Regorafenib therapy in metastatic colorectal cancer patients: markers and outcome in an actual clinical setting

Unseld, Matthias; Filip, Monalisa; Seirl, S; Gleiß, Andreas; Bianconi, Daniela; Kieler, Markus; Demyanets, Svitlana; Scheithauer, Werner; Zielinski, Christoph; Prager, Gerald W.

doi:10.4149/neo_2018_170727n506

Cited by 8 publications

(9 citation statements)

References 15 publications

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“…Because of our small sample, further studies involving more patients are needed to confirm this information. life data, regorafenib was associated with a survival similar to that reported in the randomized controlled trials (7)(8)(9)(10)(11).…”

Section: Discussionsupporting

confidence: 75%

Single Center Real Life Experience with Regorafenib in Patients with Metastatic Colorectal Cancer

Eryılmaz¹,

Karaağaç²,

Araz³

et al. 2020

Akd Med J

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Objective: To evaluate the clinical benefit of regorafenib in routine clinical practice. Material and Methods: We retrospectively evaluated the data of 45 metastatic colorectal cancer (mCRC) patients who received regorafenib between January 2016 and November 2018. Results: The median age of all patients was 54 years, and 66.7% of the patients were male. Performance status of 20 patients (44.4%) was 2, whereas in 25 patients (55.6%) it was 0-1. Thirty-six patients (80%) were performed primary tumor resection and KRAS mutation was detected in 53.3% of patients. Regorafenib was started at a dose of 160 mg in all patients, and a dose reduction was observed in 28.9% of patients. Line of regorafenib treatment was 3 rd in 66.7% of patients, whereas in 33.3% of patients it was ≥ 4 th. Best response was progressive disease (46.7%) and stable disease (35.6%). The median progression free survival (PFS) was 3.1 months (95% CI: 2.2-4.0) and overall survival (OS) was 6.4 months (95% CI: 3.2-9.5). Primary tumor resection status and using regorafenib ≥ 4 treatment line were significantly associated with both PFS and OS in multivariate analysis. Conclusion: Regorafenib was associated with survival durations similar to those reported in both randomized controlled trials and in the real-life setting, and was generally well tolerated. Patients who had primary tumor resected and using regorafenib as the ≥ 4 th treatment line (primary resected vs nonresected: PFS: 3.8 vs. 1.6 months, p: 0.006; OS: 6.1 vs. 3.1 months, p: 0.018, 3 rd vs. 4 th or more: PFS: 2.7 vs. 4.6 months, p:0.001; OS: 3.8 vs. 11.4 months, p:0.001) were associated with better PFS and OS. However, in order to explain the better survival with regorafenib in patients with primary tumor resected, this information must be confirmed with further studies.

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Section: Discussionsupporting

confidence: 75%

Single Center Real Life Experience with Regorafenib in Patients with Metastatic Colorectal Cancer

Eryılmaz¹,

Karaağaç²,

Araz³

et al. 2020

Akd Med J

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“…Similar results in PFS have been reported with either retrospective single institution or small prospective studies. 13,14 The median OS in our cohort was 8 months, which also might be related to the short follow-up duration (median, 6.3 months). This compares favorably with similar reported studies.…”

Section: Discussionmentioning

confidence: 84%

Efficacy of Regorafenib in Metastatic Colorectal Cancer: A Multi-institutional Retrospective Study

Aljubran

Elshenawy

Kandil

et al. 2019

Clin Med Insights Oncol

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Background:Regorafenib is a multi-kinase inhibitor approved for treatment of refractory advanced colorectal cancer. It was found in the clinical trials to have a modest benefit and significant toxicity. Our aim was to assess the outcome in our local clinic practice.Patients and methods:Records of patients with confirmed colorectal cancer treated with regorafenib were reviewed. Clinical, pathological, and molecular data were collected. Efficacy and factors of possible prognostic significance were analyzed.Results:A total of 78 patients with metastatic colorectal cancer were treated with regorafenib from February 2014 to February 2016 in 4 different institutions (median age: 50.5 years; male: 40 [51.3%]; KRAS mutant: 41 [52%]; right colonic primary: 18 [23%]). A total of 52 patients (66.7%) had Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1, whereas in 25 patients (32.1%) it was >1. In total, 58 patients (74%) had dose reduction. No patient achieved objective response, 15 patients (19%) achieved stable disease, and 56 patients (72%) had progressive disease. With a median follow-up of 6.5 months, the median progression-free survival was 2.8 months (95% confidence interval [CI], 2.5-3.3) and overall survival was 8.0 months (95% CI, 6.2-9.7). Only performance status of ⩽1 had a statistically significant impact on progression-free survival and overall survival in both univariate and multivariate analyses.Conclusions:Regorafenib in our clinical practice has equal efficacy to reported data from pivotal registration trials. Our data suggest that performance status is the most important prognostic factor in patients treated with regorafenib, suggesting a careful selection of patients.

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“…In addition, other subgroup analyses identified several prognostic biomarkers [ 21 ]. In real-world experiences, the potential prognostic factors were poor ECOG PS, a short time from the initial diagnosis of metastases to the start of regorafenib treatment (<160 mg), >3 metastatic sites, the presence of liver metastases, and the presence of K-RAS mutations [ 11 , 14 , 18 ]. A lung-limited metastatic disease was also associated with better survival rates [ 22 , 23 ].…”

Section: Discussionmentioning

confidence: 99%

Prognostic factors for regorafenib treatment in patients with refractory metastatic colorectal cancer: A real-life retrospective multi-center study

Goktas Aydin,

Kavak,

Topcu

et al. 2023

Biomol Biomed

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Regorafenib, an oral multikinase inhibitor, has improved survival in metastatic colorectal cancer (mCRC) patients who have progressed on standard therapies. Our study aimed to evaluate prognostic factors influencing regorafenib treatment and assess the optimal dosing regimen in a real-life setting. We retrospectively analysed 263 patients with mCRC from multiple medical oncology clinics in Turkey. Treatment responses and prognostic factors for survival were evaluated using univariate and multivariate analysis. Of the patients, 120 were male, and 143 were female; 28.9% of tumors were located in the rectum. RAS mutations were present in 3.0% of tumors, while BRAF, K-RAS, and N-RAS mutations were found in 3.0%, 29.7%, and 25.9% of tumor tissues, respectively. Dose escalation was preferred in 105 (39.9%) patients. The median treatment duration was 3.0 months, with an objective response rate (ORR) of 4.9%. Grade ≥ 3 treatment-related toxicity occurred in 133 patients, leading to discontinuation, interruption, and modification rates of 50.6%, 43.7%, and 79.0%, respectively. Median progression-free survival (PFS) and overall survival (OS) were 3.0 and 8.1 months, respectively. RAS/RAF mutation (hazard ratio [HR] 1.5, 95% confidence interval [CI] 1.1-2.3; P = 0.01), pretreatment carcinoembryonic antigen (CEA) levels (HR 1.6, 95% CI 1.1-2.3; P = 0.008), and toxicity-related treatment interruption or dose adjustment (HR 1.6, 95% CI 1.1-2.4; P = 0.01) were identified as independent prognostic factors for PFS. Dose escalation had no significant effect on PFS but was associated with improved OS (P < 0.001). Independent prognostic factors for OS were the initial TNM stage (HR 1.3, 95% CI 1.0-1.9; P = 0.04) and dose interruption/adjustment (HR 0.4, 95% CI 0.2-0.9; P = 0.03). Our findings demonstrate the efficacy and safety of regorafenib. Treatment line influences the response, with dose escalation being more favorable than adjustment or interruption, thus impacting survival.

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Regorafenib therapy in metastatic colorectal cancer patients: markers and outcome in an actual clinical setting

Cited by 8 publications

References 15 publications

Single Center Real Life Experience with Regorafenib in Patients with Metastatic Colorectal Cancer

Single Center Real Life Experience with Regorafenib in Patients with Metastatic Colorectal Cancer

Efficacy of Regorafenib in Metastatic Colorectal Cancer: A Multi-institutional Retrospective Study

Prognostic factors for regorafenib treatment in patients with refractory metastatic colorectal cancer: A real-life retrospective multi-center study

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