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. 2022 Nov 1;8(11):1644-1650.
doi: 10.1001/jamaoncol.2022.4394.

Treatment With Stereotactic Ablative Radiotherapy for Up to 5 Oligometastases in Patients With Cancer: Primary Toxic Effect Results of the Nonrandomized Phase 2 SABR-5 Clinical Trial

Robert Olson  1   2 , Will Jiang  1   2 , Mitchell Liu  1   3 , Alanah Bergman  1   3 , Devin Schellenberg  1   4 , Benjamin Mou  1   5 , Abraham Alexander  1   6 , Hannah Carolan  1   3 , Fred Hsu  1   7 , Stacy Miller  1   2 , Siavash Atrchian  1   5 , Elisa Chan  1   3 , Clement Ho  1   4 , Islam Mohamed  1   5 , Angela Lin  1   5 , Tanya Berrang  1   6 , Andrew Bang  1   3 , Nick Chng  2 , Quinn Matthews  2 , Sarah Baker  1   4 , Vicky Huang  4 , Ante Mestrovic  6 , Derek Hyde  5 , Chad Lund  1   4 , Howard Pai  1   6 , Boris Valev  1   6 , Shilo Lefresene  1   3 , Scott Tyldesley  1   3
Affiliations

Treatment With Stereotactic Ablative Radiotherapy for Up to 5 Oligometastases in Patients With Cancer: Primary Toxic Effect Results of the Nonrandomized Phase 2 SABR-5 Clinical Trial

Robert Olson et al. JAMA Oncol. .

Abstract

Importance: After the publication of the landmark SABR-COMET trial, concerns arose regarding high-grade toxic effects of treatment with stereotactic ablative body radiotherapy (SABR) for oligometastases.

Objective: To document toxic effects of treatment with SABR in a large cohort from a population-based, provincial cancer program.

Design, setting, and participants: From November 2016 to July 2020, 381 patients across all 6 cancer centers in British Columbia were treated in this single-arm, phase 2 trial of treatment with SABR for patients with oligometastatic or oligoprogressive disease. During this period, patients were only eligible to receive treatment with SABR in these settings in trials within British Columbia; therefore, this analysis is population based, with resultant minimal selection bias compared with previously published SABR series.

Interventions: Stereotactic ablative body radiotherapy to up to 5 metastases.

Main outcomes and measures: Rate of grade 2, 3, 4, and 5 toxic effects associated with SABR.

Findings: Among 381 participants (122 women [32%]), the mean (SD; range) age was 68 (11.1; 30-97) years, and the median (range) follow-up was 25 (1-54) months. The most common histological findings were prostate cancer (123 [32%]), colorectal cancer (63 [17%]), breast cancer (42 [11%]), and lung cancer (33 [9%]). The number of SABR-treated sites were 1 (263 [69%]), 2 (82 [22%]), and 3 or more (36 [10%]). The most common sites of SABR were lung (188 [34%]), nonspine bone (136 [25%]), spine (85 [16%]), lymph nodes (78 [14%]), liver (29 [5%]), and adrenal (15 [3%]). Rates of grade 2, 3, 4, and 5 toxic effects associated with SABR (based on the highest-grade toxic effect per patient) were 14.2%; (95% CI, 10.7%-17.7%), 4.2% (95% CI, 2.2%-6.2%), 0%, and 0.3% (95% CI, 0%-0.8%), respectively. The cumulative incidence of grade 2 or higher toxic effects associated with SABR at year 2 by Kaplan-Meier analysis was 8%, and for grade 3 or higher, 4%.

Conclusions and relevance: This single-arm, phase 2 clinical trial found that the incidence of grade 3 or higher SABR toxic effects in this population-based study was less than 5%. Furthermore, the rates of grade 2 or higher toxic effects (18.6%) were lower than previously published for SABR-COMET (29%). These results suggest that SABR treatment for oligometastases has acceptable rates of toxic effects and potentially support further enrollment in randomized phase 3 clinical trials.

Trial registration: ClinicalTrials.gov Identifier: NCT02933242.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Olson reported grants from Varian Medical Systems and personal fees from Need and Novartis outside the submitted work. Dr Schellenberg reported grants from Varian Medical Systems as well as personal fees from AstraZeneca, Pfizer, and Merck outside the submitted work. Dr Mou reported personal fees from AstraZeneca outside the submitted work. Dr Hsu reported grants from BC Cancer during the conduct of the study. Dr Chan reported speaker honoraria from AstraZeneca. Dr Ho reported personal fees from Bayer, Merck, AbbVie, and Tolmar outside the submitted work. Dr Bang reported grants from AstraZeneca outside the submitted work. Dr Baker reported speaker fees from AstraZeneca outside the submitted work. Dr Lefresne reported personal fees from AstraZeneca outside the submitted work. Dr Tyldesley reported personal fees from Bayer, Tera Sera, Astellas, and Janssen outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Profile
CT indicates computed tomography; SABR, stereotactic ablative body radiotherapy; sim, simulation.
Figure 2.
Figure 2.. Cumulative Incidence of Grade 2 or Higher and Grade 3 or Higher Toxic Effects
Kaplan-Meier plot of the cumulative incidence of grade 2 or higher toxic effects (A) and grade 3 or higher toxic effects (B). Median time to toxic effects was not reached.
See this image and copyright information in PMC

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