OA 16.03 Recurrences and 2nd Primary Cancers in the IFCT-0302 Trial Assessing a CT-Scan-Based Follow-Up after Lung Cancer Surgery

The IFCT-0302 trial is the first large randomized phase III multicenter trial which compared two follow-up modalities after surgery for early stage non-small cell lung cancer (NSCLC). After complete resection of a stage pI, II, IIIA or T4 (pulmonary nodules in the same lobe) N0-2 NSCLC (TNM 6th edition), patients were randomized (1/1) between 2 follow-up programs: - arm 1, clinical examination and Chest X-ray, - arm 2, clinical examination, Chest X-ray, thoraco-abdominal CT-scan plus bronchoscopy (optional for adenocarcinomas). In both arms, procedures were repeated every 6 months after randomization during the first 2 years, and yearly until 5 years. The primary endpoint was overall survival (OS). Distinction between lung recurrences and 2nd primary lung cancer was assessed by investigators, using the Martini and Melamed definition (J Thorac Cardiovasc Surg 1975). 1775 patients were randomized (arm 1: 888; arm 2: 887). Patient characteristics were well-balanced between the two arms: males 76.3%, median age 63 years (range: 34-88), squamous and large cell carcinomas 39.5%, stage I 68.1%, stage II 13.7%, stage III 18.3%, lobectomy or bilobectomy 86,6%. OS and DFS were not significantly different between arms (OS: HR=0.92, 95% CI: 0.8-1.07; p=0.27). Median disease-free survival was 4.95 years (95% CI: 4.4- not reached) in arm 1 and not reached in arm 2, respectively. A recurrence was diagnosed in 245 patients (27.6%) in arm 1, and in 291 patients (32.8%) in arm 2. Recurrences were symptomatic in 203 (82.9%) and 163 (56.0%) patients, respectively. The most frequent sites of recurrence were: ipsilateral lung (42.0 and 33.0%), brain (29.4 and 23.4%), and contralateral lung (24.9 and 22.3%), respectively. Treatment of recurrence achieved complete remission in 25 (10.2%) and 52 (17.9%) patients (p=0.01), respectively. Second primary cancers (SPC) were diagnosed in 101 patients (11.4%) in arm 1, and 97 patients (10.9%) in arm 2, with symptoms at diagnosis in 64 (63.4%) and 37 (38.1%) patients, respectively. The most frequent sites of SPC were: lung (25.7 and 41.2%), prostate (14.8 and 11.3%), and ENT (11.9 and 7.2%), respectively. Treatment of SPC achieved complete remission in 30 (29.7%) and 40 (41.2%) patients (p=0.10), respectively. Although OS and DFS were not significantly increased by thoraco-abdominal CT-scan-based follow-up, recurrences or SPCs were more frequently asymptomatic and amenable to curative treatment in patients followed by thoraco-abdominal CT scan compared to those followed by chest X-ray only.