CCC:帕尼单抗或贝伐单抗联合FOLFIRI方案二线治疗转移性结直肠癌疗效比较(SPIRITT研究)

2015-01-11 Hakim Lee MedSci原创

近日,美国加州大学洛杉矶分校David Geffen医学院肿瘤学研究所的研究人员进行了一项随机、多中心、2期评估试验(SPIRITT研究),比较了伊立替康、氟尿嘧啶和亚叶酸钙(FOLFIRI)方案联合帕尼单抗(panitumumab)或贝伐单抗(bevacizumab)治疗基于奥沙利铂化疗+贝伐单抗治疗而病情进展不可切除的野生型KRAS转移性结直肠癌患者,最新研究成果在线发表于1月7日的Clinc

目前认为,化疗联合抗表皮生长因子受体(EGFR)或抗血管内皮生长因子(VEGF)单抗二线治疗方案可改善野生型KRAS转移性结直肠癌(mCRC)患者的临床预后。但选择哪种生物制剂用于转移性结直肠癌患者的二线治疗目前尚不明确。


近日,美国加州大学洛杉矶分校David Geffen医学院肿瘤学研究所的研究人员进行了一项随机、多中心、2期评估试验(SPIRITT研究),比较了伊立替康、氟尿嘧啶和亚叶酸钙(FOLFIRI)方案联合帕尼单抗(panitumumab)或贝伐单抗(bevacizumab)治疗基于奥沙利铂化疗+贝伐单抗治疗而病情进展不可切除的野生型KRAS转移性结直肠癌患者,最新研究成果在线发表于1月7日的Clincal Colorectal Cancer杂志上。

该研究将招募的182例患者随机分配到接受FOLFIRI化疗联合帕尼单抗或贝伐单抗两治疗组。研究的主要指标为无进展生存期(PFS),次要指标包括总生存期(OS)、客观有效率(ORR)和安全性等。

研究结果显示,两治疗组无进展生存期长短相当,风险比HR为1.01(95%CI 0.68-1.50;P=0.97)。帕尼单抗组平均无进展生存期为7.7个月(95%CI 5.7-11.8),贝伐单抗组则为9.2个月(95%CI 7.8-10.6)。两组总生存期也相近,风险比HR为1.06(95%CI 0.75-1.49;P=0.75)。帕尼单抗组平均总生存期为18.0个月(95%CI 13.5-21.7),贝伐单抗组则为21.4个月(95%CI 16.5-24.6)。帕尼单抗组客观有效率为32%(95%CI 23%-43%),贝伐单抗组为19%(95%CI 11%-29%)。研究还发现,皮肤病、腹泻、低镁血症、低钾血症、脱水和低血压等药物不良事件在帕尼单抗组更为常见,而中性粒细胞减少则常见于贝伐单抗组。

综合上述数据,研究人员认为,帕尼单抗或贝伐单抗联合FOLFIRI化疗方案二线治疗基于奥沙利铂的化疗+贝伐单抗治疗而病情进展的转移性结直肠癌患者具有相似的疗效,且毒性不良事件可预期,耐受性良好。研究还认为,开发出更多更准确的生物标志物或可帮助医护人员和病人更好的制定和选择个体化治疗策略。

原始出处:
J Randolph Hecht, Allen Cohn, Shaker Dakhil, et al. SPIRITT: A Randomized, Multicenter, Phase 2 Study of Panitumumab Plus FOLFIRI and Bevacizumab Plus FOLFIRI as Second-Line Treatment in Patients With Unresectable Wild-Type KRAS Metastatic Colorectal Cancer. Clincal Colorectal Cancer, January 07, 2015, doi:http://dx.doi.org/10.1016/j.clcc.2014.12.009

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