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Cancers 2017, 9(7), 73; doi:10.3390/cancers9070073

Quality-of-Life (QOL) during Screening for Phase 1 Trial Studies in Patients with Advanced Solid Tumors and Its Impact on Risk for Serious Adverse Events

1
State University of New York at Buffalo, 12 Capen Hall, Buffalo, NY 14260, USA
2
Roswell Park Cancer Institute, Elm and Carlton Street, Buffalo, NY 14263, USA
3
sonaladmane@gmail.com
4
Mayo Clinic, 200 1st St. SW, Rochester, MN 55905, USA
*
Author to whom correspondence should be addressed.
Academic Editor: Vita Golubovskaya
Received: 8 May 2017 / Revised: 21 June 2017 / Accepted: 21 June 2017 / Published: 26 June 2017
(This article belongs to the Special Issue CAR-T Cell Therapy against Different Types of Cancer)
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Abstract

Background: Serious adverse events (SAEs) and subject replacements occur frequently in phase 1 oncology clinical trials. Whether baseline quality-of-life (QOL) or social support can predict risk for SAEs or subject replacement among these patients is not known. Methods: Between 2011–2013, 92 patients undergoing screening for enrollment into one of 22 phase 1 solid tumor clinical trials at Roswell Park Cancer Institute were included in this study. QOL Questionnaires (EORTC QLQ-C30 and FACT-G), Medical Outcomes Study Social Support Survey (MOSSSS), Charlson comorbidity scores (CCS) and Royal Marsden scores (RMS) were obtained at baseline. Frequency of dose limiting toxicities (DLTs), subject replacement and SAEs that occurred within the first 4 cycles of treatment were recorded. Fisher’s exact test and Mann-Whitney-Wilcoxon test were used to study the association between categorical and continuous variables, respectively. A linear transformation was used to standardize QOL scores. p-value ≤ 0.05 was considered statistically significant. Results: Baseline QOL, MOSSSS, CCS and RMS were not associated with subject replacement nor DLTs. Baseline EORTC QLQ-C30 scores were significantly lower among patients who encountered SAEs within the first 4 cycles (p = 0.04). Conclusions: Lower (worse) EORTC QLQ-C30 score at baseline is associated with SAE occurrence during phase 1 oncology trials. View Full-Text
Keywords: quality-of-life; QOL; EORTC QLQ-C30; FACT-G; MOSSSS; phase 1 cancer trial; oncology trials; immunotherapy; selection criteria; serious adverse events quality-of-life; QOL; EORTC QLQ-C30; FACT-G; MOSSSS; phase 1 cancer trial; oncology trials; immunotherapy; selection criteria; serious adverse events
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

Anwar, S.; Tan, W.; Hong, C.-C.; Admane, S.; Dozier, A.; Siedlecki, F.; Whitworth, A.; DiRaddo, A.M.; DePaolo, D.; Jacob, S.M.; Ma, W.W.; Miller, A.; Adjei, A.A.; Dy, G.K. Quality-of-Life (QOL) during Screening for Phase 1 Trial Studies in Patients with Advanced Solid Tumors and Its Impact on Risk for Serious Adverse Events. Cancers 2017, 9, 73.

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