Keywords
biopsy - oral lesions - oral cancer - leukoplakia - erythroplakia - oral potentially
malignant disorder - oral biopsy score
Introduction
Oral potentially malignant disorders (OPMDs) and early oral cancers pose significant
diagnostic and management challenges in clinical practice.[1] Despite increasing awareness about the importance of early detection, a substantial
number of oral cancers are diagnosed at advanced stages, largely due to delays in
detection, referral, and biopsy of suspicious lesions.[2] Presence of factors like tobacco/alcohol/areca nut use, size, duration, location,
and characteristics of lesions pose a higher risk of malignant transformation in oral
cavity cancer, especially in the Indian population.[3] For this critical need, we propose a structured and practical scoring system, the
oral biopsy score (OBS), which aims to assist in clinical decisions regarding when
to biopsy oral lesions. OBS is designed to be a user-friendly, practical tool to help
general practitioners, dentists, and oral medicine specialists quickly recognize which
oral lesions need urgent biopsy and histopathological testing. It is designed taking
into consideration the known clinical signs that suggest a higher risk of malignant
changes, combining with important patient risk factors with morphology of the lesion.
Based on the malignant transformation rates, values have been given to the following
risk factors.
Framework of the Oral Biopsy Score
Framework of the Oral Biopsy Score
The OBS assigns scores based on the following parameters, categorized into three domains,
that is, patient habit, lesion morphology, and duration. Each parameter is scored
as an “upper score” or “lower score,” reflecting the presence or absence of high-risk
factors [Table 1].
-
Tobacco/alcohol/areca nut use (ever user)
Upper: 1 (If the patient has history or is current user of above product)
Lower: 0 (If the patient has no history of any of the above habits)
These substances are International Agency for Research on Cancer (IARC) group 1 carcinogens,
and their chronic use significantly elevates the risk of malignant transformation.[4] A systematic review by Asthana et al showed that smokeless tobacco products had
a significant risk of oral cancer (4.44, 95% confidence interval [CI] = 3.51–5.61).[5] Another meta-analysis by Gandini et al concluded that tobacco smoking also has a
high risk of causing oral cancer (relative risk [RR] = 3.43; 95% CI: 2.37–4.94).[6] Alcohol consumption significantly increases cancer risk in India, with a pooled
odds ratio (OR) of 2.32 (95% CI: 1.50–3.47) in case–control studies and nearly doubles
the risk of oral cavity cancer (OR: 1.92, 95% CI: 1.54–3.96).[7] Also, data from the IARC show that areca nut chewing also has a significantly high
risk of causing oral cancer, independently (pooled adjusted RR, 7.9; 95% CI, 7.1–8.7).[8] According to Global adult tobacco survey 2 (GATS 2),more than 30% of all adult
Indians consume tobacco. Tobacco is IARC approved Group 1 carcinogen. ACC Hence, tobacco,
alcohol, and areca nut usage have been noted and given a score of 1.
-
Size of the lesion
Upper: 1 (> 2 cm)
Lower: 0 (< 2 cm)
Larger lesions, particularly those exceeding 2 cm in diameter, are more likely to
harbor dysplastic or malignant changes. A systematic review by Pimenta-Barros et al
found that larger leukoplakic patches showed higher risk of malignant transformation
(RR = 2.08, 1.45–2.96, p < 0.001).[9] Lesions of size more than 2 cm are more likely to have been there for a while, making
malignant transformation probable. Therefore, the upper score of 1 has been allotted
to larger lesions.
-
Duration of the lesion
Upper: 1 (> 5 years)
Lower: 0 (< 5 years)
Lesions persisting for over 5 years are more likely to have undergone dysplastic changes
without intervention, warranting an upper score of 1. Chronicity is a well-known predictor
of malignant transformation.[9]
-
Site of the lesion
Upper: 1 (Located on the tongue or floor of the mouth for all patients and located
on the bucco-alveolar complex for patients with history of any habit)
Lower: 0 (Located on the bucco-alveolar complex for patients with no history of habit
and any other location for all patients)
High-risk anatomical sites include the lateral tongue, floor of the mouth, and buccal
mucosa-buccal alveolar complex (especially in chronic tobacco/areca nut abusers).[9]
-
Lesion morphology: homogeneity
Upper: 2 (Heterogeneous, includes speckled, nodular, verrucous varieties)
Lower: 0 (Homogeneous)
Nonhomogeneous oral leukoplakia has a higher transformation rate than homogeneous
types. A study from Southern Iran indicated a higher risk of malignant transformation
in nonhomogeneous lesions (OR = 6.26).[10] Moreover, the meta-analysis by Pimenta-Barros et al also showed that heterogeneous
leukoplakia had a higher risk of malignant transformation (RR = 4.23, 95% CI = 3.31–5.39,
p < 0.001; nonhomogeneous: RR = 21.88, 95% CI = 16.44–27.81).[9]
-
Erythroplakia/proliferative verrucous leukoplakia
Upper: 3 (Erythroplakia/proliferative verrucous leukoplakia)
Lower: 0 (Other)
These lesions are considered high-risk for malignant transformation (40–50%). A study
by Wadde et al showed that approximately 40 and 9% cases of oral erythroplakia exhibit
mild and moderate dysplasia, respectively, on the first biopsy.[11]
-
Ulcer with induration/irregular margins
Upper: 3 (Ulcer with induration or irregular margins)
Lower: 0 (Other)
Features such as induration and irregular margins are clinical indicators of malignancy.
-
Nonhealing ulcers
Upper: 3 (Nonhealing ulcer for > 3 weeks)
Lower: 0 (Resolves within 2–3 weeks)
Persistence without resolution is a clinical red flag, as observed by the Pimenta-Barros
et al review.[9]
Scoring and inference
The total score guides clinical decision-making:
Score > 3: Immediate biopsy is recommended. Lesions in this category are considered
high-risk.
Score = 3: A period of two-weekly surveillance is advised after removal of causative
agents. If the lesion does not regress, biopsy is indicated.
Score < 3: Two-monthly surveillance is recommended, with reassessment upon symptom
escalation.
This approach allows for clinical flexibility with a structure based on risk stratification.
Implications for Practice
Implications for Practice
The OBS is not intended to replace clinical judgment but to complement it. It serves
as an adjunctive tool for early detection, helping clinicians in decision-making and
promote standardization, thereby reducing variability between clinicians. Moreover,
it improves record-keeping, communication, and follow-up processes, particularly valuable
in primary care settings where access to specialists may be limited. The strength
of the OBS lies in its simplicity. With appropriate training, it can be widely generalized
to support frontline health care providers. The scoring system is limited by validation
and need real-world data and it also involves interobserver variability but it makes
the diagnosis objective and data-friendly. OBS scoring system is designed for treatment-naive
oral lesion, thus oral submucous fibrosis and any prior history of oral cavity cancers
should be excluded.
Conclusion
The OBS is a novel, practical tool created to assist clinicians in diagnosing OPMD
or malignancy through timely biopsy. By combining well-known risk factors into a simple
scoring system, the OBS makes it easier to detect oral cancer early. It is strongly
recommended to validate the OBS through multicentric prospective studies and real-world
database.
Table 1
Oral biopsy score assessment
|
Upper limit
|
Lower limit
|
|
Tobacco/alcohol/areca nut use
|
1
|
0
|
|
Size > 2 cm (largest diameter)
|
1
|
0
|
|
Duration of lesion (> 5 years)
|
1
|
0
|
|
Located on:
1. Tongue and floor of the mouth (all)
2. Buccal mucosa and bucco-alveolar complex (for abuser)
|
1
|
0
|
|
Heterogeneous/nonhomogeneous (includes speckled, nodular, verrucous)
|
2
|
0
|
|
Erythroplakia/proliferative verrucous leukoplakia
|
3
|
0
|
|
Ulcer with induration/irregular margins
|
3
|
0
|
|
Nonhealing ulcer for more than 3 weeks
|
3
|
0
|
|
Inference
|
|
|
|
Score
|
Decision
|
|
|
> 3
|
Biopsy
|
|
3
|
Two-weekly surveillance (after removal of cause, if any. And if there is no improvement
in 2 weeks, then biopsy)
|
|
< 3
|
Two-monthly surveillance (on follow up, action as per score. Reassess sooner if symptoms
escalate)
|
