Randomized Phase II Study of Preoperative Chemoradiotherapy ± Panitumumab Followed by Consolidation Chemotherapy in Potentially Operable Locally Advanced (Stage IIIa, N2+) Non-Small Cell Lung Cancer: NRG Oncology RTOG 0839.

Authors

• Martin J Edelman
• Chen Hu
• Quynh-Thu Le
• Jessica S Donington
• Warren D D'Souza
• Adam P Dicker
• Billy W Loo
• Elizabeth M Gore
• Gregory M M Videtic
• Nathaniel R Evans
• Joseph W Leach
• Maximilian Diehn
• Steven J Feigenberg
• Yuhchyau Chen
• Rebecca Paulus
• Jeffrey D Bradley

Publication/Presentation Date

9-1-2017

Abstract

INTRODUCTION: Multimodality therapy has curative potential in locally advanced NSCLC. Mediastinal nodal sterilization (MNS) after induction chemoradiotherapy (CRT) can serve as an intermediate marker for efficacy. NRG Oncology Radiation Therapy Oncology Group (RTOG) 0229 demonstrated the feasibility and efficacy of combining full-dose radiation (61.2 Gy) with chemotherapy followed by resection and chemotherapy. On the basis of that experience and evidence that EGFR antibodies are radiosensitizing, we explored adding panitumumab to CRT followed by resection and consolidation chemotherapy in locally advanced NSCLC with a primary end point of MNS.

METHODS: Patients with resectable locally advanced NSCLC were eligible if deemed suitable for trimodality therapy before treatment. Surgeons were required to demonstrate expertise after CRT and adhere to specific management guidelines. Concurrent CRT consisted of weekly carboplatin (area under the curve = 2.0), paclitaxel (50 mg/m

RESULTS: The study was opened in November 2010 and closed in August 2015 by the Data Monitoring Committee after 71 patients had been accrued for futility and excessive toxicity in the experimental arm. A total of 60 patients were eligible: 19 patients (86%) who received CRT and 29 (76%) who received CRT plus panitumumab and underwent an operation. With regard to postoperative toxicity, there were three grade 4 adverse events (13.6%) and no grade 5 adverse events (0%) among those who received CRT versus six grade 4 (15.8%) and four grade 5 adverse events (10.5%) among those who received CRT plus panitumumab. The MNS rates were 68.2% (95% confidence interval: 45.1-86.1) and 50.0% (95% confidence interval: 33.4-66.6) for CRT and CRT plus panitumumab, respectively (p = 0.95).

CONCLUSION: The addition of panitumumab to CRT did not improve MNS. There was an unexpectedly high mortality rate in the panitumumab arm, although the relationship to panitumumab is unclear. The control arm had outcomes similar to those in NRG Oncology RTOG 0229.

Volume

12

Issue

9

First Page

1413

Last Page

1420

ISSN

1556-1380

Published In/Presented At

Edelman, M. J., Hu, C., Le, Q. T., Donington, J. S., D'Souza, W. D., Dicker, A. P., Loo, B. W., Gore, E. M., Videtic, G. M. M., Evans, N. R., Leach, J. W., Diehn, M., Feigenberg, S. J., Chen, Y., Paulus, R., & Bradley, J. D. (2017). Randomized Phase II Study of Preoperative Chemoradiotherapy ± Panitumumab Followed by Consolidation Chemotherapy in Potentially Operable Locally Advanced (Stage IIIa, N2+) Non-Small Cell Lung Cancer: NRG Oncology RTOG 0839. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 12(9), 1413–1420. https://doi.org/10.1016/j.jtho.2017.06.007

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

28629896

Department(s)

Administration and Leadership

Document Type

Article