Abstract
BackgroundTwo 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.MethodsFifty-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).ResultsMedian 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.ConclusionsIGPT appears to be effective and well tolerated for all patients with stage I NSCLC.Trial registrationLung-001, 13–02-09 (9), registered 11 June 2013 and Lung-002, 13–02-10 (10), registered 11 June 2013.
Highlights
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)
This study reported clinical outcomes of IGPT using fiducial markers and respiratory gating for operable and inoperable histologically-confirmed stage I NSCLC
The current study suggests, that in terms of both efficacy and safety, PT is suitable for adoption as a standard treatment option for stage I NSCLC even without such technologies
Summary
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). For stage I non-small cell lung cancer (NSCLC), surgical resection is the current standard treatment. Stereotactic body radiotherapy (SBRT) has been adopted as an alternative treatment modality for medically inoperable patients with stage I NSCLC, and has increasingly been used for operable patients as well [1,2,3,4]. Fiducial marker implantation for image guidance and respiratory gating are widely used for SBRT, neither have been commonly used for PT. In 2013, we started phase II clinical trials of image-guided PT (IGPT) for stage I NSCLC using fiducial markers with a respiratory gating method
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