Anwar Sidra, Tan Wei, Hong Chi-Chen, Admane Sonal, Dozier Askia, Siedlecki Francine, Whitworth Amy, DiRaddo Ann Marie, DePaolo Dawn, Jacob Sandra M, Ma Wen Wee, Miller Austin, Adjei Alex A, Dy Grace K
State University of New York at Buffalo, 12 Capen Hall, Buffalo, NY 14260, USA.
Roswell Park Cancer Institute, Elm and Carlton Street, Buffalo, NY 14263, USA.
Cancers (Basel). 2017 Jun 26;9(7):73. doi: 10.3390/cancers9070073.
: 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. : 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. -value ≤ 0.05 was considered statistically significant. : 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 ( = 0.04). : Lower (worse) EORTC QLQ-C30 score at baseline is associated with SAE occurrence during phase 1 oncology trials.
严重不良事件（SAEs）和受试者替换在1期肿瘤学临床试验中频繁发生。目前尚不清楚基线生活质量（QOL）或社会支持是否能够预测这些患者发生SAEs或受试者替换的风险。：2011年至2013年期间，罗斯韦尔帕克癌症研究所对92名正在接受筛选以纳入22项1期实体瘤临床试验之一的患者进行了本研究。在基线时获取了QOL问卷（欧洲癌症研究与治疗组织QLQ-C30和FACT-G）、医学结局研究社会支持调查（MOSSSS）、查尔森合并症评分（CCS）和皇家马斯登评分（RMS）。记录了在治疗的前4个周期内发生的剂量限制毒性（DLTs）、受试者替换和SAEs的频率。分别使用Fisher精确检验和Mann-Whitney-Wilcoxon检验来研究分类变量和连续变量之间的关联。使用线性变换对QOL评分进行标准化。P值≤0.05被认为具有统计学意义。：基线QOL、MOSSSS、CCS和RMS与受试者替换或DLTs均无关联。在第1个4周期内发生SAEs的患者中，基线欧洲癌症研究与治疗组织QLQ-C30评分显著更低（P = 0.04）。：基线时较低（更差）的欧洲癌症研究与治疗组织QLQ-C30评分与1期肿瘤学试验期间SAEs的发生相关。
