Single-Fraction vs Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases (SAFRON II)
Siva, S
Bressel, M
Mai, T
Le, H
Vinod, S
de Silva, H
Macdonald, S
Skala, M
Hardcastle, N
Rezo, A
Pryor, D
Gill, S
Higgs, B
Wagenfuehr, K
Montgomery, R
Awad, R
Chesson, B
Eade, T
Wong, W
Sasso, G
De Abreu Lourenco, R
Kron, T
Ball, D
Neeson, P
Bettington, C
Cook, O
Foote, M
Gowda, R
Haas, M
Haynes, NM
Hilder, B
Lao, L
Lim, A
Ludbrook, J
Jansen, T
MacManus, M
McCullough, SA
Moore, A
Ritchie, D
Shaw, M
Sia, J
Syed, F
Tang, C
Trapani, J
Kron, T
Ball, D
Neeson, P
Bettington, C
Cook, O
Foote, M
Gowda, R
Haas, M
Haynes, NM
Hilder, B
Lao, L
Lim, A
Ludbrook, J
Jansen, T
MacManus, M
McCullough, SA
Moore, A
Ritchie, D
Shaw, M
Sia, J
Syed, F
Tang, C
Trapani, J
- Publisher:
- American Medical Association (AMA)
- Publication Type:
- Journal Article
- Citation:
- JAMA Oncology, 2021, 7, (10), pp. 1476-1485
- Issue Date:
- 2021-08-29
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Importance
Evidence is lacking from randomized clinical trials to guide the optimal approach for stereotactic ablative body radiotherapy (SABR) in patients with pulmonary oligometastases.Objective
To assess whether single-fraction or multifraction SABR is more effective for the treatment of patients with pulmonary oligometastases.Design, setting, and participants
This multicenter, unblinded, phase 2 randomized clinical trial of 90 patients across 13 centers in Australia and New Zealand enrolled patients with 1 to 3 lung oligometastases less than or equal to 5 cm from any nonhematologic malignant tumors located away from the central airways, Eastern Cooperative Oncology Group performance status 0 or 1, and all primary and extrathoracic disease controlled with local therapy. Enrollment was from January 1, 2015, to December 31, 2018, with a minimum patient follow-up of 2 years.Interventions
Single fraction of 28 Gy (single-fraction arm) or 4 fractions of 12 Gy (multifraction arm) to each oligometastasis.Main outcomes and measures
The main outcome was grade 3 or higher treatment-related adverse events (AEs) occurring within 1 year of SABR. Secondary outcomes were freedom from local failure, overall survival, disease-free survival, and patient-reported outcomes (MD Anderson Symptom Inventory-Lung Cancer and EuroQol 5-dimension visual analog scale).Results
Ninety participants were randomized, of whom 87 were treated for 133 pulmonary oligometastases. The mean (SD) age was 66.6 [11.6] years; 58 (64%) were male. Median follow-up was 36.5 months (interquartile range, 24.8-43.9 months). The numbers of grade 3 or higher AEs related to treatment at 1 year were 2 (5%; 80% CI, 1%-13%) in the single-fraction arm and 1 (3%; 80% CI, 0%-10%) in the multifraction arm, with no significant difference observed between arms. One grade 5 AE occurred in the multifraction arm. No significant differences were found between the multifraction arm and single-fraction arm for freedom from local failure (hazard ratio [HR], 0.5; 95% CI, 0.2-1.3; P = .13), overall survival (HR, 1.5; 95% CI, 0.6-3.7; P = .44), or disease-free survival (HR, 1.0; 95% CI, 0.6-1.6; P > .99). There were no significant differences observed in patient-reported outcomes.Conclusions and relevance
In this randomized clinical trial, neither arm demonstrated evidence of superior safety, efficacy, or symptom burden; however, single-fraction SABR is more efficient to deliver. Therefore, single-fraction SABR, as assessed by the most acceptable outcome profile from all end points, could be chosen to escalate to future studies.Trial registration
ClinicalTrials.gov Identifier: NCT01965223.Please use this identifier to cite or link to this item: