Eribulin

證據等級: L5

預測適應症: 10 個

Eribulin: From Soft Tissue Sarcoma/Liposarcoma to Fibroblastic Neoplasm (Solitary Fibrous Tumor / Fibrosarcoma Spectrum)

One-Sentence Summary

Eribulin is a microtubule-dynamics inhibitor already used against soft tissue sarcoma, including liposarcoma. Among 10 TxGNN-predicted indications, the strongest evidence-backed signal points to Fibroblastic Neoplasm (covering solitary fibrous tumor and fibrosarcoma/myxofibrosarcoma), supported by 1 completed Phase II trial and 8 publications — the only candidate in this set with real-world corroboration; the other 9 predictions remain model-prediction-only (L5), with several explicitly flagged in the source rationale as likely graph-linkage noise.

Quick Overview

Item	Content
Original Indication	Not available from Germany licensing data (drug unmarketed); evidence-pack rationale confirms eribulin already has an approved indication in soft tissue sarcoma / liposarcoma via microtubule-dynamics inhibition
Predicted New Indication	Fibroblastic Neoplasm (Solitary Fibrous Tumor / Fibrosarcoma spectrum)
TxGNN Prediction Score	99.36%
Evidence Level	L3 (1 completed, non-randomized Phase II trial + multiple preclinical studies)
Germany Market Status	✗ Not marketed
Number of Authorizations	0
Recommended Decision	Proceed with Guardrails

Why is This Prediction Reasonable?

Detailed structured MOA data (DrugBank field) is currently a data gap. However, the repurposing rationale embedded across multiple predicted indications in this evidence pack consistently describes eribulin as a microtubule-dynamics inhibitor / anti-mitotic agent, with efficacy already established in soft tissue sarcoma, including an approved liposarcoma indication (noted explicitly for the myxoid liposarcoma prediction, rank 5).

Fibroblastic neoplasms — solitary fibrous tumor (SFT), fibrosarcoma, and myxofibrosarcoma — belong to the same broad soft-tissue sarcoma family as liposarcoma. They share highly proliferative, mesenchymal-origin biology that is mechanistically dependent on microtubule function, making them a biologically plausible extension of eribulin's known antitumor activity rather than an unrelated disease area.

This mechanistic plausibility is reinforced by actual data: a completed Phase II trial (ERASING, NCT03840772) specifically tested eribulin in advanced SFT, and multiple independent preclinical studies (2021–2025) demonstrate eribulin activity — including synergy with recombinant methioninase — in fibrosarcoma and myxofibrosarcoma cell lines and patient-derived xenografts. This combination of a completed clinical trial plus a consistent, growing preclinical literature is unique among the 10 candidates in this pack; nine other predictions (e.g., familial Mediterranean fever, mesothelioma subtypes, adenomatoid tumor) have zero supporting trials or literature and are explicitly annotated in the source rationale as low mechanistic plausibility or likely TxGNN graph noise.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT03840772	Phase 2	Completed	16	Italian Sarcoma Group study (ERASING) evaluating eribulin in advanced Solitary Fibrous Tumor

Literature Evidence

PMID	Year	Type	Journal	Key Findings
38136399	2023	Review	Cancers	Diagnostics and treatment landscape of extrameningeal SFT; discusses chemotherapy including microtubule-targeting agents
28284173	2017	Preclinical (PDX)	Eur J Cancer	Patient-derived SFT xenografts predict sensitivity to doxorubicin/dacarbazine, and highlight eribulin/trabectedin as potentially effective
38423656	2024	Preclinical (in vitro)	Anticancer Research	Recombinant methioninase synergizes with eribulin against fibrosarcoma cells but spares normal fibroblasts
39197933	2024	Preclinical (in vitro)	Anticancer Research	Recombinant methioninase increases eribulin efficacy 16-fold in eribulin-resistant HT1080 fibrosarcoma cells
40295012	2025	Preclinical (in vivo)	In Vivo	Super-eribulin-resistant fibrosarcoma cells become more malignant but are synergistically controlled by eribulin + methionine restriction in mice
39625530	2024	Preclinical (cell line)	Human Cell	Establishment of novel myxofibrosarcoma cell line (SMU-MFS) for future drug testing, including microtubule-targeting agents
34383271	2021	Preclinical (cell line)	Human Cell	Establishment of patient-derived myxofibrosarcoma cell line (NCC-MFS4-C1) as a model for treatment development
35906852	2023	Case report	Genes Chromosomes Cancer	Response to entrectinib (not eribulin) in NTRK-fusion malignant peripheral nerve sheath tumor; included via disease-class linkage, not eribulin-specific — weak relevance

Germany Market Information

Eribulin currently holds no marketing authorization in Germany (0 licenses on file); no product/dosage-form data is available in this evidence pack.

Cytotoxicity

Item	Content
Cytotoxicity Classification	Conventional cytotoxic (microtubule-dynamics inhibitor / anti-mitotic agent)
Myelosuppression Risk	Please refer to the package insert warnings and precautions (no toxicity data in this dataset)
Emetogenicity Classification	Please refer to the package insert warnings and precautions
Monitoring Items	Please refer to the package insert warnings and precautions
Handling Protection	Antineoplastic agent — cytotoxic drug handling precautions apply per institutional protocol

Safety Considerations

Please refer to the package insert for safety information. Key warnings, contraindications, and drug interaction data are not available in this evidence pack (flagged as a Blocking data gap pending TFDA label acquisition).

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: Fibroblastic neoplasm is the only one of 10 TxGNN-predicted indications backed by a completed clinical trial and a consistent body of preclinical literature; however, the trial is small (n=16), non-randomized, and no comparator or survival endpoints are reported in this pack, so evidence remains preliminary (L3).

To proceed, the following is needed:

TFDA/German label data (warnings, contraindications) — currently a Blocking data gap preventing full S1 safety review
Structured MOA data from DrugBank to formally confirm the microtubule-inhibition mechanism
Efficacy/safety results (not just trial registration) from NCT03840772
A larger, ideally randomized trial in SFT/fibrosarcoma to move beyond L3
DDI and contraindication profile before advancing past current review stage
Regulatory/access pathway assessment given eribulin is not currently marketed in Germany
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.