Toward less futile surgery in non-small cell lung cancer? A randomized clinical trial to evaluate the cost-effectiveness of positron emission tomography

Non-small cell lung cancer can be cured if the patient is medically operabl e and the tumor resectable. Current diagnostic strategies are aimed to dete ct tumor deposits that preclude resection with curative intent. However, th ese strategies are rather inefficient, resulting in a large number of futil e invasive procedures. In the early 1990s positron emission tomography (PET ) showed promising results at its introduction in the clinic, especially in oncology. A large number of accuracy studies have reported that PET is sup erior to conventional imaging. However, whether PET ultimately improves pat ient outcome should ideally be assessed by means of a randomized controlled trial. No such design has been applied to evaluate PET in oncology so far. The PLUS study was designed to compare the current strategy of conventiona l methods with a strategy where PET was added after completion of noninvasi ve techniques. Patients considered operable by the physician at this point were then randomly assigned to PET and further consequences or to standard procedures of mediastinoscopy or thoracotomy. Primary outcome events were f utile thoracotomies. The trial randomized 188 patients from nine hospitals in 1 year. Patient enrollment has been stopped and data collection is in pr ogress. The results will be published in 2001. (C) Elsevier Science Inc. 20 01.