A practical guide for the safe implementation of early phase drug development and immunotherapy program in gynecologic oncology practice

The success of targeted and immune therapies in other malignancies has led to an exponential increase in the number of active and pending clinical trials using these therapeutic approaches in patients with gynecologic cancers. These novel investigational agents are associated with unique and potenti...

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Bibliographic Details
Published in:Gynecologic oncology 2018-11, Vol.151 (2), p.374-380
Main Authors: Jazaeri, Amir, Coleman, Robert L., Sood, Anil K., Frumovitz, Michael M., Soliman, Pamela T., Shafer, Aaron, Cutrera, Jeffry J., Klinger, Marlana, Sharafi, Sara E., Johnson, Cynae A.L., Villanueva, Valerie F., Hinchcliff, Emily M., Dickens, Andrea, Cain, Katherine E., Anderson, Jaime E., Lu, Karen H., Westin, Shannon N.
Format: Article
Language:English
Subjects:
Adoptive cell therapy
Antineoplastic Agents, Immunological - therapeutic use
Checkpoint inhibitor
Clinical trials
Female
Genital Neoplasms, Female - immunology
Genital Neoplasms, Female - therapy
Humans
Immune-related adverse events
Immunotherapy
Immunotherapy - adverse effects
Immunotherapy - methods
Immunotherapy - standards
Immunotherapy, Adoptive - methods
Molecular Targeted Therapy
Targeted therapy
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Summary:The success of targeted and immune therapies in other malignancies has led to an exponential increase in the number of active and pending clinical trials using these therapeutic approaches in patients with gynecologic cancers. These novel investigational agents are associated with unique and potentially life-threatening toxicities and many require special multidisciplinary logistical considerations. The objective of this review is to describe a practical approach for the safe implementation of targeted and immune therapies in academic gynecologic oncology practices based on our experience at M.D. Anderson Cancer Center. •This review provides a system-based practical approach for the safe implementation of targeted and immune therapies.•Creation of a multidisciplinary EDDIT team can provide shared experience and enhanced patient safety.•Education of providers, staff, trainees, and patients is a key function of the EDDIT team.•Immediate access to expert advice serves to avoid delays in recognition and management of adverse events.
ISSN:0090-8258
1095-6859
DOI:10.1016/j.ygyno.2018.08.037