AT ESMO 2017
Madrid – Computed tomography scans do not appear to be superior to plain old chest x-rays for follow-up of patients with completely resected non–small cell lung cancer (NSCLC), results of a randomized clinical trial suggest.
Among 1,775 patients followed out to 10 years with either a “minimal” protocol – consisting of history, physical exam, and periodic chest x-rays – or a “maximal” protocol – including CT scans of the thorax and upper abdomen, as well as bronchoscopy for squamous-cell carcinomas – there were no significant differences in overall survival at either 3, 5, or 8 years of follow-up, reported Virginie Westeel, MD , from the Centre Hospitalier Régional Universitaire of the Hôpital Jean Minjoz in Besançon, France.
“Most clinical practice guidelines recommend follow-up after resection for non–small cell lung cancer, including clinic visits with history and physical examination with chest x-rays every 6 to 12 months for 2 years and then yearly. This recommendation relies on expert opinion and small prospective series, but there [were] until now no randomized controlled trials to answer this question,” she said at a briefing at the European Society of Medical Oncology Congress.
In hopes of finding that answer, Dr. Westeel and colleagues in the French Cooperative Thoracic Oncology Group conducted a clinical trial comparing the standard follow-up approach recommended in most clinical guidelines, as described by Dr. Westeel, with an experimental protocol consisting of history and exam plus chest x-ray, CT scans, and fiber-optic bronchoscopy (mandatory for squamous- and large-cell carcinomas, optional for adenocarcinomas).
Patients with completely resected stage I, II, and IIIA tumors, and T4 tumors with pulmonary nodules in the same lobe, were randomly assigned to follow-up with one of the two protocols.
In each trial arm, the assigned procedures were repeated every 6 months after randomization for the first 2 years, then yearly until 5 years.
After a median follow-up of 8.7 years, there was no significant difference in the primary endpoint of overall survival. Median OS was 123.6 months in the maximal protocol group, compared with 99.7 months in the minimal protocol group (P = .037)
The 3-, 5-, and 8-year survival rates for the maximal and minimal protocols, respectively, were 76.1% vs. 77.3%, 65.8% vs. 66.7%, and 54.6% vs. 51.7%.
Because there appeared to be a separation of the survival curve beginning around 8 years, the investigators performed an exploratory 2-year landmark analysis.
They found that, among patients who had a recurrence within 24 months of randomization, there was no difference in OS between each follow-up protocol. However, among those patients with no recurrence within 24 months of resection, the median OS was not reached among patients assigned to the maximal protocol versus 129.3 months for those assigned to the minimal protocol (P = .04).
Patients without early recurrence had higher rates of secondary primary cancers, and for these patients, early detection with CT-based surveillance could explain the differences in overall survival, Dr. Westeel said.
“Our suggestion for practice is that, because there is no survival difference, both follow-up protocols are acceptable. However, a CT scan every 6 months is probably of no value in the first 2 years,” but yearly chest CTs to detect second primary cancers early may be of interest, she said.
Enriqueta Felip, MD , from Vall D’Hebron Institute of Oncology in Barcelona, who was not involved in the trial, commented that, while the study needed to be conducted, it was unlikely to change her clinical practice because of potential differences among patients with varying stages of NSCLC at the time of resection.
“I think it’s an important trial, [but] tomorrow I will follow my patients with a CT scan,” she said.
Dr. Felip was an invited expert at the briefing.
The study was supported by the French Ministry of Health, Fondation de France, and Laboratoire Lilly. Dr. Westeel and Dr. Felip reported no conflicts of interest relevant to the study.