+ Site Statistics
References:
54,258,434
Abstracts:
29,560,870
PMIDs:
28,072,757
+ Search Articles
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ PDF Full Text
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Translate
+ Recently Requested

Phase 2 Study of Stereotactic Body Radiation Therapy and Stereotactic Body Proton Therapy for High-Risk, Medically Inoperable, Early-Stage Non-Small Cell Lung Cancer



Phase 2 Study of Stereotactic Body Radiation Therapy and Stereotactic Body Proton Therapy for High-Risk, Medically Inoperable, Early-Stage Non-Small Cell Lung Cancer



International Journal of Radiation Oncology, Biology, Physics 101(3): 558-563



To report the feasibility of conducting a randomized study to compare the toxicity and efficacy of stereotactic body radiation therapy (SBRT) versus stereotactic body proton therapy (SBPT) for high-risk, medically inoperable, early-stage non-small cell lung cancer (NSCLC). Patients with medically inoperable NSCLC with high-risk features (centrally located or <5 cm T3 tumor or isolated lung parenchymal recurrences) were randomly assigned to SBRT or SBPT. Radiation dose was 50 Gy(relative biological effectiveness [RBE]) in 4 12.5-Gy(RBE) fractions prescribed to the planning target volume. Stereotactic body radiation therapy was given using 3-dimensional conformal radiation therapy or intensity modulated radiation therapy, and SBPT was given using passive scattering. Consistency in patient setup was ensured with on-board cone beam computed tomography for the SBRT group and with orthogonal X rays for the SBPT group. The study closed early owing to poor accrual, largely because of insurance coverage and lack of volumetric imaging in the SBPT group. Ultimately, 21 patients were enrolled, and 19 patients who received 50 Gy in 4 fractions were included for analysis (9 SBRT, 10 SBPT). At a median follow-up time of 32 months, median overall survival time was 28 months in the SBRT group and not reached in the SBPT group. Three-year overall survival was 27.8% and 90%, 3-year local control was 87.5% (8 of 9) and 90.0% (9 of 10), and 3-year regional control was 47.6% (5 of 9) and 90% (9 of 10) in the SBRT and SBPT groups, respectively. One patient in the SBPT group developed grade 3 skin fibrosis. No patients experienced grade 4/5 toxicity. Poor accrual, due to lack of volumetric imaging and insurance coverage for proton therapy, led to early closure of the trial and precluded accurate assessment of efficacy and toxicity. Comparable maturity of 2 radiation therapy modalities, particularly on-board imaging, and better insurance coverage for SBPT should be considered for future studies.

(PDF emailed within 0-6 h: $19.90)

Accession: 065403224

Download citation: RISBibTeXText

PMID: 29680255

DOI: 10.1016/j.ijrobp.2018.02.022


Related references

Clinical Comparison of Proton Beam Therapy and Stereotactic Body Radiation Therapy for Medically Inoperable Stage I Non-small Cell Lung Cancer. International Journal of Radiation Oncology*biology*physics 84(3): S573-S574, 2012

Robotic stereotactic body radiation therapy for elderly medically inoperable early-stage non-small cell lung cancer. Lung Cancer 4: 35-42, 2013

The impact of tumor size on outcomes after stereotactic body radiation therapy for medically inoperable early-stage non-small cell lung cancer. International Journal of Radiation Oncology, Biology, Physics 87(5): 1064-1070, 2014

Excessive toxicity when treating central tumors in a phase II study of stereotactic body radiation therapy for medically inoperable early-stage lung cancer. Journal of Clinical Oncology 24(30): 4833-4839, 2006

Volumetric modulated arc therapy with flattening filter free (FFF) beams for stereotactic body radiation therapy (SBRT) in patients with medically inoperable early stage non small cell lung cancer (NSCLC). RadioTherapy and Oncology 107(3): 414-418, 2014

A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer: NRG Oncology RTOG 0915 (NCCTG N0927). International Journal of Radiation Oncology, Biology, Physics 93(4): 757-764, 2016

Risk-adapted robotic stereotactic body radiation therapy for inoperable early-stage non-small-cell lung cancer. Strahlentherapie und Onkologie 194(2): 91-97, 2017

Stereotactic body radiation therapy-based treatment model for stage I medically inoperable small cell lung cancer. Practical Radiation Oncology 3(4): 301-306, 2014

Long-term Results of Stereotactic Body Radiation Therapy in Medically Inoperable Stage I Non-Small Cell Lung Cancer. JAMA Oncology 4(9): 1287-1288, 2018

Stereotactic body radiation therapy versus no treatment for early stage non-small cell lung cancer in medically inoperable elderly patients: A National Cancer Data Base analysis. Cancer 121(23): 4222-4230, 2016

A Phase 2 Randomized Study of 2 Stereotactic Body Radiation Therapy Regimens for Medically Inoperable Patients With Node-Negative, Peripheral Non-Small Cell Lung Cancer. International Journal of Radiation Oncology, Biology, Physics 98(1): 221-222, 2017

Long term follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A randomized phase II study comparing 2 stereotactic body radiation therapy schedules for medically inoperable patients with stage I peripheral non-small cell lung cancer. International Journal of Radiation Oncology, Biology, Physics 2018, 2018

A Phase 2 Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node-Negative, Peripheral Non-Small Cell Lung Cancer. International Journal of Radiation Oncology*biology*physics 96(2): S8-S9, 2016

Stereotactic Body Radiation Therapy for Medically Inoperable Early-Stage Lung Cancer Patients. Clinical Pulmonary Medicine 19(6): 289-294, 2012

Mature Experience in Stereotactic Body Radiation Therapy for Early Stage Medically Inoperable Lung Cancer. International Journal of Radiation Oncology*biology*physics 84(3): S561-S562, 2012