Annual CT scan does not offer survival benefit for completely resected NSCLC
MADRID — CT scan-based follow-up provided no significant survival benefit for patients who underwent complete resection for non-small cell lung cancer, according to results of a randomized phase 3 trial presented at the European Society for Medical Oncology Congress.
However, it is possible the CT scan-based follow-up may confer a long-term benefit for patients who are at high risk for second primary cancers, making them potential candidates for screening, according to Virginie Westeel, MD, PhD, professor of pulmonology at University of Franche-Comte in Besancon, France, and head of the thoracic oncology unit at University Hospital of Besancon.
“This is the first large randomized trial on follow-up after surgery for NSCLC,” Westeel said during a press conference. “This also is the first randomized trial to evaluate the interest of chest CT scan.”
Several guidelines recommend follow-up with clinic visits and chest CT scans for patients with completely resected NSCLC. However, due to the absence of randomized data, evidence to support these recommendations is limited.
Westeel and colleagues conducted the IFCT-0302 trial to compare two follow-up programs for 1,775 patients (median age, 63 years; range, 34-88; 76.3% men) with completely resected stage I (68.1%), stage II (13.7%), IIIA (18.3%) and T4, N0-2 NSCLC.
Approximately 39.5% of patients had squamous or large-cell carcinomas, 86.6% had undergone lobectomy or bilobectomy, 8.7% had received preoperative or postoperative radiotherapy, and 45% had received preoperative or postoperative chemotherapy.
Researchers randomly assigned 888 patients to a control arm, which consisted of clinical exam and chest X-ray. The other 887 patients underwent clinical examination, chest X-ray, and CT scan of the thorax and upper abdomen. Fiberoptic bronchoscopy was mandatory for patients with squamous large-cell carcinoma.
In both groups, procedures were repeated every 6 months after randomization during the first 2 years, then annually until 5 years. The study protocol allowed for supplementary procedures for study participants who developed symptoms.
Patient characteristics were well balanced between the two groups, Westeel said.
OS served as the primary endpoint.
Median follow-up was 8.7 years (95% CI, 8.5-9).
Results showed no significant OS difference between the control group and the CT scan-based follow-up group (HR = 0.92; 95% CI, 0.8-1.07).
Median OS was 8.2 years for patients in the control group and 10.3 years for patients assigned CT scans. Eight-year OS rates were 51.1% (95% CI, 47.2-55.1) in the control group and 55.6% (95% CI, 51.7-59.4) in the CT scan group.
Researchers conducted an exploratory analysis to compare median OS among patients who developed recurrence at 24 months and those who did not.
Among patients who developed recurrence by 24 months, median OS did not differ significantly between those who underwent maximal surveillance and those who underwent minimal surveillance (48.3 months vs. 48.4 months). Among patients who did not develop recurrence by 24 months, median OS had not been reached for those who underwent maximal surveillance and was 129.3 months for those who underwent minimal surveillance (P = .04).
That finding suggests longer follow-up is necessary to ensure a potential long-term OS benefit of CT scan-based surveillance is not overlooked, Westeel said.
“Because there is no survival difference, both follow-up protocols are acceptable,” Westeel said. “However, a CT scan every 6 months is probably not useful during the first 2 years. A yearly chest CT scan might be beneficial over the long term.” – by Mark Leiser
Westeel V, et al. Abstract 1273O. Presented at: European Society for Medical Oncology Congress; Sept. 8-12, 2017; Madrid.
Disclosures: Ministere de la Sante, Fondation de France and Laboratoire Lilly funded this study. Westeel reports no relevant financial disclosures. Other researchers report nonfinancial support from Amgen, Boehringer Ingelheim, Bristol-Myers Squibb and Pfizer; and personal fees from AbbVie, Boehringer Ingelheim, Clovis and Eli Lilly.