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Purpose: Copanlisib, a pan-PI3K inhibitor, has previously shown clinical efficacy and a tolerable safety profile in patients with indolent non-Hodgkin lymphoma. However, the pharmacokinetics, safety, tolerability, and efficacy of copanlisib in Chinese patients have not been reported. Methods: This was a single-arm, open-label, phase I study of copanlisib in Chinese patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL). Patients received a single intravenous 60 mg infusion of copanlisib over 1 h on days 1, 8, and 15 of a 28-day cycle, with 1 week of rest. Safety was monitored throughout the study, and plasma copanlisib levels were measured for pharmacokinetic analysis. Tumor response was determined by independent central radiologic review. Results: Sixteen patients were enrolled and 13 were treated with 60 mg of copanlisib for a median of 15.0 weeks. With a Cmax of 566 μg/L and a AUC (0–24) of 1880 μg·h/L following single intravenous infusion, the pharmacokinetic parameters of copanlisib were consistent with that in previous studies, and no accumulation in plasma was observed. Treatment-emergent adverse events were reported for all 13 patients, the most common of which were hyperglycemia (100.0%), hypertension (76.9%), decreased neutrophil count (76.9%), and decreased white blood cell count (69.2%). Seven out of 12 evaluated patients achieved partial response, resulting in an overall response rate of 58.3% Conclusions: Copanlisib was well tolerated in Chinese patients with relapsed or refractory iNHL at the dose of 60 mg and demonstrated encouraging disease control, thus warranting further clinical investigation. Clinical trial registration number: NCT03498430 (April 13, 2018). [ABSTRACT FROM AUTHOR]

Cutaneous T-cell lymphomas (CTCLs) are a group of T-cell lymphomas with low incidence. Due to their indolent characteristics, treatment strategies have not yet been established for advanced CTCLs. In this study, relative incidence of CTCLs in Asia was estimated and the therapeutic outcomes presented based on various treatments currently used in clinics for advanced CTCLs. As part of a prospective registry study of peripheral T-cell lymphoma (PTCL) conducted across Asia, including Korea, China, Taiwan, Singapore, Malaysia, and Indonesia, subgroup analysis was performed for patients with CTCLs. Among 486 patients with PTCL, 37 with CTCL (7.6%) were identified between April 2016 and February 2019. Primary cutaneous ALK-negative anaplastic large cell lymphoma (ALCL, 35.1%) was the most common subtype. With a median follow-up period of 32.1 months, median progression-free survival (PFS) was 53.5 months (95% CI 0.0-122.5), and overall survival was not reached. 14 patients (48.2%) underwent subsequent treatment after the first relapse, but the response rate was 20% with a PFS of 2.2 months (95% CI 0.3-4.0). Six patients received autologous stem cell transplantation (auto-SCT). However, auto-SCT did not result in better outcomes. Additional studies are needed on standard care treatment of advanced or refractory and relapsed CTCLs. [ABSTRACT FROM AUTHOR]

Anthracycline-related cardiotoxicity is an important dose-limiting toxicity for Hodgkin lymphoma (HL) treatment. This study aimed to assess the efficacy and safety of pegylated liposomal doxorubicin (PLD) for HL treatment. Patients with newly diagnosed HL treated with at least two cycles of PLD-containing chemotherapy were retrospectively analyzed. The dosing and scheduling of the PLD-containing regimen (the PBVD regimen) were as follows: PLD 25 mg/m2, vincristine 1.4 mg/m2 (maximum dose of 2 mg), bleomycin 10 mg/m2, and dacarbazine 375 mg/m2 at days l and 15, repeated every 28 days. Forty-six HL patients were analyzed. The median age was 41.5 years (range 12–77 years), with a male/female ratio of 0.9:1. Fourteen (30%) patients had an Eastern Cooperative Oncology Group (ECOG) performance status score > 1, and 32 (70%) had a history of cardiovascular disease (CVD) or related risk factors. The median chemotherapy cycle number with the PBVD regimen was 6 (range, 2–8). The overall response rate (ORR) was 91% for the whole cohort; 35 (76%) patients achieved complete remission (CR), and 7 (15%) achieved partial remission. The efficacy of the PBVD regimen was similar in patients with or without CVD or related risk factors (ORR 93% vs. 91%, P = 1.00; CR 86% vs. 72%, P = 0.46). With a median follow-up of 28.5 months, the 3-year progression-free survival (PFS) and overall survival (OS) rates were 70% and 82%, respectively, for the whole cohort. The differences in the PFS and OS rates between the groups with or without CVD or related risk factors were not significant. Cardiotoxicity was observed in 6 (13%) patients. All adverse events were grades 1–2. The PBVD regimen is an effective chemotherapy option with tolerable toxicity, and it could be a substitute in HL patients who cannot be treated with conventional doxorubicin, especially those with CVD or related risk factors. [ABSTRACT FROM AUTHOR]