Division of Oncology, Department of Oncology and Hematology, University Hospital Modena, Modena, Italy.
Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.
Clin Colorectal Cancer. 2020 Jun;19(2):82-90.e9. doi: 10.1016/j.clcc.2019.10.001. Epub 2020 Mar 17.
In the absence of head-to-head comparison studies, the present network meta-analysis evaluated and compared the efficacy of 4 therapeutic alternatives for refractory colorectal cancer.
The search focused on results from phase III randomized controlled trials. Separate (subgroup) network meta-analyses were conducted to obtain drug comparisons stratified by various patient characteristics. The principal outcome of interest was overall survival (OS).
No difference in OS was found between regorafenib and TAS-102. For a rectal primary location, TAS-102 conferred benefit versus placebo (hazard ratio [HR], 0.671), but regorafenib did not (HR, 0.950). For patients aged > 65 years, TAS-102 showed benefit versus placebo (HR, 0.579) but regorafenib did not (HR, 0.816). For patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 in the indirect comparison, regorafenib showed benefit versus placebo (HR, 0.687), as did TAS-102 (HR, 0.756) but with a lower advantage. For patients with RAS wild type not previously treated with anti-EGFR antibodies, panitumumab was the optimal choice for OS.
No differences in OS were found between regorafenib and TAS-102. Possible greater efficacy was found for TAS-102 compared with regorafenib for patients with a rectal primary location, ECOG PS > 0, and age > 65 years. In contrast, regorafenib showed possible greater effectiveness for patients with ECOG PS 0 and age < 65 years. In the RAS WT population, the anti-EGFR drug showed superiority with respect to TAS-102 and regorafenib. These results should be viewed as only exploratory, and further prospective studies are warranted to validate these data.
在缺乏头对头比较研究的情况下，本网络荟萃分析评估并比较了 4 种治疗难治性结直肠癌的替代疗法的疗效。
该研究聚焦于 III 期随机对照试验的结果。分别进行了（亚组）网络荟萃分析，以根据不同的患者特征对药物进行分层比较。主要观察终点是总生存期（OS）。
regorafenib 与 TAS-102 之间的 OS 无差异。对于直肠原发部位，TAS-102 与安慰剂相比具有获益（风险比[HR]，0.671），而 regorafenib 则没有（HR，0.950）。对于年龄 > 65 岁的患者，TAS-102 与安慰剂相比具有获益（HR，0.579），而 regorafenib 则没有（HR，0.816）。在间接比较中，对于 ECOG 表现状态（PS）为 0 的患者，regorafenib 与安慰剂相比具有获益（HR，0.687），TAS-102 也是如此（HR，0.756），但获益优势较低。对于 RAS 野生型且未接受过抗 EGFR 抗体治疗的患者，panitumumab 是 OS 的最佳选择。
regorafenib 与 TAS-102 之间的 OS 无差异。对于直肠原发部位、ECOG PS > 0 和年龄 > 65 岁的患者，TAS-102 可能比 regorafenib 更有效。相比之下，对于 ECOG PS 0 和年龄 < 65 岁的患者，regorafenib 显示出可能更大的疗效。在 RAS WT 人群中，抗 EGFR 药物相对于 TAS-102 和 regorafenib 具有优势。这些结果仅应视为探索性的，需要进一步的前瞻性研究来验证这些数据。
