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 [ClinicalTrials.gov]

Staging of non–small-cell lung cancer (NSCLC) was one of the first approved indications for the use of positron-emission tomography (PET).^1,2

Since 2001, combined PET and computed tomography (PET–CT) has rapidly replaced stand-alone PET.^3,4 The diagnostic capability of PET–CT in the preoperative staging of NSCLC is superior to that of CT alone and PET alone.⁵

The advantage is based mainly on a more accurate assignment of tumor stage (T stage) and to a lesser extent on defining the lymph-node stage (N stage).^5,6,7

Whether the improved diagnostic accuracy improves management of the disease is unknown.

Two randomized trials have assessed the clinical effect of stand-alone PET. In a trial by van Tinteren et al.,⁸ the addition of stand-alone PET to conventional staging of NSCLC reduced the number of futile thoracotomies by 50%.

A second randomized trial, however, did not show that adding PET reduced the number of thoracotomies.⁹

Identifying the stage of lung cancer helps determine the appropriate treatment and is essential for prognosis.^10,11 Incorrect staging of NSCLC can result in resections of benign nodules and early local or distant relapse after surgery with curative intent.^8,12

We report on a randomized trial to assess the clinical influence of preoperative staging with PET–CT.

NEJM Volume 361:32-39July 2, 2009 Number 1

Barbara Fischer, Ph.D., Ulrik Lassen, Ph.D., Jann Mortensen, Dr.Med.Sci., Søren Larsen, Ph.D., Annika Loft, Ph.D., Anne Bertelsen, M.D., Jesper Ravn, M.D., Paul Clementsen, Dr.Med.Sci., Asbjørn Høgholm, M.D., Klaus Larsen, M.D., Torben Rasmussen, Ph.D., Susanne Keiding, Dr.Med.Sci., Asger Dirksen, Dr.Med.Sci., Oke Gerke, Ph.D., Birgit Skov, Dr.Med.Sci., Ida Steffensen, Ph.D., Hanne Hansen, M.D., Peter Vilmann, Dr.Med.Sci., Grete Jacobsen, Dr.Med.Sci., Vibeke Backer, Dr.Med.Sci., Niels Maltbæk, M.D., Jesper Pedersen, Dr.Med.Sci., Henrik Madsen, M.D., Henrik Nielsen, Dr.Med.Sci., and Liselotte Højgaard, Dr.Med.Sci.

SEE FULLTEXT

http://content.nejm.org/cgi/content/full/361/1/32

http://www.e-medicum.com/noticiasDelDia/verNoticia.php?noticia=82893