Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial
A sub-analysis of a phase 1b trial of 101 patients with cancer, describing the five who responded completely.
Eur J Cancer, 2022. Ligorio F, et al.
Funding and competing interests (as published with the paper): Conflict of interest statement The authors have declared the following conflict of interest: G. Pruneri: Consulting Fees: Roche, Bayer, Astra Zeneca;F. de Braud: Consulting Fees: Tiziana Life Sciences, BMS, Celgene, Novartis, Servier, Pharm Research Associated, Daiichi Sankyo, Ignyta, Amgen, Pfizer, Octimet Oncology, Incyte, Pierre Fabre, Eli Lilly, Roche, Astra Zeneca, Gentili, Dephaforum, Novartis, MSD, Bayer, Fondazione Menarini. Travel/Accommodation/Expenses: BMS, Roche, Celgene, Amgen. Speaker Bureau: BMS, Roche, MSD, Bayer, Ignyta, Dephaforum, Biotechespert Ltd, Prime Oncology, Pfizer. Research Grant/Funding (institution): Novartis, Roche, BMS, Celgene, Incyte, NMS, Merck KGAA, Kymab, Pfizer, Tesaro, MSD.C. Vernieri: Consulting Fees: Novartis. Travel expenses: Novartis, Eli Lilly, Istituto Gentili. All remaining authors have declared no conflicts of interest.
- Study type
- Human clinical trial (phase 1, sub-analysis, n=101)
- Journal
- Eur J Cancer
- Published
- 2022
- Authors
- Ligorio F, et al.
- DOI
- 10.1016/j.ejca.2022.05.046
- PubMed ID
- 35810555
Summary
The phase 1b NCT03340935 trial enrolled 101 patients with a range of tumour types, who received a severely calorie-restricted Fasting Mimicking Diet (FMD) in cycles alongside standard-of-care anticancer therapies. In this sub-analysis the authors searched that trial population for patients who had achieved complete and long-lasting tumour responses, and described the five they identified.
The authors reported that five patients with advanced, poor-prognosis solid tumours achieved complete and long-lasting responses while receiving cyclic FMD together with standard systemic treatment: one with extensive-stage small cell lung cancer, one with metastatic pancreatic adenocarcinoma, one with metastatic colorectal cancer, and two with metastatic triple-negative breast cancer. They restate the parent trial's findings that the regimen was safe and feasible alongside standard therapy and produced metabolic and immunologic changes. They state that these responses prompt the initiation of clinical trials.
This is a selected description of five patients out of 101, picked out because they responded, with no comparison group. Every one of them was receiving standard anticancer therapy at the same time, so their responses cannot be attributed to the diet. The population is patients with advanced cancer, not a general wellness population, and the paper does not evaluate Prolon directly. The authors present these cases as a reason to run trials, not as evidence of efficacy.
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.
