Quality of life and patient‐reported toxicities in patients with advanced Merkel cell carcinoma treated with combined nivolumab and ipilimumab with or without stereotactic body radiation therapy

Abstract Background Merkel cell carcinoma is a rare skin cancer associated with poor survival. Based on a previous Phase II trial of adults with advanced Merkel cell carcinoma by Kim and colleagues (2022), there is now a strong rationale for combination therapy (i.e., nivolumab and ipilimumab) to be...

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Main Authors: Aasha I. Hoogland, Andrew S. Brohl, Brent J. Small, Lauren Michael, Evan Wuthrick, Zeynep Eroglu, Dukagjin Blakaj, Claire Verschraegen, Nikhil I. Khushalani, Heather S. L. Jim, Sungjune Kim
Format: Article
Language:English
Published: Wiley 2024-07-01
Series:Cancer Medicine
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Online Access:https://doi.org/10.1002/cam4.7464
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author Aasha I. Hoogland
Andrew S. Brohl
Brent J. Small
Lauren Michael
Evan Wuthrick
Zeynep Eroglu
Dukagjin Blakaj
Claire Verschraegen
Nikhil I. Khushalani
Heather S. L. Jim
Sungjune Kim
author_facet Aasha I. Hoogland
Andrew S. Brohl
Brent J. Small
Lauren Michael
Evan Wuthrick
Zeynep Eroglu
Dukagjin Blakaj
Claire Verschraegen
Nikhil I. Khushalani
Heather S. L. Jim
Sungjune Kim
author_sort Aasha I. Hoogland
collection DOAJ
description Abstract Background Merkel cell carcinoma is a rare skin cancer associated with poor survival. Based on a previous Phase II trial of adults with advanced Merkel cell carcinoma by Kim and colleagues (2022), there is now a strong rationale for combination therapy (i.e., nivolumab and ipilimumab) to become a treatment option for patients with advanced Merkel cell carcinoma. The goal of this paper was to report on the secondary outcome of quality of life (QOL) among patients on this trial. Methods Patients receiving combined nivolumab and ipilimumab, with or without stereotactic body radiation therapy (SBRT), completed the European Organisation for Research and Treatment of Cancer (EORTC) QLQ‐C30 prior to starting treatment and every 2 weeks thereafter. Changes in QOL during treatment and post‐treatment were evaluated using piecewise random‐effects mixed models. Exploratory analyses compared changes in QOL between study arms. The original trial was registered with ClinicalTrials.gov (NCT03071406). Results Study participants (n = 50) reported no changes in overall QOL (ps > 0.05), but emotional functioning improved during treatment (p = 0.01). Cognitive and social functioning worsened post‐treatment (ps < 0.01). In general, patients treated with combination therapy only (n = 25) reported no change in QOL over time, whereas patients also treated with SBRT (n = 25) consistently demonstrated worsening QOL post‐treatment. Conclusion QOL is generally preserved in patients treated with combination therapy, but the addition of SBRT may worsen QOL. Combined with clinical efficacy data published previously, results support the use of combination therapy with nivolumab and ipilimumab as a treatment option for patients with advanced Merkel cell carcinoma.
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spelling doaj-art-e3252975446043b48e54b4043aea4bb32025-08-20T02:34:44ZengWileyCancer Medicine2045-76342024-07-011314n/an/a10.1002/cam4.7464Quality of life and patient‐reported toxicities in patients with advanced Merkel cell carcinoma treated with combined nivolumab and ipilimumab with or without stereotactic body radiation therapyAasha I. Hoogland0Andrew S. Brohl1Brent J. Small2Lauren Michael3Evan Wuthrick4Zeynep Eroglu5Dukagjin Blakaj6Claire Verschraegen7Nikhil I. Khushalani8Heather S. L. Jim9Sungjune Kim10Department of Health Outcomes and Behavior Moffitt Cancer Center Tampa Florida USADepartment of Cutaneous Oncology Moffitt Cancer Center Tampa Florida USASchool of Aging Studies University of South Florida Tampa Florida USADepartment of Radiation Oncology Moffitt Cancer Center Tampa Florida USADepartment of Radiation Oncology Moffitt Cancer Center Tampa Florida USADepartment of Radiation Oncology Moffitt Cancer Center Tampa Florida USADepartment of Radiation Oncology Ohio State University Columbus Ohio USADepartment of Cutaneous Oncology Ohio State University Columbus Ohio USADepartment of Cutaneous Oncology Moffitt Cancer Center Tampa Florida USADepartment of Health Outcomes and Behavior Moffitt Cancer Center Tampa Florida USADepartment of Radiation Oncology Mayo Clinic Jacksonville Florida USAAbstract Background Merkel cell carcinoma is a rare skin cancer associated with poor survival. Based on a previous Phase II trial of adults with advanced Merkel cell carcinoma by Kim and colleagues (2022), there is now a strong rationale for combination therapy (i.e., nivolumab and ipilimumab) to become a treatment option for patients with advanced Merkel cell carcinoma. The goal of this paper was to report on the secondary outcome of quality of life (QOL) among patients on this trial. Methods Patients receiving combined nivolumab and ipilimumab, with or without stereotactic body radiation therapy (SBRT), completed the European Organisation for Research and Treatment of Cancer (EORTC) QLQ‐C30 prior to starting treatment and every 2 weeks thereafter. Changes in QOL during treatment and post‐treatment were evaluated using piecewise random‐effects mixed models. Exploratory analyses compared changes in QOL between study arms. The original trial was registered with ClinicalTrials.gov (NCT03071406). Results Study participants (n = 50) reported no changes in overall QOL (ps > 0.05), but emotional functioning improved during treatment (p = 0.01). Cognitive and social functioning worsened post‐treatment (ps < 0.01). In general, patients treated with combination therapy only (n = 25) reported no change in QOL over time, whereas patients also treated with SBRT (n = 25) consistently demonstrated worsening QOL post‐treatment. Conclusion QOL is generally preserved in patients treated with combination therapy, but the addition of SBRT may worsen QOL. Combined with clinical efficacy data published previously, results support the use of combination therapy with nivolumab and ipilimumab as a treatment option for patients with advanced Merkel cell carcinoma.https://doi.org/10.1002/cam4.7464immune checkpoint inhibitor therapyMerkel cell carcinomapatient‐reported outcomesquality of life
spellingShingle Aasha I. Hoogland
Andrew S. Brohl
Brent J. Small
Lauren Michael
Evan Wuthrick
Zeynep Eroglu
Dukagjin Blakaj
Claire Verschraegen
Nikhil I. Khushalani
Heather S. L. Jim
Sungjune Kim
Quality of life and patient‐reported toxicities in patients with advanced Merkel cell carcinoma treated with combined nivolumab and ipilimumab with or without stereotactic body radiation therapy
Cancer Medicine
immune checkpoint inhibitor therapy
Merkel cell carcinoma
patient‐reported outcomes
quality of life
title Quality of life and patient‐reported toxicities in patients with advanced Merkel cell carcinoma treated with combined nivolumab and ipilimumab with or without stereotactic body radiation therapy
title_full Quality of life and patient‐reported toxicities in patients with advanced Merkel cell carcinoma treated with combined nivolumab and ipilimumab with or without stereotactic body radiation therapy
title_fullStr Quality of life and patient‐reported toxicities in patients with advanced Merkel cell carcinoma treated with combined nivolumab and ipilimumab with or without stereotactic body radiation therapy
title_full_unstemmed Quality of life and patient‐reported toxicities in patients with advanced Merkel cell carcinoma treated with combined nivolumab and ipilimumab with or without stereotactic body radiation therapy
title_short Quality of life and patient‐reported toxicities in patients with advanced Merkel cell carcinoma treated with combined nivolumab and ipilimumab with or without stereotactic body radiation therapy
title_sort quality of life and patient reported toxicities in patients with advanced merkel cell carcinoma treated with combined nivolumab and ipilimumab with or without stereotactic body radiation therapy
topic immune checkpoint inhibitor therapy
Merkel cell carcinoma
patient‐reported outcomes
quality of life
url https://doi.org/10.1002/cam4.7464
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