Medical Oncology Department, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.
Endocr Relat Cancer. 2012 Apr 10;19(2):209-16. doi: 10.1530/ERC-11-0351. Print 2012 Apr.
Although thyroid cancer usually has an excellent prognosis, few therapeutic options are available in the refractory setting. Based on the recent results of phase II studies with tyrosine kinase inhibitors, we designed a retrospective analysis of patients with metastatic thyroid cancer treated with sorafenib in seven Spanish referral centers. Consecutive patients with progressive metastatic thyroid cancer (papillary, follicular, medullary, and anaplastic) not suitable for curative surgery, radioactive-iodine therapy, or radiotherapy were treated with sorafenib 400 mg twice a day. The primary end point was objective response rate (RR). Secondary end points included toxicity, median progression-free survival (mPFS), median overall survival (mOS), and correlation between tumor marker levels (thyroglobulin, calcitonin, and carcinoembryonic antigen) and efficacy. Between June 2006 and January 2010, 34 patients were included in the study. Sixteen patients presented differentiated thyroid carcinomas (DTC) of which seven (21%) were papillary, nine (26%) follicular, 15 (44%) medullary (MTC), and three (9%) were anaplastic (ATC). Eleven (32%) patients achieved partial response and 14 (41%) had stable disease beyond 6 months. Regarding histological subtype, RRs were 47% (seven of 15) for MTC, 19% (three of 16) for DTC, and 33% (one of three) for ATC. With a median follow-up of 11.5 months, mPFS were 13.5, 10.5, and 4.4 months for DTC, MTC, and ATC respectively. Tumor markers were evaluated in 22 patients, and a statistically significant association was observed between RR and decrease in tumor marker levels >50% (P=0.033). In this retrospective trial, sorafenib showed antitumor efficacy in all histological subtypes of thyroid cancer, warranting further development in this setting.
虽然甲状腺癌通常预后良好，但在难治性疾病中治疗选择有限。基于最近酪氨酸激酶抑制剂的 II 期研究结果，我们对 7 家西班牙转诊中心的转移性甲状腺癌患者进行了sorafenib 治疗的回顾性分析。进展性转移性甲状腺癌（乳头状、滤泡状、髓样和间变性）患者，不适合进行根治性手术、放射性碘治疗或放疗，接受 sorafenib 400mg 每日两次治疗。主要终点是客观缓解率（RR）。次要终点包括毒性、中位无进展生存期（mPFS）、中位总生存期（mOS）以及肿瘤标志物水平（甲状腺球蛋白、降钙素和癌胚抗原）与疗效的相关性。2006 年 6 月至 2010 年 1 月，34 例患者纳入研究。16 例患者为分化型甲状腺癌（DTC），其中 7 例（21%）为乳头状，9 例（26%）为滤泡状，15 例（44%）为髓样（MTC），3 例（9%）为间变性（ATC）。11 例（32%）患者部分缓解，14 例（41%）患者 6 个月以上疾病稳定。根据组织学类型，MTC 的 RR 为 47%（15 例中的 7 例），DTC 的 RR 为 19%（16 例中的 3 例），ATC 的 RR 为 33%（3 例中的 1 例）。中位随访 11.5 个月，DTC、MTC 和 ATC 的 mPFS 分别为 13.5、10.5 和 4.4 个月。在 22 例患者中评估了肿瘤标志物，RR 与肿瘤标志物水平下降>50%呈统计学显著相关（P=0.033）。在这项回顾性试验中，sorafenib 在所有甲状腺癌组织学类型中均显示出抗肿瘤疗效，值得在该领域进一步开发。
