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External Validity of Somatostatin Analogs Trials in Advanced Neuroendocrine Neoplasms: The GETNE-TRASGU Study
Paula Jimenez-Fonseca1, Alberto Carmona-Bayonas2, Angela Lamarca3,4
1Medical Oncology Department, Hospital Universitario Central de Asturias, ISPA, Oviedo, Spain.
Introduction:
Somatostatin analogs (SSA) prolong progression-free survival (PFS) in patients with well-differentiated gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs). However, the eligibility criteria in randomized clinical trials (RCTs) have been restricted, which contrasts with the vast heterogeneity found in NENs.
Methods:
We identified patients with well-differentiated (Ki-67% ≤20%), metastatic GEP-NENs treated in first line with SSA monotherapy from the Spanish R-GETNE registry. The therapeutic effect was evaluated using a Bayesian Cox model. The objective was to compare survival-based outcomes from real-world clinical practice versus RCTs.
Results:
The dataset contained 535 patients with a median age of 62 years (range: 26-89). The median Ki-67% was 4 (range: 0-20). The most common primary tumor sites were as follows: midgut, 46%; pancreas, 34%; unknown primary, 10%; and colorectal, 10%. Half of the patients received octreotide LAR (n = 266) and half, lanreotide autogel (n = 269). The median PFS was 28.0 months (95% CI: 22.1-32.0) for octreotide versus 30.1 months (95% CI: 23.1-38.0) for lanreotide. The overall hazard ratio for lanreotide versus octreotide was 0.90 (95% credible interval: 0.71-1.12). The probability of effect sizes >30% with lanreotide versus octreotide was 2 and 6% for midgut and foregut NENs, respectively.
Conclusion:
Our study evaluated the external validity of RCTs examining SSAs in the real world, as well as the main effect-modifying factors (progression status, symptoms, tumor site, specific metastases, and analytical data). Our results indicate that both octreotide LAR and lanreotide autogel had a similar effect on PFS. Consequently, both represent valid alternatives in patients with well-differentiated, metastatic GEP-NENs.
Insights
Somatostatin analogs (SSAs) like octreotide LAR and lanreotide autogel show similar progression-free survival (PFS) in patients with gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs). This real-world data supports both as effective first-line treatments.
Area of Science:
- Oncology
- Endocrinology
- Clinical Pharmacology
Background:
- Somatostatin analogs (SSAs) are established treatments for prolonging progression-free survival (PFS) in well-differentiated gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs).
- Randomized clinical trials (RCTs) evaluating SSAs have used restricted eligibility criteria, potentially limiting generalizability to the heterogeneous NEN patient population.
Purpose of the Study:
- To compare the real-world effectiveness of SSA monotherapy in first-line treatment of metastatic, well-differentiated GEP-NENs.
- To evaluate the external validity of RCT findings by analyzing data from a large patient registry.
- To identify potential factors influencing treatment outcomes in a diverse patient cohort.
Main Methods:
- Analysis of 535 patients with well-differentiated (Ki-67% ≤20%), metastatic GEP-NENs from the Spanish R-GETNE registry.
- Patients received first-line SSA monotherapy (octreotide LAR or lanreotide autogel).
- A Bayesian Cox model was employed to evaluate therapeutic effects and compare survival outcomes.
Main Results:
- Median PFS was comparable between octreotide LAR (28.0 months) and lanreotide autogel (30.1 months).
- The overall hazard ratio for lanreotide versus octreotide was 0.90 (95% credible interval: 0.71-1.12), indicating similar efficacy.
- No significant differences in PFS were observed between the two SSAs in this real-world cohort.
Conclusions:
- Both octreotide LAR and lanreotide autogel demonstrate similar efficacy in terms of PFS for patients with well-differentiated, metastatic GEP-NENs.
- The findings support the use of either SSA as a valid first-line treatment option in routine clinical practice.
- Real-world data provides valuable insights into the effectiveness of SSAs beyond the confines of RCT eligibility criteria.
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