[177Lu]Lu-DOTATATE PRRT and CAPTEM chemotherapy for pancreas and small bowel neuroendocrine tumours: The AGITG CONTROL NETS Multi-centre randomized trial
- Author(s)
- Chan, DL; Sjoquist, KM; Ransom, DT; Wyld, D; Wilson, K; Gebski, V; Murray, J; Kiberu, AD; Burge, ME; Macdonald, W; Roach, P; Pattison, DA; Butler, P; Price, TJ; Michael, M; Lawrence, BJ; Bailey, DL; Leyden, J; Leyden, S; Zalcberg, JR; Turner, JH; Pavlakis, N;
- Journal Title
- European Journal of Cancer
- Publication Type
- Research article
- Abstract
- BACKGROUND/AIM: To evaluate the efficacy of [(177)Lu]Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) plus capecitabine and temozolomide (CAPTEM) in participants(pts) with progressive WHO Grade 1-2 neuroendocrine tumours: pancreas(pNETs) and small bowel(SBNETs). METHODS: Non-comparative randomized open label parallel group phase II trial, 2:1 randomization to PRRT/CAPTEM (experimental arm) vs PRRT (SBNETs control) and CAPTEM (pNETs control). PRRT/CAPTEM: 7.8 GBq [(177)Lu]Lu-DOTATATE i.v. Day 10, 8 weekly x 4, concurrent CAP 750 mg/m(2) b.i.d. Days 1-14 and TEM 75 mg/m(2) b.i.d. Days 10-14. CAPTEM Q 4 weekly (pNET control arm). PRIMARY ENDPOINT: Progression-free survival (PFS) @ 15 months (SBNETS) (target > 80%), and 12 months (pNETs) (target >75%). Other: Objective response rate (ORR), overall survival and adverse events (AE). Extended follow-up was undertaken after initial analysis. RESULTS: Seventy-two patients were enrolled and evaluable (27 pNETs, 45 SBNETs). The pNET 12 month PFS was 83.3% (PRRT/CAPTEM) and 88.9% (CAPTEM), and 27 month PFS was 61.1% (PRRT/CAPTEM) and 33.3% (CAPTEM). The SBNET 15 month PFS was 90.4% (PRRT/CAPTEM) and 92.3% (PRRT), and 36 month PFS was 60.4% (PRRT/CAPTEM) and 61.5% (PRRT). PFS HR was HR 0.41 (95% CI: 0.15-1.12, = 0.08) for pNETs and 1.17 (95% CI: 0.51-2.68, p = 0.71) for SBNETs. ORR for pNETs was 72.2% (PRRT/CAPTEM) and 33.3% for CAPTEM, and for SBNETs 34% (PRRT/CAPTEM) and 23% for PRRT. PRRT treatment-related myeloid neoplasms were noted in 2/63 participants (3%). CONCLUSIONS: AGITG CONTROL NETs is the first randomized trial to demonstrate efficacy for PRRT/CAPTEM in pNETs. Extended follow-up confirms durable activity, with higher PFS and ORR in pNETs. The efficacy of CAPTEM/PRRT in pNETs should be tested in a phase III trial. CLINICAL TRIAL REGISTRATION: NCT02358356 / ACTRN12615000909527.
- Publisher
- Elsevier
- Keywords
- Captem; Clinical trial; Neuroendocrine tumours; Prcrt; Prrt; Randomized
- Department(s)
- Medical Oncology
- Publisher's Version
- https://doi.org/10.1016/j.ejca.2026.116781
- Open Access at Publisher's Site
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Creation Date: 2026-05-28 04:25:03
Last Modified: 2026-05-28 04:25:26