Vinorelbine
| Evidence Level: L2 | Predicted Indications: 8 |
Table of Contents
Vinorelbine: Ewing sarcoma
One-Sentence Summary
Vinorelbine is a vinca alkaloid chemotherapy originally used to treat non-small cell lung carcinoma and lung cancer. The TxGNN model predicts it may be effective for Ewing sarcoma, with 3 clinical trials and 6 publications currently supporting this direction. The evidence is mostly from mixed pediatric solid-tumor studies and combination regimens, not from trials dedicated to Ewing sarcoma.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Ewing sarcoma |
| TxGNN Prediction Score | 1.0000 |
| Evidence Level | L2 |
| India Market Status | Listed in a compiled Indian medicine price dataset (13 of 13) – CDSCO approval status is not included in this data |
| Number of Listed Products | 13 (valid: 13) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Vinorelbine is a vinca alkaloid, a class that blocks microtubule polymerization, causing mitotic arrest and cell death in rapidly dividing cells. Its efficacy in lung cancer is established, and mechanistically it may be applicable to Ewing sarcoma, a rapidly dividing malignant bone tumor.
Lung cancer and Ewing sarcoma are very different diseases, but both are malignancies sensitive to antimitotic agents. Preclinical work shows that microtubule-interfering drugs, including vinorelbine, act synergistically with a PLK1 inhibitor in Ewing sarcoma cells. In the clinic, vinorelbine combined with low-dose (metronomic) cyclophosphamide has been studied in children and young adults with relapsed or refractory solid tumors. A 2026 review also discusses vinorelbine plus low-dose cyclophosphamide as maintenance therapy for Ewing sarcoma, as the rationale for the international INTER-EWING-1 trial.
This indication rests on combination regimens in relapsed or refractory disease. Vinorelbine’s benefit as a single agent in Ewing sarcoma is not established.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00180947 | Phase 2 | Unknown | 210 | Vinorelbine plus cyclophosphamide in refractory or relapsed tumors, including Ewing tumors, rhabdomyosarcoma, osteosarcoma, neuroblastoma and medulloblastoma; data may be incomplete |
| NCT00003234 | Phase 2 | Completed | 50 | Vinorelbine in children with recurrent or refractory malignancies; mixed-tumor population |
| NCT06451302 | NA | Active, not recruiting | 100 | Cohort study of risk-stratified treatment in pediatric Ewing sarcoma in China; vinorelbine’s role is unclear |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 22633624 | 2012 | Phase 2 trial | Eur J Cancer | Vinorelbine plus continuous low-dose oral cyclophosphamide in relapsed or refractory pediatric solid tumors; good tolerance, with efficacy noted in rhabdomyosarcoma |
| 12115359 | 2002 | Phase 2 trial | Cancer | Vinorelbine in previously treated advanced childhood sarcomas; activity seen in rhabdomyosarcoma |
| 42561548 | 2026 | Systematic review | Cancer Treat Rev | Rationale for vinorelbine plus low-dose cyclophosphamide as maintenance therapy in Ewing sarcoma (INTER-EWING-1 trial) |
| 37637411 | 2023 | Review | Front Pharmacol | Review of chemotherapy drugs for soft tissue sarcomas |
| 26260582 | 2016 | Preclinical | Int J Cancer | PLK1 inhibitor synergizes with microtubule-interfering drugs, including vinorelbine, in Ewing sarcoma cells |
| 36451163 | 2022 | Case report | BMC Urol | Extraosseous Ewing sarcoma of the kidney; limited relevance to vinorelbine |
India Market Information
The data compiled for this report show 13 valid single-ingredient injectable registrations. No approved-indication text is available for any of them. The main ones are:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 235620 | Vinelbine 50mg Injection | Vial of 5 ml injection | Not listed |
| 155286 | Neoben 50mg Injection | Vial of 5 ml injection | Not listed |
| 152662 | Navelbine 50mg Injection | Vial of 5 ml injection | Not listed |
| 237957 | Vinrel 50mg Injection | Vial of 5 ml injection | Not listed |
| 251847 | Zorelbin 50mg Injection | Vial of 5 ml injection | Not listed |
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic (vinca alkaloid, antimitotic) |
| Myelosuppression Risk | High; neutropenia is the dose-limiting toxicity |
| Emetogenicity Classification | Low to moderate |
| Monitoring Items | CBC with differential, liver and renal function |
| Handling Protection | Must follow cytotoxic drug handling regulations; intravenous use only |
Please also refer to the package insert warnings and precautions.
Safety Considerations
- Contraindication-related conditions (from the knowledge graph, not label text): liver failure, infectious disease, ileus, intestinal obstruction, interstitial lung disease, lung disease, leukopenia.
- Drug Interactions: 465 interactions were identified. Notable examples:
- Major: clarithromycin.
- Moderate: aprepitant, dexamethasone, metronidazole, eliglustat, miconazole, rolapitant, rosuvastatin, simvastatin, tinidazole, glycerol phenylbutyrate.
Please refer to the package insert for label warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Phase 2 data show vinorelbine combined with low-dose cyclophosphamide is tolerable and active in relapsed or refractory pediatric sarcomas. A 2026 review supports it as maintenance therapy in Ewing sarcoma. However, the trials include mixed tumor types, and the clearest efficacy signal is in rhabdomyosarcoma rather than Ewing sarcoma.
To proceed, the following is needed:
- Ewing sarcoma-specific efficacy data, such as results from the INTER-EWING-1 trial
- Package insert warnings and contraindications from Indian regulatory sources
- Detailed mechanism of action data
- A pediatric dosing and myelosuppression monitoring plan
- A review of interaction risks, especially strong CYP3A4 inhibitors such as clarithromycin
Other predicted indications (briefly):
- Small cell lung carcinoma has the most trial and literature volume (L1 by count), but the Phase 3 and adjuvant RCT evidence is in NSCLC, not SCLC. Direct SCLC evidence is limited.
- Pulmonary sulcus neoplasm, lung hilum carcinoma and lung germ cell tumor are research questions only. They largely extend the NSCLC use or draw on indirect evidence.
- Gingival fibromatosis, lung fibroma, lung hamartoma, benign lung neoplasm and pulmonary blastoma are on hold. They are benign or very rare conditions with no supporting efficacy evidence, and cytotoxic toxicity is unlikely to be justified.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.