MADRID, Spain ― Current recommendations for CT scanning as part of ongoing follow-up for patients with completely resected non–small cell lung cancer (NSCLC) have been called into question, after data from a randomized trial showed that the practice offers no survival benefit.
Major international guidelines, including recent guidelines for NSCLC from the European Society for Medical Oncology (ESMO), recommend intensive follow-up, including CT scans, every 3 to 6 months during the first 2 years after successful surgery.
But a group of French researchers from the Intergroupe Francophone de Cancerologie Thoracique (IFCT) have shown that less intensive follow-up with clinical examinations and chest X-rays achieves comparable survival rates.
The finding comes from the IFCT-0302 study, a randomized, controlled trial of more than 1700 patients who underwent complete resection for stage I, II, or IIIA NSCLC.
Full details will be presented next week at the ESMO 2017 Congress in Madrid, Spain, during a presidential symposium held on Saturday, September 9 (abstract 12730). The congress press committee presented the data early in a press release.
Lead author Virginie Westeel, MD, PhD, from Centre Hospitalier Régional Universitaire, Hôpital Jean Minjoz, in Besançon, France, said in that release that, because there was no difference in survival with either of the two types of follow-up, “both follow-up protocols are acceptable.
“A conservative point of view would be to do a yearly CT scan, which might be of interest over the long term,” she said. “However, doing regular scans every 6 months may be of no value in the first 2 postoperative years.”
However, ESMO expert Floriana Morgillo, MD, PhD, from the University of Campania Luigi Vanvitelli, Naples, Italy, who was not involved in the study, pointed out that there was a trend toward better survival with CT follow-up, suggesting it may eventually yield a benefit.
She believes that currently, CT-based surveillance remains an appropriate choice, although patients should be informed of the associated radiation exposure.
“A significant proportion of patients with early-stage NSCLC develop second cancers between the second and fourth year after surgery,” Dr Morgillo said, “and early detection of these with CT-based surveillance beyond 2 years could allow curative treatment.”
In an interview with Medscape Medical News, Solange Peters, MD, PhD, the ESMO Congress press officer, who is from the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, highlighted this study as one of several to be presented at ESMO 2017 that challenge daily practice and received wisdom regarding patient follow-up.
She said that, because intensive follow-up with chest CT scanning is included in both the American Society of Clinical Oncology recommendations and the ESMO guidelines, the researchers felt that a large, randomized study was necessary to determine the effect on survival of such a strategy in completely resected NSCLC.
Study Details
The IFCT-0302 trial compared two approaches to follow-up: in the experimental arm, patients underwent clinical examination, chest X-ray, and thoraco-abdominal CT scanning, as well as optional bronchoscopy for adenocarcinomas. In the control arm, patients underwent clinical examination and chest X-ray.
The trial included 1775 patients with completely resected stage I, II, IIIA, and T4 N0-2 NSCLC. In both arms of the trial, follow-up was conducted every 6 months for 2 years, and then once a year for 5 years. In patients who developed symptoms, supplementary procedures were permitted.
The median age of the participants was 63 years, and 76.3% were men. Squamous cell and large cell carcinomas were identified in 39.5% of the patients; 68.1% had stage I disease, 13.7% stage II disease, and 18.3% stage III disease.
Lobectomy or bilobectomy was performed in 86.6% of patients. Preoperative and/or postoperative radiotherapy was performed in 8.7% of patients; 45% of participants underwent preoperative and/or postoperative chemotherapy.
There were no significant differences in baseline characteristics between patients who underwent follow-up involving CT scanning and those who underwent only clinical examinations and chest radiography.
Over a median follow-up of 8.7 years, there were no significant difference in overall survival between the two follow-up groups. The median follow-up period was 8.2 years in the experimental arm and 10.3 years in the control arm (hazard ratio [HR], 0.92; P = .27).
There were only minor differences between the groups in rates of 3-year disease-free survival, at 63.3% in the experimental arm and 60.2% among control patients. A similar pattern was seen for 8-year overall survival rates, at 51.1% and 55.6%, respectively.
The team notes that the IFCT-0302 trial is the first randomized study of follow-up in resected NSCLC. The primary endpoint of overall survival was not significantly different between the study arms. They suggest that “a longer follow-up is necessary not to miss a potential long-term OS benefit of CT-scan-based surveillance.”
The trial was funded by the Ministère de la Santé (PHRC), Fondation de France, and Laboratoire Lilly. One coauthor received nonfinancial support from Amgen and Pfizer, personal fees from AbbVie, personal fees and nonfinancial support from Boehringer Ingelheim, nonfinancial support from BMS, and personal fees from Clovis and Lilly. All other authors have disclosed no relevant financial relationships.
European Society for Medical Oncology (ESMO) 2017 Congress. Abstract 1273O, to be presented September 9, 2017.
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