Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2018 Oct 11;13(1):199.
doi: 10.1186/s13014-018-1144-5.

Clinical outcomes of image-guided proton therapy for histologically confirmed stage I non-small cell lung cancer

Koichiro Nakajima  1   2 , Hiromitsu Iwata  3   4 , Hiroyuki Ogino  3   4 , Yukiko Hattori  3 , Shingo Hashimoto  3 , Toshiyuki Toshito  5 , Kensuke Hayashi  6 , Kenji Akita  7 , Fumiya Baba  8 , Katsumi Nakamae  9 , Jun-Etsu Mizoe  3   10 , Yuta Shibamoto  4
Affiliations
Clinical Trial

Clinical outcomes of image-guided proton therapy for histologically confirmed stage I non-small cell lung cancer

Koichiro Nakajima et al. Radiat Oncol. .

Abstract

Background: Two prospective phase II trials were designed to assess the efficacy and safety of image-guided proton therapy (IGPT) for either medically inoperable or operable stage I non-small cell lung cancer (NSCLC). The present study reports the interim results of these trials.

Methods: Fifty-five patients with histologically confirmed stage I NSCLC (IA in 33 patients and IB in 22 patients; inoperable in 21 patients and operable in 34 patients) who received IGPT between July 2013 and February 2017 were analyzed. The median patient age was 71 years (range: 48-88 years). IGPT with fiducial metallic marker matching was performed for suitable patients, and a respiratory gating method for motion management was used for all treatments. Peripherally located tumors were treated with 66 Gy relative biological effectiveness equivalents (Gy(RBE)) in 10 fractions (n = 49) and centrally located tumors were treated with 72.6 Gy(RBE) in 22 fractions (n = 6). Treatment associated toxicities were evaluated using Common Toxicity Criteria for Adverse Events (v.4.0).

Results: Median follow-up was 35 months (range: 12-54 months) for survivors. For all patients, the 3-year overall survival, progression-free survival, and local control rates were 87% (95% confidence interval: 73-94%), 74% (58-85%), and 96% (83-99%), respectively. Fiducial marker matching was used in 39 patients (71%). Grade 2 toxicities observed were radiation pneumonitis in 5 patients (9%), rib fracture in 2 (4%), and chest wall pain in 5 (9%). There were no grade 3 or higher acute or late toxicities.

Conclusions: IGPT appears to be effective and well tolerated for all patients with stage I NSCLC.

Trial registration: Lung-001, 13-02-09 (9), registered 11 June 2013 and Lung-002, 13-02-10 (10), registered 11 June 2013.

Keywords: Fiducial metallic marker; Image-guided proton therapy; Proton therapy; Respiratory gating system; Stage I non-small cell lung cancer.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

The data of this study was extracted from ongoing prospective phase II clinical trials based on protocols approved by the Institutional Review Board (IRB) of Nagoya City Hospital. The IRB numbers are 13–02-09 (9) and 13–02-10 (10). Informed consent was obtained from each participant. The study was conducted in accordance with the Declaration of Helsinki.

Consent for publication

We obtained written informed consent to publish the article from patients.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
a IGTV volume definition. IGTV-all consisted of GTV and GTVs across all respiratory phases. IGTV-gate consisted of GTV and all GTVs within the gating window around phase 50%. The latter was only used for patients whose tumor moved more than 10 mm in any direction. b Schema of the respiratory gating system. Beams turned on only when the monitored respiratory phase was within the predefined gating window. The gate level was defined for each patient by reference to the amplitude of tumor movement
Fig. 2
Fig. 2
Study flow diagram. Lung-001 was for medically inoperable patients and Lung-002 was for operable patients who refused surgery
Fig. 3
Fig. 3
Kaplan-Meier curves for local control a, progression-free survival (b) and overall survival (c) for all patients, medically inoperable and operable groups
See this image and copyright information in PMC

References

    1. Solda F, Lodge M, Ashley S, et al. Stereotactic radiotherapy (SABR) for the treatment of primary non-small cell lung cancer; systematic review and comparison with a surgical cohort. Radiother Oncol. 2013;109:1–7. doi: 10.1016/j.radonc.2013.09.006. - DOI - PubMed
    1. Eriguchi T, Takeda A, Sanuki N, et al. Stereotactic body radiotherapy for operable early-stage non-small cell lung cancer. Lung Cancer. 2017;109:62–67. doi: 10.1016/j.lungcan.2017.04.022. - DOI - PubMed
    1. Chang JY, Senan S, Marinus AP, et al. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials. Lancet Oncol. 2015;16:630–637. doi: 10.1016/S1470-2045(15)70168-3. - DOI - PMC - PubMed
    1. Shibamoto Y, Hashizume C, Baba F, et al. Stereotactic body radiotherapy using a radiobiology-based regimen for stage I non-small-cell lung cancer: five-year mature results. J Thorac Oncol. 2015;10:960–964. doi: 10.1097/JTO.0000000000000525. - DOI - PubMed
    1. Macdonald OK, Kruse JJ, Miller JM, et al. Proton beam radiotherapy versus three-dimensional conformal stereotactic body radiotherapy in primary peripheral, early-stage non-small-cell lung carcinoma: a comparative dosimetric analysis. Int J Radiat Oncol Biol Phys. 2009;75:950–958. doi: 10.1016/j.ijrobp.2009.04.023. - DOI - PubMed

Publication types

MeSH terms