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

Chonnipa Nantavithya, Daniel R. Gomez, Xiong Wei, Ritsuko Komaki, Zhongxing Liao, Steven H. Lin, Melenda Jeter, Quynh Nhu Nguyen, Heng Li, Xiaodong Zhang, Falk Poenisch, X. Ronald Zhu, Peter A. Balter, Lei Feng, Noah C. Choi, Radhe Mohan, Joe Y. Chang

Research output: Contribution to journalArticle

Abstract

Purpose: 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 and Methods: 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. Results: 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. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)558-563
Number of pages6
JournalInternational Journal of Radiation Oncology Biology Physics
Volume101
Issue number3
DOIs
StatePublished - Jul 1 2018
Externally publishedYes

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Proton Therapy
Non-Small Cell Lung Carcinoma
lungs
radiation therapy
therapy
Radiotherapy
cancer
protons
Insurance Coverage
Relative Biological Effectiveness
toxicity
Cone-Beam Computed Tomography
Survival
grade
fibrosis
Fibrosis

ASJC Scopus subject areas

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

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. / Nantavithya, Chonnipa; Gomez, Daniel R.; Wei, Xiong; Komaki, Ritsuko; Liao, Zhongxing; Lin, Steven H.; Jeter, Melenda; Nguyen, Quynh Nhu; Li, Heng; Zhang, Xiaodong; Poenisch, Falk; Zhu, X. Ronald; Balter, Peter A.; Feng, Lei; Choi, Noah C.; Mohan, Radhe; Chang, Joe Y.

In: International Journal of Radiation Oncology Biology Physics, Vol. 101, No. 3, 01.07.2018, p. 558-563.

Research output: Contribution to journalArticle

Nantavithya, C, Gomez, DR, Wei, X, Komaki, R, Liao, Z, Lin, SH, Jeter, M, Nguyen, QN, Li, H, Zhang, X, Poenisch, F, Zhu, XR, Balter, PA, Feng, L, Choi, NC, Mohan, R & Chang, JY 2018, '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, vol. 101, no. 3, pp. 558-563. https://doi.org/10.1016/j.ijrobp.2018.02.022
Nantavithya, Chonnipa ; Gomez, Daniel R. ; Wei, Xiong ; Komaki, Ritsuko ; Liao, Zhongxing ; Lin, Steven H. ; Jeter, Melenda ; Nguyen, Quynh Nhu ; Li, Heng ; Zhang, Xiaodong ; Poenisch, Falk ; Zhu, X. Ronald ; Balter, Peter A. ; Feng, Lei ; Choi, Noah C. ; Mohan, Radhe ; Chang, Joe Y. / 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. In: International Journal of Radiation Oncology Biology Physics. 2018 ; Vol. 101, No. 3. pp. 558-563.
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abstract = "Purpose: 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 and Methods: 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. Results: 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. Conclusion: 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.",
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AU - Nantavithya, Chonnipa

AU - Gomez, Daniel R.

AU - Wei, Xiong

AU - Komaki, Ritsuko

AU - Liao, Zhongxing

AU - Lin, Steven H.

AU - Jeter, Melenda

AU - Nguyen, Quynh Nhu

AU - Li, Heng

AU - Zhang, Xiaodong

AU - Poenisch, Falk

AU - Zhu, X. Ronald

AU - Balter, Peter A.

AU - Feng, Lei

AU - Choi, Noah C.

AU - Mohan, Radhe

AU - Chang, Joe Y.

PY - 2018/7/1

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N2 - Purpose: 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 and Methods: 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. Results: 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. Conclusion: 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.

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