Bevacizumab
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
- Bevacizumab
- Bevacizumab: From Anti-VEGF Oncology Therapy to Cystic Neoplasm (Ovarian/Peritoneal Cancer)
Bevacizumab: From Anti-VEGF Oncology Therapy to Cystic Neoplasm (Ovarian/Peritoneal Cancer)
One-Sentence Summary
Bevacizumab is an anti-VEGF-A monoclonal antibody used across multiple solid tumours in combination with cytotoxic chemotherapy; this Evidence Pack does not record a specific original indication for Norway. Among 10 TxGNN-predicted new indications, Cystic Neoplasm — evidence suggests this maps most closely to low-grade serous ovarian and primary peritoneal carcinoma — is the only candidate reaching actionable evidence strength, supported by 8 clinical trials (including one Phase 3 RCT with n=1052) and 20 publications, including a dedicated systematic review.
Note: Bevacizumab returned 10 TxGNN-predicted indications in this pack. The other 9 (epiglottis neoplasm, benign tongue neoplasm, testicular tumour, etc.) are rated L3–L5 with weak or absent evidence and are not the focus of this report; they are summarised briefly at the end.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (original_indications empty; no Norway licenses on file) |
| Predicted New Indication | Cystic Neoplasm (rank 7/10 by TxGNN score; supporting evidence points to low-grade serous ovarian/peritoneal carcinoma) |
| TxGNN Prediction Score | 99.89% (rank 1565 overall) |
| Evidence Level | L1 |
| Norway Market Status | 未上市 (Not marketed) |
| Number of Authorizations | 0 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in this pack's original_moa field. However, the evidence pack's own repurposing rationale text consistently describes bevacizumab as an anti-VEGF-A monoclonal antibody that blocks tumour angiogenesis — this is corroborated across nearly every one of the 10 predicted-indication entries and is consistent with its established pharmacology.
The original indication cannot be confirmed from this dataset (empty original_indications, no Norway licenses), but the supporting clinical trial evidence for the "Cystic Neoplasm" candidate is drawn almost entirely from ovarian, primary peritoneal, and fallopian tube cancer studies (e.g., NCT00565851, a Phase 3 RCT of carboplatin/paclitaxel ± bevacizumab in platinum-sensitive recurrent ovarian/peritoneal/fallopian tube cancer, n=1052). This strongly suggests the TxGNN label "Cystic Neoplasm" is an imprecise ontology mapping for a cystic/serous ovarian tumour subtype rather than a novel disease area.
Mechanistically this is plausible: VEGF-driven angiogenesis is well documented in epithelial ovarian cancer, and bevacizumab combined with platinum-based chemotherapy is already an established real-world treatment strategy for this tumour family (reflected in the systematic review PMID 37754507 on low-grade serous ovarian cancer). The main caveat is that the disease label itself needs clarification before this can be treated as a clean "new indication" rather than a restatement of known use.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00565851 | Phase 3 | Active, not recruiting | 1052 | Carboplatin/paclitaxel (or gemcitabine) ± bevacizumab, followed by bevacizumab maintenance and secondary cytoreductive surgery, in platinum-sensitive recurrent ovarian, primary peritoneal, and fallopian tube cancer. Grade A relevance — key pivotal-scale RCT. |
| NCT03074513 | Phase 2 | Active, not recruiting | 133 | Atezolizumab + bevacizumab in rare solid tumours, including rare gynecologic tumours. Grade A relevance. |
| NCT00381797 | Phase 2 | Completed | 97 | Bevacizumab + irinotecan in children with recurrent/refractory glioma, medulloblastoma, ependymoma. Grade B — related biology, different population. |
| NCT00023959 | Phase 1 | Completed | 39 | General bevacizumab safety in head & neck cancer with 5-FU/hydroxyurea/RT. Grade C — non-specific. |
| NCT00101348 | Phase 1/2 | Completed | 66 | Erlotinib + cetuximab ± bevacizumab in metastatic renal/colorectal/head & neck/pancreatic/NSCLC. Grade C. |
| NCT00324987 | Phase 3 | Terminated | 12 | Imatinib ± bevacizumab in metastatic/unresectable GIST; terminated, small sample. Grade C. |
| NCT00492089 | Phase 2 | Completed | 11 | Bevacizumab to control brain radiation damage. Grade C — unrelated endpoint. |
| NCT01096381 | N/A | Terminated | 8 | Biomarkers for bevacizumab-induced hypertension; not efficacy-focused, terminated. Grade C. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 37754507 | 2023 | Systematic Review | Current Oncology | Systematic review of bevacizumab in low-grade serous ovarian cancer; supports activity in a chemoresistant subtype. |
| 38328890 | 2024 | Cohort | Future Oncology | Retrospective cohort (n=51): ORR 54.1%, median PFS ~15 months with bevacizumab + chemotherapy in recurrent low-grade serous ovarian cancer. |
| 24978709 | 2014 | Prospective study | Int J Gynecol Cancer | Bevacizumab shows durable activity in low-grade serous ovarian and primary peritoneal cancer. |
| 18165643 | 2008 | Phase 2 Trial | J Clin Oncol | Bevacizumab + low-dose metronomic cyclophosphamide in recurrent ovarian cancer; multicenter consortium trial. |
| 18796376 | 2008 | Cohort | Clin Transl Oncol | Oral cyclophosphamide + bevacizumab in heavily pre-treated ovarian cancer. |
| 40513287 | 2025 | Ancillary study (Phase 3) | Eur J Cancer | PAOLA-1/ENGOT-ov25 ancillary analysis on bevacizumab/olaparib maintenance in HRD+ HGSOC. |
| 32494876 | 2020 | Review | Curr Oncol Rep | First-line management of advanced high-grade serous ovarian cancer; discusses VEGF-targeted therapy role. |
| 27498762 | 2016 | Mechanistic/Biomarker | Scientific Reports | VEGF-dependent gene signature predicts prognosis in mesenchymal ovarian cancer subtype — supports mechanistic rationale. |
| 31989304 | 2020 | Review | Curr Oncol Rep | Review of treatment progress in low-grade serous tumours. |
| 40644648 | 2025 | Trial (RAMP 201) | J Clin Oncol | Avutometinib ± defactinib in recurrent low-grade serous ovarian cancer; contextualises the treatment landscape bevacizumab competes in. |
Norway Market Information
Bevacizumab is currently not marketed in Norway under this dataset — taiwan_regulatory.licenses is empty and total_licenses = 0. No authorization records, product names, or approved indication text are available to populate a licensing table.
Cytotoxicity
Bevacizumab is an antineoplastic agent (anti-VEGF-A monoclonal antibody used across multiple oncology combination regimens documented throughout the evidence pack), so this section applies.
| Item | Content |
|---|---|
| Cytotoxicity Classification | Targeted therapy (anti-angiogenic monoclonal antibody) — not a conventional cytotoxic agent |
| Myelosuppression Risk | Low as monotherapy; myelosuppression seen in the supporting trials is primarily attributable to combination cytotoxic partners (carboplatin, paclitaxel, cyclophosphamide) |
| Emetogenicity Classification | Low (monoclonal antibodies are generally minimally emetogenic) |
| Monitoring Items | Blood pressure, urine protein, wound healing status, bleeding/thromboembolic signs; CBC and renal function when co-administered with cytotoxic chemotherapy |
| Handling Protection | Standard biologic infusion precautions; cytotoxic drug handling regulations apply to combination chemotherapy partners, not to bevacizumab itself |
Safety Considerations
Please refer to the package insert for safety information. This Evidence Pack's key_warnings, contraindications, and DDI fields are all marked as data gaps (DG001, Blocking severity), so no drug-specific warnings can be reported here.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Cystic Neoplasm is the only one of 10 TxGNN-predicted indications reaching L1 evidence, anchored by a Phase 3 RCT (n=1052) and a dedicated systematic review, consistent with bevacizumab's established real-world role in ovarian/peritoneal cancer. However, the disease label itself is ambiguous, the drug is not currently marketed in Norway, and core safety/MOA data are missing (blocking data gaps).
To proceed, the following is needed:
- Resolve the disease ontology mapping — confirm "Cystic Neoplasm" corresponds to low-grade serous ovarian/primary peritoneal carcinoma before treating this as a distinct new indication
- Close DG001 (package insert warnings/contraindications, Blocking) and DG002 (confirmed MOA/DrugBank categories, High) before any S1 safety review
- Assess a Norway market entry/registration pathway, since no local authorization currently exists
- Obtain DDI data (currently
not_found) - The remaining 9 predicted indications (L3–L5, Hold) require additional trial/literature evidence before re-evaluation and are not actionable at this time
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.