Damato Angela, Bergamo Francesca, Antonuzzo Lorenzo, Nasti Guglielmo, Iachetta Francesco, Romagnani Alessandra, Gervasi Erika, Larocca Mario, Pinto Carmine
Medical Oncology Unit, Azienda USL (Unità Sanitaria Locale)- IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) di Reggio Emilia, Reggio Emilia, Italy.
Department of Medical Biotechnologies, University of Siena, Siena, Italy.
Front Oncol. 2021 Dec 14;11:766500. doi: 10.3389/fonc.2021.766500. eCollection 2021.
The NIVACOR trial is a phase II study assessing the efficacy and safety of nivolumab in combination with FOLFOXIRI/bevacizumab in first-line setting in patients affected by metastatic colorectal cancer (mCRC) RAS/BRAF mutated. We report safety run-in results in the first 10 patients enrolled. Patients received triplet chemotherapy with FOLFOXIRI scheme plus bevacizumab, in association with nivolumab every 2 weeks for 8 cycles (induction phase) followed by bevacizumab plus nivolumab every 2 weeks (maintenance phase), until progression of disease or unacceptable toxicities. The first ten patients were evaluated: 7 experienced at least one adverse event (AE) related to FOLFOXIRI/bevacizumab and 2 related to nivolumab. The most frequent grade 1-2 AEs related to FOLFOXIRI/bevacizumab were diarrhea and fatigue (71%), nausea and vomiting (57%); 3 (43%) had grade 3-4 neutropenia, and 2 (20%) patients developed grade 1-2 AEs nivolumab related: skin rash and salivary gland infection. Two patients delayed the dose because of serious AEs, proteinuria and salivary gland infection; one patient discontinued experimental treatment due to the ileo-urethral fistula and concurrent infection diarrhea. No treatment- related death occurred. The safety run-in analysis of NIVACOR trial reassured using co-administration of FOLFOXIRI/bevacizumab and nivolumab was well tolerated with an acceptable toxicity profile.
https://clinicaltrials.gov/, (NCT04072198).
NIVACOR试验是一项II期研究，评估纳武利尤单抗联合FOLFOXIRI/贝伐单抗在一线治疗RAS/BRAF突变的转移性结直肠癌（mCRC）患者中的疗效和安全性。我们报告了入组的前10例患者的安全性导入期结果。患者接受FOLFOXIRI方案三联化疗加贝伐单抗，每2周联合纳武利尤单抗，共8个周期（诱导期），随后每2周给予贝伐单抗加纳武利尤单抗（维持期），直至疾病进展或出现不可接受的毒性。对前10例患者进行了评估：7例经历了至少1次与FOLFOXIRI/贝伐单抗相关的不良事件（AE），2例与纳武利尤单抗相关。与FOLFOXIRI/贝伐单抗相关的最常见1-2级AE为腹泻和疲劳（71%）、恶心和呕吐（57%）；3例（43%）出现3-4级中性粒细胞减少，2例（20%）患者出现与纳武利尤单抗相关的1-2级AE：皮疹和唾液腺感染。2例患者因严重AE（蛋白尿和唾液腺感染）延迟给药；1例患者因回肠尿道瘘和并发感染性腹泻停止试验性治疗。未发生与治疗相关的死亡。NIVACOR试验的安全性导入期分析表明，FOLFOXIRI/贝伐单抗与纳武利尤单抗联合使用耐受性良好，毒性特征可接受。
