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

Amir Jazaeri; Robert L. Coleman; Anil K. Sood; Michael M. Frumovitz; Pamela T. Soliman; Aaron Shafer; Jeffry J. Cutrera; Marlana Klinger; Sara E. Sharafi; Cynae A.L. Johnson; Valerie F. Villanueva; Emily M. Hinchcliff; Andrea Dickens; Katherine E. Cain; Jaime E. Anderson; Karen H. Lu; Shannon N. Westin

doi:10.1016/j.ygyno.2018.08.037

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

Amir Jazaeri^*, Robert L. Coleman, Anil K. Sood, Michael M. Frumovitz, Pamela T. Soliman, Aaron Shafer, Jeffry J. Cutrera, Marlana Klinger, Sara E. Sharafi, Cynae A.L. Johnson, Valerie F. Villanueva, Emily M. Hinchcliff, Andrea Dickens, Katherine E. Cain, Jaime E. Anderson, Karen H. Lu, Shannon N. Westin

^*Corresponding author for this work

Obstetrics and Gynecology

Research output: Contribution to journal › Review article › peer-review

Abstract

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.

Original language	English (US)
Pages (from-to)	374-380
Number of pages	7
Journal	Gynecologic oncology
Volume	151
Issue number	2
DOIs	https://doi.org/10.1016/j.ygyno.2018.08.037
State	Published - Nov 2018

Funding

This research was supported in part by the MD Anderson Cancer Center Support Grant ( P30 CA016672 ), a T32 training grant for gynecologic oncology ( CA101642 ; to K.H. Lu), the Ovarian Cancer Moon Shot program, and the Andrew Sabin Family Fellowship (SW). The authors wish to acknowledge the patients who courageously participate in clinical trials and their caregivers. This research was supported in part by the MD Anderson Cancer Center Support Grant (P30 CA016672), a T32 training grant for gynecologic oncology (CA101642; to K.H. Lu), the Ovarian Cancer Moon Shot program, and the Andrew Sabin Family Fellowship (SW). RLC is supported in part by the Ann Rife Cox Chair in Gynecology and the Judy Ries/Albert Pisani, MD Ovarian Cancer Research Fund.

Keywords

Adoptive cell therapy
Checkpoint inhibitor
Clinical trials
Immune-related adverse events
Immunotherapy
Targeted therapy

ASJC Scopus subject areas

Oncology
Obstetrics and Gynecology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.ygyno.2018.08.037

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Jazaeri, A., Coleman, R. L., Sood, A. K., Frumovitz, M. M., Soliman, P. T., Shafer, A., Cutrera, J. J., Klinger, M., Sharafi, S. E., Johnson, C. A. L., Villanueva, V. F., Hinchcliff, E. M., Dickens, A., Cain, K. E., Anderson, J. E., Lu, K. H., & Westin, S. N. (2018). A practical guide for the safe implementation of early phase drug development and immunotherapy program in gynecologic oncology practice. Gynecologic oncology, 151(2), 374-380. https://doi.org/10.1016/j.ygyno.2018.08.037

@article{7624802d8cfd47db9c691eaea80d270a,

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

abstract = "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.",

keywords = "Adoptive cell therapy, Checkpoint inhibitor, Clinical trials, Immune-related adverse events, Immunotherapy, Targeted therapy",

author = "Amir Jazaeri and Coleman, {Robert L.} and Sood, {Anil K.} and Frumovitz, {Michael M.} and Soliman, {Pamela T.} and Aaron Shafer and Cutrera, {Jeffry J.} and Marlana Klinger and Sharafi, {Sara E.} and Johnson, {Cynae A.L.} and Villanueva, {Valerie F.} and Hinchcliff, {Emily M.} and Andrea Dickens and Cain, {Katherine E.} and Anderson, {Jaime E.} and Lu, {Karen H.} and Westin, {Shannon N.}",

note = "Funding Information: This research was supported in part by the MD Anderson Cancer Center Support Grant ( P30 CA016672 ), a T32 training grant for gynecologic oncology ( CA101642 ; to K.H. Lu), the Ovarian Cancer Moon Shot program, and the Andrew Sabin Family Fellowship (SW). Funding Information: The authors wish to acknowledge the patients who courageously participate in clinical trials and their caregivers. This research was supported in part by the MD Anderson Cancer Center Support Grant (P30 CA016672), a T32 training grant for gynecologic oncology (CA101642; to K.H. Lu), the Ovarian Cancer Moon Shot program, and the Andrew Sabin Family Fellowship (SW). RLC is supported in part by the Ann Rife Cox Chair in Gynecology and the Judy Ries/Albert Pisani, MD Ovarian Cancer Research Fund. Publisher Copyright: {\textcopyright} 2018 Elsevier Inc.",

year = "2018",

month = nov,

doi = "10.1016/j.ygyno.2018.08.037",

language = "English (US)",

volume = "151",

pages = "374--380",

journal = "Gynecologic oncology",

issn = "0090-8258",

publisher = "Academic Press Inc.",

number = "2",

}

Jazaeri, A, Coleman, RL, Sood, AK, Frumovitz, MM, Soliman, PT, Shafer, A, Cutrera, JJ, Klinger, M, Sharafi, SE, Johnson, CAL, Villanueva, VF, Hinchcliff, EM, Dickens, A, Cain, KE, Anderson, JE, Lu, KH & Westin, SN 2018, 'A practical guide for the safe implementation of early phase drug development and immunotherapy program in gynecologic oncology practice', Gynecologic oncology, vol. 151, no. 2, pp. 374-380. https://doi.org/10.1016/j.ygyno.2018.08.037

TY - JOUR

T1 - A practical guide for the safe implementation of early phase drug development and immunotherapy program in gynecologic oncology practice

AU - Jazaeri, Amir

AU - Coleman, Robert L.

AU - Sood, Anil K.

AU - Frumovitz, Michael M.

AU - Soliman, Pamela T.

AU - Shafer, Aaron

AU - Cutrera, Jeffry J.

AU - Klinger, Marlana

AU - Sharafi, Sara E.

AU - Johnson, Cynae A.L.

AU - Villanueva, Valerie F.

AU - Hinchcliff, Emily M.

AU - Dickens, Andrea

AU - Cain, Katherine E.

AU - Anderson, Jaime E.

AU - Lu, Karen H.

AU - Westin, Shannon N.

N1 - Funding Information: This research was supported in part by the MD Anderson Cancer Center Support Grant ( P30 CA016672 ), a T32 training grant for gynecologic oncology ( CA101642 ; to K.H. Lu), the Ovarian Cancer Moon Shot program, and the Andrew Sabin Family Fellowship (SW). Funding Information: The authors wish to acknowledge the patients who courageously participate in clinical trials and their caregivers. This research was supported in part by the MD Anderson Cancer Center Support Grant (P30 CA016672), a T32 training grant for gynecologic oncology (CA101642; to K.H. Lu), the Ovarian Cancer Moon Shot program, and the Andrew Sabin Family Fellowship (SW). RLC is supported in part by the Ann Rife Cox Chair in Gynecology and the Judy Ries/Albert Pisani, MD Ovarian Cancer Research Fund. Publisher Copyright: © 2018 Elsevier Inc.

PY - 2018/11

Y1 - 2018/11

N2 - 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.

AB - 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.

KW - Adoptive cell therapy

KW - Checkpoint inhibitor

KW - Clinical trials

KW - Immune-related adverse events

KW - Immunotherapy

KW - Targeted therapy

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UR - http://www.scopus.com/inward/citedby.url?scp=85053038160&partnerID=8YFLogxK

U2 - 10.1016/j.ygyno.2018.08.037

DO - 10.1016/j.ygyno.2018.08.037

M3 - Review article

C2 - 30213435

AN - SCOPUS:85053038160

SN - 0090-8258

VL - 151

SP - 374

EP - 380

JO - Gynecologic oncology

JF - Gynecologic oncology

IS - 2

ER -

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

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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