Population Based Phase II Trial of Stereotactic Ablative Radiotherapy (SABR) for up to 5 Oligometastases: Preliminary Results of the SABR-5 Trial
| Autor: | Scott Tyldesley, Islam Gharib Mohamed, Boris Valev, S Atrchian, Tanya Berrang, Stacy Miller, Quinn Matthews, V Huang, Devin Schellenberg, Elisa K. Chan, B. Mou, Cheryl Ho, Abraham Alexander, Hannah Carolan, C.R. Lund, T. Mestrovic, Howard Pai, Robert Olson, F. Hsu, Wei Ning Jiang, Shilo Lefresne, Alanah Bergman, Angela Lin, Derek Hyde, Nick Chng, M. Liu, A Bang |
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| Rok vydání: | 2021 |
| Předmět: |
Cancer Research
medicine.medical_specialty education.field_of_study Radiation business.industry Incidence (epidemiology) Perforation (oil well) Population medicine.disease SABR volatility model Breast cancer Oncology Internal medicine medicine Clinical endpoint Radiology Nuclear Medicine and imaging Cumulative incidence Lung cancer business education |
| Zdroj: | International Journal of Radiation Oncology*Biology*Physics. 111:S4 |
| ISSN: | 0360-3016 |
| DOI: | 10.1016/j.ijrobp.2021.07.044 |
| Popis: | Purpose/objective(s) After the publication of the landmark SABR-COMET trial, concerns were raised over toxicity of SABR for oligometastases. This population-based study was designed as a bridge from phase II to phase III trials, while assessing the toxicity profile of SABR in a larger cohort from a provincial cancer program. Materials/methods From November 2016 to July 2020, 399 patients were enrolled in this single arm, phase II trial of SABR in patients with oligometastatic or oligo-progressive disease. During this period, patients were only eligible for SABR in these settings on trial within our province, and therefore this analysis is population-based, with resultant minimal selection bias in comparison to previously published SABR series. The primary endpoint was toxicity and we hypothesized grade 4 toxicity Results The mean age was 68 years (SD 10.9, range 30-97). The participants were mostly male (69%). The most common histologies were prostate cancer (33%), colorectal cancer (14%), breast cancer (11%), and lung cancer (9%). The number of SABR treated sites were one (69%), two (22%), and three or more (9%). The most common sites of SABR were lung (33%), non-spine bone (28%), spine (14%), lymph nodes (13%), liver (5%) and adrenal (3%). Grade 2, 3, and 4 toxicity cumulative incidences were 11.4%, 4.6%, and 0.5%, respectively. There were no grade 5 toxicities. Grade 2 or higher specific toxicity included 4.8% pain, 1.3% pneumonitis, and 0.8% neuropathy. There were no reported gastrointestinal fistula, perforation, or hemorrhage. Cumulative incidence and prevalence of toxicity at 1 & 3 years will be updated and presented. Conclusion The incidence of grade 2+ SABR toxicity on this population-based study was 16.5%, which is lower than that reported on SABR-COMET (29%). Importantly, there were no grade 5 toxicities attributed to SABR in this study to date. Severe (grade 3 or higher) toxicities were uncommon (5.0%). These results are encouraging that, in a population-based program with rigorous peer review quality assurance, SABR treatment for oligometastases has acceptable rates of toxicity. This supports further enrollment in randomized phase III trials. |
| Databáze: | OpenAIRE |
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