ArticleEClinicalMedicine2020
Assessing the risk-benefit profile of ramucirumab in patients with advanced solid tumors: A meta-analysis of randomized controlled trials.
Article in EClinicalMedicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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
9 citing papers in PubMed, 17 citations in OpenAlex.
- A phase II study of ramucirumab and somatostatin analog therapy in patients with advanced neuroendocrine tumors.The oncologist · 2025Trial
- Exposure-response relationship of ramucirumab in RANGE, a randomized phase III trial in advanced urothelial carcinoma refractory to platinum therapy.British journal of clinical pharmacology · 2022Trial
- Assessing patient risk, benefit, and outcomes in drug development: A decade of ramucirumab clinical trials.Cancer medicine · 2024Article
- Vascular Endothelial Growth Factor Ligands and Receptors in Breast Cancer.Journal of clinical medicine · 2023Review
- An appraisal of FDA approvals for adult solid tumours in 2017-2021: has the eagle landed?Nature reviews. Clinical oncology · 2022Review
- Article
- Targeting Angiogenesis in Breast Cancer: Current Evidence and Future Perspectives of Novel Anti-Angiogenic Approaches.Frontiers in pharmacology · 2022Review
- Hypoxia-induced therapy resistance: Available hypoxia-targeting strategies and current advances in head and neck cancer.Translational oncology · 2021Review
- The State-of-the-Art of Phase II/III Clinical Trials for Targeted Pancreatic Cancer Therapies.Journal of clinical medicine · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRamucirumab is a widely used cancer drug having gained six regulatory approvals in various advanced solid tumors. Thus, assessing the risk-benefit profile of such a commonly used drug across multiple tumor types is necessary to inform clinical and reimbursement decisions. To objectively assess the risks and benefits of ramucirumab in patients with advanced solid tumors, we performed a systematic review and meta-analysis of published randomized controlled trials (RCTs).
methodsA systematic search of PubMed, the Cochrane Library, Google Scholar and conference abstracts for all RCTs of ramucirumab in patients with advanced solid cancer was conducted according to the PRISMA guidelines. Data on treatment-related serious adverse events (SAEs), fatal adverse events (FAEs), primary endpoint, gains in median overall survival (OS), progression-free survival (PFS) with their hazard ratios (HR) and 95% confidence intervals (CIs) and quality of life (QOL) were extracted from each RCT. Summary relative risks (RR) with 95% CI for SAEs and FAEs were calculated by pooling data across the RCTs using random-effects model. Treatment benefit was evaluated descriptively in terms of median and HR with 95% CI of OS and PFS gains as well as improvements in QOL. ESMO-Magnitude of Clinical Benefit Scale (MCBS), a validated tool, was used to objectively quantify clinical benefit of ramucirumab in approved settings.
findingsTen RCTs met our inclusion criteria. Compared with the control arm, the use of ramucirumab was associated with a significantly increased risk of developing SAE (RR 1.13, 95% CI 1.05-1.21, incidence 37.5% v 33.5%). The increase in risk of FAE (RR 1.41, 95% CI 0.96-2.07, incidence 1.8% v 1.3%) was not statistically significant. Using the ESMO MCBS tool, clinical benefit with ramucirumab was not substantial in any indication, five of six approvals scoring a "negligible benefit" score of 1 or 2. QOL was either not reported (30%) or not improved (70%) in these RCTs.
interpretationIn this meta-analysis of RCTs, use of ramucirumab in patients with advanced cancer was associated with increased risk of treatment related serious and possibly fatal adverse events but the magnitude of clinical benefit from ramucirumab was mostly negligible with no trial reporting an improvement in QOL. These relative risks and benefits should be considered in clinical and regulatory decision making.
fundingNone.
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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 OpenQuestion graph.