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  • American Society of Clinical Oncology (ASCO)  (42)
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  • American Society of Clinical Oncology (ASCO)  (42)
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  • 1
    Online Resource
    Online Resource
    Relationship of anti-proliferative activity of TAS-108, a steroid anti-estrogen, and high expression of ERα in MCF7 cells.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e11566-e11566
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e11566-e11566
    Abstract: e11566 Background: TAS-108 is an anti-estrogen that binds to both ERα and ERβ and has potent anti-proliferative activity in vitro and in vivo assay. Recently, the phase II clinical study of TAS-108 showed that it has competitive clinical benefic with lower level of adverse effects. However, the effect of TAS-108 on molecular mechanism, including ER dimerization, remains largely uninvestigated. Methods: The plasmids containing ERα or ERβ fused with N- and C-terminal fragments of firefly luciferase were constructed for split luciferase complementation assays. The resulting plasmids were transfected in HEK293 cells for 24 hr and TAS-108 was added to the media for 6 hr. For RT-qPCR of AREG and TFF1 and proliferation assay, ERβ was transfected in MCF7 cells for 24hr. The proliferation level was determined by measuring the fluorescent level induced by Prestoblue reagent. Results: Using split luciferase complementation assay, we determined that TAS-108 induced ERα/β heterodimerization about 100-fold more potently than ERα/α homodimerization. Increasing the ERβ level by transfection in MCF7 cells (MCF7-ERβ), potency of TAS-108 was increased significantly; 30nM TAS-108 was suitable to block the E2 mediated increase of AREG and TFF1 expression and significantly decrease proliferation of MCF7-ERβ. Conclusions: Taken together, these data suggest that TAS-108 has a higher affinity for ERα/β heterodimerization than ERα/α homodimerization and TAS-108 shows more effective anti-proliferative activity by blocking the expression of E2-induced proliferative genes when coupled with increased levels of ERβ. These findings also underscore the molecular role of ERβ in the biology and suggest the possibility of the compound inducing ERα/β heterodimerization as anti-breast cancer drugs.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.e11566
    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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  • 2
    Online Resource
    Online Resource
    Anti-estrogenic effect of TAS-108 in breast cancer cell lines.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. e11029-e11029
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e11029-e11029
    Abstract: e11029 Background: TAS-108 (TAS) is an antiestrogen that binds to both ERα and ERβ and inhibits both estrogen-dependent and independent tumors and TAM resistant tumors. Breast cancer cell lines (BCC) with different pheno- and genotypes are reasonably acceptable models of in vivo breast cancer cell behavior. Thus, we have investigated anti-estrogenic activity of TAS on BCC in the presence of diarylpropionitrile (DPN), a pure ERβ agonist to find ERβ role in TAS activity. Methods: Cultured cells of (1) MCF-7 and ZR-75 (luminal epithelial cells), (2) BT-474 and SK-BR-3 (weakly luminal epithelial cells), and (3) MDA-MB-231 and Hs578T (invasive, mesenchymal-like cells) were treated with: (1) increasing concentrations of DPN or E2, (2) 100nM of 4-hydroxytamoxifen (4-HT) or TAS, and (3) 100nM of DPN or E2 with increasing concentrations of either 4-HT or TAS. After 6 days, cell proliferation was analyzed. The mRNA levels of ERβ and ERα isoform were determined by RT-qPCR. ERα, PR, and Her-2 status was determined by IHC. Percent proliferation compared to the control was calculated and P 〈 0.05 based on T-test was considered significant. Results: The most significant proliferation and growth inhibition was seen in MCF-7 BCC. In the presence of DPN, IC 50 (50% inhibitory concentration) was 12.5nmol of TAS vs 33.1nmol of 4-HT. In the presence of E2, IC 50 was 2.15 nmol of TAS vs 49.7nmol of 4-HT. Other BCC showed insignificant or variable proliferative and inhibitory response. Overall, DPN displayed high proliferation in most BCC. TAS exhibited higher growth inhibition than 4-HT. Conclusions: Variable responses of different BCC lines to ERα and ERβ agonists and antagonists may be instructive in modeling in vivo breast cancer response to these compounds. Overall, exposure to ERβ agonists showed a significant proliferation in ERα+, ERα- and ERβ+ cells. TAS activity was more pronounced and its anti-estrogen activity may involve ERβ in addition to ERα. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.e11029
    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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  • 3
    Online Resource
    Online Resource
    ERβ mRNA expression in ERα-negative and triple-negative breast cancers.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 574-574
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 574-574
    Abstract: 574 Background: ERα is the main prognostic and therapeutic marker in breast cancer (BC). About 30% of BC cases are negative for ER (ERα-) and do not benefit from antiestrogen therapy (TAM). We aim to study ER-beta (ERβ) expression in ERα- and triple negative (TN) cancers to explore alternate pathway of treatment in this cohort. Methods: We studied 67 ERα- BC cases including 44 TN together with 74 ERα +BC cases obtained from patients aged 29 to 97 years old between 2003 and 2010. The histology included 110 intraductal, 12 medullary and 19 other types. 78 cases were grade 3, 52 were grade 2, and 11 were grade 1. RNA was extracted from FFPE and mRNA levels of ERβ isoform and ERα were determined by real-time quantitative reverse transcription PCR. IHC stains were done on TMA the sections for ERα, PR, Her-2, Ki-67, CK5/6 and Cyclin D1. Results: ERβ isoforms were highly expressed in ERα-, TN, basal-like and HER2 type BC cases. ERβ2 was the major ERβ variant expressed. Ki-67 proliferating cells ( 〉 20% nuclear staining) were mostly in ERα- rather than ERα+ cases (69.0% vs. 31.0%) as were cyclin D1- cells (82.2% vs. 17.8%). On the other hand, in ERα+ BC, ERα mRNA expression was consistently high and upregulated, and ERβ, low and down regulated, and the ratio of ERα+ to ERβ+ ranged from 3 to 100. ERβ1, 2 and 5 were co-expressed with ERα in 56%, 63%, and 30% of cases, respectively. Overall, ERβ mRNA levels did not show any significant correlation with age, tumor size, lymph node status and histological grades. Conclusions: ERβ-dependent proliferating tumor cells may render them more sensitive to TAM, and increase the effectiveness of TAM and its metabolites in ERα- and TN cases. Increased overall survival after adjuvant TAM ERα-BC may be directly related to ERβ over-expression. ERβ isoform is potential selective therapeutic target in a sub-cohort of ERα- BC. Additionally, when ERβ and ERα are co-expressed, ERβ appears to play a distinct role from its action in ERα- BC. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.574
    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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  • 4
    Online Resource
    Online Resource
    Clinical significance of ERβ mRNA expression in ERα-negative and triple-negative breast cancers.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 545-545
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 545-545
    Abstract: 545 Background: Previously at the 2012 ASCO meeting, we reported significant ERβ mRNA expression in ERα-negative (ERα-) and triple negative breast cancers (TNBC). In this study, we analyzed its clinical outcome and correlation with other clinical parameters. Methods: A total of 141 cases consisted of 69 ERα- BC including 41 TNBC and 72 ERα+ BC were obtained from patients aged 29 to 97 years old between 2003 and 2010. Treatments included surgery, hormone, chemo- or radiotherapy, or any combinations. The follow-up period ranged from 1 to 132 months. ERβ mRNA was analyzed from formalin-fixed tumor tissues by RT-PCR. ERα, PR, Her-2, Ki-67, AIB-1, NFk/p65, p-c-jun, Ki-67, TIF-2, SRC-1, CK5/6 and p53 were tested by immunohistochemistry. The correlation was deemed significant if p value less than 0.05 from Chi-square. Overall survival (SVR) was defined from the date of diagnosis to last follow-up or death attributed to BC and was analyzed by the Kaplan-Meier curves and Wilcoxon rank sum. Results: Single or combination of ERβ isoform(s) was highly expressed in both ERα- and TNBC and ERβ2 was the most frequent (48.8%) and ERβ5, the least (30.2%). In contrast, ERβ5 was the most frequent in ERα+BC. Presence of all or any ERβ isoform was associated with significantly higher SVR in all cases, and in TNBC (ERβ total, Wilcoxon p = 0.0177, ERβ2, p= 0.0329), and also with negative LN (p 〈 0.0001). ERβ2 and ERβ5 were expressed in 63.2% and 30 %, respectively, in 20 patients died in 1 to 60 months. Over expression of AIB-1, NF-kB/p65 and TIF-2 was associated with ERβ1 and ERβ2 (p 〈 0.05). Ki-67 + cells were mostly ERβ + BC than ERα+. ERα mRNA expression was up-regulated, and ERβ,down- regulated, with the ERα: ERβ+ ratio of 3-1000:1. There was no association between ERβ expression and the stage, age, tumor size, and postmenopausal status. Conclusions: Specific ERβ isoform appears to be a significant discriminating factor for SVR and negative node. ERβ2 is the predominant isoform in ERα- but ERβ5 in ERα+BC, suggesting a distinct role of ERβ isoform in ERα- and ERα+BC. ERβ isoform may be a selective therapeutic target in this cohort. ERβ+/ Ki-67+cells appear to be a sub-population of BC arising from basal-myoepithelial cells in this cohort.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.545
    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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  • 5
    Online Resource
    Online Resource
    Deep Learning–Based Survival Analysis Identified Associations Between Molecular Subtype and Optimal Adjuvant Treatment of Patients With Gastric Cancer
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  JCO Clinical Cancer Informatics , No. 2 ( 2018-12), p. 1-14
    Details
    In: JCO Clinical Cancer Informatics, American Society of Clinical Oncology (ASCO), , No. 2 ( 2018-12), p. 1-14
    Abstract: Gastric cancer (GC) is the third-leading cause of cancer-related deaths. Several pivotal clinical trials of adjuvant treatments were performed during the previous decade; however, the optimal regimen for adjuvant treatment of GC remains controversial. Patients and Methods We developed a novel deep learning–based survival model (survival recurrent network [SRN]) in patients with GC by including all available clinical and pathologic data and treatment regimens. This model uses time-sequential data only in the training step, and upon being trained, it receives the initial data from the first visit and then sequentially predicts the outcome at each time point until it reaches 5 years. In total, 1,190 patients from three cohorts (the Asian Cancer Research Group cohort, n = 300; the fluorouracil, leucovorin, and radiotherapy cohort, n = 432; and the Adjuvant Chemoradiation Therapy in Stomach Cancer cohort, n = 458) were included in the analysis. In addition, we added Asian Cancer Research Group molecular classifications into the prediction model. SRN simulated the sequential learning process of clinicians in the outpatient clinic using a recurrent neural network and time-sequential outcome data. Results The mean area under the receiver operating characteristics curve was 0.92 ± 0.049 at the fifth year. The SRN demonstrated that GC with a mesenchymal subtype should elicit a more risk-adapted postoperative treatment strategy as a result of its high recurrence rate. In addition, the SRN found that GCs with microsatellite instability and GCs of the papillary type exhibited significantly more favorable survival outcomes after capecitabine plus cisplatin chemotherapy alone. Conclusion Our SRN predicted survival at a high rate, reaching 92% at postoperative year 5. Our findings suggest that SRN-based clinical trials or risk-adapted adjuvant trials could be considered for patients with GC to investigate more individualized adjuvant treatments after curative gastrectomy.
    Type of Medium: Online Resource
    ISSN: 2473-4276
    URL: Article
    DOI: 10.1200/CCI.17.00065
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
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  • 6
    Online Resource
    Online Resource
    ARTIST 2: Interim results of a phase III trial involving adjuvant chemotherapy and/or chemoradiotherapy after D2-gastrectomy in stage II/III gastric cancer (GC).
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. 4001-4001
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. 4001-4001
    Abstract: 4001 Background: Adjuvant chemotherapy and/or chemoradiotherapy have been the standard of care in GC for years, supported by randomized trials. We compared the efficacy of different chemotherapy regimens and chemoradiotherapy in patients with D2-resected, stage II/III, node-positive GC. Methods: From Feb 2013 through Nov 2018, we randomly assigned, in a 1:1:1 ratio, patients with pathologically-staged II or III, node-positive, D2-resected GC, to receive adjuvant S-1 (40-60 mg twice daily 4-weeks-on/2-weeks-off) for one year, S-1 (2-weeks-on/1-week-off) plus oxaliplatin 130 mg/m2 (SOX) for six months, or SOX plus chemoradiotherapy 45 Gy (SOXRT). Randomization was stratified according to the type of surgery (total or subtotal gastrectomy), stage (II or III), and Lauren histologic classification (diffuse or intestinal). The primary endpoint was disease-free survival (DFS). A total of 900 patients had to be enrolled to demonstrate superiority of SOX or SOXRT to S-1 (hazard ratio [HR] 0.667), with 90% power at a two-sided significance level of 5%. Results: A total of 538 patients were included for this interim efficacy analysis. Median age was 58 years, men constituted 65%, and stage II and III were 31% and 69%, respectively. Baseline tumor and patient characteristics were balanced between treatment arms. Adverse events were as anticipated in each arm, generally well-tolerated and manageable. DFS in the control arm (S-1) were significantly shorter than in SOX and SOXRT arms (stratified HR for recurrence): S-1 vs. SOX, 0.617 (P = 0.016) and S-1 vs. SOXRT, 0.686 (P = 0.057). The DFS at 3-years was found to be 65%, 78% and 73% in S-1, SOX and SOXRT arms, respectively. No difference in DFS between SOX and SOXRT was found (HR 0.910, P = 0.667). Based on the results after the observation of 145 recurrence events at the cutoff date of Dec 27, 2018, the independent data monitoring committee considered the results sufficient to meet the endpoint of the trial and recommended early stopping of the trial. Conclusions: In patients with curatively D2-resected, stage II/III, node-positive GC, adjuvant SOX or SOXRT was effective in prolonging DFS, when compared to S-1 monotherapy. Clinical trial information: NCT0176146.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.4001
    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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  • 7
    Online Resource
    Online Resource
    Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 28 ( 2015-10-01), p. 3130-3136
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 28 ( 2015-10-01), p. 3130-3136
    Abstract: The Adjuvant Chemoradiotherapy in Stomach Tumors (ARTIST) trial tested whether the addition of radiotherapy to adjuvant chemotherapy improved disease-free survival (DFS) in patients with D2-resected gastric cancer (GC). Patients and Methods Between November 2004 and April 2008, 458 patients with GC who received gastrectomy with D2 lymph node dissection were randomly assigned to either six cycles of adjuvant chemotherapy with capecitabine and cisplatin (XP) or to two cycles of XP followed by chemoradiotherapy and then two additional cycles of XP (XPRT). This final update contains the first publication of overall survival (OS), together with updated DFS and subset analyses. Results With 7 years of follow-up, DFS remained similar between treatment arms (hazard ratio [HR], 0.740; 95% CI, 0.520 to 1.050; P = .0922). OS also was similar (HR, 1.130; 95% CI, 0.775 to 1.647; P = .5272). The effect of the addition of radiotherapy on DFS and OS differed by Lauren classification (interaction P = .04 for DFS; interaction P = .03 for OS) and lymph node ratio (interaction P 〈 .01 for DFS; interaction P 〈 .01 for OS). Subgroup analyses also showed that chemoradiotherapy significantly improved DFS in patients with node-positive disease and with intestinal-type GC. There was a similar trend for DFS and OS by stage of disease. Conclusion In D2-resected GC, both adjuvant chemotherapy and chemoradiotherapy are tolerated and equally beneficial in preventing relapse. Because results suggest a significant DFS effect of chemoradiotherapy in subsets of patients, the ARTIST 2 trial evaluating adjuvant chemotherapy and chemoradiotherapy in patients with node-positive, D2-resected GC is under way.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2014.58.3930
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
    detail.hit.zdb_id: 2005181-5
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  • 8
    Online Resource
    Online Resource
    Magnetic marking clip for easier laparoscopic localization of small gastrointestinal tumors.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 4_suppl ( 2020-02-01), p. 386-386
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 4_suppl ( 2020-02-01), p. 386-386
    Abstract: 386 Background: Laparoscopic surgery for gastrointestinal tumors requires fast and precise tumor localization. As tumor palpation is not possible during laparoscopic surgery, tumor identification is often difficult for some cases. Despite various methods, such as tattooing or endo-clipping, have been introduced for the localization of tumors, these methods own clear limitations. To overcome the drawbacks of these conventional marking methods, we designed a magnetic marking device linked to an endo-clip(MMC, Magnetic Marking Clip) for endoscopy. We performed preoperative endoscopic clipping with MMC and analyzed the intraoperative localization efficacy and safety during laparoscopic surgery. Methods: Study enrolled 30 patients with gastric and colorectal neoplasms scheduled to undergo endoscopic clipping before laparoscopic surgery at the Korea University Medical Center, Korea, between August 2017 and June 2019. A silicone-coated high-power neodymium marking device (ring or rod type) was fixed together with an endo-clip and applied on the center of the lesion during preoperative endoscopy. During laparoscopic surgery, a detecting magnetic body was inserted through a laparoscopic trocar and was used to localize the tumor that is marked with MMC. The time needed for endoscopists to place MMC at the lesion, laparoscopic clip detection time and success rate were studied. Results: Endoscopists placed MMC within 30 seconds. It was possible to find MMC in all cases of laparoscopic surgery. Time needed to find the MMC laparoscopically was relatively shorter than the time conventionally taken just with an endo-clip itself. There was no reported dislodgement of the clip before the surgery or any other adverse events associated with the MMC procedure. Conclusions: The MMC method enabled simple and fast tumor localization and showed excellent outcomes in efficacy of tumor localization. The MMC method may help surgeons localize GI tumor lesions easily and safely during laparoscopic surgery.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.4_suppl.386
    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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  • 9
    Online Resource
    Online Resource
    Irreversible electroporation of the bile duct in swine: A pilot study.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 4_suppl ( 2020-02-01), p. 541-541
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 4_suppl ( 2020-02-01), p. 541-541
    Abstract: 541 Background: Irreversible electroporation (IRE) is a relatively new ablative method. However, the application of IRE ablation has not been attempted for the treatment of biliary disease. Minimally invasive approach using endoscopic retrograde cholangio-pancreatography (ERCP) can be a novel therapeutic modality for IRE ablation. In this study, we investigated the feasibility and effect of endoscopic IRE for biliary tract in animal model. Methods: A new catheter electrode was developed for endoscopic IRE ablation of biliary tract. The electrode for IRE ablation has two band-shaped electrodes on catheter tip. We performed ERCP and endoscopic IRE ablations on normal common bile duct in 6 Yorkshire pigs. Experimental parameters of IRE were 500V/cm, 1000V/cm and 2000V/cm (under 50 pulses, 100 µs length). Animals were sacrificed after 24 hours and ablated bile duct were collected. H & E stain, immunohistochemistry and western blot were performed. Results: Well-demarcated focal color changes were observed on the mucosa of the common bile duct under all experimental parameters. After IRE ablation, bile duct epithelium was disappeared around ablated area and it showed fibrotic change in H & E stain. Depth of change after IRE was different between each experimental parameters. Apoptotic change of bile duct was localized around mucosa in 500V. Diffuse transmural fibrosis of bile duct was shown after IRE ablation with 2000V. TUNEL immunohistochemistry showed the cell death of bile duct mucosa and submucosa along the electrode. Within 24 hours, no complication was observed in pigs after endoscopic IRE ablation. Conclusions: Endoscopic IRE ablation using ERCP was successfully performed on common bile duct by using catheter-shaped electrode. It can be a potential therapeutic option as minimally invasive ablation for treatment of biliary tumors.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.4_suppl.541
    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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  • 10
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    Online Resource
    Preoperative chemoradiotherapy with capecitabine with or without temozolomide in patients with locally advanced rectal cancer: A prospective, randomized phase 2 study stratified by MGMT (O 6 -methylguanine DNA methyltransferase) status: KCSG-CO17-02.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 3605-3605
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 3605-3605
    Abstract: 3605 Background: We aimed to evaluate the clinical efficacy of adding temozolomide (TMZ) to preoperative capecitabine (CAP)-based chemoradiotherapy (CRT) in patients with locally advanced rectal cancer (LARC) and validate O 6 -methylguanine DNA methyltransferase (MGMT) methylation status as a predictive marker for TMZ combined regimens. Methods: : LARC patients with clinical stage II (cT3-4N0) or III (cT any N+) disease were enrolled. They were stratified into MGMT unmethylated (uMGMT) and MGMT methylated (mMGMT) groups by methylation-specific PCR before randomization, and then were randomly assigned (1:1) to one of four treatment arms: uMGMT/CAP (arm A), uMGMT/TMZ+CAP (arm B), mMGMT/CAP (arm C), and mMGMT/TMZ+CAP (arm D). The primary endpoint was the pathologic complete response (pCR) rate. Results: Between November 2017 and July 2020, 64 patients were randomized. Slow accrual caused early study termination. After excluding 4 ineligible patients, 60 were included in the full analysis set. The pCR rate was 15.0% (9/60), 0%, 14.3%, 18.8%, and 26.7% for arms A, B, C, and D, respectively ( p= 0.0498 between arms A and D). The pCR rate was 9.7% in the CAP group (arms A+C), 20.7% in the TMZ+CAP group (arms B+D), 6.9% in the uMGMT group (arms A+B), and 22.6% in the mMGMT group (arms C+D). Grade 1–2 nausea or vomiting was significantly more frequent in the TMZ+CAP treatment groups (arms B+D) than in the CAP treatment groups (arms A+C, p 〈 0.001) with no difference in grade 3 adverse events (AEs). There were no grade 4 or 5 AEs. Conclusions: The addition of TMZ to CAP-based CRT tended to improve pCR rates, particularly in those with mMGMT LARC. MGMT status may warrant further investigation as a predictive biomarker for chemotherapeutic agents and radiotherapy. Clinical trial information: NCT03156036.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.3605
    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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