Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: A US Food and Drug Administration pooled analysis
The Lancet Oncology Feb 06, 2018
Beaver JA, et al. - Patients who receive immunotherapeutic drugs might develop an atypical response pattern, wherein they initially meet conventional response criteria for progressive disease but later have decreases in tumour burden. Among melanoma patients, potential benefits and risks of continuing immunotherapy beyond disease progression defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, were investigated. It was demonstrated that since the clinical benefit of these immunotherapies remains to be proven, continuation of treatment beyond progression in the product labelling of these immunotherapies has not been recommended. In selected patients with unresectable or metastatic melanoma, treatment beyond progression with anti-programmed death receptor-1 antibody therapy might be appropriate as identified by specific criteria at the time of progression, based on the potential for late responses in the setting of the known toxicity profile.
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