| Title | Association of pegylated liposomal doxorubicin and ifosfamide in early recurrent ovarian cancer patients: A Multicenter Phase II Trial. | | Author(s) | Joly F, Sevin E, Lortholary A, Priou F, Paitel JF, Fabbro M, Henry-Amar M, Hamond K, Bourgeois H | | Institution | Centre François Baclesse, 3 avenue du Général Harris, 14076 CAEN cedex 05, France. | | Source | Gynecol Oncol 2009 Nov 2. | | Abstract | 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 >/=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 >/=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.
CONCLUSION: 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. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19887304 |
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