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  • American Society of Clinical Oncology (ASCO)  (66)
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  • American Society of Clinical Oncology (ASCO)  (66)
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  • 1
    Online Resource
    Online Resource
    Deintensified Chemoradiotherapy for Pretreatment Epstein-Barr Virus DNA-Selected Low-Risk Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II Randomized Noninferiority Trial
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 11 ( 2022-04-10), p. 1163-1173
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 11 ( 2022-04-10), p. 1163-1173
    Abstract: Cumulative doses of 200 mg/m 2 for concurrent cisplatin (DDP) were indicated by retrospective studies as sufficient in conferring survival benefit for locoregionally advanced nasopharyngeal carcinoma (LA-NPC). We performed an open-label, phase II, randomized, controlled trial to test the noninferiority of a two-cycle 100 mg/m 2 concurrent DDP regimen over three-cycle in patients with low-risk LA-NPC with pretreatment Epstein-Barr virus DNA levels 〈 4,000 copies/mL. PATIENTS AND METHODS Eligible patients were randomly assigned 1:1 to receive two cycles or three cycles concurrent DDP-based chemoradiotherapy. The primary end point was 3-year progression-free survival (PFS). The secondary end points included overall survival, distant metastasis-free survival, locoregional relapse-free survival, etc. RESULTS Between September 2016 and October 2018, 332 patients were enrolled, with 166 in each arm. After a median follow-up of 37.7 months, the estimated 3-year PFS rates were 88.0% in the two-cycle group and 90.4% in the three-cycle group, with a difference of 2.4% (95% CI, –4.3 to 9.1, P noninferiority = .014). No differences were observed between groups in terms of PFS, overall survival, and the cumulative incidences of locoregional relapse and distant metastasis. Patients in the three-cycle group developed significantly more grade 3-4 mucositis (41 [24.8%] v 25 [15.1%] ), hyponatremia (26 [15.8%] v 14 [8.4%] ), and dermatitis (9 [5.5%] v 2 [1.2%] ). The overall all-grade and grade 3-4 toxicity burdens were heavier in three-cycle group (T-scores, 12.33 v 10.57, P 〈 .001 for all grades; 1.76 v 1.44, P = .05 for grade 3-4). Patients in the three-cycle group also showed more all-grade hearing impairment, dry mouth and skin fibrosis, and impaired long-term quality of life. CONCLUSION Intensity-modulated radiotherapy plus two cycles of concurrent 100 mg/m 2 DDP could be an alternative treatment option for patients with low-risk LA-NPC.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.21.01467
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 2
    Online Resource
    Online Resource
    Induction-concurrent versus concurrent-adjuvant chemoradiotherapy in patients with high-risk N2–3 nasopharyngeal carcinoma: An open-label, randomised, controlled, phase 3 trial.
    American Society of Clinical Oncology (ASCO) ; 2024
    In:  Journal of Clinical Oncology Vol. 42, No. 16_suppl ( 2024-06-01), p. 6072-6072
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 42, No. 16_suppl ( 2024-06-01), p. 6072-6072
    Abstract: 6072 Background: It remains uncertain which chemotherapy sequence is more effective for locoregionally advanced nasopharyngeal carcinoma (NPC). We aimed to compare the efficacy and safety of induction-concurrent with concurrent-adjuvant chemotherapy in high-risk N2–3 NPC. Methods: We conducted an open-label, phase 3, single-centre, randomised controlled trial. Patients aged 18–65 years with stage T1-4N2-3M0 (AJCC 7th staging system) and pretreatment Epstein–Barr virus DNA level ≥1500 copies/ml were enrolled. Eligible patients were randomly assigned (1:1) to receive paclitaxel liposome (135 mg/m² intravenously on day 1), cisplatin (25 mg/m² intravenously on days 1-3), and fluorouracil (3.75g/m² continuous intravenous infusion for 120 h) induction chemotherapy once every 3 weeks, for 3 cycles, followed by concurrent cisplatin (100 mg/m² intravenously) on days 1, 22, and 43 of intensity-modulated radiotherapy or concurrent chemoradiotherapy followed by fluorouracil (4 g/m² in continuous intravenous infusion for 96 h) and cisplatin (80 mg/m² intravenously on day 1) once every 4 weeks, for 3 cycles. Randomisation was performed using computer-generated random number code with a block size of 6, stratified by nodal category (N2 or N3). The primary endpoint was 3-year progression-free survival (PFS) in the intention-to-treat population. This trial was registered with ClinicalTrials.gov (number NCT03306121). Results: Between 20 November 2017 and 19 March 2021, 162 patients were assigned to the induction-concurrent group and 162 to the concurrent-adjuvant group. Regarding the data cutoff (20 January 2024), the median follow-up period was 51.7 months. The 3-year PFS rates were 73.4% (95%CI 65.9%-79.5%) in the induction-concurrent group and 69.8% (95%CI 62.0%-76.2%) in the concurrent-adjuvant group (HR 0.85, [95%CI 0.58-1.26], P=0.43). Patients in the induction-concurrent group had significantly better 3-year distant metastasis-free survival rate at 81.4% (95% CI, 74.5%–86.6%) compared with those in the concurrent-adjuvant group at 71.0% (95% CI, 63.3%–77.3%) (HR, 0.64; 95% CI, 0.42–0.98; p=0.04). There were no differences on overall survival and locoregional failure-free survival between the two groups. The most common acute grade 3 + adverse events were leukopenia (53 [33.1%] of 160 in the induction-concurrent group vs. 47 [33.1%] of 142 in the concurrent-adjuvant group), neutropenia (51 [31.9%] vs. 32 [22.5%]), and mucositis (47 [29.4%] vs. 42 [29.6%]). The most common grade 3 + late adverse event was auditory or hearing loss (10 [6.3%] vs. 12 [8.5%]). Conclusions: Induction-concurrent chemotherapy does not significantly improve PFS compared with concurrent-adjuvant chemotherapy in high-risk N2–3 NPC. Long-term follow-up is required to determine long-term efficacy and toxicities. Clinical trial information: NCT03306121 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2024.42.16_suppl.6072
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2024
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 3
    Online Resource
    Online Resource
    Study RC48-C014: Preliminary results of RC48-ADC combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 6_suppl ( 2022-02-20), p. 515-515
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. 515-515
    Abstract: 515 Background: RC48-ADC is a novel humanized anti-HER2 antibody-drug conjugate (ADC), which showed promising data in HER2-positive and even negative patients (pts) with metastatic urothelial carcinoma (mUC). Toripalimab is an anti-PD-1 antibody with a durable antitumor effect for mUC. The combination may have a synergistic antitumor effect. Initial RC48-C014 data was previously presented (ASCO 2021); here we reported an update on safety and ORR. Methods: In dose-escalation cohort, pts received 1.5 or 2 mg/kg RC48-ADC + 3mg/kg toripalimab with the traditional 3+3 escalation design. In the expansion cohort, patients received the recommended dose of RC48-ADC + toripalimab every 2 weeks. The primary endpoints were safety/tolerability and recommended RC48-ADC dose; secondary endpoints included pharmacokinetics, ORR per RECIST 1.1, PFS, and OS, stratified by HER2 and PD-L1 expression. Results: As of 23 Sep 2021 (data cutoff), 32 mUC pts (18 males; median age 67 y [52-76]) were enrolled since 20 Aug 2020. Fifty-three percent pts were systemic treatment naïve in the locally advanced or metastatic setting. The primary site was in upper tract UC in 56%; 53% had visceral metastases (mets), including 28% with liver mets; HER2 expression was positive (IHC 3+ or 2+ ISH+) in 19% pts, and PD-L1 CPS≥1 in 56%. No dose-limiting toxicity was reported, and the recommended dose for RC48-ADC was 2mg/kg. At data cutoff, confirmed investigator-assessed ORR was 75% (95%CI: 50.9, 91.3), including 15% CRs; DCR was 95% (95%CI: 75.1, 99.9). The ORR for 1L previously untreated mUC pts was 80% and 75% for pts with liver mets. The ORR was 100% for pts with HER2 (3+), 77.8% for HER2 (2+), 66.7% for HER2 (1+), and 50% for HER2 (0) respectively. The ORR was 97.1% in pts with PD-L1 CPS≥1 and 50% in CPS 〈 1. Follow-up continues for PFS and OS. Most common treatment-related AEs were anorexia (72%), asthenia (56%, 8%≥G3), aminotransferase level increased (56%, 4%≥G3), peripheral sensory neuropathy (56%), alopecia (52%), nausea (36%), and anemia (32%). The most common immune-related AE was pneumonitis (20%). Conclusions: RC48-ADC in combination with toripalimab demonstrated promising efficacy in pts with mUC and a manageable safety profile. Further evaluation of RC48 + toripalimab in mUC is ongoing. Clinical trial information: NCT04264936.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.6_suppl.515
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 4
    Online Resource
    Online Resource
    De-intensified chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma based on plasma EBV DNA: A phase 2 randomized noninferiority trial.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 110-110
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 110-110
    Abstract: 110 Background: The cisplatin-based chemoradiotherapy (CCRT), given at a dose of 100 mg/m 2 for 3 cycles during radiotherapy, is the major treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). As several retrospective studies showed that receiving a cumulative cisplatin dose of 200 mg/m 2 can bring survival benefits to NPC patients, we sought to test the non-inferiority of 2-cycle concurrent cisplatin over 3-cycle in locoregionally advanced NPC with Epstein-barr virus (EBV) DNA levels 〈 4000 copies/ml. Methods: We did a non-inferiority, phase 2, randomised controlled trial. Patients were enrolled with stage III–IVB NPC, EBV DNA levels 〈 4000 copies/ml, aged 18–70 and adequate haematological, renal, and hepatic function. Eligible patients were randomly assigned (1:1) to receive 2 or 3 cycles of cisplatin-based CCRT. Patients in the 2-cycle group were scheduled to receive 100 mg/m 2 cisplatin given every 3 weeks concurrently with radiotherapy, and patients in the 3-cycle group received 100 mg/m 2 cisplatin given every 3 weeks for 3 cycles. Randomization was done by a computer-generated random number code with a block size of six, stratified by clinical stage III or IV. The primary endpoint was 3-year progression-free survival (PFS), with a non-inferiority margin of 10%. This study was registered with ClinicalTrials.gov, ID. NCT02871518. Results: Between September 2016 and October 2018, 342 patients were enrolled, of whom 332 were randomly assigned to receive 2 or 3 cycles of cisplatin. 314 (94.6%) patients completed protocol-defined cycles of chemotherapy. After median follow-up of 33.6 months, 20 (12.0%) patients in the 2-cycle group and 17 (10.2%) patients in the 3-cycle group had tumor progression, and the 3-year PFS rates were 88.0% and 90.4% respectively, with a difference of 2.4% (95%CI -4.3 to 9.1, P non-inferiority 〈 0.001). In the per-protocol analysis, 3-year PFS was 88.5% in the 2-cycle group and 90.6% in the 3-cycle group, with a difference of 2.1% (95% CI –4.7 to 8.9; P non-inferiority = 0.001). No significant difference was observed concerning OS, LRRFS and DMFS. The grade 3 or 4 acute adverse events were recorded in 113 (68.1%) patients in the 2-cycle group and 116 (69.9%) patients in the 3-cycle group. Patients in the 3-cycle group was observed to have significantly more hyponatremia. Besides, patients in the 3-cycle group presented with more grade 1 or 2 dry mouth, dysphagia, weight loss, fatigue, constipation, fever, mucositis and dermatitis. More grade 3 or 4 anorexia, mucositis and dermatitis were also recorded in the 3-cycle group. No patients died from treatment-related toxicities. Conclusions: IMRT plus 2 cycles of concurrent 100 mg/m 2 cisplatin could be an alternative option for patients with low-risk locoregionally advanced NPC. Further phase III studies are needed to validate the findings of this study. Clinical trial information: NCT02871518.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.110
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 5
    Online Resource
    Online Resource
    Phase I/II safety and preliminary efficacy of PM1022, a bispecific antibody targeting PD-L1 and TIGIT, in patients with advanced solid tumors.
    American Society of Clinical Oncology (ASCO) ; 2024
    In:  Journal of Clinical Oncology Vol. 42, No. 16_suppl ( 2024-06-01), p. e14694-e14694
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 42, No. 16_suppl ( 2024-06-01), p. e14694-e14694
    Abstract: e14694 Background: PM1022 is an anti-PD-L1 × TIGIT bispecific antibody that is engineered with a fully human IgG targeting TIGIT in an IgG1 wild type Fc backbone, fused to a VHH at the c-terminus targeting PD-L1. The potential MOA includes releasing T cell inhibition by blocking both the PD-L1/PD-1 and CD155/CD112/TIGIT pathways, as well as depleting Treg cells in the tumor microenvironment and engaging FcγRs to activate myeloid cells. PM1022 showed robust in vitro and in vivo efficacy in preclinical studies, and this is the first in human study. Methods: This phase Ⅰ/Ⅱ study consists of a standard 3+3 dose escalation and dose expansion part. PM1022 was administered intravenously as monotherapy on Day 1 of 21-day cycle. The primary objectives were to assess safety, tolerability and pharmacokinetics in patients with advanced solid tumors. Results: As of January 28, 2024, a total of 15 patients in dose escalation part have received at least 1 dose of PM1022, with 3 patients in each of the 100, 200, 400, 800 and 1200 mg dose levels respectively. No DLT was observed up to 1200 mg. Of the 15 patients, TRAEs occurred in 8 patients (53.3%), ≥ Grade 3 TRAEs occurred in 1 patient with platelet count decreased. No patients were discontinued from PM1022 due to TRAE. The most common TRAEs were rash (20%) and aspartate transaminase increased (20%). 14 patients completed at least one tumor evaluation. The median duration of PM1022 exposure was 6.1 weeks (range, 5.0-48.0 weeks). The ORR per RECIST 1.1 was 7.1% with a DCR of 35.7%. Preliminary antitumor activity has been observed in 1 patient with NSCLC (1200 mg, still on treatment) with previous PD-L1 TPS 100% who was enrolled after previous 3 lines therapy, including chemotherapy and anti-PD-1 treatment, and had a partial response in target lesion with 56.8% reduction. Another patient with esophageal cancer had been on PM1022 for total of 48 weeks until initiation of new anti-cancer therapy. Pharmacokinetics were dose-proportional with a terminal half-life of 7-13 days across the dose range of 100-1200 mg. Conclusions: PM1022 was safe and well-tolerated up to 1200 mg Q3W with preliminary anti-tumor activity. These findings could support further exploration of PM1022 in advanced solid tumors. Clinical trial information: NCT05867771 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2024.42.16_suppl.e14694
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2024
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 6
    Online Resource
    Online Resource
    mRNA expression pattern study of esophageal basaloid squamous cell carcinoma.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e16062-e16062
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e16062-e16062
    Abstract: e16062 Background: Esophageal squamous cell carcinoma (SCC) is one of the most common cancers and the leading cause of cancer-related death in China, and esophageal basaloid squamous cell carcinoma (BSC) is a rare variant (2.2%-11.3%) of SCC with highly aggressive behavior due to its propensity for vessel invasion and distant metastasis. Most reports stated that BSCs had poorer prognosis than conventional esophageal SCC. However, because of the histological morphologic similarity and lacking of diagnostic approaches, esophageal BSC can easily result in misdiagnosis as SCC. Methods: To deepen our understanding of esophageal BSC and seek for diagnostic biomarkers, we analyze the difference of mRNA expression between esophageal BSC and conventional SCC. Nanostring nCounter PanCancer Progression gene expression panel was used on different tumor components from 36 patients diagnosed with esophageal BSC component (Ba) coexisting with conventional SCC component (Co), who underwent esophagectomy at our Hospital (Cancer Hospital, Chinese Academy of Medical Sciences, China). Immunohistochemistry (IHC) was used for verification of candidate biomarkers sFRP1 concluded from mRNA expression analysis. The expression of sFRP1 was evaluated by H-score = % cells staining (0-100%) * intensity (1 to 3). Results: Among 770 RNAs analyzed in the study, 22.9% (176/770) showed downregulation (FDR-adjusted p 〈 0.05) in Ba than Co, while 5.3% (41/770) showed upregulation. A set of significantly upregulated RNAs (FDR-adjusted p 〈 0.01, log2(fold change) 〉 2) were observed in Ba, including sFRP1, FGFR1, ITGA9, VIT, VWA2 and PROM1, which were associated with angiogenesis response, basement membrane, and epithelial-mesenchymal transition (EMT). Besides, significant downregulation (FDR-adjusted p 〈 0.01, log2(fold change) 〈 -2) of KRT14 was observed in Ba, which was well known as a biomarker for squamous differentiation. Clustering analysis with different pathway scores according to mRNA expression results of Ba yielded two major clusters: Cluster1 with higher pathway scores with resembled to Co, and Cluster2 with lower pathway scores. Survival analysis revealed that patients in Cluster1 seemed to have a longer RFS and a longer OS than those in Cluster2 (Figure 4C & D), although with no statistically significance (RFS: p = 0.322, median RFS = 23.7 vs 10.8 months; OS: p = 0.217, median OS = 51.6 vs 26.5 months), which was probably due to the limited number of patients evolved (10 patients in Cluster1 and 26 in Cluster2). The most upregulated mRNA, sFRP1, was validated by IHC. Receiver operating characteristic (ROC) curve revealed that sFRP1 IHC could be a remarkable diagnosis biomarker to distinguish BSC from conventional SCC (area under ROC = 0.935, p 〈 0.001 95%CI = 0.871-1.000). Conclusions: Our results revealed BSC as a subtype with distinct RNA expression pattern compared with conventional SCC, and provided a remarkable biomarker, sFRP1, for diagnosis.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.e16062
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 7
    Online Resource
    Online Resource
    Preliminary results of a phase Ib/II combination study of RC48-ADC, a novel humanized anti-HER2 antibody-drug conjugate (ADC) with toripalimab, a humanized IgG4 mAb against programmed death-1 (PD-1) in patients with locally advanced or metastatic urothelial carcinoma.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 4518-4518
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 4518-4518
    Abstract: 4518 Background: RC48-ADC has shown promising data in HER2-positive and even negative patients with metastatic urothelial carcinoma (mUC) who failed with platinum-based chemotherapy. RC48-ADC combined with anti-PD-1 antibody may have a synergistic antitumor effect. Methods: This is an open-label, multicenter, phase 1b/II trial to evaluate the safety and activity of RC48 combined with toripalimab in mUC. Patients received RC48-ADC at 1.5 or 2 mg/kg, in combination with 3mg/kg toripalimab every two weeks in a dose-escalation and expansion cohort until confirmed disease progression, unacceptable toxicity, or voluntary withdrawal. The key primary endpoint was safety; secondary endpoints included efficacy and tumor tissue biomarkers. Results: As of 17 Jan 2022 (data cutoff), 41 la/mUC pts (19 males; median age 66 y [42-76]) were enrolled since 20 Aug 2020. 61% patients were systemic treatment naïve, and 54% had visceral metastases (mets), including 24% with liver mets. The primary site was in upper tract UC in 54%. HER2 expression was positive (IHC 2+ or 3+) in 59% patients, and PD-L1 positive (CPS ≥ 10) in 32%. No dose-limiting toxicity was observed. The recommended dose was RC48-ADC 2mg/kg + toripalimab 3mg/kg every 2 weeks. With a median follow-up of 8.0 mos, 36 patients had at least one tumor assessment, the best ORR was 83.3%, and the confirmed ORR was 76.7% (95%CI: 57.7, 90.1), including 10% CR. The cORR was 82.4% for 1L previously untreated mUC patients, 100% for patients with HER2 IHC (2+ or 3+) & PD-L1 (+), 92.3% for HER2 (2+ or 3+) & PD-L1 (-), 50% for HER2 (0 or 1+) & PD-L1 (+), and 50% HER2 (0 or 1+) & PD-L1 (-). DCR was 96.7% (95%CI: 82.8, 99.9). The median PFS was immature and 9.2 mos (95%CI: 5.49, 10.32) by the time and the median OS was not reached. The most common treatment-related AEs were ALT/AST increase (65.9%), peripheral sensory neuropathy (58.5%), appetite decrease (56.1%), asthenia (56.1%), hypertriglyceridemia (48.8%). Grade ≥3 TRAEs included γ-glutamyl transferase increase (12.2%), ALT/AST increase (7.3%), asthenia (7.3%), hypertriglyceridemia (4.9%), and neutropenia (4.9%). 9 pts had irAEs (22.0%, 7.3% ≥ G3), including immune-related pneumonitis, hepatitis, and myositis. Conclusions: RC48-ADC in combination with toripalimab demonstrated promising efficacy in patients with mUC and a manageable safety profile. A randomized study of RC48-ADC and toripalimab vs. platinum-based chemotherapy in previously untreated la/mUC patients is ongoing. Clinical trial information: NCT04264936. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.4518
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 8
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    Tislelizumab versus placebo combined with induction chemotherapy followed by concurrent chemoradiotherapy and adjuvant tislelizumab or placebo for locoregionally advanced nasopharyngeal carcinoma: Interim analysis of a multicenter, randomized, placebo-controlled, double-blind, phase 3 trial.
    American Society of Clinical Oncology (ASCO) ; 2024
    In:  Journal of Clinical Oncology Vol. 42, No. 16_suppl ( 2024-06-01), p. 6001-6001
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 42, No. 16_suppl ( 2024-06-01), p. 6001-6001
    Abstract: 6001 Background: Patients with locoregionally advanced nasopharyngeal carcinoma (LANPC) have a risk of disease relapse after induction chemotherapy (IC)-concurrent chemoradiotherapy (CCRT). Early phase trials indicated that tislelizumab (PD-1 inhibitor) plus IC followed by CCRT have the potential to deepen responses and extend survival in LANPC. Here, we report the interim results of a phase 3 trial to evaluate the efficacy and safety of tislelizumab plus IC, followed by CCRT and adjuvant tislelizumab therapy in LANPC. Methods: Patients with high-risk LANPC (stage III-IVa, AJCC 8 th Staging System, excluding T3N0, and T3N1 with retropharyngeal lymph nodes +) were randomized (1:1) to receive 200 mg tislelizumab or placebo + gemcitabine and cisplatin (GP) every 3 weeks (Q3W) for 3 cycles, followed by CCRT and adjuvant tislelizumab or placebo Q3W for up to an additional 8 cycles. Stratification factors were center and disease stage (III or IVa). Dual primary endpoints were complete response rate (CRR) after induction therapy and progression-free survival (PFS) per RECIST 1.1 by investigator under blinded review. The planned interim analysis (IA) for evaluating the first primary endpoint, CRR, was scheduled at 4 weeks after the completion of induction therapy to test whether addition of tislelizumab to standard IC significantly improved CRR, with allocated alpha at 0.005. Results: Between June 2022, and May 2023, 450 patients were randomized to tislelizumab arm (n = 223) and placebo arm (n = 227). Baseline characteristics were balanced between the two arms. At IA, 93.7% and 93.8% of patients completed 3 cycles of induction therapy in tislelizumab arm and placebo arm, respectively. Significant improvement in CRR was observed in tislelizumab arm vs placebo arm in the intent-to-treat population (ITT) (30.5% vs 16.7%; P = 0.0006). Improvement in CRR in tislelizumab arm vs placebo arm was consistent across key subgroups including disease stage (III [33.8% vs 20.7%] ; IVa [28.7% vs 14.5%]), sex (male [28.3 % vs 15.7%] ; female [38.0% vs 19.7%]), and ECOG PS (PS of 0 [28.8% vs 16.2%] ; PS of 1 [40.6% vs 19.4%]). The ORR was 93.3% in the tislelizumab arm and 90.7% in the placebo arm. In safety population (tislelizumab arm, n=219; placebo arm, n=224), the incidence of Grade ≥3 TEAEs (40.6% vs 39.3%) and SAEs (2.3% vs 1.3%) were similar between two arms. Conclusions: The trial met its first primary endpoint with a statistically significant improvement of CRR with the addition of tislelizumab to standard IC in high-risk LANPC. Induction therapy with tislelizumab plus GP was generally well tolerated with manageable safety profile. Continued follow-up is being conducted to assess long-term efficacy and safety. Clinical trial information: NCT05211232 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2024.42.16_suppl.6001
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2024
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 9
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    Neoadjuvant and adjuvant toripalimab for high-risk locoregionally advanced nasopharyngeal carcinoma: A randomized, double-blind, placebo-controlled phase 2 trial.
    American Society of Clinical Oncology (ASCO) ; 2024
    In:  Journal of Clinical Oncology Vol. 42, No. 16_suppl ( 2024-06-01), p. 6084-6084
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 42, No. 16_suppl ( 2024-06-01), p. 6084-6084
    Abstract: 6084 Background: Patients with locoregionally advanced nasopharyngeal carcinoma with high pretreatment plasma Epstein–Barr virus (EBV) DNA levels remain at high risk for recurrence after platinum-based concurrent chemoradiotherapy. We aimed to assess whether the addition of neoadjuvant and adjuvant toripalimab (anti-PD-1) to chemoradiotherapy could improve treatment outcomes in this patient population. Methods: We conducted a single-center, randomized, double-blind phase 2 trial to evaluate neoadjuvant and adjuvant toripalimab treatment for high-risk locoregionally advanced nasopharyngeal carcinoma. Participants with nasopharyngeal carcinoma (stage III-IVA, AJCC 8 th Staging System, pretreatment plasma EBV DNA ≥1500 copies/ml) were assigned in a 2:1 ratio to receive neoadjuvant toripalimab (240 mg) or placebo once every 2 weeks for 2 cycles, followed by concurrent chemoradiotherapy and adjuvant toripalimab (240 mg) or placebo once every 3 weeks for up to 8 cycles. The primary endpoint was progression-free survival at 2 years in the intention-to-treat population. The secondary endpoints included overall survival, locoregional relapse-free survival, distant metastasis-free survival at 2 years, a major pathological response in nasopharynx biospy, overall response, treatment adherence, quality-of-Life and safety. Results: From December 2019 through December 2021,100 patients were assigned to the neoadjuvant-adjuvant toripalimab group, and 50 to the placebo group. At a median follow-up of 26.9 months, progression-free survival at 2 years was 91.8% in the toripalimab group and 73.9% in the placebo group (hazard ratio for disease progression or death = 0.33; 95% confidence interval [CI], 0.15 to 0.76; P = 0.006). Overall survival was longer in the toripalimab group than in the placebo group (100% vs. 94.0% of patients alive at 2 years; hazard ratio for death, 0.10; 95% CI, 0.01 to 0.82). Distant metastasis–free survival at 2 years was 92.8% and 80.0% (hazard ratio for distant metastasis or death, 0.39; 95% CI, 0.16 to 0.96); locoregional recurrence–free survival at 2 years was 99.0% and 82.0% (hazard ratio for locoregional recurrence or death, 0.09; 95% CI, 0.02 to 0.41). Across all treatment phases, 73.7% of toripalimab group participants and 68.0% of placebo group participants had grade 3 or higher treatment-related adverse events. No deaths related to toripalimab therapy occurred. Conclusions: In patients with high-risk locoregionally advanced nasopharyngeal carcinoma, compared with concurrent chemoradiotherapy, neoadjuvant toripalimab combined with concurrent chemoradiotherapy and adjuvant toripalimab significantly improved progression-free survival, overall survival, locoregional recurrence–free survival, and distant metastasis–free survival. Clinical trial information: NCT03925090 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2024.42.16_suppl.6084
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2024
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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    Disitamab vedotin, a novel humanized anti-HER2 antibody-drug conjugate (ADC), combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma: An open-label phase 1b/2 study.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 4566-4566
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 4566-4566
    Abstract: 4566 Background: Disitamab vedotin has shown promising data across a spectrum of HER2 expression in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who progressed on chemotherapy. This study was conducted to evaluate the safety and efficacy of disitamab vedotin plus anti-PD-1 antibody in advanced urothelial carcinoma. Methods: This is an open-label, multicenter, phase 1b/2 trial to evaluate the safety and activity of RC48-ADC combined with toripalimab, a humanized immunoglobin G 4 monoclonal antibody against PD-1 in mUC. Patients received RC48-ADC at 1.5 or 2 mg/kg, in combination with 3mg/kg toripalimab every two weeks in a dose-escalation and expansion cohort until confirmed disease progression assessed by the investigators, unacceptable toxicity, or voluntary withdrawal. The primary endpoint was safety; secondary endpoints included efficacy and tumor tissue biomarkers. Results: Forty-one la/mUC patients were enrolled (22 males; median age 66 y [42-76]; 61% treatment-naïve). 54% of patients had visceral metastases (mets), including 24% with liver mets. The primary site was in upper tract UC in 54%. HER2 expression IHC 2+ or 3+ was in 59% patients, and PD-L1 positive in 32%. No dose-limiting toxicity was observed and the recommended dose was RC48-ADC 2mg/kg plus toripalimab 3mg/kg every two weeks. By the cutoff date of 18 November 2022, the confirmed ORR was 73.2% (95%CI: 57.1, 85.8), including 9.8% CR. The ORR was 76.0% for treatment-naïve patients. In HER2 IHC 3+/2+, IHC 1+, and IHC 0 subgroups, the ORR was 83.3%, 64.3%, and 33.3%, respectively. The ORR was 61.5% and 78.6% in PD-L1 positive and negative subgroups. DCR was 90.2% (95% CI, 76.9–97.3), with a median progression-free survival (PFS) of 9.2 months (95%CI: 5.7-10.3) and 2-year overall survival (OS) rate of 63.2%. All patients experienced treatment-related adverse events (TRAEs). The most common TRAEs were AST/ALT increase (68.3%), peripheral sensory neuropathy (61.0%), asthenia (61.0%), γ-glutamyl transferase increase (56.1%), hypertriglyceridemia (53.7%), and appetite decrease (51.2%). Grade 3 or greater TRAEs occurred in 43.9% of patients. Twenty-three patients (56.1%) had immune-related AEs (14.6% ≥ G3), including immune-related skin reactions, hyperglycemia, pneumonitis, hepatitis, and myositis. Conclusions: RC48-ADC in combination with toripalimab demonstrated promising efficacy in patients with la/mUC and a manageable safety profile. A phase 3 study is currently ongoing to compare the safety and efficacy of this regimen with standard of care. Clinical trial information: NCT04264936 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.4566
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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