A multicenter phase II study of pegylated liposomal doxorubicin and oxaliplatin in recurrent ovarian cancer.
OBJECTIVE
Pegylated liposomal doxorubicin (PLD) and oxaliplatin (LOHP) are active as single agents in the treatment of recurrent ovarian cancer (ROC). This phase II study investigated the safety and activity of PLD and LOHP used in combination to treat ROC.


METHODS
Eligibility criteria included disease recurrence after one (45%) or more lines (55%) of chemotherapy, performance status <or=2 and life expectancy >3 months. Treatment was 40 mg/m(2) PLD and 120 mg/m(2) LOHP, administered over 2 days, every 3 weeks. Response to therapy was assessed using the RECIST criteria.


RESULTS
Forty patients with ROC enrolled in the study from 10/2001 to 10/2005; 27 patients were platinum-sensitive and 13 were platinum-resistant. Major toxicities included grade 3-4 neutropenia (37%) and grade 2 palmar-plantar erythrodysesthesia (10%). The overall response rate was 67.5%, with 30% stable disease rate and 2.5% progressive disease rate. The median progression-free survival (PFS) was 9.6 months, while median overall survival was 18.3 months, with no statistically significant difference in PFS between platinum-resistant and platinum-sensitive patients.


CONCLUSIONS
We conclude that the combination of PLD and LOHP shows activity in ROC with a manageable toxicity profile and can be safely administered in heavily pre-treated patients.
Recchia
Francesco
F
Unità operativa di Oncologia, Ospedale Civile di Avezzano, AQ, Italy. frecchia1946@libero.it <frecchia1946@libero.it>
Saggio
Gaetano
G
Amiconi
Giovanna
G
Di Blasio
Anna
A
Cesta
Alisia
A
Candeloro
Giampiero
G
Carta
Gaspare
G
Necozione
Stefano
S
Mantovani
Giovanni
G
Rea
Silvio
S
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000077150:Oxaliplatin; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects
D009944:Organoplatinum Compounds; C506643:liposomal doxorubicin; D000077150:Oxaliplatin; D011092:Polyethylene Glycols; D004317:Doxorubicin