Long-term outcome of phase I/II prospective study of dose-escalated proton therapy for early-stage non-small cell lung cancer.

Abstract

PURPOSE:

The aim of this phase I/II study was to assess the long-term clinical benefits and toxicities of proton beam therapy for medically inoperable early-stage non-small cell lung cancer (NSCLC).

PATIENTS AND METHODS:

From June 2006 to September 2011, 35 patients with medically inoperable T1N0M0 (central or superior location, 12 patients) or T2-3N0M0 (any location, 23 patients) NSCLC were treated with 87.5Gy at 2.5Gy/fraction of proton therapy. Toxicities were scored according to the Common Terminology Criteria for Adverse Events, version 4.0.

RESULTS:

The median follow-up time was 83.1months (95% CI: 69.2-97.1months). For all 35 patients, the 1, 3, and 5-year overall survival rates were 85.7%, 42.9%, and 28.1%, respectively. The 5-year local recurrence-free, regional recurrence-free, and distant metastasis-free survival rates were 85.0%, 89.2%, and 54.4%, respectively. Different T stages had no effect on local and regional recurrence (p=0.499, p=1.00). However, with the increase in T stages, the distant metastasis rate increased significantly (p=0.006). The most common adverse effects were dermatitis (grade 2, 51.4%; grade 3, 2.9%) and radiation pneumonitis (grade 2, 11.4%; grade 3, 2.9%). Other grade 2 toxicities included esophagitis (2.9%), rib fracture (2.9%), heart toxicities (5.7%), and chest wall pain (2.9%).

CONCLUSIONS:

According to our long-term follow-up data, proton therapy with ablative doses is well tolerated and effective in medically inoperable early-stage NSCLC. Systemic therapy should be considered to reduce the rate of distant metastasis in cases of T2 and T3 lesions.

• Authors: Joe Y Chang, Wencheng Zhang, Ritsuko Komaki, Noah C Choi, Shen Chan, Daniel Gomez, Michael O'Reilly, Melenda Jeter, Michael Gillin, Xiaorong Zhu, Xiaodong Zhang, Radhe Mohan, Stephen Swisher, Stephen Hahn, James D Cox
• Journal: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology (Radiother Oncol) Vol. 122 Issue 2 Pg. 274-280 (02 2017) ISSN: 1879-0887 [Electronic] Ireland
• PMID: 28139305 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article)
• Copyright: Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Topics

• Aged
• Aged, 80 and over
• Carcinoma, Non-Small-Cell Lung (mortality, pathology, radiotherapy)
• Female
• Follow-Up Studies
• Humans
• Lung Neoplasms (mortality, pathology, radiotherapy)
• Male
• Neoplasm Staging
• Positron Emission Tomography Computed Tomography
• Prospective Studies
• Proton Therapy (adverse effects)
• Radiotherapy Dosage
• Survival Rate