Interventional procedure consultation document

Percutaneous radiofrequency ablation for primary or secondary lung cancers

Percutaneous radiofrequency ablation of cancer in the lung involves inserting one or more electrodes (needle-like probes) through the chest into the lung. The electrodes are placed within the tumour and connected to a source of electrical current, producing heat with the aim of destroying (‘ablating’) the cancer cells.

The National Institute for Health and Clinical Excellence (NICE) is examining percutaneous radiofrequency ablation for primary or secondary lung cancers and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about percutaneous radiofrequency ablation for primary or secondary lung cancers.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

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

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

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

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

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 24 August

Target date for publication of guidance: December 2010

1  Provisional recommendations

1.1  Current evidence on the efficacy of percutaneous radiofrequency ablation (RFA) for primary or secondary lung cancers is adequate in terms of tumour control. There is a small incidence of complications, specifically pneumothorax, which may have serious implications for these patients with already compromised respiratory reserve. This procedure may be used provided that normal arrangements are in place for clinical governance, consent and audit.

1.2  Patient selection for percutaneous RFA for primary or secondary lung cancers should be carried out by a multidisciplinary team, which will usually include a thoracic surgeon, an oncologist and a radiologist.

1.3  This procedure should only be carried out by radiologists who regularly undertake image-guided interventional procedures.

2   The procedure

2.1  Indications and current treatments

2.1.1  Both primary and metastatic lung cancer are common, and the prognosis for most patients is poor.

2.1.2  Treatment depends mainly on tumour histology and stage, and may include surgical resection (open or thoracoscopic), external beam radiotherapy, chemotherapy or a combination of these treatments. If the tumour protrudes into the major airways, bronchoscopic treatments including diathermy, laser therapy, cryotherapy, brachytherapy and photodynamic therapy may be used.

2.2   Outline of the procedure

2.2.1  Percutaneous RFA may be used in patients with small, early-stage lung cancers or small numbers of lung metastases who are not suitable for (or are unwilling to undergo) surgery. It may also have a place in multi-modality treatment of more advanced primary lung cancers. 

2.2.2  The procedure is usually carried out under local anaesthesia with conscious sedation, although tumour size and anatomy may dictate the use of general anaesthesia. The procedure involves inserting a small needle electrode through the skin directly into the tumour, usually under computed tomography (CT) guidance. Radiofrequency energy, in the form of an alternating electrical current, is passed through the electrode causing heating of the tissues around the tip of the needle. The tumour tissue in the target area is coagulated, and a small margin of normal tissue around the tumour is also destroyed to reduce the risk of local recurrence.

2.2.3  The procedure can be applied to more than one tumour during a single treatment session, or repeated in subsequent sessions. It can be used alone or in combination with surgery, radiotherapy or chemotherapy.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP316aoverview

2.3   Efficacy

2.3.1  In a case series of 153 patients, survival at 1, 3 and 5 years after RFA for 75 patients with stage 1 non-small cell lung cancer (NSCLC) was 78%, 36% and 27% respectively (absolute figures not stated). A case series of 106 patients reported overall 1- and 2-year survival rates of 70% and 48% for 33 patients with NSCLC, and 89% and 66% for 53 patients with colorectal lung metastases. In a case series of 78 patients with colorectal lung metastases, overall 1-, 3- and 5-year survival rates were 84%, 56% and 35% respectively.

2.3.2  A case series of 100 patients reported a median overall survival of 27 months for patients with primary lung cancer, 33 months for patients with recurrent lung cancer and 18 months for patients with metastatic disease.

2.3.3  The case series of 153 patients reported that the median time to progression (assessed by follow-up CT scans and also positron-emission tomography [PET] scans in selected patients) for tumours of 3 cm or smaller was 45 months, with 1-, 3- and 5-year local tumour progression-free rates of 83%, 57% and 47% respectively. Median time to progression for larger tumours was 12 months, with 1-, 3- and 5-year progression-free rates of 45%, 25% and 25% respectively. The case series of 78 patients with colorectal lung metastases reported 1-, 3- and 5-year overall progression rates (assessed by follow-up CT scans) of 10%, 21% and 21% respectively. The case series of 100 patients reported local progression (assessed by CT scans and also PET scans in selected patients) in 35% (35/100) of patients after a mean follow-up of 17 months; the median time to local progression was 15 months.

2.3.4  In the case series of 106 patients, there was no significant difference between quality of life at baseline and at 12 months after RFA, using the Functional Assessment of Cancer Therapy – Lung and Short-Form 12 questionnaires.

2.3.5  The Specialist Advisers listed key efficacy outcomes as symptomatic improvement, quality of life, local tumour control, progression-free survival, overall survival, respiratory morbidity and the need for repeat interventions.

2.4   Safety

2.4.1  Four procedure-related deaths within 30-days were reported in the case series of 153 patients. The causes of death were haemorrhage into the pleural space; exacerbation of underlying pulmonary fibrosis; congestive heart failure; and respiratory arrest while undergoing conscious sedation. Two deaths were reported in a case series of 137 patients: 1  resulting from intractable pneumothorax and pneumonia at 53 days, and the other from massive haemoptysis 28 days after RFA. Two deaths resulting from interstitial pneumonia were reported in a case series of 130 patients (timing of events not stated).

2.4.2  Pneumothorax requiring the insertion of a chest tube was reported in less than 10% of patients in 4 centres and in 10–30% of patients in 3 centres in a case series of 493 RFA procedures performed in 7 different centres. In 5 further case series, the rate of pneumothorax requiring chest tube drainage ranged from 10% (18/183) to 20% (27/137).

2.4.3  Pleural effusion requiring drainage was reported in less than 10% of patients in 6 centres and more than 30% in 1 centre in the case series of 493 RFA procedures. In 3 further case series, the rates of pleural effusion requiring drainage were 2% (4/211), 3% (4/137) and 3% (3/100).

2.4.4  The Specialist Advisers considered theoretical adverse events to include abscess, infection, pleural effusion, pulmonary embolism, pain, damage to other intrathoracic structures, post procedure mortality and death from interstitial pneumonitis.

3   Further information

3.1  This guidance is a review of ‘Percutaneous RFA for primary and secondary lung cancers’ NICE interventional procedures guidance 109 (2006).

3.2  For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

July 2010