Ovarian Neoplasms
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.
Detailed description
This observational program is aimed at gaining tolerability and safety data with the routine use of Caelyx in its labelled indication in ovarian cancer, focusing on infusion reaction and PPE. Data will be raised about the premedication routinely used for the prevention of side effects caused by Caelyx. Premedications for infusion reactions include corticosteroids, serotonin 3 (5HT3) antagonists, histamine 1 (H1) blockers, and histamine 2 (H2) blockers. Premedications for PPE include oral dexamethasone and vitamin B6. The management of infusion reactions and PPE will be recorded. A detailed record of the medical history may reveal patient groups at a higher risk of experiencing these side effects.
Interventions
DRUGCaelyx (Pegylated Lyposomal Doxorubicin)
Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Women with advanced ovarian cancer with: * previous platin/taxane therapy and documented measureable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.
Exclusion criteria
* Patients that are not treated according to the Austrian Summary of Product Characteristics (SPC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) | The observational program was conducted over a period of 2 years | Definitions in assessment of adverse event severity: Mild: awareness of sign, symptom, or event, but easily tolerated. Moderate: discomfort enough to cause interference with usual activity and may warrant intervention. Severe: incapacitating with inability to do usual activities or significantly affects clinical status, and warrants intervention. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pegylated Lyposomal Doxorubicin 50 mg/m2 every 4 weeks for 6 cycles | 224 |
| Total | 224 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 9 |
| Overall Study | No documentation available | 13 |
| Overall Study | Reason for discontinuation not specified | 29 |
| Overall Study | Toxicity | 6 |
| Overall Study | Tumor progression | 56 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Pegylated Lyposomal Doxorubicin |
|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 10.95 |
| Region of Enrollment Austria | 224 participants |
| Sex: Female, Male Female | 224 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 214 |
| serious Total, serious adverse events | 14 / 214 |
Outcome results
Primary
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)
Definitions in assessment of adverse event severity: Mild: awareness of sign, symptom, or event, but easily tolerated. Moderate: discomfort enough to cause interference with usual activity and may warrant intervention. Severe: incapacitating with inability to do usual activities or significantly affects clinical status, and warrants intervention.
Time frame: The observational program was conducted over a period of 2 years
Population: Intent-to-treat (ITT) (N=214). This is also the Safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegylated Lyposomal Doxorubicin | Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) | Mild infusion reaction | 2 Events |
| Pegylated Lyposomal Doxorubicin | Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) | Moderate infusion reaction | 5 Events |
| Pegylated Lyposomal Doxorubicin | Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) | Severe infusion reaction | 2 Events |
| Pegylated Lyposomal Doxorubicin | Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) | infusion reaction - severity not specified | 1 Events |
| Pegylated Lyposomal Doxorubicin | Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) | Mild PPE | 37 Events |
| Pegylated Lyposomal Doxorubicin | Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) | Moderate PPE | 23 Events |
| Pegylated Lyposomal Doxorubicin | Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) | Severe PPE | 5 Events |