Data from Phase II Trial of Ipilimumab with Stereotactic Radiation Therapy for Metastatic Disease: Outcomes, Toxicities, and Low-Dose Radiation–Related Abscopal Responses
Year: 2023
Type: other
Abstract: Ipilimumab is effective for patients with melanoma, but not for those with less immunogenic tumors. We report a phase II trial of ipilimumab with concurrent or sequential stereotactic ablative radiotherapy to metastatic lesions in the liver or lung (NCT02239900). Ipilimumab (every 3 weeks for 4 doses) was given with radiotherapy begun during the first dose (concurrent) or 1 week after the second dose (sequential) and delivered as 50 Gy in 4 fractions or 60 Gy in 10 fractions to metastatic liver or lung lesions. In total, 106 patients received ≥1 cycle of ipilimumab with radiation. Median follow-up was 10.5 months. Median progression-free survival time was 2.9 months (95% confidence interval, 2.45–3.40), and median overall survival time was not reached. Rates of clinical benefit of nonirradiated tumor volume were 26% overall, 28% for sequential versus 20% for concurrent therapy (P = 0.250), and 31% for lung versus 14% for liver metastases (P = 0.061). The sequential lung group had the highest rate of clinical benefit at 42%. There were no differences in treatment-related adverse events between groups. Exploratory analysis of nontargeted lesions revealed that lesions receiving low-dose radiation were more likely to respond than those that received no radiation (31% vs. 5%, P = 0.0091). This phase II trial of ipilimumab with stereotactic radiotherapy describes satisfactory outcomes and low toxicities, lending support to further investigation of combined-modality therapy for metastatic cancers.
Authors: James W. Welsh, Chad Tang, Patricia de Groot, Aung Naing, Kenneth R. Hess, John V. Heymach, Vassiliki A. Papadimitrakopoulou, Taylor R. Cushman, Vivek Subbiah, Joe Y. Chang, George R. Simon, Rishab Ramapriyan, Hampartsoum B. Barsoumian, Hari Menon, Maria Angelica Cortez, Erminia Massarelli, Quynh Nguyen, Padmanee Sharma, James P. Allison, Adi Diab, Vivek Verma, Uma Raju, Sherif G. Shaaban, Ramona Dadu, Maria E. Cabanillas, Kelvin Wang, Clark Anderson, Daniel R. Gomez, Stephen Hahn, Ritsuko Komaki, David S. Hong
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4362525114