1201P - Evaluation of efficacy TEMCAP regiment as first-line or further line therapy in patients with advanced, unresectable, progressive GEP-NET. Real-world data

Background

Retrospective, single-institution study accessing the efficacy of TEMCAP regiment in pts. with advanced, unresectable progressive GEP-NET as a first or further lines after initial disease progression. Primary endpoint: progression-free survival (PFS), as initial with/without SST analogues previous therapy, PFS as second or further lines therapy using locally evaluation according to RECIST 1.1. Secondary goals: PFS in different subgroups and overall survival (OS).

Methods

54 pts with advanced unresectable, progressive GEP-NET. Mean age 58.0 (SD+/-12.4). All histological confirmed NETs: G1 n=10, G2 n=31, G3 n=13. Standard therapy approach using TEMCAP in all subjects. Disease status and treatment efficiency were evaluated according to localization of primary, initial vs. second or further line systemic therapy, bulky (>25% of liver volume) vs. not bulky liver disease, male vs. female, BMI ≤24 or BM I>24. Standard KM method used to assess PFS and OS for all subjects and in different subgroups. Cox regression model to assess any significant covariates of PFS and OS.

Results

Pancreatic (panNET) n=32, midgut n=8; hindgut n=7 and 7 pts with CUP. PFS for all group 8.0 months (IQR 5.0-15.0), OS from initial diagnosis of GEP-NET 56.8 months (IQR 25.3-96.5); panNET n=32 -PFS=8.0 months (IQR 5.0-16.1), non-pancreas (n=22) PFS=6.2 (IQR 4.0-10.0), n.s. Initial therapy with TEMCAP n=24- PFS=9.2 (6.0-15.0) vs. second or further therapy n=30, PFS=6.0 (IQR 4.1-9.9) n.s. Bulky liver disease (n=31) PFS=7.9 (IQR 5.0-10.0) v.s. non-bulky liver disease (n=23) PFS=7.4 (IQR 4.4-17.0) n.s. Male (n=20) PFS=9.0 (IQR 5.7-15.0), vs. female (n=34) PFS=6.5 (IQR 5.0-11.5), n.s. Median BMI >24.0 PFS=7.0 (IQR 5.0-10.9), vs BMI≤24 PFS=9.0 (IQR 9.0-15.0), n.s. Cox Regression model did not find any significant predictor of improvement in PFS. In Cox regression model of OS indicated that high grade NET (G3) had HR=2.92 (CI 1.17-17.2) of death.

Conclusions

TEMCAP in real world data seems to be a good option in advanced, progressive GEP-NET with PFS=8 months, independently from the primary site, sex, BMI, liver involvement and previous therapy. Overall potential benefits in OS is seen in NETG1 or G2, but not in G3 with HR=2,92.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.