Fanotto Valentina, Rossini Daniele, Casagrande Mariaelena, Bergamo Francesca, Spagnoletti Andrea, Santini Daniele, Antoniotti Carlotta, Cupini Samanta, Daniel Francesca, Nasca Vincenzo, Vetere Guglielmo, Zaniboni Alberto, Borelli Beatrice, Carullo Martina, Conca Veronica, Passardi Alessandro, Tamburini Emiliano, Masi Gianluca, Pella Nicoletta, Cremolini Chiara
Department of Oncology, Academic Hospital of Udine, Azienda Sanitaria Universitaria Friuli Centrale (ASUFC), 33100 Udine, Italy.
Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Via Savi 10, 56126 Pisa, Italy.
Cancers (Basel). 2023 Nov 16;15(22):5451. doi: 10.3390/cancers15225451.
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 ( < 0.001) and 26.6 vs. 22.5 ( < 0.001), respectively. In multivariate models, PTR was confirmed as an independent prognostic factor for better PFS ( = 0.032) and OS ( = 0.018). Patients with PTR experienced a higher incidence of grade 3 or 4 diarrhea ( = 0.055) and lower incidence of anemia ( = 0.053), perforation ( = 0.015), and serious gastrointestinal and surgical AEs ( < 0.001). No statistically significant differences were noted in incidence of bleeding ( = 0.39). The benefit of FOLFOXIRI + bevacizumab in terms of PFS ( for interaction: 0.46), OS ( for interaction: 0.80), ORR ( for 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：对于无症状的同时性转移性结直肠癌（mCRC）患者，决定是否切除原发肿瘤对肿瘤学家来说是一个复杂且具有挑战性的问题，尤其是在计划采用基于抗血管生成的治疗方案时。 方法：纳入参加III期TRIBE和TRIBE2研究的患者，这两项研究分别比较了初始FOLFOXIRI + 贝伐单抗与FOLFIRI或FOLFOX + 贝伐单抗。我们评估了原发肿瘤切除（PTR）与无进展生存期（PFS）、总生存期（OS）、缓解率（ORR）、≥2级不良事件（AE）发生率以及严重胃肠道和手术AE在总体人群中以及根据治疗组的相关性。 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，切除患者的PFS和OS更长：分别为11.2个月对10.0个月（P < 0.001）和26.6个月对22.5个月（P < 0.001）。在多变量模型中，PTR被确认为PFS更好（P = 0.032）和OS更好（P = 0.018）的独立预后因素。接受PTR的患者3级或4级腹泻发生率更高（P = 0.055），贫血（P = 0.053）、穿孔（P = 0.015）以及严重胃肠道和手术AE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级或4级AE发生率方面的获益与PTR无关。 结论：基线时的PTR与同时性mCRC患者的良好预后独立相关，并且在前瞻性化疗加贝伐单抗期间严重胃肠道和手术AE的发生率较低。FOLFOXIRI加贝伐单抗的获益和毒性特征与PTR无关。
Clin Exp Metastasis. 2018-5-4
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