A phase II evaluation of belinostat and carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma: a Gynecologic Oncology Group study.
A phase II evaluation of belinostat and carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma: a Gynecologic Oncology Group study.
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DOI：
10.1016/j.ygyno.2012.02.019
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发表时间：
2012-05
影响因子：
4.7
通讯作者：
Fader AN
中科院分区：
文献类型：
--
作者：
Dizon DS;Blessing JA;Penson RT;Drake RD;Walker JL;Johnston CM;Disilvestro PA;Fader AN
复发性卵巢癌患者的选择有限，尤其是在主要铂类治疗后不到六个月的情况下复发的情况。这项妇科肿瘤小组 (GOG) 研究的目的是评估组蛋白脱乙酰酶抑制剂贝利司他 (belinostat) 与卡铂联合治疗对铂类耐药卵巢癌女性的影响。符合条件的患者在最后一次接受铂类组合治疗后六个月内出现可测量的复发性疾病。贝利司他每天服用 1,000 mg/m2，持续五天，并在 21 天周期的第三天服用卡铂 AUC 5。主要终点是总体缓解率 (ORR)，采用两阶段设计。 29 名女性参加了研究，其中 27 名女性可进行评估。给出的中位周期数为 2（范围 1-10）。一名患者获得完全缓解，一名患者获得部分缓解，ORR 为 7.4%（95% CI，0.9% - 24.3%）。十二名患者病情稳定，八名患者病情加重。有 5 名患者 (18.5%) 无法评估疗效。超过 10% 的治疗患者发生 3 级和 4 级事件并不常见，仅限于中性粒细胞减少症 (22.2%)、血小板减少症 (14.8%) 和呕吐 (11.1%)。中位无进展生存期 (PFS) 为 3.3 个月，总生存期为 13.7 个月。 29.6% 的患者的 PFS 至少为 6 个月。由于缺乏药物活性，该研究在第一阶段后结束。在卡铂中添加贝利司他对铂类耐药卵巢癌人群几乎没有作用。
Patients with recurrent ovarian cancer have limited options, especially in the context of relapse less than six months from primary platinum-based therapy. This Gynecologic Oncology Group (GOG) study was conducted to evaluate the impact of the histone deacetylase inhibitor, belinostat, in combination with carboplatin in women with platinum-resistant ovarian cancer. Eligible patients had measurable, recurrent disease within six months of their last dose of a platinum-based combination. Belinostat was dosed at 1,000 mg/m2 daily for five days with carboplatin AUC 5 on day three of 21-day cycles. The primary endpoint was overall response rate (ORR), using a two-stage design. Twenty-nine women enrolled on study and 27 were evaluable. The median number of cycles given was two (range 1–10). One patient had a complete response and one had a partial response, for an ORR of 7.4% (95% CI, .9% - 24.3%). Twelve patients had stable disease while eight had increasing disease. Response could not be assessed in five (18.5%). Grade 3 and 4 events occurring in more than 10% of treated patients were uncommon and limited to neutropenia (22.2%), thrombocytopenia (14.8%), and vomiting (11.1%). The median progression-free survival (PFS) was 3.3 months and overall survival was 13.7 months. PFS of at least six months was noted in 29.6% of patients. Due to the lack of drug activity, the study was closed after the first-stage. The addition of belinostat to carboplatin had little activity in a population with platinum-resistant ovarian cancer.
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