TY - JOUR
T1 - Patient-reported outcomes with nivolumab in advanced solid cancers
AU - Tykodi, Scott S.
AU - Schadendorf, Dirk
AU - Cella, David
AU - Reck, Martin
AU - Harrington, Kevin
AU - Wagner, Samuel
AU - Shaw, James W.
N1 - Funding Information:
SST reports clinical trial support received on behalf of his institution from ARGOS Therapeutics, Bristol-Myers Squibb, Calithera Biosciences, Genentech, Jounce Therapeutics, Merck, Nektar Therapeutics, Peloton Therapeutics, Pfizer, and Prometheus Laboratories; served on advisory boards for Calithera Biosciences and Prometheus Laboratories; and is a consultant for Amgen and Bristol-Myers Squibb. DS reports personal fees from Bristol-Myers Squibb during the conduct of the study, and from 4SC, Amgen, Array, AstraZeneca, Boehringer Ingelheim, Incyte, Leo Pharma, Merck-EMD, Merck/MSD, Novartis, Philiogen, Pfizer, Pierre Fabre, Regeneron, and Roche outside the submitted work. DC reports consulting honoraria from AstraZeneca, Bristol-Myers Squibb, Merck, Novartis, Pfizer, and Puma. MR reports honoraria for lectures and consultancy from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Lilly, Merck/MSD, Novartis, Pfizer, and Roche/Genentech. KH served on advisory boards and reports honoraria from Amgen, AstraZeneca, Bristol-Myers Squibb, Merck/MSD, and Pfizer, and grants from AstraZeneca and Merck/MSD. SW reports being an employee of Bristol-Myers Squibb. JWS reports being an employee and shareholder of Bristol-Myers Squibb.
Publisher Copyright:
© 2018 The Authors
PY - 2018/11
Y1 - 2018/11
N2 - Patients with recurrent or metastatic cancer commonly suffer from debilitating toxicity associated with conventional treatment modalities, as well as disease-related symptoms, often with a concomitant negative impact on health-related quality of life (HRQoL). Patient-reported outcomes (PROs) provide important insights into the patient experience in clinical trials. Nivolumab is a programmed death-1 receptor inhibitor that extends survival in patients with recurrent or metastatic disease in multiple tumor types. In this review, we summarize published PRO analyses from eight phase II–IV clinical trials with nivolumab for the treatment of melanoma, non-small cell lung cancer, renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN). Symptom burden, physical functioning, and HRQoL were measured using generic, cancer-specific, and tumor type–specific validated PRO instruments. Nivolumab showed sustained stabilization across all tumor types and, in some cases, clinically meaningful improvement in HRQoL, whereas standard of care therapies often led to deteriorations. Exploratory analyses found a positive correlation between baseline HRQoL scores and overall survival in RCC, and between baseline HRQoL scores and healthcare resource utilization in SCCHN, suggesting that patient-reported symptoms at treatment initiation may have clinical value. In the era of value-based oncology care, stakeholders are increasingly interested in PRO findings to guide clinical, regulatory, and reimbursement decisions. However, missing data remain a significant challenge in PRO analyses, including in nivolumab trials. Future clinical trials in immuno-oncology should incorporate PRO data collection, including beyond treatment discontinuation or trial completion to assess the long-term effects of treatment on HRQoL.
AB - Patients with recurrent or metastatic cancer commonly suffer from debilitating toxicity associated with conventional treatment modalities, as well as disease-related symptoms, often with a concomitant negative impact on health-related quality of life (HRQoL). Patient-reported outcomes (PROs) provide important insights into the patient experience in clinical trials. Nivolumab is a programmed death-1 receptor inhibitor that extends survival in patients with recurrent or metastatic disease in multiple tumor types. In this review, we summarize published PRO analyses from eight phase II–IV clinical trials with nivolumab for the treatment of melanoma, non-small cell lung cancer, renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN). Symptom burden, physical functioning, and HRQoL were measured using generic, cancer-specific, and tumor type–specific validated PRO instruments. Nivolumab showed sustained stabilization across all tumor types and, in some cases, clinically meaningful improvement in HRQoL, whereas standard of care therapies often led to deteriorations. Exploratory analyses found a positive correlation between baseline HRQoL scores and overall survival in RCC, and between baseline HRQoL scores and healthcare resource utilization in SCCHN, suggesting that patient-reported symptoms at treatment initiation may have clinical value. In the era of value-based oncology care, stakeholders are increasingly interested in PRO findings to guide clinical, regulatory, and reimbursement decisions. However, missing data remain a significant challenge in PRO analyses, including in nivolumab trials. Future clinical trials in immuno-oncology should incorporate PRO data collection, including beyond treatment discontinuation or trial completion to assess the long-term effects of treatment on HRQoL.
KW - Head and neck cancer
KW - Melanoma
KW - Nivolumab
KW - Non-small cell lung cancer
KW - Patient-reported outcomes
KW - Renal cell carcinoma
UR - http://www.scopus.com/inward/record.url?scp=85051625027&partnerID=8YFLogxK
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U2 - 10.1016/j.ctrv.2018.08.001
DO - 10.1016/j.ctrv.2018.08.001
M3 - Review article
C2 - 30125799
AN - SCOPUS:85051625027
VL - 70
SP - 75
EP - 87
JO - Cancer Treatment Reviews
JF - Cancer Treatment Reviews
SN - 0305-7372
ER -