Patient-Reported Outcomes in the Era of Immunotherapy Trials

Gadgeel, Shirish M.

doi:10.1016/j.jtho.2021.02.014

Cited by 3 publications

(3 citation statements)

References 18 publications

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“…It would have been informative to assess whether a correlation (or lack thereof) was observed for PRO benefits and progression-free or overall survival. [37] …”

Section: Discussionmentioning

confidence: 99%

“…[ 47 , 48 ] In the future, baseline PROs could emerge as a better stratification factor than performance status. [37] Also, worsening in PRO scores may correlate with disease progression. [ 47 , 49 ] However, there is a paucity of information in the literature regarding the quality of the data collected from patients during follow-up (i.e., after treatment discontinuation) in clinical trials.…”

Section: Discussionmentioning

confidence: 99%

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Analysis of patient reported outcomes included in the registrational clinical trials of nivolumab for advanced non-small cell lung cancer

Zaim

Redekop

Groot

2022

Translational Oncology

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“…It would have been informative to assess whether a correlation (or lack thereof) was observed for PRO benefits and progression-free or overall survival. [37] …”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Analysis of patient reported outcomes included in the registrational clinical trials of nivolumab for advanced non-small cell lung cancer

Zaim

Redekop

Groot

2022

Translational Oncology

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“…However, suboptimal reporting of PROs is common in cancer immunotherapy trials, and increased efforts are needed to maximize the value of these data in cancer immunotherapy development and approval. [6][7][8][9][10] As there are no longitudinally validated PRO instruments in the setting of CAR-T cell therapy, universally validated measures like PROMIS (Patient-Reported Outcomes Measurement Information System) are available to capture the patient experience. Although limited studies evaluating PROs for those undergoing CAR-T cell treatments have been reported, most of these studies detail CD19-directed CAR-T cell therapies and, to date, there have been no PRO studies for patients receiving CD30-directed CAR-T cell therapy.…”

Section: Introductionmentioning

confidence: 99%

Patient-reported outcomes in CD30-directed CAR-T cells against relapsed/refractory CD30+ lymphomas

Tschernia

Heiling

Deal

et al. 2023

J Immunother Cancer

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Chimeric antigen receptor (CAR)-T cells targeting CD30 have demonstrated high response rates with durable remissions observed in a subset of patients with relapsed/refractory CD30+ hematologic malignancies, particularly classical Hodgkin lymphoma. This therapy has low rates of toxicity including cytokine release syndrome with no neurotoxicity observed in our phase 2 study. We collected patient-reported outcomes (PROs) on patients treated with CD30 directed CAR-T cells to evaluate the impact of this therapy on their symptom experience. We collected PROs including PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health and Physical Function questionnaires and selected symptom questions from the NCI PRO-CTCAE in patients enrolled on our clinical trial of CD30-directed CAR-T cells at procurement, at time of CAR-T cell infusion, and at various time points post treatment. We compared PROMIS scores and overall symptom burden between pre-procurement, time of infusion, and at 4 weeks post infusion. At least one PRO measurement during the study period was found in 23 out of the 28 enrolled patients. Patient overall symptom burden, global health and mental health, and physical function were at or above baseline levels at 4 weeks post CAR-T cell infusion. In addition, PROMIS scores for patients who participated in the clinical trial were similar to the average healthy population. CD30 CAR-T cell therapy has a favorable toxicity profile with patient physical function and symptom burden recovering to at least their baseline pretreatment health by 1 month post infusion. Trial registration number:NCT02690545.

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Cancer Nanovaccines: Nanomaterials and Clinical Perspectives

Desai,

Chavda,

Singh

et al. 2024

Small

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Cancer nanovaccines represent a promising frontier in cancer immunotherapy, utilizing nanotechnology to augment traditional vaccine efficacy. This review comprehensively examines the current state‐of‐the‐art in cancer nanovaccine development, elucidating innovative strategies and technologies employed in their design. It explores both preclinical and clinical advancements, emphasizing key studies demonstrating their potential to elicit robust anti‐tumor immune responses. The study encompasses various facets, including integrating biomaterial‐based nanocarriers for antigen delivery, adjuvant selection, and the impact of nanoscale properties on vaccine performance. Detailed insights into the complex interplay between the tumor microenvironment and nanovaccine responses are provided, highlighting challenges and opportunities in optimizing therapeutic outcomes. Additionally, the study presents a thorough analysis of ongoing clinical trials, presenting a snapshot of the current clinical landscape. By curating the latest scientific findings and clinical developments, this study aims to serve as a comprehensive resource for researchers and clinicians engaged in advancing cancer immunotherapy. Integrating nanotechnology into vaccine design holds immense promise for revolutionizing cancer treatment paradigms, and this review provides a timely update on the evolving landscape of cancer nanovaccines.

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Patient-Reported Outcomes in the Era of Immunotherapy Trials

Cited by 3 publications

References 18 publications

Analysis of patient reported outcomes included in the registrational clinical trials of nivolumab for advanced non-small cell lung cancer

Analysis of patient reported outcomes included in the registrational clinical trials of nivolumab for advanced non-small cell lung cancer

Patient-reported outcomes in CD30-directed CAR-T cells against relapsed/refractory CD30+ lymphomas

Cancer Nanovaccines: Nanomaterials and Clinical Perspectives

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