Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

Comparison of Quality of Life in Patients With Platinum-sensitive Recurrent Ovarian, Fallopian Tube and Peritoneal Cancer When Treated With Treatment With Trabectedin/PLD or Standard Platinum-based Therapy

Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life

Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions e.g. palmar-plantar erythrodysesthesia (PPE) were reported as being the dose-limiting toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL was investigated. Secondary objective of this study was to evaluate the response rates of this new regimen.

Inclusion Criteria:

• Patients ≥ 18 years of age
• recurrent ovarian, peritoneal, or tubal cancer and prior treatment with platinum- and paclitaxel were eligible to this trial.
• Eastern Cooperative Oncology Group (ECOG) performance status less than 3.
• renal function (serum creatinine 1.25 times the upper limit of normal, glomerular filtration rate greater than 60 ml/min)
• liver function (AST/ ALT three times the upper limit of normal, bilirubin concentrations 1.25 the upper limit of normal)
• bone marrow function (neutrophil count greater than 1.5 x 109/l, and a platelet count greater than 100 x 109/l).

Exclusion Criteria:

• patients with more than 4 chemotherapies in medical history
• severe cardiac disease