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学术前沿

索拉非尼治疗转移性甲状腺癌的II期临床试验结果

发表者:龙斌 3384人已读

译文:

基于Ras-Raf-MAP-ERK信号和血管内皮生长因子(VEGF)在乳头状甲状腺癌(PTC)中的重要作用,研究人员通过索拉非尼II期临床试验来考察其对PTC患者RAF和VEGF受体激酶的作用。

研究的主要评价指标为客观缓解率,其次包括血清甲状腺球蛋白(Tg)情况、功能状况、肿瘤基因型及肿瘤切片检查中的信号抑制情况。采用Simon最大最小双平台设计,A组纳入16或25名未接受过化疗的转移性PTC患者(接受肿瘤切片检查);B组纳入其他亚型甲状腺癌患者或之前接受过化疗的患者,不需进行肿瘤切片。患者口服索拉非尼治疗,一日两次,共400mg。每两个月通过RECIST(实体瘤疗效评价标准)评价疗效。浙江省肿瘤医院(中国科学院大学附属肿瘤医院)核医学科龙斌

结果发现,41名PTC患者中,其中6名部分缓解(PR; 15%; 95% CI, 6-29),23名患者(56%; 95% CI, 40-72)的肿瘤稳定期超过6个月。PR中位持续期为7.5个月(范围:6-14)。中位无进展存活期为15个月(95% CI, 10 -27.5)。18名可检测到Tg的PTC患者中有14名(78%)Tg下降超过25%。常见的3级不良反应包括手脚皮肤反应、肌肉骨骼疼痛及疲劳。22名接受检测的PTC患者中有17位(77%)存在BRAF基因变异。从PTC患者获得的10对肿瘤切片其中4对显示血管内皮生长因子受体磷酸化水平、ERK磷酸化水平及索拉非尼治疗期间的VEGF表达均下降。而非PTC患者未见症状缓解。

因此研究人员得出结论,索拉非尼对转移性PTC有临床及生物学抗肿瘤活性,且耐受良好。(译文转自丁香)

原文

Phase II Trial of Sorafenib in Metastatic Thyroid Cancer

Purpose Based on the pivotal role of Ras-Raf-MAP-ERK signaling and vascular endothelial growth factor (VEGF) in papillary thyroid cancer (PTC), we conducted a phase II clinical trial of sorafenib targeting RAF and VEGF receptor kinases in PTC.

Patients and Methods The primary end point was the objective response rate. Secondary end points included response correlation with serum thyroglobulin (Tg); functional imaging; tumor genotype; and signaling inhibition in tumor biopsies. Using a Simon minimax two-stage design, 16 or 25 chemotherapy-naïve metastatic PTC patients were to be enrolled in arm A (accessible tumor for biopsy). Arm B patients had other subtypes of thyroid carcinoma or prior chemotherapy, and did not require tumor biopsies. Patients received 400 mg orally twice per day of sorafenib. Response was assessed every 2 months using RECIST (Response Evaluation Criteria in Solid Tumors).

Results Of 41 PTC patients, six patients had a partial response (PR; 15%; 95% CI, 6 to 29) and 23 patients (56%; 95% CI, 40 to 72) had stable disease longer than 6 months. Median duration of PR was 7.5 months (range, 6 to 14). Median progression-free survival was 15 months (95% CI, 10 to 27.5). In 14 (78%) of 18 Tg-assessable PTC patients, Tg declined more than 25%. Common grade 3 adverse events included hand-foot skin reaction, musculoskeletal pain, and fatigue. BRAF mutation was detected in 17 (77%) of 22 PTCs analyzed. Four of 10 paired tumor biopsies from PTC patients showed a reduction in levels of vascular endothelial growth factor receptor phosphorylation, ERK phosphorylation, and in VEGF expression during sorafenib therapy. No PRs were noted among non-PTC patients.

Conclusion Sorafenib is reasonably well-tolerated therapy with clinical and biologic antitumor activity in metastatic PTC.

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发表于:2009-04-27 23:32

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