Real-Life Treatment of Metastatic Colorectal Cancer with Regorafenib: A Single-Centre Review

Gotfrit, Joanna; Vickers, Michael M.; Sud, Shelly; Asmis, Timothy R.; Cripps, C.; Goel, Rakesh; Hsu, Tina; Jonker, Derek J.; Goodwin, Rachel

doi:10.3747/co.24.3562

Cited by 11 publications

(12 citation statements)

References 5 publications

(4 reference statements)

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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: 74%

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: 74%

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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“…A Japanese retrospective study demonstrated that there was no clear reduction in clinical efficacy when the regorafenib dose was modified to an intensity of 59% compared with the standard dose. 39 The other study that analyzed data from patients with mCRC used different regorafenib starting doses: 54% of patients received 160 mg, 40% received 120 mg, and 6% received 80 mg. 40 Those results indicated that various starting doses had no association with survival in univariate or multivariate analysis. Recently presented data from the Regorafenib Dose Optimization Study (ReDOS) demonstrated that a strategy with weekly dose escalation of regorafenib from 80 to 160 mg daily was superior to the standard dose of 160 mg daily in patients with mCRC.…”

Section: Discussionmentioning

confidence: 96%

A phase 2 trial of regorafenib as a single agent in patients with chemotherapy‐refractory, advanced, and metastatic biliary tract adenocarcinoma

Sun

Patel

Normolle

et al. 2018

Cancer

104

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BACKGROUND: Biliary tract cancers are rare, aggressive neoplasms. Most patients present with advanced/unresectable or metastatic disease at diagnosis, and no second-line regimen has demonstrated clinical benefit. This was a phase 2 study evaluating the efficacy and safety of regorafenib in patients who had advanced/unresectable or metastatic disease after receiving standard therapy. METHODS:In this single arm-study, patients with advanced/unresectable or metastatic biliary tract cancer who failed at least 1 line of systemic chemotherapy received regorafenib once daily on a schedule of 21-days on/7-days off in a 28-day cycle. Patients initially received a standard 160 mg dose. After toxicity assessments in the first 3 patients, the dose was reduced to 120 mg for subsequent patients, as preplanned. The primary endpoint was progression-free survival (PFS). Secondary objectives included overall survival (OS), the objective response rate, and the disease control rate. RESULTS: Forty-three patients received at least 1 dose of regorafenib, and 34 patients who received at least 1 cycle of treatment were evaluable for tumor response. The median PFS was 15.6 weeks (90% confidence interval, 12.9-24.7 weeks), and the median OS was 31.8 weeks (90% confidence interval, 13.3-74.3 weeks), with survival rates 40% at 12 months and 32% at 18 months. A partial response was achieved in 5 patients (11%), and 19 had stable disease (44%), for a disease control rate of 56%. The toxicity profile was as expected, with grade 3 and 4 adverse events reported in 40% of patients. The most common toxicities were hypophosphatemia (40%), hyperbilirubinemia (26%), hypertension (23%), and hand-foot skin reaction (7%). CONCLUSIONS: The current results suggest promising efficacy of regorafenib in patients with chemotherapy-refractory, advanced/ metastatic biliary tract cancer, warranting further studies to confirm its clinical efficacy. There is a clear unmet need for effective therapies in patients who have advanced and metastatic biliary tract cancer. Cancer 2019;125:902-909.

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“…This approach differs from tumor response assessments in clinical trials that are performed at regular intervals. However, this real-world best tumor response assessment approach has been used in other observational settings 1,7,8 . OS was defined as the time between index date and death.…”

Section: Study Design and Study Populationmentioning

confidence: 99%

Trifluridine/Tipiracil and Regorafenib in Patients with Metastatic Colorectal Cancer: A Retrospective Study at a Tertiary Oncology Center

et al. 2021

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Background. Trifluridine/tipiracil (FTD/TPI) and regorafenib prolong survival for patients with refractory metastatic colorectal cancer (mCRC); limited comparative effectiveness data exist. Materials and Methods. A retrospective, longitudinal cohort study of patients with mCRC who initiated FTD/TPI or regorafenib (index therapy) between 2012-2017 at a US tertiary oncology center, Dana-Farber Cancer Institute, was conducted. Using best tumor response assessments, realworld overall response rates (rwORR) and disease control rates (rwDCR) were described and analyzed using logistic regression. Survival rate was examined for each month after index therapy using Kaplan-Meier. Overall survival (OS) was assessed using Cox proportional hazards models. Subgroup analyses among patients with index therapy as 2nd-or 3rdline were performed. Results. 126 and 95 patients were treated with FTD/TPI or regorafenib as index therapy, respectively. Patients treated with FTD/TPI versus regorafenib had a better response (rwORR 52.5% vs. 34.2%, adjusted OR=2.6, all p-value<0.05; rwDCR 64.2% vs. 46.1%, adjusted OR=2.5, all p-value<0.05). Similar findings were observed for FTD/TPI versus regorafenib as 2nd-or 3rd-line therapy (rwORR 54.8% vs. 25.9%, adjusted OR=4.1, all p-value<0.05; rwDCR 69.0% vs. 37.0%, adjusted OR=4.9, all p-value<0.05). A greater proportion of patients treated with FTD/TPI versus regorafenib survived at 3 months (86.2% vs. 73.4%, p=0.016) and 4 months (79.6% vs. 65.8%, p=0.017). Adjusted OS hazard ratio for FTD/TPI versus regorafenib was 0.80, p=0.157. Conclusion.Patients treated with FTD/TPI had better tumor response and disease control than patients treated with regorafenib. Subgroup analysis in 2nd-or 3rd-line suggests that early use of FTD/TPI may have clinical benefits.Implications for Practice Statement: This real-world retrospective study compared clinical outcomes and clinical conditions between patients with refractory mCRC treated with FTD/TPI vs. regorafenib. Compared with patients treated with regorafenib, patients treated with FTD/TPI were significantly less likely to have dose modifications and more likely to have higher real-world objective response rate (rwORR) and real-world disease control rate (rwDCR) based on best tumor response while treated. Patients treated with FTD/TPI vs. regorafenib had significantly greater odds of having rwORR or rwDCR in adjusted analyses. Monthly survival rates were higher overall in patients treated with FTD/TPI vs. regorafenib in the first 6 months of follow-up, particularly at months 3 and 4. Adjusted overall survival results were similar between treatment groups. Clinical conditions while on treatment were consistent with the literature. This study offers insight into patients' treatment experience in real-world clinical settings. The Oncologist 2021;9999:• •

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Real-Life Treatment of Metastatic Colorectal Cancer with Regorafenib: A Single-Centre Review

Abstract: Background Various tyrosine kinase signalling pathways affect the development and progression of colorectal

Cited by 11 publications

References 5 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

A phase 2 trial of regorafenib as a single agent in patients with chemotherapy‐refractory, advanced, and metastatic biliary tract adenocarcinoma

Trifluridine/Tipiracil and Regorafenib in Patients with Metastatic Colorectal Cancer: A Retrospective Study at a Tertiary Oncology Center

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