TY - JOUR
T1 - Health-Related Quality of Life With Nivolumab Plus Chemotherapy Versus Chemotherapy in Patients With Advanced Gastric/Gastroesophageal Junction Cancer or Esophageal Adenocarcinoma From CheckMate 649
AU - Moehler, Markus
AU - Xiao, Hong
AU - Blum, Steven I.
AU - Elimova, Elena
AU - Cella, David
AU - Shitara, Kohei
AU - Ajani, Jaffer A.
AU - Janjigian, Yelena Y.
AU - Garrido, Marcelo
AU - Shen, Lin
AU - Yamaguchi, Kensei
AU - Liu, Tianshu
AU - Schenker, Michael
AU - Kowalyszyn, Ruben
AU - Bragagnoli, Arinilda Campos
AU - Bruges, Ricardo
AU - Montesarchio, Vincenzo
AU - Pazo-Cid, Roberto
AU - Hunter, Shannon
AU - Davenport, Eric
AU - Wang, Jinyi
AU - Kondo, Kaoru
AU - Li, Mingshun
AU - Wyrwicz, Lucjan
N1 - Publisher Copyright:
© 2023 by American Society of Clinical Oncology.
PY - 2023/12/10
Y1 - 2023/12/10
N2 - PURPOSE In CheckMate 649, first-line nivolumab plus chemotherapy prolonged overall survival versus chemotherapy in patients with advanced/metastatic non–human epidermal growth factor receptor 2 (HER2)-positive gastric/ gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC). We present exploratory patient-reported outcomes (PROs). METHODS In patients (N 5 1,581) concurrently randomly assigned 1:1 to nivolumab plus chemotherapy or chemotherapy and in those with tumor PD-L1 expression at a combined positive score (CPS) of ≥5, health-related quality of life (HRQoL) was assessed using the EQ-5D and Functional Assessment of Cancer Therapy-Gastric (FACT-Ga), which included the FACT-General (FACT-G) and Gastric Cancer subscale (GaCS). The FACT-G GP5 item assessed treatment-related symptom burden. Longitudinal changes in HRQoL were assessed using mixed models for repeated measures in the PRO analysis population (randomly assigned patients with baseline and ≥1 postbaseline assessments). Time to symptom or definitive deterioration analyses were also conducted. RESULTS In the PRO analysis population (n 5 1,360), PRO questionnaire completion rates were mostly >80% during treatment. Patient-reported symptom burden was not increased with nivolumab plus chemotherapy versus chemotherapy. Mean improved changes from baseline were greater with nivolumab plus chemotherapy versus chemotherapy for FACT-Ga total, GaCS, and EQ-5D visual analog scale in patients with a CPS of ≥5; results were similar for the overall PRO analysis population. In CPS ≥5 and all randomly assigned populations, nivolumab plus chemotherapy reduced the risk of symptom deterioration versus chemotherapy, on the basis of FACT-Ga total score and GaCS; time to definitive deterioration was longer, and the risk of definitive deterioration in HRQoL was reduced with nivolumab plus chemotherapy across EQ-5D and most FACT-Ga measures (hazard ratio [95% CI] <1). CONCLUSION Compared with chemotherapy alone, first-line nivolumab plus chemotherapy showed stable or better on-treatment HRQoL in patients with advanced/ metastatic non–HER2-positive GC/GEJC/EAC and also showed decreased risk of definitive HRQoL deterioration.
AB - PURPOSE In CheckMate 649, first-line nivolumab plus chemotherapy prolonged overall survival versus chemotherapy in patients with advanced/metastatic non–human epidermal growth factor receptor 2 (HER2)-positive gastric/ gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC). We present exploratory patient-reported outcomes (PROs). METHODS In patients (N 5 1,581) concurrently randomly assigned 1:1 to nivolumab plus chemotherapy or chemotherapy and in those with tumor PD-L1 expression at a combined positive score (CPS) of ≥5, health-related quality of life (HRQoL) was assessed using the EQ-5D and Functional Assessment of Cancer Therapy-Gastric (FACT-Ga), which included the FACT-General (FACT-G) and Gastric Cancer subscale (GaCS). The FACT-G GP5 item assessed treatment-related symptom burden. Longitudinal changes in HRQoL were assessed using mixed models for repeated measures in the PRO analysis population (randomly assigned patients with baseline and ≥1 postbaseline assessments). Time to symptom or definitive deterioration analyses were also conducted. RESULTS In the PRO analysis population (n 5 1,360), PRO questionnaire completion rates were mostly >80% during treatment. Patient-reported symptom burden was not increased with nivolumab plus chemotherapy versus chemotherapy. Mean improved changes from baseline were greater with nivolumab plus chemotherapy versus chemotherapy for FACT-Ga total, GaCS, and EQ-5D visual analog scale in patients with a CPS of ≥5; results were similar for the overall PRO analysis population. In CPS ≥5 and all randomly assigned populations, nivolumab plus chemotherapy reduced the risk of symptom deterioration versus chemotherapy, on the basis of FACT-Ga total score and GaCS; time to definitive deterioration was longer, and the risk of definitive deterioration in HRQoL was reduced with nivolumab plus chemotherapy across EQ-5D and most FACT-Ga measures (hazard ratio [95% CI] <1). CONCLUSION Compared with chemotherapy alone, first-line nivolumab plus chemotherapy showed stable or better on-treatment HRQoL in patients with advanced/ metastatic non–HER2-positive GC/GEJC/EAC and also showed decreased risk of definitive HRQoL deterioration.
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U2 - 10.1200/JCO.23.00170
DO - 10.1200/JCO.23.00170
M3 - Article
C2 - 37713657
AN - SCOPUS:85179126673
SN - 0732-183X
VL - 41
SP - 5388
EP - 5399
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 35
ER -