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An Ontario Clinical Oncology Group (OCOG) randomized trial (PET START) of FDG PET/CT in patients with stage III non-small cell lung cancer (NSCLC): Predictors of overall survival.

7018 Background: Patients with stage 3 NSCLC are potentially curable using combined modality therapy (CMT) with chemotherapy and radical radiation therapy (RT). PET/CT imaging is commonly used to stage patients with NSCLC. In addition, PET/CT for planning of RT may improve the definition of RT treatment volumes compared with conventional CT planning and thus improve outcomes.


METHODS
Patients with stage 3 NSCLC, who were considered candidates for CMT, were randomized to either PET/CT or CT alone for RT treatment planning. The proportion of patients who did not receive CMT because their tumor was upstaged to stage 4 or their intra-thoracic tumor was too extensive for radical RT was presented at the ASCO 2009 meeting. The secondary outcomes of overall survival (OS) and relationship of the standard uptake value (SUV) and OS are reported now.


RESULTS
Overall 310 patients were randomized, 152 to the PET/CT and 158 to standard CT planning. 118 (78%) of the 152 patients randomized to the PET/CT arm received radical RT compared with 146 (92%) of the 158 CT patients. The median follow-up was 17 months. The 2-year OS of the PET/CT group was 47% compared with 39% for the CT arm (hazard ratio [HR] = 0.8; 95% confidence interval [CI]: 0.6 - 1.0). A multivariable analysis (MVA) for OS indicated that in addition to the intervention, stage (3B vs 3A; HR = 1.4, 95% CI: 1.1 - 1.9) and ECOG status (HR = 1.7 per unit increase, 95% CI: 1.3 - 2.6) were predictive of OS. In the 142 PET/CT patients with complete PET scans, a MVA showed that SUV (HR = 1.03 per unit increase, 95% CI: 1.01 - 1.05) and stage (3B vs 3A; HR = 1.9, 95% CI: 1.2 - 3.0) were strong predictors of OS.


CONCLUSIONS
The PET START trial is the first randomized trial comparing PET/CT planning with standard CT planning in patients with NSCLC. As expected, the use of PET/CT resulted in fewer patients receiving radical RT. The OS trend favoring PET/CT may be primarily due to more accurate staging. The SUV and stage were strong predictors of OS in patients with stage 3 NSCLC.