Cremolini Chiara, Marmorino Federica, Loupakis Fotios, Masi Gianluca, Antoniotti Carlotta, Salvatore Lisa, Schirripa Marta, Boni Luca, Zagonel Vittorina, Lonardi Sara, Aprile Giuseppe, Tamburini Emiliano, Ricci Vincenzo, Ronzoni Monica, Pietrantonio Filippo, Valsuani Chiara, Tomasello Gianluca, Passardi Alessandro, Allegrini Giacomo, Di Donato Samantha, Santini Daniele, Falcone Alfredo
Dipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Oncologia Medica 2 Universitaria, Azienda Ospedaliero-Universitaria Pisana, Via Roma 67, 56126, Pisa, Italy.
Centro per il Coordinamento per le Sperimentazioni Cliniche, Istituto Toscano Tumori, AOU Careggi, viale Pieraccini 6, 50139, Florence, Italy.
BMC Cancer. 2017 Jun 9;17(1):408. doi: 10.1186/s12885-017-3360-z.
Chemotherapy plus bevacizumab is a standard first-line treatment for unresectable metastatic colorectal cancer patients. Different chemotherapy backbones may be chosen, including one to three drugs, based on patients' general conditions and comorbidities, treatments' objectives, and disease characteristics. TRIBE trial demonstrated a significant advantage in terms of progression-free survival and overall survival for FOLFOXIRI plus bevacizumab as compared with FOLFIRI plus bevacizumab. Based on recent evidence, the de-intensification of the upfront regimen after 4-6 months of treatment is nowadays regarded as a valuable option. Moreover, the prolonged inhibition of angiogenesis, and in particular the continuation of bevacizumab beyond the evidence of disease progression, is an efficacious strategy in the treatment of metastatic colorectal cancer patients.
METHODS/DESIGN: TRIBE-2 is a prospective, open-label, multicentric phase III randomized trial in which unresectable and previously untreated metastatic colorectal cancer patients are randomized to receive first-line FOLFOX plus bevacizumab followed by FOLFIRI plus bevacizumab after disease progression or FOLFOXIRI plus bevacizumab followed by the re-introduction of the same regimen after disease progression. The primary endpoint is to compare the efficacy of the two proposed treatment strategies in terms of Progression Free Survival 2.
The TRIBE-2 study aims at answering the question whether the upfront use of FOLFOXIRI improves the clinical outcome of metastatic colorectal cancer patients, when compared with the pre-planned, sequential use of oxaliplatin-based and irinotecan-based doublets. Both proposed treatment strategies are designed to exploit the effectiveness of the prolonged inhibition of angiogenesis, alternating short (up to 4 months) induction periods and less intensive maintenance phases.
TRIBE2 is registered at Clinicaltrials.gov: NCT02339116 . January 12, 2015. TRIBE-2 is registered at EUDRACT 2014-004436-19, October 10, 2014.
化疗联合贝伐单抗是不可切除转移性结直肠癌患者的标准一线治疗方案。根据患者的一般状况和合并症、治疗目标及疾病特征，可选择不同的化疗方案，包括一至三种药物。TRIBE试验表明，与FOLFIRI联合贝伐单抗相比，FOLFOXIRI联合贝伐单抗在无进展生存期和总生存期方面具有显著优势。基于近期证据，治疗4 - 6个月后简化初始治疗方案如今被视为一种有价值的选择。此外，延长血管生成抑制时间，尤其是在疾病进展证据出现后继续使用贝伐单抗，是治疗转移性结直肠癌患者的有效策略。
方法/设计：TRIBE - 2是一项前瞻性、开放标签、多中心III期随机试验，不可切除且既往未接受过治疗的转移性结直肠癌患者被随机分配接受一线FOLFOX联合贝伐单抗，疾病进展后接受FOLFIRI联合贝伐单抗，或接受FOLFOXIRI联合贝伐单抗，疾病进展后重新引入相同方案。主要终点是比较两种治疗策略在无进展生存期2方面的疗效。
TRIBE - 2研究旨在回答与预先计划的基于奥沙利铂和伊立替康的双联化疗序贯使用相比，初始使用FOLFOXIRI是否能改善转移性结直肠癌患者的临床结局这一问题。两种治疗策略均旨在利用延长血管生成抑制的有效性，交替进行短（最长4个月）诱导期和强度较低的维持期。
TRIBE2于2015年1月12日在Clinicaltrials.gov注册，注册号为NCT02339116。TRIBE - 2于2014年10月10日在欧盟临床试验注册数据库注册，注册号为2014 - 004436 - 19。
