243- PHASE II STUDY OF PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) PLUS OXALIPLATIN (OXA) FOR RESISTANT OR REFRACTORY OVARIAN CANCER PATIENTS

Int J Gynecol Cancer 2006, 16 (Suppl. 3), 624–694
In coll. L. Carlini, A. Villa, L. Busci, G. Trezzi, A. Gallo, L. Frigerio
Department of Obstetrics and Gynecology, Ospedali Riuniti Bergamo
Universita` Di Milano Bicocca, Bergamo, Italy
Background: Platinum-refractory and resistant ovarian-cancerpatients
have a poor prognosis. Since PLD has shown activity in this
setting and OXA produces responses in cancer patients resistant to
platinum, this drug combination was tested.
Methods: A PhaseII study was conducted in a population of ovarian-
cancer-patients, with the combination of PLD (40mg/m2) and
oxaliplatin (120mg/m2) administered every three weeks. Treatment
continued to 6 cycles in the absence of disease progression or
unacceptable toxicity. To date, 15 patients platinum-resistantrefractory
have been treated.
Results: The median age of the study group was 61 years (range
38-77). Patients had Stage-III disease (FIGO-Staging-System) and
were pretreated with carboplatin and taxol. The 15 patients received
70 courses of therapy and the number of cycles administered per patient
was 4.6 (range 1-6 courses). Of 14 evaluable patients, 4 complete
(CR) and 3 partial responses (PR) have been observed
according to Recist-criteria (overall response rate, ORR ¼ 50%). The
most common toxicity was G3-4-neutropenia in 7 patients (50%),
with G3-4-thrombocytopenia, in 2 patients (14.2%), and peripheral
neuropathy in 3 patients (21.4%). Palmar-plantar-erythrodysesthesia
and mucositis were mild. No toxic death was reported.
Conclusions: In ovarian cancer patients with platinum-refrectory or
platinum-resistant disease, the combination of pegylated liposomal
doxorubicin and oxaliplatin appears to be an active regimen with
manageable toxicity, and thus should be studied further as a potential
therapy for these patients.