|Ahead of print publication
Use of misoprostol before tandem application for intracavitary brachytherapy in patients of carcinoma cervix: An institution study
Tauseef Ali, Sahaj Palod, Aafreen Khan, Shalu Verma, Sumit Gupta, Saurabh Karnawat, Virendra Bhandari
Department of Radiation Oncology, Sri Aurobindo Medical College and PG Institute, Indore, Madhya Pradesh, India
|Date of Submission||01-Feb-2020|
|Date of Decision||28-May-2020|
|Date of Acceptance||22-Jun-2020|
|Date of Web Publication||20-Aug-2021|
Department of Radiation Oncology, Sri Aurobindo Medical College and PG Institute, Indore, Madhya Pradesh
Source of Support: None, Conflict of Interest: None
Aim: To investigate the ease of tandem application and external os identification by giving sublingual misoprostol before initiation of intracavitary brachytherapy in cancer cervix patients.
Materials and Methods: 36 patients with cervical cancer stage IIIB which were supposed to undergo intracavitary brachytherapy(ICBT) were randomly divided into 2 subgroups, group A patients receiving misoprostol and group B not receiving misoprostol.Misoprostol 400 mcg was given sublingually 3 hrs prior to the procedure. The efficacy of the drug was measured as per the ease of identification of os and easier tandem application and amount of bleeding during procedure.
Results: Application of tandem and identification of external os was easier and amount of bleeding was also less in patients that were administered sublingual misoprostol.
Conclusion: Sublingual Misoprostol given before ICBT helps in cervical ripening and thus leads to easier os recognition and central tandem application and reduce overall anaesthesia time.
Keywords: Ease of procedure, intracavitary brachytherapy, misoprostol
|How to cite this URL:|
Ali T, Palod S, Khan A, Verma S, Gupta S, Karnawat S, Bhandari V. Use of misoprostol before tandem application for intracavitary brachytherapy in patients of carcinoma cervix: An institution study. J Can Res Ther [Epub ahead of print] [cited 2022 Jun 25]. Available from: https://www.cancerjournal.net/preprintarticle.asp?id=324160
| > Introduction|| |
Cervical cancer is one of the most common malignancies encountered in India. Due to social taboo, patients end up hiding the initial symptoms of foul-smelling white discharge or bleeding per vaginum, causing most of the patients to report at a later stage of the disease. The treatment of carcinoma cervix consists of radical radiotherapy, which includes external beam radiotherapy (EBRT) followed by intracavitary brachytherapy (ICBT). Brachytherapy ensures higher dose delivery to the local tumor site and minimal dose to the organs at risk that include bladder and rectum. Frequent complications that are encountered during the procedure are related to difficulties in cervical dilatation; due to distortion of the cervix and cervical canal or obliteration of canal due to fibrosis caused by disease or EBRT, tandem insertions can be difficult.
Misoprostol is a well-known prostaglandin E1 analog used for cervical ripening and labor induction. Cervical priming is dilatation or softening of the external os of the cervix by mechanical or medical means; the mechanism of action is a complex process which involves various inflammatory reactions. Misoprostol is an inexpensive drug that can be stored at room temperature, and is readily available. Oppegaard et al. in their study had found greater mean cervical dilatation with misoprostol in postmenopausal women than that with placebo.
In female patients that have firmly closed and rigid cervix, dilatation using cervical dilators such as Hegar dilator can cause considerable traumatization of the tissue. There is always an associated risk of lacerations caused by the tenaculum, creation of false passages, and an increased chance of uterine perforation.
| > Materials And Methods|| |
This study was conducted prospectively between November 2019 and January 2020. A total of 36 patients of cervical cancer Stage IIIB that had received 50 Gray (Gy) in 25 fractions of EBRT and then planned for ICBT were selected and had been divided and placed in two groups, and the patients were randomly assigned to Group A consisting of patients that received misoprostol and Group B not receiving misoprostol.
Eighteen patients received 400 μg of misoprostol sublingually, 3 h prior to the procedure. Before starting the procedure, utero cervical length was measured using ultrasonography and during the procedure, the length of the endometrial cavity was measured and confirmed by uterine sound. All ICBT procedures were done on short-acting general anesthesia. The International Federation of Gynaecology and Obstetrics classification was used for staging of the disease. Pain was assessed by visual analog scale (0 = no pain, 1–5 = minimum pain, and 6–10 = severest pain).
The ease of the procedure and bleeding post procedure were graded by the physicians. Bleeding was graded as absent (no bleeding), minor (bleeding not requiring any intervention), moderate (bleeding stops by pressure application for 2 min), and severe (bleeding stops by suturing). The ease of procedure was graded as easy, moderate, or difficult.
High dose-rate brachytherapy was delivered by cobalt-60 unit after loading system Gynae Source from Eckert and Ziegler BEBIG, Berlin, Germany.
The results were represented as mean ± standard deviation for quantitative variables and in the form of percentage for qualitative variables. Data were analyzed by Chi-square test. P < 0.05 was considered statistically significant.
| > Results|| |
Patient characteristics are summarized in [Table 1]. The mean age of the patients in Group A was 51.88 ± 9.68 years (standard deviation) and Group B was 56.72 ± 12.80 (standard deviation).
Nearly 66.6% of the patients that were in Group A had no bleeding during the procedure as the os was easily identified and the tandem was applied in a single attempt due to the dilated os. Almost 50% of the patients in Group B had no bleeding during the procedure. No patient of Group A had heavy bleeding during the procedure, and one patient of Group B experienced heavy bleeding during the procedure because of residual disease present over the cervix. [Table 2] shows the amount of bleeding during tandem application in two groups. The Chi-square test value was 0.457 with 1 degree of freedom. The two-tailed P value was 0.4990 and was not statistically significant.
[Table 3] shows the difficulty of the procedure between the two groups as per the procedure performing physician. It was observed that in 17 patients of Group A, there was ease in external os identification and tandem application (two-tailed P = 0.0092). The Chi-square test value was 6.785 with 1 degree of freedom, implying that misoprostol makes tandem insertion easier, as the data were statistically significant. There was difficulty though in one patient where there was significant cervical fibrosis due to disease and EBRT, and the procedure had to be abandoned.
Six patients of Group A and four patients of Group B did not experience pain post procedure. [Table 4] shows pain experienced by patient post tandem application. The Chi-square test value was 0.138 with 1 degree of freedom. The two-tailed P value was 0.7098, which was not statistically significant.
We did not encounter any complications due to the administration of misoprostol.
| > Discussion|| |
ICBT plays a major role in the treatment of patients with cervical cancer. Several studies have shown improved overall survival and decreased rate of recurrence by the administration of ICBT post EBRT.,, Brachytherapy alone is used as primary treatment for patients with early-stage disease (IA-IB1). Brachytherapy utilizes the advantage of inverse square law, and ensures higher dose delivery to the local tumor site and minimal dose to the organs at risk that include bladder and rectum. For best possible dose distribution to the cervix, the applicator placement should be ideal.
Development of fibrosis after EBRT predisposes to retraction, obstruction, and deviation of the cervical canal, making recognition of external os and central tandem placement a challenge for the physician. Misoprostol is a well-known cervical dilator, and has been utilized for various gynecological procedures. Perrone et al. had shown that misoprostol used in patients had significant cervical dilation and decreased force essential for cervical dilation. Use of misoprostol 3 h prior to our procedure made recognition of external os and central tandem placement easier.
| > ConclusioN|| |
Looking at the ease in the identification of external os and tandem application, we have concluded from our study that misoprostol helps in the ease of the procedure and can be used for proper ICBT implant placement.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| > References|| |
Cepni K, Gul S, Cepni I, Güralp O, Sal V, Mayadagli A. Randomized trial of oral misoprostol treatment for cervical ripening before tandem application in cervix cancer. Int J Radiat Oncol Biol Phys 2011;81:778-81.
Oppegaard KS, Lieng M, Berg A, Istre O, Qvigstad E, Nesheim BI. A combination of misoprostol and estradiol for preoperative cervical ripening in postmenopausal women: A randomised controlled trial. BJOG 2010;117:53-61.
Lanciano RM, Won M, Coia LR, Hanks GE. Pretreatment and treatment factors associated with improved outcome in squamous cell carcinoma of the uterine cervix: A final report of the 1973 and 1978 patterns of care studies. Int J Radiat Oncol Biol Phys 1991;20:667-76.
Hanks GE, Herring DF, Kramer S. Patterns of care outcome studies. Results of the national practice in cancer of the cervix. Cancer 1983;51:959-67.
Coia L, Won M, Lanciano R, Marcial VA, Martz K, Hanks G. The patterns of care outcome study for cancer of the uterine cervix. Results of the second national practice survey. Cancer 1990;66:2451-6.
Viswanathan AN, Beriwal S, De Los Santos JF, Demanes DJ, Gaffney D, Hansen J, et al
. American brachytherapy society consensus guidelines for locally advanced carcinoma of the cervix. Part II: High-dose-rate brachytherapy. Brachytherapy 2012;11:47-52.
Perrone JF, Caldito G, Mailhes JB, Tucker AN, Ford WR, London SN. Oral misoprostol before office endometrial biopsy. Obstet Gynecol 2002;99:439-44.
[Table 1], [Table 2], [Table 3], [Table 4]