At several centers near Copenhagen, investigators randomized 98 patients with NSCLC to preoperative staging with PET-CT plus conventional procedures and 91 to conventional staging alone. The primary endpoint was the number of futile thoracotomies, which were defined as: surgery showing mediastinal lymph node involvement at stage IIIA[N2], IIIB, or IV; or a benign lung lesion; or exploratory surgery; or surgery in a patient with recurrent disease or death from any cause with a year after randomization.
According to lead author Dr. Barbara Fischer at Odense University Hospital, Denmark, and colleagues, disease was considered operable in 60 PET-CT patients (61%) and 73 conventionally staged patients (80%). Ultimately, 55 PET-CT patients and 73 conventional staging patients underwent thoracotomy.
“Among these…21 in the PET-CT group and 38 in the conventional-staging group were futile (p=0.05),” the authors said.
They add, “The number of justified thoracotomies and survival were similar in the two groups.”
The researchers note that the trial was closed prematurely because of slow accrual. Even so, they were able to conclude that “adding a PET-CT examination to the diagnostic regiment for patients with NSCLC improves sensitivity in preoperative staging (and) reduces the frequency of futile thoracotomies, with no effect…on overall survival.”
N Engl J Med 2009;361:32-39.