Randomized controlled trial in gastric or gastroesophageal junction adenocarcinoma undergoing systemic therapy over
Bin-Bin Xu1, Jun Lu1, Hua-Long Zheng1
1Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China; Fujian Province Minimally Invasive Medical Center, Fuzhou, China.
Introduction:
The number of randomized controlled trials (RCTs) investigating the systemic treatment of gastric or gastroesophageal junction adenocarcinoma (GA-RCTs) is increasing. We aimed to describe the characteristics and evaluate the clinical benefit of GA-RCTs over the past 20 years.
Materials And Methods:
We searched for RCTs of systemic treatment in GA published in eight major journals between 2001 and 2020 in PubMed. From the included studies, the characteristics and results of GA-RCTs were extracted. Clinical benefit was assessed using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).
Results:
About 93 RCTs with 38365 patients were included. Seventy-one (76.3%) studies received external funding, with an increase from 27.3% (2001-2005) to 94.1% (2016-2020). RCTs on targeted therapy and/or immunotherapy have also increased over time, but only 14 (41.2%) were restricted to specific biomarkers. Forty-four (47.3%) studies met their primary endpoint (defined as positive RCTs), but median overall survival has not improved over time. Moreover, only 16 (36.4%) studies met the ESMO-MCBS threshold. RCTs whose study design and results met the ESMO-MCBS thresholds has not increased over time (p = 0.827 and p = 0.733, respectively).
Conclusions:
GA-RCTs are increasingly focused on targeted therapy and/or immunotherapy, and are more likely to receive external funding. However, the effect size has not shown significant improvement in the past 20 years. Only a few RCTs with positive results met ESMO thresholds. Future RCTs should prioritize the clinical benefits and provide direct evidence to optimize and reform GA treatment practices.
Insights
Despite an increase in randomized controlled trials (RCTs) for gastric cancer, systemic treatments show no significant survival improvement. Few trials meet clinical benefit thresholds, indicating a need to prioritize patient outcomes in future research.
Area of Science:
- Oncology
- Clinical Trials
- Gastrointestinal Cancer Treatment
Background:
- The number of randomized controlled trials (RCTs) for gastric or gastroesophageal junction adenocarcinoma (GA) systemic treatment is rising.
- Understanding the evolution and clinical benefit of these trials over two decades is crucial for advancing GA treatment.
Purpose of the Study:
- To characterize the trends in GA-RCTs over the past 20 years (2001-2020).
- To evaluate the clinical benefit of systemic treatments investigated in GA-RCTs using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).
Main Methods:
- A systematic search of PubMed for GA-RCTs published in eight major journals from 2001 to 2020.
- Extraction of study characteristics and results, with clinical benefit assessed by ESMO-MCBS.
Main Results:
- 93 RCTs involving 38,365 patients were analyzed, showing increased external funding and a rise in targeted therapy/immunotherapy trials.
- Despite increased trial activity, median overall survival has not improved, and only 36.4% of studies met the ESMO-MCBS threshold.
- No significant increase in RCTs meeting ESMO-MCBS thresholds for study design or results was observed over time.
Conclusions:
- GA-RCTs increasingly incorporate targeted therapies and immunotherapies, with greater external funding.
- However, the clinical benefit and effect size of systemic treatments in GA have not significantly improved over the past two decades.
- Future GA-RCTs must prioritize demonstrable clinical benefits to optimize treatment strategies and reform clinical practice.
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