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Patient‐reported outcomes and inflammatory biomarkers in patients with locally advanced/metastatic urothelial carcinoma treated with durvalumab in phase 1/2 dose‐escalation study 1108
Author(s) -
O'Donnell Peter H.,
Arkenau Hendrick Tobias,
Sridhar Srikala S.,
Ong Michael,
Drakaki Alexandra,
Spira Alexander I.,
Zhang Jingsong,
Gordon Michael S.,
Degboe Arnold N.,
Gupta Ashok K.,
Mukhopadhyay Pralay,
Huang Wenmei,
Abdullah Shaad E.,
Angra Natasha,
Roskos Lorin K.,
Guo Xiang,
Friedlander Terence
Publication year - 2020
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.32532
Subject(s) - medicine , durvalumab , quality of life (healthcare) , cancer , bladder cancer , metastatic urothelial carcinoma , oncology , performance status , urothelial carcinoma , immunotherapy , nursing , nivolumab
Background Durvalumab has shown meaningful clinical activity in patients with metastatic urothelial carcinoma (mUC) in Study 1108 (NCT01693562). An important focus in treatment is health‐related quality of life (HRQOL). Here, patient‐reported outcomes (PROs) from Study 1108 and their relationship with inflammatory biomarkers are explored. Methods Disease‐related symptoms, functioning, and HRQOL were assessed with the Functional Assessment of Cancer Therapy–Bladder (FACT‐Bl) and the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ‐C30). Relationships between PRO improvements and the best changes in the tumor size, albumin level, and neutrophil‐lymphocyte ratio (NLR) were assessed with Spearman correlation analysis. Results The mean FACT‐Bl total score improved from 107.5 (standard deviation [SD], 23.0) at the baseline to 115.4 (SD, 22.6) on day 113, with similar increases found for the Trial Outcome Index (TOI) and Bladder Cancer Subscale (BLCS) scores. The mean FACT‐Bl total scores improved over time, and the FACT‐Bl TOI scores significantly improved by day 113 ( P < .05). The mean EORTC QLQ‐C30 Global Health Status/Quality of Life score improved from 57.1 (SD, 24.8) at the baseline to 69.0 (SD, 21.4) on day 113; the functional scale and symptom scores (day 113) were higher than the baseline scores ( P < .05) for EORTC Social Functioning. The FACT‐Bl total, BLCS, and TOI scores improved in 32.6%, 34.9%, and 32.6% of the patients by day 113; 26.3% to 37.8% of the patients exhibited improvements in EORTC QLQ‐C30 functional scores. The best tumor shrinkage and posttreatment improvements in serum albumin and NLR correlated with increases in FACT‐Bl total, TOI, and BLCS scores and in EORTC Physical Functioning and Role Functioning scores ( P < .05). Conclusions Durvalumab was associated with improvements in disease‐related symptoms, functioning, and HRQOL in patients with mUC. Improvements in systemic inflammation may contribute to PRO improvements in these patients.