Salivary gland cytology report

Milan System for Salivary Gland Cytology — What Your Category Means

If your FNAC report mentions the Milan System, it is using a six-category framework that tells your surgeon how likely the lump is to be cancerous and what to do next. The category number is not a final diagnosis — it is a probability estimate that guides the next decision.

Medically reviewed by Dr. C. Raghavendra Reddy, Medical Oncologist, MBBS (Gold Medal) · DNB · DM (Medical Oncology, Gold Medal) · Last reviewed September 2026

Six categories, not a diagnosis — The Milan System tells your surgeon the likelihood of malignancy, not a confirmed finding.
Each category has a next step — Your category points toward observation, repeat sampling, or surgery — your surgeon explains which.
Sample quality matters — Category I means the sample was inadequate, not that something is definitely wrong with you.
Most salivary lumps are benign — The majority of salivary gland FNACs fall into non-neoplastic or benign neoplasm categories.

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The Milan System groups your salivary gland FNAC result into one of six categories, numbered I to VI. Each category carries a different estimated risk of malignancy and guides whether your surgeon recommends observation, repeat sampling, or an operation. Category VI carries the highest estimated risk; Category II the lowest.

What is the Milan System and why is it on your report?

The Milan System for Reporting Salivary Gland Cytopathology is a standardised framework, published in 2018 by an international working group, that pathologists use to describe fine needle aspiration findings from the parotid, submandibular, and sublingual glands in consistent terms.

Each of its six categories carries an estimated malignancy risk and a management recommendation. It replaced non-standardised descriptive language that varied between laboratories, so surgeons in different hospitals can interpret the same report the same way.

What does each Milan System category mean?

Category I — Non-diagnostic: The sample did not yield enough cells for a reliable assessment. This is a sample quality issue, not a finding about the tumour itself. A repeat FNAC is usually the recommended next step. Malignancy risk cannot be reliably estimated from an inadequate sample.
Category II — Non-neoplastic: The cells look normal or show a benign process — infection, inflammation, a cyst, or reactive gland tissue. No tumour is identified. The estimated malignancy risk in this group is low, as reported in MSRSGC validation studies. Most patients here are monitored rather than offered surgery immediately.
Category III — Atypia of Undetermined Significance (AUS): Some cells look mildly abnormal, but not enough to diagnose a tumour. This is a genuinely uncertain finding, not a default when the pathologist is unsure. Estimated malignancy risk falls in an intermediate range in MSRSGC validation studies published through 2024. Repeat sampling or additional imaging is usually recommended.
Category IVA — Benign neoplasm: A tumour is present and appears benign. Pleomorphic adenoma and Warthin tumour are the most common examples. Estimated malignancy risk is low. Surgery is often recommended because benign salivary tumours grow over time and some carry a small long-term risk of malignant change.
Category IVB — Salivary gland neoplasm of uncertain malignant potential (SUMP): A tumour is present, but cytology alone cannot determine whether it is benign or malignant — some salivary tumours are indistinguishable on needle sampling. MSRSGC validation studies report an intermediate-to-elevated estimated malignancy risk for this group. Surgery is typically recommended so that the full tissue can be examined.
Category V — Suspicious for malignancy: The cells show strong features of malignancy but fall short of the threshold for a definitive call. MSRSGC validation studies published through 2024 report estimated malignancy risk above 60 percent in this group. Surgery is generally planned.
Category VI — Malignant: The cytology meets the accepted criteria for malignancy. MSRSGC validation studies report malignancy confirmed on final surgical pathology in the large majority of Category VI cases. Your team will plan treatment on this basis.

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Dr. Raghavendra Naik

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What should you do after receiving your FNAC report?

Note your Milan System category number before your appointment so you can refer to it.
Ask your surgeon what the category means for your specific situation and what happens next.
Ask whether the next step is observation, a repeat FNAC, imaging, or surgery.
Bring any previous imaging of the same lump — ultrasound, CT, or MRI.
If you are in Category III or IVB, ask whether an MRI has been requested.
Ask your team to explain any words on the report that are not clear to you.

Questions families ask about salivary gland FNAC and the Milan System

Does Category VI definitely mean cancer?

A Category VI result means the cytology meets the accepted criteria for malignancy, and in the large majority of cases this is confirmed when the full surgical specimen is examined. Cytology and final histology do not always match exactly, but your surgeon will proceed on the basis that cancer is present until the tissue says otherwise. This is the correct approach and is not a reason to delay treatment.

Why did the pathologist write Category III instead of a clearer answer?

Atypia of Undetermined Significance is used when the cells are genuinely ambiguous — not when the pathologist is being vague or non-committal. Some salivary gland cells look mildly abnormal for reasons unrelated to cancer, and distinguishing them from early malignancy on needle cytology alone is sometimes not possible. The Milan System created this category so that real uncertainty is communicated honestly rather than forced into a more definitive box that does not fit.

Can I ask for a second opinion on the cytology?

Yes, and for Categories III, IVB, and V in particular, a second opinion from a pathologist with salivary gland experience is a reasonable step. Your team can arrange for the slides to be reviewed at another centre. Tertiary cancer centres with head and neck programmes in India typically have subspecialty pathology expertise. A second opinion does not mean the original report is wrong — it is appropriate when the finding is genuinely uncertain.

My report shows Category IVA but the surgeon wants to operate. Should I be concerned?

Surgery for a benign salivary tumour does not mean the surgeon suspects cancer. Pleomorphic adenoma tends to grow over time and carries a small but real risk of malignant change if left for many years. Removing it while it is clearly benign is often the right decision. Your surgeon will explain the reasoning for your specific situation based on the size and location of the tumour.

What can the FNAC not tell us?

Fine needle aspiration samples only a portion of the tumour. It cannot show whether the tumour has breached its capsule or invaded surrounding tissue — features that are only visible once the full specimen is removed and examined. This is why a Category IVB or V result leads to surgery even when malignancy has not been confirmed. Surgical histology is always the definitive finding.

Did you know?

Salivary gland tumours include more than 20 recognised histological subtypes, many of which look similar on needle cytology regardless of how they behave.

The Milan System was developed partly because this variety made standardised reporting especially difficult outside specialist centres.

Source: Milan System for Reporting Salivary Gland Cytopathology, Springer, 2018

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Common questions

Frequently asked questions

What is the Milan System for salivary gland FNAC?

The Milan System for Reporting Salivary Gland Cytopathology is a standardised six-category framework published in 2018. Pathologists use it to describe FNAC findings consistently across laboratories. Each category carries an estimated malignancy risk and a management recommendation, replacing the varied, non-standardised language that different centres previously used.

Is Category III on a salivary gland FNAC serious?

It should be taken seriously even though it is not a malignancy finding. Validation studies in the MSRSGC literature report an intermediate estimated malignancy risk for this group, meaning a meaningful proportion of patients have cancer confirmed on surgery. Your team will usually recommend a repeat FNAC, additional imaging, or both. Do not read the word 'undetermined' as reassurance that everything is fine.

How accurate is salivary gland FNAC?

FNAC is a useful screening tool but not a definitive test. Accuracy depends on the skill of the person performing it, the quality of the sample, and the experience of the reviewing pathologist. Some salivary tumour subtypes are inherently difficult to characterise on cytology, which is why the Milan System includes a specific category for uncertain findings. Final diagnosis always comes from the surgical specimen.

Will I need surgery for every Milan System category?

Not necessarily. Category II is usually managed with observation. Categories IVB, V, and VI generally lead to surgery. Category I is followed by a repeat FNAC before any further decision. Category IVA usually leads to surgery, depending on size and location. Category III is managed case by case. Your surgeon weighs the cytology result alongside clinical findings and imaging before making a recommendation.

Can the Milan System category change if I have a second FNAC?

Yes, and this is expected. A Category I result may become Category IVA when a better sample is obtained on repeat. A Category III result may clarify or remain indeterminate. This does not mean the first result was wrong — it reflects the limitation of sampling part of a tumour with a needle. A repeat FNAC is recommended when the first result does not give enough information to act on safely.

Is salivary gland FNAC available at CION?

Yes. FNAC for salivary gland lumps is performed at CION centres. If imaging is needed alongside the cytology — such as ultrasound or MRI to assess the extent of the lump — this is coordinated with partner imaging centres. Your treating oncologist and head and neck surgeon will review both results together to plan the next step.

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