|Ahead of print publication
Single step “See and Treat” strategy might be replacing the “conventional three step strategy” in management of preinvasive cervical lesions at tertiary center: A North Indian study
Rekha Sachan1, Ayushi Shukla1, Munna Lal Patel2, Pushplata Sachan3, Manjulata Verma1, Uma Singh1
1 Department of Obstetrics and Gynaecology, King George Medical University, Lucknow, Uttar Pradesh, India
2 Department of Medicine, King George Medical University, Lucknow, Uttar Pradesh, India
3 Department of Physiology, Career Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
|Date of Submission||10-Jul-2020|
|Date of Decision||29-Aug-2020|
|Date of Acceptance||30-Sep-2020|
|Date of Web Publication||18-Aug-2021|
Department of Obstetrics and Gynaecology, King George Medical University, C-28, Sec-J Aliganj, Lucknow - 226 024, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Introduction: The aim of this study was to compare overtreatment rates of see and treat colposcopy-based single step protocol with cytology and colposcopy-guided biopsy-based conventional three-step protocol using loop electrosurgical excision procedure (LEEP) for treatment of preinvasive lesions of cervix.
Materials and Methods: Prospective interventional study was carried out over a period of 1 year. Recruitment of cases was done from the 664 diagnostic colposcopies performed for various gynecological indications. Among 496 colposcopies performed exclusively for unhealthy cervix on per speculum examination, 74 women had high-grade colposcopy (Swede score ≥5). Subsequently, 50 women were enrolled under the see and treat arm, arm 1 and underwent LEEP. In study arm 2, conventional three-step strategy, concurrently 22 women with abnormal cytology. ≥ Atypical squamous cells of undetermined significance and unhealthy cervix were enrolled for colposcopy and if indicated, guided biopsy was obtained and tissue was sent for histopathology. Only 12 such women having HPE reports of cervical intraepithelial neoplasia (CIN) 2 or 3 were subjected to LEEP. Overtreatment was defined as CIN 1 or less on final LEEP tissue histopathology.
Results: The overtreatment rate in See and Treat protocol was 44% when colposcopy Swede score cutoff was considered 5, which fell down to 0% when Swede score cutoff was taken 7. Conventional three step protocol had an overtreatment rate of 8.3%. Incidentally diagnosed high-grade CIN or invasive cancer was found in 24%. Discrepancy between biopsy tissue and LEEP tissue histopathology was 50% in conventional arm.
Conclusion: Women with unhealthy cervix having high-grade colposcopy (Swede score ≥7) can be directly subjected to LEEP without waiting for results of any initial screening modality. Advantages include minimal over treatment coupled with reduced patient visits and interventions.
Keywords: Cervical cancer, cervical intraepithelial neoplasia, loop electrosurgical excision procedure, “See-and-Treat”
|How to cite this URL:|
Sachan R, Shukla A, Patel ML, Sachan P, Verma M, Singh U. Single step “See and Treat” strategy might be replacing the “conventional three step strategy” in management of preinvasive cervical lesions at tertiary center: A North Indian study. J Can Res Ther [Epub ahead of print] [cited 2022 Jul 1]. Available from: https://www.cancerjournal.net/preprintarticle.asp?id=324039
| > Introduction|| |
Cervical cancer is the second leading cause of new cancer cases and cancer-related deaths among women in India. It is one of the few preventable cancers and the only preventable female genital cancer. Screening has decreased the incidence of cervical cancer in the past few decades mainly in developed countries., Cervical intraepithelial neoplasia (CIN) is a premalignant lesion that can exist in any one of the three stages: CIN1, CIN2, or CIN3.
In developing country like India, women have limited access to health-care system and are mostly nonadherent with multistep approaches for diagnosis and treatment of CIN. To minimize the burden of cancer cervix, early detection and proper treatment of precancerous lesions is very important. Thus, one step management approach “See-and-Treat” loop electrosurgical excision procedure (LEEP) for precancerous cervical lesions provides screening and treatment simultaneously in the same visit., It involves excision of cervical transformation zone and enables simultaneous histopathological diagnosis and treatment of cervical precancerous lesions, thus eliminating the need for a cervical punch biopsy and an additional visit. Various advantages of this strategy include simultaneous treatment, reduction of outpatient department (OPD) visits, and hospital burden along with improved histopathological diagnosis due to large size of tissue specimen removed by LEEP. Mostly studies have reported the concept of See and Treat based on women referred for colposcopy with the reports of high-grade squamous intraepithelial lesion (HSIL) on cytology. This strategy minimizes the possibility of overtreatment, but limitations are low sensitivity of cytology and need of more follow-up visit. Hence, the need for modification in concept of see and treat approach.,
Over treatment in See and Treat protocol has been defined as the percentage of women undergoing treatment without the presence of a high-grade lesion., Large majority of studies included CIN 1 histology when defining over treatment since it has high spontaneous regression rate. Both American society and British society for colposcopy and cervical pathology define over treatment rate as the proportion of women whose excised specimens contains CIN1 or less.
Hence, this study was planned to compare between see and treat colposcopy-based single step protocol and cytology-based conventional three-step treatment protocol using LEEP to assess effectiveness and overtreatment rates of both protocol.
| > Materials and Methods|| |
This prospective comparative interventional study was carried out over a period of 1 year from September 2018 to September 2019. Two strategies were followed first one colposcopy-based see and treat strategy labeled as Arm 1 and another one was conventional three-step strategy (cytology followed by colposcopy and after biopsy, LEEP) were labeled as arm 2. Both of these strategies were compared in terms of over treatment rate and effectiveness of the treatment. After informed consent and ethical clearance from the institutional ethics committee (ref code 90th ECM II B–Thesis/p40), recruitment of cases was done from women having unhealthy cervix presenting with symptoms including, vaginal discharge, postcoital bleeding, postmenopausal bleeding, and menstrual abnormalities or referred to gynecology OPD with abnormal cytology reports for colposcopy. Colposcopy was performed after application of 3% acetic acid on cervix. The colposcopic scoring was made depending on visualization of transformation zone of cervix, density of acetowhite area, sharpness of margins, and distribution pattern of underlying vessels.
LEEP was carried out using intracervical 1% xylocain infiltration as local anesthetic. No routine prophylactic antibiotics were given to the patients. Postoperative advice was given to avoid sexual intercourse and vaginal douching for 6 weeks after LEEP. Intraoperative hemorrhage was defined as a complication when it required vaginal packing and cervical suturing to achieve adequate hemostasis.
The recruitment of cases was done from the 664 diagnostic colposcopies performed for various gynecological indications at our department over the period of 1 year. Out of 496 colposcopies performed for unhealthy cervix, only 74 had high-grade colposcopy (Swede score ≥ 5). Out of these 74 women, fifty were enrolled in Arm 1 (See and Treat) because twenty women were not willing to participate in our study. Four women had colposcopy findings suggestive of frank malignancy were excluded from the study. Out of these twenty women, 16 women underwent hysterectomy because ten women had associated fibroid and six women not willing for conservative treatment and four women were loss to follow-up.
For conventional three step strategy, concurrently, 22 women recruited from OPD with abnormal cytology reports were examined. Only those women with abnormal cytology who also had unhealthy cervix on perspeculum examination underwent colposcopy-guided biopsy and tissue was sent for histopathology. Only 12 such women with biopsy tissues report of CIN 2 or 3 were subjected for LEEP.
Thus, total 62 women were enrolled for this study. Of these in Arm 1 (See and Treat), 50 women with unhealthy cervix having high-grade Swede score (≥5) on colposcopy underwent LEEP directly and tissue was sent for histopathological examination. Cytology in these women was obtained during colposcopy and analyzed retrospectively. In Arm 2 (conventional three step strategy), 12 women whose initial cytology was high grade and colposcopy score high grade and biopsy reports were CIN II or III, these were underwent LEEP procedure in this arm and finally analyzed.
Exclusion criteria for this study were women not willing to participate, pregnant females, visible growth on cervix or acute PID, type 2 or 3 transformation zone on colposcopy, immunocompromised women, or who had previously undergone any treatment for CIN or other malignancy were excluded from the study. In the present study, over treatment was defined as LEEP tissue histopathology report of ≤CIN 1.
Statistical analysis was done using Statistical Package for the Social Sciences version 21.0 statistical analysis software (SPSS, Inc., Chicago, IL, USA). The values were represented in number (%) and mean ± SD. Comparison between the groups was evaluated by Chi-square test, and P < 0.05 was considered to be statistically significant. In addition, the final histological results were divided into two groups: (1). Overtreatment group (final histology ≤CIN 1) and (2) correct treatment group (final histology ≥ CIN2), and the rate of agreement between the initial and final diagnosis in the see-and-treat and three-step group was compared.
| > Results|| |
During this study period, 62 women underwent LEEP either having CIN2 or 3 on Histopathological examination (HPE) after abnormal cytology, or high-grade colposcopy score, and after confirmation of LEEP tissue histopathology, final analysis was done.
Mean age of women was 42.68 ± 11.69 years, ranged from 25 to 66 years. Mean age at consummation of marriage was 20.94 ± 3.21 years. Most of the women were of parity 3–5 and maximum females (66.7%) with high-grade cytology were of more than 45 years of age.
In See and Treat arm 1, high-grade cytology, atypical squamous cells cannot exclude HSIL (ASC-H) and HSIL was found in 26% (n = 13), 18% (n = 9) had atypical squamous cells of undetermined significance (ASCUS), 16% (n = 8) had negative for intraepithelial lesion or malignancy (NILM), and 24% (n = 12) had low-grade intraepithelial lesion (LSIL) on cytology. Reactive cellular changes were observed in 8% of patients (n = 4), while 8% cytology (n = 4) reports had reports of inadequate smears.
In conventional strategy arm 2, 25% cytology reports (n = 3) showed ASCUS, while 25% (n = 3) had LSIL. High-grade cytology (ASC-H and HSIL) was present in remaining 50% (n = 6) of patients [Table 1].
|Table 1: Distribution of cytological abnormalities in patients who underwent loop electrosurgical excision procedure in see and treat (Arm 1) and three step conventional strategy (Arm 2)|
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Final LEEP tissue histopathology reported as per the WHO classification system. In study arm 1, 30% (n = 15) of patients who underwent LEEP for high-grade colposcopy had final HPE report of chronic cervicitis. While CIN1 was found in 14% (n = 7), 14% (n = 7) LEEP HPE reports showed CIN2, and 38% (n = 19) showed CIN3. 4% (n = 2) of patients were found as a case of squamous cell carcinoma (SCC) of cervix after LEEP tissue HPE reports.
In conventional arm 2, final diagnosis was made after LEEP tissue histopathology, only 8.3% (n = 1) had CIN1, while 41.7% (n = 5) had CIN2, 8.3% (n = 1) had CIN3, and 41.7% (n = 5) were upgraded to SCC after LEEP tissue histology report [Table 2].
|Table 2: Distribution of histopathological examination of tissue in patients who underwent loop electrosurgical excision procedure in see and treat (Arm 1) and three step conventional strategy (Arm 2)|
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In Study arm 1, on retrospective analysis of cytology reports with HPE, all high-grade cytology reports (ASC-H and HSIL) had final HPE reports of CIN2 or above, thereby justifying the See and Treat strategy on high-grade cytology and on high score colposcopy. Eight patients in study arm 1 had NILM (No Infective Lesion or Malignancy) on cytology although colposcopy findings were suggestive of CIN2. Among this group, 87.5% (n = 7) were over treated, final HPE report being CIN1 or chronic cervicitis. However, 12.5% (n = 1) of patients in NILM group had HPE report of CIN2. Such patient would have been missed in the conventional strategy. Among low-grade cytology abnormalities, 55.5% (n = 5) of patients with ASCUS and 41.6% (n = 5) with LSIL were over treated in study arm. 50% (n = 2) patients with Reactive Cellular Changes on cytology showed final HPE report of CIN3, thereby justifying study arm protocol retrospectively. Similarly, 25% (n = 1) of patients with inadequate smear had high-grade disease on HPE [Table 3].
|Table 3: Comparison of loop electrosurgical excision procedure histopathological examination of tissue with initial cytology (Pap/LBC) in see and treat (Arm 1) versus three step conventional strategy (Arm 2)|
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In Conventional arm 2, all patients with high-grade cytology (ASC-H and HSIL) had a final HPE report of CIN2 or worse. Nearly 33.3% (n = 1) of patients with ASCUS, who initially had a biopsy report of CIN2 was downgraded to CIN1 on LEEP tissue HPE. 66.7% (n = 2) patients with ASCUS and 100% (n = 3) patients with LSIL had a final HPE report of CIN2 or worse [Table 3] and [Table 4].
After comparison of both groups in terms of initial colposcopy findings as reflected by Swede score. In study arm 1, 68.75% (n = 22) of patients with Swede score of 5–6 were over treated while none of the patients with Swede score of 7 and above were over treated. Overall overtreatment rates of study arm1 (n = 50) were 44% (n = 22) and effectiveness was 56% (n = 28).
In conventional arm 2, only 16.7% (n = 1) with a colposcopy score of 5–6 had CIN1 on final HPE. Rest all patients were adequately judged as high-grade disease by colposcopy [Table 5].
|Table 5: Comparison of loop electrosurgical excision procedure histopathological examination of tissue with colposcopy (swede score) in see and treat (Arm 1) and three step conventional strategy (Arm 2)|
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Most of the cases (90.2%) did not encounter any complication. Only 8.2% of patients required pack insertion and 1.6% of patients were required stitches to control bleeding from cervix. No complication related to anesthesia (intracervical block) or burns were found during LEEP. Statistically, no significant difference was observed with respect to LEEP complications between two arms of the study (P = 0.890) [Table 6].
|Table 6: Distribution of patients in both groups according to complications during loop electrosurgical excision procedure|
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Discrepancy between colposcopy-guided biopsy tissue HPE and LEEP tissue HPE was analyzed retrospectively. One patient with CIN2 on biopsy was subsequently downgraded to CIN1 on LEEP, while other patients with CIN2 on biopsy were later diagnosed as SCC on LEEP. Similarly, four patients with CIN3 on biopsy were later upgraded to SCC on LEEP tissue HPE. Thus, overall 50% of cases (n = 6) had a discrepancy between initial biopsy report and final LEEP tissue HPE and the difference was statistically significant (P = 0.033) [Table 7].
|Table 7: Comparison of colposcopy guided biopsy and final loop electrosurgical excision procedure tissue histopathological examination of tissue in three step conventional strategy (Arm 2)|
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| > Discussion|| |
Under conventional treatment strategy, women with abnormal cytology usually require multiple visits including appointment for colposcopy, undergoing colposcopic examination, awaiting histopathology, treatment planning, and making an appointment for definite treatment. This approach is not cost effective for developing countries, time consuming and even increases the hospital patient's load. However, with see and treat strategy, provisional diagnosis by colposcopy and using LEEP for treatment enables final histological assessment and therapeutic excision in same setting. The probability of having no cervical tissues or only CIN 1 on LEEP tissue histopathology the so-called overtreatment, might be possible with this strategy. For mild or borderline cytology, one study reported over treatment rate was 22.9% which was comparatively high while it was decreased with high-grade cytology (7%). “See and treat” strategy was good without any overtreatment rate when cutoff of colposcopy Swede score 7 or above was considered for analysis, which was even lower as per standard set by the National Health Services Cervical Screening Program (NHSCSP) 2010 (<10%). None of the patients with high-grade cytology were over treated in our study arm 1, while other authors reported high overtreatment rates between 16.7% and 25%.,
Two authors also reported over treatment in their study, one author reported 32.5% in high-grade cytology (HSIL), another reported quite high over treatment rate in high-grade cytology in “see and treat” arm (ASC-H-52.8%, HSIL-26.1%). According to ASCCP guideline, it is acceptable to treat women with a high-grade smear in same setting. In our study under see and treat arm 1, 44% (n = 22) of patients with Swede score of 5–6 on colposcopy were over treated which was well above the acceptable rate of 10% as prescribed by NHSCSP 2010. Effectiveness of study see and treat protocol was 56% (n = 28).
For low-grade preceding cytological abnormality, reported overtreatment rate was 51.6% and 36.5% by two different authors in conventional treatment protocol., When colposcopic-guided biopsy tissue HPE reports were compared with LEEP tissue HPE in conventional arm 2, it was found that 83.3% of patients were adequately judged as high-grade disease and only16.7% were overtreated by colposcopic-guided biopsy in our study.
On retrospective analysis, overtreatment rate was zero with high-grade cytology in arm 1 and only 8.3% were overtreated with high-grade cytology analysis in arm 2. Hence, if LEEP is strictly implemented on high-grade cytology or high score colposcopy, even only single step see and treat strategy might be more useful in treatment of preinvasive lesions of cervix. Although one author reported 5.8% overtreatment with HSIL. While another studies reported over treatment rates with HSIL were of 16% and 22.9%.,
The significance of the incidence of occult invasive lesions might be equally considerable which was 11.1% in see and treat arm with high-grade score ≥7 where overtreatment rate was zero and occult invasive lesions were 41.66% in conventional arm 2 with high-grade cytology. Thus, role of colposcopy and LEEP equally important in detection of occult lesions along with cytology, while another study reported incidence of occult lesion was 9%–10% among women who had either pap smear or colposcopic impression, suggesting high-grade disease. One study reported invasive cervical cancer rates were 8.6% in see and treat arm and 8.3% in conventional treatment arm in ASC-H group, while in HSIL group, 8.6% in see and treat arm and 7.6% in conventional arm. Another author observed probability of skipping high-grade lesion was 6.1% in high-grade cytology. See and treat strategy using LEEP appropriate to minimize overtreatment rate and to provide adequate treatment for preinvasive lesions as well as occult lesions of the cervix similarly, observed in our study.
Discrepancy between colposcopy-guided biopsy tissue HPE and LEEP tissue HPE, in conventional arm was quite high, one biopsy finding of CIN2 was upgraded to CIN3, and another upgraded in SCC after LEEP HPE reports and four biopsy findings of CIN3 were upgraded into SCC. The discrepancy between colposcopy-guided biopsy tissue HPE and LEEP tissue HPE in our study arm 2 was 50%. Similarly, other authors reported 54%, 43.3% discrepancy in their studies., This emphasizes the role of LEEP and LEEP tissue HPE even after low-grade cytology and normal biopsy tissue HPE reports, to detect undiagnosed high-grade diseases.
In our study, all women with high-grade cytology had high-grade disease (CIN III) on histopathology in arm 1, 80% women with HSIL in our study had SCC of cervix on HPE in arm 2, and 18.1% in arm 1. Another study reported 41.67% had high-grade disease in high-grade cytology.
In the present study, 25% (n = 1) inadequate smear had CIN3 on HPE, thereby justifying the increased risk of high-grade CIN in inadequate smears as proposed by one author. This emphasizes the need of evaluating in adequate smear in symptomatic females with unhealthy cervix.
Our findings of overtreatment in ASC-H were similar to study done by Guducu et al. As per our study, overtreatment rates in HSIL were very low (0%) compared to study done by other authors (8.2%), (22.6%), (20%), (16%), and (22.9%).,,,, Overtreatment rates with low-grade cytology (ASCUS and LSIL) in our study were 42%, which was lower compared to findings of other studies (64.7%) and (68%).,
A meta-analysis evaluating see and treat approach on all grades of colposcopy and cytological abnormalities conducted by Ebisch et al., the pooled overtreatment rates in women with low-grade smear and high-grade colposcopy was 46.4%. Overtreatment rates in various studies for abovementioned combination of low-grade cytology and high-grade colposcopy of are 42.5%, 29.2%, 82.1%, and 31.3%, respectively.,,,
In our study, total 62 patients (including both arms) who underwent LEEP were assessed for intraoperative and immediate postoperative complications. There were no major complications found in our study. Bleeding was assessed on the basis of need of vaginal pack insertion or requirement of suturing. 90.2% cases in our study did not had any bleeding complication. Only one patient required suturing. Our findings were similar to reported in another study (9.4%).,
Limitation of study
Although the sample size of our study is small, findings of occult lesions before spread of disease could not be ignored, so in future larger studies will be required to obtain better outcome. Before opting see and treat strategy cytology or colposcopy findings should be evaluated by senior experts otherwise unnecessary low-grade disease might be subjected for overtreatment. Benefits of this strategy are higher patient's compliance, lower treatment cost, and better treatment in single setting. Hence, we can subject the patients directly for LEEP who are having unhealthy cervix and high-grade colposcopy score 7 or above or high grade cytology (ASC-H, HSIL).
| > Conclusion|| |
The “see and treat” strategy using LEEP is an appropriate management in women with high grade cytology on pap smear or high-grade colposcopy (Swede score ≥7) with zero overtreatment rate. This approach is quite good and can be implemented at tertiary center.
Financial support and sponsorship
Conflicts of interest
There no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]