Safety analyses of the INAVO120 randomised phase III trial of inavolisib or placebo with palbociclib-fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-resistant advanced breast cancer
Abstract
Background: INAVO120 (NCT04191499) demonstrated significantly improved progression-free/overall survival with inavolisib plus palbociclib-fulvestrant versus placebo plus palbociclib-fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-resistant advanced breast cancer. We provide comprehensive analyses of key selected adverse events and their management.
Materials and methods: Inavolisib was given 9 mg orally once daily on days 1-28 of each 28-day cycle; palbociclib, at 125 mg orally once daily on days 1-21; fulvestrant, at 500 mg intramuscularly on days 1 and 15 of cycle 1, and every ∼28 days thereafter. Supportive therapies were used as clinically indicated. Key selected adverse events assessed included hyperglycaemia, stomatitis/mucosal inflammation, rash and diarrhoea, graded per National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
Results: Data cut-off was 29 September 2023; median follow-up was 21.3 months (range 0-43.1; inavolisib arm) and 21.5 months (0.1-40.3; placebo arm). Inavolisib dose interruptions, reductions and discontinuations due to hyperglycaemia were observed in 27.2%, 2.5% and 0.6% of patients, respectively; the median time to first onset was 7.0 days (range 2.0-955.0). Metformin was the most commonly used antihyperglycaemic. No patients in the prediabetic population discontinued inavolisib due to hyperglycaemia. Inavolisib dose interruptions, reductions and discontinuations due to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Metformin as an adjuvant in breast cancer treatment
- Metformin Lysosomal Targeting: A Novel Aspect to Be Investigated for Metformin Repurposing in Neurodegenerative Diseases?
- Aberrant HSF1 signaling activation underlies metformin amelioration of myocardial infarction in mice
- Metformin induces ZFP36 by mTORC1 inhibition in cervical cancer-derived cell lines
- Protein Interaction Network for Identifying Vascular Response of Metformin (Oral Antidiabetic)
- Preventing Long COVID With Metformin
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.