Oxaliplatin

Evidence Level: L2

Predicted Indications: 4

Oxaliplatin

Pharmacist Assessment Report

Oxaliplatin: From Metastatic Colon Cancer to Malignant Pleural Mesothelioma

One-Sentence Summary

Oxaliplatin is a platinum-based chemotherapy drug, originally used to treat metastatic colon cancer. The TxGNN model predicts it may be effective for malignant pleural mesothelioma, with 3 registered clinical trials (2 directly relevant Phase II studies) and 20 publications currently supporting this direction. The evidence is limited to small, single-arm Phase II studies, with no evidence of superiority over current standard care.

Quick Overview

Item	Content
Original Indication	Metastasis from malignant tumour of colon
Predicted New Indication	Malignant pleural mesothelioma
TxGNN Prediction Score	0.9968
Evidence Level	L2
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

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, oxaliplatin is a platinum agent that forms DNA adducts and crosslinks, which induces apoptosis in rapidly dividing cells. Its efficacy in metastatic colon cancer is established.

Mesothelioma responds modestly to platinum-based chemotherapy (cisplatin or carboplatin is the standard backbone), so oxaliplatin is a mechanistically plausible alternative platinum partner. Phase II data exist for oxaliplatin combined with gemcitabine, raltitrexed, vinorelbine, and bortezomib.

However, the reported activity is modest and comparable to existing platinum regimens. There is no evidence of superiority over standard care (platinum plus pemetrexed, and more recently immune checkpoint combinations). The other predicted mesothelioma-related diseases (epithelioid and sarcomatoid mesothelioma, malignant visceral pleura tumour) have high scores largely because they are close to pleural mesothelioma in the disease ontology, not because of independent evidence.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT00996385	Phase 2	Unknown	29	Bortezomib plus oxaliplatin in previously treated pleural or peritoneal mesothelioma; open-label, small sample
NCT00859469	Phase 2	Completed	29	Oxaliplatin plus gemcitabine as first- or second-line chemotherapy in pleural or peritoneal mesothelioma; single-arm, response rate as primary question
NCT07532902	Phase 1	Recruiting	60	Basket trial of BMS-986504 with standard-of-care therapy in MTAP-deleted solid tumours; oxaliplatin likely only background therapy, so low relevance

Literature Evidence

PMID	Year	Type	Journal	Key Findings
14609447	2003	Phase II	Clin Lung Cancer	Gemcitabine plus oxaliplatin in 25 patients with malignant pleural mesothelioma
12525529	2003	Phase II	J Clin Oncol	Raltitrexed plus oxaliplatin described as an active regimen in 70 patients (15 pretreated, 55 chemotherapy-naive)
15639727	2005	Phase II	Lung Cancer	Vinorelbine plus oxaliplatin as first-line therapy in untreated mesothelioma
11989592	2001	Phase II (pilot)	Tumori	Oxaliplatin plus raltitrexed in inoperable pleural mesothelioma
19091133	2008	Phase II (observational)	J Occup Med Toxicol	Oxaliplatin with or without gemcitabine in patients pretreated with pemetrexed
15893013	2005	Phase II	Lung Cancer	Raltitrexed plus oxaliplatin inactive as second-line therapy: no objective responses in 14 patients
15261443	2004	Review	Lung Cancer	Review of phase II-III chemotherapy trials in pleural mesothelioma
12610498	2003	Review	Br J Cancer	Review of chemotherapy results; response rates above 30% rarely achieved with cytotoxic drugs
31455014	2019	Review	Int J Mol Sci	Effect of cisplatin, oxaliplatin and pemetrexed on immune checkpoint expression, relevant to combining with immunotherapy
25680983	2015	Cohort / case series	Surg Oncol	Cytoreductive surgery plus HIPEC with oxaliplatin in peritoneal mesothelioma (indirect evidence)

India Market Information

Showing 5 of 20 valid registrations (all single-ingredient injectable products). Approved indication text was not available in the data compiled for this report.

Authorization Number	Product Name	Dosage Form	Approved Indication
244700	Xylotin 100mg Injection (Getwell Oncology)	Vial of 50 ml injection	Not listed
249482	Zildox 100mg Injection (Miracalus Pharma)	Vial of powder for injection	Not listed
165036	Oxitoz 50mg Injection (Intas Pharmaceuticals)	Vial of injection	Not listed
79782	Es Oxali 100 Injection (Esperer Bioresearch)	Vial of injection	Not listed
167947	Oxol 100mg Infusion (Venus Remedies)	Bottle of 50 ml infusion	Not listed

Cytotoxicity

Item	Content
Cytotoxicity Classification	Conventional cytotoxic (platinum class)
Myelosuppression Risk	Please refer to the package insert warnings and precautions
Emetogenicity Classification	Please refer to the package insert warnings and precautions
Monitoring Items	CBC with differential, liver and renal function, neurological assessment (peripheral neuropathy)
Handling Protection	Must follow cytotoxic drug handling regulations

Safety Considerations

Disease-level contraindication signals (knowledge graph, not label text): kidney disease, liver disease, gallbladder disease, peripheral nervous system disease and peripheral neuropathy, interstitial lung disease and pulmonary fibrosis (including postinflammatory pulmonary fibrosis), and pyoureter.
Drug Interactions: 631 interactions were recorded. Most of the 20 listed are Moderate (for example famotidine, amphotericin B, loperamide, mesalazine, metronidazole, clarithromycin, vancomycin, levofloxacin, palonosetron). Dolasetron is classed as Major. Several listed items are laxatives and bowel-preparation agents.

Package insert warnings and contraindications for the India-marketed products were not available, so please refer to the package insert for full safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: Only small, single-arm Phase II studies (about 25 to 70 patients each) support oxaliplatin in pleural mesothelioma. Activity is modest, one second-line study showed no objective responses, and there is no evidence of superiority over platinum plus pemetrexed or immune checkpoint combinations. At present this is best treated as a research question rather than a development priority.

To proceed, the following is needed:

Package insert warnings and contraindications for India-marketed products (required for safety screening)
Detailed mechanism of action data
Comparative data against current standard of care (platinum plus pemetrexed, immune checkpoint combinations)
Subtype-specific evidence (epithelioid, sarcomatoid) before any of those predictions are considered, as they currently rest on model inference and indirect peritoneal data
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.