Randomized Phase II Trial Comparing Chemoradiotherapy with Chemotherapy for Completely Resected Unsuspected N2-Positive Non-Small Cell Lung Cancer
Jong-Mu Sun, Jae Myung Noh, Dongryul Oh, Hong Kwan Kim, Se-Hoon Lee, Yong Soo Choi, Hongryull Pyo, Jin Seok Ahn, Sin-Ho Jung, Yong Chan Ahn, Jhingook Kim, Myung-Ju Ahn, Jae Ill Zo, Young Mog Shim, Keunchil Park, Jong-Mu Sun, Jae Myung Noh, Dongryul Oh, Hong Kwan Kim, Se-Hoon Lee, Yong Soo Choi, Hongryull Pyo, Jin Seok Ahn, Sin-Ho Jung, Yong Chan Ahn, Jhingook Kim, Myung-Ju Ahn, Jae Ill Zo, Young Mog Shim, Keunchil Park
Abstract
Introduction: We investigated whether concurrent chemoradiotherapy (CCRT) would increase survival in patients with completely resected unsuspected N2-positive NSCLC versus in patients who received adjuvant chemotherapy alone.
Methods: Eligible patients were randomly assigned (1:1) to either the CCRT arm or the chemotherapy arm. In the CCRT arm, patients received concurrent thoracic radiotherapy (50 Gy in 25 fractions) with five cycles of weekly paclitaxel (50 mg/m2) and cisplatin (25 mg/m2), followed by two additional cycles of paclitaxel (175 mg/m2) plus cisplatin (80 mg/m2) at 3-week intervals. In the chemotherapy arm, patients received four cycles of adjuvant paclitaxel (175 mg/m2) and carboplatin (area under the curve = 5.5) every 3 weeks. The primary end point was disease-free survival.
Results: We enrolled and analyzed 101 patients (51 received CCRT and 50 received chemotherapy). In all, 74 and 27 patients were preoperatively staged as N0 and N1 diseases, respectively. The baseline characteristics were well balanced between the two arms. The median disease-free survival of the CCRT arm was 24.7 months, which was not significantly different from that of the chemotherapy arm (21.9 months) (hazard ratio = 0.94, 95% confident interval: 0.58-1.52, p = 0.40). There was no difference in overall survival (74.3 months in CCRT arm and 83.5 months in the chemotherapy arm) (hazard ratio = 1.33, 95% confident interval: 0.71-2.49).
Conclusions: There was no survival benefit from adjuvant CCRT compared with from platinum-based chemotherapy alone for completely resected unsuspected N2-positive NSCLC. However, the role of sequential radiotherapy administered after adjuvant chemotherapy is being evaluated, and further study is needed to evaluate the optimal radiotherapy approach for completely resected N2-positive NSCLC.
Trial registration: ClinicalTrials.gov NCT01066234.
Keywords: Adjuvant concurrent chemoradiotherapy; Adjuvant radiotherapy; Non–small cell lung cancer; Unsuspected N2 lymph node.
Copyright © 2017 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
Source: PubMed