Randomized chemoradiation for patients with locally advanced inoperable non-small cell lung cancer (NSCLC): Long-term follow-up of RTOG 92-04

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7147 Background: Although concurrent chemoradiotherapy (CT/RT) is associated with increased survival for patients (pts) with locally advanced non-small cell lung cancer (NSCLC), long-outcomes beyond 5 years have not been fully analyzed. Methods: Between 1994 and 1999, we conducted two phase II studies examining concurrent CT/RT for treatment of surgically unresectable stage IIIA or IIIB NSCLC. One regimen consisted of three cycles of 5-fluorouracil 500mg/m2 and cisplatin 20mg/m2, days 1–5, every 4 weeks and concurrent hyperfractionated thoracic RT (1.25Gy twice daily, total 62.5–70Gy) [FP-TRT] (Segawa et al. BJC 82, 2000). The other consisted of docetaxel 40mg/m2 and cisplatin 40mg/m2, days 1, 8, 29 and 36 and concurrent thoracic RT (2Gy daily, total 60Gy) [DP-TRT] (Kiura et al. BJC 89, 2003). Long-term data is presented. Results: In 50 pts treated with FP-TRT, the median survival time (MST) was 1.6 years (yr; 95% confidential interval [CI]: 0.91 - 2.25 yr) by a median follow-up time of 10.4 yr and the actual 5 yr-survival rate was 30%. In 15 long-term survivors, 3 and 2 pts died due to primary NSCLC and secondary primary cancer (SPC), respectively, 1 was lost to follow-up, and 9 are still alive. In 42 pts treated with DP-TRT, the MST was 2.1 yr (95% CI: 0.82 - 2.48 yr) by a median follow-up time of 6.3 yr and the actual 5 yr-survival rate was 31%. In 13 long-term survivors, 1 pt died due to primary NSCLC, 1 died due to SPC, 1 was lost to follow-up, and 10 are still alive. Overall, 7 of 92 pts enrolled in these studies developed SPCs (2 NSCLC, 1 small cell lung cancer, 2 esophageal cancers, 2 gall bladder cancers) although no pts developed leukemia or myelodysplastic syndrome. An observed incidence rate of SPCs was 2356.1/100,000 (95% CI: 947.6 - 4856.0). Cumulative incidence was 5.8% (standard error [SE] 4.0%) at 5 yr, 10.0% (SE 5.6%) at 8 yr and 60.8% (SE 18.9%) at 10 yr. The median time from the beginning of CT/RT to the diagnosis of SPC was 9.6 yr (95% CI: 8.1 - 11.1 yr). Conclusions: Approximately 30% of pts survived more than 5 years after concurrent CT/RT, however, they were still at risk of dying from primary NSCLC. Occurrence of SPC in long-term survivors should be concerned in follow-up. No significant financial relationships to disclose.


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