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Purpose: The use of PET/CT for monitoring treatment response in cancer patients after chemo- or radiotherapy is a very promising approach to optimize cancer treatment. However, the timing of the PET/CT-based evaluation of reduction in viable tumor tissue is a crucial question. We investigated how to plan and analyze studies to optimize this timing.; Methods: General considerations about studying the optimal timing are given and four fundamental steps are illustrated using data from a published study.; Results: The optimal timing should be examined by optimizing the schedule with respect to predicting the overall individual time course we can observe in the case of dense measurements. The optimal timing needs not to and should not be studied by optimizing the association with the prognosis of the patient.; Conclusions: The optimal timing should be examined in specific 'schedule optimizing studies'. These should be clearly distinguished from studies evaluating the prognostic value of a reduction in viable tumor tissue.;
Background: Fast and accurate staging is essential for choosing treatment for non–small-cell lung cancer (NSCLC). The purpose of this randomized study was to evaluate the clinical effect of combined positron-emission tomography and computed tomography (PET–CT) on preoperative staging of NSCLC. Methods: We randomly assigned patients who were referred for preoperative staging of NSCLC to either conventional staging plus PET–CT or conventional staging alone. Patients were followed until death or for at least 12 months. The primary end point was the number of futile thoracotomies, defined as any one of the following: a thoracotomy with the finding of pathologically confirmed mediastinal lymph-node involvement (stage IIIA [N2]), stage IIIB or stage IV disease, or a benign lung lesion; an exploratory thoracotomy; or a thoracotomy in a patient who had recurrent disease or death from any cause within 1 year after randomization. Results: From January 2002 through February 2007, we randomly assigned 98 patients to the PET–CT group and 91 to the conventional-staging group. Mediastinoscopy was performed in 94% of the patients. After PET–CT, 38 patients were classified as having inoperable NSCLC, and after conventional staging, 18 patients were classified thus. Sixty patients in the PET–CT group and 73 in the conventional-staging group underwent thoracotomy (P=0.004). Among these thoracotomies, 21 in the PET–CT group and 38 in the conventional-staging group were futile (P=0.05). The number of justified thoracotomies and survival were similar in the two groups. Conclusions: The use of PET–CT for preoperative staging of NSCLC reduced both the total number of thoracotomies and the number of futile thoracotomies but did not affect overall mortality. (ClinicalTrials.gov number, NCT00867412.) N Engl J Med 2009;361:32-9.