title: Improvements in Clinical Trials Information Will Improve the Reproductive Health and Fertility of Cancer Patients.
abstract: There are a number of barriers that result in cancer patients not being referred for oncofertility care, which include knowledge about reproductive risks of antineoplastic agents. Without this information, clinicians do not always make recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information and recommendations that clinicians have available in clinical trial protocols regarding oncofertility management and follow-up, and the information that patients may receive in clinical trials patient information sheets or consent forms. A literature review of the 71 antineoplastic drugs included in the 68 clinical trial protocols showed that 68% of the antineoplastic drugs had gonadotoxic animal data, 32% had gonadotoxic human data, 83% had teratogenic animal data, and 32% had teratogenic human data. When the clinical trial protocols were reviewed, only 22% of the protocols reported the teratogenic risks and 32% of the protocols reported the gonadotoxic risk. Only 56% of phase 3 protocols had gonadotoxic information and 13% of phase 3 protocols had teratogenic information. Nine percent of the protocols provided fertility preservation recommendations and 4% provided reproductive information in the follow-up and survivorship period. Twenty-six percent had a section in the clinical trials protocol, which identified oncofertility information easily. When gonadotoxic and teratogenic effects of treatment were known, they were not consistently included in the clinical trial protocols and the lack of data for new drugs was not reported. Very few protocols gave recommendations for oncofertility management and follow-up following the completion of cancer treatment. The research team proposes a number of recommendations that should be required for clinicians and pharmaceutical companies developing new trials.
authors.affiliation: 1 College of Arts and Sciences, Department of Chemistry, New York University , New York City, New York.|2 Population Sciences Department, Dana-Farber Cancer Institute , Boston, Massachusetts.|3 Department of Women's and Children's Medicine, School of Medical Sciences, University of New South Wales , Sydney, Australia .
authors.forename: Angela
authors.initials: A
authors.lastname: Dauti
authors.affiliation: 4 Kids Cancer Centre, Sydney Children's Hospital , Sydney, Australia .
authors.forename: Brigitte
authors.initials: B
authors.lastname: Gerstl
authors.affiliation: 3 Department of Women's and Children's Medicine, School of Medical Sciences, University of New South Wales , Sydney, Australia .
authors.forename: Serena
authors.initials: S
authors.lastname: Chong
authors.affiliation: 5 Department of Pharmaceutical Medicine, School of Medical Sciences, University of New South Wales , Sydney, Australia .
authors.forename: Orin
authors.initials: O
authors.lastname: Chisholm
authors.affiliation: 3 Department of Women's and Children's Medicine, School of Medical Sciences, University of New South Wales , Sydney, Australia .|4 Kids Cancer Centre, Sydney Children's Hospital , Sydney, Australia .|6 Nelune Comprehensive Cancer Centre, Prince of Wales Hospital , Randwick, Australia .
authors.forename: Antoinette
authors.initials: A
authors.lastname: Anazodo
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000818:Animals; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D005298:Fertility; D059247:Fertility Preservation; D006801:Humans; D007246:Infertility / Q000139:chemically induced* / Q000517:prevention & control; D009369:Neoplasms / Q000188:drug therapy*; D060728:Reproductive Health
chemical_list: D000970:Antineoplastic Agents
keywords: chemotherapy; clinical trials; oncofertility