An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without bevacizumab in platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer patients previously treated with bevacizumab for front-line or platinum-sensitive ovarian cancer: rationale, design, and methods of the Japanese Gynecologic Oncology Group study JGOG3023.
An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without bevacizumab in platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer patients previously treated with bevacizumab for front-line or platinum-sensitive ovarian cancer: rationale, design, and methods of the Japanese Gynecologic Oncology Group study JGOG3023.
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一项开放标签，随机的II期试验，评估具有或不使用贝伐单抗的护理标准的功效和安全性卵巢癌：日本妇科肿瘤学组研究JGOG3023的基本原理，设计和方法。
DOI：
10.1186/s12885-018-4505-4
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发表时间：
2018-07-31
期刊：
影响因子：
3.8
通讯作者：
Japanese Gynecologic Oncology Group
中科院分区：
文献类型：
--
作者：
Shoji T;Komiyama S;Kigawa J;Tanabe H;Kato K;Itamochi H;Fujiwara H;Kamiura S;Hamano T;Sugiyama T;Japanese Gynecologic Oncology Group
我们介绍了JGOG 3023研究的研究原理和设计，这是一项开放标签、平行组、随机、II期试验，旨在评估联合或不联合贝伐珠单抗化疗对铂类耐药复发性上皮性卵巢癌、输卵管癌或原发性腹膜癌患者的疗效和安全性。既往曾接受过贝伐珠单抗治疗一线或铂敏感性卵巢癌。我们假设，在既往贝伐单抗治疗后疾病进展以外的情况下，与单药化疗相比，单药化疗和贝伐单抗联合治疗的患者将显示出无进展生存期（PFS）的改善。共106例在接受化疗期间或铂末次给药后6个月内，完成至少3个周期的贝伐珠单抗加铂化疗后发生卵巢癌复发或进展的患者将以1：1的比例随机分配至单药化疗或单药化疗联合贝伐珠单抗治疗组。对于化疗，研究者将选择以下四种药物之一：聚乙二醇化脂质体多柔比星、拓扑替康、紫杉醇或吉西他滨。主要终点是评估者评估的PFS。次要终点是总生存期、客观缓解率、穿刺次数和CA125缓解率。将通过不良事件的发生率评价安全性。本研究将评估贝伐珠单抗联合单药化疗的疗效和安全性，贝伐珠单抗标准铂类化疗后疾病进展后可持续使用。UMIN000017247（2015年4月22日注册）。
We present the study rationale and design of the JGOG3023 study, an open-label, parallel-arm, randomized, phase II trial that aimed to assess the efficacy and safety of chemotherapy with or without bevacizumab in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who were previously treated with bevacizumab for front-line or platinum-sensitive ovarian cancer. We hypothesize that patients treated with a combination of single-agent chemotherapy and bevacizumab will show improved progression-free survival (PFS) compared with those treated with single-agent chemotherapy alone, in the setting beyond disease progression following prior bevacizumab treatment. A total of 106 patients who have recurrence or progression of ovarian cancer, while receiving chemotherapy or within 6 months after the final dose of platinum, after completing at least three cycles of bevacizumab plus platinum chemotherapy will be randomized in a 1:1 ratio to treatment with single-agent chemotherapy or single-agent chemotherapy combined with bevacizumab. For chemotherapy, one of the following four drugs will be chosen by an investigator: pegylated liposomal doxorubicin, topotecan, paclitaxel, or gemcitabine. The primary endpoint is investigator-assessed PFS. The secondary endpoints are overall survival, objective response rate, number of paracentesis, and response rate by CA125. Safety will be evaluated by the incidence of adverse events. This study will assess the efficacy and safety of bevacizumab in combination with single-agent chemotherapy, which could be used continuously after disease progression following standard platinum-based chemotherapy with bevacizumab. UMIN000017247 (registered April 22, 2015).
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DOI：
10.1016/s1470-2045(15)00086-8
发表时间：
2015-08
期刊：
The Lancet. Oncology
影响因子：
--
作者：
Oza AM;Cook AD;Pfisterer J;Embleton A;Ledermann JA;Pujade-Lauraine E;Kristensen G;Carey MS;Beale P;Cervantes A;Park-Simon TW;Rustin G;Joly F;Mirza MR;Plante M;Quinn M;Poveda A;Jayson GC;Stark D;Swart AM;Farrelly L;Kaplan R;Parmar MK;Perren TJ;ICON7 trial investigators
通讯作者：
ICON7 trial investigators
影响因子：
50.5
作者：
Fotopoulou, C.;Vergote, I.;Gabra, H.
通讯作者：
Gabra, H.
影响因子：
4.7
作者：
Richardson, D. L.;Backes, F. J.;O'Malley, D. M.
通讯作者：
O'Malley, D. M.
影响因子：
45.3
作者：
Markman, M;Markman, J;Belinson, J
通讯作者：
Belinson, J
影响因子：
9.8
作者：
Bocci, Guido;Di Paolo, Antonello;Danesi, Romano
通讯作者：
Danesi, Romano