Journal of the European Academy of Dermatology and Venereology : JEADV · 2011
Oral etoposide as first-line therapy in the treatment of patients with advanced classic Kaposi's sarcoma (CKS): a single-arm trial (oral etoposide in CKS).
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод в очереди
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Tas F, Sen F, Keskin S, Kilic L
Аннотация
BACKGROUND: Classic Kaposi's sarcoma (CKS) affects an elderly population; it is important to have effective treatment options with high activity and relatively low toxicity, and availability to be used for long periods.
OBJECTIVE: We investigated the activity and safety of single-agent etoposide with an oral administration schedule in patients with advanced CKS.
METHODS: Histologically confirmed, CKS patients were eligible for study. All had a negative test for HIV and good performance status. All patients received oral etoposide 50 mg twice daily for 10 days every 3 weeks.
RESULTS: Thirty patients (median age 66 and 22 males) were enrolled into the study. The majority of them had non-metastatic, local advanced disease and symptoms in nearly half of patients. Complete and partial responses were observed in 10% and 77% of patients, respectively, giving an overall response rate of 87%. Stable disease occurred in the other 13% of patients. Treatment was well tolerated. Grade IV toxicity was not observed. Haematological toxicity was the principal dose-limiting side effect. Severe leucopaenia and neutropaenia were observed in 7% and 10% of patients respectively. No patient was complicated by febrile neutropaenia. Mild-moderate anaemia observed frequently, but only 3% of patients had severe anaemia and severe thrombocytopaenia was not observed. The 5-year overall survival rate was 92%.
CONCLUSIONS: Single-agent oral etoposide is an effective treatment option and is acceptably toxic and easily administered. Therefore, we recommend the single agent of oral etoposide as the first-line chemotherapy for advanced CKS.
OBJECTIVE: We investigated the activity and safety of single-agent etoposide with an oral administration schedule in patients with advanced CKS.
METHODS: Histologically confirmed, CKS patients were eligible for study. All had a negative test for HIV and good performance status. All patients received oral etoposide 50 mg twice daily for 10 days every 3 weeks.
RESULTS: Thirty patients (median age 66 and 22 males) were enrolled into the study. The majority of them had non-metastatic, local advanced disease and symptoms in nearly half of patients. Complete and partial responses were observed in 10% and 77% of patients, respectively, giving an overall response rate of 87%. Stable disease occurred in the other 13% of patients. Treatment was well tolerated. Grade IV toxicity was not observed. Haematological toxicity was the principal dose-limiting side effect. Severe leucopaenia and neutropaenia were observed in 7% and 10% of patients respectively. No patient was complicated by febrile neutropaenia. Mild-moderate anaemia observed frequently, but only 3% of patients had severe anaemia and severe thrombocytopaenia was not observed. The 5-year overall survival rate was 92%.
CONCLUSIONS: Single-agent oral etoposide is an effective treatment option and is acceptably toxic and easily administered. Therefore, we recommend the single agent of oral etoposide as the first-line chemotherapy for advanced CKS.