axitaxel® - non-interventional observational study (official registration title)Investigation into the use of axitaxel® in the therapy of malignant tumors Non-interventional observational study (subtitle)

The present results reflect medical practice in outpatient oncology care and are based on a random sample of a total of 510 patients (d/m/w) and patients. This result can be regarded as sufficiently representative for application areas that were documented particularly frequently in this study. The vast majority of patients treated were women with gynecological tumors, while non-small cell lung cancer was underrepresented. The dosages and combination partners were in line with expectations. Deviations were observed in a few cases and can be attributed to individual medical decisions against the background of patient-specific initial situations. Half of the dose changes and discontinuations were due to adverse drug reactions. A total of 10% of the study participants discontinued treatment for this reason. No causal connection with axitaxel® therapy was found in the 15 deaths that occurred. Both the general condition and the clinical tolerability were assessed as positive by the majority of patients, thus enabling a regular end to treatment in 72% of cases. More than half of the documented patients (d/m/w) were able to achieve a complete remission. In a comparison of the two age groups under and over 70, complete remission is 12% (FU 1) and 4.1% (FU 2) higher in those under 70 than in those over 70. Every 10th patient was progressive. No clear trend was found with regard to age and the occurrence of progression. If the two age groups are considered with the addition of the combination partner variable monoclonal antibody yes/no, complete remission was achieved in 25% of cases in the over-70 age group at both follow-up times. This rate is better than that in the under 70 age group (21%). Together with the partial remission, the response rate in the first follow-up is 50% and thus affects every second patient over 70 years of age. This could give rise to a hypothesis that the effectiveness of the additional administration of MAK is a beneficial treatment option for the treatment of older cancer patients. The observed off-label use, i.e. use for indications not listed in the prescribing information, is presumably not based on a lack of knowledge of the prescribing information, but should be seen as individual, patient-specific therapy adjustments and can at least remotely be understood as approaches to personalized therapy. Weekly application at the various dose levels clearly predominates. This finding is supported by study results from the Eastern Cooperative Oncology Group based on 4950 patients (d/m/w) with breast cancer and shows a longer overall survival and longer disease-free survival with weekly administration (Sparano, 2008). Obviously, this application method has become established in routine practice. The combination with bevacizumab, although not explicitly mentioned in the prescribing information, was frequently indicated. First-line use against metastatic, Her2-negative breast cancer is permitted in Germany, although the FDA prohibited this in its scope in 2011. As expected, trastuzumab was frequently mentioned as a monoclonal antibody combination partner according to the standard treatment guidelines for HER2-positive breast cancer. Doxorubicin was not mentioned as a combination partner, while epirubicin was used more frequently among the anthracyclines. The frequent use of the concomitant medications ranitidine, clemastine and dexamethasone is in line with the treatment guidelines. The observed frequency of side effects is in line with the known safety profile. Side effects not yet known were not observed. A causal relationship with axitaxel® in the 15 deaths that occurred was not established in any of the deceased patients (d/m/w). With regard to question 8 of the observation plan, it can be stated that no new economically relevant aspects arise from the findings of this study in routine practice.