Evaluation of sexuality, health-related quality-of-life and depression in advanced cancer patients: A prospective study in a Phase i clinical trial unit of predominantly targeted anticancer drugs

Background: The advent of molecular targeted agents (MTA) has opened a new era of therapy in oncology. However, some of the toxicities and side-effects of these new drugs are not explored as is the case with the potential impact of MTA on sexuality. This study aimed to prospectively evaluate health-related quality of life (HRQoL), depression and sexual function in advanced cancer patients treated in a Phase I drug unit evaluating MTA. Patents and methods: In total, 63 of 74 eligible patients agreed to participate in the study. Four validated self-questionnaires were used: the Medical Outcomes Study Short-Form General Health Survey (SF12), the short form Beck Depression Inventory (BDI), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). Forty-seven patients (75%) responded at baseline and 31 (65%) at 1-month. Results: This is the first evaluation of HRQoL, depression and sexual function in a Phase I drug unit. 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 1-month of treatment, sexual dysfunction included lack of lubrication and comfort in females and erectile dysfunction 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 declined in both sexes. The impact of MTA on HRQoL and especially sexual function should be routinely assessed in further studies to better understand their potential impact in advanced cancer patients.