Vinblastine
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Vinblastine: Rhabdomyosarcoma (disease)
One-Sentence Summary
Vinblastine is a vinca alkaloid that disrupts microtubule assembly and causes mitotic arrest in rapidly dividing cells. The TxGNN model predicts it may be effective for rhabdomyosarcoma. Support is limited to case reports and preclinical work (evidence level L4), with no registered clinical trials in the data compiled for this report.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Rhabdomyosarcoma (disease) |
| TxGNN Prediction Score | 0.9986 |
| Evidence Level | L4 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data are not available in the data compiled for this report. Vinblastine is generally known as a vinca alkaloid: it binds tubulin, disrupts microtubule assembly and arrests cells in mitosis. This is plausibly relevant to rhabdomyosarcoma, a highly proliferative paediatric sarcoma.
Vincristine, a related vinca alkaloid, is a standard member of paediatric sarcoma regimens. Vinblastine would therefore be a class-based extension rather than an independently validated option. Preclinical work in human rhabdomyosarcoma xenografts has examined the selectivity of vinca alkaloids, and case reports describe vinblastine as part of combination regimens. The specific contribution of vinblastine cannot be separated from the other agents used.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 38050209 | 2023 | Case report/Review | Medicine | Adult with perineal rhabdomyosarcoma; partial response after nivolumab, dacarbazine, cisplatin and vinblastine, followed by surgical resection |
| 2451411 | 1987 | Case report/Review | Hinyokika Kiyo | Child with refractory prostatic rhabdomyosarcoma; the pelvic mass reduced rapidly with cisplatin, vinblastine and peplomycin |
| 22156656 | 2011 | Pilot study | Oncotarget | Paediatric metronomic 4-drug regimen pilot (regimen-level evidence, not specific to vinblastine) |
| 3329524 | 1987 | Preclinical | Anti-Cancer Drug Design | Human rhabdomyosarcoma xenografts in mice used to examine the therapeutic selectivity of vinca alkaloids |
| 26024389 | 2015 | Preclinical | Cell Death Differ | PLK1 inhibitors and microtubule-destabilising drugs show synthetic lethality in rhabdomyosarcoma models |
| 41216926 | 2026 | Cohort | Pediatr Blood Cancer | CWS-96 and CWS-2002P trials in non-rhabdomyosarcoma soft tissue sarcoma (indirect) |
| 14328283 | 1965 | Review (historical) | Br J Clin Pract | Historical overview of tumour chemotherapy in children |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 4618C | DBL Vinblastine | Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL | Not available in the data compiled for this report |
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic (vinca alkaloid, antimicrotubule agent) |
| Myelosuppression Risk | Please refer to the Product Information (PI) warnings and precautions |
| Emetogenicity Classification | Please refer to the Product Information (PI) warnings and precautions |
| Monitoring Items | Full blood count with differential, liver function; refer to the PI for further items |
| Handling Protection | Must follow cytotoxic drug handling regulations |
Safety Considerations
Label-based warnings and contraindications are not available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for safety information.
- Drug Interactions: 100 interactions were identified in the interaction screen; the first 20 returned are summarised here.
- Major: clarithromycin.
- Moderate: aprepitant, dexamethasone, metronidazole, eliglustat, miconazole, rolapitant, rosuvastatin, simvastatin, tinidazole, glycerol phenylbutyrate, troglitazone.
- Minor: levofloxacin.
- Level not classified: pantoprazole, omeprazole, misoprostol, prednisone, prednisolone, ondansetron, famotidine.
- Related literature signal: one report describes severe ileus with cisplatin and vinblastine infusion in a child with another tumour.
Conclusion and Next Steps
Decision: Hold
Rationale: The evidence for rhabdomyosarcoma is limited to case reports of vinblastine-containing combination regimens (L4), with no registered trials. The effect of vinblastine alone cannot be separated from the other agents, and vincristine is the established vinca alkaloid in paediatric sarcoma regimens.
To proceed, the following is needed:
- Mechanism of action data and TGA Product Information warnings and contraindications for safety screening
- Comparative or prospective clinical data showing a vinblastine-specific contribution in rhabdomyosarcoma
- Confirmation of the approved indication for the Australian product
- A safety and monitoring plan for paediatric and adult use, including neurotoxicity, myelosuppression and interaction management
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.