TOPLINE:
Irradiating a small number of metastatic lesions does not appear to improve progression-free or overall survival in patients receiving immune checkpoint inhibitor monotherapy for advanced cancer.
METHODOLOGY:
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In the phase 2 CHEERS trial, 52 patients with advanced solid tumors were randomized to anti-PD-1/PD-L1 monotherapy and 47 patients to the same treatment plus stereotactic body radiotherapy (3 x 8 Gy) to a maximum of three lesions prior to the second or third cycle of an immune checkpoint inhibitor.
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Patients had locally advanced or metastatic melanoma, renal cell carcinoma, urothelial carcinoma, non-small cell lung carcinoma, or head and neck squamous cell carcinoma and were treated at five Belgian hospitals.
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Most patients had more than three lesions.
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Seven patients in the experimental group did not complete radiotherapy due to early progression or intercurrent illness.
TAKEAWAY:
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Over a median follow-up of 12.5 months, median progression-free survival was 4.4 months in the radiotherapy group versus 2.8 months in the control group (hazard ratio [HR], 0.95; P = .82).
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Median overall survival was not significantly better with radiotherapy compared with the control group (14.3 vs 11 months; HR, 0.82; P = .47), nor was the objective response rate (27% vs 22%; P = .56).
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However, a post hoc analysis demonstrated a significant association between the number of irradiated lesions and overall survival among patients receiving radiotherapy (HR, 0.31; P = .002).
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The incidence of grade 3 or worse treatment-related adverse events was 18% in both groups.
IN PRACTICE:
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Although the study was negative overall, the post hoc analysis coupled with “recent evidence suggests that treating all active disease sites with higher radiation doses…may be a more promising strategy to optimize systemic disease control,” the authors concluded.
SOURCE:
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The study was led by Mathieu Spaas, MD, Department of Radiation Oncology, Ghent University, Belgium, and published online July 6 in JAMA Oncology.
LIMITATIONS:
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There was insufficient power to detect if certain cancers benefited more from add-on radiation because of the small sample size.
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More than half of patients in the control group had already received some form of radiotherapy before study inclusion, which may mean the study underestimated the benefit of radiotherapy.
DISCLOSURES:
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The work was funded by Kom Op Tegen Kanker and Varian Medical Systems.
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Investigators disclosed numerous industry ties, including Merck, Novartis, and Bristol Myers Squibb.
M. Alexander Otto is a physician assistant with a master ‘ s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape and is also an MIT Knight Science Journalism fellow. Email: [email protected]
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