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
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 = 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 = 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:41 |
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| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 41(2023), 35 vom: 10. Dez., Seite 5388-5399 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Moehler, Markus [VerfasserIn] |
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| Links: |
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| Themen: |
31YO63LBSN |
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| Anmerkungen: |
Date Completed 11.12.2023 Date Revised 16.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT02872116 Citation Status MEDLINE |
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| doi: |
10.1200/JCO.23.00170 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM362107998 |
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| 100 | 1 | |a Moehler, Markus |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 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 |
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| 500 | |a Date Completed 11.12.2023 | ||
| 500 | |a Date Revised 16.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02872116 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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) | ||
| 520 | |a METHODS: In patients (N = 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 | ||
| 520 | |a RESULTS: In the PRO analysis population (n = 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) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
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| 650 | 7 | |a 31YO63LBSN |2 NLM | |
| 700 | 1 | |a Xiao, Hong |e verfasserin |4 aut | |
| 700 | 1 | |a Blum, Steven I |e verfasserin |4 aut | |
| 700 | 1 | |a Elimova, Elena |e verfasserin |4 aut | |
| 700 | 1 | |a Cella, David |e verfasserin |4 aut | |
| 700 | 1 | |a Shitara, Kohei |e verfasserin |4 aut | |
| 700 | 1 | |a Ajani, Jaffer A |e verfasserin |4 aut | |
| 700 | 1 | |a Janjigian, Yelena Y |e verfasserin |4 aut | |
| 700 | 1 | |a Garrido, Marcelo |e verfasserin |4 aut | |
| 700 | 1 | |a Shen, Lin |e verfasserin |4 aut | |
| 700 | 1 | |a Yamaguchi, Kensei |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Tianshu |e verfasserin |4 aut | |
| 700 | 1 | |a Schenker, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Kowalyszyn, Ruben |e verfasserin |4 aut | |
| 700 | 1 | |a Bragagnoli, Arinilda Campos |e verfasserin |4 aut | |
| 700 | 1 | |a Bruges, Ricardo |e verfasserin |4 aut | |
| 700 | 1 | |a Montesarchio, Vincenzo |e verfasserin |4 aut | |
| 700 | 1 | |a Pazo-Cid, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a Hunter, Shannon |e verfasserin |4 aut | |
| 700 | 1 | |a Davenport, Eric |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Jinyi |e verfasserin |4 aut | |
| 700 | 1 | |a Kondo, Kaoru |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Mingshun |e verfasserin |4 aut | |
| 700 | 1 | |a Wyrwicz, Lucjan |e verfasserin |4 aut | |
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