Cytarabine
| Evidence Level: L4 | Predicted Indications: 9 |
Table of Contents
- Cytarabine
- Pharmacist Assessment Report
- Cytarabine: From Acute Leukemia to Small Cell Lung Carcinoma
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Cytotoxicity
- Safety Considerations
- Conclusion and Next Steps
- Other Predicted Indications (Reference)
- Disclaimer
Cytarabine: From Acute Leukemia to Small Cell Lung Carcinoma
One-Sentence Summary
Cytarabine is a pyrimidine antimetabolite chemotherapy originally used to treat acute lymphoblastic and acute myeloid leukemia. The TxGNN model predicts it may be effective for small cell lung carcinoma, but this rests on a computational prediction only, with no registered clinical trials and no SCLC-specific publications in the data compiled for this report.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Acute lymphoblastic leukemia and acute myeloid leukemia (including several AML subtypes) |
| Predicted New Indication | Small cell lung carcinoma |
| TxGNN Prediction Score | 0.9978 |
| Evidence Level | L4 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
The original indications are not available from the Indian licence records, which contain no approved-indication text. The predicted indications on this page come from the TxGNN model (deep learning); its scores may reflect similarities the model learned between related diseases, not biological evidence.
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known information, cytarabine is a pyrimidine nucleoside antimetabolite that inhibits DNA synthesis in cells in S phase. Its efficacy in acute leukemia is established, and mechanistically it may be applicable to rapidly proliferating tumors such as small cell lung carcinoma.
The supporting literature is indirect. Most retrieved studies concern non-small cell lung cancer (NSCLC), not SCLC:
- Two 1990 phase II studies tested cytarabine with cisplatin, with or without vindesine, in advanced NSCLC. In the high-dose cytarabine plus cisplatin study (37 patients), the response rate was only 14%, with grade IV myelosuppression in 32%.
- A 1990 randomized phase II trial from CALGB compared cisplatin-cytarabine with cisplatin-vinblastine in 151 NSCLC patients.
- A 1987 report on high-dose cytarabine in small cell lung cancer exists (PMID 3030547), but no abstract or results were available.
Reviews also note that many solid tumors are insensitive to cytarabine. The high TxGNN score reflects a network-based association, not demonstrated activity.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 2156598 | 1990 | Phase II trial | Cancer | High-dose cytarabine + cisplatin in 37 untreated NSCLC patients; response rate 14%, grade IV myelosuppression in 32%, 4 deaths on study |
| 2157307 | 1990 | Phase II trial | Tumori | Cytarabine + cisplatin + vindesine in 32 advanced NSCLC patients; 18% response among evaluable patients |
| 2158614 | 1990 | Randomized phase II | Med Pediatr Oncol | CALGB, 151 NSCLC patients; cisplatin-cytarabine compared with cisplatin-vinblastine |
| 2820740 | 1987 | Pilot study | Eur J Cancer Clin Oncol | Cisplatin + cytarabine combination in advanced NSCLC (no abstract available) |
| 3030547 | 1987 | Study (type not classified) | Cancer Treat Rep | High-dose cytarabine in small cell lung cancer (no abstract available) |
| 1332622 | 1992 | Review | Gan To Kagaku Ryoho | Gemcitabine and DMDC, cytarabine-related antimetabolites; many solid tumors are insensitive to cytarabine |
| 38377785 | 2024 | Phase II | ESMO Open | Intrathecal pemetrexed for leptomeningeal metastases from EGFR+ NSCLC; not a cytarabine study |
| 22836285 | 2012 | Review | Curr Treat Options Oncol | Treatment of leptomeningeal spread of NSCLC |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 12826 | Arasid 500mg Injection (Intas) | Vial, injection | Not stated in records |
| 35861 | Cytosar 100mg Injection (Pfizer) | Vial of 5 ml, injection | Not stated in records |
| 44620 | Cytosar 500mg Injection (Pfizer) | Vial, injection | Not stated in records |
| 39721 | Cytosar 1000mg Injection (Pfizer) | Vial of 10 ml, injection | Not stated in records |
| 40397 | Cytarine 500mg Injection (Fresenius Kabi) | Vial of 5 ml, injection | Not stated in records |
There are 20 valid single-ingredient registrations in total, all injectable forms.
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic (pyrimidine nucleoside antimetabolite) |
| Myelosuppression Risk | High (grade IV myelosuppression in 32% of patients in the high-dose cytarabine + cisplatin NSCLC study) |
| Emetogenicity Classification | Nausea and vomiting were reported as principal non-hematologic toxicities in the NSCLC study; please refer to the package insert |
| Monitoring Items | CBC with differential, liver and renal function |
| Handling Protection | Must follow cytotoxic drug handling regulations |
Safety Considerations
- Contraindication signals (knowledge graph, not label text): kidney disease, liver disease, pancreatitis, gallbladder disease, thrombocytopenia, anemia, leukopenia, neutropenia and related congenital neutropenias, agranulocytosis, peripheral neuropathy, pulmonary edema, diarrheal disease, necrotizing enterocolitis, fungal infections, and hyperuricemia.
- Drug interactions: 365 interactions were recorded. The most notable are naltrexone (Moderate) and levofloxacin (Minor). Most others have no assigned severity, including mannitol, pantoprazole, glimepiride, doxycycline, morphine, metformin, omeprazole, vancomycin, prednisone and simvastatin.
Package insert warnings and contraindications were not available. Please refer to the package insert for authoritative safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a computational score alone. The only clinical data concern NSCLC, with low response rates (14–18%) and substantial myelosuppression, and there are no SCLC-specific trials or results. Evidence is indirect (L4).
To proceed, the following is needed:
- SCLC-specific clinical or preclinical data on cytarabine, including the full results of the 1987 high-dose cytarabine study
- Mechanism of action data
- Package insert warnings and contraindications from the Indian regulatory sources
- A safety and myelosuppression monitoring plan
Other Predicted Indications (Reference)
| Rank | Predicted Indication | TxGNN Score | Evidence Level | Decision |
|---|---|---|---|---|
| 2 | Primary pulmonary lymphoma | 0.9978 | L4 (indirect; evidence from other lymphoma sites such as CNS lymphoma) | Hold |
| 3 | Well-differentiated fetal adenocarcinoma of the lung | 0.9976 | L5 | Hold |
| 4 | Pulmonary blastoma | 0.9976 | L5 | Hold |
| 5 | Upper aerodigestive tract neoplasm | 0.9949 | L5 (indirect) | Hold |
| 6 | Ganglioneuroblastoma | 0.9936 | L5 | Hold |
| 7 | Vertebral anomalies and variable endocrine and T-cell dysfunction | 0.9932 | L5 (likely a network artifact) | Hold |
| 8 | Retroperitoneal neoplasm | 0.9923 | L4 (indirect, mostly case reports) | Hold |
| 9 | Neuroblastoma | 0.9919 | L3 (preclinical cytarabine activity; the three registered trials do not clearly test cytarabine) | Research question |
Among the alternatives, neuroblastoma has the most direct preclinical support, with in vitro cytarabine activity in neuroblastoma cell lines and a priming strategy using cyclopentenyl cytosine.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.