ArticleThe oncologist2025
Dynamics of hyperglycemia of patients treated with alpelisib: exploratory interim analysis of ITACA trial.
Article in The oncologist, 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
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlpelisib and fulvestrant combination has improved outcomes in patients with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-)- advanced breast cancer (BC) who relapsed or progressed on prior endocrine therapy. Hyperglycemia, on target toxicity, is a frequent adverse event occurring in over 60% of patients.
objectivesThe ITACA trial explores whether low carbohydrate dietary modifications and evening dosing of alpelisib to potentially mitigate impact of food on hyperglycemia. This exploratory interim analysis aimed to quantify the incidence and timing of hyperglycemia in the ITACA trial's pooled sample.
methodsThis exploratory interim analysis of the ongoing ITACA trial included 23 patients with HR+, HER2-negative metastatic BC receiving alpelisib and fulvestrant. The exploratory outcomes were grade 2-4 hyperglycemia-free survival and time to onset of hyperglycemia.
resultsMost patients, 21 (91.3%), experienced any-grade hyperglycemia (Grade 1: 9 [39.1%], Grade 2: 8 [34.8%], Grade 3: 4 [17.4%], and Grade 4: 0 [0.0%]) within the first week of alpelisib initiation. The median grade 2-4 hyperglycemia-free survival was 6 days (95% CI 3; 44 days).
conclusionsThis exploratory interim analysis demonstrated the rapid onset of hyperglycemia in patients receiving alpelisib, even with the ITACA trial's dietary interventions. Proactive monitoring, within the first week after initiation of treatment, and early management of hyperglycemia are crucial in this patient population.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.