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O14 - Radiotherapy - Toxicity and Clinical Trials (ID 105)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Radiation Oncology + Radiotherapy
- Presentations: 1
- Moderators:G. Pratt, S.K. Vinod
- Coordinates: 10/29/2013, 10:30 - 12:00, Parkside Ballroom A, Level 1
O14.05 - Effect of Postoperative 3D-Conformal Radiotherapy (3DCRT) for Patients with pIIIA-N2 non-small-cell lung cancer (NSCLC) after Complete Resection and Adjuvant Chemotherapy: Interim Analysis of a Prospective Phase III Study (ID 2299)
10:30 - 12:00 | Author(s): Z. Xiao
For patients with completely resected pⅢA-N2 NSCLC, the role of postoperative radiotherapy (PORT) is not well defined. 3D-conformal radiotherapy (3DCRT) can deliver high dose to the target volume while decreasing the toxicity of normal tissues, which may improve the treatment outcomes. This interim analysis of our phase III randomized clinical trial (NCT00880971) is to evaluate the effect of postoperative 3DCRT on the overall survival (OS) and failure pattern in pⅢA-N2 NSCLC patients after complete resection and adjuvant chemotherapy.
Between Jan. 2009 and May 2012, 128 consecutive patients with pⅢA-N2 NSCLC, after complete resection and four courses of platinum based chemotherapy, were randomized into PORT group or control group. Only patients who had finished the first follow-up 3 months after treatment were included in this interim analysis. PORT, using 3D conformal techniques, was 60 Gy by 30 fractions to the subcarinal nodes, ipsilateral mediastinum and ipsilateral hilum. The effect of PORT on survival was evaluated with Kaplan-Meier method and log-rank test. The treatment failure pattern was also analyzed. Pearson chi-Square test was used to compare the constituent ratios in different groups.
Totally 96 patients were analyzed, including 49 in the PORT group and 47 in the control group. The clinical features were comparable between the two groups. For all the patients, the 3-y OS, disease free survival (DFS), loco-regional recurrence free survival (LRFS) and distant metastasis free survival (DMFS) were 68.4%, 54.6%, 68.6% and 63.0%, respectively. The survival rates of patients in the PORT and control groups are listed in the table. PORT markedly increased the 3-y OS, DFS, LRFS and DMFS by 21.6%, 18.7%, 16.4% and 20.4%, respectively. But the difference was not statistically significant due to the limited samples. There were 33 patients (34.3%) with treatment failure, including 7 (7.3%) with loco-regional recurrence only, 13 (13.5%) with distant metastasis only, and 13 (13.5%) with the both. PORT markedly decreased the loco-regional recurrence from 27.7% to 14.3% (P=0.107), but not the distant metastasis (from 29.8% to 24.5%, P=0.559). Eight deaths were observed up to the last follow-up, which were all caused by cancer progression. No death caused by radiation toxicities was observed.
*Between PORT and control groups.
All Patients (n=96) PORT Group (n=49) Control Group (n=47) P Value* OS 68.4% 80.8% 59.2% 0.432 DFS 54.6% 64.2% 45.5% 0.256 LRFS 68.6% 76.4% 60.0% 0.105 DMFS 63.0% 67.1% 46.7% 0.542
For pⅢA-N2 NSCLC patients after complete resection and adjuvant chemotherapy, postoperative 3DCRT can markedly improve the survival and loco-regional control. Further accumulation of patients in our prospective randomized study is warranted.
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