Journal article
Relationship between physician-adjudicated adverse events and patient-reported health-related quality of life in a phase II clinical trial (NCT01143402) of patients with metastatic uveal melanoma
Journal of cancer research and clinical oncology, Vol.143(3), pp.439-445
03/2017
DOI: 10.1007/s00432-016-2318-x
PMCID: PMC5303646
PMID: 27921276
Abstract
Clinical trials commonly use physician-adjudicated adverse event (AE) assessment via the common terminology criteria for adverse events (CTCAE) for decision-making. Patient-reported health-related quality of life (HRQoL) data are becoming more frequent in oncology; however, the relationship between physician-adjudicated AE assessment and HRQoL is understudied.
Data from a phase II trial (clinicaltrials.gov identifier: NCT01143402) where patients with metastatic uveal melanoma were randomized to receive selumetinib, an oral MEK inhibitor, or chemotherapy were analyzed. Patients reported HRQoL at baseline, after 1 month, and end of treatment (n = 118), whereas physicians adjudicated AEs via CTCAE. Mean HRQoL scores were compared between patient randomization arms, as well as between those patients who did/did not receive dose modifications.
Ninety-four percent had a CTCAE grade ≥1 for at least one treatment-associated AE, with 18% undergoing dose modification due to toxicity. Mean HRQoL scores did not significantly differ at each of the three time points. Patient and physician-adjudicated reports of nausea were significantly correlated at the start (r = 0.31, p < 0.01) and end of treatment (r = 0.42, p < 0.05). There were no significant correlations between need for dose modification and HRQoL scores.
Despite the high rate of physician-adjudicated AEs and need for dose modifications with selumetinib, patient-reported HRQoL was not impacted by treatment. Since HRQoL did not differ in the subgroup of patients who received dosage reductions due to AEs, patients may be willing to tolerate select AEs without dose modification (if medically appropriate). More research is needed to determine how to best integrate HRQoL data into clinical trial conduct.
Details
- Title: Subtitle
- Relationship between physician-adjudicated adverse events and patient-reported health-related quality of life in a phase II clinical trial (NCT01143402) of patients with metastatic uveal melanoma
- Creators
- Thomas M Atkinson - Memorial Sloan Kettering Cancer CenterJennifer L Hay - Memorial Sloan Kettering Cancer CenterAlexander Shoushtari - Memorial Sloan Kettering Cancer CenterYuelin Li - Memorial Sloan Kettering Cancer CenterDaniel J Paucar - Montefiore Medical CenterSloane C Smith - Memorial Sloan Kettering Cancer CenterRagini R Kudchadkar - Emory UniversityAustin Doyle - National Cancer InstituteJeffrey A Sosman - Northwestern UniversityJorge Fernando Quevedo - Mayo CLinic, Rochester, MN, USA,Mohammed M Milhem - University of IowaAnthony M Joshua - Princess Margaret Hospital, University Health Network, Toronto, ON, Canada;Gerald P Linette - University of Pennsylvania Health SystemThomas F Gajewski - University of ChicagoJose Lutzky - Mount Sinai Medical CenterDavid H Lawson - Emory UniversityChristopher D Lao - University of Michigan–Ann ArborPatrick J Flynn - Minnesota OncologyMark R Albertini - University of Wisconsin–MadisonTakami Sato - Thomas Jefferson UniversityKarl Lewis - University of DenverBrian Marr - Memorial Sloan Kettering Cancer CenterDavid H Abramson - Memorial Sloan Kettering Cancer CenterMark Andrew Dickson - Memorial Sloan Kettering Cancer CenterGary K Schwartz - Columbia University Irving Medical CenterRichard D Carvajal - Columbia University Irving Medical Center
- Resource Type
- Journal article
- Publication Details
- Journal of cancer research and clinical oncology, Vol.143(3), pp.439-445
- DOI
- 10.1007/s00432-016-2318-x
- PMID
- 27921276
- PMCID
- PMC5303646
- ISSN
- 0171-5216
- eISSN
- 1432-1335
- Grant note
- P30 CA008748 / NCI NIH HHS P30 CA086862 / NCI NIH HHS P30 CA060553 / NCI NIH HHS
- Language
- English
- Date published
- 03/2017
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359914702771
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