Prognostic impact of clinical trial eligibility in patients with advanced gastric cancer
- Takaaki Arigami 1, Daisuke Matsushita 2, Masataka Shimonosono 2, Yuki Hirase 2, Yusuke Tsuruda 2, Ken Sasaki 2, Kenji Baba 2, Yota Kawasaki 2, Takao Ohtsuka 2
- 1Department of Digestive Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan. arigami@m.kufm.kagoshima-u.ac.jp.
- 2Department of Digestive Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
- 0Department of Digestive Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan. arigami@m.kufm.kagoshima-u.ac.jp.
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View abstract on PubMed
Summary
This summary is machine-generated.The CheckMate 649 trial eligibility criteria identified patients with better prognoses in advanced gastric cancer. Patients not meeting these criteria had poorer outcomes and less access to further chemotherapy.
Area Of Science
- Oncology
- Clinical Trials
- Gastrointestinal Cancers
Background
- The CheckMate 649 trial established clinical benefits of nivolumab plus chemotherapy for HER2-negative advanced gastric cancer.
- Discrepancies exist between randomized controlled trial eligibility and clinical practice, potentially affecting patient outcomes.
- The clinical significance of CheckMate 649 eligibility criteria in real-world settings requires evaluation.
Purpose Of The Study
- To assess the clinical significance of CheckMate 649 eligibility criteria in patients with HER2-negative metastatic gastric cancer.
- To identify prognostic factors influencing treatment outcomes in clinical practice.
- To understand the impact of trial eligibility on subsequent chemotherapy and overall survival.
Main Methods
- Retrospective analysis of 160 patients with HER2-negative metastatic gastric cancer receiving chemotherapy.
- Classification of patients into eligible and ineligible groups based on CheckMate 649 criteria.
- Comparison of second- and third-line chemotherapy rates, overall survival, and prognostic factors between groups.
Main Results
- 47.5% of patients were eligible, and 52.5% were ineligible for CheckMate 649 criteria.
- The ineligible group showed significantly lower rates of second- and third-line chemotherapy (P=0.02).
- Median overall survival was 22.9 months for eligible vs. 10.5 months for ineligible patients (P<0.01), indicating a poorer prognosis for the ineligible group. Disease control was an independent prognostic factor in both groups.
Conclusions
- CheckMate 649 eligibility criteria are associated with significant differences in chemotherapy access and prognosis for advanced gastric cancer patients in clinical practice.
- Patients with poor general condition, often meeting ineligibility criteria, face worse outcomes.
- These findings highlight the importance of considering real-world patient characteristics beyond trial eligibility for optimizing treatment strategies.
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