PMID- 30482633 OWN - NLM STAT- MEDLINE DCOM- 20190227 LR - 20190227 IS - 1532-8708 (Electronic) IS - 0093-7754 (Linking) VI - 45 IP - 4 DP - 2018 Aug TI - Age-related differences in patient-reported outcomes in patients with advanced lung cancer receiving anti-PD-1/PD-L1 therapy. PG - 201-209 LID - S0093-7754(18)30127-1 [pii] LID - 10.1053/j.seminoncol.2018.06.003 [doi] AB - BACKGROUND: Older adults with lung cancer often have comorbidities that may increase risk of symptomatic adverse events (AEs) and physical function decline. The objective of this study was to examine age-related differences in patient-reported symptoms and functional domains in patients with advanced lung cancer receiving immunotherapy drugs. METHODS: Three randomized controlled trials of anti-programmed death receptor-1/programmed death-ligand 1 therapy in patients with advanced non-small cell lung cancer that included patient-reported outcomes (PROs) were identified. Baseline PRO data were pooled for treatment arms from 2 trials that included the same PRO tools. Age-related differences in baseline mean scores for each of the health-related quality of life functional and symptom scales were assessed for patients >/=70 years and <70 years. Mean change from Baseline at 3 months was also calculated and plotted for each age group. The adequacy of PRO assessments was assessed by comparing clinician-reported AE data in the 3 trials to the item content of the PRO tools included. RESULTS: Across the 3 trials, 75 of patients were under 70 and 26% patients were 70 and older. Comparing baseline scores in the 2 trials with the same PRO tool, older adults reported small differences including lower physical functioning, less pain, insomnia and financial difficulties, and higher social functioning than younger patients at baseline. No large differences in the distributions of mean change from baseline in function or symptom were identified. Several common clinician-reported symptomatic AEs were not assessed by the PRO strategy employed in the 3 trials. Three clinician-reported symptomatic AEs (rash, fever, and pruritus) that were commonly reported in the safety data (9%-19%) were not assessed using the PRO tools employed. CONCLUSION: While several small differences were seen, there did not appear to be large differences at baseline or in the distributions of change from baseline in PRO functional domains between younger and older patients with lung cancer undergoing anti-programmed death receptor -1/programmed death-ligand 1 therapy. Relevant symptomatic side effects were not assessed by PRO measures in these trials, and this is a limitation of current PRO assessment strategies. CI - Published by Elsevier Inc. FAU - King-Kallimanis, B L AU - King-Kallimanis BL AD - Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: belinda.kallimanis@fda.hhs.gov. FAU - Kanapuru, B AU - Kanapuru B AD - Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, MD, USA. FAU - Blumenthal, G M AU - Blumenthal GM AD - Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA. FAU - Theoret, M R AU - Theoret MR AD - Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA. FAU - Kluetz, P G AU - Kluetz PG AD - Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA. LA - eng PT - Journal Article PT - Review DEP - 20181025 PL - United States TA - Semin Oncol JT - Seminars in oncology JID - 0420432 RN - 0 (Antineoplastic Agents, Immunological) RN - 0 (B7-H1 Antigen) RN - 0 (CD274 protein, human) RN - 0 (PDCD1 protein, human) RN - 0 (Programmed Cell Death 1 Receptor) SB - IM MH - *Age Factors MH - Aged MH - Antineoplastic Agents, Immunological/*adverse effects MH - B7-H1 Antigen/antagonists & inhibitors MH - Carcinoma, Non-Small-Cell Lung/*drug therapy MH - Female MH - Humans MH - Immunotherapy/adverse effects/methods MH - Lung Neoplasms/*drug therapy MH - Male MH - Middle Aged MH - Patient Reported Outcome Measures MH - Programmed Cell Death 1 Receptor/antagonists & inhibitors MH - Quality of Life MH - Randomized Controlled Trials as Topic MH - Surveys and Questionnaires MH - Treatment Outcome OTO - NOTNLM OT - Health-related quality of life OT - Immunotherapy OT - Lung cancer OT - Older adults OT - Patient-reported outcomes EDAT- 2018/11/30 06:00 MHDA- 2019/02/28 06:00 CRDT- 2018/11/29 06:00 PHST- 2018/06/07 00:00 [received] PHST- 2018/06/19 00:00 [accepted] PHST- 2018/11/30 06:00 [pubmed] PHST- 2019/02/28 06:00 [medline] PHST- 2018/11/29 06:00 [entrez] AID - S0093-7754(18)30127-1 [pii] AID - 10.1053/j.seminoncol.2018.06.003 [doi] PST - ppublish SO - Semin Oncol. 2018 Aug;45(4):201-209. doi: 10.1053/j.seminoncol.2018.06.003. Epub 2018 Oct 25.