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Association details:
| Biomarker: | RAS mutation |
|---|---|
| Cancer: | Colorectal Cancer |
| Drug: | Stivarga (regorafenib) (Multi-tyrosine kinase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Regorafenib monotherapy as second-line treatment of patients with RAS-mutant advanced colorectal cancer: a multicentre, single-arm, two-stage, phase 2 study. Regorafenib in monoterapia come trattamento di seconda linea di pazienti affetti da carcinoma colorettale con mutazioni di RAS: studio mutlicentrico di fase 2, a singolo braccio, a due stadi.
Excerpt:
...Any RAS mutation that prevent treatment with anti-EGFR antibodies3. ...
Trial ID:
Source:
Title:
An Observational Study, Called RegoFlex EU, to Learn More About the Use of Stivarga at Reduced Doses as Recommended (Flexible Dosing) to Treat People With Metastatic Colorectal Cancer in Real World Settings in Europe
Excerpt:
...Descriptive summary of demographics characteristics`Descriptive summary of Stage of disease`Descriptive summary of Eastern Cooperative Oncology Group (ECOG) performance status`Descriptive summary of Primary tumor status`Descriptive summary of Number of metastatic`Descriptive summary of Site of metastasis`Descriptive summary of K-RAS mutation status and N-RAS mutation status`Descriptive summary of Line of therapy (LOT) for regorafenib`Descriptive summary of Prior adjuvant treatment`Descriptive summary of Treatments prior to index date, overall and by LOT`Descriptive summary of Pre-existing comorbidities...
Trial ID:
More C2 evidence
Source:
Title:
maintenance therapy with regorafenib
Excerpt:
...•Male or female patients > 18 years •Histological or cytological documentation of adenocarcinoma of the colon or rectum •Genetic diagnosis of RAS(hot spot mutations KRAS codon 2-3-4 and NRAS at least codon 2-3) wild type tumor . ...
Trial ID:
Source:
Title:
Oral Steroids for Regorafenib-induced Fatigue/Malaise in Unresectable mCRC (KSCC1402/HGCSG1402)
Excerpt:
...- Histological diagnosis of adenocarcinoma of either the colon or the rectum, regardless of RAS mutation...
Trial ID:
Source:
Title:
Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib
Excerpt:
...Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sample`ECOG: Eastern Cooperative Oncology Group`ECOG performance status (0, 1)`Rectum, Left-sided colon, Right-sided colon, Colon and rectum, Transverse, Unknown (in colon)`Primary site of disease`Tumor resection (yes, no, unknown)`Lung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknown`Specific site of metastasis`KRAS mutation (yes, no, unknown)`RAS mutation (yes, no, unknown)`BRAF mutation (yes, no, unknown)...
Trial ID:
Source:
Title:
Safety, Tolerability and Efficacy of Regorafenib in Combination With FOLFIRINOX in Patients With Colorectal Cancer
Excerpt:
...Documentation of tumor RAS mutation, wild-type homozygous, heterozygous status of UGT1A1 gene....
Trial ID:
Source:
Title:
Regorafenib Monotherapy as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer
Excerpt:
...Any RAS mutation that prevent treatment with anti-EGFR antibodies 3....
Trial ID:
Less C2 evidence
Source:
Title:
Efficacy and safety of regorafenib plus biweekly TAS-102 for refractory metastatic colorectal cancer (REGTAS): A multicenter single-arm phase II trial.
Published date:
05/25/2023
Excerpt:
11 (68.7%) patients were enrolled within 18 months from diagnosis of mCRC. RAS and BRAF mutation were detected in 8 (50.0%) and 1 (6.3%) patients. Among 13 evaluable patients, 11 achieved SD and 2 had PD, with the DCR of 84.6% (95% CI: 54.6%-98.1%). The median PFS was 4.9 months (95% CI: 2.8-7.0)...Regorafenib plus biweekly TAS-102 exhibited promising benefits in terms of DCR and PFS, and could be a novel treatment option for patients with refractory mCRC. The adverse events were generally tolerable and manageable.
Secondary therapy:
trifluridine/tipiracil
DOI:
10.1200/JCO.2023.41.16_suppl.e15567
Source:
Title:
Regorafenib is suitable for advanced colorectal cancer patients who have previously received trifluridine/tipiracil plus bevacizumab
Published date:
02/10/2023
Excerpt:
Thirty-four advanced CRC patients who received regorafenib were analyzed....Twenty-two patients had left-sided tumors, 18 patients had RAS mutants, and 1 patient had a BRAF V600E mutation. The response rate was 0%, and the disease control rate was 31%. The median progression-free survival was 70 days (95% CI: 56-91), and the overall survival was 233 days (95% CI: 188-324)....Regorafenib after TFTD plus bevacizumab showed efficacy similar to that of the previous study, and no new adverse events were observed.
DOI:
10.1038/s41598-023-29706-6
