Prospective non-interventional double study about gender specific differences in the treatment of colorectal cancer - Version: Treatment with oxaliplatin containing regimens LIV Pharma - Colorsex-O

Background: Women's metabolism differs from that of men, which is reflected in pharmacokinetics in that efficacy and tolerability are different. Disease processing, mental state and quality of life are also perceived in a gender-specific manner. Follow-up care is utilized to varying degrees. Colorectal cancer represents one of the three most common cancer entities of both sexes in Germany. Gender-specific differences should be explored to improve evidence-based medicine in this area. Results: This was a non-interventional prospective observational single-arm cohort study of treatment with oxaliplatin LIV Pharma with parallel patient survey (DRKS-ID: DRKS00009341). During the documentation period, which lasted up to two years depending on the therapy regimen, parameters regarding the underlying oncological disease and its therapy were collected at regular intervals. Patients were regularly questioned about their disease management (TSK questionnaire), quality of life (FACT-C) and general mental state (HADS-D). In the follow-ups, patients were asked about the use of follow-up measures. There are associations between these Patient Reported Outcomes with respect to the study objective. 17 patients were included in the study. Due to noncompliance with inclusion and exclusion criteria and documentation dropout, 9 of these patients dropped out of the population. All other documentation could not be used for analysis due to missing patient questionnaires and incomplete documentation. Conclusion: An evaluation of the study is not possible. Despite scientific relevance, there was too little interest on the part of potential study centers to recruit patients into the project. It seems reasonable to investigate the gender-specific differences in the treatment of colorectal carcinoma within a registry study in order to achieve the statistically necessary number of cases.