Reporting patient characteristics and stratification factors in randomized trials of systemic chemotherapy for...

There is no consensus on which patient characteristics are the most suitable to report or to be used as stratification factors in clinical trials for advanced gastric cancer (AGC), to our knowledge.

We conducted a comprehensive review of published randomized trials for AGC to examine the patient characteristics that were reported.

Among the 67 analyzed trials, age, gender, performance status, proportion of patients with measurable disease, and previous gastrectomy were frequently reported (>69%). Histology, number of disease sites, and adjuvant treatment were reported in less than 50% of trials. Although the reporting of second-line chemotherapy has increased in recent trials, it remains at less than 50%. Notably, recent trials have tended to include patients with better performance status and less locally advanced disease, with Asian trials more frequently including patients with more diffuse histology and less locally advanced disease or liver metastasis than non-Asian trials. Stratification was conducted in approximately 60% of the trials, using quite variable stratifying factors.

Inconsistency exists in the reporting of patient characteristics, the characteristics themselves, and the use of stratification factors in clinical trials for AGC. A consensus set of important patient characteristics and strata may be necessary to conduct and interpret quality randomized studies.