It was our purpose to evaluate the clinical impact of systematic PET/CT for the diagnosis of infectious embolisms in patients with infectious endocarditis (IE) in comparison with a historic cohort of IE patients managed without this technique. Detection of extracardiac lesions is an essential component of the management and outcome of IE. Studies using PET/CT for the evaluation of patients with IE are scarce, lack a control group, evaluate a small number of patients, or consist of case reports. Methods: We performed a prospective cohort study (47 patients with definite IE undergoing PET/ CT) with matched controls (94 patients with definite IE not undergoing PET/CT) from January 2012 to July 2013 in a tertiary hospital. The results were compared with those of conventional diagnostic techniques and clinical follow-up. Results: PET/CT revealed at least 1 lesion in 35 patients (74.5%): 18 showed an embolic complication, 8 showed pathologic uptake on the valves or cardiac devices, 1 showed both, 5 had incidental noninfectious findings, and the findings for 3 were considered false-positive. The validity values for the efficacy of PET/CT in the diagnosis of septic lesions were as follows: sensitivity, 100%; specificity, 80%; positive predictive value, 90%; and negative predictive value, 100%. PET/CT was the only initially positive imaging technique in 15 true-positive cases (55.5%). The systematic use of PET/CT was associated with a 2-fold reduction in the number of relapses (9.6% vs. 4.2%, P 5 0.25) and enabled significantly more infectious complications to be diagnosed (18% vs. 57.4%, P 5 0.0001). Conclusion: PET/CT enables the extent of IE to be assessed using a single test. It is fast (,2 h) and comfortable for the patient, gathers whole-body data, and detects significantly more infectious complications.

PURPOSE The need for an individualized management of indolent clinical forms in mantle cell lymphoma (MCL) is increasingly recognized. We hypothesized that a tailored treatment with ibrutinib in combination with rituximab (IR) could obtain significant responses in these patients. METHODS This is a multicenter single-arm, open-label, phase II study with a two-stage design conducted in 12 Spanish GELTAMO sites (ClinicalTrials.gov identifier: NCT02682641 ). Previously untreated MCL patients with indolent clinical forms defined by the following criteria were eligible: no disease-related symptoms, nonblastoid variants, Ki-67 < 30%, and largest tumor diameter ≤ 3 cm. Both leukemic non-nodal and nodal subtypes were recruited. Patients received ibrutinib 560 mg once daily and a total of eight doses of rituximab 375 mg/m2. Ibrutinib could be discontinued after 2 years in the case of sustained undetectable minimal residual disease (MRD). The primary end point was the complete response (CR) rate achieved after 12 cycles according to Lugano criteria. RESULTS Fifty patients with MCL (male 66%; median age 65 years) were enrolled. After 12 cycles of treatment, 42 (84%; 95% CI, 74 to 94) patients had an overall response, including 40 (80%; 95% CI, 69 to 91) with CR. Moreover, undetectable MRD in peripheral blood was achieved in 87% (95% CI, 77 to 97) of cases. At 2 years, 24 of 35 evaluable patients (69%) could discontinue ibrutinib because of undetectable MRD. Four patients had disease progression; three were non-nodal MCL and carried high genomic complexity and TP53 mutations at enrollment. No unexpected toxicity was seen except one patient with severe aplastic anemia. CONCLUSION Frontline IR combination achieves a high rate of CRs and undetectable MRD in indolent clinical forms of MCL. Discontinuation seems appropriate in cases with undetectable MRD, except for TP53-mutated cases.

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