Phase II study of the combination carboplatin plus celecoxib in heavily pre-treated recurrent ovarian cancer patients.
Phase II study of the combination carboplatin plus celecoxib in heavily pre-treated recurrent ovarian cancer patients.
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卡铂联合塞来昔布联合治疗已接受过多次治疗的复发性卵巢癌患者的 II 期研究。
DOI：
10.1186/1471-2407-11-214
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发表时间：
2011-05-31
期刊：
影响因子：
3.8
通讯作者：
Ferrandina G
中科院分区：
文献类型：
--
作者：
Legge F;Paglia A;D'Asta M;Fuoco G;Scambia G;Ferrandina G
环氧合酶-2过度表达与卵巢癌预后不良及对铂类化疗耐药相关我们评估了卡铂联合考克斯-2抑制剂塞来昔布治疗复发性重度OC患者的抗肿瘤活性和安全性。患者口服塞来昔布（400 mg/天）联合静脉卡铂（AUC 5，q28）。采用Simon的两阶段设计。入组了45例患者：23例（51.1%）出现铂类耐药，27例（60%）接受过至少3种既往复发治疗方案。缓解率为28.9%，3例完全缓解，10例部分缓解（中位缓解持续时间= 6个月）。仅观察到1例（0.4%）G4非发热性中性粒细胞减少;分别在2.5%、1.7%和1.7%的周期中观察到G3中性粒细胞减少、贫血或血小板减少。仅1.7%报告了G3-4呕吐，0.4%的周期与G3消化不良或腹泻或便秘相关。仅1例患者发生与G2超敏反应相关的G3高血压。未观察到基线与治疗后生活质量评分的差异。中位无进展生存期和总生存期分别为5个月和13个月。塞来昔布联合卡铂显示出有希望的活性，并且在重度治疗的复发性卵巢癌患者中耐受性良好。NCT 01124435（ClinicalTrials.gov标识符）和935/03（研究ID编号）。
Cyclooxygenase-2 overexpression is associated with poor outcome and resistance to platinum-based chemotherapy in ovarian cancer. We evaluated the antitumor activity and safety of the combination carboplatin plus the COX-2 inhibitor celecoxib in recurrent heavily-treated OC patients. Patients were administered oral celecoxib (400 mg/day) in combination with intravenous carboplatin (AUC5, q28). A Simon's two-stage design was employed. 45 patients were enrolled: 23 (51.1%) presented platinum-resistance, and 27 (60%) had received at least 3 prior regimens for recurrence. The response rate was 28.9% with 3 complete and 10 partial responses (median duration of response = 6 months). Only one (0.4%) G4 non-febrile neutropenia was observed; G3 neutropenia, anemia, or thrombocytopenia, were observed in 2.5%, 1.7%, and 1.7% of the cycles, respectively. G3-4 vomiting was reported in only 1.7%, and 0.4% of the cycles were associated with G3 dyspepsia or diarrhea or constipation. Only one patient experienced G3 hypertension associated to G2 hypersensitivity reaction. No differences in baseline versus post-treatment Quality of Life scores were observed. Median progression free survival and overall survival were 5 and 13 months, respectively. Celecoxib combined with carboplatin showed promising activity and it is well tolerated in heavily-treated recurrent ovarian cancer patients. NCT01124435 (ClinicalTrials.gov Identifier) and 935/03 (study ID numbers).
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影响因子：
11.5
作者：
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通讯作者：
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