Pegylated liposomal doxorubicin treatment in recurrent gynecologic cancer patients with renal dysfunction.

OBJECTIVES

A paucity of data exists regarding the efficacy and toxicity of pegylated liposomal doxorubicin (PLD) in cancer patients with chronic kidney disease (CKD). We sought to investigate the toxicity and efficacy of PLD in gynecologic cancer patients with CKD.

METHODS

The clinical records of all patients with recurrent gynecological cancer and CKD at the University of Texas M.D. Anderson Cancer Center from 08/1999 to 08/2006 were reviewed retrospectively to identify patients who received PLD.

RESULTS

Twenty-eight patients were identified, which included 14 with epithelial ovarian cancer, 4 with peritoneal cancer, and 10 with other gynecologic cancers. CKD was defined as a creatinine clearance (CrCl) of <90 ml/min/1.73 m(2) and classified as mild (5 patients), moderate (16 patients), or severe (7 patients) (CrCl 60-89, 30-59, and <30 ml/min/1.73 m(2), respectively). The initial doses of PLD were classified into regular initial dose (40 mg/m(2)/4 weeks) and lower initial dose (30-35 mg/m(2)/4 weeks). The median cycle was 4.5 (range 1-17). The incidence of grade 3-4 palmar-plantar erythrodysesthesia, stomatitis, and hematologic toxicity was 11.1% (2/18), 5.6% (1/18), and 16.7% (3/18) among 18 patients with an initial dose of 40 mg/m(2)/4 weeks, which included 5, 10, and 3 patients with mild, moderate, and severe CKD, respectively. Dose reduction due to toxicities occurred in 33.3% (6/18) patients. In 18 patients with ovarian and peritoneal cancer (all platinum-resistant), the rates of complete response, partial response, stable disease, and progression were 0%, 11.1%, 44.4%, and 44.4%, respectively.

CONCLUSIONS

Patients with CKD who received PLD therapy at an initial dose of 40 mg/m(2)/4 weeks may require greater subsequent dose reduction mainly secondary to mucocutaneous and hematologic toxicities. Treatment response in this population with ovarian and peritoneal cancer was similar to that of patients with normal renal function.