1201P Evaluation of Efficacy TEMCAP Regiment As First-Line or Further Line Therapy in Patients with Advanced, Unresectable, Progressive GEP-NET. Real-world Data
Annals of Oncology（2023）
Maria Sklodowska Curie Natl Res Inst Oncol
Abstract
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). 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. 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. 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.
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