Purpose: To investigate the efficacy and safety of the novel orally active phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor in relapsed and/or refractory follicular lymphoma (FL) patients who had received at least two prior systemic treatments. Patients and Methods: Histologically confirmed relapsed and/or refractory FL patients with disease progression after receiving second-line or greater systemic therapy were enrolled. Linperlisib was administered at 80 mg qd, po in a 28-day cycle until disease progression or intolerable toxicity occurred. The primary outcome for the study was the objective response rate (ORR), with secondary outcomes including the duration of response (DOR), progression free survival (PFS), overall survival (OS), disease control rate and drug safety profile. Of 114 screened relapsed and/or refractory FL patients, 84 were enrolled in the full analysis set (FAS). Results: The ORR of 84 FAS patients was 79.8% (95%CI: 69.6-87.8, 67 patients), with 13 patients (15.5%) achieving a complete response and 54 patients (64.3%) with a partial response. The median DOR was 12.3 months (range: 9.3-15.9). The median PFS was 13.4 months (95%CI: 11.1-16.7). The 12-month OS rate was 91.4% (95%CI: 82.7-95.8. and a median OS not reached by 42 months. The most frequent (>3%) treatment-related adverse events grade ≥3 were infectious pneumonia (19.0%), neutropenia (15.5%), decreased lymphocyte count (4.8%), decreased leukocyte count (4.8%), increased lipase (3.6%), decreased platelet count (3.6%), hypertriglyceridemia (3.6%) and interstitial lung disease (3.6%). Conclusions: Linperlisib demonstrated compelling clinical activity and manageable tolerability for relapsed and/or refractory FL patients who had received at least two prior systemic therapies.
Purpose:This study aimed to compare the efficacy of two different catheters in hybrid surgery for salvage of thrombosed hemodialysis accesses.Materials and Methods:The hybrid salvage procedure (surgical thrombectomy followed by endovascular angioplasty) of the thrombosed hemodialysis access, was performed using adherent clot (AC) catheter in 140 cases and Fogarty balloon catheter in 68 cases. Procedure-related outcomes such as the clot removal status, clinical success, complications, and primary patency rates were analyzed retrospectively.Results:The proportion of cases with good clot removal scores in the AC catheter and Fogarty balloon catheter groups was 77.9% and 91.2%, respectively (P=0.018). Clinical success was achieved in 90.7% of the cases in the AC catheter group and in 98.5% of the cases in the balloon catheter group (P=0.035). The mean patency rates of the two groups were 50.7% and 63.2% at 3 months, 40.7% and 47.1% at 6 months, and 17.9% and 19.1% at 12 months. The complication rates (12.1% and 5.9%) and primary patency rates between the two catheters were not statistically different (P=0.328). On the analysis of the patency rate on access type of autologous (P=0.169) and prothetic graft (P=0.423), there was no significant difference between the two catheter groups.Conclusion:In terms of clot removal and clinical success, the AC catheter did not demonstrate better outcomes than the Fogarty balloon catheter. However, primary patency was not related to the type of catheter. Adherent clot catheter can be a useful alternative to Fogarty balloon catheter for thrombosed hemodialysis access.
Background:The optimal treatment strategy for refractory or relapse (R/R) indolent non-Hodgkin lymphoma (iNHL) has not been fully identified. This study aims to investigate the efficacy and tolerance of bendamustine hydrochloride developed in native Chinese corporation in the treatment of patients with R/R iNHL.Methods: A total of 101 patients from 19 centers were enrolled in this study from July 2016 to February 2019. Bendamustine hydrochloride (120 mg/m 2 ) was given on days 1 and 2 of each 21-day treatment cycle for six planned cycles or up to eight cycles if tolerated. Parameters of efficacy and safety were analyzed. Results:The median age of the patients was 53.44 (range, 24.4-74.6) years old. A total of 56 (55.44%) patients completed at least six treatment cycles, and the relative dose intensity was 93.78%. The overall response rate was 72.28%, and the median duration of response was 15.84 months (95% confidence interval [CI],13.77-27.48 months). Median progression-free survival was 16.52 months (95% CI, 14.72-23.41 months), and the median overall survival was not reached. Grade 3 or 4 hematologic toxicities included neutropenia (77.22%), thrombocytopenia (29.70%), and anemia (15.84%). The most frequent nonhematologic adverse events (any grade) included nausea, vomiting, fatigue, fever, decreased appetite, and weight loss.Seven patients died during the trial, and four cases may be related to the investigational drug.Conclusions: This study reveals that bendamustine hydrochloride is a feasible treatment option for the indolent B-cell non-Hodgkin lymphoma patient who has not remitted or relapsed after treatment with rituximab. All adverse events were predictable and manageable.
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