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  • 1
    In: Liver Transplantation, Ovid Technologies (Wolters Kluwer Health), Vol. 27, No. 3 ( 2021-03), p. 444-449
    Type of Medium: Online Resource
    ISSN: 1527-6465 , 1527-6473
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 2002186-0
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 4099-4099
    Abstract: 4099 Background: Lenvatinib monotherapy and lenvatinib plus PD-1 antibody have shown some clinical benefit for advanced intrahepatic cholangiocarcinoma (ICC) in the second-line setting. Our study assesses the role of lenvatinib plus toripalimab (PD-1 antibody) for advanced ICC patients as the first line therapy. Methods: Patients (pts) with locally advanced or metastatic ICC received 12 mg/day (Body Weight ≥60 kg) or 8 mg/day (Body Weight 〈 60 kg) oral lenvatinib daily plus 240 mg intravenous toripalimab every 3 weeks. The primary endpoint was objective response rate (ORR) and evaluated according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1). Secondary endpoints included safety, progression-free survival (PFS) and overall survival (OS). Treatment continued until confirmed disease progression, unacceptable toxicity, or voluntary withdrawal. This trial is registered with ClinicalTrials.gov (NCT04361331). Results: From March 2020 to Sep. 2020, 31 pathologically confirmed advanced ICC pts with a mean age of 58.4 (range, 25-73) years, including 18 women (58.0%), were enrolled at Zhongshan Hospital, Fudan University. At the end of last follow-up (February 10, 2021), the ORR was 32.3% (10/31; 95% CI: 16.7%-51.4%) and the disease control rate (DCR) was 74.2% (23/31; 95% CI: 55.4%-88.1%). Median follow-up was 6.9 months. Two pts with locally advanced disease were down-staged and then underwent resection. They remained disease-free survival at the end of last follow-up. 11 pts exerted disease progression and 7 pts died. The median PFS and OS have not been reached. Median duration of response (DOR) has not been reached and responses were ongoing in 9/10 (90.0%) pts at data cutoff. 6-months OS rate was 87.1%. No grade 5 adverse event (AE) was observed in present study. 32.3% (10/31) of pts experienced Grade 3 or higher AEs and 1 pts discontinued the treatment owing to severe fatigue. Conclusions: As the first-line therapy, lenvatinib plus toripalimab provided promising efficacy with reasonable safety profile in advanced ICC patients. It offered an alternative treatment for advanced ICC who cannot tolerate gemcitabine-based chemotherapy. Clinical trial information: NCT04361331.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 3
    In: Hepatology, Ovid Technologies (Wolters Kluwer Health), Vol. 76, No. 1 ( 2022-07), p. 66-77
    Type of Medium: Online Resource
    ISSN: 0270-9139 , 1527-3350
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 1472120-X
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e16158-e16158
    Abstract: e16158 Background: Chinese guidelines recommend surgical resection for patients with China Liver Cancer (CNLC) Stage Ia−IIIa HCC (equal to BCLC stage A/B and selected patients with BCLC stage C). Despite treatment, however, patients with CNLC stage IIb (tumor number 〉 3) and IIIa (vascular invasion) disease have a high recurrence risk and poor overall survival (OS). Here we assessed the efficacy and safety of adjuvant lenvatinib in patients with high risk of disease recurrence. Methods: In this multi-center, single-arm, prospective clinical trial (NCT04227808), patients underwent radical (R0) resection for CNLC Stage IIb/IIIa HCC within 4-6 weeks were eligible and received treatment of lenvatinib (8 or 12 mg/day for body weight 〈 60 and ≥60 kg, respectively. Dose modifications were permitted due to adverse reactions) until disease recurrence, intolerable toxicity or death. The primary endpoint was 1-year recurrence-free survival (RFS), and secondary endpoints included OS and safety. The total planned enrollment for this study is 50 patients and here we report our preliminary analysis results. Results: A total of 59 patients were screened from Mar 2020 to Dec 2021 and 50 were enrolled in the study. By the cut of date (Dec 31, 2021), 42 patients had at least one set of follow-up data and were included in the present analysis. The 42 patients were predominantly male (83.3%, n = 35), and the median age was 55.5 years (range: 26–73). 78.6% (n = 33) were HBV-positive and 21.4% (n = 9) of disease were non-viral. Five patients (11.9%) had CNLC Stage IIb and 37 (88.1%) had CNLC Stage IIIa HCC. The median duration of treatment was 8.4 months (range: 1.7-18.7) with a median follow-up of 11.3 months (95% CI: 6.6−15.9). 24% (n = 10) had experienced dose reduction or delay. The 1-year RFS rate was 50.5%, while the median RFS was 16.5 months (95% CI: 11.3–21.7). Two deaths occurred: one secondary to disease recurrence and one from hepatic encephalopathy without recurrence. In total, 90.5% (n = 38) of patients experienced ≥1 treatment-related adverse events (AE) of any grade, and five patients (11.9%) had grade 3 treatment-related AEs (thrombocytopenia in two cases, proteinuria in two cases, and elevated aspartate aminotransferase in one case). There was no treatment-related death. Conclusions: Adjuvant lenvatinib was well-tolerated in patients with CNLC Stage IIb/IIIa HCC after R0 resection. The median RFS was longer than our historical data (mRFS = 9.03 months), and these findings warrant further investigation in a controlled study. Funding: Eisai Co., Ltd. Clinical trial information: NCT04227808.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 5
    In: Signal Transduction and Targeted Therapy, Springer Science and Business Media LLC, Vol. 8, No. 1 ( 2023-03-17)
    Abstract: Advanced intrahepatic cholangiocarcinoma (ICC) has a dismal prognosis. Here, we report the efficacy and safety of combining toripalimab, lenvatinib, and gemcitabine plus oxaliplatin (GEMOX) as first-line therapy for advanced ICC. Thirty patients with pathologically confirmed advanced ICC received intravenous gemcitabine (1 g/m 2 ) on Days 1 and 8 and oxaliplatin (85 mg/m 2 ) Q3W for six cycles along with intravenous toripalimab (240 mg) Q3W and oral lenvatinib (8 mg) once daily for one year. The expression of programmed death-ligand 1 (PD-L1) and genetic status was investigated in paraffin-embedded tissues using immunohistochemistry and whole-exome sequencing (WES) analysis. The primary endpoint was the objective response rate (ORR). Secondary outcomes included safety, overall survival (OS), progression-free survival (PFS), disease control rate (DCR) and duration of response (DoR). As of July 1, 2022, the median follow-up time was 23.5 months, and the ORR was 80%. Twenty-three patients achieved partial response, and one achieved complete response. Patients (21/30) with DNA damage response (DDR)-related gene mutations showed a higher ORR, while patients (14/30) with tumor area positivity ≥1 (PD-L1 staining) showed a trend of high ORR, but without significant difference. The median OS, PFS, and DoR were 22.5, 10.2, and 11.0 months, respectively. The DCR was 93.3%. Further, 56.7% of patients experienced manageable grade ≥3 adverse events (AEs), commonly neutropenia (40.0%) and leukocytopenia (23.3%). In conclusion, toripalimab plus lenvatinib and GEMOX are promising first-line regimens for the treatment of advanced ICC. A phase-III, multicenter, double-blinded, randomized study to validate our findings was approved by the National Medical Products Administration (NMPA, No. 2021LP01825). Trial registration Clinical trials : NCT03951597.
    Type of Medium: Online Resource
    ISSN: 2059-3635
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2886872-9
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  • 6
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 4094-4094
    Abstract: 4094 Background: The outcome of advanced intrahepatic cholangiocarcinoma (ICC) remains poor with current gemcitabine-based chemotherapy. This study is to evaluate the safety and efficacy of anti-PD1 agent toripalimab, lenvatinib in combination with oxaliplatin and gemcitabine (Gemox) chemotherapy. Methods: Locally advanced or metastatic ICC patients (pts) were given 240 mg toripalimab Q3W via intravenous (IV) infusion, 8 mg lenvatinib QD orally, and 1g/m² gemcitabine on Day 1 and Day 8, and 85 mg/m² oxaliplatin Q3W by IV for 6 cycles. The primary outcome was objective response rate (ORR), which was evaluated according to RECIST v1.1. Secondary outcomes included safety, progression-free survival (PFS) and overall survival (OS). Treatment would be terminated by confirmed disease progression, unacceptable toxicity, or voluntary withdrawal. Whole exome sequencing was performed on available tumor tissues and PD-L1 expression was determined by immunohistochemistry staining. Results: From May 2019 to Oct 2019, 30 pathologically-confirmed advanced ICC pts with a mean age of 56.5 (range, 25-73) years, including 11 women (37%), were enrolled at Zhongshan Hospital, Fudan University (one pt withdrawn). At the end of last follow-up (February 1, 2021), the ORR was 80% (24/30; 95% CI: 61.4%-92.3%), and disease control rate (DCR) was 93.3% (28/30; 95% CI:77.9%-99.2%). Median follow-up was 16.6 months. One pt achieved complete response (CR). Three pts with locally advanced disease were down-staged and then underwent resection. They remained disease-free survival at the end of last follow-up. 23 pts experienced disease progression and 12 pts (including one pt withdrawn) have died. The median PFS was 10.0 months and median duration of response (DOR) was 9.8 months. The median OS have not been reached. 12-months OS rate was 73.3% (95% CI: 57.5%-89.2%). No grade 5 adverse event (AE) was observed in present study. Grade 3 or 4 neutropenia and thrombocytopenia observed in 3 (10%) and 1 (3.3%) patient, respectively. Non-hematological toxic effects were jaundice (10 %), rash (6.7 %), proteinuria (6.7 %), increased AST level (3.3%), vomiting (3.3%), upper gastrointestinal hemorrhage (3.3%), sepsis (3.3%), gastrointestinal fistula (3.3%), adrenocortical insufficiency (3.3%), interstitial pneumonia (3.3%), and hyponatremia (3.3%). High ORR was significantly associated with positive PD-L1 expression ( p= 0.048) and DNA damage repair (DDR)-related mutations ( p= 0.022) in tumor samples. Conclusions: Gemox chemotherapy in combination with Anti-PD1 antibody Toripalimab and Lenvatinib provided remarkable efficacy with reasonable tolerability in advanced ICC patients. These findings warrant further validation in a large randomized clinical trial. Clinical trial information: NCT03951597.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 7
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e16163-e16163
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e16163-e16163
    Abstract: e16163 Background: The prognosis of advanced intrahepatic cholangiocarcinoma (ICC) remains dismal with gemcitabine-based first-line chemotherapy. This study is to evaluate the safety and efficacy of lenvatinib in combination with gemcitabine and oxaliplatin (Gemox) chemotherapy in the advanced ICC. Methods: Locally advanced or metastatic ICC patients (pts) were given lenvatinib 12 mg/day (body weight ≥60 kg) or 8 mg/day (body weight 〈 60 kg) oral administration, once daily. They also received 1g/m² gemcitabine on Day 1 and Day 8, and 85 mg/m² oxaliplatin Q3W by IV for 6-8 cycles. The primary outcome was objective response rate (ORR) and secondary outcomes included safety, disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). ORR, DCR and PFS were measured according to RECIST 1.1. Treatment would be terminated by confirmed disease progression, unacceptable toxicity, or voluntary withdrawal. Results: From March 2020 to Sep. 2020, 30 pathologically-confirmed advanced ICC pts with a mean age of 59.2 (range, 33-74) years, including 14 women (46.7%), were enrolled at Zhongshan Hospital, Fudan University. At the end of last follow-up (February 10, 2021), the ORR was 30.0% (9/30; 95% CI: 14.7%-49.4%). The disease control rate (DCR) was 86.7% (26/30; 95% CI: 69.3%-96.2%). Median follow-up was 6.8 months. One pt with locally advanced disease was down-staged and then underwent resection. This patient remained disease-free survival at the end of last follow-up. 11 pts experienced disease progression and 8 pts have died. The median PFS and OS have not been reached. Median duration of response (DOR) has not been reached and responses were ongoing in 6/9 (66.7%) pts. 6-months OS rate was 92.6%. No grade 5 adverse event (AE) was observed in present study. 40.0% (12/30) of pts experienced grade 3 or higher AEs and 5 pts discontinued the treatment owing to fatigue (3 pts), jaundice (1 pt) and vomiting (1 pt). Conclusions: Addition of lenvatinib to Gemox chemotherapy provided modest efficacy with reasonable tolerability in advanced ICC patients. Clinical trial information: (NCT04361331). Clinical trial information: NCT04361331.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 8
    In: Radiation Oncology, Springer Science and Business Media LLC, Vol. 8, No. 1 ( 2013-12)
    Abstract: To compare the dosimetry for the left-sided breast cancer treatment using five different radiotherapy techniques. Materials and methods Twenty patients with left sided breast cancer were treated with conservative surgery followed by radiotherapy. They were planned using five different radiotherapy techniques, including: 1) conventional tangential wedge-based fields (TW); 2) field-in-field (FIF) technique; 3) tangential inverse planning intensity-modulated radiation therapy (T-IMRT); 4) multi-field IMRT (M-IMRT); and 5) volumetric modulated arc therapy (VMAT). The CTV, PTV and OARs including the heart, the regions of coronary artery (CA), the contralateral breast, the left and right lung were delineated. The PTV dose was prescribed 50Gy and V 47.5 ≥95%. Same dose constraint was used for all five plans. The planned volumetric dose of PTV and PRV-OARs were compared and analyzed. Results Except VMAT (Average V 47.5 was 94.72%±1.2%), all the other four plans were able to meet the V95% (V 47.5 ) requirement. T-IMRT plan improved the PTV dose homogeneity index (HI) by 0.02 and 0.03 when compared to TW plan and VMAT plan, and decreased the V 5 , V 10 and V 20 of all PRV-OARs. However, the high dose volume (≥ 30Gy) of the PRV-OARs in T-IMRT plan had no statistically significant difference compared with the other two inverse plans. In all five plans, the dose volume of coronary artery area showed a strong correlation to the dose volume of the heart (the correlation coefficients were 0.993, 0.996, 1.000, 0.995 and 0.986 respectively). Conclusion Compared to other techniques, the T-IMRT technology reduced radiation dose exposure to normal tissues and maintained reasonable target homogeneity, VMAT is not recommended for left-sided breast cancer treatment. In five techniques, the dose-volume histogram (DVH) of the heart can be used to predict the dose-volume histogram (DVH) of the coronary artery.
    Type of Medium: Online Resource
    ISSN: 1748-717X
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2013
    detail.hit.zdb_id: 2224965-5
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  • 9
    In: Frontiers in Cellular and Infection Microbiology, Frontiers Media SA, Vol. 12 ( 2022-6-16)
    Abstract: Metagenomic next-generation sequencing (mNGS) has emerged as an effective method for the noninvasive and precise detection of infectious pathogens. However, data are lacking on whether mNGS analyses could be used for the diagnosis and treatment of infection during the perioperative period in patients undergoing liver transplantation (LT). Methods From February 2018 to October 2018, we conducted an exploratory study using mNGS and traditional laboratory methods (TMs), including culture, serologic assays, and nucleic acid testing, for pathogen detection in 42 pairs of cadaveric liver donors and their corresponding recipients. Method performance in determining the presence of perioperative infection and guiding subsequent clinical decisions was compared between mNGS and TMs. Results The percentage of liver donors with mNGS-positive pathogen results (64.3%, 27/42) was significantly higher than that using TMs (28.6%, 12/42; P & lt;0.05). The percentage of co-infection detected by mNGS in liver donors was 23.8% (10/42) significantly higher than 0.0% (0/42) by TMs (P & lt;0.01). Forty-three pathogens were detected using mNGS, while only 12 pathogens were identified using TMs. The results of the mNGS analyses were consistent with results of the TM analyses in 91.7% (11/12) of donor samples at the species level, while mNGS could be used to detect pathogens in 66.7% (20/30) of donors deemed pathogen-negative using TMs. Identical pathogens were detected in 6 cases of donors and recipients by mNGS, among which 4 cases were finally confirmed as donor-derived infections (DDIs). For TMs, identical pathogens were detected in only 2 cases. Furthermore, 8 recipients developed early symptoms of infection ( & lt;7 days) after LT; we adjusted the type of antibiotics and/or discontinued immunosuppressants according to the mNGS results. Of the 8 patients with infections, 7 recipients recovered, and 1 patient died of severe sepsis. Conclusions Our preliminary results show that mNGS analyses can provide rapid and precise pathogen detection compared with TMs in a variety of clinical samples from patients undergoing LT. Combined with symptoms of clinical infection, mNGS showed superior advantages over TMs for the early identification and assistance in clinical decision-making for DDIs. mNGS results were critical for the management of perioperative infection in patients undergoing LT.
    Type of Medium: Online Resource
    ISSN: 2235-2988
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2619676-1
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  • 10
    Online Resource
    Online Resource
    Springer Science and Business Media LLC ; 2023
    In:  Journal of Medical Case Reports Vol. 17, No. 1 ( 2023-02-08)
    In: Journal of Medical Case Reports, Springer Science and Business Media LLC, Vol. 17, No. 1 ( 2023-02-08)
    Abstract: Immune thrombocytopenic purpura and thrombotic thrombocytopenic purpura are both causes of thrombocytopenia. Recognizing thrombotic thrombocytopenic purpura is crucial for subsequent treatment and prognosis. In clinical practice, corticosteroids and rituximab can be used to treat both immune thrombocytopenic purpura and thrombotic thrombocytopenic purpura; plasma exchange therapy is the first-line treatment in thrombotic thrombocytopenic purpura, while corticosteroids are strongly recommended as first-line treatment in immune thrombocytopenic purpura. The differential diagnosis of immune thrombocytopenic purpura and thrombotic thrombocytopenic purpura is essential in clinical practice. However, case reports have suggested that immune thrombocytopenic purpura and thrombotic thrombocytopenic purpura can occur concurrently. Case presentation We report the case of a 32-year-old Asian female without previous disease who presented with pancytopenia, concurrent with immune thrombocytopenic purpura and thrombotic thrombocytopenic purpura. The morphology of the megakaryocytes in the bone marrow indicated immune-mediated thrombocytopenia. The patient received glucocorticoid treatment, and her platelet count increased; however, schistocytes remained high during the course of the therapy. Further investigations revealed ADAMTS13 activity deficiency and positive ADAMTS13 antibodies. The high titer of antinuclear antibody and positive anti-U1-ribonucleoprotein/Smith antibody indicated a potential autoimmune disease. However, the patient did not fulfill the current criteria for systemic lupus erythematosus or mixed connective tissue disease. The patient responded well to plasma exchange therapy, and her platelet count remained normal on further follow-up. Conclusions Concurrence of immune thrombocytopenic purpura and thrombotic thrombocytopenic purpura is rare, but clinicians should be aware of this entity to ensure prompt medical intervention. Most of the reported cases involve young women. Human immunodeficiency virus infection, pregnancy, and autoimmune disease are the most common underlying conditions.
    Type of Medium: Online Resource
    ISSN: 1752-1947
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2269805-X
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