Effects of treatments in clinical trials: surgery

The results of surgery for liver cancer (resection or transplantation) have so far been evaluated against older retrospective reports of the survival of series of patients left untreated. Even though it has been taken for granted that "surgical therapy offers the only chance of cure," the validity of this comparison may be challenged. The key problem is that it is impossible from the available evidence to calculate with any reasonable accuracy the expected distribution of survival times of the patients undergoing surgery had they not been treated. Even though there is a group of surgically treated patients who remain alive without signs of recurrence for 5 years or more, the current strategy for surgical treatment may not be favorable for the patient group as a whole. Despite the forseeable difficulties, it seems timely to encourage randomized trials to obtain a proper evaluation of this treatment.