Journal
ANNALS OF ONCOLOGY
Volume 24, Issue 7, Pages 1813-1821Publisher
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mdt107
Keywords
ipilimumab; metastatic castration-resistant prostate cancer; phase I/II trial; prostate-specific antigen and radiotherapy; immunotherapy
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Funding
- Bristol-Myers Squibb
- NIH [P50 CA092629]
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Background: This phase I/II study in patients with metastatic castration-resistant prostate cancer (mCRPC) explored ipilimumab as monotherapy and in combination with radiotherapy, based on the preclinical evidence of synergistic antitumor activity between anti-CTLA-4 antibody and radiotherapy. Patients and methods: In dose escalation, 33 patients (>= 6/cohort) received ipilimumab every 3 weeks x 4 doses at 3, 5, or 10 mg/kg or at 3 or 10 mg/kg + radiotherapy (8 Gy/lesion). The 10-mg/kg cohorts were expanded to 50 patients (ipilimumab monotherapy, 16; ipilimumab + radiotherapy, 34). Evaluations included adverse events (AEs), prostate-specific antigen (PSA) decline, and tumor response. Results: Common immune-related AEs (irAEs) among the 50 patients receiving 10 mg/kg +/- radiotherapy were diarrhea (54%), colitis (22%), rash (32%), and pruritus (20%); grade 3/4 irAEs included colitis (16%) and hepatitis (10%). One treatment-related death (5 mg/kg group) occurred. Among patients receiving 10 mg/kg +/- radiotherapy, eight had PSA declines of >= 50% (duration: 3-13+ months), one had complete response (duration: 11.3+ months), and six had stable disease (duration: 2.8-6.1 months). Conclusions: In mCRPC patients, ipilimumab 10 mg/kg +/- radiotherapy suggested clinical antitumor activity with disease control and manageable AEs. Two phase III trials in mCRPC patients evaluating ipilimumab 10 mg/kg +/- radiotherapy are ongoing.
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