Construction of clinical evaluation index system for first-line ICIs in HER-2-negative advanced gastric cancer using...

To develop a scientific, objective, and quantitative clinical comprehensive evaluation index system for the first-line treatment of HER-2-negative advanced gastric cancer with immune checkpoint inhibitors, to provide a reference index for the clinical comprehensive evaluation of similar drugs in clinical settings, and to inform decision-making regarding the rational clinical use of medication and directory access in hospitals. A preliminary indicator pool was established based on the literature analysis method, and the final indicator system and weights were clarified by combining the use of two rounds of the Delphi expert consultation method and analysis hierarchical process (AHP). After expert consultation and validation, a comprehensive evaluation system of four primary indicators, 10 secondary indicators, and 18 tertiary indicators for the first-line treatment of HER-2-negative advanced gastric cancer with immune checkpoint inhibitors was finalized. The primary indicators were effectiveness (47%), safety (34%), economy (10%), and pharmacological properties (9%). The top three weights of the combination of secondary indicators were adverse reactions (26.8%), clinical efficacy (20.8%), and indications (15.6%), respectively. The top-ranked secondary indicators among the economic and pharmacological characteristics indicators were whether they were included in the national essential drug list (3.9%) and whether their pharmacological effects were clear (6.3%). The weights of the combination of tertiary indicators ranged from 0.4% to 15.3%, with the highest weights being the incidence of CTCAE grade ≥ 3 adverse events under the safety adverse reaction indicator (15.3%) and the incidence of adverse events leading to treatment interruption (11.6%). The comprehensive evaluation system based on the Delphi method and AHP for constructing the first-line treatment of HER-2-negative advanced gastric cancer with immune checkpoint inhibitors has a high degree of authority, scientificity and reliability. In view of the differences in drug attributes, disease characteristics, and medication populations, it is necessary to carry out a comprehensive clinical evaluation based on these three to meet the needs of the current medication.