1288PD - Randomized Phase II Trial Comparing Chemoradiotherapy with Chemotherapy for Completely Resected Unsuspected N2-Positive Non-Small Cell Lung Cancer

Date 11 September 2017
Event ESMO 2017 Congress
Session Non-metastatic NSCLC and other thoracic malignancies
Topics Anti-Cancer Agents & Biologic Therapy
Cancer in Adolescents
Non-Small-Cell Lung Cancer, Locally Advanced
Lung and other Thoracic Tumours
Surgery and/or Radiotherapy of Cancer
Presenter Jong-Mu Sun
Citation Annals of Oncology (2017) 28 (suppl_5): v457-v459. 10.1093/annonc/mdx379
Authors J. Sun1, M. Ahn1, J.S. Ahn1, H.K. Kim2, Y.C. Ahn3, J.I. Zo2, Y.M. Shim2, K. Park1
  • 1Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 2Thoracic And Cardiovascular Surgery, Samsung Medical Center Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 3Radiation Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, 06351 - Seoul/KR

Abstract

Background

We investigated whether concurrent chemoradiotherapy (CCRT) would increase survival in patients with completely resected unsuspected N2-positive non-small cell lung cancer (NSCLC), compared with adjuvant chemotherapy alone.

Methods

Eligible patients were randomly assigned (1:1 ratio) 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 three-week intervals. In the chemotherapy arm, patients received four cycles of adjuvant paclitaxel (175 mg/m2) and carboplatin (AUC 5.5) every three weeks. The primary endpoint was disease-free survival.

Results

We enrolled and analyzed 101 patients. 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 [HR] 0.94, 95% CI: 0.58–1.52, P = 0.40). There was no difference in overall survival (CCRT: 74.3 months, chemotherapy: 83.5 months, HR: 1.33, 95% CI: 0.71–2.49). Subgroup analysis showed chemotherapy alone increased overall survival in never-smokers and multi-station N2-positive patients. The pattern of disease recurrence was similar between the two arms.

Conclusions

There was no survival benefit from adjuvant CCRT compared with 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.

Clinical trial identification

(NCT01066234)

Legal entity responsible for the study

Keunchil Park

Funding

None

Disclosure

All authors have declared no conflicts of interest.