Use of pegilated liposomal anthracycline (PLD) in clinical practice: Results and toxicity

Abstract

5180 Background: Pegilated liposomal doxorubicin (PLD) is considered a less toxic drugs as compared to conventional doxorubicin. The drug has the following indications: AIDS related Kaposi sarcoma, pretreated ovarian carcinoma and breast cancer patients (pts) at risk of cardiotoxicity. Methods: We have reviewed all the cases treated with PLD in our Institute in the last 3 years, out of clinical studies, in order to define the results and toxicity of these very expensive drug in daily clinical practice. Results: From Jan 2001 to Dec 2003 we have treated 108 pts with the following characteristics: 103 women and 5 men, median age 63 yr (range 38–82), 51 ovarian, 37 breast, 5 sarcoma, 4 endometrial, 4 NHL, 3 Kaposi, 2 biliary tract, 1 thyroid and 1 mesothelioma. With regard to ovarian cancer series, 36 pts have been treated with PLD as single agent, 11 in combination with oxaliplatin, 3 with paraplatin and 1 with gemcitabine, respectively. Responses were observed in 7 pts (3 CR + 4 PR) out of 51 pts (14%) and SD was observed in 12 (23%) of pts. With regard to breast cancer pts, 6/37 (16%) PR and 11/37 (29%) SD were observed in this series of heavily pretreated patients. In fact, all breast cancer pts had previously received anthracyclines and most of them also taxanes. Of the 4 NHL patients, 3 responded, whereas no one of the other tumor types responded. With regard to the toxicity, 28 out of 108 (26%) pts showed either palmo-plantar erytrodisestesia (PPD) at various degree or any form of cutaneous toxicity or first dose reaction which prevented drug continuation in 11 (10%) pts. Moreover, mucositis was observed in 24% of pts treated with doses over 40 mg/mq every 3 weeks, whereas neutropenia and alopecia were rarely complained. Cardiac toxicity was observed in 3/108 (3%) pts who were heavily pretreated with conventional anthracyclines at dosage of 755, 875 and 1234 mg/mq PLD respectively. Conclusions: From our retrospective study we learnt that the cost-effectiveness of PLD is high, and that toxicity, other than cardiac hematologic and alopecia, is also severe in heavily pretreated pts. On the other hand, the low incidence of cardiovascular events should advice to a better selection of pts to submit to PLD and to an earlier use in the course of the neoplastic disease. No significant financial relationships to disclose.