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OA12 - Profiling the Multidisciplinary Management of Stage III NSCLC (ID 144)
- Event: WCLC 2019
- Type: Oral Session
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Now Available
OA12.06 - A Prospective Randomized Phase Ⅲ Study of Precise PORT for Patients with pⅢA-N2 NSCLC After Complete Resection and Adjuvant Chemotherapy (Now Available) (ID 2487)
15:45 - 17:15 | Author(s): Dongfu Chen
For patients with completely resected pⅢA-N2 non-small cell lung cancer (NSCLC), the role of postoperative radiotherapy (PORT) is not well defined. 3D-conformal or simplified intensity modulated radiotherapy (3D-CRT/sIMRT) can precisely deliver high dose to the target volume while decreasing the toxicity of normal tissues, which may improve the treatment outcomes. This phase III randomized clinical trial (NCT00880971) is designed to evaluate the effect of precise PORT on survival and failure pattern in patients with pⅢA-N2 NSCLC after complete resection and adjuvant chemotherapy.Method
After complete resection and four cycles of platinum based chemotherapy, patients with pⅢA-N2 NSCLC were randomized equally into PORT group or observation group. Using 3D-CRT/sIMRT techniques, PORT of 50 Gy by 25 fractions was given to the ipsilateral hilum, subcarinal region and ipsilateral mediastinum. The primary endpoint was disease free survival (DFS). Secondary endpoints include overall survival (OS), loco-regional recurrence free survival (LRFS), distant metastasis free survival (DMFS) and toxicity. Targeted accrue was 360 patients. With at least 230 DFS events it was designed to detect an improvement in 3-year DFS from 30% to 44% (equivalent to HR=0.69) at 1-sided type 1 error of 0.025 with 80% power. Intent-to-treat populations is used for primary analyses, supplemented with sensitivity analyses using per-protocol population. Log-rank test is used for time-to-event data comparisons.Result
Between Jan. 2009 and Dec. 2017, 364 consecutive eligible patients were randomized, including 184 in the PORT group and 180 in the observation group. For this initial reporting of planned final analysis, as Jan 31, 2019, 230 DFS events were reported and the median follow up time was 53.3 months. The clinical features were comparable between the two groups. The 3-year DFS rates in PORT and observation were 42.7% vs. 34.5% (mDFS: 26.5 vs 22.7 months, HR=0.85, 95% CI: 0.65-1.10, 1-sided p=0.10), with OS of 81.5% vs. 85.4% (mOS: not reached vs 90.9 months, HR=1.01, 95% CI: 0.68-1.51, 2-sided p=0.94), LRFS of 69.8% vs. 62.4% (HR=0.71, 95% CI: 0.51-0.97, 2-sided p=0.03), and DMFS of 44.8% vs. 43.5% (HR=0.93, 95% CI 0.71-1.22, 2-sided p=0.60), respectively. For 310 per-protocol patients (140 with PORT and 170 without PORT), PORT marginally improve the DFS (44.8% vs 32.6%, HR=0.76, 95% CI: 0.57-1.00, 2-sided p=0.05), but not OS (85.7% vs 85.0%, HR=0.83, 95% CI: 0.53-1.30, p=0.41). Relapses of any type were observed in 110 (59.8%) and 116 patients (64.4%) in the PORT and observation groups, respectively. Forty-seven over 50 deaths (94.0%) in the PORT group and 42 over 47 deaths (89.4%) in the observation group died of cancer progression, respectively. No radiotherapy-related grade 5 AE was observed.
For pⅢA-N2 NSCLC patients after complete resection and adjuvant chemotherapy, precise PORT has not been shown to significantly improve DFS or OS , though it can significantly improve LRFS.
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