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  • American Society of Clinical Oncology (ASCO)  (6)
  • Oh, Sung Yong  (6)
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  • American Society of Clinical Oncology (ASCO)  (6)
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  • 1
    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
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 2
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 3_suppl ( 2015-01-20), p. 185-185
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 3_suppl ( 2015-01-20), p. 185-185
    Abstract: 185 Background: Trastuzumab-based chemotherapy became the standard option for patients with HER2 (+) metastatic gastric cancer after ToGA study. However, the OS benefit was not found in Asian and diffuse-type cancer patients. The aim of the current study is to analyze whether Asian ethnicity or poorly differentiated histology (PDH) affects the clinical outcomes of patients who were treated with trastuzumab-based chemotherapy. Methods: We collected the medical records of the patients with HER2 (+) (IHC3+ or IHC2+ & FISH+) gastric/GEJ cancer who were treated with trastuzumab-based chemotherapy. The ORR, PFS, and OS were compared according to the patients’ clinicopathologic features and data from ToGA trial. Results: From March 2012 to June 2014, data of 163 Asian patients from 11 institutes in South Korea were collected. The median age was 60 (range 27-85) and the male:female ratio was 116 (71.2%):47 (28.8%). 157 (96.3%) had stomach cancer and 6 (3.7%) had GEJ cancer. Fourteen (8.6%), 62 (38.0%), 71 (43.6%) and 11 (6.7%) patients had well, moderately, poorly differentiated tubular adenocarcinoma (TAC) and signet ring cell carcinoma (SRC), respectively. The ORR was 52.7% (86/163) which is similar to that of the ToGA trial. (47%) The median PFS was 9.8 months (95% CI 8.6 – 11.0 and the median OS was 18.5 months. (95% CI 16.5 – 20.5) These numerical data are slightly better than those of the ToGA trial. (PFS, 6.7 months; OS, 16.0 months) Next, we investigated if PDH (poorly differentiated TAC + SRC) affected on clinical outcomes. The ORR (50.0% vs. 56.6%, p = 0.408) and the PFS (8.8 months vs. 11.2 months, p = 0.109) were slightly inferior in PDH patients but still, they were better than that of the ToGA trial. The median OS was significantly shorter for PDH patients (14.1 months vs. 19.0 months, p = 0.046). Conclusions: While subset analysis of ToGA trial has demonstrated that trastuzumab-based chemotherapy may not be beneficial for Asian ethnicity and poorly differentiated histology, our real world data suggested that even in Asian and patients with PDH, trastuzumab-based chemotherapy is associated with improved clinical outcomes in patients with HER2 (+) gastric cancer.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. 4024-4024
    Abstract: 4024 Background: The VIKTORY trial is a biomarker-based umbrella trial in GC. Methods: See table below. Results: From June 2014 to Jan 2017, 432 metastatic gastric cancer patients were enrolled. 124 (28.7%) were treated on one of the associated study protocols. At January 2017, 25 pts were allocated to selumetinib/paclitaxel arm, 25 to AZD1775/paclitaxel arm, 16 to AZD5363/paclitaxel arm, 16 to vistusertib/paclitaxel arm, 4 to savolitinib monotherapy, 19 to savolitinib/docetaxel arm, 19 to phase I AZD6738/paclitaxel arm. Initial efficacy signals have been seen in several arms (selumetinib/paclitaxel, 6 of 21 evaluable patients in PR). Correlative analyses between molecular signatures and treatment response are ongoing and will be presented at the meeting. For vistusertib/paclitaxel in the biomarker negative arm, we found RICTOR amplification as a promising predictive biomarker for response. Two (of three) GC patients with RICTOR amplification achieved PR to vistusertib/paclitaxel. Conclusions: This is one of the first attempts to undertake a biomarker-driven trial in metastatic GC. 28.7% of the patients were guided to one of the parallel arms based on molecular screening outcomes. We were able to identify potential molecular targets in the biomarker-negative arm, for further assessment in new protocols. Clinical trial information: 02299648. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 4_suppl ( 2019-02-01), p. 344-344
    Abstract: 344 Background: Nal-IRI plus 5-FU/LV has demonstrated efficacy in mPDAC pts who previously received gemcitabine-based therapy in the pivotal NAPOLI-1 trial. Real-world data are helpful to measure the clinical outcomes and safety profile of this regimen in daily practice setting. Methods: Between January 2017 and April 2018, a Named Patient Program (NPP) was activated to provide controlled, pre-approval access of nal-IRI in Korea. This analysis is multicenter retrospective study for patients who received nal-IRI plus 5-FU/LV under the NPP. Results: A total of 86 patients entered into this NPP among 10 Korean institutions. Median age was 61 years (range, 37-79) and 52 pts (60%) were male. Liver (n=49, 57%), peritoneum (30, 35%), and lung (27, n=31%) were the most common metastatic sites. All patients had ECOG performance status 0-1 and previously received gemcitabine-based therapy. Prior to nal-IRI plus 5-FU/LV, 35 (41%) and 51 (59%) patients received 〈 2 and ≥ 2 lines of chemotherapy for unresectable/metastatic disease, respectively. Best response was complete response (n=2, 2%), partial response (7, 8%), stable disease (38, 44%), and progressive disease (32, 37%), indicating overall response rates of 10% and disease control rate of 55%. With median follow-up duration of 6.4 months, median progression-free survival (PFS) was 3.5 months (95% CI, 1.3-5.7) and median overall survival (OS) was not yet reached. The 6-month PFS and OS rates were 37.5% and 65.1%, respectively. Most common grade 3-4 toxicities were neutropenia (n=32, 37%), nausea (9, 10%), vomiting (8, 9%), anemia (7, 8%), and diarrhea (4, 5%). Febrile neutropenia occurred in 7 patients (8%). Conclusions: Nal-IRI plus 5-FU/LV was well tolerated and effective for mPDAC patients who progressed on gemcitabine-based therapy. Despite heavily pretreated patients were included, efficacy and safety outcomes in our cohort were consistent with the results of previous NAPOLI-1 trial.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 15_suppl ( 2018-05-20), p. 10054-10054
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 6
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2016
    In:  Journal of Clinical Oncology Vol. 34, No. 4_suppl ( 2016-02-01), p. 355-355
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 4_suppl ( 2016-02-01), p. 355-355
    Abstract: 355 Background: There is still debated regarding the optimal treatment strategy in cholangiocarcinoma after curative resection. The aim of this study was to analyze the role of adjuvant therapy in R0-resected distal cholangiocarcinoma. Methods: We retrospectively reviewed the medical records of patients who underwent R0 resection for distal cholangiocarcinoma between January 2001 and December 2013 at six cancer centers in Korea. Adjuvant therapy consisted of chemotherapy (CT), chemoradiotherapy (CRT), or radiotherapy (RT). Multivariable Cox proportional hazards model was used to identify prognostic factors for overall survival (OS). Results: A total of 158 patients were included in the analysis; 47 patients (29.7%) had lymph node involvement. Fifty-six patients (35.4%) received adjuvant therapy (CT/CRT/RT: 27/20/9, respectively). Patients with advanced TNM stage (p = 0.001), T3/T4 disease (p = 0.009), positive lymph nodes (p = 0.052) and elevated CA 19-9 (p = 0.071) were more likely to receive adjuvant therapy. The effect of adjuvant therapy varied according to the treatment modality. Multivariable analysis showed a significant improvement in OS with CRT (Hazard ratio (HR) 0.25, 95% CI 0.08-0.83, p = 0.024) and CT (HR 0.21, 95% CI 0.08-0.53, p = 0.001). However, RT alone was associated with shorter OS (HR 2.38, p = 0.040), along with T3/T4 disease (HR 2.12, p = 0.012) and positive lymph nodes (HR 2.30, p = 0.008). In the subset analysis according to lymph node status, adjuvant therapy not including RT alone was associated with a significant OS advantage both in node-negative patients (median, 103.3 vs. 54.9 months, p = 0.037) and node-positive patients (not reached vs. 22.6 months, p = 0.013). Conclusions: Our results showed that patients receiving adjuvant CT or CRT had significant improvement in OS. In addition, the benefit of adjuvant therapy (except RT alone) was observed even in patients with negative lymph nodes.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2016
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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