A phase I study of pegylated liposomal doxorubicin hydrochloride (Caelyx) in combination with cyclophosphamide and vincristine as second-line treatment of patients with small-cell lung cancer.

Autor: Leighl NB; Department of Medical Oncology, Princess Margaret Hospital, 610 University Ave, Toronto, ON M5G 2M9, Canada. natasha.leighl@uhn.on.ca, Burkes RL, Dancey JE, Lopez PG, Higgins BP, David Walde PL, Rudinskas LC, Rahim YH, Rodgers A, Pond GR, Shepherd FA
Jazyk: angličtina
Zdroj: Clinical lung cancer [Clin Lung Cancer] 2003 Sep; Vol. 5 (2), pp. 107-12.
DOI: 10.3816/CLC.2003.n.024
Abstrakt: The purpose of this study was to determine the recommended phase II dose of liposomal doxorubicin (Caelyx ; Doxil in the United States) in combination with cyclophosphamide and vincristine for previously treated patients with good performance status with relapsed or refractory small-cell lung cancer. Twenty-one eligible patients were enrolled between November 1999 and September 2001 and received liposomal doxorubicin 25-40 mg/m2, cyclophosphamide 750-1000 mg/m2, and vincristine 1.2 mg/m2 intravenously (I.V.) every 21 days. At doses of liposomal doxorubicin 40 mg/m2, cyclophosphamide 750 mg/m2, and vincristine 1.2 mg/m2 I.V., 1 of 6 patients had dose-limiting neutropenia and fever in cycle 2 and 2 of 6 developed grade 3 hand-foot syndrome during cycle 3. Therefore, the recommended phase II doses are liposomal doxorubicin 35 mg/m2, cyclophosphamide 750 mg/m2, and vincristine 1.2 mg/m2 I.V. every 21 days. Antitumor activity was seen at all dose levels. This combination is well tolerated and has evidence of antitumor activity. A phase II evaluation is ongoing.
Databáze: MEDLINE
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