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Aug 8, 2020 06:37PM
- edited
Aug 8, 2020 11:42PM
by
Lumpie
Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial
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 a of .20 (wherein P , .20 indicates a positive trial). Secondary end points included progressionfree 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 5 18), lung (n 5 18), colorectal (n 5 18), and prostate (n 5 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 5 .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 5 .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.
CONTEXT
Key Objective: To determine the impact of stereotactic ablative radiotherapy (SABR) on overall survival (OS) in patients with a controlled primary tumor and 1-5 oligometastases.
Knowledge Generated: In this long-term report from an international randomized phase II trial, patients who received SABR demonstrated a 22- month improvement in median OS compared with patients who received a standard-of-care approach alone, corresponding to an absolute survival benefit of 25% at 5 years. There were no new safety signals detected.
Relevance: These data add to the growing evidence base that suggests that SABR can improve long-term outcomes in patients with a limited burden of metastatic disease. These results may influence treatment decisions while awaiting the results of phase III trials.
CLINICAL TRIAL INFORMATION NCT01446744
https://ascopubs.org/doi/pdf/10.1200/JCO.20.00818
DOI: 10.1200/JCO.20.00818 Journal of Clinical Oncology Published online June 02, 2020.
{Wow. These are HUGE improvements. It is a small study, so that has to be taken into account. If you are oligometastatic, be sure your doctor is up to date on this research. Free access to full article on ASCO website.}
"We must be willing to let go of the life we have planned, so as to have the life that is waiting for us." "If adventures will not befall a young lady in her own village, she must seek them abroad." "Buy the ticket, take the ride."
Dx
2015, DCIS/IDC, Right, 3cm, Stage IIA, Grade 3, 0/1 nodes, ER-/PR-, HER2+ (IHC)
Chemotherapy
1/14/2016 Cytoxan (cyclophosphamide), Taxotere (docetaxel)
Targeted Therapy
1/14/2016 Herceptin (trastuzumab)
Dx
2017, IDC, Stage IV, metastasized to liver, ER-/PR-, HER2+
Surgery
Lumpectomy: Right
Surgery
Lumpectomy: Right
Radiation Therapy
Whole-breast: Breast