Abstract 730P
Background
Prospective, single-arm, open-label, case series study evaluating efficacy and safety of combined radioligand therapy (RLT) and CAPTEM in advanced, unresectable progressive GEP-NET (NCT04194125). Primary endpoint: progression-free survival (PFS) secondary: ORR, DCR, clinical response, OS, safety.
Methods
Twenty-one patients in group of 23 screened subjects between February 2019 to May 2023 included into analysis. All patients with histopathological confirmation of GEP-NETs. Therapy consists of combine RLT (177Lu DOTATOC) and CAPTEM. Disease status and treatment efficiency were evaluated by clinical assessment including PS, ORR, also biochemical response and safety profile of combine therapy.
Results
Clinical follow-up at least 48 months. Mean age 58.6 +12.6. Pancreatic (panNET) n=14, midgut n=7; NETG1=9, G2=10, G3=2. Cumulative activity 177Lu (GBq) of whole therapy; median=25.1GBq (20.4-27.0), per therapy median=6.5 GBq (5.8-6.8). Median PFS for all (IQR) 31.5 months (16.0-n.r.), panNET PFS=28.0 m (14.0-n.r.), midgut PFS=31.5 m (24.5-n.r). After 6 weeks of follow-up 9 (42%) had partial response (PR) and 11 (52%) had stable disease (SD), after 3 m 9 had PR, 8 had SD, single had disease progression (DP). After 6 m 9 PR, 9 SD and 2 DP, after 12 m single 1 complete response, 10 PR, 5 SD and 2 DP. DCR after 6 weeks all patients, after 3 months 17 subjects (90%), 6 months 18 patients (85%) and after 12 months 16 subjects (89%). Clinical evaluation including 12 subjects with PS=1 improved to PS=0 in 6 subjects in 2 with PS=2 improve to PS=1, no change in 7 subjects. The most common AEs was a transient lymphopenia G2 (44%) and G3 (8%); others AEs and their significant intensity (at least G3) were observed sporadically, no G4, during and after therapy. Persistent lymphopenia noted in 16% of cases.
Conclusions
Combine therapy composed with RLT and CAPTEM is very effective therapy in advanced, GEP-NET in terms of improvement of PFS in those who had documented DP. Clinical response, DCR of combine therapy seen in most of subjects during follow-up. Significant benefit in terms of ORR reported in panNET but not in midgut. In panNET who had PR four of them had primary tumor removal, single with CR for 4 years.
Clinical trial identification
NCT04194125.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Narodowe Centrum Badań I Rozwoju (National Center for Research and Development).
Disclosure
All authors have declared no conflicts of interest.
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