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Author(s):  
Yuko Takano ◽  
Satoshi Furune ◽  
Yuki Miyai ◽  
Sachi Morita ◽  
Megumi Inoue ◽  
...  

AbstractHere, we report a 57-year-old female patient with HER2-positive recurrent gastric cancer who experienced drug-induced thrombocytopenia associated with trastuzumab, a humanized anti-HER2 monoclonal antibody. Shortly after the initiation of S-1, oxaliplatin, and trastuzumab chemotherapy, the patient experienced severe thrombocytopenia and did not respond to platelet transfusions. Based on the findings of increased numbers of polynuclear megakaryocytes in the bone marrow and an elevated level of platelet-associated IgG (PA-IgG), the patient was diagnosed with drug-induced thrombocytopenia (DITP). The platelet count recovered rapidly with oral prednisolone (1 mg/kg). Since we initially suspected oxaliplatin as the causal agent, S-1 was restarted as a monotherapy, followed by trastuzumab after a 3-week interval, without oxaliplatin. On the second day after the addition of trastuzumab, severe thrombocytopenia occurred again, which suggests that trastuzumab was responsible for the DITP. The patient no longer experienced severe thrombocytopenia during the subsequent S-1 and oxaliplatin chemotherapy, which supports this hypothesis.


Author(s):  
Beryl L. Manning-Geist ◽  
Sushmita B. Gordhandas ◽  
Dilip D. Giri ◽  
Alexia Iasonos ◽  
Qin Zhou ◽  
...  

2021 ◽  
Vol 42 (5) ◽  
pp. 820-832
Author(s):  
Kwon-jun Jang ◽  
Jung-min Yang ◽  
Ji-yoon Lee ◽  
Eun-bi Ko ◽  
Hyang-ran Moon ◽  
...  

Objectives: This study examined the case of a patient with ROS1-positive recurrent non-small-cell lung cancer treated with crizotinib and traditional Korean medicine.Methods: The patient was treated with crizotinib from January 20 2021 to May 22 2021, together with Haedogyangpye-tang and Haengso-tang. The tumor size was measured using computed tomography (CT), and adverse events were evaluated according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.Results: After four months of combined treatment, the sizes of the lymph nodes in the porta hepatis, hepatoduodenal, retrocrural, aortocaval, and para-aortic areas had decreased, and no lymph nodes larger than 1 cm in diameter were observed. The side effects of chemotherapy also improved.Conclusions: This case study suggests that traditional Korean medicine may alleviate the side effects of chemotherapy, improve quality of life, and complement chemotherapy itself.


2021 ◽  
Vol 28 ◽  
Author(s):  
Hind M. Osman ◽  
Meral Tuncbilek

Background: Entrectinib is a highly potent ATP-competitive and selective inhibitor of tyrosine kinases - Trk A B C, ALK, and ROS1. It was developed by Roche and initially approved in Japan in 2019 for the treatment of pediatric and adult patients with NTRK fusion-positive, recurrent, or advanced solid tumors. In August 2019, entrectinib received accelerated approval by the U.S FDA for this indication. It is also the first FDA-approved drug designed to target both NTRK and ROS1. Objective: We aim to summarize recent studies related to the synthesis, mechanism of action, and clinical trials of the newly approved selective tyrosine kinase inhibitor entrectinib. Method: We conduct a literature review of the research studies on the new highly-potent small-molecule entrectinib. Conclusion: Entrectinib, based on three clinical studies (ALKA, STARTRK-1, and STARTRK-2), was well tolerated, with a manageable safety profile. It induced clinically meaningful responses in recurrent or advanced solid tumors associated with NTRK fusion-positive or ROS1+ NSCLC. It demonstrated substantial efficacy in patients with CNS metastases.


2021 ◽  
Vol 11 ◽  
Author(s):  
Qingtang Lin ◽  
Teer Ba ◽  
Jinyuan Ho ◽  
Dandan Chen ◽  
Ye Cheng ◽  
...  

Glioblastoma is the most common primary brain malignancy with limited treatment options. EphA2 is a tumor-associated-antigen overexpressed in glioblastoma. Pre-clinical studies have demonstrated the promise of EphA2-redirected CAR T-cells against glioblastoma. We conduct the first-in-human trial of EphA2-redirected CAR T-cells in patients with EphA2-positive recurrent glioblastoma and report the results of three patients enrolled as the first cohort receiving the starting dosage (1×106 cells/kg). A single infusion of EphA2-redirected CAR T-cells was administrated intravenously, with the lymphodepletion regimen consisting of fludarabine and Cyclophosphamide. In two patients, there was grade 2 cytokine release syndrome accompanied by pulmonary edema, which resolved completely with dexamethasone medication. Except that, there was no other organ toxicity including neurotoxicity. In both the peripheral blood and cerebral-spinal-fluid, we observed the expansion of CAR T-cells which persisted for more than four weeks. In one patient, there was a transit diminishment of the tumor. Among these three patients, one patient reported SD and two patients reported PD, with overall survival ranging from 86 to 181 days. At the tested dose level (1×106 cells/kg), intravenously infusion of EphA2-rediretected CAR T-cells were preliminary tolerable with transient clinical efficacy. Future study with adjusted dose and infusion frequency of CAR T-cells is warranted.Trial Registration NumbersNCT 03423992


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5512-5512
Author(s):  
Chel Hun Choi ◽  
Byoung-Gie Kim ◽  
Jeong-Won Lee ◽  
Duk-Soo Bae ◽  
Eun-Suk Kang ◽  
...  

5512 Background: BVAC-C is a B cell- and monocyte-based immunotherapeutic vaccine transfected with recombinant HPV E6/E7, which was well tolerated in HPV positive recurrent cervical carcinoma in phase I study (J Clin Med. 2020 Jan 5;9(1):147). This phase IIa study sought to determine the antitumor activity of BVAC-C. Methods: Twenty-one patients with HPV 16 or 18 positive recurrent cervical cancer who had experienced recurrence after one prior platinum-based combination chemotherapy were enrolled. They were allocated to 3 arms; Arm 1, BVAC-C injection at 0, 4, 8 weeks (1x108 cells/dose); Arm 2, BVAC-C injection at 0, 4, 8, 12 weeks (5x107 cells/dose); Arm 3, BVAC-C injection at 0, 4, 8, 12 weeks (5x107 cells/dose) with topotecan at 2, 6, 10, 14 weeks (0.75 mg/m2 for 3 days). Results: The overall response rate was 21% (Arm 1: 29% (2/7), Arm 2: 25% (1/4), Arm 3 : 0 % (0/3)) among the evaluable patients (N = 14), and the median duration of response was 18 months (range, 9 – 26 months). The disease control rate was 43% (Arm 1: 29% (2/7), Arm 2: 50% (2/4), Arm 3 : 67 % (2/3)) and the median duration of stable disease were 12 months (range, 6 - 26 months). The median progression-free survival in all patients was 4 months (95% CI, 2 to Infinite months). Immune responses of patients after vaccination were shown to be correlated with clinical responses of them. Consistent with Phase I study, all evaluated patients showed not only inflammatory cytokine responses (IFN-γ or TNF-α), which might be mediated by the activation of natural killer cells and natural killer T cells, but also potent E6/E7-specific T cell responses upon vaccinations. Conclusions: BVAC-C demonstrated a durable antitumor activity with an immune response in HPV 16- or 18-positive recurrent cervical carcinoma patients who failed 1st line platinum based chemotherapy. Clinical trial information: NCT02866006.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Conxita Jacobs Cachá ◽  
Natàlia Puig Gay ◽  
Ander Vergara ◽  
Alejandra Gabaldon ◽  
Joana Sellares ◽  
...  

Abstract Background and Aims A major complication primary focal segmental glomerulosclerosis (FSGS) is its recurrence after kidney transplantation that happens in 30 to 40% of the patients. The diagnosis of this relapses is not always easy as the histological lesions are not highly specific and appear after the proteinuria increase. Currently, there are no accurate biomarkers to detect FSGS recurrence. Our group identified a modified form of Apolipoprotein A-I (ApoA-I), named ApoA-Ib, specifically present in urine of recurrent FSGS patients after kidney transplantation. Aberrant forms of ApoA-I have also been described in urine of native primary FSGS patients and have associated this feature to a prominent staining of ApoA-I at the apical membrane of the tubular cells. In this study we aim to analyze the ApoA-I distribution in kidney allograft biopsies of recurrent FSGS patients. Method We detected ApoA-I by immunohistochemistry in kidney allograft biopsies of patients with FSGS relapse after kidney transplantation (urinary ApoA-Ib positive) and in kidney allograft biopsies of patients with a disease different from FSGS in the native kidney (No-FSGS, urinary ApoA-Ib negative). Results In ApoA-Ib positive recurrent FSGS patients, ApoA-I was prominently localized at the brush border of the tubular cells while in the No-FSGS patients ApoA-I was found along the cytoplasm of the tubular cells (Figure 1). Conclusion The localization of ApoA-I at the brush border of the tubular cells is a specific feature of primary FSGS in relapse. This suggests that ApoA-I staining in kidney biopsies, coupled with ApoA-Ib measurement in urine, could be used as a diagnostic tool of primary FSGS relapse after kidney transplantation due to its highly specific tubular distribution.


2021 ◽  
pp. 1-41
Author(s):  
MATTHIEU DUSSAULE

Abstract This is the first of a series of two papers dealing with local limit theorems in relatively hyperbolic groups. In this first paper, we prove rough estimates for the Green function. Along the way, we introduce the notion of relative automaticity which will be useful in both papers and we show that relatively hyperbolic groups are relatively automatic. We also define the notion of spectral positive recurrence for random walks on relatively hyperbolic groups. We then use our estimates for the Green function to prove that $p_n\asymp R^{-n}n^{-3/2}$ for spectrally positive-recurrent random walks, where $p_n$ is the probability of going back to the origin at time n and where R is the inverse of the spectral radius of the random walk.


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