Trial reportThe oncologist2024
A phase IV study to evaluate the safety of fruquintinib in Chinese patients in real-world clinical practice.
Trial report in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.
- Efficacy and safety of fruquintinib in the treatment of colorectal cancer: a systematic review and meta-analysis of studies in China.Frontiers in pharmacology · 2025Pooled it
- Efficacy and safety of fruquintinib plus capecitabine as first-line treatment in patients with metastatic colorectal cancer ineligible for intravenous chemotherapy: a two-stage, single-armed, phase II study.Investigational new drugs · 2025Trial
- Proteinuria as the cause of early dose modification in Japanese patients with metastatic colorectal cancer treated with fruquintinib: a multicenter real-world study.International journal of clinical oncology · 2026Article
- Safety of fruquintinib mono- and combo therapy in metastatic colorectal cancer: real-world subgroup analysis from China.Future oncology (London, England) · 2026Article
- From Synthesis to Mechanism: Biological Evaluation of a p-Toluidine-Based Thiazolidinone-Quinoline VEGFR-2 Candidate Supported by CADD.International journal of molecular sciences · 2026Article
- Angiotensin‑converting enzyme 2 as an immune and prognostic biomarker in colorectal cancer.Scientific reports · 2026Article
- Efficacy and safety of fruquintinib in refractory metastatic colorectal cancer: a systematic review and meta-analysis.Journal of gastrointestinal oncology · 2025Article
- A Real-World Pharmacovigilance Study of Fruquintinib Based on the FDA Adverse Event Reporting System (FAERS) Database.Cancer medicine · 2025Article
- Cardiovascular toxicity of Fruquintinib in patients with colorectal and other cancers: a systematic review and meta-analysis.Cardio-oncology (London, England) · 2025Article
- The impact of sarcopenia on prognosis and fruquintinib efficacy in advanced colorectal cancer: a retrospective and mendelian randomization study.Frontiers in immunology · 2025Article
- Safety of fruquintinib in Chinese patients with colorectal cancer: an age subgroup analysis from a phase IV real-world clinical practice study.Therapeutic advances in medical oncology · 2025Article
- Fruquintinib in metastatic colorectal cancer: a multicenter real-world analysis on efficacy, safety, and predictive and prognostic factors.Journal of gastrointestinal oncology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors at 20 institutions in 1 country.
Funding
Abstract
introductionFruquintinib is approved in China for patients with metastatic colorectal cancer (CRC) who progressed after 2 lines of chemotherapy. This postmarketing study was conducted to evaluate the safety of fruquintinib in the Chinese population, including previously treated patients with advanced CRC and other solid tumors.
methodsPatients in the first cycle of fruquintinib or expected to start fruquintinib within a week were enrolled. Fruquintinib was administrated according to the label or per physicians' discretion. Patient characteristics and safety information were collected at baseline, 1 month, and 6 months after consent (or 30 days after the last dose).
resultsOverall, 3005 patients enrolled between April 24, 2019 and September 27, 2022. All enrolled patients received at least one dose of fruquintinib. Most patients had metastases at baseline. The median age was 60 years. More than half (64.0%) of the patients started fruquintinib at 5 mg, and the median treatment exposure was 2.7 months. Nearly one-third (32.5%) of patients with CRC received fruquintinib with concomitant antineoplastic agents. Treatment-emergent adverse events (TEAEs) leading to dose modification were reported in 626 (20.8%) patients, and 469 (15.6%) patients experienced TEAEs leading to treatment discontinuation. The most common grade ≥ 3 TEAEs were hypertension (6.6%), palmar-plantar erythrodysesthesia syndrome (2.2%), and platelet count decreased (1.0%). Combination therapy did not lead to excessive toxicities.
conclusionsThe safety profile of fruquintinib in the real world was generally consistent with that in clinical studies, and the incidence of TEAEs was numerically lower than known VEGF/VEGFR inhibitor-related AEs. Fruquintinib exhibited manageable safety and tolerability in Chinese patients in the real-world setting.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.