Interventional procedure consultation document - high dose rate brachytherapy for carcinoma of the cervix

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

High dose rate brachytherapy for carcinoma of the cervix

The National Institute for Health and Clinical Excellence is examining high dose rate brachytherapy for carcinoma of the cervix and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made a provisional recommendation about high dose rate brachytherapy for carcinoma of the cervix.
This document summarises the procedure and sets out the provisional recommendation made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

  • comments on the preliminary recommendation
  • the identification of factual inaccuracies
  • additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

  • The Advisory Committee will meet again to consider the original evidence and its provisional recommendation in the light of the comments received during consultation.
  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 20 December 2005
Target date for publication of guidance: March 2006


Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.


1 Provisional recommendations
1.1

Current evidence on the safety and efficacy of high dose rate brachytherapy for carcinoma of the cervix appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.



2 The procedure
2.1 Indications
2.1.1 There are two main types of cancer of the cervix. The most common, squamous cell carcinoma, usually develops from the cells which cover the outer surface of the cervix (the ectocervix). The other, adenocarcinoma, usually develops from the glandular cells which line the cervical canal (the endocervix). The stage of the cancer is defined by its size and by the extent of spread beyond the cervix.
2.1.2 The most common symptoms of cervical cancer are abnormal vaginal bleeding or discharge and discomfort during intercourse.
2.1.3 Cancer of the cervix can be treated with surgery, radiotherapy, chemotherapy or a combination of these treatments. Surgery is often the main treatment for cancer of the cervix in its early stages (where cancer is found only in the cervix). Chemotherapy is occasionally used before surgery, shrinking the cancer to make the operation simpler. However, it is mainly given in combination with radiotherapy, either as a primary therapy or after surgery.
2.1.4

Brachytherapy can be given in low, medium or high dose rates. Low dose rate brachytherapy delivers radiation slowly. In order to administer a radiation dose that will eliminate the cancer, applicators need to be in place in the vagina for 2 to 3 days.

2.2 Outline of the procedure
2.2.1 High dose rate (HDR) brachytherapy was developed to reduce the radiation hazard to staff, and to reduce the length of inpatient treatment, with a requirement for isolation of the patient. HDR brachytherapy may be used for palliation of advanced disease, but this guidance refers only to HDR brachytherapy used with curative intent.
2.2.2

An implant containing a high dose of radioactivity (microSelectron) is inserted into the cervix and left in place, typically for a few minutes. The treatment is often repeated several times, a few days apart, on an outpatient basis. This procedure gives a high dose of radiation to the cervix and the adjacent area, but a low dose to tissues and organs more than a few centimetres away. Practically all HDR brachytherapy is given in conjunction with external-beam radiation therapy.

2.3 Efficacy
2.3.1

In two randomised controlled trials (RCT) that compared patients treated with HDR and those treated with low dose rate (LDR) brachytherapy, the overall survival (across all stages of disease) with HDR was 54% and 68% at 5 and 3 years' follow-up, respectively, compared with 71% and 55% after LDR brachytherapy. These differences were not significant.

2.3.2 In an RCT, the overall 5-year survival (across all stages) in 31 patients who had received HDR brachytherapy was 61%, compared with 63% in 29 patients who had received medium dose rate (MDR) treatment (p = 0.98). In the same study, local disease-free survival was achieved in 67% of patients who had received HDR brachytherapy compared with 78% in the MDR treated patients (p = 0.86).
2.3.3 Distant metastases occurred in 6% (15/236), 19% (372/1992), and 22% (43/200 and 25/112) of HDR-treated patients in RCTs and a case series. Where the outcome was reported, local recurrence occurred in 6% (7/112), 21% (415/1992), and 22% (51/236) of HDR-treated patients, with follow-up ranging from 3 to 10 years. For more details, refer to the sources of evidence (see Appendix).
2.3.4

Some of the Specialist Advisors stated that HDR brachytherapy had equivalent efficacy to LDR brachytherapy.

 

2.4 Safety
2.4.1

In a large case series of 1992 patients, with a median 8-year follow-up, the overall bowel and bladder complication rate was 35%. Radiation Therapy Oncology Group grade 3 or 4 complications occurred in 7% of patients. In an RCT that compared HDR and MDR brachytherapy, the grade 2 complication rate among HDR-treated patients was 13% (4/31). In the MDR arm, there were grade 2 complications in 3% (1/29) of patients.

2.4.2 Where reported separately, rectal complications (all grades) affected 4% to 20% (22/112) of patients, and bladder complications affected 4% (8/200) of patients. Serious complications such as bowel obstruction, severe rectal bleeding and stenosis, which required subsequent surgery occurred in 2% and 6% (11/200) of patients in two case series. For more details, refer to the sources of evidence (see Appendix).
2.4.3 The Specialist Advisors reported that complications include diarrhoea, bleeding, colitis, and cystitis, and also fistulae requiring surgery. They noted the possibility of long-term problems affecting the bowel, bladder and rectum.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
December 2005

Appendix: Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

  • Interventional procedure overview of high dose rate (HDR) brachytherapy for carcinoma of the cervix, August 2005

Available from: www.nice.org.uk/ip305overview

This page was last updated: 04 February 2011