Nursing support program to decrease or prevent side effects of pegylated liposomal doxorubicin (PLD) in patients with recurrent epithelial ovarian cancer (REOC)

Abstract

8198 Background: A significant long-term survival with PLD compared to topotecan was recently reported in a phase III randomized study of women with REOC (Gyn. Oncol. 2004). PLD is known to be relatively less toxic than topotecan and conventional doxorubicin, however side effects such as palmar-plantar erythrodysesthesia (PPE) may lead to sub-optimal drug exposure and treatment discontinuation. Methods: A nursing support program was created to determine if patient education and proactive nursing care could improve treatment outcomes by decreasing the occurrence and/or severity of PLD-related side effects. Patients who agreed to participate in the program were: educated about potential toxicities associated with PLD, received written instructions on the prevention and management of side effects and were provided with a diary to record symptoms and interventions. Results: A total of 112 ovarian cancer patients who relapsed after one or more prior therapies were accrued in 8 different centers. PLD was administered as 2nd, 3rd and ≥ 4th line therapy in 51%, 34% and 15% of patients, respectively. The majority of patients (85%) received a Taxol/platinum combination as 1st line therapy. The median patient age was 62 years (32–87). The average dose of PLD was 40.4 mg/m2 (35–50) every 28 days for an average of 4.01 cycles (1–23). Efficacy was evaluated using clinical symptoms and/or radiological evaluation. A majority of patients (69%) benefited from therapy characterized as disease stabilization or better. Overall the frequency of adverse events, in these heavily pretreated patients, was similar to that observed in a previous phase III clinical trial (Gordon JCO 2001) where patients had received only one prior therapy. However, the incidence of some grade 3/4 toxicities was substantially decreased, thus grade 3/4 PPE and mucositis were reduced from 21% to 4% and 8% to 3%, respectively. Conclusions: The nursing support program helped to reduce the severity of PPE and mucositis in patients receiving PLD for recurrent epithelial ovarian cancer. No significant financial relationships to disclose.