Soufyan Annakib, Emma Di Méglio, Yona Dibert-Bekoy, Thierry Chevallier, Guilhem Roubaud, Pierre Fournel, Aline Guillot, Delphine Borchiellini, Damien Pouessel, Elouen Boughalem, Remy Delva, Philippe Barthelemy, Stéphane Oudard, Constance Thibault, Diego Tosi, Nadine Houédé, Frédéric Fiteni
{"title":"晚期转移性膀胱癌患者与临床医生报告症状的一致性","authors":"Soufyan Annakib, Emma Di Méglio, Yona Dibert-Bekoy, Thierry Chevallier, Guilhem Roubaud, Pierre Fournel, Aline Guillot, Delphine Borchiellini, Damien Pouessel, Elouen Boughalem, Remy Delva, Philippe Barthelemy, Stéphane Oudard, Constance Thibault, Diego Tosi, Nadine Houédé, Frédéric Fiteni","doi":"10.1002/cam4.70896","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Immune checkpoint inhibitors (ICIs) improved survival in patients with locally advanced or metastatic urothelial carcinoma (la/mUC). Patient-reported symptoms in this context were poorly studied. The study aimed to compare symptom severity between patients and clinicians.</p>\n </section>\n \n <section>\n \n <h3> Methodology</h3>\n \n <p>The secondary analysis of the AMI clinical trial comparing changes in the gut microbiota in patients with la/mUC treated with pembrolizumab was conducted in nine French centers. Secondary endpoints were expected in this prospective study. Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) and CTCAE were assessed respectively by patients and clinicians before pembrolizumab initiation, and at each treatment visit until treatment cycle 12. Agreement in severity between clinicians and patients for grade ≥ 3 symptoms was calculated with Cohen's kappa coefficient. The toxicity index was generated for CTCAE and PRO-CTCAE to assess discordance in a longitudinal manner. The Wilcoxon test was used to compare clinicians' and patients' toxicity index and symptom severity frequencies.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Thirty-nine patients were included (M/F sex ratio: 2.5) from December 2020 to March 2022. PRO-CTCAE baseline completion rate was 77.5%. Cohen's kappa coefficient ranged from −0.017 (95% confidence interval (CI), [−0.039, 0.005]) for numbness/tingling to 0.161 (95% CI, [0.045, 0.276]) for fatigue. The patient self-rated symptom toxicity index was > 2 for all symptoms compared to ≤ 0.62 (fatigue) when assessed by clinicians in longitudinal reporting of symptom frequency and severity with a <i>p</i> value < 0.001. The three most commonly reported symptoms by patients and clinicians, respectively, were: Fatigue 53.3% versus 23.4%, generalized pain 42.4% versus 16.5%, and insomnia 41.1% versus 9.5%. Symptom frequency reports between clinicians and patients were statistically different (<i>p</i> < 0.009).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Symptom severity assessment showed discordance between patients and physicians. Clinicians reported fewer symptoms and graded them less severely than patients. PROs should be used to accurately reflect patient experience.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>ClinicalTrials.gov identifier: NCT04566029</p>\n </section>\n </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 8","pages":""},"PeriodicalIF":3.1000,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.70896","citationCount":"0","resultStr":"{\"title\":\"Patient Versus Clinician Reported Symptoms Agreement in Advanced Metastatic Bladder Cancer Patients\",\"authors\":\"Soufyan Annakib, Emma Di Méglio, Yona Dibert-Bekoy, Thierry Chevallier, Guilhem Roubaud, Pierre Fournel, Aline Guillot, Delphine Borchiellini, Damien Pouessel, Elouen Boughalem, Remy Delva, Philippe Barthelemy, Stéphane Oudard, Constance Thibault, Diego Tosi, Nadine Houédé, Frédéric Fiteni\",\"doi\":\"10.1002/cam4.70896\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Immune checkpoint inhibitors (ICIs) improved survival in patients with locally advanced or metastatic urothelial carcinoma (la/mUC). Patient-reported symptoms in this context were poorly studied. The study aimed to compare symptom severity between patients and clinicians.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methodology</h3>\\n \\n <p>The secondary analysis of the AMI clinical trial comparing changes in the gut microbiota in patients with la/mUC treated with pembrolizumab was conducted in nine French centers. Secondary endpoints were expected in this prospective study. Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) and CTCAE were assessed respectively by patients and clinicians before pembrolizumab initiation, and at each treatment visit until treatment cycle 12. Agreement in severity between clinicians and patients for grade ≥ 3 symptoms was calculated with Cohen's kappa coefficient. The toxicity index was generated for CTCAE and PRO-CTCAE to assess discordance in a longitudinal manner. The Wilcoxon test was used to compare clinicians' and patients' toxicity index and symptom severity frequencies.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Thirty-nine patients were included (M/F sex ratio: 2.5) from December 2020 to March 2022. PRO-CTCAE baseline completion rate was 77.5%. Cohen's kappa coefficient ranged from −0.017 (95% confidence interval (CI), [−0.039, 0.005]) for numbness/tingling to 0.161 (95% CI, [0.045, 0.276]) for fatigue. The patient self-rated symptom toxicity index was > 2 for all symptoms compared to ≤ 0.62 (fatigue) when assessed by clinicians in longitudinal reporting of symptom frequency and severity with a <i>p</i> value < 0.001. The three most commonly reported symptoms by patients and clinicians, respectively, were: Fatigue 53.3% versus 23.4%, generalized pain 42.4% versus 16.5%, and insomnia 41.1% versus 9.5%. 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Patient Versus Clinician Reported Symptoms Agreement in Advanced Metastatic Bladder Cancer Patients
Background
Immune checkpoint inhibitors (ICIs) improved survival in patients with locally advanced or metastatic urothelial carcinoma (la/mUC). Patient-reported symptoms in this context were poorly studied. The study aimed to compare symptom severity between patients and clinicians.
Methodology
The secondary analysis of the AMI clinical trial comparing changes in the gut microbiota in patients with la/mUC treated with pembrolizumab was conducted in nine French centers. Secondary endpoints were expected in this prospective study. Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) and CTCAE were assessed respectively by patients and clinicians before pembrolizumab initiation, and at each treatment visit until treatment cycle 12. Agreement in severity between clinicians and patients for grade ≥ 3 symptoms was calculated with Cohen's kappa coefficient. The toxicity index was generated for CTCAE and PRO-CTCAE to assess discordance in a longitudinal manner. The Wilcoxon test was used to compare clinicians' and patients' toxicity index and symptom severity frequencies.
Results
Thirty-nine patients were included (M/F sex ratio: 2.5) from December 2020 to March 2022. PRO-CTCAE baseline completion rate was 77.5%. Cohen's kappa coefficient ranged from −0.017 (95% confidence interval (CI), [−0.039, 0.005]) for numbness/tingling to 0.161 (95% CI, [0.045, 0.276]) for fatigue. The patient self-rated symptom toxicity index was > 2 for all symptoms compared to ≤ 0.62 (fatigue) when assessed by clinicians in longitudinal reporting of symptom frequency and severity with a p value < 0.001. The three most commonly reported symptoms by patients and clinicians, respectively, were: Fatigue 53.3% versus 23.4%, generalized pain 42.4% versus 16.5%, and insomnia 41.1% versus 9.5%. Symptom frequency reports between clinicians and patients were statistically different (p < 0.009).
Conclusions
Symptom severity assessment showed discordance between patients and physicians. Clinicians reported fewer symptoms and graded them less severely than patients. PROs should be used to accurately reflect patient experience.
期刊介绍：
Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas:
Clinical Cancer Research
Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations
Cancer Biology:
Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery.
Cancer Prevention:
Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach.
Bioinformatics:
Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers.
Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.
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