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

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247

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Does immune checkpoint inhibitor increase the risks of poor outcomes in COVID-19-infected cancer patients? A systematic review and meta-analysis

Cancer Immunology Immunotherapy ◽

10.1007/s00262-021-02990-9 ◽

2021 ◽

Author(s):

Gilbert Lazarus ◽

Refael Alfa Budiman ◽

Ikhwan Rinaldi

Keyword(s):

Systematic Review ◽

Cancer Patients ◽

Immune Checkpoint ◽

Immune Checkpoint Inhibitor ◽

Checkpoint Inhibitor ◽

Meta Analysis ◽

Poor Outcomes

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Neoadjuvant Immunotherapy for Muscle-Invasive Bladder Cancer

Medicina ◽

10.3390/medicina57080769 ◽

2021 ◽

Vol 57 (8) ◽

pp. 769

Author(s):

Arthur Peyrottes ◽

Idir Ouzaid ◽

Gianluigi Califano ◽

Jean-Francois Hermieu ◽

Evanguelos Xylinas

Keyword(s):

Bladder Cancer ◽

Clinical Trials ◽

Immune Checkpoint ◽

Immune Checkpoint Inhibitor ◽

Response Rate ◽

Checkpoint Inhibitor ◽

Invasive Bladder Cancer ◽

Muscle Invasive Bladder Cancer ◽

Neoadjuvant Immunotherapy ◽

Muscle Invasive

Background and Objectives: Facing neoadjuvant chemotherapy followed by surgery, neoadjuvant immunotherapy is an innovative concept in localized muscle-invasive bladder cancer. Herein, we performed a review of the available and ongoing evidence supporting immune checkpoint inhibitor (ICI) administration in the early stages of bladder cancer treatment. Materials and Methods: A literature search was performed on Medline and clinical trials databases, using the terms: “bladder cancer” OR “urothelial carcinoma”, AND “neoadjuvant immunotherapy” OR “preoperative immunotherapy”. We restricted our investigations to prospective clinical trials evaluating anti-PD-(L)1 and anti-CTLA-4 monoclonal antibodies. Data on efficacy, toxicity and potential biomarkers of response were retrieved. Results: The search identified 6 ICIs that were tested in the neoadjuvant setting for localized bladder cancer—4 anti-PD-(L)1 inhibitors (Pembrolizumab, Atezolizumab, Nivolumab and Durvalumab) and 2 anti-CTLA-4 inhibitors (Ipilimumab and Tremelimumab). Most of the existing literature was based on single-arm phase 2 clinical trials that included from 23 to 143 patients. The pathological complete response rate (pCR) and pathological response rate (pRR) ranged from 31% to 46% and from 55.9% to 66%, respectively. Survival data were immature at this time. The safety profile was acceptable, with severe treatment-related adverse events ranging from 6% to 41%. Conclusions: The results of early phase trials are encouraging, and more investigations are needed to strengthen the rationale for immune checkpoint inhibitor administration in localized muscle-invasive bladder cancer.

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The efficacy and safety of immune checkpoint inhibitor in patients with relapsed small‐cell lung cancer: A systematic review and meta‐analysis

Journal of Clinical Pharmacy and Therapeutics ◽

10.1111/jcpt.13552 ◽

2021 ◽

Author(s):

Yulian Xu ◽

Mingxian Chen ◽

Yanpeng Ding ◽

Feng Guo ◽

Min Chen ◽

...

Keyword(s):

Lung Cancer ◽

Systematic Review ◽

Small Cell Lung Cancer ◽

Immune Checkpoint ◽

Immune Checkpoint Inhibitor ◽

Checkpoint Inhibitor ◽

Meta Analysis ◽

Small Cell ◽

Efficacy And Safety ◽

Small Cell Lung

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Possibilities of Improving the Clinical Value of Immune Checkpoint Inhibitor Therapies in Cancer Care by Optimizing Patient Selection

International Journal of Molecular Sciences ◽

10.3390/ijms21020556 ◽

2020 ◽

Vol 21 (2) ◽

pp. 556 ◽

Cited By ~ 2

Author(s):

Sanna Iivanainen ◽

Jussi P. Koivunen

Keyword(s):

Clinical Trials ◽

Immune Checkpoint ◽

Tumor Immunology ◽

Large Scale ◽

Immune Checkpoint Inhibitor ◽

Checkpoint Inhibitor ◽

Unmet Need ◽

Combination Therapies ◽

Small Cell Lung ◽

Clinical Value

Immune checkpoint inhibitor (ICI) therapies have become the most important medical therapies in many malignancies, such as melanoma, non-small-cell lung cancer, and urogenital cancers. However, due to generally low response rates of PD-(L)1 monotherapy, both PD-(L)1 combination therapies and novel therapeutics are under large-scale clinical evaluation. Thus far, clinical trials have rather suboptimally defined the patient population most likely to benefit from ICI therapy, and there is an unmet need for negative predictive markers aiming to reduce the number of non-responding patients in clinical practice. Furthermore, there is a strong need for basic tumor immunology research and innovative clinical trials to fully unleash the potential of ICI combinations for the benefit of patients.

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