Identifying symptomatic adverse events using the patient‐reported outcomes version of the common terminology criteria for adverse events in patients with non‐small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations
Abstract Objective Tolerability and safety of treatments are important in oncology trials and should be informed by patient assessments. We identified the most relevant patient‐reported symptomatic adverse events (AEs) to measure in patients with non‐small cell lung cancer (NSCLC) with epidermal gro...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-03-01
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| Series: | Cancer Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/cam4.5376 |
| _version_ | 1797866827375706112 |
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| author | Yanyan Zhu Milenka Jean‐Baptiste William R. Lenderking Jill A. Bell Dennis A. Revicki Huamao M. Lin Rachael Brake Bryce B. Reeve |
| author_facet | Yanyan Zhu Milenka Jean‐Baptiste William R. Lenderking Jill A. Bell Dennis A. Revicki Huamao M. Lin Rachael Brake Bryce B. Reeve |
| author_sort | Yanyan Zhu |
| collection | DOAJ |
| description | Abstract Objective Tolerability and safety of treatments are important in oncology trials and should be informed by patient assessments. We identified the most relevant patient‐reported symptomatic adverse events (AEs) to measure in patients with non‐small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Methods This study selected relevant symptomatic AEs from 78 AEs available in the Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE) measurement system. Initially, symptomatic AEs were selected based on literature and product labeling reviews, and then core sets of symptomatic AEs were identified by patient and clinician interviews. Qualitative and descriptive analyses were performed using the data collected from three iterative rounds of patient interviews. Results During concept elicitation interviews involving 29 patients, 12 symptomatic AEs were identified and were then adapted into a 25‐item PRO‐CTCAE form for use in future clinical trials along with commonly used PRO measures. Cognitive interviews showed that the PRO‐CTCAE items were easy to answer and appropriate for assessing the patients' experience with symptomatic AEs. This study also assessed disease symptoms, impacts, and overall patient experience. Conclusions The 25‐item PRO‐CTCAE form captures the most relevant symptomatic AEs in this patient population, and it is available for future studies. Baseline characterization of AEs associated with this distinct patient group contributes to our broader knowledge about NSCLC and through platforms like Project Patient Voice will expand our understanding of treatment tolerability and safety for NSCLC. Ultimately, this data collection will help inform decision‐making for patients, caregivers, healthcare providers, and regulators. |
| first_indexed | 2024-04-09T23:31:35Z |
| format | Article |
| id | doaj.art-3419abaa721f4c988a745640dd27f47b |
| institution | Directory Open Access Journal |
| issn | 2045-7634 |
| language | English |
| last_indexed | 2024-04-09T23:31:35Z |
| publishDate | 2023-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj.art-3419abaa721f4c988a745640dd27f47b2023-03-21T05:20:40ZengWileyCancer Medicine2045-76342023-03-011255494550510.1002/cam4.5376Identifying symptomatic adverse events using the patient‐reported outcomes version of the common terminology criteria for adverse events in patients with non‐small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutationsYanyan Zhu0Milenka Jean‐Baptiste1William R. Lenderking2Jill A. Bell3Dennis A. Revicki4Huamao M. Lin5Rachael Brake6Bryce B. Reeve7Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of TakedaPharmaceutical Company Limited Massachusetts Cambridge USAEvidera Inc. Bethesda Maryland USAEvidera Inc. Bethesda Maryland USAMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of TakedaPharmaceutical Company Limited Massachusetts Cambridge USAEvidera Inc. Bethesda Maryland USAMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of TakedaPharmaceutical Company Limited Massachusetts Cambridge USAMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of TakedaPharmaceutical Company Limited Massachusetts Cambridge USADuke University School of Medicine Durham North Carolina USAAbstract Objective Tolerability and safety of treatments are important in oncology trials and should be informed by patient assessments. We identified the most relevant patient‐reported symptomatic adverse events (AEs) to measure in patients with non‐small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Methods This study selected relevant symptomatic AEs from 78 AEs available in the Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE) measurement system. Initially, symptomatic AEs were selected based on literature and product labeling reviews, and then core sets of symptomatic AEs were identified by patient and clinician interviews. Qualitative and descriptive analyses were performed using the data collected from three iterative rounds of patient interviews. Results During concept elicitation interviews involving 29 patients, 12 symptomatic AEs were identified and were then adapted into a 25‐item PRO‐CTCAE form for use in future clinical trials along with commonly used PRO measures. Cognitive interviews showed that the PRO‐CTCAE items were easy to answer and appropriate for assessing the patients' experience with symptomatic AEs. This study also assessed disease symptoms, impacts, and overall patient experience. Conclusions The 25‐item PRO‐CTCAE form captures the most relevant symptomatic AEs in this patient population, and it is available for future studies. Baseline characterization of AEs associated with this distinct patient group contributes to our broader knowledge about NSCLC and through platforms like Project Patient Voice will expand our understanding of treatment tolerability and safety for NSCLC. Ultimately, this data collection will help inform decision‐making for patients, caregivers, healthcare providers, and regulators.https://doi.org/10.1002/cam4.5376adverse eventsnon‐small cell lung canceroncologypatient‐reported outcome measuresPRO‐CTCAEsymptoms |
| spellingShingle | Yanyan Zhu Milenka Jean‐Baptiste William R. Lenderking Jill A. Bell Dennis A. Revicki Huamao M. Lin Rachael Brake Bryce B. Reeve Identifying symptomatic adverse events using the patient‐reported outcomes version of the common terminology criteria for adverse events in patients with non‐small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations Cancer Medicine adverse events non‐small cell lung cancer oncology patient‐reported outcome measures PRO‐CTCAE symptoms |
| title | Identifying symptomatic adverse events using the patient‐reported outcomes version of the common terminology criteria for adverse events in patients with non‐small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations |
| title_full | Identifying symptomatic adverse events using the patient‐reported outcomes version of the common terminology criteria for adverse events in patients with non‐small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations |
| title_fullStr | Identifying symptomatic adverse events using the patient‐reported outcomes version of the common terminology criteria for adverse events in patients with non‐small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations |
| title_full_unstemmed | Identifying symptomatic adverse events using the patient‐reported outcomes version of the common terminology criteria for adverse events in patients with non‐small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations |
| title_short | Identifying symptomatic adverse events using the patient‐reported outcomes version of the common terminology criteria for adverse events in patients with non‐small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations |
| title_sort | identifying symptomatic adverse events using the patient reported outcomes version of the common terminology criteria for adverse events in patients with non small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations |
| topic | adverse events non‐small cell lung cancer oncology patient‐reported outcome measures PRO‐CTCAE symptoms |
| url | https://doi.org/10.1002/cam4.5376 |
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