期刊
GYNECOLOGIC ONCOLOGY
卷 108, 期 1, 页码 90-94出版社
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.ygyno.2007.08.075
关键词
platinum-sensitive; ovarian cancer; pegylated liposomal doxorubicin; carboplatin
资金
- NCI NIH HHS [N01 CA067575, U10 CA035119, U10 CA035431, U10 CA038926, N01 CA035178, U10 CA032102, U10 CA035178, N01 CA063844, N01 CA046441, N01 CA035119, N01 CA045807, U10 CA013612, N01 CA013612, N01 CA032102, U10 CA045560, N01 CA004919, U10 CA067575, N01 CA045560, N01 CA038926, N01 CA035431, N01 CA027057, U10 CA046441, U10 CA004919, U10 CA045807, U10 CA035176, U10 CA063844, U10 CA027057, N01 CA035176] Funding Source: Medline
- NATIONAL CANCER INSTITUTE [U10CA027057, U10CA063844, U10CA038926, U10CA032102, U10CA045807, U10CA035178, U10CA035431, U10CA046441, U10CA035119, U10CA013612, U10CA067575, U10CA045560, U10CA035176, U10CA004919] Funding Source: NIH RePORTER
Objective. Because debate continues over the role of combination, platinum-based chemotherapy for platinum-sensitive (PS), recurrent ovarian cancer (OC), we compared overall survival (OS), progression-free survival (PFS), confirmed complete response rate and time to treatment failure in this population. Methods. Patients with recurrent stage III or IV OC, a progression-free and platinum-free interval of 6-24 months after first-line platinum-based chemotherapy and up to 12 courses of a non-platinum containing consolidation treatment were eligible. Patients were randomized to IV pegylated liposomal doxorubicin (PLD) (30 mg/m(2)) plus IV carboplatin (AUC = 5 mg/mL min) once every 4 weeks (PLD arm) or IV carboplatin alone (AUC=5 mg/mL min) once every 4 weeks. Results. The PLD arm enrolled 31 patients and the carboplatin alone arm 30 for a total of 61 patients out of 900 planned. Response rates were 67% for the PLD arm and 32% for the carboplatin only arm (Fisher's exact p = 0.02). The estimated median PFS was 12 and 8 months for PLD versus carboplatin alone. The estimated median OS on the PLD arm was 26 months and 18 months on the carboplatin only arm (p=0.02). Twenty-six percent of the patients on the PLD arm reported grade 4 toxicities, all hematological in nature. Conclusion. This study was closed early because of slow patient accrual. The response rate, median PFS and OS results are intriguing. These data suggest that there may be an advantage to the PLD plus carboplatin combination treatment in patients with PS, recurrent OC. The regimen should be further tested. (c) 2007 Elsevier Inc. All rights reserved.
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