Optimal dosage and duration of treatment for patients with malignant tumors. are approved guidelines always correct?


DOI:  https://www.doi.org/10.31917/2501008

Recently pharmaceutical industry significantly influences medical community and healthcare system, especially in the oncology. It is notably expressed in manipulating clinical studies results, surrogate endpoints (profression-free survival, objective responce rate) usage, not usually converting into overall survival or quality of life increasing, imposition of profitable approaches to the medical community, approval of unreasonable dosage regimes. For the noval anti-tumor drugs the old principle of maximum tolerated dose is still used despite its original development for cytostatic agents. This approach looks questionable for targeted or checkpoint inhibitors therapy in the absence of linear dose-efficacy curve. Nowadays we have a huge amount of preclinical and clinical data that suggest opportunity of low-dose targeted or immune therapy, with longer cycles of therapy and shorter treatment courses without loss of efficacy. It is essential to provide government support for further research and establish higher responsibility for pharmaceutical industry.