Abstract
BackgroundThe RECIST guidelines are commonly used in phase II and III clinical trials. The correct definition of response can be controversial in some situations, as in the case we describe.Case presentationA 43 year-old man with advanced gastric cancer was enrolled in a phase II trial where he was treated with pemetrexed 500 mg/m2 plus oxaliplatin 120 mg/m2 every 3 weeks. At baseline, the target lesions were lymph-nodes, and the non-target lesions were small pulmonary nodules. At first re-evaluation, the target lesions showed partial response and the non-target lesions showed complete response, but new diffuse osteoblastic lesions appeared. The investigator decided to continue treatment until the second re-evaluation. CT scan confirmed the response of the target and non-target lesions, while the osteoblastic lesions did not change.ConclusionThe appearance of osteoblastic lesions after an active antitumor treatment, a phenomenon known as flare, can complicate the definition of the best overall response using RECIST criteria. This possibility should be considered by oncologists involved in clinical trials.
Highlights
The RECIST guidelines are commonly used in phase II and III clinical trials
Phase II clinical studies that explore the activity of new drugs or new drug combinations demand a rigorous evaluation of tumor response
In B, the computed tomography (CT) scan of the same region after two cycles of pemetrexed and oxaliplatin shows diffuse osteoblastic lesions which are apparent in the sacrum and iliac bones
Summary
The RECIST criteria are frequently used to assess response in clinical trials investigating new treatments for solid tumors. The RECIST criteria are imperfect in precisely measuring tumor response and progression, and fall short in some situations and with some types of cancer therapeutics [10]. For this reason, it is important to report controversial cases that physicians often face in the conduct of phase II clinical studies. It is important to report controversial cases that physicians often face in the conduct of phase II clinical studies We believe it is reasonable for a phenomenon such as osteoblastic flare to be considered in the version of RECIST guidelines
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