Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial

American Society of Clinical Oncology (ASCO) - Tập 38 Số 25 - Trang 2830-2838 - 2020
David A. Palma1, Robert Olson2, Stephen Harrow3, Stewart Gaede1, Alexander V. Louie4, Cornelis J.A. Haasbeek5, Liam Mulroy6, Michael Lock1, George Rodrigues1, Brian Yaremko1, Devin Schellenberg7, Belal Ahmad1, Sashendra Senthi8, Anand Swaminath9, Neil Kopek10, Mitchell Liu11, Karen Moore3, Suzanne Currie3, Roel Schlijper2, Glenn Bauman1, Joanna Laba1, Xiaotao Qu1, Andrew Warner1, Suresh Senan5
1London Health Sciences Centre, London, Ontario, Canada
2BC Cancer, Centre for the North, Prince George, British Columbia, Canada
3Beatson West of Scotland Cancer Centre, Glasgow, Scotland
4Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
5Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
6Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
7BC Cancer, Surrey Centre, Surrey, British Columbia, Canada
8Alfred Health Radiation Oncology, Melbourne, Victoria, Australia
9Juravinski Cancer Centre, Hamilton, Ontario, Canada
10McGill University Health Centre, Montreal, Quebec, Canada
11BC Cancer – Vancouver Centre, Vancouver, British Columbia, Canada

Tóm tắt

PURPOSE The 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 that test this paradigm are lacking. METHODS We 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 v 4-5) and randomized in a 1:2 ratio between palliative standard-of-care (SOC) treatments (arm 1) and SOC plus SABR (arm 2). We used a randomized phase II screening design with a primary end point of overall survival (OS), using an α of .20 (wherein P < .20 indicates a positive trial). Secondary end points included progression-free survival (PFS), toxicity, and quality of life (QOL). Herein, we present long-term outcomes from the trial. RESULTS Between 2012 and 2016, 99 patients were randomly assigned at 10 centers internationally. 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. The 5-year OS rate was 17.7% in arm 1 (95% CI, 6% to 34%) versus 42.3% in arm 2 (95% CI, 28% to 56%; stratified log-rank P = .006). The 5-year PFS rate was not reached in arm 1 (3.2%; 95% CI, 0% to 14% at 4 years with last patient censored) and 17.3% in arm 2 (95% CI, 8% to 30%; P = .001). There were no new grade 2-5 adverse events and no differences in QOL between arms. CONCLUSION With 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.

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American Society of Clinical Oncology (ASCO)

Tập 38 Số 25

2830-2838

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