ArticleEClinicalMedicine2023
NET-02: a randomised, non-comparative, phase II trial of nal-IRI/5-FU or docetaxel as second-line therapy in patients with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma.
Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 20 citations in OpenAlex.
- What are the Unmet Needs in Managing Digestive Neuroendocrine Carcinomas?Current oncology reports · 2026Review
- Lurbinectedin plus irinotecan in pretreated gastroenteropancreatic neuroendocrine neoplasms: results of a phase II expansion cohort.ESMO open · 2026Article
- Efficacy and safety of nanoliposomal irinotecan plus 5-fluorouracil and l-leucovorin in rare histological subtypes of pancreatic cancer.Japanese journal of clinical oncology · 2026Article
- Molecular-clinical characteristics and treatment outcomes in 163 metastatic colorectal neuroendocrine carcinomas with a comparison to colorectal adenocarcinomas.International journal of cancer · 2026Article
- Efficacy and safety of surufatinib and sintilimab with or without chemotherapy for advanced high-grade neuroendocrine neoplasms and pancreatic cancer.NPJ precision oncology · 2026Article
- Progress in the treatment of esophageal neuroendocrine carcinoma (Review).Oncology letters · 2026Review
- Systemic therapy for gastroenteropancreatic neuroendocrine neoplasms: current landscape and future directions.Therapeutic advances in medical oncology · 2026Review
- Controversies in NEN: An ENETS position statement on the treatment of patients with Grade 3 well-differentiated neuroendocrine tumours of the gastro-enteropancreatic tract.Journal of neuroendocrinology · 2025Review
- Clinical/pathological features and survival outcomes of extra-pulmonary neuroendocrine carcinomas: A retrospective single-center series.Journal of neuroendocrinology · 2025Article
- Multimodal Treatment Approach for Mixed Neuroendocrine-Non-Neuroendocrine Neoplasms of the Gallbladder: A Patient with a Favorable Survival Outcome.Internal medicine (Tokyo, Japan) · 2025Article
- PRRT in high-grade digestive neuroendocrine neoplasms (NET G3 and NEC).Journal of neuroendocrinology · 2025Review
- Patterns and outcomes of current antitumor therapy for high-grade neuroendocrine neoplasms: perspective of a tertiary referral center.Journal of cancer research and clinical oncology · 2025Article
- Emerging Treatment Options for Neuroendocrine Neoplasms of Unknown Primary Origin: Current Evidence and Future Perspectives.Cancers · 2024Review
- Gastric neuroendocrine neoplasms.Nature reviews. Disease primers · 2024Review
- Extrapulmonary Neuroendocrine Carcinomas: Current Management and Future Perspectives.Journal of clinical medicine · 2023Review
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Authors and funding
24 authors at 15 institutions in 1 country.
Funding
Abstract
Background: The prognosis for patients with poorly-differentiated extra-pulmonary neuroendocrine carcinoma (PD-EP-NEC) is poor. A recognised first-line (1L) treatment for advanced disease is etoposide/platinum-based chemotherapy with no standard second-line (2L) treatment. Methods: Patients with histologically-confirmed PD-EP-NEC (Ki-67 > 20%; Grade 3) received IV liposomal irinotecan (nal-IRI) (70 mg/m Findings: Of 58 patients (29 each arm); 57% male, 90% ECOG PS 0/1, 10% PS 2, 89.7% Ki-67 ≥ 55%, primary site: 70.7%-gastrointestinal, 18.9%-other, 10.3%-unknown, 91.4%/6.9%/1.7% were resistant/sensitive/intolerant to 1L platinum-based treatment, respectively. The primary end-point of 6-month PFS rate was met by ARM A: 29.6% (lower 95% Confidence-Limit (CL) 15.7), but not by ARM B: 13.8% (lower 95%CL:4.9). ORR, median PFS and OS were 11.1% (95%CI:2.4-29.2) and 10.3% (95%CI:2.2-27.4%); 3 months (95%CI:2-6) and 2 months (95%CI:2-2); and 6 months (95%CI:3-10) and 6 months (95%CI:3-9) in ARMS A and B, respectively. Adverse events ≥ grade 3 occurred in 51.7% and 55.2% (1 and 6 discontinuations due to toxicity in ARMS A and B), respectively. QoL was maintained in ARM A, but not ARM B. Interpretation: nal-IRI/5-FU/folinic acid, but not docetaxel, met the primary endpoint, with manageable toxicity and maintained QoL, with no difference in OS. ORR and median PFS were similar in both arms. This study provides prospective efficacy, toxicity and QoL data in the 2L setting in a disease group of unmet need, and represents some of the strongest evidence available to recommend systemic treatment to these patients. Funding: Servier.
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