Paclitaxel plus nedaplatin vs. paclitaxel plus carboplatin in women with epithelial ovarian cancer: A multi-center, randomized, open-label, phase III trial.
Paclitaxel plus nedaplatin vs. paclitaxel plus carboplatin in women with epithelial ovarian cancer: A multi-center, randomized, open-label, phase III trial.
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紫杉醇加奈达铂与紫杉醇加卡铂治疗上皮性卵巢癌女性的疗效：一项多中心、随机、开放标签 III 期试验
DOI：
10.3892/ol.2018.7761
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发表时间：
2018-03
期刊：
影响因子：
2.9
通讯作者：
Wang C
中科院分区：
文献类型：
--
作者：
Li L;Zhuang Q;Cao Z;Yin R;Zhu Y;Zhu L;Xie X;Zhang Y;Li L;Wu Q;Zheng J;Zhou Q;Li X;Wu L;Feng Y;Wang C
本研究讨论的多中心、随机、开放标签 III 期试验旨在比较奈达铂 (NDP) 加紫杉醇和卡铂 (CBP) 加紫杉醇治疗上皮性卵巢癌 (EOC) 的临床结果。在本研究中，182 名国际妇产科联合会 (FIGO) II-IV 期 EOC 患者被随机分配接受 NDP 加紫杉醇或 CBP 加紫杉醇治疗，间隔 3 周，总共 6 个疗程。主要终点是无进展生存率（PFS）和总生存率（OS）。次要终点是毒性特征。 NDP 组的中位随访时间为 44.63 个月 [95% 置信区间 (CI) 33.67–46.47 个月]，CBP 组的中位随访时间为 47.63 个月（95% CI 45.13–49.07 个月）。总体而言，两组之间的 PFS 或 OS 没有显着差异（PFS 为 P=0.09，OS 为 P=0.65）。对于FIGO III-IV期EOC患者，与CBP组相比，NDP加紫杉醇方案显着延长PFS（P=0.02），但没有改善OS（P=0.53）。 NDP联合紫杉醇组患者的3级或4级白细胞减少症发生率也较低（P=0.03）。两组之间的其他血液学和非血液学毒性特征相似。与 CBP 加紫杉醇方案相比，NDP 加紫杉醇方案实现了可比的生存结果和相似的毒性特征。然而，FIGO III-IV 期 EOC 患者可能会从 NDP 加紫杉醇治疗中获得更多临床益处，包括延长 PFS 和降低白细胞减少症发生率。因此，当使用铂类药物治疗 EOC 时，基于 NDP 的方案可能是一种替代选择。
The multi-center, randomized, open-label, phase III trial discussed in the present study was performed to compare the clinical outcomes of nedaplatin (NDP) plus paclitaxel, and carboplatin (CBP) plus paclitaxel for the treatment of epithelial ovarian cancer (EOC). In the current study, 182 patients with International Federation of Gynecology and Obstetrics (FIGO) stage II–IV EOC were randomly assigned to receive NDP plus paclitaxel or CBP plus paclitaxel at 3-week intervals for a total of six courses. The primary endpoints were progression-free survival rate (PFS) and overall survival rate (OS). The secondary endpoints were toxicity profiles. The median follow-up was 44.63 months [95% confidence interval (CI) 33.67–46.47 months] for the NDP group and 47.63 months (95% CI 45.13–49.07 months) for the CBP group. Overall, there was no significant difference in PFS or OS between the two groups (P=0.09 for PFS, and P=0.65 for OS). For the patients with FIGO stage III–IV EOC, the NDP plus paclitaxel regimen significantly prolonged PFS (P=0.02) but did not result in improved OS (P=0.53) when compared with the CBP group. The patients in the NDP plus paclitaxel group also exhibited a lower incidence rate of grade 3 or 4 leucopenia (P=0.03). Other hematological and non-hematological toxicity profiles were similar between the two groups. Compared with CBP plus paclitaxel regimens, NDP plus paclitaxel regimens achieved comparable survival outcomes and similar toxicity profiles. However, patients of FIGO stage III–IV EOC may experience more clinical benefits from NDP plus paclitaxel treatment, including a prolonged PFS and a lower incidence rate of leucopenia. Therefore, an NDP-based regimen may be an alternative choice when using platinum-based agents to treat EOC.
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影响因子：
3
作者：
AKAZA, H;TOGASHI, M;ASO, Y
通讯作者：
ASO, Y
影响因子：
2
作者：
Li, Yimei;Zhang, Qiang
通讯作者：
Zhang, Qiang
影响因子：
45.3
作者：
Giantonio, Bruce J.;Catalano, Paul J.;Benson, Al B., III
通讯作者：
Benson, Al B., III
影响因子：
10.3
作者：
du Bois, A;Lück, HJ;Pfisterer, J
通讯作者：
Pfisterer, J
影响因子：
4.7
作者：
Monk, BJ;Alberts, DS;Salmon, SE
通讯作者：
Salmon, SE