Thomas M Atkinson1, Jennifer L Hay2, Alexander Shoushtari2, Yuelin Li2, Daniel J Paucar3, Sloane C Smith2, Ragini R Kudchadkar4, Austin Doyle5, Jeffrey A Sosman6, Jorge Fernando Quevedo7, Mohammed M Milhem8, Anthony M Joshua9, Gerald P Linette10, Thomas F Gajewski11, Jose Lutzky12, David H Lawson4, Christopher D Lao13, Patrick J Flynn14, Mark R Albertini15, Takami Sato16, Karl Lewis17, Brian Marr2, David H Abramson2, Mark Andrew Dickson2, Gary K Schwartz18, Richard D Carvajal18. 1. Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA. atkinsot@mskcc.org. 2. Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA. 3. Montefiore Medical Center, Albert Einstein Cancer Center, Bronx, NY, USA. 4. Winship Cancer Institute of Emory University, Atlanta, GA, USA. 5. Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA. 6. Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA. 7. Mayo Clinic, Rochester, MN, USA. 8. University of Iowa Carver College of Medicine, Iowa City, IA, USA. 9. Princess Margaret Hospital University Health Network, Toronto, ON, Canada. 10. Penn Medicine, Philadelphia, PA, USA. 11. University of Chicago, Chicago, IL, USA. 12. Mount Sinai Medical Center, Miami Beach, FL, USA. 13. University of Michigan, Ann Arbor, MI, USA. 14. Minnesota Oncology, Woodbury, MN, USA. 15. Univeristy of Wisconsin School of Medicine and Public Health, Madison, WI, USA. 16. Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA, USA. 17. University of Colorado - Denver, Denver, CO, USA. 18. Columbia University Medical Center, New York, NY, USA.
Abstract
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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