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

O’Donnell, Peter H.; Arkenau, Hendrick-Tobias; Sridhar, Srikala S.; Ong, Michael; Drakaki, Alexandra; Spira, Alexander I.; Zhang, Jingsong; Gordon, Michael; Degboe, Arnold; Gupta, Ashok; Mukhopadhyay, Pralay; Huang, Wenmei; Abdullah, Shaad E.; Angra, Natasha; Roskos, Lorin; Guo, Xiang; Friedlander, Terence W.

doi:10.1002/cncr.32532

Cited by 13 publications

(8 citation statements)

References 21 publications

(40 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…For two of the latter, additional full-text manuscripts on PRO results alone were published. Thus, the 28 publications referred to 26 individual ICI-CTs on lung carcinoma ( n = 11) [ 14 – 24 ], melanoma ( n = 6) [ 25 – 30 ], renal cell carcinoma ( n = 3) [ 31 – 33 ], urothelial carcinoma ( n = 2) [ 34 , 35 ], Hodgkin’s lymphoma (n = 1) [ 36 , 37 ], head and neck carcinoma (n = 1) [ 38 , 39 ], Merkel cell carcinoma (n = 1) [ 40 ], and cervical and vaginal carcinoma (n = 1) [ 41 ] (Table S5 ). With regard to measured PRO concepts, all publications reported on health-related quality of life (HRQoL) or global health status (GHS) as assessed by the cancer-specific EORTC QLQ-C30 (17/26) and/or the generic EQ-5D (15/26).…”

Section: Resultsmentioning

confidence: 99%

Patient-reported outcome instruments used in immune-checkpoint inhibitor clinical trials in oncology: a systematic review

Colomer‐Lahiguera

Bryant‐Lukosius

Rietkoetter

et al. 2020

J Patient Rep Outcomes

View full text Add to dashboard Cite

Context: Immune-checkpoint inhibitors (ICI) have shown significant benefits for overall survival across various cancer types. Patient-reported outcomes (PROs) are assessed in clinical trials as a measure of efficacy. However, it remains unclear to what extent current PRO instruments capture symptoms specific to ICI toxicities. We conducted a systematic review to identify the use and content validity of PRO instruments in ICI clinical trials in oncology. Methods: Literature was retrieved from PubMed, Embase, PsycINFO, Medline and CINAHL databases. Articles presenting ICI clinical trials' PRO results, clinical trial study protocols, and conference abstracts stating the use of PRO measures were assessed. We evaluated the validity of identified instruments by comparing their symptomrelated content with the adverse events reported in each ICI clinical trial. Results: From database inception until January 2020, we identified 191 ICI clinical trials stating the use of PRO measures of which 26 published PRO results. The cancer-specific EORTC QLQ-C30 and the generic EQ-5D questionnaires were the most widely used instruments, often in combination with disease-specific PROs. Instruments used to report PRO symptom-related toxicities covered 45% of the most frequently reported AEs, whereas 23% of AEs were partially covered and 29% were not covered at all. Of non-covered AEs, 59% referred to the dermatologic system. Partially covered AEs related to endocrine and specific types of pain. Conclusion: Despite the high frequency of symptom-related toxicities related to ICI, these events are only partially covered (or not addressed) by current PRO instruments, even when combined. Further research is needed to develop new strategies to tailor PRO instruments to specific ICI toxicities.

show abstract

Section: Resultsmentioning

confidence: 99%

Patient-reported outcome instruments used in immune-checkpoint inhibitor clinical trials in oncology: a systematic review

Colomer‐Lahiguera

Bryant‐Lukosius

Rietkoetter

et al. 2020

J Patient Rep Outcomes

View full text Add to dashboard Cite

show abstract

“…Lymphocytes, different from neutrophils and monocytes, play a crucial role in host cell-mediated immunity regulation, which is important to destruct residual malignant cells and related micrometastases. It is now widely believed that tumor-infiltrating lymphocytes (TILs) are associated with better clinical outcomes in cancers 13 . Consequently, higher MLR has a significant diagnostic value of EEC.…”

Section: Discussionmentioning

confidence: 99%

Predictive Value of Routine Blood Test in patients with Early Esophageal Cancer: A Matched Case-Control Study

Zhou¹,

Han²,

Zhang³

et al. 2021

J. Cancer

View full text Add to dashboard Cite

Aims: The present study was to evaluate the diagnostic value of routine blood test as potential inflammatory markers in early esophageal cancer (EEC) patients. Methods: A matched case-control study was conducted by recruiting 314 patients who were pathologically diagnosed with EEC and then underwent Endoscopic Submucosal Dissection (ESD) from July 2015 to July 2019 in First Affiliated Hospital of Nanjing Medical University. Each EEC patient was matched against one healthy control on the criteria of gender, and age (±2 years). Additionally, a total of 40 subjects (20 cases and 20 controls) were also included in the validation set. Statistical analysis of selected hematological parameters was performed between the two groups. The correlation between preoperative blood indexes and clinicopathological characteristics after ESD in EEC patients were further assessed. Results: Mono-factor analysis showed that the index of monocyte ( p<0.001 ), MCV ( p=0.018 ), MCH ( p=0.01 ), MPV ( p=0.022 ), PT ( p=0.003 ), PT-INR ( p=0.003 ), PDW ( p<0.001 ) and MLR ( p<0.001 ) were statistically significant in EEC patients when compared with those in healthy controls. Multivariate logistic regression analysis further identified that PDW and MLR was independently associated with the risk of early esophageal cancer (both p<0.001 ). The higher level of NLR (P=0.007) and MLR (P=0.015) were statistically significant with submucosal invasion in EEC patients and the level of MLR were significantly associated with larger tumor size (P=0.030) . The results of the validation group were in consistence with the primary group. Conclusions: Hematological parameters of MLR and PDW can be used as an adjuvant tool for the diagnosis of EEC. Moreover, the value of MLR can reflect the invasion depth index.

show abstract

“…In Study 1108 mentioned above, O'Donnell et al . explored the patient‐reported outcomes and their relationship with inflammatory biomarkers, indicating that the best decrease in NLR from the baseline was significantly greater in responders compared with nonresponders 85 . As a result, durvalumab may reduce inflammation, which is an advantage of immunotherapy.…”

Section: Biomarkers Predicted Treatment Responsementioning

confidence: 99%

The evolving role of checkpoint inhibitors in the treatment of urothelial carcinoma

Tang

Liu

et al. 2022

Brit J Clinical Pharma

View full text Add to dashboard Cite

The most prevalent pathological subtype of bladder and upper urinary tract malignancy is urothelial carcinoma (UC). Traditional therapies mainly include surgical resection, chemotherapy and radiotherapy. Checkpoint inhibitors, which are monoclonal antibodies developed to specifically target immune checkpoint molecules, have recently emerged as potential treatment options for UC patients, especially those targeting the programmed cell death protein 1 (PD-1) and its ligand (PD-L1). However, anti-PD-1/PD-L1 therapy does not work for a considerable number of UC patients.Current antitumour immunotherapy research hotspots include seeking biomarkers that might predict therapeutic effects and exploring novel immune checkpoint molecules crucial for the antitumour immune response. Hence, we will recapitulate the latest preclinical and clinical trials of 5 PD-1/PD-L1 inhibitors, 1 cytotoxic T-lymphocyte-associated protein 4 inhibitor and combination therapies for UC treatment, including combined immunotherapy and immunotherapy with chemotherapy or radiotherapy. We will also summarize other potential immune checkpoint molecules found in ongoing UC studies. Moreover, we will highlight the role of biomarkers linked with the oncological efficacy of anti-PD-1/PD-L1 immunotherapy and address the mechanisms of immunotherapy drug resistance in UC, with the hope of providing more systematic guidance for its application and development.

show abstract

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

Cited by 13 publications

References 21 publications

Patient-reported outcome instruments used in immune-checkpoint inhibitor clinical trials in oncology: a systematic review

Patient-reported outcome instruments used in immune-checkpoint inhibitor clinical trials in oncology: a systematic review

Predictive Value of Routine Blood Test in patients with Early Esophageal Cancer: A Matched Case-Control Study

The evolving role of checkpoint inhibitors in the treatment of urothelial carcinoma

Contact Info

Product

Resources

About