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Identifying Early-Phase Clinical Trial Participants at Risk for Experiencing Worse Clinical Outcomes

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Debra M. Lundquist , PhD, RN1
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Debra M. Lundquist
; Rachel Jimenez , MD2
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Rachel Jimenez
; Sienna Durbin , MD3
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Sienna Durbin
; Nora Horick, MS4
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Nora Horick
; Megan Healy, BS1
x
Megan Healy
; Andrew Johnson , BS1
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Andrew Johnson
; Viola Bame, BS1
x
Viola Bame
; Virginia Capasso , PhD, CNP, CNS, CWS5
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Virginia Capasso
; Casandra McIntyre , MTS, RN5
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Casandra McIntyre
; Barbara Cashavelly, RN, DNP, NE-BC5
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Barbara Cashavelly
; Dejan Juric , MD3
x
Dejan Juric
; and Ryan D. Nipp , MD, MPH6
x
Ryan D. Nipp
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https://doi.org/10.1200/OP.22.00742

Abstract

PURPOSE:

To identify early-phase clinical trial (EP-CT) participants at risk for experiencing worse clinical outcomes and describe receipt of supportive care services.

METHODS:

A retrospective review of the electronic health records of consecutive patients enrolled in EP-CTs from 2017 to 2019 examined baseline characteristics, clinical outcomes, and receipt of supportive care services. The validated Royal Marsden Hospital (RMH) prognosis score was calculated using data at the time of EP-CT enrollment (scores range from 0 to 3; scores ≥ 2 indicate poor prognosis). Differences in patient characteristics, clinical outcomes, and receipt of supportive care services were compared on the basis of RMH scores.

RESULTS:

Among 350 patients (median age = 63.2 years [range, 23.0-84.3 years], 57.1% female, 98.0% metastatic cancer), 31.7% had an RMH score indicating a poor prognosis. Those with poor prognosis RMH scores had worse overall survival (hazard ratio [HR], 2.00; P < .001), shorter time on trial (HR, 1.53; P < .001), and lower likelihood of completing the dose-limiting toxicity period (odds ratio, 0.42; P = .006) versus those with good prognosis scores. Patients with poor prognosis scores had greater risk of emergency room visits (HR, 1.66; P = .037) and hospitalizations (HR, 1.69; P = .016) while on trial, and earlier hospice enrollment (HR, 2.22; P = .006). Patients with poor prognosis scores were significantly more likely to receive palliative care consultation (46.8% v 27.6%; P < .001), but not other supportive care services.

CONCLUSION:

This study found that RMH prognosis score could identify patients at risk for decreased survival, shorter time on trial, and greater use of health care services. The findings underscore the need to develop supportive care interventions targeting EP-CT participants' distinct needs.

© 2023 by American Society of Clinical Oncology
PRIOR PRESENTATION

Presented as a Poster at the 2021 ASCO Quality Care Symposium, September 25, 2021, Boston, MA.

SUPPORT

The ESSCO-MGH Breast Cancer Research Fund.

AUTHOR CONTRIBUTIONS

Conception and design: Debra M. Lundquist, Rachel Jimenez, Andrew Johnson, Viola Bame, Virginia Capasso, Dejan Juric, Ryan D. Nipp

Financial support: Rachel Jimenez, Dejan Juric

Administrative support: Barbara Cashavelly, Dejan Juric

Provision of study materials or patients: Rachel Jimenez, Dejan Juric

Collection and assembly of data: Debra M. Lundquist, Rachel Jimenez, Sienna Durbin, Megan Healy, Andrew Johnson, Viola Bame, Ryan D. Nipp

Data analysis and interpretation: Debra M. Lundquist, Rachel Jimenez, Sienna Durbin, Nora Horick, Megan Healy, Andrew Johnson, Viola Bame, Barbara Cashavelly, Ryan D. Nipp

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
Identifying Early-Phase Clinical Trial Participants at Risk for Experiencing Worse Clinical Outcomes

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/op/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Rachel Jimenez

Employment: Biogen

Stock and Other Ownership Interests: Biogen

Research Funding: Focal Therapeutics

Nora Horick

Employment: Northwest Biotherapeutics

Stock and Other Ownership Interests: Northwest Biotherapeutics

Patents, Royalties, Other Intellectual Property: An immediate family member holds patents, has patents pending, and receives royalties from a technology relating to health or medicine

Viola Bame

Employment: Surface Oncology

Casandra McIntyre

Consulting or Advisory Role: Putnam Associates

Dejan Juric

Stock and Other Ownership Interests: Relay Therapeutics, PIC Therapeutics, Vibliome Therapeutics

Consulting or Advisory Role: Novartis, EMD Serono, Eisai, Genentech, Ipsen, Syros Pharmaceuticals, MapKure, Vibliome Therapeutics, PIC Therapeutics, Relay Therapeutics, AstraZeneca

Research Funding: Novartis (Inst), Genentech (Inst), Takeda (Inst), Eisai (Inst), Amgen (Inst), Syros Pharmaceuticals (Inst), InventisBio (Inst), Infinity Pharmaceuticals (Inst), Takeda (Inst), Pfizer (Inst), Arvinas (Inst), Blueprint Medicines (Inst), AstraZeneca (Inst), Ribon Therapeutics (Inst)

Ryan D. Nipp

This author is an Associate Editor for JCO Oncology Practice. Journal policy recused the author from having any role in the peer review of this manuscript.

No other potential conflicts of interest were reported.

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ARTICLE CITATION

DOI: 10.1200/OP.22.00742 JCO Oncology Practice 19, no. 6 (June 01, 2023) e829-e837.

Published online February 15, 2023.

PMID: 36791343

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