ArticleOncology and therapy2025
Assessing Safety of the Transition to Generic Imatinib in Patients with Gastrointestinal Stromal Tumours.
Article in Oncology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionFollowing patent expiration of branded imatinib (Glivec®), all Dutch patients with gastrointestinal stromal tumours (GIST) switched from Glivec to generic forms. Following this switch, many patients reported new symptoms. Therefore, we conducted this observational study to assess safety of generic imatinib among patients with GIST in the Netherlands.
methodsWe included patients with GIST from four hospitals that switched from Glivec to generic imatinib. Within these patients, adverse events (AEs) without the switch to a generic were compared with AEs after the switch using a self-controlled case series design. The reference group was formed by the subset of patients who used imatinib for at least 1 year prior to the switch. As potential causes of increased AEs, we reviewed excipients and analysed plasma trough levels from 1 year prior to 1 year after the switch.
resultsIn total, 201 patients switched to three generics: Accord® (n = 107), Amarox® (n = 81), and Sandoz® (n = 13). In the reference group (n = 150), 21.3% experienced new AEs, compared with 29.9-34.6% in the different generic groups. All patients that switched to Amarox (odds ratio 2.3; 95% confidence interval (CI): 1.2-4.5) and females that switched to Accord (odds ratio 2.7; 95% CI: 1.1-7.0) experienced a significant increase in AEs. Plasma trough levels were similar among all different formulations. Apart from titanium dioxide in Amarox, no additional excipients were used in any generic form.
conclusionsThe transition to generic imatinib in Dutch patients with GIST was safe. After switching to generic imatinib, up to 34.6% of patients experienced new AEs, compared with 21.3% in the reference group, indicating that many AEs may have been mistakenly attributed to the switch. The small increase in AEs that we found was unlikely due to pharmacokinetics or excipients. Therefore, we argue that the nocebo effect, where negative expectations about treatment lead to worsened symptoms, played a large role.
Indexed as
Identifiers
What Socratic holds
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.