Evaluation of clinicopathological factors in PD-1 response: derivation and validation of a prediction scale for response to PD-1 monotherapy

BackgroundAnti-PD-1 therapy has shown significant clinical activity in advanced melanoma. We developed and validated a clinical prediction scale for response to anti- PD-1 monotherapy.MethodsA total of 315 patients with advanced melanoma treated with pembrolizumab (2 or 10 mg kg-1 Q2W or Q3W) or nivolumab (3 mg kg-1 Q2W) at four cancer centres between 2011 to 2013 served as the setting for the present cohort study. Variables with significant association to response on a univariate analysis were entered into a forward stepwise logistic regression model and were given a score based on ORs to calculate a clinical prediction scale.ResultsThe developed clinical prediction scale included elevated LDH (1 point), age <65 years (1 point), female sex (1 point), history of ipilimumab treatment (2 points) and the presence of liver metastasis (2 points). The scale had an area under the receiver-operating curve (AUC) of 0.73 (95% CI 0.67, 0.80) in predicting response to therapy. The predictive performance of the score was maintained in the validation cohort (AUC 0.70 (95% CI 0.58, 0.81)) and the goodness-to-fit model demonstrated good calibration.ConclusionsBased on a large cohort of patients, we developed and validated a simple five-factor prediction scale for the clinical activity of PD-1 antibodies in advanced melanoma patients. This scale can be used to stratify patients participating in clinical trials

Non-Hodgkin’s lymphoma—PET for diagnosis and treatment evaluation

Background. F-18-fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) is an internationally recognized standard for the diagnosis and treatment guidance in non-Hodgkin's lymphoma (NHL). The use of PET in NHL is also becoming increasingly established in Germany. Objective. Presentation of clinically relevant indications for FDG-PET/CT in the treatment of patients with indolent and aggressive NHL. Material and methods. Evaluation of relevant guidelines, examples of typical findings, discussion of clinically relevant expert recommendations and the reimbursement situation in Germany. Results. The FDGPET/CT procedure is the most accurate non-invasive method for staging and restaging in NHL. International guidelines provide well-founded recommendations for the targeted use of FDG PET/CT in NHL patients. The indications for and extent of radiotherapy for follicular lymphoma are largely dependent on the PET/CT findings. In aggressive NHL the interim results of the OPTIMAL>60 study raise the expectation of a survival benefit after radiotherapy of PET-positive bulk residues. The measurement of total metabolic tumor volume by PET provides outstanding prognostic information. The availability of PET in Germany is still limited by regional differences in reimbursement policies of statutory health insurance providers. Conclusion. The selective use of FDG PET/CT in patients with NHL is an international standard of care that facilitates staging, risk stratification, assessment of treatment response and treatment guidance. In the light of international recommendations and national S3 guidelines, earlier negative decisions by the Federal Joint Committee (G-BA) on PET in lymphomas need to be reconsidered