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OA 16 - Treatment Strategies and Follow Up (ID 686)
- Event: WCLC 2017
- Type: Oral
- Track: Early Stage NSCLC
- Presentations: 1
OA 16.03 - Recurrences and 2<Sup>Nd</Sup> Primary Cancers in the IFCT-0302 Trial Assessing a CT-Scan-Based Follow-Up after Lung Cancer Surgery (ID 9006)
14:30 - 16:15 | Author(s): S. Dehette
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 6[th] 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 2[nd] 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.
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