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Bayesian Adaptive Randomization Trial of Passive Scattering Proton Therapy and Intensity-Modulated Photon

Zhongxing Liao1, J Jack Lee1, Ritsuko Komaki1

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Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
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Summary
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Passive scattering proton therapy (PSPT) did not reduce radiation pneumonitis or local failure compared to intensity-modulated radiotherapy (IMRT) for non-small-cell lung cancer. Improvements were seen over time for both treatment types.

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Area of Science:

  • Radiation Oncology
  • Medical Physics
  • Thoracic Oncology

Background:

  • Inoperable non-small-cell lung cancer (NSCLC) treatment often involves chemoradiation.
  • Comparing passive scattering proton therapy (PSPT) with intensity-modulated radiotherapy (IMRT) is crucial for optimizing outcomes.
  • Reducing radiation toxicity while maintaining tumor control is a key objective.

Purpose of the Study:

  • To compare the efficacy and toxicity of PSPT versus IMRT with concurrent chemotherapy in patients with inoperable NSCLC.
  • To test the hypothesis that PSPT reduces lung toxicity without compromising local tumor control.
  • To evaluate radiation pneumonitis (RP) and local failure (LF) as primary endpoints.

Main Methods:

  • A randomized trial comparing PSPT and IMRT in patients with stage IIB-IIIB or specific stage IV NSCLC.
  • Paired treatment plans for both modalities were created for each patient, ensuring comparable dose constraints.
  • Patients were randomized only if both plans met prespecified dose-volume constraints for organs at risk.

Main Results:

  • PSPT exposed less heart tissue to radiation across dose levels compared to IMRT.
  • PSPT exposed less lung tissue to low doses (5-10 Gy(RBE)) but more to higher doses (≥ 20 Gy(RBE)) than IMRT.
  • Rates of grade ≥ 3 radiation pneumonitis were 10.5% for PSPT and 6.5% for IMRT; local failure rates were 10.5% for PSPT and 10.9% for IMRT.
  • Exploratory analysis showed significant improvements in RP and LF rates over time for both IMRT and PSPT groups.

Conclusions:

  • PSPT did not demonstrate improved dose-volume indices for the lung or reduced rates of radiation pneumonitis or local failure compared to IMRT.
  • While PSPT offered dosimetric advantages for the heart, it did not translate to improved clinical outcomes in this trial.
  • Improvements in treatment outcomes were observed during the trial, suggesting learning curve effects or other temporal factors.