Background: The decision to resect or not the primary tumor in asymptomatic patients with synchronous metastatic colorectal cancer (mCRC) is a complex and challenging issue for oncologists, especially when an antiangiogenic-based therapy is planned. Methods: Patients enrolled in the phase III TRIBE and TRIBE2 studies that compared upfront FOLFOXIRI + bevacizumab to FOLFIRI or FOLFOX + bevacizumab, respectively, were included. We assessed the association of primary tumor resection (PTR) with progression-free survival (PFS), overall survival (OS), response rate (ORR), rate of grade > 2 adverse events (AEs), and serious gastrointestinal and surgical AEs in the overall population and according to the treatment arm. Results: Of the 999 patients included, 513 (51%) underwent PTR at baseline. Longer PFS and OS were observed in resected patients compared to those with unresected primary tumors: 11.2 vs. 10.0 months (p< 0.001) and 26.6 vs. 22.5 (p< 0.001), respectively. In multivariate models, PTR was confirmed as an independent prognostic factor for better PFS (p= 0.032) and OS (p= 0.018). Patients with PTR experienced a higher incidence of grade 3 or 4 diarrhea (p= 0.055) and lower incidence of anemia (p= 0.053), perforation (p= 0.015), and serious gastrointestinal and surgical AEs (p< 0.001). No statistically significant differences were noted in incidence of bleeding (p= 0.39). The benefit of FOLFOXIRI + bevacizumab in terms of PFS (pfor interaction: 0.46), OS (pfor interaction: 0.80), ORR (pfor interaction: 0.36), and incidence of grade 3 or 4 AEs was independent of PTR. Conclusions: PTR at baseline was independently associated with good prognosis in synchronous mCRC patients and with lower incidence of serious gastrointestinal and surgical AEs during upfront chemotherapy plus bevacizumab. The benefit and toxicity profile of FOLFOXIRI plus bevacizumab was independent of PTR.
背景：对于无症状的同步转移性结直肠癌（mCRC）患者，是否切除原发肿瘤是肿瘤科医生面临的一个复杂且具有挑战性的决策，尤其是在计划进行抗血管生成治疗时。方法：本研究纳入了分别比较FOLFOXIRI+贝伐珠单抗与FOLFIRI或FOLFOX+贝伐珠单抗作为初始治疗的III期TRIBE和TRIBE2研究中的患者。我们评估了原发肿瘤切除术（PTR）与无进展生存期（PFS）、总生存期（OS）、客观缓解率（ORR）、≥2级不良事件（AEs）发生率以及严重胃肠道和手术AEs发生率之间的关联，分析在总体人群及各治疗组中进行。结果：在纳入的999例患者中，513例（51%）在基线时接受了PTR。与未切除原发肿瘤的患者相比，接受切除的患者观察到更长的PFS和OS：分别为11.2个月 vs. 10.0个月（p<0.001）和26.6个月 vs. 22.5个月（p<0.001）。在多变量模型中，PTR被证实是改善PFS（p=0.032）和OS（p=0.018）的独立预后因素。接受PTR的患者3或4级腹泻发生率更高（p=0.055），而贫血（p=0.053）、穿孔（p=0.015）以及严重胃肠道和手术AEs的发生率更低（p<0.001）。出血发生率无统计学显著差异（p=0.39）。FOLFOXIRI+贝伐珠单抗在PFS（交互作用p值：0.46）、OS（交互作用p值：0.80）、ORR（交互作用p值：0.36）以及3或4级AEs发生率方面的获益与PTR无关。结论：在同步mCRC患者中，基线时进行PTR与良好预后独立相关，并且在初始化疗联合贝伐珠单抗治疗期间，与较低的严重胃肠道和手术AEs发生率相关。FOLFOXIRI联合贝伐珠单抗的获益和毒性特征与PTR无关。
肿瘤(癌症)患者之家