Platinum
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
Platinum (DB12257): From Undefined Indication to Urinary Bladder Carcinoma
⚠️ Data Quality Notice: DrugBank entry DB12257 is registered simply as “Platinum” — a generic/elemental entry, not a specific prescribable compound (e.g., cisplatin, carboplatin, oxaliplatin each have their own DrugBank IDs).
original_moa,original_indications, and Taiwan market status are all empty or unmarketed. All clinical and literature evidence below was retrieved under this generic label and reflects platinum-based chemotherapy in general, not a verified pharmacological profile of this specific entity. This caveat should be resolved before any downstream decision is finalized.
One-Sentence Summary
Platinum (DB12257) has no recorded original indication or mechanism of action in the source data. The TxGNN model predicts activity against Urinary Bladder Carcinoma, with 50 clinical trials and 20 publications retrieved as supporting evidence — however, this evidence largely reflects the already-established role of platinum-based chemotherapy (e.g., cisplatin/gemcitabine regimens) as standard of care in bladder cancer, rather than a genuinely novel repurposing signal.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded (drug entry has no listed original indications) |
| Predicted New Indication | Urinary Bladder Carcinoma |
| TxGNN Prediction Score | 99.34% |
| Evidence Level | L1 |
| US/Taiwan Market Status | Not Marketed (0 licenses) |
| Number of NDAs | 0 |
| Recommended Decision (algorithmic) | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available for DB12257 (original_moa = data gap). Based on the naming convention and the retrieved evidence, this entry most likely functions as an upper-level/generic label for platinum-class chemotherapy agents, whose established mechanism is DNA cross-linking leading to apoptosis of rapidly dividing cells.
Notably, all top 10 TxGNN predictions for this drug are bladder cancer subtypes (urinary bladder carcinoma, infiltrating bladder urothelial carcinoma, non-invasive bladder urothelial carcinoma, urachal/signet-ring/colonic-type/colloid/mixed/clear-cell adenocarcinoma variants, and urinary bladder neoplasm). This pattern strongly suggests the model is detecting an already well-known clinical association — platinum-based chemotherapy (cisplatin + gemcitabine) is the existing standard-of-care first-line and neoadjuvant/adjuvant regimen for muscle-invasive and metastatic urothelial carcinoma (NCCN/EAU/ESMO guidelines). This is therefore best interpreted as confirmation of established practice rather than a novel repurposing hypothesis, pending clarification of what specific compound DB12257 represents.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT04700124 | Phase 3 | Completed | 808 | KEYNOTE-B15/EV-304: perioperative enfortumab vedotin + pembrolizumab vs. standard neoadjuvant gemcitabine/cisplatin in cisplatin-eligible MIBC |
| NCT00028756 | Phase 3 | Completed | 285 | Immediate vs. deferred adjuvant chemotherapy after radical cystectomy for pT3-pT4/N+ bladder TCC |
| NCT01993979 | Phase 3 | Unknown | 261 | Perioperative platinum-based chemotherapy vs. surveillance in upper tract urothelial cancer (POUT-type design) |
| NCT01089088 | Phase 2 | Completed | 63 | Cisplatin + gemcitabine + sunitinib as first-line therapy for advanced urothelial carcinoma |
| NCT00055601 | Phase 2 | Completed | 97 | Paclitaxel/cisplatin vs. 5-FU/cisplatin with bladder preservation for muscle-invading bladder cancer |
| NCT00003930 | Phase 1/2 | Completed | 84 | Transurethral surgery + taxol/cisplatin + irradiation for stage II-III bladder cancer |
| NCT00714948 | Phase 2 | Terminated | 2 | Gemcitabine + split-dose cisplatin + sorafenib in chemo-naïve advanced urothelial carcinoma |
| NCT02631590 | Phase 2 | Completed | 24 | Copanlisib + gemcitabine + cisplatin in advanced urothelial/cholangiocarcinoma |
| NCT00777491 | Phase 2 | Completed | 70 | Comparison of chemoradiation regimens (5-FU/cisplatin vs. gemcitabine) for muscle-invasive bladder cancer |
| NCT01326871 | Phase 1/2 | Completed | 68 | ALT-801 + cisplatin + gemcitabine in muscle-invasive/metastatic urothelial cancer |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 32145825 | 2020 | RCT (Phase 3) | Lancet | POUT trial: adjuvant platinum-based chemotherapy improves outcomes in upper tract urothelial carcinoma after nephroureterectomy |
| 36967359 | 2023 | Review | European Urology | EAU guidelines update on upper urinary tract urothelial carcinoma |
| 38702396 | 2024 | Review | Nature Reviews Urology | Evolving treatment landscape of metastatic urothelial cancer; cisplatin-based chemotherapy remains first-line SOC |
| 34861372 | 2022 | Review (Guideline) | Annals of Oncology | ESMO Clinical Practice Guideline for bladder cancer diagnosis, treatment and follow-up |
| 40478748 | 2025 | Review | CA: A Cancer Journal for Clinicians | Perioperative considerations in urothelial carcinoma management |
| 37071838 | 2023 | Trial Update (Phase 3) | J Clin Oncol | JAVELIN Bladder 100: avelumab first-line maintenance after platinum chemotherapy |
| 39536751 | 2024 | Cohort/Trial | Cell Reports Medicine | PD-1 blockade + platinum chemotherapy in small cell/neuroendocrine bladder and prostate cancers |
| 38244927 | 2024 | Phase 2 Trial | Annals of Oncology | TROPHY-U-01: sacituzumab govitecan in mUC progressing after platinum chemotherapy and checkpoint inhibitors |
| 40782344 | 2025 | Review | Cancer | Top clinical advances in bladder cancer, including new perioperative and first-line standards |
| 28982752 | 2017 | Review | JNCCN | Urothelial carcinoma of the bladder and the rise of immunotherapy following platinum-based chemotherapy failure |
Cytotoxicity
Included because the predicted indication is oncologic and the evidence base is dominated by platinum-based cytotoxic chemotherapy regimens; however, the exact compound identity behind DB12257 remains unconfirmed.
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic — platinum-class agent (representative of cisplatin/carboplatin/oxaliplatin family; specific compound unconfirmed) |
| Myelosuppression Risk | Moderate–High; typical of platinum agents (carboplatin generally more myelosuppressive than cisplatin) |
| Emetogenicity Classification | High (platinum agents, particularly cisplatin, are classified as highly emetogenic) |
| Monitoring Items | CBC with differential, renal function (creatinine clearance), electrolytes (Mg, K, Ca), audiometry, peripheral neuropathy assessment |
| Handling Protection | Yes — must follow cytotoxic/hazardous drug handling regulations |
Safety Considerations
Please refer to the package insert for safety information. No key warnings, contraindications, or drug interaction data are currently available for this entry (TFDA label data collection is a blocking gap — see Next Steps).
Conclusion and Next Steps
Decision: Hold (Data Quality Review Required)
Rationale: Although the aggregated evidence reaches L1 strength and the algorithmic scoring suggests “Proceed with Guardrails,” this evidence is proxy evidence for platinum-based chemotherapy as a drug class — already the established standard of care in bladder cancer — rather than a confirmed profile of the specific DB12257 “Platinum” entity. A blocking data gap (TFDA warnings/contraindications, DG001) also prevents any safety pre-screening. Proceeding on repurposing logic without first resolving the entity’s identity risks producing a report that misrepresents an already-standard therapy as a novel finding.
To proceed, the following is needed:
- Clarify which specific platinum compound (cisplatin, carboplatin, oxaliplatin, or true elemental platinum) DB12257 is intended to represent
- Obtain TFDA package insert data to resolve DG001 (blocking) before any S1 safety screening
- Obtain mechanism of action data via DrugBank API to resolve DG002
- If DB12257 is confirmed to correspond to a platinum compound already indicated for bladder cancer, reclassify this as “existing standard of care” rather than a repurposing candidate
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.