Randomized trial of thoracic radiotherapy with or without concurrent daily low-dose carboplatin in elderly patients with locally advanced non-small cell lung cancer (NSCLC): Long-term follow-up of Japan Clinical Oncology Group (JCOG) Study JCOG0301.

Abstract

8532 Background: In the phase III JCOG0301 trial, concurrent chemoradiotherapy (CRT) was compared with radiotherapy (RT), demonstrating clinically significant survival benefits in elderly patients with locally advanced NSCLC after a median follow-up of 19.4 months. However, the long-term patterns and cumulative incidences of toxicity associated with CRT and RT are poorly understood for elderly patients. We report long-term survival data and late toxicities after a minimum follow-up of 6.4 years. Methods: Eligible patients were older than 70 years and had unresectable stage III NSCLC. They were randomly assigned to RT alone (RT arm: irradiation with 60 Gy in 30 fractions) or CRT (CRT arm: the same RT with additional concurrent use of carboplatin 30 mg/m2 per fraction up to the first 20 fractions). The primary endpoint was overall survival (OS). Prognosis and adverse events data were collected beyond those in the initial report of this trial. Kaplan-Meier survival curves and 3- and 5-year survival proportions were calculated. Late toxicities were defined as occurring later than 90 days after RT initiation. Results: From September 2003 to May 2010, 200 patients (RT arm, n = 100; CRT arm, n = 100) were enrolled. Consistent with the initial report, the CRT arm had better OS than the RT arm (HR = 0.743, 95% CI = 0.552 – 0.998, one-sided p = 0.0239 by stratified log-rank test). In the RT and CRT arms, median OS was 16.5 and 21.7 months, 3-year survival was 16.3% and 34.3%, and 5-year survival was 9.2% and 15.2%, respectively. %Grade 3/4 late toxicities were 7.4% (heart 2.1%, lung 5.3%) in the RT arm (n = 94) and 7.5% (esophagus 1.1%, lung 6.5%) in the CRT arm (n = 93). No additional cases of late toxicity (Grade 3/4) were seen since the initial report. There were 7 treatment-related deaths, all of which were recorded in the initial report: 4 (4.0%) in the RT arm and 3 (3.0%) in the CRT arm. Conclusions: Long-term follow-up confirms the survival benefits of CRT for elderly patients with locally advanced NSCLC. There was no observed increase in late toxicity with CRT, as compared with RT alone. Clinical trial information: 00132665.