A phase II study of frontline paclitaxel/carboplatin/bevacizumab, paclitaxel/carboplatin/temsirolimus, or ixabepilone/carboplatin/bevacizumab in advanced/recurrent endometrial cancer.
A phase II study of frontline paclitaxel/carboplatin/bevacizumab, paclitaxel/carboplatin/temsirolimus, or ixabepilone/carboplatin/bevacizumab in advanced/recurrent endometrial cancer.
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DOI：
10.1016/j.ygyno.2018.05.018
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发表时间：
2018-08
影响因子：
4.7
通讯作者：
Levine DA
中科院分区：
文献类型：
--
作者：
Aghajanian C;Filiaci V;Dizon DS;Carlson JW;Powell MA;Secord AA;Tewari KS;Bender DP;O'Malley DM;Stuckey A;Gao J;Dao F;Soslow RA;Lankes HA;Moore K;Levine DA
紫杉醇和卡铂（PC）是晚期子宫内膜癌的标准初始治疗。我们评估了将三种新型药物纳入初始治疗的疗效和耐受性。在这项随机II期试验中，未经化疗的11 I/IVA期（有可测量的疾病）和IVB期或复发性（有或无可测量的疾病）子宫内膜癌患者被随机分配至PC+贝伐珠单抗（第1组）、PC+替西罗莫司（第2组）或伊沙匹隆和卡铂（IC）+贝伐珠单抗（第3组）治疗。主要终点为无进展生存期（PFS）。试验GOG 209 PC组的可比患者用作历史对照。次要终点为缓解率、总生存期（OS）和安全性。总体而言，349例患者接受了随机化。与历史对照组相比，任何实验组的PFS持续时间均未显著增加（p> 0.039）。第1、2和3组相对于对照组的治疗HR（92% CI）分别为0.81（0.63 - 1.02）、1.22（0.96 - 1.55）和0.87（0.681.11）。两组的缓解率相似（分别为60%、55%和53%）。相对于对照组，第1组的OS持续时间（在36个月时删失）显著增加（p <0.039），但第2组和第3组未增加; HR（92% CI）分别为0.71（0.55 ± 0.91）、0.99（0.78 - 1.26）和0.97（0.77 - 1.23）。未发现新的安全性信号。常见的突变和错配修复蛋白丢失率由组织型描述。确定了替西罗莫司和贝伐单抗的潜在预测生物标志物。与历史对照相比，任何实验组的PFS均未显著增加。NRG肿瘤/妇科肿瘤组研究GOG-86 P
Paclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of incorporating three novel agents into initial therapy. In this randomized phase II trial, patients with chemotherapy-naive stage 11I/IVA (with measurable disease) and stage IVB or recurrent (with or without measurable disease) endometrial cancer were randomly assigned to treatment with PC plus bevacizumab (Arm 1), PC plus temsirolimus (Arm 2) or ixabepilone and carboplatin (IC) plus bevacizumab (Arm 3). The primary endpoint was progression-free survival (PFS). Comparable patients on the PC Arm of trial GOG209 were used as historical controls. Secondary endpoints were response rate, overall survival (OS), and safety. Overall, 349 patients were randomized. PFS duration was not significantly increased in any experimental arm compared with historical controls (p>0.039). Treatment HRs (92% CI) for Arms 1, 2, and 3 relative to controls were 0.81 (0.63–1.02), 1.22 (0.96–1.55) and 0.87 (0.681.11), respectively. Response rates were similar across arms (60%, 55% and 53%, respectively). Relative to controls, OS duration (with censoring at 36 months), was significantly increased in Arm 1 (p<0.039) but not in Arms 2 and 3; the HRs (92% CIs) were 0.71 (0.550.91), 0.99 (0.78–1.26), and 0.97 (0.77–1.23), respectively. No new safety signals were identified. Common mutations and rates of mismatch repair protein loss are described by histotype. Potential predictive biomarkers for temsirolimus and bevacizumab were identified. PFS was not significantly increased in any experimental arm compared to historical controls. NRG Oncology/Gynecologic Oncology Group Study GOG-86P
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影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
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Fleming, Gini F.;Filiaci, Virginia L.;Leslie, Kimberly K.
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