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  • American Society of Clinical Oncology (ASCO)  (13)
  • Yamada, Yasuhide  (13)
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  • American Society of Clinical Oncology (ASCO)  (13)
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  • 1
    In: Journal of Oncology Practice, American Society of Clinical Oncology (ASCO), Vol. 7, No. 3 ( 2011-05), p. 148-153
    Abstract: There is insufficient data to verify whether participation in clinical trials in itself can lead to better clinical outcomes. We have analyzed the characteristics and outcomes of patients who declined to participate in a randomized trial in comparison with those who participated in the trial. Patients and Methods: A randomized trial for naive advanced gastric cancer was offered to 286 patients. The trial investigated the superiority of irinotecan plus cisplatin and the noninferiority of S-1 compared with continuous fluorouracil infusion. We retrospectively reviewed the characteristics and outcomes for both participants and nonparticipants in this trial. Results: Of the 286 patients, 98 (34%) declined to participate in the trial. The rate of declining was significantly higher among younger patients (P = .003), and it varied significantly between attending physicians (range, 23% to 58%; P = .004). There were no other significant correlations between rate of declining and patient characteristics. No significant differences were observed in the clinical outcomes between the participants and nonparticipants, for whom the median survival times were 367 versus 347 days, respectively. The hazard ratio for overall survival, adjusted for other confounding variables, was 1.21 (95% CI, 0.91 to 1.60). No interaction was observed between participation and the various regimens. Conclusion: There was no difference in clinical outcomes between participants and nonparticipants. However, the patient's age and the doctor-patient relationship may have an effect on patient accrual to randomized trials.
    Type of Medium: Online Resource
    ISSN: 1554-7477 , 1935-469X
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2011
    detail.hit.zdb_id: 3005549-0
    detail.hit.zdb_id: 2236338-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. e14126-e14126
    Abstract: e14126 Background: Previous studies showed that gene mutations (NRAS, BRAF, PIK3CA) are associated with a poor prognosis or resistance of anti-EGFR antibody in metastatic colorectal cancer (mCRC) patients with wild type (WT) of KRAS codon 12/13 (KRAS-WT). However the significance of these biomarkers has not been clarified. In addition, EGFR immunohistochemistry (IHC) and EGFR gene amplification to evaluate the efficacy of anti-EGFR antibody treatment has not been reported for mCRC. Methods: We evaluated tumor response and survival in patients who received anti-EGFR antibody by mutation analysis of KRAS, NRAS, BRAF, and PIK3CA in KRAS-WT patients with mCRC. Tumor DNA samples are obtained from patients treated in our hospital with anti-EGFR antibody between August 2008 and August 2011. Results: A total of 117 patients were enrolled in this analysis, including 100 KRAS-WT patients. Seventy-one patients (60.7%) were all WT for KRAS, NRAS, BRAF, and PIK3CA, and 46 patients (39.3%) had at least 1 mutation or had insufficient DNA samples to analyze. Mutations of KRAS codon 61 (2 patients), KRAS codon 146 (5), BRAF V600E (2), PIK3CA exon9 (8), NRAS codon 12/13 (2), and NRAS codon 61 (5) were detected. No patients had a mutation of PIK3CA exon 20. Patients with at least 1 mutation had no response. Mutations of NRAS codon 61, KRAS codon 146, and BRAF V600E were associated with a shorter progression free survival (PFS) compared with all WT patients (p=0.049, p=0.004, p=0.036, respectively). Twelve patients (12% of KRAS-WT patients) with a mutation of NRAS codon 61, KRAS codon146, and BRAF V600E had poor prognosis compared with the other KRAS-WT patients (PFS, 6.4 vs 2.0 months, p 〈 0.001; overall survival (OS), 13.7 vs 7.9 months, p=0.012). In all WT patients, moderate to strong EGFR IHC was associated with a better response rate than negative and weak IHC (p=0.046). Conclusions: Mutations of NRAS codon 61, KRAS codon 146, and BRAF V600E could be a strong prognostic factor of anti-EGFR antibody in patients with mCRC. Combination of IHC and DISH of EGFR could identify patients with a tumor response to anti-EGFR antibody in patients that are all WT for KRAS, NRAS, BRAF, and PIK3CA.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 4_suppl ( 2012-02-01), p. 516-516
    Abstract: 516 Background: KRAS mutation status is a strong predictive factor for anti-EGFR monoclonal antibody therapy efficacy in metastatic colorectal cancer (mCRC). In the BOND trial, objective response rates to cetuximab in irinotecan-refractory mCRC were not significantly different based on the intensity of EGFR staining by immunohistrochemistry (IHC). However, this result was not evaluated by KRAS mutation status, so we retrospectively evaluated the relationship between the efficacy of chemotherapy containing cetuximab and the intensity of membranous EGFR staining in KRAS wild type (KRAS-WT) patients. Methods: Between August 2008 and July 2011, specimens of 391 CRC patients were collected by endoscopic biopsy or surgical resection. EGFR staining by IHC and genetic screening for KRAS status were performed and intensity of EGFR staining was scored by the Guidelines for Interpreting EGFR pharmDx, DAKO. We analyzed 94 KRAS-WT patients who received combination chemotherapy with an irinotecan-regimen plus cetuximab or cetuximab monotherapy and met the following criteria: histologically proven mCRC adenocarcinoma , at least 1 previous regimen of standard fluoropyrimidine - containing chemotherapy , ECOG PS score 0-2, and adequate hepatic and renal function. Patients were classified into 2 groups by intensity of EGFR staining: (A) absence of staining and weakly to moderately positive (IHC 1+ and IHC 2+), (B) strongly positive (IHC 3+). Progression-free survival (PFS) and overall survival (OS) were estimated by the Kaplan-Meier method, and compared in Groups A and B by the log-rank test. Results: There was no significant difference in patient characteristics between the 2 groups except for primary site. The median PFS of Groups A (n=76) and B (n=18) were 5.4 months and 9.1 months (p= 0.029), the median OS was 8.1 months and 13.2 months (p=0.054) and response rate was 20.1% and 33.3%, respectively. Conclusions: In KRAS-WT patients with fluoropyrimidine-containing chemotherapy-refractory mCRC, strong intensity of EGFR staining by IHC might be predictive for efficacy of chemotherapy containing cetuximab.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 3_suppl ( 2015-01-20), p. 204-204
    Abstract: 204 Background: Patients with metastatic or recurrent esophageal squamous cell carcinoma (ESCC) have a poor prognosis. For decades, 5-fluorouracil /Cisplatin (FP) have been mostly used for these patients as first line chemotherapy. But there were few reports which reveal the reality containing the efficacy of FP regimen for ESCC. We conduct this retrospective study to reveal the efficacy and prognostic factors of the patients treated with FP as first line chemotherapy for ESCC. Methods: Patients with metastatic or recurrent ESCC after esophagectomy were enrolled. FP comprised of CDDP at a dose of 80mg/m 2 on day1, and 5-FU at a dose of 800mg/m 2 given by continuous on days 1-5 every 4 weeks. Cox-proportional hazard model was used for multivariate analysis to evaluate prognostic factors. Results: Between April 2001 and March 2012 in the National Cancer Center Hospital, data of 187 patients were collected by medical records. Characteristics of 187 patients were as follows; the median age (range) 62 (34-84); (male/female) 163/24; (performance status: 0/1/2) 69/110/8; (metastatic/recurrent) 116/71; median number of metastasis 1(range1-4); median cycles of FP 2(range1-10). Overall response rate was 31.6% (95%CI: 25.0-38.7%). Median progression free and overall survival time was 4.9 month and 10.5 month, respectively. In multivariate analysis, serum CRP (≥2 vs 〈 2 mg/dl) (HR=2.61, p 〈 0.001), serum albumin ( 〈 3.5 vs 〉 3.5 mg/dl) (HR=1.85, p=0.001) at the time of diagnosis and number of metastatic site (≥2 vs 〈 2) (HR=1.563, p=0.01) were remaining independent prognostic factor for survival. Survival time of the patients who had no these poor prognostic factors was 17.9 month, while survival time who had all poor prognostic factors was only 4.0 month. Conclusions: Number of metastatic site, CRP, and serum albumin are independent prognostic factor on metastatic or recurrent ESCC patients treated with FP. Information from this analysis can be used to aid clinical decision-making and help individual patient risk stratification.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 4_suppl ( 2013-02-01), p. 137-137
    Abstract: 137 Background: Recurrence after definitive chemoradiotherapy (dCRT) for locally advanced esophageal cancer is associated with poor outcome. No standard treatment strategy exist for recurrence after complete response (CR) to dCRT. We examined patterns of recurrence and clinical outcomes in patients with disease recurrence after dCRT. Methods: We retrospectively investigated 197 patients who had achieved initial CR after dCRT for locally advanced esophageal cancer between January 2000 and December 2008. We analyzed data from the 69 patients who had developed disease recurrence after CR, excluding 11 who died of other causes. Time to event was calculated by the Kaplan-Meier method, and the Cox proportional hazard model was used in univariate and multivariate analyses. Results: Characteristics of the 69 patients were as follows: male: female = 61:8; median age = 65 years (range 47 to 82); clinical stage at diagnosis (UICC 6th edition) IIA/IIB/III = 15/22/32; and performance status at recurrence (0/1/2) = (35/32/2). Primary CRT consisted of 5-FU+cisplatin (n = 66), 5-FU+nedaplatin (n = 2), or S-1+cisplatin (n = 1). The pattern of recurrence was locoregional failure (n = 35), or any distant failure (n = 34). Median time to recurrence from the start of dCRT was 13.6 months, and median survival time after recurrence was 17.4 months. Median survival time according to pattern of failure was 27.5 months (locoregional failure), and 17.4 months (any distant failure). In the univariate analysis, locoregional failure (HR 0.51), time to recurrence 〉 13 months (HR0.38), clinical stage II (HR0.48), and any treatment for recurrence (HR: 0.15) were associated with better prognosis after recurrence. In the multivariate analysis, only time to recurrence ( 〉 13 months) was associated with better prognosis with HR 0.31(95%CI:0.14-0.66) Conclusions: Our study suggested that patients with early recurrence have a poor prognosis. More intensive treatment is needed to improve survival.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 6
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 3_suppl ( 2014-01-20), p. 438-438
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 3_suppl ( 2014-01-20), p. 438-438
    Abstract: 438 Background: Colorectal adenoma is a well-established precursor lesion of colorectal cancer, so the prevention of adenoma may also contribute to the prevention of cancer. Adipocyte secretes hormones, namely adipocytokines, some of which are likely to be associated with malignancies such as colorectal, breast, and prostate gland cancer. Among several adipocytokines, resistin and visfatin have been suggested to be associated with the progression of colon cancer, and they could therefore be good biomarkers for colorectal adenoma and cancer. Methods: Prior to any procedures, healthy volunteers provided their venous blood, from which we obtained the plasma to measure concentrations of adiponectin, visfatin, and resistin. We underwent total colonoscopy, and identified 776 adenoma cases (522 males, 254 females), 734 controls (478 males, 256 females) were selected from those without adenoma. An unconditional logistic regression model was used to estimate odds ratios for colorectal adenoma after adjustment for potential confounders, including body mass index (BMI). Results: We found no positive association between the presence of colorectal adenoma and the levels of either visfatin (P trend: male 0.24, female 0.87), or resistin (P trend: male 0.85, female 0.71). After adjusting for potential confounders, we still saw no association. On the other hand, adiponectin levels showed a correlation with both BMI (P: male 〈 0.0001, female 0.0007) and the volume of fat. Furthermore, adiponectin levels indicated no positive correlation with visfatin (P: male 0.656, female 0.1445) or resistin (P: male 0.2116, female 0.1352). Conclusions: In this study, no association was observed between visfatin/resistin levels and colorectal adenoma, and they showed no positive correlation with BMI or the volume of intra-abdominal fat. However, other confounders may account for these results, so we plan to conduct further differential analyses.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
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  • 7
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 3_suppl ( 2014-01-20), p. 96-96
    Abstract: 96 Background: Definitive chemoradiotherapy is one of the options for stage II/III esophagealsquamous cell carcinoma (ESCC). RTOG9405 recently reported that a higher dose of radiation did not confer any additional survival benefit over the standard dose (50.4 Gy). We comparedthe long-term toxicities conferred by chemoradiation at a dose of 60 Gy and 50.4 Gy for stage II/III ESCC. Methods: Eligibility criteria included clinical stage II/III (non-T4) (UICC-TNM, 6 th edition) ESCC, performance status 0-2, and age 20-75 years. The study group comprised 254 patients who received definitive chemoradiotherapy as first-line therapy between January 2000 and August 2010 in our hospital. Group J (n=207) received 2 cycles of cisplatin (40 mg/m 2 on days 1 and 8) with fluorouracil infusion (400 mg/m 2 /day on days 1-5 and 8-12), or 2 cycles of cisplatin(70 mg/m 2 on day 1) with fluorouracil infusion (700 mg/m 2 /day on days 1-4) and concurrent radiotherapy at 60 Gy. Group R (n = 47) received 2 cycles of cisplatin (75 mg/m 2 on day 1) with fluorouracil infusion (1000 mg/m 2 /day on days 1–4) and concurrent radiotherapy at 50.4 Gy. Long-term toxicity was evaluated according to the Common Terminology Criteria for Adverse Event Ver. 3.0. Results: The characteristics of both groups are as follows (J:R group): median age, 64:63; male/female, 178/29:42/5; PS 0/1/2, 90/104/1:33/14/0; stage IIA/IIB/III: 48/58/101:6/20/21. The median follow-up period was more than 60 months for both groups, with 5-year survival rates of 43.6% and 58.6% for the J and R group, respectively. The proportion of patients with grade 3/4 long-term toxicity in each group was as follows (J/R group): pleural effusion, (8.7%/0%; p = 0.036); pericardial effusion, (6.7%/2.1%; p = 0.196); radiation pneumonitis, (2.4%/4.2%); esophagitis, (0.9%/0%); and pericarditis, (2.4%/0%). Grade 3/4 late toxicity was observed more frequently in the J group (15.0%) than in the R group (6.4%) (p = 0.087). Treatment-related death due to pneumonitis was observed in only 1 patient in group J. Conclusions: The RTOG regimen at a dose of 50.4 Gy showed promising results while inducing lower late toxicity rates than when administered at 60 Gy.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
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  • 8
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 3559-3559
    Abstract: 3559 Background: c-Met is a receptor for hepatocyte growth factor that has been implicated in the pathogenesis and growth of a wide variety of human malignancies, including colorectal cancer (CRC). The aim of the present study was to clarify the correlation between c-Met protein expression in the primary lesion and relapse-free survival (RFS) in patients who had undergone curative hepatectomy for colorectal metastases. Methods: Between January 2004 and December 2009, formalin-fixed paraffin-embedded sections of surgical specimens from 108 CRC patients who had undergone hepatectomy were obtained at a single center. We performed immunohistochemical staining to detect c-Met expression. c-Met expression levels were scored dependent on staining intensity; 0, negative; 1, weak; 2, moderate; 3, strong. We defined scores 0 and 1 as c-Met-low, and scores 2 and 3 as c-Met-high. The Kaplan-Meier method and Cox proportional hazards model were used to investigate relationships between c-Met expression, patient characteristics, and RFS. Results: We identified 65 males and 43 females with a median age of 62 years. A total of 53% of patients underwent simultaneous resection of primary and metastatic liver lesions, and the others underwent metachronous resection. High levels of c-Met expression (c-Met-high) in the primary tumor were observed in 52% of patients. There were no differences in terms of size or number of metastatic liver lesions between the c-Met-low patients and the c-Met-high patients. RFS was significantly shorter in the c-Met-high patients (9.7 months) than that in the c-Met-low patients (21.1 months) in primary tumors (p=0.013). Multivariate analyses demonstrated that c-Met-high (hazards ratio [HR] , 1.73; 95% confidence interval [95% CI], 1.08-2.79 for c-Met-high vs. c-Met-low) and hepatic resection for synchronous disease (HR, 2.17; 95% CI, 1.36-3.46 for synchronous vs. metachronous resection) were associated with worse RFS. Conclusions: High levels of c-Met expression in the primary tumor were associated with shorter RFS after hepatic metastasectomy.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
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  • 9
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. e15165-e15165
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 10
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 4_suppl ( 2012-02-01), p. 138-138
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 4_suppl ( 2012-02-01), p. 138-138
    Abstract: 138 Background: 5-FU induced encephalopathy was known as uncommon toxicity during the treatment which contain with 5-FU. But there were few reports such as clinical feature and risk factors of 5-FU induced encephalopathy. We conducted retrospective case-control study to investigate the clinical feature and risk factor of them. Methods: Data was collected by medical record. The selection criteria were as follows: Pathologically proven esophageal squamous cell carcinoma, patents who received 5-FU containing regimen in our hospital. The diagnostic criteria of the 5-FU induced encephalopathy includes: (i) development of encephalopathy during or shortly after completion of 5-FU administration; (ii) exclusion of other metabolic factors that may affect consciousness and (iii) exclusion of an adverse effect by concomitant medications. 5-FU containing regimens include that 5-FU+CDDP with or without radiation, 5-FU=Nedaplatin with or without radiation and 5-FU=CDDP=docetaxel. Results: From January 2008 to March 2010, 317 patients were collected. Of 317 patients, the median age was 64 (range 36-79); male/female: 267/49; cStage I/IIA/IIB/III/IV: 63/19/53/91/85. Median and total course of 5-FU containing regimen and were 2 (range1-14) and 943. The object of first treatment was as follows; Neoadjuvant (n=114), definitive chemoradiotherapy (n=110), palliative chemotherapy (n=81) and others (N=24). Nine patients (2.8%) were diagnosed as 5-FU encephalopathy. The median course and time to onset of encephalopathy was 3 course (range1-4) and 5 days (range 3-6) from start of 5-FU. Five of 6 pts who examined NH 3 were observed the elevation of NH 3 . All patients recovered within 1-2 days after stopping administration of 5-FU. Head CT or MRI showed no abnormality in all pts. Univariate analysis showed that only age ( 〉 60) was risk factor for encephalopathy. The other thing such as regimen and sex were not associated with encephalopathy. Conclusions: This is the first report which described 5-FU induced encephalopathy in such large population. 5-FU encephalopathy was very rare but recovered with adequate treatment. In aged patients we should pay more attention about 5-FU encephalopathy than younger patients.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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