Efficacy and toxicity profile of pegylated liposomal doxorubicin in patients with advanced ovarian cancer.

BACKGROUND: The prognosis of patients with non-platinum-sensitive recurrent ovarian cancer is poor. There is a need for salvage therapies with anti-tumor activity and acceptable toxicity for maintaining quality of life. Pegylated liposomal doxorubicin (PLD, Caelyx(®)) is a promising drug fulfilling these demands. We present retrospective data of patients with advanced epithelial ovarian cancer (EOC) who were treated with pegylated liposomal doxorubicin at the University of Heidelberg between 2007 and 2009. PATIENTS AND METHODS: Eligible patients for this retrospective study had advanced ovarian cancer and were treated in a palliative setting with PLD at the university hospital of Heidelberg, Germany. Primary objectives were toxicity and efficacy of PLD. 34 patients were included in this study between November 2007 and December 2009; one patient received PLD twice as palliative treatment. RESULTS: The median age of the 34 patients enrolled in this study was 59.9 years (range 27-77 years). The median weight of the patients was 69 kg (range 47-109 kg), the median height 164 cm (range 140-176 cm). Pegylated liposomal doxorubicin was administered every 4 weeks with a dosage of 40 mg/m(2) body surface. PLD was administered for three cycles in median (range 1-9 cycles). Dose reduction was necessary in only four patients. In our study time to progression and overall survival was 8.74 and 14.23 months. CONCLUSIONS: In conclusion, this retrospective study showed the efficacy and low toxicity of pegylated liposomal doxorubicin in patients with advanced EOC. Further observations are needed to confirm these preliminary experiences on a larger number of patients.

Treatment of localized mycosis fungoides with digital UV photochemotherapy.

BACKGROUND/PURPOSE: Photochemochemotherapy with 8-methoxypsoralen and UV-A light (PUVA) is a well-established treatment for mycosis fungoides (MF), although evidence for this therapy by means of prospective studies is scarce. However, long-term risks of PUVA are premature skin aging and development of nonmelanoma skin cancer. We therefore evaluated a device for targeted UV therapy, which reduces irradiation of unaffected skin in MF patients. METHODS: Ten patients with patch- or plaque-type MF affecting less than 10% body surface area were included in a prospective study. A total of 14 lesions were treated with cream PUVA using the digital phototherapy device skintrek(®) PT3. RESULTS: Seven of ten patients showed response to treatment. Complete clinical remission was achieved in four of ten patients (complete remission of seven of fourteen treated lesions) after an average of 13.4 weeks and an average cumulative UV dose of 42.6 J/cm(2) in a mean of 31.2 treatment sessions. Adverse events were rare and of mild severity. CONCLUSIONS: This study is the first prospective trial demonstrating efficacy and safety of cream PUVA in MF patients. As healthy adjacent skin remains unaffected, the potential to reduce the carcinogenic risk of PUVA treatment makes this new method a promising therapeutic option for localized MF.

Efficacy and toxicity profile of pegylated liposomal doxorubicin (Caelyx) in patients with advanced breast cancer.

Many patients with metastatic breast cancer (MBC) have been treated previously with taxanes and/or anthracyclines, which renders reinduction of anthracyclines in the palliative setting impossible because of the high cardiotoxicity of these drugs. Pegylated liposomal doxorubicin represents a means of reinducing anthracyclines without increasing cardiotoxicity. The aim of this retrospective study was to evaluate the efficacy and toxicity of Caelyx in patients with MBC. Patients with histologically confirmed MBC were eligible for this retrospective study if they had received palliative chemotherapy with pegylated liposomal doxorubicin between 1 January 2002 and 31 December 2006 at the Department for Gynecology and Obstetrics at the University of Heidelberg (Germany). The main endpoints were time to progression, overall survival, and safety of the treatment with pegylated liposomal doxorubicin. In all, 141 patients were included in this retrospective trial. The median age of the patients was 54 years (range 24-84 years). Of the patients, 43% had received five to six previous chemotherapy regimens before pegylated liposomal doxorubicin was recommended. In 33% of patients, more than three organs were involved. The most commonly involved organs were bones, liver, and lungs; 37 patients had received three or at least six cycles of Caelyx. During the treatment with pegylated liposomal doxorubicin, left ventricular ejection function was not reduced by more than 15%. The major effects (grade 4) were hematological toxicity (anemia, leukopenia, and thrombocytopenia), hand-foot syndrome, and stomatitis. In nine patients, the dose was reduced and in three patients chemotherapy with Caelyx was stopped owing to hematological toxicity. In 20 patients, the dose was reduced and in nine patients chemotherapy was stopped owing to nonhematological toxicity. The median time to disease progression was 6.5 months; the overall median survival was 13 months after the first course of pegylated liposomal doxorubicin was initiated. This retrospective study confirmed the efficacy and good tolerability of pegylated liposomal doxorubicin in patients with MBC who had been treated previously with anthracycline. A dosage of 40 mg/m² body surface every 4 weeks is equally effective with less toxicity.