Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies.
Status:
Withdrawn
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
The mechanisms of action of the side effects associated with targeted therapies are still
poorly understood. He was found in patients treated with gefitinib, increased levels of
thromboxane B2 and P-selectin Thromboxane B2 is the result of the hydrolysis of thromboxane
A2, which is itself obtained from Prostaglandin H2 under the action of the thromboxane
synthetase. The thromboxane A2 is produced by platelets and the active pro-thrombotic
properties as follows: stimulation of platelets and activation of other increased platelet
aggregation.
The selectins are cell adhesion proteins with a role in the adhesion phenomena. P-selectin is
expressed by platelets and endothelial cells.
The demonstration of increased plasma levels of thromboxane B2 and P-selectin leaves suggest
a role of platelet activation in the occurrence of side effects associated with targeted
therapies.
Kanazawa's study was conducted in 39 Japanese patients, trying to assess the value of
low-dose acetylsalicylic acid or 100mg per day, that is to say, anti-aggrégantes doses, the
occurrence rash and diarrhea induced by gefitinib.
In this study, the group of patients treated with acetylsalicylic acid presented a lower rate
of side effects significantly, 58.3% versus 77.8%. The frequency of diarrhea was 18.5% (or 5
patients) in the standard group versus 0% in the group with acetylsalicylic acid. Similarly,
it was found a reduction in the occurrence of skin rash, 33.3% or 4 patients in the
acetylsalicylic acid group versus 74.1% s, 20 patients in the standard group. Finally, in
this study, it was not revealed significant differences in terms of response to treatment
with gefitinib (37% in the standard group versus 33% in the group treated with aspirin
patient) It does not exist in our knowledge of prospective data evaluating the effect of
acetylsalicylic acid on the reduction of side effects associated with targeted in a
population of patients of Caucasian-type treatment.
Phase:
Phase 2
Details
Lead Sponsor:
Centre Francois Baclesse
Collaborators:
Canceropôle Nord Ouest Ligue contre le cancer, France