Cancer chemotherapy and pharmacology · 2013
Phase II study of ifosfamide and cisplatin for the treatment of recurrent ovarian cancer.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Song Taejong, Kim Min Kyu, Lee Yoo-Young, Choi Chel Hun, Kim Tae-Joong, Lee Jeong-Won, Kim Byoung-Gie, Bae Duk Soo
Аннотация
PURPOSE: The aim of this phase II study was to investigate the efficacy and toxicity of combined ifosfamide and cisplatin chemotherapy in patients with recurrent epithelial ovarian cancer (EOC).
EXPERIMENTAL DESIGN: Forty-seven patients with recurrent EOC were treated with ifosfamide 5 g/m(2) and cisplatin 50 mg/m(2) on day 1, every 3 weeks for 6 cycles. The primary outcomes were response rate (RR) and toxicity. Other measurements were duration of response, time to progression (TTP), and overall survival (OS).
RESULTS: All 47 patients with 160 cycles were assessed for response and toxicity. The overall RR was 31.9 %; there were 3 complete responses (6.4 %) and 12 partial responses (25.5 %). Grade 3 and 4 hematologic toxicities included neutropenia (23.6 %), anemia (12.8 %), and thrombocytopenia (10.7 %). Non-hematologic toxicities were mild, and no drug-related toxic deaths occurred. The median duration of response, TTP, and OS was 5.1, 4.8, and 17.0 months, respectively. In the initially platinum-sensitive group, RR and OS were 44.4 % and 20.4 months, while in the initially platinum-resistant group, these values were 15.0 and 8.7 months, respectively (P = 0.027 and P = 0.002, respectively).
CONCLUSION: Ifosfamide combined with cisplatin is a well-tolerated regimen with modest activity in recurrent EOC. In addition, this regimen was especially effective in patients whose disease was initially platinum-sensitive.
EXPERIMENTAL DESIGN: Forty-seven patients with recurrent EOC were treated with ifosfamide 5 g/m(2) and cisplatin 50 mg/m(2) on day 1, every 3 weeks for 6 cycles. The primary outcomes were response rate (RR) and toxicity. Other measurements were duration of response, time to progression (TTP), and overall survival (OS).
RESULTS: All 47 patients with 160 cycles were assessed for response and toxicity. The overall RR was 31.9 %; there were 3 complete responses (6.4 %) and 12 partial responses (25.5 %). Grade 3 and 4 hematologic toxicities included neutropenia (23.6 %), anemia (12.8 %), and thrombocytopenia (10.7 %). Non-hematologic toxicities were mild, and no drug-related toxic deaths occurred. The median duration of response, TTP, and OS was 5.1, 4.8, and 17.0 months, respectively. In the initially platinum-sensitive group, RR and OS were 44.4 % and 20.4 months, while in the initially platinum-resistant group, these values were 15.0 and 8.7 months, respectively (P = 0.027 and P = 0.002, respectively).
CONCLUSION: Ifosfamide combined with cisplatin is a well-tolerated regimen with modest activity in recurrent EOC. In addition, this regimen was especially effective in patients whose disease was initially platinum-sensitive.