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  • American Society of Clinical Oncology (ASCO)  (35)
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  • American Society of Clinical Oncology (ASCO)  (35)
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  • English  (35)
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  • 1
    Online Resource
    Online Resource
    Impact of Awareness of Terminal Illness and Use of Palliative Care or Intensive Care Unit on the Survival of Terminally Ill Patients With Cancer: Prospective Cohort Study
    American Society of Clinical Oncology (ASCO) ; 2011
    In:  Journal of Clinical Oncology Vol. 29, No. 18 ( 2011-06-20), p. 2474-2480
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 29, No. 18 ( 2011-06-20), p. 2474-2480
    Abstract: We conducted this study to evaluate the validity of the perception that awareness of their terminal prognosis and use of palliative care or nonuse of an intensive care unit (ICU) causes patients to die sooner than they would otherwise. Patients and Methods In this prospective cohort study at 11 university hospitals and the National Cancer Center in Korea, we administered questionnaires to 619 consecutive patients immediately after they were determined by physicians to be terminally ill. We followed patients during 6 months after enrollment and assessed how their survival was affected by the disclosure of terminal illness and administration of palliative care or nonuse of the ICU. Results In a follow-up of 481 patients and 163.8 person-years, we identified 466 deceased patients. Nineteen percent of the patients died within 1 month, while 41.3% lived for 3 months, and 17.7% lived for 6 months. Once the cancer was judged terminal, the median survival time was 69 days. On multivariate analysis, neither patient awareness of terminal status at baseline (adjusted hazard ratio [aHR], 1.20; 95% CI, 0.96 to 1.51), use of a palliative care facility (aHR, 0.96; 95% CI, 0.76 to 1.21), nor general prostration (aHR, 1.23; 95% CI, 0.96 to 1.57) was associated with reduced survival. Use of the ICU (aHR, 1.47; 95% CI, 1.06 to 2.05) and poor Eastern Cooperative Oncology Group performance status (aHR, 1.37; 95% CI, 1.10 to 1.71) were significantly associated with poor survival. Conclusion Patients' being aware that they are dying and entering a palliative care facility or ICU does not seem to influence patients' survival.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2010.30.1184
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2011
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    A phase 1 study of AT101, a novel anti-CD19 CAR-T cell therapy targeting a membrane-proximal epitope of CD19, in patients with relapsed or refractory B cell non-Hodgkin lymphoma.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 7522-7522
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 7522-7522
    Abstract: 7522 Background: All the FDA-approved CD19 CAR-T products are based on FMC63 scFv, which binds to the membrane-distal region of CD19. We developed a novel anti-CD19 antibody clone (1218) that binds to a membrane-proximal epitope of CD19, thereby not competing with FMC63. AT101 is an autologous CAR T cell transduced with a lentiviral vector, including the CD19-CAR with a humanized scFv of 1218, 4-1BB costimulatory, and CD3zeta domain. Methods: In this phase 1 trial, patients (n = 3 per dose level; up to n = 18 in total) are treated with AT101 in 3 dose-escalation cohorts based on a standard 3 + 3 design. Each patient received a single intravenous dose of AT101 at dose level (DL) 1 (0.2 x 10 6 cells/kg), DL2 (1.0 x 10 6 cells/kg), or DL3 (5.0 x 10 6 cells/kg). The primary objective is to determine the safety, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of AT101. The secondary objective is to evaluate the pharmacokinetics of AT101 and the preliminary efficacy, such as overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), event-free survival (EFS), and overall survival (OS). Key eligibility criteria include patients aged ≥19 with histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). Results: Fourteen patients were enrolled from March 2022 to December 2022, and nine were treated. The median age of treated patients was 61.6 years (ranged from 39 to 84) after a median of 4 prior lines of therapy (range 2-10). Their subtypes of NHL were as follows: diffuse large B cell lymphoma (n = 4), follicular lymphoma (n = 3), mantle cell lymphoma (n = 1), or marginal zone lymphoma (n = 1). The dosing of AT101 at DL1 and DL2 was completed. The dosing at DL3 is ongoing. Across cohorts 1 and 2, no grade 3 or higher cytokine release syndrome (CRS) was reported. Among the first three patients at DL1, one dose-limiting toxicity (DLT) of grade 4 neurotoxicity was observed but resolved in a week without sequelae. No other DLTs were observed in the additional three patients at the DL1 and three at the DL2 cohort. Another one at DL2 experienced grade 1 CRS with grade 1 neurotoxicity. Five patients experienced Grade ≥3 hematologic toxicities. An ORR is 66.7% (4/6) in cohort 1 and 100% (3/3) in cohort 2, including six complete responses (CR, 50.0% [3/6] in cohort 1 and 100% [3/3] in cohort 2). As of February 13, 2023, all six CRs are ongoing, including two patents exceeding six months after the treatments. Updated results will be presented at the meeting, including the cohort of DL3. Conclusions: In this phase I study, AT101 was well tolerated at the first two dose levels and showed promising efficacy in relapsed or refractory B-cell NHL patients. The majority of adverse effects were transient and manageable. The administrations of DL3 are currently ongoing, and updated results will be presented at the meeting. Clinical trial information: NCT05338931 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.7522
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 3
    Online Resource
    Online Resource
    The oncologic implications of tumor multiplicity in intrahepatic cholangiocarcinoma: Its prognostic value might be underestimated.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 4_suppl ( 2023-02-01), p. 611-611
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 611-611
    Abstract: 611 Background: In the latest staging system of the American Joint Committee on Cancer (AJCC) for intrahepatic cholangiocarcinoma (IHCCC), solitary tumor with vascular invasion and multiple tumors are grouped together as T2. However, recent studies have reported that multifocal IHCCC have worse prognosis than a single lesion. This study aimed to investigate risk factors of IHCCC and to explore the prognostic significance of multiplicity identified by surgical resection. Methods: A total of 277 patients underwent surgery for IHCCC from 2010 to 2019 and the clinicopathological data were retrospectively reviewed. Risk factor analysis was performed to identify variables associated with survival of resected IHCCC. Survival outcomes were compared between patients with solitary tumors and those with multiple tumors. Results: In multivariable analysis, presence of preoperative symptoms, tumor size, lymph node ratio, multiplicity, and tumor differentiation were risk factors for survival. Among 82 patients with T2, overall survival was significantly better in patients with solitary tumors (sT2) than in those with multiple tumors (mT2) (p = 0.017). Survival was compared among patients with stage II-sT2, stage II-mT2, and stage III. Stage II-sT2 group showed prolonged survival than those with stage II-mT2 or stage III. Survival of stage II-mT2 patients was not statistically different from that of stage III patients. Conclusions: Tumor multiplicity was an independent risk factor for overall survival of IHCCC after surgical resection. Patients with multiple tumors showed poorer survival than patients with a single tumor. The oncologic significance of multiplicity in IHCCC should be reappraised and be reflected in the next update of staging system.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.4_suppl.611
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    Inhibition of gastric cancer by a new controlled releasing compound of TLR-7/8 agonist via immune activation in a gastric cancer xenograft mice model.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 4_suppl ( 2023-02-01), p. 420-420
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 420-420
    Abstract: 420 Background: TLR-7/8 agonist has been suggested to be an effective immunotherapeutic agent, possible systemic side effect has forbid its clinical usage. A new controlled-releasing compound of TLR-7/8 agonist was developed to overcome the limitations, and this study aimed to evaluate efficacy and safety of this new compound in xenograft mouse model using cell-lines derived from triple conditional (Tcon) mouse which develop gastric cancer spontaneously. Methods: A cell line was established by tumor tissue in Tcon mouse which was developed by activation of Kras and suppression of E-cadherin and P53. Tcon cell line was evaluated its growth rate, sensitivity to anticancer agents and in vivo tumorigenicity. Tcon cell line was subcutaneously injected to the flank of the syngeneic mice, and 5-FU and/or TLR-7/8 agonist were administered into 4 groups of mice (control group, 5-FU alone, TLR-7/8 agonist alone, and combination of 5-FU and TLR-7/8). 5-FU was administered i.p(intra-peritoneal) in once a week and TLR-7/8 agonist was injected i.t(intra-tumoral) 3 times a week. Tumor size and mouse weight were measured for drug efficacy and safety. Immune profile of the tumor was analyzed by fluorescence-activated cell sorting. Results: Tcon cell-line show a rapid growth with 24 hours of doubling time, and good in vivo tumorigenicity in syngeneic mice. Cell-line showed moderate sensitivity to 5-FU and paclitaxel but resistance to oxaliplatin. Tumors in 5-FU alone group showed slight decrease in size compared with that in control group, However, TLR-7/8 agonist alone and combination significantly inhibited tumor growth. Weight loss or any significant side effect was not observed in any group. In immune profiling, TLR-7/8 mono or combination group showed increased levels of infiltrating CD4, CD8 T cells, and recruited NK cell as well as significantly increase M1/M2 ratio of macrophages compared to 5-FU alone or control group. Conclusions: A new controlled releasing system of TLR-7/8 agonist with or without 5-FU showed a excellent tumor inhibition efficacy with low toxicity in gastric cancer xenograft model. The effect seemed to be through multiple immune activations including cell-mediated immune response, M1 macrophage polarization as well as innate NK cells.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.4_suppl.420
    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
    Prognostic stratification of locoregional esophageal cancer (EC) patients (pts) treated with definitive chemoradiotherapy (dCRT).
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. e15578-e15578
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e15578-e15578
    Abstract: e15578 Background: Although dCRT is the standard treatment for pts who have locally advanced unresectable EC or refuse surgery, the prognosis of these pts remains dismal. There are urgent needs to develop the novel treatment strategy based on prognostic stratification after dCRT. Methods: A total of 382 pts with locoregional EC without distant metastasis except for supraclavicular lymph node who received dCRT at Asan Medical Center in South Korea from 2006 to 2015 were included. Overall survival (OS) and progression-free survival (PFS) were analyzed using Kaplan-Meier method. Risk factors were analyzed using Cox regression. Risk scores were calculated by multiplying coefficients in Cox proportional hazard model. Results: Baseline characteristics were as follows: median age = 66 yrs (range: 40-85); male = 359 pts (94.0%); squamous cell carcinoma = 375 (98.2%); cTNM stage (AJCC 8th) I = 40 (10.5%), II = 122 (31.9%), III = 128 (33.5%), IV = 92 (24.1%). During median follow-up of 52.9 mo, median PFS was 13.5 mo (95% CI, 10.9-16.1), and median OS was 26.7 mo (95% CI, 19.8-33.7). In the univariate analyses, sex (only for PFS), weight loss (≥ 5 kg) during dCRT, cT stage, cN stage, cTNM stage, clinical response after dCRT, reason for dCRT were significant prognostic factors for PFS and OS. In the multivariate analyses, clinical response after dCRT, cTNM stage, and weight loss were independent prognostic factors for PFS and OS (Table). Risk-scoring model using these factors stratified pts into four groups: for median PFS (p 〈 0.0001), group 1 = 58.2 mo (95% CI, 43.5-73.0), group 2 = 17.0 mo (95% CI, 11.9-22.1), group 3 = 9.0 mo (95% CI, 7.0-11.1), and group 4 = 3.9 mo (95% CI, 3.7-4.2); for median OS (p 〈 0.0001), group 1 = 106.2 mo (95% CI, 44.9-167.6), group 2 = 38.0 mo (95% CI, 24.4-51.5), group 3 = 13.0 mo (95% CI, 8.5-17.6), and group 4 = 8.0 mo (95% CI, 7.4-8.6). Conclusions: In dCRT-treated locoregional EC pts, survival outcome significantly varied according to baseline clinical stage, treatment response, and dynamic change in body weight. Different treatment and surveillance strategies based on the risk score might be needed in these pts.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.e15578
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 6
    Online Resource
    Online Resource
    Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 5 ( 2020-02-10), p. 434-443
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 5 ( 2020-02-10), p. 434-443
    Abstract: The addition of ovarian function suppression (OFS) for 5 years to tamoxifen (TAM) for treatment of premenopausal patients with breast cancer after completion of chemotherapy has beneficial effects on disease-free survival (DFS). This study evaluated the efficacy of adding 2 years of OFS to TAM in patients with hormone receptor–positive breast cancer who remain in a premenopausal state or resume ovarian function after chemotherapy. PATIENTS AND METHODS We enrolled 1,483 premenopausal women (age ≤ 45 years) with estrogen receptor–positive breast cancer treated with definitive surgery after completing adjuvant or neoadjuvant chemotherapy. Ovarian function was assessed every 6 months for 2 years since enrollment on the basis of follicular-stimulating hormone levels and vaginal bleeding history. If ovarian function was confirmed to be premenopausal at each visit, the patient was randomly assigned to complete 5 years of TAM alone (TAM-only) group or 5 years of TAM with OFS for 2 years that involved monthly goserelin administration (TAM + OFS) group. DFS was defined from the time of enrollment to the time of the first event. RESULTS A total of 1,293 patients were randomly assigned, and 1,282 patients were eligible for analysis. The estimated 5-year DFS rate was 91.1% in the TAM + OFS group and 87.5% in the TAM-only group (hazard ratio, 0.69; 95% CI, 0.48 to 0.97; P = .033). The estimated 5-year overall survival rate was 99.4% in the TAM + OFS group and 97.8% in the TAM-only group (hazard ratio, 0.31; 95% CI, 0.10 to 0.94; P = .029). CONCLUSION The addition of 2 years of OFS to TAM significantly improved DFS compared with TAM alone in patients who remained premenopausal or resumed ovarian function after chemotherapy.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.19.00126
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 7
    Online Resource
    Online Resource
    Applicability of advanced endoscopic balloon-type irreversible electroporation catheter on the esophagus: Preclinical animal study.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 4_suppl ( 2022-02-01), p. 339-339
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 4_suppl ( 2022-02-01), p. 339-339
    Abstract: 339 Background: Irreversible electroporation (IRE) is a new destructive technique that removes undesirable tissues using an electric field. Main mechanism of IRE is through the creation of permanent, nano-sized pores on the cell membranes, resulting in cell death. It poses, however, one technical challenge as contractions of smooth muscle of the gastrointestinal tract may prevent IRE from effectively electroporate the cell. The present study aims to demonstrate the applicability of this newly designed endoscopic balloon-type IRE catheter in destroying undesired tissues. Methods: The electrical field generated at 1500V with 40 pulses during ablation with the balloon-type catheter in esophagus were simulated using COMSOL Multiphysics. After a pig was anesthetized, a 0.035-inch Jagwire was inserted through the duodenum using a gastroscope. An IRE catheter was then manually advanced into the esophagus along with a guidewire. The fluoroscopy with contrast medium was employed to determine target lesions with clips. Following the sequential ablation along the esophagus, electrical parameters as well as the number of interruptions encountered were recorded. The pigs used in the experiments were sacrificed after 24 hours and tissue specimens obtained were evaluated using H & E and terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay. Results: Based on the COMSOL simulation, the heated portion, approximately 57 degrees of Celsius, was observed only at the edge of the electrodes. Fluoroscopy demonstrated the balloon-type catheter was not adjacent to the heart and tightly blocked the lumen of esophagus as it adheres to the mucosal layer during inflation. The IRE catheter was able to overcome muscle contractions during ablative process and deliver all electrical energy of the scheduled sequences. A total of 12 ablations were performed in three pigs, and the success rate of balloon catheter was 91.7% (11/12). Histological slides from H & E staining and TUNEL assay showed nuclei, stained brown, which indicates apoptosis at the ablation site. Conclusions: The IRE balloon-type catheter demonstrated its applicability and effectiveness as an electroporation-based treatment in esophagus as validated in the experimental results. Further studies regarding electrodes improvement to heat-free condition and its safety related assessment would be needed.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.4_suppl.339
    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
    Online Resource
    Online Resource
    Cancer signature ensemble integrating cfDNA methylation, copy number, and fragmentomic patterns for multi-cancer early detection.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. e15040-e15040
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e15040-e15040
    Abstract: e15040 Background: The use of cfDNA sequencing has demonstrated great potential for cancer screening; particularly, methylation signatures, copy number variations, and fragmentomic profiles have proven to be effective for identifying early cancer signals. However, most large-scale studies have only focused on either targeted methylation sites or whole-genome sequencing, limiting comprehensive analysis that integrates both epigenetic and genetic signatures. In this study, we present a platform for multi-cancer early detection that enables simultaneous analysis of whole-genome methylation, copy number, and fragmentomic patterns of cfDNA in a single assay. Methods: For a total of 950 plasma samples (361 healthy controls and 107 colon, 113 liver, 238 lung, and 131 prostate cancer) and 239 tissue samples, whole-genome methylation sequencing data were generated. Machine learning was conducted for multiple feature types engineered from cfDNA samples, and independent test performance was assessed. Results: A multi-feature cancer signature ensemble (CSE) classifier, integrating all features, outperformed single-feature classifiers. At 95.2% specificity, the cancer detection sensitivity with methylation, copy number, and fragmentomic models were 77.2% [CI 72-82], 61.4% [CI 56-67] , and 60.5% [CI 55-66], respectively; but it was significantly increased to 87.7% [CI 84-91] with CSE ( p-value 〈 0.0001). For tracing the tissue of origin, CSE enhanced the accuracy beyond the methylation classifier, from 74.7% [CI 69-80] to 77.5% [CI 72-82] . Conclusions: This work proves the utility of a signature ensemble integrating epigenetic and genetic information for accurate cancer detection.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.e15040
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 9
    Online Resource
    Online Resource
    Prospective single-arm study of endocrine therapies with ovarian function suppression in premenopausal patients with node-positive early breast cancer with low genomic risk (INTERSTELLAR trial, KBCSG-25).
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. TPS618-TPS618
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. TPS618-TPS618
    Abstract: TPS618 Background: It is unclear whether the clinical benefit of cytotoxic adjuvant chemotherapy (CT) could be replaced by ovarian-function suppression (OFS) in premenopausal, estrogen receptor (ER)+HER2- breast cancer patients who have high clinical risk score and low genomic risk assessed by multigene assays. The TAILORx trial included a subgroup of premenopausal women with high clinical risk scores and midrange RS scores and found that CT, in addition to endocrine treatment (ET), offered clear benefits in terms of invasive disease-free survival (iDFS) and distant-recurrence-free survival (DRFS) compared to ET alone. However, a majority of the patients did not receive OFS, and the use of OFS as an alternative to chemotherapy in this population is still an area of ongoing research and debate. In addition, in premenopausal women of the RxPonder trial, which enrolled node-positive disease, it is noted that the addition of OFS to ET for at least 12 months improved iDFS numerically in the ET-alone arm, although this improvement did not reach statistical significance. We hypothesized that a favorable DRFS could be achieved by OFS plus ET without CT in premenopausal, pN1, ER+HER2- breast cancer with low genomic risk identified by an NGS-based multigene assay, the OncoFREE. Methods: The INTERSTELLAR trial is a prospective, multicenter, single-arm, non-inferiority clinical study. Premenopausal women aged ≤50 years with pT1-2 ER+HER2- breast cancer and 1-3 lymph node metastasis will be enrolled. They will be tested with OncoFREE, an NGS-based breast cancer prognosis multigene assay developed and available in South Korea, where a higher portion of the patients is premenopausal. Patients with low genomic risk (Decision Index≤20) are administered OFS plus tamoxifen or an aromatase inhibitor for five years. We hypothesize that the 5-year DRFS of the single arm treated with OFS plus ET would be not inferior to 96.1%, which is observed in the chemo-ET arm from the premenopausal subgroup of the RxPonder trial. The one-sided test with a non-inferiority margin of 3% and statistical power of 80% at a significance level of 0.05 resulted in a sample size of 380 patients with low genomic risk. Considering a 70% designation to low genomic risk by OncoFREE and a 10% drop-out rate, 604 patients will be enrolled from 15 tertiary care hospitals in South Korea. The primary endpoint will be tested in the 380 patients with low genomic risk. The patients with high genomic risk will receive CT followed by ET and will be followed for survival analysis as a secondary end-point. The trial has not enrolled its first patient yet at the time of submission. Clinical trial information: NCT05333328 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.TPS618
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 10
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    Neoadjuvant pembrolizumab, GX-188E, and GX-I7 in patients with human papillomavirus-16- and/or 18-positive head and neck squamous cell carcinoma: Single-arm, phase 2 trial with single cell transcriptomic analysis and artificial intelligence-powered spatial analysis.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 6075-6075
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 6075-6075
    Abstract: 6075 Background: With the increasing prevalence of head and neck squamous cell carcinoma (HNSCC) associated with human papilloma virus (HPV) infection, effective treatment strategies for HPV-positive HNSCC are urgently needed. Here, we present the results of neoadjuvant checkpoint blockade of pembrolizumab, therapeutic HPV DNA vaccine of GX-188E, and long-acting interleukin-7 of GX-I7 for patients with resectable HPV-16 and/or 18-positive HNSCC. Methods: In this single-arm, phase 2 trial, patients with resectable HPV-16 and/or 18-positive HNSCC were enrolled. Patients were given pembrolizumab 200mg on day 1 and day 22; GX-188E 2mg on day 1, 8, and 22; and GX-I7 1200 ug/kg on day 8 before surgical resection. Major pathologic response (MPR; defined as residual viable tumor of less than or equal to 10%) was primary endpoint with null and alternative hypothesis of MPR rate ≤5% and ≥35%, respectively. Secondary objectives were safety, recurrence, and survival. Results: Of the 11 patients included, all underwent surgical resection after neoadjuvant treatment without delays in surgery or increased surgical complications. MPR was achieved in seven patients (63.6%) and pathologic complete response was achieved in four patients (36.3%), which met the primary endpoint. Single cell RNA sequencing of baseline and post-treatment paired specimens revealed that the proportion of follicular helper T cell cluster, featured with CXCR5 and BCL6 expression, was significantly increased among tumor-infiltrating immune cells, accompanied with the reinvigoration of CD8 T cell cluster toward less exhausted phenotypes, represented with the upregulation of TCF7 and CD28 expression. In addition, artificial intelligence-powered spatial analysis revealed that triple combination significantly increased the density of tumor-infiltrating lymphocytes, completely converting immune-desert and immune-excluded type of tumor to inflamed immune phenotype. Conclusions: Neoadjuvant pembrolizumab, GX-188E, and GX-I7 showed promising activity and manageable safety profile in patients with resectable HPV-16 and/or 18-positive HNSCC. Therapeutic induction of brisk immune responses significantly reshaped the tumor microenvironment and associated with pathologic regression, warranting further investigation of pembrolizumab, GX-188E, and GX-I7 for patients with HPV-positive HNSCC. Clinical trial information: NCT05286060 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.6075
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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