Efficacy and safety of regorafenib and fruquintinib as third-line treatment for colorectal cancer: a narrative review

Xu, Xiaojing; Yu, Yiyi; Liu, Mengling; Li, Liang; Liu, Tianshu

doi:10.21037/tcr-20-3539

Cited by 16 publications

(15 citation statements)

References 57 publications

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“…However, a more detailed analysis of its safety features indicates that Reg is a viable treatment alternative. [27] One of the limitations of this study was its retrospective design. So the assessment of adverse effects related to laboratory abnormalities was based on objective criteria, while the evaluation of other effects relied on subjective judgments made by physicians.…”

Section: Discussionmentioning

confidence: 97%

Regorafenib therapy as a third-line treatment for metastatic colorectal cancer: A single center long term experience

Ozkan,

Oflazoglu,

Yildiz

et al. 2023

Medicine

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This study examined the effects of regorafenib (Reg) on progression-free survival (PFS), overall survival (OS), and adverse events (AEs) in metastatic colorectal cancer (mCRC) patients who underwent targeted treatment and chemotherapy. Reg was administered as a third-line treatment to 84 patients who had undergone 2 rounds of chemotherapy and targeted therapy and subsequently experienced progression. Treatment was initiated with a daily dose of 80 or 120 mg, based on the patient’s ability to tolerate the medication, which was increased to 160 mg/day. The median PFS with Reg was 4 ± 0.2 months, while the median OS was 9 ± 1.2 months. When compared to patients who started Reg treatment at 80 mg, patients starting at 160 mg had longer median PFS and OS (PFS:6 ± 2.1 months vs 4 ± 0.2 months; P = .05; OS:13 ± 0.7 months vs 6 ± 1.3 months; P = .069). Patients with right-sided colon cancer who received Reg as third-line therapy had a significantly longer mPFS than those with left-sided colon cancer (8 months ± 4 vs 4 months ± 0.3, P = .039). Patients with KRAS mutations had a prolonged mPFS than those with panRAS-wild type (6 ± 1.6 months vs 4 ± 0.3 months, P = .06). The mPFS contribution in the BRAF mutant subgroup with poor prognosis is promising, as it is similar to that of patients without BRAF mutations (4 months ± 0.8 × 4 months ± 0.5, P = .74). The most common AEs reported were elevated liver enzyme levels and dermatological toxicities.

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Section: Discussionmentioning

confidence: 97%

Regorafenib therapy as a third-line treatment for metastatic colorectal cancer: A single center long term experience

Ozkan,

Oflazoglu,

Yildiz

et al. 2023

Medicine

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“…According to the 2023 ESMO guidelines, regorafenib is recommended as a third- and further-line treatment in patients pre-treated with fluoropyrimidines, oxaliplatin, irinotecan, and biologics, if available, or in earlier lines of therapy following oxaliplatin and irinotecan regimen failure [ 34 ]. Regorafenib was also evaluated for safety and efficacy compared to other agents such as trifluridine/tipiracil (TAS-102) and fruquintinib [ 35 , 36 , 37 ]. Regorafenib and TAS-102 appeared to have similar efficacy; however, regorafenib was associated with more toxicity compared with TAS-102 [ 35 ].…”

Section: Discussionmentioning

confidence: 99%

A Phase II Exploratory Study to Identify Biomarkers Predictive of Clinical Response to Regorafenib in Patients with Metastatic Colorectal Cancer Who Have Failed First-Line Therapy

Gambaro,

Marques,

McNamara

et al. 2023

IJMS

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Single-agent regorafenib is approved in Canada for metastatic colorectal cancer (mCRC) patients who have failed previous lines of therapy. Identifying prognostic biomarkers is key to optimizing therapeutic strategies for these patients. In this clinical study (NCT01949194), we evaluated the safety and efficacy of single-agent regorafenib as a second-line therapy for mCRC patients who received it after failing first-line therapy with an oxaliplatin or irinotecan regimen with or without bevacizumab. Using various omics approaches, we also investigated putative biomarkers of response and resistance to regorafenib in metastatic lesions and blood samples in the same cohort. Overall, the safety profile of regorafenib seemed similar to the CORRECT trial, where regorafenib was administered as ≥ 2 lines of therapy. While the mutational landscape showed typical mutation rates for the top five driver genes (APC, KRAS, BRAF, PIK3CA, and TP53), KRAS mutations were enriched in intrinsically resistant lesions. Additional exploration of genomic-phenotype associations revealed several biomarker candidates linked to unfavorable prognoses in patients with mCRC using various approaches, including pathway analysis, cfDNA profiling, and copy number analysis. However, further research endeavors are necessary to validate the potential utility of these promising genes in understanding patients’ responses to regorafenib treatment.

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“… 9 , 10 However, the disappointing ORR of fruquintinib and regorafenib (4.7% and 4.0%, respectively) highlighted that novel therapeutic options were still needed to be explored to provide patients with promising efficacy and acceptable safety profile in clinical practice. 11 …”

Section: Introductionmentioning

confidence: 99%

Feasibility and Tolerability of Anlotinib Plus PD-1 Blockades for Patients with Treatment-Refractory Metastatic Colorectal Cancer: A Retrospective Exploratory Study

Bai,

Wang,

Zhou

et al. 2024

CMAR

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Objective Therapeutic regimens are relatively scarce among patients with treatment-refractory metastatic colorectal cancer (CRC). This study aimed to determine the feasibility and tolerability of anlotinib plus PD-1 blockades in patients with treatment-refractory metastatic CRC retrospectively. Methods A total of 68 patients with previously treated metastatic CRC who received anlotinib plus PD-1 blockades in clinical practice were included in this study retrospectively. Demographic and clinical characteristics of the patients, therapeutic outcomes and safety profile during administration were collected and briefly analyzed. All subjects were followed up regularly. Therapeutic outcomes, including drug response and prognosis, were presented, and a safety profile was depicted to illustrate the adverse reactions. Results A total of 68 patients with treatment-refractory metastatic CRC who received anlotinib plus PD-1 blockades in clinical practice were included in the final analysis. Best therapeutic response during treatment indicated that partial response was observed in 11 patients, stable disease was noted in 41 patients, and progressive disease was found in 16 patients, producing an objective response rate of 16.2% (95% CI: 8.4%–27.1%) and a disease control rate of 76.5% (95% CI: 64.6%–85.9%). Prognostic analysis suggested that the median progression-free survival (PFS) of the 68 patients was 5.3 months (95% CI: 3.01–7.59), and the median overall survival (OS) was 12.5 months (95% CI: 9.40–15.60). Of the 11 patients who responded, the median duration of response was 6.7 months (95% CI: 2.89–10.53). Safety profile during treatment showed that patients experienced adverse reactions regardless of grade, and grade ≥3 adverse reactions were found in 61 patients (89.7%) and 41 patients (60.3%), respectively. Common adverse reactions were hypertension, myelosuppression (including leukopenia, neutropenia, thrombocytopenia, and anemia), fatigue, and hand-foot syndrome. Conclusion Anlotinib plus PD-1 blockades demonstrated encouraging efficacy and acceptable safety profile in patients with treatment-refractory metastatic CRC preliminarily in clinical practice. This conclusion should be confirmed in prospective clinical trials.

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Efficacy and safety of regorafenib and fruquintinib as third-line treatment for colorectal cancer: a narrative review

Cited by 16 publications

References 57 publications

Regorafenib therapy as a third-line treatment for metastatic colorectal cancer: A single center long term experience

Regorafenib therapy as a third-line treatment for metastatic colorectal cancer: A single center long term experience

A Phase II Exploratory Study to Identify Biomarkers Predictive of Clinical Response to Regorafenib in Patients with Metastatic Colorectal Cancer Who Have Failed First-Line Therapy

Feasibility and Tolerability of Anlotinib Plus PD-1 Blockades for Patients with Treatment-Refractory Metastatic Colorectal Cancer: A Retrospective Exploratory Study

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