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Estudio Fase II: doxorrubicina liposomal pegilada y ciclofosfamida en pacientes con cáncer de ovario avanzado platinorresistente

DOI: 10.4321/S0378-48352006000300004

Keywords: liposomal adriamycin, cyclophosphamide, ovary cancer, platinum-resistant.

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Abstract:

purpose: to evaluate the efficacy and safeness of patients with advanced ovary cancer resistant to platinum-based drugs receiving a regime of liposomal adriamycin 35 mg/m2 and cyclophosphamide 600 mg/m2 day 1 every 28 days, up to a maximum of 8 cycles. material y métodos: twenty two evaluable patients were enrolled using the indicated phase ii methodology. results: a response was achieved in 5 out of 21 evaluable patients (23.8%; ic: 5.6-42), with 4 pr (19%; ic: 2.3-35.8) and 1 cr (4.8%; ic: 0-13.9). hematological toxicity was grade 1, 2 anemia in 12 (59%), and 3 (4%), and grade 1-2 neutropenia (26%). significant non-hematological toxicity was grade 3 fatigue (4%), nausea (4%), and palmoplantar erythrodisesthesia (4%). the mean progression time was 3.03 months (ic: 0.96-5.11). the median of survival was 6.13 months (ic: 4.32-7.95). the mean duration of the response in patients responding to treatment was 4.73 months (ic: 4.59-4.88). conclusion: the pegilated liposomal doxorubicin and cyclophosphamide regime administered to patients with advanced ovary cancer resistant to platinum-based drugs is relatively effective and shows low toxicity.

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