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Does the use of targeted agents in advanced gastroesophageal cancer increase complete response? A meta-analysis of 18
Yanyang Pang1, Zhen Shen2, Jiancheng Sun3
1Department of Traditional Chinese Medicine, Hainan Medical University, Haikou, Hainan 571101, China.
Purpose:
We aimed to investigate whether the use of targeted agents (TAs) in advanced gastroesophageal cancer (GEC) increased the complete response (CR) and to assess the surrogate endpoints for survival in the targeted treatment of GEC by using a meta-analysis of randomized controlled trials (RCTs).
Methods:
Eligible studies were identified using Medline, PubMed, and meeting abstracts. Searches were last updated on April 30, 2018. We calculated the incidence and Peto odds ratio (Peto OR) of CR events in patients assigned to TAs compared with controls. Simple linear regression models were fitted for median overall survival (OS) and each surrogate [median progression-free survival (PFS), CRs, objective response rate (ORR), and disease control rate (DCR), respectively].
Results:
A total of 7,892 GEC patients from 18 RCTs were included for analysis. The incidence of CR in GEC patients treated with TAs was 2.0% (95% CI, 1.3%-3.0%) compared with 1.7% (95% CI, 1.0%-2.7%) in the control arms. The use of TAs in advanced GEC had a tendency to improve the possibility of archiving CR (Peto OR 1.42; 95% CI, 0.98-2.04; P=0.064) compared with controls. Subgroup analysis according to treatment TAs showed that the addition of antiepidermal growth factor receptor (EGFR) agents to chemotherapy in GEC significantly improved the CR rate in comparison with control (Peto OR 1.77; 95% CI, 1.02-3.09; P=0.044), but not for other molecular TAs (P=0.49 for angiogenesis inhibitors, P=0.66 for mesenchymal-epithelial transition inhibitors). We also found that the addition of TAs to first-line therapy (Peto OR 1.41; 95% CI, 0.94-2.11; P=0.098) had a tendency to increase the chance of obtaining a CR, but not for second-line therapy (Peto OR 1.47; 95% CI, 0.60-3.55; P=0.40). In addition, correlation analysis indicates that PFS, ORR, and DCR were strongly correlated with OS for GEC patients receiving TAs (r=0.85 for PFS; r=0.86 for ORR; r=0.81 for DCR). No marked correlation was found between OS and CRs (r=0.43; P=0.18).
Conclusion:
Although the CR is a rate event in advanced GEC patients, adding the TAs to therapies, especially for anti-EGFR agents, increases the chance of archiving CR in comparison with the controls. PFS, ORR, and DCR are significantly correlated with OS and could be used as surrogate endpoints in patients with GEC who have received TA therapy, but not for CR.
Insights
Targeted agents (TAs), particularly anti-EGFR therapies, show a trend towards improving complete response (CR) in advanced gastroesophageal cancer (GEC). Progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) are reliable survival surrogates in GEC patients receiving TAs.
Area of Science:
- Oncology
- Gastroenterology
- Clinical Trials
- Pharmacology
Background:
- Advanced gastroesophageal cancer (GEC) presents significant treatment challenges.
- Targeted agents (TAs) are increasingly explored to improve outcomes in GEC.
- Identifying reliable surrogate endpoints for overall survival (OS) is crucial for efficient clinical trial design.
Purpose of the Study:
- To determine if targeted agents (TAs) improve complete response (CR) rates in advanced GEC.
- To evaluate surrogate endpoints for survival in advanced GEC patients treated with TAs.
- To conduct a meta-analysis of randomized controlled trials (RCTs) to assess TA efficacy.
Main Methods:
- Systematic literature search of Medline, PubMed, and meeting abstracts up to April 30, 2018.
- Meta-analysis of 18 RCTs including 7,892 GEC patients to calculate the odds ratio (OR) of CR.
- Linear regression models used to assess correlations between OS and surrogate endpoints (PFS, CR, ORR, DCR).
Main Results:
- TAs showed a trend towards improving CR in advanced GEC (Peto OR 1.42, P=0.064).
- Anti-EGFR agents significantly improved CR rates (Peto OR 1.77, P=0.044), unlike other TAs.
- PFS, ORR, and DCR demonstrated strong correlations with OS (r=0.85, 0.86, 0.81 respectively); CR did not correlate significantly (r=0.43).
Conclusions:
- While CR is infrequent in advanced GEC, TAs, especially anti-EGFR agents, enhance CR likelihood.
- PFS, ORR, and DCR are validated surrogate endpoints for OS in GEC patients receiving TA therapy.
- CR is not a reliable surrogate endpoint for OS in this patient population.
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