Abstract

ABSTRACT Background The advent of molecular targeted agents (MTA) opened a new era therapy in oncology. The objective of this study was to investigate quality of life, depression and sexual function in patients treated in a phase I drug unit evaluating MTA. Patients and methods All patients included in a phase I clinical trial at the Gustave Roussy Institute were proposed a personal interview regarding their quality of life, depression, and sexual function. They completed 4 self-questionnaires containing the Medical Outcomes Study Short-Form General Health Survey (SF12), the Beck Depression Inventory (BDI-II), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). Results This is, to our knowledge, the first evaluation of quality of life, depression and sexual function in a phase I drug unit. Sixty-three patients were evaluated at baseline. Patients had a good mental and physical function despite their disease progression. The response rate was 75% for sexual questionnaires. For 57% of females and 68% of males, quality of sexual life was a subject of interest. After one month treatment, sexual dysfunction increased especially in lubrication and pain in females and erection in males with a statistical association of anti-angiogenic inhibitors in males (p = 0.04). Conclusions Patients on MTA in phase I clinical trials had a preserved mental and physical activity whereas their sexual activity decline in both sexes. The impact of MTA on sexual function should be routinely assessed. Disclosure All authors have declared no conflicts of interest.

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