PMID- 36583557
OWN - NLM
STAT- MEDLINE
DCOM- 20230324
LR  - 20230326
IS  - 2045-7634 (Electronic)
IS  - 2045-7634 (Linking)
VI  - 12
IP  - 5
DP  - 2023 Mar
TI  - 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.
PG  - 5494-5505
LID - 10.1002/cam4.5376 [doi]
AB  - 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.
CI  - (c) 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
FAU - Zhu, Yanyan
AU  - Zhu Y
AD  - Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of 
      TakedaPharmaceutical Company Limited, Massachusetts, Cambridge, USA.
FAU - Jean-Baptiste, Milenka
AU  - Jean-Baptiste M
AD  - Evidera Inc., Bethesda, Maryland, USA.
FAU - Lenderking, William R
AU  - Lenderking WR
AUID- ORCID: 0000-0002-3080-3643
AD  - Evidera Inc., Bethesda, Maryland, USA.
AD  - Evidera Inc., Waltham, Massachusetts, USA.
FAU - Bell, Jill A
AU  - Bell JA
AD  - Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of 
      TakedaPharmaceutical Company Limited, Massachusetts, Cambridge, USA.
FAU - Revicki, Dennis A
AU  - Revicki DA
AD  - Evidera Inc., Bethesda, Maryland, USA.
FAU - Lin, Huamao M
AU  - Lin HM
AD  - Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of 
      TakedaPharmaceutical Company Limited, Massachusetts, Cambridge, USA.
FAU - Brake, Rachael
AU  - Brake R
AD  - Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of 
      TakedaPharmaceutical Company Limited, Massachusetts, Cambridge, USA.
FAU - Reeve, Bryce B
AU  - Reeve BB
AUID- ORCID: 0000-0002-6709-8714
AD  - Duke University School of Medicine, Durham, North Carolina, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221230
PL  - United States
TA  - Cancer Med
JT  - Cancer medicine
JID - 101595310
RN  - EC 2.7.10.1 (ErbB Receptors)
RN  - EC 2.7.10.1 (EGFR protein, human)
SB  - IM
MH  - Humans
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics
MH  - ErbB Receptors/genetics
MH  - *Lung Neoplasms/drug therapy/genetics
MH  - Mutagenesis, Insertional
MH  - *Neoplasms/drug therapy
MH  - Patient Reported Outcome Measures
PMC - PMC10028096
OTO - NOTNLM
OT  - PRO-CTCAE
OT  - adverse events
OT  - non-small cell lung cancer
OT  - oncology
OT  - patient-reported outcome measures
OT  - symptoms
OT  - tolerability
COIS- YZ and JAB were former employees of Takeda when this research was conducted and 
      are current employees of AstraZeneca. HML and RB are current employees of Takeda. 
      WRL is a full-time employee of Evidera, DAR was a former employee of Evidera (now 
      deceased), and MJB is a part-time employee of Evidera, which received funding 
      from Takeda to carry out this research. BBR served as a paid consultant for 
      Takeda.
EDAT- 2022/12/31 06:00
MHDA- 2023/03/24 06:00
PMCR- 2022/12/30
CRDT- 2022/12/30 08:12
PHST- 2022/08/25 00:00 [revised]
PHST- 2022/04/28 00:00 [received]
PHST- 2022/10/08 00:00 [accepted]
PHST- 2022/12/31 06:00 [pubmed]
PHST- 2023/03/24 06:00 [medline]
PHST- 2022/12/30 08:12 [entrez]
PHST- 2022/12/30 00:00 [pmc-release]
AID - CAM45376 [pii]
AID - 10.1002/cam4.5376 [doi]
PST - ppublish
SO  - Cancer Med. 2023 Mar;12(5):5494-5505. doi: 10.1002/cam4.5376. Epub 2022 Dec 30.