Stereotactic ablative radiotherapy for the comprehensive treatment of oligometastatic cancers: Long-term results of the SABR-COMET Phase II randomized trial
| Autor: | X. Melody Qu, Belal Ahmad, Stewart Gaede, Roel Schlijper, Sashendra Senthi, Mitchell Liu, Michael Lock, Glenn Bauman, Robert Olson, Anand Swaminath, Liam Mulroy, George Rodrigues, Devin Schellenberg, Stephen Harrow, Brian Yaremko, Alexander V. Louie, Andrew Warner, Joanna Laba, Neil Kopek, David A. Palma, Cornelis J.A. Haasbeek, Suresh Senan, S. Currie, Karen Moore |
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| Přispěvatelé: | Radiation Oncology, CCA - Cancer Treatment and quality of life |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Oncology
0301 basic medicine Cancer Research medicine.medical_specialty medicine.medical_treatment SABR volatility model Radiosurgery law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Prostate law Internal medicine Neoplasms Ablative case RAPID COMMUNICATIONS Clinical endpoint medicine Humans Adverse effect business.industry Long term results medicine.disease Primary tumor Disease control Confidence interval Radiation therapy Clinical trial medicine.anatomical_structure 030104 developmental biology Multicenter study 030220 oncology & carcinogenesis Radiation Oncology Radiology business |
| Zdroj: | Journal of Clinical Oncology, 38(25), 2830-2838. American Society of Clinical Oncology Journal of Clinical Oncology Palma, D A, Olson, R, Harrow, S, Gaede, S, Louie, A V, Haasbeek, C, Mulroy, L, Lock, M, Rodrigues, G B, Yaremko, B P, Schellenberg, D, Ahmad, B, Senthi, S, Swaminath, A, Kopek, N, Liu, M, Moore, K, Currie, S, Schlijper, R, Bauman, G S, Laba, J, Qu, X M, Warner, A & Senan, S 2020, ' Stereotactic ablative radiotherapy for the comprehensive treatment of oligometastatic cancers : Long-term results of the SABR-COMET Phase II randomized trial ', Journal of Clinical Oncology, vol. 38, no. 25, pp. 2830-2838 . https://doi.org/10.1200/JCO.20.00818 |
| ISSN: | 0732-183X |
| Popis: | PurposeThe oligometastatic paradigm hypothesizes that patients with a limited number of metastases may achieve long-term disease control, or even cure, if all sites of disease can be ablated. However, long-term randomized data testing this paradigm are lacking.MethodsWe enrolled patients with a controlled primary malignancy and 1-5 metastatic lesions, with all metastases amenable to stereotactic ablative radiotherapy (SABR). We stratified by the number of metastases (1-3 vs. 4-5) and randomized in a 1:2 ratio between palliative standard of care (SOC) treatments (Arm 1) vs. SOC plus SABR (Arm 2). We employed a randomized phase II screening design with a primary endpoint of overall survival (OS), using an alpha of 0.20 (wherein a p-value ResultsBetween 2012 and 2016, 99 patients were randomized (33 in Arm 1, 66 in Arm 2) at 10 centres internationally. Median age was 68 (range 43-89) and the majority (n=59; 60%) were male. The most common primary tumor types were breast (n=18), lung (n=18), colorectal (n=18), and prostate (n=16). Median follow-up was 51 months. Five-year OS was 17.7% in Arm 1 (95% confidence interval [CI]: 6-34%) vs. 42.3% in Arm 2 (95% CI: 28-56%; stratified log-rank p=0.006). Five-year PFS was ‘not reached’ in Arm 1 (3.2% [95% CI: 0-14%] at 4-years with last patient censored) and was 17.3% (95% CI: 8-30%) in Arm 2 (p=0.001). There were no new grade 2-5 adverse events and no differences in QOL between arms.ConclusionsWith extended follow-up, the impact of SABR on OS was larger in magnitude than in the initial analysis, and durable over time. There were no new safety signals, and SABR had no detrimental impact on QOL. (NCT01446744)FundingOntario Institute for Cancer Research and London Regional Cancer Program Catalyst Grant |
| Databáze: | OpenAIRE |
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