التفاصيل البيبلوغرافية
| العنوان: |
Table_1_FOLFOXIRI/Bevacizumab Plus Nivolumab as First-Line Treatment in Metastatic Colorectal Cancer RAS/BRAF Mutated: Safety Run-In of Phase II NIVACOR Trial.doc |
| المؤلفون: |
Angela Damato (4877341), Francesca Bergamo (4780986), Lorenzo Antonuzzo (11541011), Guglielmo Nasti (826156), Francesco Iachetta (11540978), Alessandra Romagnani (11541002), Erika Gervasi (11834330), Mario Larocca (11834333), Carmine Pinto (336915) |
| سنة النشر: |
2021 |
| المجموعة: |
Smithsonian Institution: Digital Repository |
| مصطلحات موضوعية: |
Cancer, Cancer Cell Biology, Cancer Diagnosis, Cancer Genetics, Cancer Therapy (excl. Chemotherapy and Radiation Therapy), Chemotherapy, Haematological Tumours, Molecular Targets, Radiation Therapy, Solid Tumours, Oncology and Carcinogenesis not elsewhere classified, safety run-in, nivolumab, FOLFOXIRI, bevacizumab, colorectal cancer, RAS mutation, BRAF mutation |
| الوصف: |
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 Clostridium 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. Clinical Trial Registration https://clinicaltrials.gov/, (NCT04072198). |
| نوع الوثيقة: |
dataset |
| اللغة: |
unknown |
| Relation: |
https://figshare.com/articles/dataset/Table_1_FOLFOXIRI_Bevacizumab_Plus_Nivolumab_as_First-Line_Treatment_in_Metastatic_Colorectal_Cancer_RAS_BRAF_Mutated_Safety_Run-In_of_Phase_II_NIVACOR_Trial_doc/17194853 |
| DOI: |
10.3389/fonc.2021.766500.s001 |
| الاتاحة: |
https://doi.org/10.3389/fonc.2021.766500.s001 |
| Rights: |
CC BY 4.0 |
| رقم الانضمام: |
edsbas.CAF46E0C |
| قاعدة البيانات: |
BASE |