JMIR Publications

ABSTRACT

Background:

Only 5% of the molecules tested in oncology phase I trials reach the market after an average of 7.5 years of waiting and at a cost of tens of millions of euros. To reduce the cost and shorten the times of discovery of new treatments, “drug repurposing” (research with molecules already approved for another indication) and the use of secondary data (not collected for the purpose of research) have been proposed. Due to advances in informatics in clinical care, secondary data can, in some cases, be of equal quality to primary data generated through prospective studies.

Objective:

The objective of this study is to identify drugs currently marketed for other indications which may have an effect on the prognosis of cancer patients.

Methods:

For this purpose, a cohort of patients with high-lethality neoplastic diseases, treated in the public health system of Catalonia between 2006 and 2012, will be monitored retrospectively for survival for 5 years after diagnosis or until death. A control cohort, comprising people without neoplasms, will be also retrospectively monitored for 5 years. The following study variables will be extracted from different population databases: type of neoplasm (cancer patient cohort), date and cause of death, pharmacological treatment, sex, age and place of residence. In the first stage of the statistical analysis of the cancer patient cohort, the drugs consumed by the long-term survivors (alive at 5 years) will be compared with those consumed by nonsurvivors. In a second stage, the survival associated with the consumption of each relevant drug will be analysed. For the analyses, groups will be matched for potentially confounding variables, and multivariate analyses will be performed to adjust for residual confounding variables if necessary. The control cohort will be used to verify whether the associations found are exclusive to patients with neoplasms or whether they also occur in patients without cancer.

Results:

The cancer patient cohort includes 100,218 patients, including patients with primary cancers of the lung, esophagus, stomach, pancreas, liver, and metastatic cancers of any origin. The mean age of the cohort is 68.4 years (SD 13.5), 63.4% are men, and of these only 16,443 (16.4%) were alive at 5 years after diagnosis (median survival: 185 months). In May 2023, the control cohort is being prepared. There are 1355 different drugs, belonging to 483 ATC5 classes in the database, whose relationship with survival is going to be analyzed. We expect the first results in the winter of 2023.

Conclusions:

All analyses are considered exploratory; therefore, the results will have to be confirmed in subsequent clinical trials; however, the results of this study may accelerate drug discovery in oncology.