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  • American Society of Clinical Oncology (ASCO)  (5)
  • 1
    Online Resource
    Online Resource
    Association of the bevacizumab pharmacokinetics with efficacy and toxicity in advanced non-squamous non-small cell lung cancer: Kumamoto Thoracic Oncology Study Group (KTOSG) 1003 study.
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 15_suppl ( 2017-05-20), p. e20559-e20559
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. e20559-e20559
    Abstract: e20559 Background: Biomarkers predicting the efficacy and toxicity of bevacizumab (Bev) have not yet been established. Therefore we conducted this pharmacokinetic study to elucidate the role of plasma concentration of Bev as a biomarker to predict outcome in the treatment of patients with lung cancer. Methods: This multicenter prospective pharmacokinetic study was conducted among nine centers in Kumamoto Prefecture, Japan. Patients with non-squamous non-small cell lung cancer who were treated using tri-weekly Bev (15mg/kg) with platinum-doublet chemotherapy were enrolled. Plasma samples were collected from all patients before the administration of every dose of Bev until disease progression or treatment discontinuation owing to toxicity. Plasma concentrations of Bev were analyzed via nano-surface and molecular-orientation limited proteolysis coupled with liquid chromatography-mass spectrometry. Results: Between July 2010 and May 2014, 30 patients were enrolled in this study. Majority of the patients received pemetrexed with cisplatin or carboplatin (24 patients, 80%) and others received paclitaxel with carboplatin. The trough concentrations of Bev after first administration (day 22) were 63.19 ± 19.57 μg/mL. Trough concentrations gradually increased until the six cycle of Bev and reached a steady state. Plasma concentrations of Bev did not decrease until disease progression in patients with a long treatment period. Higher mean plasma concentrations of Bev correlated with female sex (p = 0.034) and high serum albumin levels (p = 0.034). Patients who received pemetrexed had higher mean concentrations of Bev (p = 0.038) than those who received paclitaxel. The response rate and progression-free survival did not correlate with the plasma concentration of Bev. Proteinuria (≥Grade 2) correlated with higher concentrations of Bev. Conclusions: Our study demonstrated that various types of chemotherapy influenced the concentrations of Bev, and a higher concentration of Bev may predict the incidence of proteinuria. In addition, clearance of Bev did not change after long treatment period until disease progression. Clinical trial information: 000007630.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.15_suppl.e20559
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    Japanese nationwide multi-institutional cohort study of prostate cancer brachytherapy with permanent seed implantation.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. e16090-e16090
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e16090-e16090
    Abstract: e16090 Background: Brachytherapy with permanent iodine-125 seed implantation (PI) has been approved in 2003 in Japan. Multi-institutional cohort study (Japanese Prostate Cancer Outcome Study of Permanent Seed Implantation; J-POPS, NCT00534196) assessing the treatment feature, efficacy, safety and health-related quality of life (QOL) has started in July 2005. Six thousand nine hundred and twenty-seven cases were enrolled to this study until December 2010 from 68 institutes around the country, which is approximately 40% of all the cases treated in Japan at that time. Methods: Patient’s background, cancer character, treatment feature such as combined therapy of external beam or hormone, post PI dosimetric information, treatment efficacy with PSA level, voiding symptoms with IPSS and treatment related adverse events according to NCI-CTCAE are investigated. PSA was measured every 3 months and symptoms accompanied to the treatment were assessed 3 to 6 months after the treatment. Backgrounds and treatment assessments of 2,341 patients enrolled in J-POPS during the initial 2 years are evaluated. Results: Patients’ age ranged from 45 to 89 (median 69) year-old and 99.0% of the cases were performance status 0 (ECOG criteria). Family history of prostate cancer was seen in 6.2%. PSA levels on cancer diagnosis were 1.60 to 42.0 (mean 6.80) ng/ml, clinical stage T2a or less was 89.9%, T2b was 5.2%, T2c was 2.9% and T3a-T3b was 0.8%. Gleason score (GS) less than 7 was 56.6%, GS 7 was 39.7%, and GS above 7 was 3.6%. According to NCCN risk classification, 44.2% was classified as low risk, 48.3% as intermediate risk and 5.7% as high risk. Androgen deprivation therapy (ADT) was performed in 48.5% of the patients and 23.4% was combined with external beam radiation therapy (EBRT). CT scan based first post therapeutic month dosimetry revealed that prostatic mean V100 and D90 for the cases treated with seed alone were 94.8% and 160.7 Gy, respectively. As for adequate control of radiation dose at rectum (mean R100 = 0.3 cc) and urethra (mean D5 = 223.4 Gy), high grade toxicities appeared very seldom. Conclusions: Outcomes of J-POPS will produce clinical evidence of PI that can be internationally accepted.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.e16090
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 3
    Online Resource
    Online Resource
    Single-sample enrichment analysis identified predictive biomarker candidates for nivolumab in patients with non-small cell lung cancer.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e21097-e21097
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e21097-e21097
    Abstract: e21097 Background: Although anti-PD-1/PD-L1 monotherapy has achieved clinical success in non-small cell lung cancer (NSCLC), definitive predictive biomarkers remain to be elucidated. We assumed that by combining gene expression signatures with patient clinical data, we could identify a novel promising biomarker to predict response to anti-PD-1/PD-L1 monotherapy in NSCLC patients. Moreover, the characterization of these signatures will help us to decipher the complexity of tumor-immune interactions and better understand the tumor microenvironment (TME) that favors clinical response to nivolumab monotherapy. Methods: From clinically annotated NSCLC patients (n = 40) with nivolumab monotherapy in the second- or later-line settings, we prospectively collected tumor tissues and peripheral blood mononuclear cells (PBMCs) before first dose of nivolumab and PBMCs after first 4 or 5 doses of nivolumab. All tumor tissue and PBMC samples obtained were applied to whole-transcriptome sequencing (RNA-seq). We extracted transcriptomic datasets of lung adenocarcinoma (LUAD) (n = 20) and lung squamous cell carcinoma (LUSC) (n = 18) from the results, separately analyzed each histological subtype. To elucidate biological processes associated with clinical outcomes, we performed a supervised gene set enrichment analysis (GSEA) approach and an unsupervised single sample scoring approach. Results: In LUAD, we observed that gene sets related to interferon (type I and II) signaling (‘IFN signatures’) and antigen processing and presentation (‘APP signatures’) were significantly enriched in pre-treatment PBMCs of responders. IFN and APP signatures, which are closely related to each other, functionally cooperate to activate anti-tumor immune response. The enrichment of IFN and APP signatures provides the possibility that responders have a pre-existing anti-tumor immunity prior to nivolumab monotherapy. In LUSC, neither IFN nor APP signatures were enriched in pre-treatment tumor tissues and PBMCs of responders. Instead, gene sets related to the regulation of the TME (‘TME signatures’) are significantly enriched in pre-treatment tumor tissues of non-responders. The enrichment of TME signatures suggested that non-responders have an extremely immunosuppressive TME. These findings highlighted that responsive LUAD inherently have a high immunogenicity to elicit effective anti-tumor responses, whereas responsive LUSC have a similar level of immunogenicity as non-responsive LUSC but are free from an extremely immunosuppressive TME. Conclusions: We found that nivolumab enhanced anti-tumor immunity in patients with LUAD in a quite different way from patients with LUSC. Our study provides a blueprint for innovating combinational immunotherapy and supporting patient selection and treatment strategies on long-term clinical outcomes.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.e21097
    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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  • 4
    Online Resource
    Online Resource
    Rectal toxicity after permanent iodine-125 seed implantation: Nationwide cohort study in Japan (J-POPS).
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 4_suppl ( 2014-02-01), p. 73-73
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 4_suppl ( 2014-02-01), p. 73-73
    Abstract: 73 Background: The purpose of this report is to describe acute and late rectal toxicities and to evaluate factors associated with rectal toxicity in permanent seed implantation (PI) patients enrolled in a nationwide cohort study in Japan. Methods: A total of 2,339 patients in 46 institutes were evaluated. They were treated in the nationwide cohort study entitled Japanese Prostate Cancer Outcome Study of Permanent I-125 Seed Implantation (J-POPS) during the first two years, until June 2007. Rectal toxicities were evaluated using the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, which were obtained at 3, 12, 24, and 36 months after completion of radiotherapy. The odds ratios (OR) of factors associated with greater than or equal to grade 2 rectal toxicity were calculated using a logistic regression model, and the 95% confidence intervals (CI) were estimated. Results: Greater than or equal to grade 2 rectal toxicities were seen in 2.8% of all patients (1.7% in the PI monotherapy group and 6.4% in the external beam radiation therapy [EBRT] combination therapy group). On multivariate analysis, among all patients, greater than or equal to grade 2 rectal toxicity was associated with rectal volumes receiving 100% of the prescribed dose (R100) (OR, 1.93; 95% CI, 1.39–2.68) and EBRT addition (OR, 3.00; 95% CI, 1.39–6.32). R100 in the PI monotherapy group (OR, 1.67; 95% CI, 1.06–2.64), and R100 (OR, 2.07; 95% CI, 1.30–3.30) and interactive planning (OR, 0.46; 95% CI, 0.23–0.92) in the EBRT combination therapy group were also associated with greater than or equal to grade 2 toxicity. Greater than or equal to grade 2 toxicity was seen in 3.7% and 1.4% of patients with R100 greater than or equal to 1 ml and R100 less than 1 ml, respectively, in the PI monotherapy group (OR, 2.78; 95% CI, 1.28–6.05) and in 14.1% and 5.4% of patients with R100 greater than or equal to 1 ml and R100 less than 1 ml, respectively, in the EBRT combination therapy group (OR, 2.88; 95% CI, 1.28–6.45). Conclusions: Rectal toxicity was relatively limited compared to other reports. For Japanese PI patients, R100 should be less than 1 ml, both in PI monotherapy and in EBRT combination therapy, and interactive planning should be performed for EBRT combination therapy.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2014.32.4_suppl.73
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 5
    Online Resource
    Online Resource
    Genomic analysis of advanced malignant soft tissue tumors to suggest effect of genome-wide loss-of-heterozygosity of germline mutations/variants on anti-PD-1 immunotherapy response and survival of the patients.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 11531-11531
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 11531-11531
    Abstract: 11531 Background: Malignant soft tissue tumor is a rare cancer with few therapeutic options. Although recent genomic characterization of soft tissue sarcoma revealed massive CNA and an excess of polygenic burden of pathological germline variants, their clinical and therapeutic significance remains to be understood. Methods: We recruited 155 patients with malignant soft tissue tumors (135 female and 20 male, mean age 51, 100 LMS, 19 LPS, 4 ESS, 3 UPS, 3 AS, 3 MPT, 3 GIST and others) of confirmed metastasis/recurrence. Whole exome sequencing was performed as reported in 2018ASCO. The MSI status was analyzed by PCR. Tumor immune microenvironment was assessed by immunohistochemistry. Results: Of the 595 COSMIC genes, heterozygous germline mutations/variants of the genome-wide 0-44 genes (av. 9.7/tumor) showed somatic loss-of-heterozygosity (LOH) with allele frequency of more than 70%. Patients with less than 33% LOH (n=53) in the total of somatic and LOH mutations showed improved 5-year survival rate compared with those (n=102) with more LOH (71% vs 52%, p=0.037). LMS (n=100) had higher value of LOH mutations than other tumors (n=55)(av. 55.5 vs 31.2%, p 〈 0.001). Two patients with bone metastasis, one from liver undifferentiated sarcoma (case 1) and the other from uterine LMS (case 2) were identified as MSI-High and resultant higher TMB of 6.48 and 6.60/Mb, respectively than 1.47/Mb in av. Tumors from both cases had de novo mutations of MMR deficiency as EXO I (A153V) and WRN (S1120F) in case 1 and MSH2 (G674D) in case 2. Case 1 with pleural dissemination was treated with 5 cycles of Pembrolizumab (200mg/body, d1 q3weeks) but was progressive disease, while case 2 had no evaluable lesion after surgical removal of bone metastasis. Number of CD8+ T-cell infiltration (TIL), one of the best parameter with response to PD-1 blockade, was much higher in case 2 than in case 1 (av. 907 vs 290/mm 2 ). Case 2 had no LOH mutations while case 1 had 37% LOH with more total mutations in tumor (16.1 vs 85.9/Mb). Higher values of LOH (av. 67 vs 19%) were clearly correlated with decreased density of CD8+TIL in tumor tissues (av. 9.6 vs 429/mm 2 , n=5, p=0.018). Conclusions: Our results, for the first time, suggest that in malignant soft tissue tumors, accumulation of genome-wide LOH of germline mutations/variants, from which self-antigens could be generated, may influence tumor immune microenvironment, and thus influence immunotherapy response and survival of the patients.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.11531
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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