Pegylated liposomal doxorubicin: tolerability and toxicity

We evaluated the tolerability and toxicity attributed to pegylated liposomal doxorubicin (PL-DOX) in women with recurrent or refractory ovarian cancer, and reviewed procedures to prevent or treat toxicity induced by the agent. Medical records of 13 women who received PL-DOX between October 1997 and December 2000 were reviewed. Patients 1-8 received PL-DOX once it was added to the hospital formulary in 1997. Patients 9-13 received it after medical staff education. Data on premedications, number of cycles, dosage, length of infusion, tolerability, side effects, and indicators for response were collected. The median number of cycles and cumulative dose/patient of PL-DOX were higher (6 and 420 mg) in the second group than in the first group (2 and 240 mg). Patient factors such as duration of disease and number of chemotherapy cycles influenced tolerability. One patient experienced a life-threatening adverse reaction within minutes of receiving the first dose. Treatment was discontinued, and she was resuscitated successfully. Other dose- or treatment-limiting complications (neutropenia, stomatitis, plantar-palmar erythrodysesthesia) were documented. Toxicity management consisted of dosage reduction or treatment delay; treatment often was discontinued. Patients with recent disease tolerated more cycles of PL-DOX when given early in recurrence compared with heavily pretreated women with long-standing disease. Tolerability was not necessarily indicative of response. The agent is simple to administer, but its tolerability and lack of uniform toxicity management remain concerns.