Abstract
Objectives
Due to the importance of clinical impression in accurate final diagnosis of oral pathologic lesions, this study evaluated the agreement rate between clinical and histopathological diagnosis in of oral premalignant (PML) and malignant lesions, over a period of 22 years.
Materials and Methods
In this retrospective and cross-sectional study, 861 cases were reviewed. Patients’ clinical data, type of biopsy, clinical appearance of the lesion, as well as clinical impression and histopathological diagnosis were noted using the archived medical files. Descriptive statistics and Chi-square test were used for analyzing the data.
Results
Overall, the agreement rate between histopathological and clinical diagnoses was 71.9%. This rate was 71.8% in PML and 75.7% in malignant lesions. The highest agreement among all lesions was found in OLP, in the mouth floor and by oral medicine specialists.
Conclusion
The results showed a relatively high agreement rate between clinical and histopathologic diagnosis of PML and malignant lesions. Clinical presentation, site and type of biopsy, as well as clinicians’ specialty were associated with this rate. More education, careful clinical examination, and more cooperation between the surgeon and pathologist are necessary for accurate diagnosis and management.
Keywords: Cancer, Diagnosis, Biopsy, Dysplasia, Oral lichen planus, Concordance
Introduction
Oral mucosal lesions occur in about 30% of the population [1]. Diagnosis of oral lesions should be based on clinical appearance, and radiographic and histopathological features [2].
Oral premalignant lesions (PML) and malignancies are an important part of oral pathology. Early diagnosis and treatment are important to improve the survival rate and quality of life of patients and prevent unnecessary treatments and delays in surgery [3, 4].
PMLs include a wide range of lesions such as leukoplakia and oral lichen planus (OLP) [5]. The possible serious nature of PMLs requires an accurate final diagnosis that must be made both clinically and histopathologically [4]. The most common malignancy in the oral cavity is squamous cell carcinoma (SCC), and other malignant tumors such as lymphoma and salivary gland tumors are rare [6]. SCC is a major health problem in developing countries. [7].
For managing oral lesions, accuracy in clinical impression is important. The accurate diagnosis is related to knowledge about clinical impression, observing the sampling principles and taking a complete history [3, 8].This diagnostic accuracy has been investigated in various studies. Different agreement between clinical and histopathological diagnosis ranged from 50 to 93% in the previous studies [2, 3, 7, 9–14].
Since we have little information about the compatibility of clinical and histopathological diagnoses of PML and malignant lesions, the rate of concordance and, as far as possible, the factors affecting them such as the type of biopsy were evaluated over a 23 years, in the cases referred to oral pathology department in Southern Iran.
Method and Materials
The research was approved by the institutional ethics committee with the code IR.SUMS.DENTAL.REC.1398.115. In this retrospective and cross-sectional study, the histopathological reports of PML and malignant oral lesions from the oral and maxillofacial pathology department at Shiraz University of medical sciences from 1998 to 2020 were reviewed to identify the agreement rate between clinical and histopathological diagnoses.
PMLs included leukoplakia, erythroplakia, OLP, and lichenoid reaction with dysplasia. Malignant lesions included all oral cancers: SCC, verrucous carcinoma, melanoma, basal cell carcinoma, malignant salivary gland tumors, sarcomas, lymphomas, and malignant undifferentiated tumors. The clinical and histopathologic data including the patients’ age and gender, site of the lesion, type of biopsy, clinical appearance of the lesion, clinical impression and histopathological diagnosis, as well as specialty of the clinicians who did the biopsy, were noted using the patients’ medical files. Also, the type of OLP were considered. Reports without clinical impression were excluded. Data were analyzed using SPSS version 26.0 software. Descriptive statistics and Chi-square test were used to analyze the data, and P ≤ 0.05 was considered as statistically significant.
Results
Out of 915 reports, 54 were excluded due to lack of clinical impression. A total of 355 males and 506 females were included in this study. Patients’ baseline data are illustrated in Table 1. The type of OLP was noted in 119 cases. Forty-one cases (34.45%) were plaque-type, 29 cases (24.37%) were ulcerative, 25 cases (21.01%) were erosive, 17 cases (14.29%) were bullous, and seven cases (5.88%) showed reticular type. In the group of lichenoid reaction with dysplasia, 85% showed mild and 15% moderate dysplasia.
Table 1.
Baseline data of the patients
| Groups | Diagnosis | Prevalence N (%) | Age (Mean ± SD) |
Common decade | Gender (M:F) |
|---|---|---|---|---|---|
| Leukoplakia | 211 (12.41) | 51.14 ± 15.37 | 6th | 68: 86 | |
| Premalignant | OLP | 319 (34.74) | 46.80 ± 13.63 | 5th | 100: 219 |
| LR with Dysplasia | 56 (6.1) | 52.74 ± 14.78 | 7th | 17: 39 | |
| Erythroplakia | 11 (1.19) | 54.09 ± 12.04 | 6th | 3: 8 | |
| Sarcoma | 34 (3.7) | 35.34 ± 20.07 | 3rd | 11: 6 | |
| SCC | 191 (20.8) | 57.13 ± 14.76 | 7th | 102: 89 | |
| SGT | 29 (3.15) | 41.57 ± 17.59 | 3,4,6th | 9: 20 | |
| Malignant | Verrucous C | 13 (1.41) | 64.38 ± 14.21 | 6th | 6: 7 |
| Melanoma | 4 (0.43) | 42.50 ± 14.45 | 6th | 1: 1 | |
| Undiff. Tumor | 42 (4.57) | 48.07 ± 19.57 | 6th | 4: 3 | |
| BCC | 5 (0.54) | 53.60 ± 16.86 | 5th, 7th | 4: 1 |
OLP Oral lichen planus; LR Lichenoid reaction; SCC Squamous cell carcinoma; SGT Salivary gland tumor; C Carcinoma; Undiff Undifferentiated; BCC Basal cell carcinoma
Out of 861 patients, in 28.10% cases, histopathological diagnosis was not consistent with the clinical diagnosis. In 58.65% cases, the final diagnosis was consistent with the first clinical impression; in 11.3% cases, histopathological diagnosis was consistent with the following clinical impressions; and in 2.2% cases, the surgeons noted the histopathologic group of the lesion without any definitive diagnosis. Details for each lesion are shown in Table 2.
Table 2.
frequency of agreement rates between clinical and histopathological diagnoses
| Lesions | Agreement N (%) | Total | ||||
|---|---|---|---|---|---|---|
| No | First CI* | Following CI | Group of the lesion | |||
| Leukoplakia | 98 (49) | 68(34) | 34 (17) | (0%)0 | 200 | |
| OLP | 23 (7.32) | 263 (83.75) | 28 (12.10) | 0 (0) | 314 | |
| Sarcoma | 18 (60) | 11 (36.66) | 1 (3.33) | 0 (0) | 30 | |
| SCC | 18 (10.28) | 128 (73.14) | 26 (14.85) | 3 (1.71) | 175 | |
| Salivary gland tumor | 13 (50) | 4 (15.38) | 0 (0) | 9 (34.61) | 26 | |
| Verrucous carcinoma | 5 (41.66) | 5 (41.66) | 2 (16.66) | 0 (0) | 12 | |
| Melanoma | 1 (33.33) | 1 (33.33) | 1 (33.33) | 0 (0) | 3 | |
| Lichenoid reaction with dysplasia | 36 (65.45) | 13 (23.63) | 3 (5.45) | 3 (5.45) | 55 | |
| Undifferentiated malignant tumor | 6 (66.66) | 3 (33.33) | 0 (0) | 0 (0) | 9 | |
| Erythroplakia | 22 (66.66) | 7 (21.21) | 0 (0) | 4 (12.12) | 33 | |
| BCC | 2 (50) | 2 (50) | 0 (0) | 0 (0) | 4 | |
| Total | 242 (28.10) | 505 (58.65) | 95 (11.03) | 19 (2.2) | 861 | |
* CI clinical impression
Overall agreement rate between histopathological and clinical diagnosis was 71.89%. This rate was 71.79% in premalignant lesions, and 75.67% in malignant lesions. The highest agreement was found in OLP patients (92.67%) and the lowest in erythroplakia and undifferentiated malignant tumors (33.33%). The highest agreement in malignant lesions was found in SCC (89.71%) (Table 2, Fig. 1). Also, agreement between histopathological and clinical diagnosis was 72.95% in males, and 71.14% in females.
Fig. 1.
Frequency of general agreement rates between clinical and histopathological diagnoses
Out of 861 reports, 740 cases reported the clinical appearance of the lesion. Details are illustrated in Table 3.
Table 3.
Frequency of agreement rates between clinical and histopathological diagnosis based on clinical presentation
| Presentation | No | Yes | Total |
|---|---|---|---|
| White | 67 (28.78) | 165 (71.12) | 232 |
| Red | 6 (35.29) | 11 (64.7) | 17 |
| Red and white | 32 (13.79) | 200 (86.20) | 232 |
| Mass | 53 (36.55) | 92 (63.44) | 145 |
| Ulcer | 28 (30.1) | 65 (69.89) | 93 |
| verrucous | 9 (42.85) | 12 (57.14) | 21 |
| Total | (26.35%)195 | (73.64%)545 | 740 |
Buccal mucosa was the most common location of biopsies (33.21%). Figure 2 shows the details of biopsy location. The highest agreement between histopathological and clinical diagnosis was found in the floor of mouth (81.81%) and the lowest agreement in the mandible (41.66%).
Fig. 2.
Frequency of agreement rates between clinical and histopathological diagnoses based on location of the lesions
In the 36 reports, the patients’ age was not mentioned. Patients’ age and agreement rate of diagnoses are shown in Fig. 3. The highest agreement between histopathological and clinical diagnosis was found in the fourth decade of age (77.37%) and the lowest in the second decade of age (50%). Due to the limited number of cases in the tenth decade of age, these cases were not considered in the comparison.
Fig. 3.
Frequency of agreement rates between clinical and histopathological diagnosis based on the age
The type of biopsy was not noted in 227 cases. In others, 495 biopsies were incisional (78.07%) and 139 excisional (21.92%) (Table 4). The agreement between histopathological and clinical diagnosis was more in incisional biopsies (75.95%) in comparison with 65.46% in excisional biopsies.
Table 4.
Percentage of the incisional and excisional biopsies in the lesions
| Incisional | Excisional | Total | ||
|---|---|---|---|---|
| Leukoplakia | 96 (61.93) | 59 (38.06) | 155 | |
| OLP | 183 (83.6) | 36 (16.4) | 219 | |
| Sarcoma | 14 (77.8) | 4 (22.2) | 18 | |
| SCC | 131 (84.5) | 24 (15.5) | 155 | |
| Salivary gland tumor | 12 (80.0) | 3 (20.0) | 15 | |
| Verrucous carcinoma | 10 (83.3) | 2 (16.7) | 12 | |
| Melanoma | 3 (75.0) | 1 (25.0) | 4 | |
| Lichenoid reaction with dysplasia | 36 (78.3) | 10 (21.7) | 46 | |
| Undifferentiated malignant tumor | 6 (66.7) | 3 (33.3) | 9 | |
| Erythroplakia | 33 (84.6) | 6 (15.4) | 39 | |
| BCC | 0 (0.0%) | 1 (100.0) | 1 | |
| Total | 524 (77.86) | 149 (22.13) | 673 | |
Most of the cases were diagnosed by oral medicine specialists (67.36%), followed by oral and maxillofacial surgeons (31.12%) and periodontists (1.5%). Oral medicine specialists had the highest agreement between histopathological and clinical diagnosis in their cases (76.89%), followed by oral and maxillofacial surgeons (61.94%) and periodontitis (53.84%). The most common lesion biopsied by oral and maxillofacial surgeons was SCC, and that biopsied by other specialists was OLP.
Chi-square analysis revealed that the association of the agreement between clinical and histopathological diagnosis and clinical appearance (PV = 0.000), site of lesions (PV = 0.00), biopsy type (PV = 0.01), and clinicians’ specialty (PV = 0.00) was statistically significant. However, this rate was not related to different patients’ gender (PV = 0.70) and age (PV = 0.28).
Discussion
The serious nature of potentially malignant oral lesions (PMOL) and oral cancer requires a precise clinical examination and a definitive final diagnosis that must be made according to both clinical and histopathological data. The present study evaluated the agreement rate between clinical and histopathological diagnosis. In this study, the overall agreement rate was 71.89%. This rate ranged from 50 to 93.3% [2, 3, 7, 9–14] in the studies analyzing all oral lesions. In general, the process of clinical diagnosis of different lesions can vary according to their nature [9]. The difference in the rates of agreement can be explained by the difference in the surgeons’ and pathologists’ skills, the sampling method, manner of transfer to the laboratory, fit cut of the sample, and the cooperation between the surgeon and pathologist [8]. The other reasons for the difference can be attributed to different categories of oral lesions used in the studies, different sample size, and different evaluation criteria, differences in study periods, and study population. [2, 13, 15]. In the present study, flexible criteria were used to evaluate the accuracy of clinical diagnosis [1]. This can increase the degree of concordance. Also, the study was done in a specialized center for diagnosis and management of orofacial lesions, which made clinical diagnosis easier.
Some cases were excluded due to the lack of clinical impression, and this lack of data limits the research and affects the results. Also smoking, alcohol consumption and UV radiation, as the risk factors, were not recorded in many cases [1, 16].
Oral lesions have certain clinical features, but similarities in clinical appearance, lack of precise definition of these appearances, and different presentation in different patients complicate the clinical diagnosis. Also, some lesions are not included in the surgeons’ diagnosis due to their low prevalence and rarity, and this can reduce the accuracy of diagnosis [1, 9, 10, 13, 14].
According to our results, the agreement rate between histopathological and clinical diagnosis in premalignant lesions was 71.79%. Mendez and Curra reported a high degree of concordance in PMD in evaluation of 132 and 22 cases, respectively. Curra et al. showed 97.4% accuracy of clinical diagnoses for identifying the lip lesions [1, 16]. Bokor-Bratiæ (82.4%) and also Tatli et al.’s studies (93.1%) showed higher agreement rates [14, 17]. The present study was a 22-year study, and clinical data were collected by different specialists in different periods. Over the years, many changes have been made in the diagnostic sciences regarding the diagnosis of lesions [16]. This can cause the lower agreement compared to some studies.
One common lesion in this study was OLP. In our study, the highest agreement in premalignant lesions was found in OLP (92.67%). The highest percentage of mismatch was also found in the lichenoid reaction (53.3%). One study showed 86.3% clinico-pathological agreement in OLP [13]. In Enomoto’s study, agreement between the clinical and histopathological diagnoses of OLP was 65.1% that was the lowest concordance between these studies [18]. It is known that white soft tissue lesions with negative Nikolsky sign are difficult to diagnose [14]. Usually, biopsy is not performed in the typical cases of OLP. Since the histopathological diagnosis of OLP requires sufficient tissue, limited tissue sampling can increase the disagreement between clinical and histopathological diagnosis [18]. The lack of diagnostic criteria in clinical and pathological levels in differentiation of OLP from oral lichenoid reaction might be a reason for disagreement between the clinico-pathological diagnosis of OLP [13]. Accurate diagnosis of OLP and lichenoid lesions needs the pathologist’s awareness about clinical information including multiple-site involvement and location of lesions, history of patients’ medications, etc. Not reporting this information may cause misdiagnosis.
In our study, the agreement rate between histopathological and clinical diagnosis of malignant lesions was 75.67%. The most accurate diagnosis was made in SCC lesions (89.7%). Tatli et al. [14] and also Shiva et al. [12] reported this rate in malignant lesions about 91%, and 75%, respectively. SCC was clinically diagnosed in 74.4% of the cases in Gambino et al.’s study [19], and 36.3% in one study in Iran [13]. OSCC is usually diagnosed at an advanced stage that clearly shows the clinical features of the malignancy, thus reducing the difficulty of diagnosis. Therefore, a high concordance would be expected [1]. However, other rare malignant tumors might show similar presentations which lead to a more complicated clinical diagnosis.
The most common clinical appearance and also the highest agreement rate were found in red and white lesions. The high prevalence of these lesions such as OLP makes it easier to diagnose by the surgeon. The lowest agreement was reported in verrucous lesions that are rare in the oral cavity. The verrucous lesions are challenging both clinically and histopathologically and require an appropriate clinico-pathologic correlation.
The highest agreement rate of diagnoses was found in the floor of the mouth, followed by the buccal mucosa and lateral border of the tongue. That might be due to the high number of OLP and SCC cases in these locations. The lowest agreement was found in the mandible. As it was mentioned earlier, it was more difficult for surgeons to diagnose malignant mesenchymal lesions, which were more frequent in that location. Another study reported a similar finding about low accuracy rate of clinical diagnosis in mandibular lesions [14].
The agreement rate of diagnoses was 75.9% in incisional biopsies and 65.5% in excisional biopsies. Similarly, another study reported 90% concordance for incisional biopsy and 71.3% concordance for excisional biopsy [20]. However, Chen et al.’ s study showed 88.9% concordance for incisional oral biopsy diagnoses in the intraosseous, mucosal and salivary gland lesions [21]. Failure to perform an appropriate biopsy may lead to misdiagnosis of pathologic lesions, resulting in the lesion progression [22, 23]. The type of biopsy was not recorded in a high number of reports. Problems in interpreting the samples and presenting descriptive or inconclusive pathologic reports can be due to incomplete reports. These reports were excluded, and this may cause the higher agreement rate in cases who have undergone incisional biopsies in comparison with excised lesions. Moreover, the final diagnosis may change after complete excision of some incomplete biopsied specimens [20].
Oral medicine specialists had the highest concordance index in their cases in comparison with oral and maxillofacial surgeons, and periodontists. This finding can be attributed to the type of investigated lesions, which are referred to oral medicine specialists who are specialized in diagnosis of lesions. A study in Nigeria reported the same result [15]. Two studies in the north of Iran stated different results and showed the highest coefficient agreement with pathology results in maxillofacial surgeons in diagnosis of all oral lesions [12, 13]. A study in America showed 61% clinically matched histologic diagnosis by oral surgeons [24]. These findings indicate that all surgeons must be trained and improve their diagnostic skills about oral pathologic lesions, especially premalignant and malignant lesions. Inappropriate clinical impression can delay or interfere with the final diagnosis and, consequently, impact the outcome and prognosis of the disease. It is important to emphasize that both clinical and pathological findings lead to an accurate final diagnosis. [1, 23].
Conclusion
The results showed a relatively high agreement between clinical and histopathologic diagnoses of oral malignant and premalignant lesions. More attention and education, careful clinical examination, and more cooperation between the surgeon and pathologist are necessary for correct diagnosis and treatment. Also, an appropriate and adequate biopsy specimen improves the agreement. Further studies conducting prospective studies involving diverse populations, and standardizing the research methods and protocols for collecting the samples are suggested.
Acknowledgements
The authors thank the Vice-Chancellery of Shiraz University of Medical Sciences for supporting this research (Grant 98-01-03-20389). This manuscript is based on the thesis of Rojin Khaksar as partial fulfillment of DDS degree. The authors would like to thank Dr. Shokrpour at the Research Consultation Center (RCC) of Shiraz University of Medical Sciences for her invaluable assistant in editing this article.
Author Contribution
Not applicable.
Funding
This research program was funded by the Vice-Chancellery of Shiraz University of Medical Sciences for supporting this research (Grant 20389).
Availability of Data and Materials
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Code Availability
Not applicable.
Declarations
Conflicts of interest
The author declares no conflict of interest.
Consent to Participate
Not applicable.
Consent for Publication
All authors agree.
Ethics Approval
The research plan of this study was approved by the institutional ethics committee with the code IR.SUMS.DENTAL.REC.1398.115.
Human Participants or Animals rights
Human Participants and Animals were not involved in the research.
Footnotes
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