3 Committee discussion

The following sections 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.

Efficacy

3.1

A case series of 38 patients with a variety of tumours reported no satisfactory tumour response in any of the 4 patients treated for lung tumours, and all 4 patients had progressive disease when assessed by the modified 'Response Evaluation Criteria in Solid Tumors' at 3 months.

3.2

A case report of 2 patients with primary and metastatic lung tumours reported progression of disease (at 2 months after the procedure in 1 patient and at 6 months in the other patient).

3.3

The Specialist Advisers listed key efficacy outcomes as patient survival, tumour response on follow-up imaging, local tumour control, time to disease progression, improvement in health-related quality of life and reduction in tumour-related symptoms.

Safety

3.4

The case series of 38 patients reported cardiac arrhythmia in 6 patients (4 patients had ventricular tachycardia, 1 patient had supraventricular tachycardia and 1 patient had atrial fibrillation). Two of these patients had arrhythmias despite the use of cardiac synchronisation. All the arrhythmias resolved spontaneously except for the atrial fibrillation, which was treated by cardioversion.

3.5

A case series of 21 patients with primary or metastatic cancer (liver, kidney and lung) reported transient ventricular tachycardia during 2 out of 3 procedures in patients with lung tumours.

3.6

A case series of 45 patients (12 lung lesions) reported pneumothorax in 14% (7 out of 50) of procedures. The case series of 38 patients (4 patients with lung cancer) reported 2 cases of pneumothorax (50% incidence). The case series of 21 patients (3 patients with lung cancer) reported 2 cases of pneumothorax (67% incidence).

3.7

The case series of 38 patients reported collapse of the right upper lobe in 1 patient with advanced lung cancer: the lobe re-expanded spontaneously.

3.8

The case report of 2 patients reported moderate parenchymal haemorrhage at the time of the procedure in 1 patient.

3.9

One Specialist Adviser reported an anecdotal adverse event of sepsis. The Specialist Advisers listed theoretical adverse events as tumour seeding, bronchopleural fistula, residual necrotic tissue and changes such as fibrosis.

Other comments

3.10

The Committee noted that most of the published studies included patients with a variety of different types of tumour, among whom there were few with primary lung cancer or metastases in the lung.

3.11

The Committee noted the claim that this procedure may cause less damage to surrounding structures (such as major blood vessels) than other types of ablative treatment for lung cancer, but considered that more evidence is needed to support this.