Use of Antiangiogenics Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as antiangiogenic by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | 89 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 30 | 12 |
| Overall Study | Did not receive PLD | 2 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Progressive disease | 6 | 1 |
| Overall Study | Protocol amendment not signed | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Prior Use of Antiangiogenics | No Prior Use of Antiangiogenics | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 54 Participants | 35 Participants | 89 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants | 54 Participants | 129 Participants |
| Age, Continuous | 61.0 years | 61.0 years | 61.0 years |
| Best response to prior therapy regimen Complete Response | 24 Participants | 31 Participants | 55 Participants |
| Best response to prior therapy regimen Disease recurrence/Progression disease | 26 Participants | 6 Participants | 32 Participants |
| Best response to prior therapy regimen Not Evaluable/Not done/Unknown | 12 Participants | 17 Participants | 29 Participants |
| Best response to prior therapy regimen Partial Response | 31 Participants | 23 Participants | 54 Participants |
| Best response to prior therapy regimen Stable Disease | 36 Participants | 12 Participants | 48 Participants |
| BRCA 1/2 status tested Negative | 68 Participants | 32 Participants | 100 Participants |
| BRCA 1/2 status tested Not tested | 45 Participants | 38 Participants | 83 Participants |
| BRCA 1/2 status tested Positive | 15 Participants | 19 Participants | 34 Participants |
| BRCA 1/2 status tested Unknown | 1 Participants | 0 Participants | 1 Participants |
| Calculated body surface area | 1.7 m^2 | 1.7 m^2 | 1.7 m^2 |
| ECOG performance status Missing | 22 Participants | 26 Participants | 48 Participants |
| ECOG performance status PS 0 | 63 Participants | 45 Participants | 108 Participants |
| ECOG performance status PS 1 | 41 Participants | 15 Participants | 56 Participants |
| ECOG performance status PS 2 | 3 Participants | 3 Participants | 6 Participants |
| Height | 160 cm | 158 cm | 160 cm |
| Histopathology at initial ovarian cancer diagnosis Clear cell carcinoma | 6 Participants | 4 Participants | 10 Participants |
| Histopathology at initial ovarian cancer diagnosis Endometroid | 6 Participants | 8 Participants | 14 Participants |
| Histopathology at initial ovarian cancer diagnosis Fallopian tube carcinoma | 0 Participants | 2 Participants | 2 Participants |
| Histopathology at initial ovarian cancer diagnosis Mixed epithelial tumour | 4 Participants | 1 Participants | 5 Participants |
| Histopathology at initial ovarian cancer diagnosis Mucinous | 2 Participants | 1 Participants | 3 Participants |
| Histopathology at initial ovarian cancer diagnosis Papillary/serous | 97 Participants | 60 Participants | 157 Participants |
| Histopathology at initial ovarian cancer diagnosis Peritoneal carcinoma | 6 Participants | 3 Participants | 9 Participants |
| Histopathology at initial ovarian cancer diagnosis Transitional carcinoma (brenner) | 0 Participants | 1 Participants | 1 Participants |
| Histopathology at initial ovarian cancer diagnosis Transitional carcinoma (no brenner) | 0 Participants | 1 Participants | 1 Participants |
| Histopathology at initial ovarian cancer diagnosis Undifferentiated carcinoma | 2 Participants | 1 Participants | 3 Participants |
| Histopathology at initial ovarian cancer diagnosis Unknown | 6 Participants | 7 Participants | 13 Participants |
| Investigator reported body surface area | 1.6 m^2 | 1.7 m^2 | 1.7 m^2 |
| Number of prior chemotherapy lines 1 prior line | 22 Participants | 37 Participants | 59 Participants |
| Number of prior chemotherapy lines 2 prior lines | 48 Participants | 23 Participants | 71 Participants |
| Number of prior chemotherapy lines 3 prior lines | 32 Participants | 11 Participants | 43 Participants |
| Number of prior chemotherapy lines 4-8 prior lines | 27 Participants | 17 Participants | 44 Participants |
| Number of prior chemotherapy lines None | 0 Participants | 1 Participants | 1 Participants |
| Platinum sensitivity Fully Platinum Sensitive | 48 Participants | 41 Participants | 89 Participants |
| Platinum sensitivity Missing | 1 Participants | 1 Participants | 2 Participants |
| Platinum sensitivity Partially Platinum Sensitive | 80 Participants | 47 Participants | 127 Participants |
| Prior chemotherapy | 129 Participants | 88 Participants | 217 Participants |
| Prior radiotherapy | 4 Participants | 3 Participants | 7 Participants |
| Prior surgery | 118 Participants | 81 Participants | 199 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Belgium | 10 Participants | 2 Participants | 12 Participants |
| Region of Enrollment France | 9 Participants | 5 Participants | 14 Participants |
| Region of Enrollment Germany | 16 Participants | 2 Participants | 18 Participants |
| Region of Enrollment Italy | 57 Participants | 37 Participants | 94 Participants |
| Region of Enrollment Spain | 39 Participants | 43 Participants | 82 Participants |
| Sex: Female, Male Female | 129 Participants | 89 Participants | 218 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgery residual disease | 58 Participants | 26 Participants | 84 Participants |
| Tumor grade at diagnosis High grade | 95 Participants | 61 Participants | 156 Participants |
| Tumor grade at diagnosis Intermediate grade | 9 Participants | 5 Participants | 14 Participants |
| Tumor grade at diagnosis Low grade | 6 Participants | 6 Participants | 12 Participants |
| Tumor grade at diagnosis Not done/not reported/unknown | 19 Participants | 17 Participants | 36 Participants |
| Weight | 64.0 Kg | 68.0 Kg | 65.0 Kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 30 / 129 | 12 / 89 |
| other Total, other adverse events | 106 / 129 | 78 / 89 |
| serious Total, serious adverse events | 23 / 129 | 14 / 89 |
Outcome results
Primary
Progression-Free Survival
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Set | Progression-Free Survival | 9.46 months |
Primary
Progression Free Survival by BRCA1/2 Status
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Set | Progression Free Survival by BRCA1/2 Status | 9.23 months |
| No Prior Use of Antiangiogenics | Progression Free Survival by BRCA1/2 Status | 8.97 months |
p-value: 0.58Log Rank
Primary
Progression Free Survival by Platinum Sensitivity
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Set | Progression Free Survival by Platinum Sensitivity | 9.26 months |
| No Prior Use of Antiangiogenics | Progression Free Survival by Platinum Sensitivity | 9.46 months |
p-value: 0.62Log Rank
Primary
Progression Free Survival by Prior Antiangiogenic Treatment
PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Set | Progression Free Survival by Prior Antiangiogenic Treatment | 7.59 months |
| No Prior Use of Antiangiogenics | Progression Free Survival by Prior Antiangiogenic Treatment | 12.45 months |
p-value: 0.007Log Rank
Secondary
Best Response by Prior Antiangiogenic Treatment
Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Time frame: From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Analysis Set | Best Response by Prior Antiangiogenic Treatment | Stable disease | 32 Participants |
| Full Analysis Set | Best Response by Prior Antiangiogenic Treatment | Complete response | 11 Participants |
| Full Analysis Set | Best Response by Prior Antiangiogenic Treatment | Partial response | 27 Participants |
| Full Analysis Set | Best Response by Prior Antiangiogenic Treatment | Not evaluable/Not done | 13 Participants |
| Full Analysis Set | Best Response by Prior Antiangiogenic Treatment | Progressive disease | 46 Participants |
| No Prior Use of Antiangiogenics | Best Response by Prior Antiangiogenic Treatment | Not evaluable/Not done | 3 Participants |
| No Prior Use of Antiangiogenics | Best Response by Prior Antiangiogenic Treatment | Progressive disease | 16 Participants |
| No Prior Use of Antiangiogenics | Best Response by Prior Antiangiogenic Treatment | Stable disease | 27 Participants |
| No Prior Use of Antiangiogenics | Best Response by Prior Antiangiogenic Treatment | Partial response | 30 Participants |
| No Prior Use of Antiangiogenics | Best Response by Prior Antiangiogenic Treatment | Complete response | 13 Participants |
p-value: 0.01Chi-squared
Secondary
Best Tumor Response
Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Time frame: From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Analysis Set | Best Tumor Response | Complete response | 24 Participants |
| Full Analysis Set | Best Tumor Response | Partial response | 57 Participants |
| Full Analysis Set | Best Tumor Response | Stable disease | 59 Participants |
| Full Analysis Set | Best Tumor Response | Progressive disease | 62 Participants |
| Full Analysis Set | Best Tumor Response | Not evaluable/Not done | 16 Participants |
Secondary
Change From Baseline to Best Post-baseline ECOG Performance Status Score
Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead
Time frame: Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Analysis Set | Change From Baseline to Best Post-baseline ECOG Performance Status Score | Less than 0 (improvement) | 24 Participants |
| Full Analysis Set | Change From Baseline to Best Post-baseline ECOG Performance Status Score | 0 (no change) | 125 Participants |
| Full Analysis Set | Change From Baseline to Best Post-baseline ECOG Performance Status Score | More than 0 to 2 (deterioration) | 14 Participants |
| Full Analysis Set | Change From Baseline to Best Post-baseline ECOG Performance Status Score | Missing | 55 Participants |
Secondary
Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment
Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead
Time frame: Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Full Analysis Set | Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment | Less than 0 (improvement) | 14 Participants |
| Full Analysis Set | Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment | 0 (no change) | 83 Participants |
| Full Analysis Set | Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment | More than 0 to 2 (deterioration) | 5 Participants |
| Full Analysis Set | Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment | Missing | 27 Participants |
| No Prior Use of Antiangiogenics | Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment | Missing | 28 Participants |
| No Prior Use of Antiangiogenics | Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment | Less than 0 (improvement) | 10 Participants |
| No Prior Use of Antiangiogenics | Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment | More than 0 to 2 (deterioration) | 9 Participants |
| No Prior Use of Antiangiogenics | Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment | 0 (no change) | 42 Participants |
Secondary
Overall Survival
Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Time frame: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Set | Overall Survival | 23.56 months |
Secondary
Overall Survival by BRCA1/2 Status
Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Time frame: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Set | Overall Survival by BRCA1/2 Status | 23.56 months |
| No Prior Use of Antiangiogenics | Overall Survival by BRCA1/2 Status | 21.85 months |
p-value: 0.51Log Rank
Secondary
Overall Survival by Platinum Sensitivity
Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Time frame: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Set | Overall Survival by Platinum Sensitivity | 23.56 months |
| No Prior Use of Antiangiogenics | Overall Survival by Platinum Sensitivity | 26.05 months |
Secondary
Overall Survival by Prior Antiangiogenic Treatment
Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Time frame: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Full Analysis Set | Overall Survival by Prior Antiangiogenic Treatment | 21.85 months |
| No Prior Use of Antiangiogenics | Overall Survival by Prior Antiangiogenic Treatment | 26.28 months |
p-value: 0.048Log Rank