Phase II trial of cetuximab in the treatment of persistent or recurrent squamous or non-squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study.
Phase II trial of cetuximab in the treatment of persistent or recurrent squamous or non-squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study.
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DOI：
10.1016/j.ygyno.2011.05.040
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发表时间：
2011-09
影响因子：
4.7
通讯作者：
Boardman CH
中科院分区：
文献类型：
--
作者：
Santin AD;Sill MW;McMeekin DS;Leitao MM Jr;Brown J;Sutton GP;Van Le L;Griffin P;Boardman CH
妇科肿瘤组(GOG)进行了一项II期试验，以评估抗EGFR抗体西妥昔单抗在持续性或复发性宫颈癌中的疗效和耐受性。符合条件的患者有宫颈癌、可测量的疾病和GOG表现状态≤2。治疗包括西妥昔单抗初始剂量400 mg/m2，随后每周250 mg/m2，直到疾病进展或禁止性毒性。主要终点为6个月的无进展生存期(PFS)和有效率。本研究采用两阶段成组序贯设计。38例患者进入，排除3例，剩下35例可评价用于分析。31例患者(88.6%)既接受放射治疗，又接受1(n=25，71.4%)或2(n=10)细胞毒化疗。24例(68.6%)有鳞状细胞癌。可能与西妥昔单抗有关的3级不良事件包括皮肤病(n=5)、胃肠道感染(n=4)、贫血(n=2)、体质(n=3)、感染(n=2)、血管(n=2)、疼痛(n=2)以及肺、神经、呕吐和代谢(n=1)。未检测到临床反应。5名患者(14.3%；双侧90%CI，5.8%至30%)存活至少6个月，无进展。中位生存期和总生存期分别为1.97个月和6.7个月。在这项研究中，所有6个月大的PFS患者都有鳞状细胞组织学肿瘤。西妥昔单抗耐受性良好，但在该人群中的活性有限。西妥昔单抗的活性可能仅限于鳞状细胞组织学患者。
The Gynecologic Oncology Group (GOG) conducted a phase II trial to assess the efficacy and tolerability of the anti-EGFR antibody cetuximab, in persistent or recurrent carcinoma of the cervix. Eligible patients had cervical cancer, measurable disease, and GOG performance status ≤2. Treatment consisted of cetuximab 400 mg/m2 initial dose followed by 250 mg/m2 weekly until disease progression or prohibitive toxicity. The primary endpoints were progression-free survival (PFS) at 6 months and response. The study used a 2-stage group sequential design. Thirty-eight patients were entered with 3 exclusions, leaving 35 evaluable for analysis. Thirty-one patients (88.6%) received prior radiation as well as either 1 (n = 25, 71.4%) or 2 (n = 10) prior cytotoxic regimens. Twenty-four patients (68.6%) had a squamous cell carcinoma. Grade 3 adverse events possibly related to cetuximab included dermatologic (n = 5), GI (n = 4), anemia (n = 2), constitutional (n = 3), infection (n = 2), vascular (n = 2), pain (n = 2), and pulmonary, neurological, vomiting and metabolic (n = 1 each). No clinical responses were detected. Five patients (14.3%; two-sided 90% CI, 5.8% to 30%) survived without progression for at least 6 months. The median PFS and overall survival (OS) times were 1.97 and 6.7 months, respectively. In this study, all patients with PFS at 6 months harbored tumors with squamous cell histology. Cetuximab is well tolerated but has limited activity in this population. Cetuximab activity may be limited to patients with squamous cell histology.
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