Presentation Title

What information do cancer clinical trial protocols include on the reproductive risk of treatment and oncofertility management?

Faculty Mentor

Dr. Antoinette Anazodo

Start Date

18-11-2017 2:15 PM

End Date

18-11-2017 3:15 PM

Location

BSC-Ursa Minor 107

Session

Poster 3

Type of Presentation

Poster

Subject Area

health_nutrition_clinical_science

Abstract

There are many barriers for oncofertility care which include clinician’s knowledge about the teratogenic and gonadotoxic risk of cancer protocols and the recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information about the gonadotoxic and teratogenic risk of chemotherapy treatment in clinical trial protocols and the recommendations for oncofertility investigation and management.

The study team reviewed 84 clinical trials protocols (pediatric, adolescent and young adult and adult) covering tumors found in patients of a reproductive age from 0-45 years of age and reviewed the literature for the 78 individual chemotherapy drugs. The team then reviewed each clinical trial protocol to document the reported information on gonadotoxicity and teratogenic risk, as well as recommendations for oncofertility care.

The known information on reproductive risk of chemotherapy was not well-incorporated into the clinical trials protocols and when information was not available for new chemotherapy drugs the lack of animal or human data was also not reported.

The reproductive complications of cancer treatment are poorly studied and reported in animal and human studies and the research team found information inconsistent and hard to find in the literature. However, when gonadotoxicity and teratogenic effect of treatment were known they were not consistently included into all protocols and the lack of data for new drugs was not reported. Very few protocols gave recommendations for oncofertility management and follow up and this is an additional barrier for fertility preservation consultation or management. Clear accurate information in clinical trials protocols will help to improve oncofertility care for patients of a reproductive age and will avoid medical legal ramifications.

A number of recommendations are required for clinicians and pharmaceutical companies developing new trials, enabling clearer information and recommendations for oncofertility. These recommendations will lead to improved patient reproductive outcomes.

Summary of research results to be presented

A literature review of the 78 chemotherapy drugs included in the clinical trial protocols showed that information on the teratogenic and gonadotoxicity risk of chemotherapy was available from animal or human studies for many drugs, but was often difficult to find and was reported in an inconsistent manner.

Only 21 (25%) of the protocols had teratogenic information, 27 (32%) of the protocols had information on gonadotoxicity risk of individual drugs, and only 16 (19%) of the protocols gave information on the gonadotoxic risk of the whole protocol. Recommendations for fertility preservation were only found in 7 (8.3%) protocols with 3 (3.5%) of the protocols giving recommendations for reproductive follow up in the survivorship period. The reproductive risk of chemotherapy was only reported in 13 (15%) of patient information sheets.

Clinical trial protocols in the last three years (2013-2016) did not have more information on the reproductive risks of chemotherapy when compared to clinical trials protocols in the preceding three-year period.

From our literature review, we found that known information on reproductive risk of chemotherapy was not well-incorporated into the clinical trial protocols over a wide span of chemotherapy types and target age ranges. Recommendations to clinicians and pharmaceutical companies are required to inform patients and their families of reproductive risks of certain chemotherapy drugs. Clear accurate information in clinical trial protocols will help to improve oncofertility care for patients of a reproductive age.

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Nov 18th, 2:15 PM Nov 18th, 3:15 PM

What information do cancer clinical trial protocols include on the reproductive risk of treatment and oncofertility management?

BSC-Ursa Minor 107

There are many barriers for oncofertility care which include clinician’s knowledge about the teratogenic and gonadotoxic risk of cancer protocols and the recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information about the gonadotoxic and teratogenic risk of chemotherapy treatment in clinical trial protocols and the recommendations for oncofertility investigation and management.

The study team reviewed 84 clinical trials protocols (pediatric, adolescent and young adult and adult) covering tumors found in patients of a reproductive age from 0-45 years of age and reviewed the literature for the 78 individual chemotherapy drugs. The team then reviewed each clinical trial protocol to document the reported information on gonadotoxicity and teratogenic risk, as well as recommendations for oncofertility care.

The known information on reproductive risk of chemotherapy was not well-incorporated into the clinical trials protocols and when information was not available for new chemotherapy drugs the lack of animal or human data was also not reported.

The reproductive complications of cancer treatment are poorly studied and reported in animal and human studies and the research team found information inconsistent and hard to find in the literature. However, when gonadotoxicity and teratogenic effect of treatment were known they were not consistently included into all protocols and the lack of data for new drugs was not reported. Very few protocols gave recommendations for oncofertility management and follow up and this is an additional barrier for fertility preservation consultation or management. Clear accurate information in clinical trials protocols will help to improve oncofertility care for patients of a reproductive age and will avoid medical legal ramifications.

A number of recommendations are required for clinicians and pharmaceutical companies developing new trials, enabling clearer information and recommendations for oncofertility. These recommendations will lead to improved patient reproductive outcomes.