A phase II trial of intraperitoneal EGEN-001, an IL-12 plasmid formulated with PEG-PEI-cholesterol lipopolymer in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: a gynecologic oncology group study.
A phase II trial of intraperitoneal EGEN-001, an IL-12 plasmid formulated with PEG-PEI-cholesterol lipopolymer in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: a gynecologic oncology group study.
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DOI：
10.1016/j.ygyno.2014.03.571
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发表时间：
2014-06
影响因子：
4.7
通讯作者：
Huh WK
中科院分区：
文献类型：
--
作者：
Alvarez RD;Sill MW;Davidson SA;Muller CY;Bender DP;DeBernardo RL;Behbakht K;Huh WK
该II期试验的目的是评估EGEN-001在铂耐药复发性卵巢癌中的毒性和抗肿瘤活性。合格患者每周IP输注剂量为24 mg/m2的EGEN-001。分别使用CTCAE和RESIST标准评价毒性和抗肿瘤活性。共同主要终点为肿瘤缓解和至少6个月的无进展生存期（PFS）。还考虑了在进行后续治疗（EFS）之前至少6个月的无进展生存期。20/ 22例入组患者共接受了58个EGEN-001周期（中位数2个周期，范围1-9）。与EGEN-001治疗特别相关的最常见的相关不良事件是1/2级疲劳、发热、寒战、腹痛、恶心、呕吐、贫血、血小板减少和白细胞减少。20名EGEN-001治疗的可评价毒性的患者中有3名选择退出研究，部分原因是1级治疗相关毒性。无部分或完全缓解患者（0%; 90%CI 0~10.9%）。7/16例（35%）可评价缓解的患者病情稳定，9/16例（45%）病情进展。6例（30%）患者的PFS超过6个月，尽管3例在6个月前退出研究并接受其他治疗。估计6个月的EFS为15%。中位PFS和OS分别为2.89和9.17个月。EGEN-001在评估的剂量和时间表与一些但有限的活性相关，并且在铂抗性复发性卵巢癌患者中似乎耐受性较低。
The purpose of this phase II trial was to evaluate the toxicity and antitumor activity of EGEN-001 in platinum resistant recurrent ovarian cancer. Eligible patients had weekly IP infusion of EGEN-001 at a dose of 24 mg/m2. Toxicity and antitumor activity were evaluated using CTCAE and RESIST criteria, respectively. Co-primary endpoints were tumor response and survival without progression (PFS) for at least 6 months. Survival without progression before going onto a subsequent therapy (EFS) for at least six months was also considered. A total of 58 EGEN-001 cycles were administered to 20/ 22 enrolled patients (median 2 cycles, range 1–9). The most frequently associated adverse events related specifically to EGEN-001 treatment were grade 1/2 fatigue, fever, chills, abdominal pain, nausea, vomiting, anemia, thrombocytopenia, and leukopenia. Three of 20 EGEN-001 treated patients evaluable for toxicity elected to withdraw from the study motivated in part by grade 1 treatment related toxicities. There were no patients with partial or complete response (0%; 90% CI 0~10.9%). Seven (35%) of 16 patients evaluable for response had stable disease, and 9 (45%) had progressive disease. Six (30%) patients had a PFS of greater than six months, although three had gone off study and onto other therapies before six months. The estimated six-month EFS was 15%. The median PFS and OS was 2.89 and 9.17 months, respectively. EGEN-001 at the dose and schedule evaluated was associated with some but limited activity and was seemingly less tolerated in platinum resistant recurrent ovarian cancer patients.
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DOI：
10.1084/jem.20050915
发表时间：
2005-12-19
期刊：
The Journal of experimental medicine
影响因子：
--
作者：
Casares N;Pequignot MO;Tesniere A;Ghiringhelli F;Roux S;Chaput N;Schmitt E;Hamai A;Hervas-Stubbs S;Obeid M;Coutant F;Métivier D;Pichard E;Aucouturier P;Pierron G;Garrido C;Zitvogel L;Kroemer G
通讯作者：
Kroemer G
影响因子：
7.4
作者：
Alagkiozidis, Ioannis;Facciabene, Andrea;Coukos, George
通讯作者：
Coukos, George
影响因子：
5.1
作者：
Anwer, K.;Barnes, M. N.;Alvarez, R. D.
通讯作者：
Alvarez, R. D.
影响因子：
10.8
作者：
Fewell, JG;Matar, M;Anwer, K
通讯作者：
Anwer, K
影响因子：
2.7
作者：
Sill, Michael W.;Rubinstein, Larry;Yothers, Greg
通讯作者：
Yothers, Greg