Lead Investigator: Jorge Hernando, Vall d ́Hebron University Hospital
Title of Proposal Research: Impact of gender on multikinase inhibitors (MKIs) toxicity in patients (pts) with advanced pancreatic and gastrointestinal neuroendocrine tumors (NETs)
Vivli Data Request: 5099
Funding Source: None.
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Despite the advances in precision medicine, we still do not understand the differences in toxicity between men and women with the different cancer treatments. To date, we only have some preliminary studies regarding the toxicity of 5FU in colorectal cancer.
With respect to neuroendocrine tumors (NETs), there are no specific gender studies regarding the efficacy or toxicity of the treatment. Our group at the Vall d ́Hebron University Hospital in Barcelona, has presented at the ESMO and ASCO congresses of 2019 (attached in this application) an analysis of the differences in sex toxicity in patients with NETs treated with multikinase inhibitors (MKI) in 3 phase 2 clinical trials (see methodology section), with almost 200 patients analyzed. In these works, the existence of different toxicities is evidenced in a statistically significant way between men and women, including some as relevant as the elevation of transaminases and vomiting (see attached documents).
Our current plan is to add evidence of toxicity in sunitinib clinical trials in NETs, to incorporate a larger number of patients and thus have information on the only approved MKI in this group of tumors.
Potentially, all patients with TNEs candidates for treatment with MKI would benefit from this work. Toxicity studies by gender allow personalizing information on toxicity and better monitoring of adverse effects. In this way it is likely that we can maintain a better dose intensity in order to improve the efficacy of MKI treatment in the context of TNEs.
Requested Studies:
Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors
Sponsor: Pfizer
Study ID: NCT00428597
Sponsor ID: A6181111
A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor
Sponsor: Pfizer
Study ID: NCT00056693
Sponsor ID: RTKC-0511-015
Update: This data request was withdrawn on 4 September 2020 by the researcher.