Bortezomib, used as initial therapy, is able to increase the percentage and the quality of responses in PPCL patients, producing a significant improvement of survival.

NCT00510926, NCT00514488, NCT00769327, NCT00481052.

The number of total knee arthroplasty (TKA) procedures continuously increases, with good to excellent results. In the last few years, new surgical techniques have been developed to improve prosthesis positioning. In this context, patient-specific instrumentation is included. The goal of this study was to compare the perioperative parameters and the spatial positioning of prosthetic components in TKA procedures performed with patient-specific instrumentation vs traditional TKA. In this prospective comparative randomized study, 15 patients underwent TKA with 3-dimensional magnetic resonance imaging (MRI) preoperative planning (patient-specific instrumentation group) and 15 patients underwent traditional TKA (non-patient-specific instrumentation group). All patients underwent postoperative computed tomography (CT) examination. In the patient-specific instrumentation group, preoperative data planning regarding femoral and tibial bone resection was correlated with intraoperative measurements. Surgical time, length of hospitalization, and intraoperative and postoperative bleeding were compared between the 2 groups. Positioning of implants on postoperative CT was assessed for both groups. Data planned with 3-dimensional MRI regarding the depth of bone cuts showed good to excellent correlation with intraoperative measurements. The patient-specific instrumentation group showed better perioperative outcomes and good correlation between the spatial positioning of prosthetic components planned preoperatively and that seen on postoperative CT. Less variability was found in the patient-specific instrumentation group than in the non-patient-specific instrumentation group in spatial orientation of prosthetic components. Preoperative planning with 3-dimensional MRI in TKA has a better perioperative outcome compared with the traditional method. Use of patient-specific instrumentation can also improve the spatial positioning of both prosthetic components.

Background: ENKTL account for more than 20% of the peripheral T-cell lymphoma in Asia. Patients with r/r ENKTL have a poor prognosis after failing an L-asparaginase based regimen, and the median overall survival is less than 6 months. The overexpression of PD-L1 induced by EBV infection is a potential mechanism for ENKTL to avert immune surveillance, and recent studies of PD-1 antibodies in pts with r/r ENKTL have demonstrated potential efficacy. Sintilimab, a fully human anti-PD-1 monoclonal antibody, has a safety profile consistent with other approved PD-1 antibodies and was approved for r/r classical Hodgkin lymphoma in China in 2018. Aims: This multicenter, single-arm, phase 2 study aims to validate the efficacy and safety of sintilimab monotherapy in patients with r/r EN-KTL in China. Methods: Patients with pathologically confirmed r/r ENKTL were enrolled. Sintilimab was given 200 mg IV Q3W, until PD, death, unacceptable toxicity, or withdrawal from the study. Treatment beyond PD is allowed. Tumor response evaluation was performed by both PET-CT and CT/MRI with contrast. The primary endpoint was objective response rate based on LUGANO 2014 criteria. Data cut-off date for this analysis was Feb 2, 2019. Results: From Aug 31, 2017 to Feb 7, 2018, a total of 28 patients were enrolled: 60.7% male and the median age was 37 (range: 19~65) yr. Sixty-eight percent of patients were stage IV and 89.3% were ECOG PS  1. All patients had failed an L-asparaginase based regimen, the median lines of previous therapy were 3 (range: 1~13), 78.6% patients received prior radiotherapy and 7.1% had failed HSCT. Median duration of therapy was 14.04 (range: 1.4~17.3) months and 19 patients are still receiving sintilimab. Sixty-eight percent (19/28, 95%CI: 47.6%~84.1%) of patients achieved response (CR+PR), including 4 pts who experienced PD prior to having a response. DCR was 85.7%, including 5 pts who experienced PD before SD or response. The 1-year OS rate was 82.1% and the median OS has not been reached. Most TRAEs were G1~2 (67.9%) and no patients discontinued treatment due to AEs. The most common TRAE was decreased lymphocyte count (46.4%) and 84.6% were grade 1~2. SAEs occurred in 21.4% of patients and none were related to sintilimab. No patients died from AEs. Summary/Conclusion: Sintilimab is effective and well tolerated in r/r ENKTL and could be a promising treatment option for these patients. Early disease progression observed by PET scan in this study could be pseudo-progression as it did not correlate with poor outcome, which warrants further investigation. NCT03228836

No abstract

Although most patients (pts) achieve complete remission (CR) following intensive chemotherapy, relapse occurs in about 50% of the cases and is associated with poor prognosis. In this AML subset monitoring of measurable residual disease (MRD) has been shown to identify pts at higher risk of relapse. Aims: To assess the prognostic impact of MRD monitoring in bone marrow (BM) and peripheral blood (PB) in a large cohort of 155 homogeneously treated and clinically well-annotated patients with t(8;21)-AML. Methods: Quantification of RUNX1-RUNX1T1 transcript levels (TL) was performed by RT-qPCR. TL were reported as normalized values of RUNX1-RUNX1T1 per 10 6 transcripts of the housekeeping gene B2 M. Samples were analyzed in triplicate, the sensitivity of our assay was up to 10 -6 . Results: While pretreatment RUNX1-RUNX1T1 TL did not impact prognosis, both reduction of RUNX1-RUNX1T1 TL and achievement of MRD negativity (MRD neg ) at defined time points were of significant prognostic importance. First, achievement of MR 2.5 (>2.5 log reduction) after treatment cycle 1 and achievement of MR 3.0 after cycle 2 were significantly associated with a reduced risk of relapse (P = 0.034 and P = 0.028, respectively). Second, after completion of therapy, achievement of MRD neg in both, BM and PB, was an independent favorable prognostic factor for cumulative incidence of relapse (4-year CIR BM: 17% vs 36%, P = 0.021; PB: 23% vs 55%; P = 0.001) and overall survival (4-year OS rate BM: 93% vs 70%, P = 0.007; PB: 87% vs 47%; P < 0.0001). Finally, during follow-up serial RT-qPCR analyses allowed prediction of relapse in 77% of pts exceeding a cut-off of 150 RUNX1-RUNX1T1 TL in BM, and in 84% of pts with > 50 RUNX1-RUNX1T1 TL in PB, respectively. KIT mutation observed in 28% of pts predicted for lower CR rate and inferior outcome, but its prognostic impact was outweighed by RUNX1-RUNX1T1 TL during treatment. Virtually all relapses occurred within one year after end of treatment (EOT) with a very short latency from molecular to morphologic relapse, necessitating MRD assessment at short intervals during this period. Based on our data we suggest a refined practical guideline for MRD assessment in RUNX1-RUNX1T1-positive AML: Along with the current ELN MRD recommendations, BM and PB should be analyzed after each treatment cycle. According to MRD at EOT and during follow-up we suggest MRD monitoring as follows: (i) MRD neg : PB monthly can be used, (ii) MRD pos (TL < 150 in BM and < 50 in PB): BM 3-monthly and PB monthly, and (iii) MRD pos (TL >150 in BM and/or >50 in PB) or increase of MRD >1-log or conversion from MRD neg to MRD pos : BM and PB, both monthly, should be analyzed. Summary/Conclusion: RUNX1-RUNX1T1 MRD monitoring allows for the discrimination of pts at high and low risk of relapse. MRD neg in both, BM and PB, after completion of therapy was the most valuable independent favorable prognostic factor for relapse risk and OS. During follow-up, serial MRD analyses allowed the definition of cut-offs predicting relapse. Moreover, con...

A443 chemotherapy after the index date to the earliest of mean time to HSCT, death, loss to follow-up, or last chemotherapy dose plus 30 days. The primary endpoint was the percent of time in the hospital during the salvage chemotherapy period. Key secondary endpoints were number of hospitalisations and length of hospital stay. Hospitalisations associated with HSCT were excluded. Results are presented as mean (SD) unless indicated. Results: Twenty-two patients were included, with a mean age of 44 (18) years. After the index date, 19 patients died and 8 patients received a HSCT. During the chemotherapy salvage period, patients spent a mean of 56% (95% CI: 46%-69%) of their time in the hospital. There were a mean of 2.2 (1.5) inpatient hospitalisations, 3.2 (6.2) day stays, and 1.6 (3.0) outpatient visits per patient, and the mean length of inpatient hospitalisation was 20.0 (20.0) days. From the index date to death, there were a mean of 2.8 (1.4) inpatient hospitalisations, 4.7 (7.3) day stays, and 4.6 (7.4) outpatient visits per patient and the mean length of inpatient hospitalisation was 19.0 (19.0) days. ConClusions: Adult patients receiving salvage chemotherapy for R/R ALL in Italy spend more than half their time in the hospital. Costs of hospitalisations will be presented. PCN79 Budget ImPaCt aNalysIs of the treatmeNt of ChroNIC myeloId leukemIa wIth tyrosINe kINase INhIBItors-NIlotINIB IN the fIrst aNd seCoNd lINes of theraPy

No abstract