Abstract 567P
Background
Few information is available about the impact of concomitant medication (CM) on the tolerability of chemotherapy as well as on the outcome of cancer patients. Therefore, we evaluated the impact of CM on disease-free survival (DFS), overall survival (OS) as well as side effects under adjuvant chemotherapy in a large cohort of early colon cancer (CC) patients.
Methods
Patients of the phase III randomized trial PETACC8 had resection with curative intent of a stage II or III CC and were treated with standard adjuvant fluoropyrimidine and oxaliplatin (+/- cetuximab) over 6 months.Information on CM intake has been gathered by study visits at inclusion and during chemotherapy. We investigated the association between number of CM as well as the 5 most frequently applied CM categories according to the WHO ATC classification system (gastro-esophageal reflux disease (GERD) treatment, anticoagulants, aggregation inhibitors, cardiovascular sphere (CVS) treatment and antidiabetic drugs) with DFS, OS and grade 3/4 adverse events (AEs).
Results
Within 2537 patients eligible for this analysis, median number of CM intake was 8 (range 0 to 25), with only 22 patients (0.9%) without any CM. 1328 (51.9%) reported a GERD treatment, 452 (17.7%) an anticoagulant, 279 (10.9%) an anti-aggregant therapy, 1028 (40.2%) a CVS treatment and 236 (9.2%) an antidiabetic drug. Anticoagulation was the only CM category significantly and independently associated with a shorter DFS (HR 1.29, 95%CI 1.07-1.56, p=0.009) as well as OS (HR 1.29, 95%CI 1.03-1.61, p=0.027). No association of number of CM (<5, 5-10, >10) has been observed neither with DFS (ref.; HR 0.98; HR 1.17) nor OS (ref.; HR 0.98; HR 1.15) (p>0.05). Grade 3/4 AEs directly correlated with number of CM (p<0.001) and occurred significantly more frequently in patients with GERD treatment (78.8 vs 66.6%, p<0.001), anticoagulation (81.4 vs 71.1%, p<0.001) and anti-aggregants (79.2 vs 72.1%, p=0.001).
Conclusions
Early CC patients with a high CM intake did not generally exhibit an impaired outcome, even though tolerability of adjuvant chemotherapy was reduced. Anticoagulation was the only CM category associated with a shorter DFS and OS.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
J. Taieb: Financial Interests, Personal, Advisory Board: MSD, Astellas, Merck, Servier, Pierre Fabre, Amgen, Bristol Myers Squibb, Novartis, Pfizer; Financial Interests, Personal, Invited Speaker: Amgen, Bristol Myers Squibb, Merck, MSD, Novartis; Non-Financial Interests, Leadership Role, President of the scientific committee of the ARCAD foundation until end 2022: ARCAD Foundation; Non-Financial Interests, , Leadership Role, Chair of the ARCAD pancreas research group: ARCAD Foundation; Non-Financial Interests, Leadership Role, Member of the administrative council, the scientific committee, the executive board and responsible for the international relationships /partnership for FFCD in the prodige intergroup: Federation Francophone de Cancerologie Digestive (FFCD). All other authors have declared no conflicts of interest.
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