Response of the Primary Tumor to Neoadjuvant Sunitinib in Patients With Advanced Renal Cell Carcinoma
Response of the Primary Tumor to Neoadjuvant Sunitinib in Patients With Advanced Renal Cell Carcinoma
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DOI：
10.1016/j.juro.2008.10.001
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发表时间：
2009-02-01
影响因子：
6.6
通讯作者：
Campbell, Steven C.
中科院分区：
文献类型：
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作者：
Thomas, Anil A.;Rini, Brian I.;Campbell, Steven C.
目的：我们评估了活性的新辅助舒尼替尼对原发性肾肿瘤的晚期肾细胞癌患者以及后续手术切除术的可行性和安全性。方法：共19例晚期肾细胞癌患者被认为不适合初始肾切除术，由于局部晚期疾病或广泛的转移负担，治疗与舒尼替尼50毫克，每天4周，随后2周关闭。肿瘤反应评估标准在实体瘤每2个周期和转换到可切除状态的速度进行了estimated.Results：中位患者年龄为64岁，最初的中位数放射学肾肿瘤大小为10.5厘米。临床分期：N+10例，M+15例。没有患者出现完全缓解。在3例患者（16%）中观察到原发性肿瘤的部分缓解，7例（37%）原发性肿瘤疾病稳定，9例（47%）原发性肿瘤疾病进展。总体肿瘤缓解包括2例患者（11%）部分缓解，7例患者（37%）疾病稳定，10例患者（53%）疾病进展。在中位随访6个月（范围1 - 15）时，4例患者（21%）接受了肾切除术，5例死于疾病进展。未发生意外手术并发症。所有4个标本中均存在活肿瘤。舒尼替尼与3-4级毒性7例（37%）和治疗被中止在1由于toxicity.Conclusions：舒尼替尼在晚期肾细胞癌患者的原发性肿瘤的地方是可行的，可以导致肿瘤负荷的减少，可以促进随后的手术切除。
Purpose: We assessed the activity of neoadjuvant sunitinib on primary renal tumors in patients with advanced renal cell carcinoma as well as the feasibility and safety of subsequent surgical resection.Methods: A total of 19 patients with advanced renal cell carcinoma deemed unsuitable for initial nephrectomy due to locally advanced disease or extensive metastatic burden were treated with 50 mg sunitinib daily for 4 weeks on followed by 2 weeks off. Tumor response was assessed by Response Evaluation Criteria in Solid Tumors every 2 cycles and the rate of conversion to resectable status was estimated.Results: Median patient age was 64 years and initial median radiographic renal tumor size was 10.5 cm. Clinical stage was N+ (10) and M+ (15). No patients experienced a complete response. Partial responses of the primary tumor were noted in 3 patients (16%), 7 (37%) had stable disease and 9 (47%) had disease progression in the primary tumor. Overall tumor response included 2 patients (11%) with partial response, 7 (37%) with stable disease and 10 (53%) with disease progression. At a median followup of 6 months (range 1 to 15) 4 patients (21%) had undergone nephrectomy and 5 died of disease progression. No unexpected surgical morbidity was encountered. Viable tumor was present in all 4 specimens. Sunitinib was associated with grade 3-4 toxicity in 7 patients (37%) and treatment was discontinued in 1 due to toxicity.Conclusions: Administration of sunitinib in patients with advanced renal cell carcinoma with the primary tumor in place is feasible and can lead to a reduction in tumor burden that can facilitate subsequent surgical resection.