P-186 * PULMICC INTERNATIONAL: A RANDOMIZED CONTROLLED TRIAL OF PULMONARY METASTASECTOMY IN COLORECTAL CANCER: WORK IN PROGRESS

Abstract

Objectives: To adequately inform patients with lung metastases of the effect of metastasectomy we need evidence-based estimates of the survival after metastasectomy compared with the course of the disease without surgery. There have been no control data in over 100 studies since the 1960s but increasingly sophisticated means of analysis have shown recurrence free survival is probably largely confined to people with a solitary metastasis and an interval since primary resection counted in years. Therefore, we cannot know from observational data whether survival is a result of surgery or is due to systematic selection of those with the best natural prognosis. Advanced colorectal cancer predominately affects the liver, abdomen and pelvis; it is rare for pulmonary disease to contribute to the clinical picture. There is no palliative role for lung metastasectomy in asymptomatic patients. The patient's only gain is hope of cure. If that is not attained by pulmonary metastasectomy, patients should be informed and spared unavailing surgery. Methods: We are recruiting to a randomized trial in which patients are evaluated according to protocol in Stage 1 and fully informed individualized decisions can be made for or against metastasectomy. If benefit is uncertain, random allocation to active monitoring only, or active monitoring plus metastasectomy, is offered in Stage 2 of the study. Survival, lung function, and quality of life are measured for up to 5 years from randomization. Results: Over 240 patients have been enrolled into Stage 1 and more than 60 have been randomized into Stage 2 from centres in the UK, Serbia and Italy. Conclusions: Amongst patients made aware of the uncertain benefit of surgery, randomization as a means of treatment allocation has been found to be acceptable. The Data Monitoring Committee, at the time of submission, recommends that the study continues as planned.