Relapsed / Refractory · Randomized non-comparative phase II; N=84 pretreated progressive SSTR-positive metastatic pancreatic NET. 177Lu-DOTATATE 7.4 GBq q8w up to four cycles vs sunitinib 37.5 mg daily. Primary endpoint 12-month PFS. · 12-month PFS 80.5% (33/41) vs 41.9% (18/43)

OCLURANDOM

Primary setting: Relapsed / Refractory · Disease extent: Advanced / metastatic · Prior-treatment context: Relapsed / refractory or previously treated population; see trial-specific eligibility

Clinical question: Does 177Lu-DOTATATE provide greater 12-month PFS than sunitinib in progressive metastatic pancreatic neuroendocrine tumours?

12-month PFS 80.5% (33/41) vs 41.9% (18/43); absolute gain 38.6 points; No NNT calculated. · Registry:

Design, population and treatment

Randomized non-comparative phase II; N=84 pretreated progressive SSTR-positive metastatic pancreatic NET. 177Lu-DOTATATE 7.4 GBq q8w up to four cycles vs sunitinib 37.5 mg daily. Primary endpoint 12-month PFS.

Key efficacy outcome

80.5 · intervention

41.9

80.5 · comparator

No NNT is calculated: the sunitinib arm served as an internal control in a non-comparative phase II design, so the between-arm contrast is descriptive rather than a formal comparative treatment effect.

Grade 3–4 AEs 44% vs 72%; one treatment-related death (acute leukaemia) with 177Lu-DOTATATE; late grade ≥2 AEs noted.

Safety and absolute effect

12-month PFS (%)

https://pubmed.ncbi.nlm.nih.gov/42225102/

Interpretation and limitations

Current-practice context · 14 November 2026: Primary publication/abstract and trial identifier checked. Guideline-level current-practice mapping was not established in this publication-led batch; no NCCN citation provenance is claimed. Where detailed QoL, follow-up or toxicity data were not present in the retrieved abstract, they are not inferred.

Primary source

Primary publication · DOI: 10.1016/S1470-2045(26)00108-7