医学
贝伐单抗
临床终点
内科学
西妥昔单抗
叶酸
伊立替康
临床研究阶段
耐受性
结直肠癌
胃肠病学
外科
随机对照试验
肿瘤科
不利影响
癌症
临床试验
化疗
作者
Sebastian Stintzing,Kathrin Heinrich,David Tougeron,Dominik Paul Modest,Ingo Schwaner,Jan Euker,Rudolf Pihusch,Martina Stauch,Florian Kaiser,Christoph Kahl,Meinolf Karthaus,Christian Mueller,Christoph Burkart,Anke Reinacher‐Schick,Stefan Kasper,Ludwig Fischer von Weikersthal,Beate Krammer-Steiner,Gerald W. Prager,Julien Taı̈eb,Volker Heinemann
标识
DOI:10.1200/jco.2021.39.15_suppl.3502
摘要
3502 Background: FIRE-4.5 (AIO KRK-0116) compared FOLFOXIRI plus either cetuximab or bevacizumab in BRAF V600E-mutant metastatic colorectal cancer (mCRC) patients not treated for metastatic disease before. Methods: Within this 1:2 randomized, controlled, open-label phase-II study, patients received FOLFOXIRI every two weeks at the following schedule: irinotecan 150mg/m² (30-90min, day 1), folinic acid 400mg/m² (120min, day 1), oxaliplatin 85mg/m² (120 min, day 1), followed by 5-fluorouracil 3,000 mg/m², 48h. FOLFOXIRI was combined with either bevacizumab (arm A) at a dose of 5mg/kg body weight, every 2 weeks or cetuximab (arm B) at a loading dose of 400mg/m² and subsequent weekly doses of 250mg/m². FOLFOXIRI was applied for a maximum of 12 cycles before maintenance treatment was recommended. Primary endpoint was superiority of Arm B with respect to overall response rate (ORR) according to RECIST 1.1 criterions. Secondary endpoints included PFS, OS, and tolerability. Results: From November 2016 to December 2020 108 patients were randomized in 90 German and 10 French centers (35 arm A and 73 in arm B). No new or unexpected toxicities were observed. Primary endpoint was not met with an ORR of 66.7% and 52.0% (p =0.23) in the respective arms. Median PFS was significantly longer in arm A vs arm B (8.3 months vs 5.9 months; logrank p = 0.03; HR 1.8). While OS data is still immature, median OS time are comparable at the time of analysis. Patients with left-sided primary tumors had comparable results with either bevacizumab or cetuximab, whereas those with right-sided primary tumors showed a trend towards better efficacy of the bevacizumab combination. Updated results will be presented at the annual meeting. Conclusions: FIRE-4.5 is the first prospective and randomized study investigating efficacy of FOLFOXIRI combined with targeted therapy in the first-line treatment of BRAF V600E-mutant mCRC. FOLFOXIRI plus either bevacizumab or cetuximab have comparable efficacy with differential effects according to primary tumor sidedness supporting the heterogeneity of BRAF V600E-mutant subpopulation of mCRC. Clinical trial information: NCT04034459.
科研通智能强力驱动
Strongly Powered by AbleSci AI