Adding fasting-mimicking diet to first-line carboplatin-based chemotherapy is associated with better overall survival in advanced triple-negative breast cancer patients: A subanalysis of the NCT03340935 trial
A retrospective survival comparison between 14 patients who received the diet with chemotherapy and 76 who received chemotherapy alone.
Int J Cancer, 2024. Ligorio F, et al.
Funding and competing interests (as published with the paper): Sources of supportThis research was funded by the National Cancer Institute (NCI) grant number R01 CA258222. The NCI was not involved in the study design, data collection, statistical analyses, data interpretation, or manuscript writing. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
- Study type
- Human retrospective comparative analysis (14 patients receiving FMD vs 76 receiving chemotherapy alone)
- Journal
- Int J Cancer
- Published
- 2024
- Authors
- Ligorio F, et al.
- DOI
- 10.1002/ijc.34701
- PubMed ID
- 37615485
Summary
The authors compared overall survival in 14 patients with advanced triple-negative breast cancer who received first-line carboplatin and gemcitabine plus cyclic Fasting Mimicking Diet (FMD) within the NCT03340935 trial, against 76 consecutive patients with advanced triple-negative breast cancer treated with carboplatin-based chemotherapy alone at one institute. The comparison was retrospective. Multivariable Cox regression and propensity score matching on performance status and de novo metastatic disease were used to adjust for other prognostic variables.
The authors reported a median overall survival of 30.3 months in the group receiving the diet with chemotherapy and 17.2 months in the group receiving chemotherapy alone. They reported that the association between diet use and better overall survival persisted after multivariable adjustment and after propensity score matching. They state that cyclic FMD with first-line chemotherapy may improve clinical outcomes and that their study paves the way for phase II trials.
This is a retrospective, non-randomized comparison between trial participants and a separate series of patients treated at one institute, so the two groups may differ in ways the statistical adjustment did not capture. Only 14 patients received the diet, which is a very small group on which to base a survival comparison. All of these patients were receiving chemotherapy throughout, and the population is advanced triple-negative breast cancer, not a general wellness population. The study does not evaluate Prolon directly, and the authors present it as grounds for running trials rather than as a result.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
