Eribulin

證據等級: L5

預測適應症: 10 個

Eribulin: From Liposarcoma to Fibroblastic Neoplasm (Solitary Fibrous Tumor)

One-Sentence Summary

Eribulin is a microtubule inhibitor chemotherapy agent, with FDA-approved use in unresectable liposarcoma referenced in the underlying evidence. The TxGNN model generated 10 candidate indications for this drug; among them, Fibroblastic Neoplasm (Solitary Fibrous Tumor) stands out as the only candidate backed by a completed Phase II clinical trial and multiple supporting publications, while 7 of the other 9 candidates (including the model's #1-ranked prediction, "familial Mediterranean fever") have zero clinical or literature support and are flagged by the evidence pack itself as likely model noise.

Quick Overview

Item	Content
Original Indication	Unresectable liposarcoma (soft tissue sarcoma) — noted in evidence pack rationale; no formal indication list was returned for this drug
Predicted New Indication	Fibroblastic Neoplasm (Solitary Fibrous Tumor)
TxGNN Prediction Score	99.36%
Evidence Level	L3 (one completed, single-arm Phase II trial specific to this indication + supportive preclinical literature; not yet a randomized Phase 2/3 trial, so short of L2)
Norway Market Status	✗ Not Marketed
Number of Authorizations	0
Recommended Decision	Proceed with Guardrails

Note on selection: This report evaluates the best-evidenced candidate from the 10 TxGNN predictions supplied, not the top-ranked one. The #1 ranked prediction ("autosomal recessive familial Mediterranean fever," score 99.82%) has no clinical or literature evidence at all, and its own mechanistic rationale explicitly states it is "very likely TxGNN model noise/false positive." Fibroblastic neoplasm (model rank 8, score 99.36%) is the only candidate with a dedicated completed trial.

Why is This Prediction Reasonable?

Currently, detailed mechanism-of-action data for eribulin is not available in this evidence pack (flagged as a High-severity data gap, DG002). Based on the information that is available, eribulin is a microtubule dynamics inhibitor (halichondrin B analog class) used as cytotoxic chemotherapy, with an established, FDA-approved role in unresectable liposarcoma — a soft-tissue sarcoma.

Fibroblastic neoplasms, and specifically Solitary Fibrous Tumor (SFT), belong to the same broad soft-tissue sarcoma family as liposarcoma. Multiple preclinical studies in the evidence pack demonstrate eribulin activity and resistance mechanisms specifically in fibrosarcoma cell lines (e.g., HT1080), and a patient-derived xenograft (PDX) study (PMID 28284173) explicitly identified eribulin and trabectedin as effective candidates against SFT — a finding that appears to have directly motivated the dedicated ERASING Phase II trial (NCT03840772).

This gives fibroblastic neoplasm/SFT a stronger and more mechanistically coherent rationale than most of the other 9 TxGNN predictions in this pack, most of which (mesothelioma subtypes, pleural adenomatoid tumor, familial Mediterranean fever) have no clinical trials, no literature, and mechanistic rationales that acknowledge the connection is speculative.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT03840772	Phase 2	Completed	16	ERASING trial (Italian Sarcoma Group): single-arm Phase II study of eribulin in advanced Solitary Fibrous Tumor

Literature Evidence

PMID	Year	Type	Journal	Key Findings
28284173	2017	Preclinical (PDX)	European Journal of Cancer	Patient-derived SFT xenografts show high sensitivity to doxorubicin/dacarbazine; also highlight eribulin and trabectedin as effective candidates — basis for later clinical testing
38136399	2023	Review	Cancers	Overview of diagnosis and treatment of extrameningeal Solitary Fibrous Tumor
40295012	2025	Preclinical (in vivo)	In Vivo	Eribulin-resistant HT1080 fibrosarcoma cells become more malignant; combination with methionine restriction overcomes resistance in mouse models
39197933	2024	Preclinical (in vitro)	Anticancer Research	Recombinant methioninase increases eribulin efficacy 16-fold in eribulin-resistant HT1080 fibrosarcoma cells
38423656	2024	Preclinical (in vitro)	Anticancer Research	Strong synergy between recombinant methioninase and eribulin against fibrosarcoma cells, sparing normal fibroblasts

Norway Market Information

No marketing authorization records were found for Eribulin in Norway (0 authorizations; market status: not marketed).

Cytotoxicity

Item	Content
Cytotoxicity Classification	Conventional cytotoxic (microtubule inhibitor, halichondrin B analog class)
Myelosuppression Risk	Please refer to the package insert warnings and precautions
Emetogenicity Classification	Please refer to the package insert warnings and precautions
Monitoring Items	Please refer to the package insert warnings and precautions
Handling Protection	Standard cytotoxic drug handling precautions apply, consistent with other antineoplastic chemotherapy agents

Safety Considerations

Please refer to the package insert for safety information. Note: retrieval of TFDA-equivalent label warnings and contraindications for this drug is currently a blocking data gap (DG001) — this must be resolved before any clinical safety assessment (S1 stage) can proceed.

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: Fibroblastic neoplasm/Solitary Fibrous Tumor is supported by a completed, dedicated Phase II trial (ERASING, n=16) and consistent preclinical mechanistic evidence, making it the only credible candidate among the 10 TxGNN predictions supplied. However, the trial is small and single-arm (not randomized), and drug-level safety/label data is entirely missing, so this cannot yet support a full "Go" decision.

To proceed, the following is needed:

Resolve blocking data gap DG001: obtain package insert warnings, contraindications, and DDI data
Resolve data gap DG002: obtain formal mechanism-of-action data from DrugBank
Seek confirmatory or larger-cohort data beyond the 16-patient ERASING trial before considering formal repurposing
Deprioritize (Hold) the 7 low-evidence TxGNN candidates in this pack (mesothelioma subtypes, pleural adenomatoid tumor, familial Mediterranean fever) unless new clinical or literature evidence emerges
Continue monitoring dermatofibrosarcoma protuberans and ovarian myxoid liposarcoma as secondary "Research Question" leads (currently L4, mechanism-only support)
Disclaimer

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