title: 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.
abstract: 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.
  
  
  METHODS
  [corrected] 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.
authors.affiliation: Department of Medicine, Institut Gustave Roussy, Villejuif, Université Paris XI, France.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Rouanne
authors.forename: Christophe
authors.initials: C
authors.lastname: Massard
authors.forename: Antoine
authors.initials: A
authors.lastname: Hollebecque
authors.forename: Vanessa
authors.initials: V
authors.lastname: Rousseau
authors.forename: Andrea
authors.initials: A
authors.lastname: Varga
authors.forename: Anas
authors.initials: A
authors.lastname: Gazzah
authors.forename: Yann
authors.initials: Y
authors.lastname: Neuzillet
authors.forename: Thierry
authors.initials: T
authors.lastname: Lebret
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Soria
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003863:Depression / Q000139:chemically induced / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058990:Molecular Targeted Therapy / Q000009:adverse effects / Q000379:methods* / Q000523:psychology; D009369:Neoplasms / Q000188:drug therapy* / Q000523:psychology*; D011446:Prospective Studies; D011788:Quality of Life; D020018:Sexual Dysfunctions, Psychological / Q000139:chemically induced / Q000209:etiology*; D019529:Sexuality; D011795:Surveys and Questionnaires
chemical_list: D000970:Antineoplastic Agents