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  • American Society of Clinical Oncology (ASCO)  (11)
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  • American Society of Clinical Oncology (ASCO)  (11)
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  • 1
    Online Resource
    Online Resource
    Vorolanib, everolimus, and the combination in patients with pretreated metastatic renal cell carcinoma (CONCEPT study): A randomized, phase 3, double-blind, multicenter trial.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 4512-4512
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 4512-4512
    Abstract: 4512 Background: The combination of agents targeting both VEGF- and mTOR-mediated pathways has been investigated in renal cell carcinoma (RCC). We conducted the CONCEPT study to assess vorolanib, everolimus, or their combination as second-line treatment in Chinese patients (pts) with metastatic RCC. Methods: Pts with cytologically or histologically confirmed RCC who had disease progression after one prior VEGFR-TKI were eligible for participation in the study. They will be randomized by 1:1:1 ratio to receive matching placebo plus vorolanib or everolimus, or the combination. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), and safety. Results: Between November 2016 and June 2019, 399 pts (133 pts in each group) were enrolled. At the data cutoff (October 23, 2020), the median PFS in combination group was significantly longer than that in single-agent everolimus group (10.0 months [95% CI, 8.2-10.4] vs. 6.4 months [95% CI, 4.7-8.3] ; HR = 0.70 [95% CI, 0.52-0.94]; P = 0.0171), while the median PFS was similar between single-agent vorolanib group and single-agent everolimus group (6.4 months [95% CI, 4.6-8.3] vs. 6.4 months [95% CI, 4.7-8.3]; HR = 0.94 [95% CI, 0.69-1.24] ; P = 0.6856). An objective response was achieved by 33 (24.8%) of 133 pts allocated vorolanib plus everolimus compared with 11 (8.3%) of 133 who received single-agent everolimus and 14 (10.5%) of 133 pts assigned single-agent vorolanib. OS was immature with no significant difference between pts assigned vorolanib plus everolimus (30.4 months [95% CI, 16.5-NE]) and those allocated single-agent everolimus (25.4 months [95% CI 19.4-NE] ) or single-agent vorolanib (30.5 months [95% CI, 22.8-NE]). Treatment-related adverse event (TRAE) occurred in 132 (99%) of 133 pts with vorolanib plus everolimus, 127 (96%) of 133 pts with single-agent vorolanib and 131 (99%) of 133 pts with single-agent everolimus, respectively. Grade 3 or higher TRAEs occurred in fewer patients who received single-agent vorolanib (52 [39%] ) than in those who received single-agent everolimus (71 [53%] ) or vorolanib plus everolimus (96 [72%]). Safety profiles of both agents were consistent with previous studies. Conclusions: This is the first phase 3 study of combination of mTOR- and VEGF-targeted agents in second-line treatments. Vorolanib plus everolimus showed a PFS benefit for patients with metastatic RCC who have progressed after one previous VEGF-targeted therapy with a safe tolerance profile. Clinical trial information: NCT03095040.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.4512
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 2
    Online Resource
    Online Resource
    Safety and efficacy of HX008: A humanized immunoglobulin G4 monoclonal antibody in patients with locally advanced or metastatic melanoma—A single-arm, multicenter, phase II study.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 9554-9554
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 9554-9554
    Abstract: 9554 Background: HX008 is a new recombinant humanized anti-PD-1 monoclonal antibody, belonging to human IgG4 / kappa subtype, which can selectively block the binding of PD-1 with its ligands PD-L1 and PD-L2. Methods: In this single arm phase 2 trial, eligible patients (pts) were aged from18 to 75, who previously failed with conventional treatment for locally advanced or metastatic melanoma, with an ECOG performance status of 0 or 1 and had measurable lesions according to the RECIST criteria (V1.1). Ocular melanoma, brain metastasis or previous use of anti PD-1 ab were excluded. Pts received HX008 3mg/kg every 3 weeks, until disease progression, intolerable toxicity or treatment discontinuation for any other reasons. The primary endpoint was ORR according to RECIST criteria, and the secondary endpoints were OS, PFS, DCR and the toxicity. The iRECIST criteria would also be used in the evaluation of response and treatment discontinuation. Clinical trial information: NCT04749485. Results: From Oct 2018 to Jan 2021, 119 pts have been eligible and enrolled. Basic characteristics: median age 59 years; 57 males (42.9%) ; stage 22%, stage 78%; primary: acral 52.1%, mucosal 19.3%, cutaneous 18.5% and unknown 10.1%; Gene mutation status: Braf 10.9%, Nras 9.2%, cKit 4.2%; condition of previous treatments: 67.26%, 25.21%,7.56% pts had received 1st, 2nd and 3rd line or above treatments respectively (chemotherapy 69.7%, targeted therapy 15.1%, immunotherapy 43.7%). The ORR according to RECIST V1.1 and iRECIST was 18.49% (1CR, 21 PR, 95% CI 11.96-26.64) and 20.17% (1 iCR, 23 iPR,95% CI 13.37-28.50), respectively. For PD-L1 positive pts the ORR was 15.09% (95%CI 6.75-27.60) and 12% for negative (95%CI 10.98-32.83). For different subtypes, the ORR was 36.36% for cutaneous melanoma, 14.52% for acral primary, 8.7% for mucosal primary, and 25% for unknown primary. The DCR and iDCR was 44.54% and 47.06%, respectively. With a median follow up time of 13.2 months, the median PFS was 3.25 months (95% CI 2.0, 4.1) and the PFS rate at 1 year was 25.8% (95%CI 17.19,35.33). The median OS was 17.91 months (95% CI 13.08,NR) and the OS rates at 1 year was 63.9% (95% CI 53.02, 73.00). Median DOR has not reached and the DOR and iDOR rates at 1 year were 80.64% and 87.39%, respectively. TRAEs occurred in 89.9% of the pts, with grade 3/4 AEs 31.9%, the followings were those incidences ≥1%, hyperglycemia (2.5%), elevated aspartate aminotransferase (1.7%), elevated serum bilirubin (1.7%), elevated serum creatine phosphokinase (1.7%), elevated lipase (1.7%), hypoalbuminemia (1.7%), hypokalemia (1.7%) and diabetic ketoacidosis (1.7%). Conclusions: HX008 shows its efficacy and safety in locally advanced or metastatic melanoma pts in the treatments of 2nd line or above. Randomized controlled studies are now on pending. Clinical trial information: NCT04749485.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.9554
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 3
    Online Resource
    Online Resource
    Safety and efficacy of SHR-1316 combined with chemotherapy and sequential chest radiotherapy as first-line therapy for extensive-stage small cell lung cancer (ES-SCLC): The results from a phase II single-arm trial.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 8563-8563
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 8563-8563
    Abstract: 8563 Background: Impower133 and CASPIAN studies showed that PD-L1 antibody combined with first-line chemotherapy could prolong the overall survival. Previous studies have shown that radiotherapy could potentially promote tumor antigen presentation and reverse immunosuppressive microenvironment in tumor. The purpose of this study was to explore the efficacy and safety of SHR-1316 (PD-L1 antibody) combined with chemotherapy and sequential chest radiotherapy as first-line therapy for ES-SCLC. Methods: Key inclusion factors were 18-75 years old, histologically or cytologically confirmed ES-SCLC, ECOG performance status 0-1, no previous systematic treatment. Patients (pts) included in this study received 4̃6 cycles of SHR-1316 (20mg/kg, D1, q3w) combined with EP/EC (cisplatin 75mg/m² D1-3 q3w or carboplatin AUC = 5, D1 q3w; etoposide 100mg/m 2 , D1-5, q3w), sequentially SHR-1316 combined with chest radiotherapy (≥3Gy*10f or ≥2Gy*25f, involved- field irradiation), and then entered the maintenance treatment stage until disease progression or intolerable side effects. The main endpoints included PFS, ORR and safety. Results: From October 2020 to December 2021, 31 pts with ES-SCLC received at least one dose of SHR-1316. The median age was 64 (range: 37-75) with 25(80.6%) male, 22(71%) former smokers and 31 (100%) ECOG performance status 1. 17 (54.8%) pts were with brain metastasis, 8 (25.8%) pts with liver metastasis, 8 (25.8%) pts with kidney/adrenal metastasis, 7(22.6%) pts with bone metastasis. At the data cutoff date, 15 pts remained on treatment, the average number of treatment cycles was 5.19. 24 pts had at least one 1 post-treatment tumor assessment. The median PFS was 7.56 months, the confirmed ORR and DCR in all pts were 50% (12/24) and 87.5% (21/24), respectively. The confirmed ORR and DCR in pts with brain metastasis were 38.5% (5/13) and 76.9% (10/13), and were 63.6% (7/11) and 100% (11/11) in pts without brain metastasis. In pts received chest radiotherapy, the confirmed ORR and DCR were 80% (8/10) and 100% (10/10). During the study period, 23 (74.2%) pts had adverse drug reactions, and 16 (51.6%) pts had grade 3 or 4 adverse drug reactions, including 12 (38.7%) neutropenia 8 (25.8%) leukopenia, 2 (6.5%) thrombocytopenia, 2 (6.5%) anemia, 1(3.2%) lymphocytopenia, 1(3.2%) amylase increased. No grade 5 adverse drug reaction was observed. Conclusions: SHR-1316 combined with chemotherapy and sequential chest radiotherapy as first-line therapy for ES-SCLC showed promising efficacy and acceptable safety. It is worthy of further clinical exploration. Clinical trial information: NCT04562337.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.8563
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    Efficacy and safety of tunlametinib in patients with advanced NRAS-mutant melanoma: A multicenter, open-label, single-arm, phase 2 study.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 9510-9510
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 9510-9510
    Abstract: 9510 Background: NRAS-mutant melanoma is an aggressive subtype with worse prognosis. However, no targeted therapy has been approved to date worldwide. Tunlametinib (HL-085), a novel, potent, selective, oral small-molecule MEK1/2 inhibitor, has showed a favorable pharmacokinetics profile, acceptable tolerability and encouraging antitumor activity in the phase 1 study (BMC Med. 2023 Jan 4;21(1):2). Methods: This is an ongoing, multicenter, open-label, single-arm, phase 2 pivotal registration study. Patients (pts) with NRAS-mutant unresectable stage III or IV melanoma were enrolled and received tunlametinib 12 mg orally twice daily. A historical control of objective response rate (ORR) of 10% was predefined for sample size estimation (100 pts, assuming loss to follow-up rate of 5%) and efficacy evaluation. The primary endpoint was the confirmed ORR per RECIST v1.1 assessed by independent radiology review committee. Results: A total of 100 pts were enrolled. All pts were included in the safety analysis set and 95 pts were included in the full analysis set (FAS) for efficacy analysis. At cut-off date (August 17, 2022), median follow-up was 7.9 months (95% CI: 6.6, 9.8). In the FAS, the median age was 58.0 years (range: 24 to 84). Sixty-four pts (67.4%) had received prior immunotherapy (PD-1/PD-L1 inhibitor). Fifty-six pts (58.9%) were acral melanoma, 16 (16.8%) mucosal melanoma and 12 (12.6%) skin melanoma. Fourteen pts (14.7%) were stage III and 81 (85.3%) stage IV. The most frequent NRAS mutation types were Q61R (40.0%), Q61K (29.5%) and G12D (9.5%). Confirmed ORR was 34.7% (95%CI: 25.3%, 45.2%). Median progression-free survival was 4.2 months (95%CI: 3.5, 5.6), overall survival was immature, and 1-year survival rates was 57.2% (95% CI, 44.7%, 67.8%). Subgroup analysis showed that, in pts who had previously received immunotherapy, the confirmed ORR was 39.1% (95% CI: 27.1%, 52.1%). The most frequent treatment related adverse events (TRAEs) were increased blood creatine phosphokinase (CK), diarrhea, peripheral oedema, facial oedema and increased aspartate aminotransferase. Grade ≥3 TRAEs occurred in 68 pts (68.0%), of which 38.0% (38/100) were increased blood CK. Most of pts with CK elevation are asymptomatic and can be managed by dose interruption or reduction without permanent treatment discontinuation. No treatment-related death was reported. Conclusions: Tunlametinib was well tolerated and demonstrated encouraging treatment response rate in pts with advanced NRAS-mutant melanoma. These results indicate that tunlametinib could be a promising treatment option for NRAS-mutant melanoma, even for those immunotherapy failed pts. Clinical trial information: NCT05217303 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.9510
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 5
    Online Resource
    Online Resource
    Sorafenib treatment of Asian patients with advanced renal cell carcinoma (RCC) in daily practice: Subset analysis of the large non-interventional PREDICT study.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 4628-4628
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 4628-4628
    Abstract: 4628 Background: Previous studies with sorafenib in Asian patients with advanced RCC were relatively small and used strict entry criteria. Here we investigated safety and efficacy in a large subset of Asian patients in the prospective, non-interventional PREDICT study of sorafenib in routine practice (NCT 00895674). Methods: Patients were eligible based on a diagnosis of advanced RCC and the decision by the investigator to prescribe sorafenib under compliance of the local product label. Tumor status, patients’ performance and physician assessment of efficacy and tolerability were collected up to 12 months. Results: Between Jan 2007 and June 2010, 1092 patients were enrolled in China (n=1033), South Korea (n=55), the Philippines (n=3) and Indonesia (n=1). In the efficacy population (n=909), baseline characteristics were: 71% male; 89% 〈 70 years old; 89% clear cell histology; 78% prior nephrectomy; 56% prior systemic therapy; 16% high MSKCC risk; 35% ECOG PS ≥2; 5% brain metastases. Overall, 19% of patients had ≥1 concomitant disease at baseline; the most frequent concomitant diseases were hypertension (14%) and diabetes (6%). Initial sorafenib dose was 800 mg daily in 97% of patients, of whom 91% were also receiving 800 mg daily as last dose. Median duration of sorafenib treatment was 9.7 months (range 0.2–24.1), and in clinically relevant subgroups was as follows: treatment-naïve, 9.7 months; high MSKCC risk, 9.3 months; brain metastases, 8.4 months; age ≥70 years, 7.6 months; ECOG PS 2, 9.7 months; ECOG PS 3, 6.1 months. At last follow up, 63% of physicians reported good/very good efficacy and 59% good/very good tolerability. Sorafenib was well tolerated; 〈 2% of the safety population (n=1022) reported serious drug-related adverse events (SDRAEs) and only 3% discontinued due to DRAEs. In all, 35% of patients reported a DRAE, with the most frequent being hand-foot skin reaction (21%), diarrhea (7%), rash (7%), alopecia (5%), hypertension (3%). Conclusions: In this large subset of Asian patients with advanced RCC treated in daily practice settings, sorafenib was well tolerated and provided benefit, including in clinically relevant patient subgroups.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.4628
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 6
    Online Resource
    Online Resource
    Updated safety and efficacy results from the phase I study of either LBL-007 (an anti-LAG-3 antibody) in combination with toripalimab (an anti-PD-1 antibody) or LBL-007 in combination with toripalimab and axitinib in patients with advanced melanoma.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 9541-9541
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 9541-9541
    Abstract: 9541 Background: Initial safety and efficacy data of LBL-007 plus toripalimab in patients with advanced melanoma (Part A) have been reported in 2022 ASCO (Abstract 9538). Here we present the updated results of part A and the preliminary results of part B (LBL-007 plus toripalimab with axitinib). Median follow-up was 9.7 months at cut-off data (January 11, 2023). Methods: Patients with advanced melanoma with or without prior therapy were enrolled during Jan 2021 - Aug 2022. This trial comprised 2 parts: Part A, patients received LBL-007 (0.25 - 10 mg/kg for dose escalation; 3 or 6 mg/kg for dose expansion) plus toripalimab at 3 mg/kg (both i.v. Q2W); and Part B, patients received LBL-007 at 3 or 6 mg/kg plus toripalimab at 3 mg/kg (both i.v. Q2W) and axitinib at 5 mg BID. The primary objective was safety, the second objectives were pharmacokinetics, pharmacodynamics and efficacy (per RECIST v.1.1). Results: In part A, 68 patients in total (57 treatment-naïve) were enrolled including 20 patients in dose escalation and 48 patients in dose expansion, and among which, 31 additional patients have been enrolled since 2022 ASCO report. Nineteen (27.9%) patients occurred grade ≥3 TEAEs, the common grade ≥3 TEAEs was anaemia (11.8%). No new safety signals were detected. Among 55 efficacy evaluable treatment-naïve patients (41 with acral, 7 mucosal, 7 others), ORR was 23.6%, DCR was 58.2%, and mPFS was 5.7 months (95% CI: 3.7, 9.5). In part B, 11 patients (10 mucosal, 1 acral) were enrolled. No DLT was observed. Five patients (45.5%) occurred grade ≥3 TEAEs, the common grade ≥3 TEAEs included blood pressure increased (18.2%) and transaminases increased (18.2%). One (9.1%) patient discontinued treatment due to TEAEs. ORR was 45.4% (including 4 mucosal and 1 acral), DCR was 72.7%, and mPFS was 5.5 months (95% CI: 1.8, 9.1). Conclusions: LBL-007 plus toripalimab continued to show promising antitumor activity and manageable safety profile in patients with treatment-naïve melanoma, which support further development in this indication. LBL-007/toripalimab/axitinib combination demonstrated acceptable safety profile and encouraging antitumor activity in patients with mucosal melanoma. Acknowledgements: Junshi Biosciences. Clinical trial information: NCT04640545 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.9541
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 7
    Online Resource
    Online Resource
    Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 22 ( 2022-08-01), p. 2420-2425
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 22 ( 2022-08-01), p. 2420-2425
    Abstract: Clinical trials frequently include multiple end points that mature at different times. The initial report, typically on the based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. We previously reported significantly improved failure-free survival using gemcitabine plus cisplatin induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma. Here, we present the final overall survival (OS) analysis. In this multicenter, randomized trial, patients were assigned to be treated with concurrent chemoradiotherapy alone (standard therapy, n = 238) or gemcitabine and cisplatin induction chemotherapy before concurrent chemoradiotherapy (n = 242). With a median follow-up of 69.8 months, the induction chemotherapy group had a significantly higher 5-year OS (87.9% v 78.8%, hazard ratio, 0.51 [95% CI 0.34 to 0.78]; P = .001) and a comparable risk of late toxicities (≥ grade 3, 11.3% v 11.4%). Notably, the depth of the tumor response to induction chemotherapy correlated significantly and positively with survival (complete response v partial response v stable/progressive disease, 5-year OS, 100% v 88.4% v 61.5%, P = .005). Besides, patients with a low pretreatment cell-free Epstein-Barr virus DNA load ( 〈 4,000 copies/mL) might not benefit from induction chemotherapy (5-year OS, 90.6% v 91.4%, P = .77). In conclusion, induction chemotherapy before concurrent chemoradiotherapy improved OS significantly in patients with locally advanced nasopharyngeal carcinoma, without increasing the risk of late toxicities. Tumor response to induction chemotherapy and pretreatment cell-free Epstein-Barr virus DNA might be useful to guide individualized treatment.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.22.00327
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 8
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    Online Resource
    Prospective Study of Tailoring Whole-Body Dual-Modality [ 18 F]Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography With Plasma Epstein-Barr Virus DNA for Detecting Distant Metastasis in Endemic Nasopharyngeal Carcinoma at Initial Staging
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 23 ( 2013-08-10), p. 2861-2869
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 23 ( 2013-08-10), p. 2861-2869
    Abstract: To evaluate which patients with nasopharyngeal carcinoma (NPC) obtained the greatest benefits from the detection of distant metastasis with [ 18 F]fluorodeoxyglucose positron emission tomography and computed tomography (PET/CT) combined with plasma Epstein-Barr virus (EBV) DNA levels. Patients and Methods Consecutive patients with NPC were prospectively enrolled. PET/CT, conventional work-up (CWU), and quantification of plasma EBV DNA were performed before treatment. The accuracy of these strategies for distant metastases was assessed. The costs of the diagnostic strategies were compared. Results Eighty-six (14.8%) of the 583 eligible patients were found to have distant metastases; 71 patients (82.6%) by PET/CT and 31 patients (36.0%) by CWU. In the multivariable analysis, advanced N stage (odds ratio, 2.689; 95% CI, 1.894 to 3.818) and pretreatment EBV DNA level (odds ratio, 3.344; 95% CI, 1.825 to 6.126) were significant risk factors for distant metastases. PET/CT was not superior to CWU for detecting distant metastases in very low–risk patients (N0-1 with EBV DNA 〈 4,000 copies/mL; P = .062), but was superior for the low-risk patients (N0-1 with EBV DNA ≥ 4,000 copies/mL and N2-3 with EBV DNA 〈 4,000 copies/mL; P = .039) and intermediate-risk patients (N2-3 disease with EBV DNA ≥ 4,000 copies/mL; P 〈 .001). The corresponding patient management changes based on PET/CT were 2.9%, 6.3%, and 16.5%, respectively. The costs per true-positive case detected by PET/CT among these groups were ¥324,138 (≈$47,458), ¥96,907 (≈$14,188), and ¥34,182 (≈$5,005), respectively. Conclusion PET/CT detects more distant metastases than conventional staging in patients with NPC. The largest benefit in terms of cost and patient management was observed in the subgroup with N2-3 disease and EBV DNA ≥ 4,000 copies/mL.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2012.46.0816
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 9
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    A phase 3 trial of SHR3680 versus bicalutamide in combination with androgen deprivation therapy (ADT) in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC).
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 5005-5005
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 5005-5005
    Abstract: 5005 Background: Both TITAN and ARCHES studies have demonstrated significant clinical benefits of second-generation androgen receptor inhibitors (ARIs) plus ADT versus placebo plus ADT in the treatment of mHSPC. However, first-generation ARIs plus ADT is also widely used in clinic and how superior second-generation ARIs is to first-generation ones remains to be determined. Here, we evaluated the efficacy and safety of SHR3680, a novel oral ARI, versus bicalutamide (Bica) in high-volume mHSPC. Methods: CHART is a randomized, open-label, phase 3 study (NCT03520478). Patients (pts) with mHSPC were randomized 1:1 to ADT plus either SHR3680 (240 mg/d) or Bica (50 mg/d). All pts had high-volume disease adapted from the CHAARTED study. The primary endpoints were radiographic progression-free survival (rPFS) assessed by independent review committee (IRC) and overall survival (OS). As of May 16, 2021, 209 rPFS events per IRC and 153 deaths occurred and a preplanned interim analysis for rPFS was done. Results: 654 pts were randomized to receive SHR3680 (n = 326) or Bica (n = 328). At data cutoff, the median follow-up duration was 22.1 mo in SHR3680 group and 20.4 mo in Bica group. SHR3680 significantly reduced the risk of radiographic progression or death than Bica (HR, 0.44; 95% CI, 0.33-0.58; p 〈 0.0001; median, not reached vs 25.1 mo). OS data were immature but an improved OS was observed in SHR3680 group compared to Bica group (HR, 0.58; 95% CI, 0.42-0.80; p = 0.0009). All secondary efficacy endpoints favored SHR3680 plus ADT (Table). Frequencies of adverse events of any cause in any grade were similar between groups. Grade ≥3 treatment-related adverse events occurred in 19.2% and 13.9% of pts in SHR3680 and Bica groups, respectively. No seizure occurred in SHR3680 group. Conclusions: SHR3680 plus ADT significantly improved rPFS versus Bica plus ADT in pts with high-volume mHSPC, with a desirable safety profile. New drug application has been submitted to seek approval based on the data presented here. Clinical trial information: NCT03520478. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.5005
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 10
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    Two-year follow-up result of RELIANCE study, a multicenter phase 2 trial of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 7529-7529
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 7529-7529
    Abstract: 7529 Background: RELIANCE study is the first pivotal CD19 CAR-T study that got IND approval by the authority in China (NCT04089215). Initial findings of this study demonstrated high response rates and low rates of CAR-T–associated toxicity with Relmacabtagene autoleucel (Carteyva, also known as Relma-cel, JWCAR029) treatment in heavily pretreated patients with Relapsed/Refractory (r/r) large B-cell lymphoma (LBCL) (Ying et al. Cancer Med, 2020). Here we provide 2-year follow-up result of RELIANCE study. Methods: 59 adults (age ≥18 years) with ≥2 prior therapies r/r LBCL were randomized to receive lymphodepletion chemotherapy followed by a single infusion of Carteyva at a dose of 100×10 6 or 150×10 6 CAR+T cells, patients were evaluated for efficacy using Lugano criteria (Cheson 2014), for toxicity using CTCAE v4.03 and for cytokine release syndrome (CRS) using Lee et al. criteria (Blood 2014). Primary endpoint was 3-month objective response rate (ORR); key secondary endpoints included complete response rate (CRR) at 3 months, duration of response (DOR), progression-free survival (PFS), overall survival (OS) and treatment-emergent adverse event (TEAE) profile. Results: The cutoff date was December 22, 2021. All 59 patients (median age 56.0 years, range 18–75 years) were post-treatment with Carteyva, among of them 26 patients completed trial, 8 patients on study, 25 patients withdrew. Among the modified intent-to-treat (mITT) population of 58 efficacy-evaluable patients, best ORR and CRR was 77.6% and 53.5%, respectively. The median follow-up was 24 months(95% CI 23.9-24.1), median PFS and DOR was 7 months (95% CI 4.76–24.15) and 20.3 months (95% CI 4.86–NA), median OS was NA (95% CI NA–NA). 2-year PFS, DOR and OS rates were 38.3%, 38.1% and 69.0%, respectively. 91.5% patients reported treatment–related TEAEs with 72.9% patients had Grade ≥3, among this, the most common Grade ≥3 AE were neutropenia (42.4%) and leukopenia (22%). CRS and NT of any grade occurred in 47.5% and 20.3% of patients (Grade 3–4 CRS, 5.1%; Grade 3–4 NT, 3.4%). Median onset of CRS and NT was 4 (1–10) days and 8.5 (2–11) days, After Day 90, 6(10.2%) patients reported AEs Grade ≥3, the most common were lymphocytopenia 2(3.4%), neutropenia 2(3.4%) and leukopenia 1(1.7%). Grade ≥ 3 infections occurred in 2(3.4%) patients, which was gastroenteritis and herpes zoster. 17 (28.8%) patients died in this study, 12(20.3%) due to disease progression. Conclusions: As the longest follow-up term of CD19+ CAR T cell study in heavily pretreated patients with r/r LBCL in China, Carteyva demonstrated durable responses with a high 2-year OS rate, the median OS not yet reached for responding patients, and a manageable safety profile. These data continue supporting the compelling clinical benefit-risk profile of Carteyva for r/r LBCL patients. Clinical trial information: NCT04089215.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.7529
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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