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
Study Type
OBSERVATIONAL
Enrollment
220
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)
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)
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.
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O.L.V. Aalst
Aalst, Flanders, Belgium
AZ Maria Middelares
Ghent, Flanders, Belgium
Centre Hospitalier de Jolimont
La Louvière, Henao, Belgium
CHU Ambroise-Paré
Mons, Henao, Belgium
Centre Hospitalier de Wallonie Picarde
Tournai, Henao, Belgium
CHIREC - Cancer Institute
Brussels, Belgium
Centre d'Oncologie et de Radiothérapie du Parc
Dijon, Borgoña, France
Clinique Saint Jean
Toulon, Provence, France
Institut d'Oncologie Hauts-de-Seine Nord
Neuilly-sur-Seine, Seine, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, Sharte, France
...and 55 more locations
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)