Association of pegylated liposomal doxorubicin and ifosfamide in early recurrent ovarian cancer patients: a multicenter phase II trial.
OBJECTIVE
To evaluate the efficacy of pegylated liposomal doxorubicin (PLD) and continuous infusion ifosfamide (IFO) in ovarian cancer patients who relapse within 1 year after first-line paclitaxel-platinum-based chemotherapy.


METHODS
Patients were stratified according to treatment-free interval (TFI) (<or >or=6 months). PLD (40 mg/m(2), day 1), IFO (1700 mg/m(2), infusion days 1-3), and mesna were given every 28 days for 6-9 cycles. Primary endpoint was objective response rate (ORR). Secondary endpoints were response duration, progression free survival (PFS), overall survival (OS), and toxicity.


RESULTS
There were 98 evaluable patients (58%, TFI<6 months). Median number of cycles was 5 (range: 1-9). The frequency of grade 3/4 anemia, thrombocytopenia, and neutropenia was 7%, 3%, and 48%, respectively; febrile neutropenia was 3%. A low rate of grade 3/4 non-hematologic toxicities was reported, including nausea/vomiting (3/4%), hand-foot syndrome (2%), and mucositis (2%). The ORR was 28% (41% and 19% in patients with TFI >or=6, or <6 months, respectively); rate of disease stabilization was 26%; response duration and median OS were 6 (2.4-26) and 14 (1-46) months, respectively.


CONCLUSIONS
The combination of PLD and continuous IFO is a feasible and efficient treatment in patients with relapsed ovarian cancer, especially with TFI between 6 and 12 months. This regimen may represent an alternative to platinum reintroduction and should be evaluated in a randomized trial.
Joly
Florence
F
Centre François Baclesse, 3 avenue du Général Harris, Caen cedex 05, France. f.joly@baclesse.fr
Sevin
Emmanuel
E
Lortholary
Alain
A
Priou
Frank
F
Paitel
J F
JF
Fabbro
Michel
M
Henry-Amar
Michel
M
Hamond
Karim
K
Bourgeois
Hugues
H
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate
C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D007069:Ifosfamide