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  • American Society of Clinical Oncology (ASCO)  (6)
  • 1
    Online Resource
    Online Resource
    A phase I/II study of definitive chemoradiotherapy with docetaxel, nedaplatin, and 5-fluorouracil (DNF-R) for advanced esophageal cancer.
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 3_suppl ( 2015-01-20), p. 123-123
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 3_suppl ( 2015-01-20), p. 123-123
    Abstract: 123 Background: Definitive chemoradiotherapy is one of the options for advanced esophageal cancer (AEC). However, AEC patient survival remains unsatisfactory. To investigate a regimen of definitive chemoradiotherapy that exerts good local control of AEC, we performed a phase I/II study to assess the safety and efficacy of triple-drug chemoradiotherapy with docetaxel, 5-fluorouracil, and nedaplatin (DNF-R) that has less adverse events than cisplatin. Methods: Eligible patients had stage II-IVA AEC. Patients received 2 cycles of docetaxel (20, 30, or 40 mg/m 2 for dose levels 1, 2, or 3) and nedaplatin (50 mg/m 2 ) on days 1 and 8, and a continuous infusion of 5-fluorouracil (400 mg/m 2 /day) on days 1-5 and 8-12, with concurrent radiotherapy (on days 1-5, 8-12, and 15-19, total 60 Gy) every 5 weeks. After DNF-R, patients received at least 2 more cycles of DNF. The recommended dose (RD) was determined with a 3 + 3 design. Results: Thirty-one patients were enrolled from July 2010 to April 2013. In the phase I study, the dose-limiting toxicity (DLT) was grade 4 neutropenia, which was observed in all 3 patients at dose level 2.Thus, the RD schedule was level 1. In the phase II study, the 25 eligibles had a median age of 64 (range 56-78; male/female: 21/4), with PS0/1/2 of 13/10/2 and cStage II/III/IVA of 6/10/9. Grade 3/4 acute toxicity included neutropenia (46%), leukopenia (43%), febrile neutropenia (11%), thrombocytopenia (18%), esophagitis (18%), and nausea (11%) during CRT. Grade3/4 late radiotoxicity included 2 cases of esophagostenosis (7%), but they improved by dilatation. Of the 28 patients treated at the RD level 1, including 3 patients of the RD phase I portion, all of them showed response including 23 (82%) CR and 5 PR. The protocol completion rate was 96.4% (27/28). No treatment-related death was observed. The median PFS (1-year PFS: 67.6% and 3-year PFS: 44.8%) and OS were 21 months and 33.2 months, respectively. The 3-year survival rate was 62.5%. Conclusions: DNF-R showed good tolerability and achieved a high CR rate, suggesting that it is a potentially effective therapeutic regimen for AEC. Clinical trial information: UMIN000005446.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2015.33.3_suppl.123
    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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  • 2
    Online Resource
    Online Resource
    Myopenia as a significant prognostic factor in BCLC-B intermediate-stage hepatocellular carcinoma treated with sorafenib.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. e15639-e15639
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e15639-e15639
    Abstract: e15639 Background: Tyrosine kinase inhibitors (TKI) are important treatment options for unresectable hepatocellular carcinoma (HCC). The survival benefit of sorafernib was demonstrated not only in advanced stage but also for BCLC-B intermediate stage who are refractory to transcatheter arterial chemoembolization by OPTIMIS study. Skeletal muscle mass depletion (Myopenia) is a poor prognostic factor in HCC treated by resection or loco-reginal ablation, but its effect on survival in TKI treated patients, especially in those within BCLC-B stage remains unclear. The aim of the present study is to elucidate the impact of myopenia on survival among HCC treated with sorafenib, especially in BCLC-B stage. Methods: In 213 patients who started treatment with sorafenib between 2009 and 2016, myopenia at baseline was determined by using skeletal muscle index calculated from CT images of the third lumber vertebra level. The impact of myopenia on survival was analyzed in whole patients, after stratification by BCLC stage, and after matching for backgrounds within BCLC-B patients. Results: The median survival in whole, BCLC-C, and –B was 13.7, 8.7 and 15.2 months, respectively. Myopenia was not a significant prognostic factor in whole patients and in BCLC-C stage. However, among BCLC-B patients (n = 104), survival was significantly better in patients with no myopenia (p = 0.05). Among them, 85 patients who continued sorafenib for more than 8 weeks were extracted and those with or without myopenia were matched for backgrounds by propensity score. Backgrounds including etiology, Child-Pugh score, BMI, AFP and PIVKA-Ⅱwas not different between myopenia (n = 30) and no myopenia group (n = 30) after matching. The overall survival at 6-, 12-, and 24-months was 96%, 74%, and 62% in no myopenia group which was significantly better compared to 89%, 64%, and 28% in myopenia group (p = 0.019). The hazard ratio was 2.12 (95% CI 1.11-4.03). Conclusions: Absence of myopenia predicts favorable outcome in sorafenib treated HCC patients within BCLC-B intermediate stage.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.e15639
    RVK:
    XA 52760
    RVK:
    XA 10000
    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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  • 3
    Online Resource
    Online Resource
    Phase I/II Study of Vinorelbine, Mitomycin, and Cisplatin for Stage IIIB or IV Non–Small-Cell Lung Cancer
    American Society of Clinical Oncology (ASCO) ; 1999
    In:  Journal of Clinical Oncology Vol. 17, No. 10 ( 1999-10), p. 3195-3200
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 17, No. 10 ( 1999-10), p. 3195-3200
    Abstract: PURPOSE: To determine the maximum-tolerated doses (MTDs) of vinorelbine (VRB), mitomycin (MMC), and cisplatin (P), given in two courses every 28 days to previously untreated patients with stage IIIB or IV non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS: At least three or four patients were entered at each dose level. The starting dose was 20 mg/m 2 for VRB on days 1 and 8 and 4 mg/m 2 for MMC on day 1, with a fixed dose of P 80 mg/m 2 on day 1 every 4 weeks. MMC was increased to 6 mg/m 2 at dose level 2 and subsequently to 8 mg/m 2 at dose level 4. At dose level 3, VRB was increased to 25 mg/m 2 . Twenty-five patients were entered onto the phase I study and 19 patients were entered onto phase II study. RESULTS: Nadir leukocyte and platelet counts decreased at each dose level. At dose levels 1 and 2, the dose-limiting toxicity (DLT) was not seen, but at dose levels 3 and 4, DLT was encountered in two patients. Nearly half the patients at dose level 4 had dose reduction due to grade 4 leukopenia. A mathematic model of all toxicity suggested that dose level 4 (VRB 25 mg/m 2 on days 1 and 8 and MMC 8 mg/m 2 and P 80 mg/m 2 on day 1, every 4 weeks) would be the recommended dose for phase II study at which grade 4 toxicity is expected in ≤ 25% of patients over two courses. Of the 25 assessable patients in the phase I study, 13 achieved a partial response and one had a complete response for a response rate of 56.0%. Of the 19 assessable patients in the phase II study, 12 had a partial response (63.2%; 95% confidence interval, 38.4% to 83.7%). Grade 3 and 4 leukopenia was observed in 19 (100%), and grade 3 thrombocytopenia was seen in seven (36.8%). Median survival time was 10.7 months and the 1-year survival rate was 43.2% in the 44 assessable patients. CONCLUSION: The VRB/MMC/P regimen is effective against NSCLC, and its efficacy should be confirmed through a randomized study.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.1999.17.10.3195
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 1999
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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  • 4
    Online Resource
    Online Resource
    Phase III Study of Concurrent Versus Sequential Thoracic Radiotherapy in Combination With Cisplatin and Etoposide for Limited-Stage Small-Cell Lung Cancer: Results of the Japan Clinical Oncology Group Study 9104
    American Society of Clinical Oncology (ASCO) ; 2002
    In:  Journal of Clinical Oncology Vol. 20, No. 14 ( 2002-07-15), p. 3054-3060
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 20, No. 14 ( 2002-07-15), p. 3054-3060
    Abstract: PURPOSE: To evaluate the optimal timing for thoracic radiotherapy (TRT) in limited-stage small-cell lung cancer (LS-SCLC), the Lung Cancer Study Group of the Japan Clinical Oncology Group conducted a phase III study in which patients were randomized to sequential TRT or concurrent TRT. PATIENTS AND METHODS: We treated 231 patients with LS-SCLC. TRT consisted of 45 Gy over 3 weeks (1.5 Gy twice daily), and the patients were randomly assigned to receive either sequential or concurrent TRT. All patients received four cycles of cisplatin plus etoposide every 3 weeks (sequential arm) or 4 weeks (concurrent arm). TRT was begun on day 2 of the first cycle of chemotherapy in the concurrent arm and after the fourth cycle in the sequential arm. RESULTS: Concurrent radiotherapy yielded better survival than sequential radiotherapy (P = .097 by log-rank test). The median survival time was 19.7 months in the sequential arm versus 27.2 months in the concurrent arm. The 2-, 3-, and 5-year survival rates for patients who received sequential radiotherapy were 35.1%, 20.2%, and 18.3%, respectively, as opposed to 54.4%, 29.8% and 23.7%, respectively, for the patients who received concurrent radiotherapy. Hematologic toxicity was more severe in the concurrent arm. However, severe esophagitis was infrequent in both arms, occurring in 9% of the patients in the concurrent arm and 4% in the sequential arm. CONCLUSION: This study strongly suggests that cisplatin plus etoposide and concurrent radiotherapy is more effective for the treatment of LS-SCLC than cisplatin plus etoposide and sequential radiotherapy.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2002.12.071
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2002
    detail.hit.zdb_id: 2005181-5
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  • 5
    Online Resource
    Online Resource
    Initial and maintenance dose of sorafenib in female patients with advanced hepatocellular carcinoma should be modified to maximize therapeutic effect.
    American Society of Clinical Oncology (ASCO) ; 2018
    In:  Journal of Clinical Oncology Vol. 36, No. 4_suppl ( 2018-02-01), p. 497-497
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 4_suppl ( 2018-02-01), p. 497-497
    Abstract: 497 Background: Sorafenib is the only approved first-line agent in patients with advanced HCC and patients who showed progressive disease after sorafenib therapy have an opportunity to receive regorafeib as 2 nd -line agent. Therefore, it is very important to maintain sorafenib therapy until sorafenib resistance occurs. We retrospectively analyzed initial and maintenance dose especially in female patients. Methods: A total of 232 patients with advanced HCC who received sorafenib in our institution from July, 2009 until May, 2017 were enrolled. Overall survival (OS), radiological response evaluated by modified RECIST criteria and dose of sorafenib were analyzed. Results: The 232 patients included 179 males and 53 females, with a mean age of 71 ± 9 years. The majority of patients (N = 131, 56.4%) were HCV Ab positive and HBs Ag was positive in 29 patients. Eighty-six patients had extrahepatic metastasis and 50 patients showed major portal invasion defined as VP3 or VP4 by Liver Cancer Study Group of Japan. The overall survival rates of the 232 patients at 6, 12 and 18 were 72.4%, 53.6% and 41.9%, and MST was 14 months. In all patients no existence of major portal invasion, serum Albumin level ≧3.5g/dl before administration of sorafenib, and post-sorafenib anticancer therapy were independently associated with OS. The mean age of female patients was 75 years and mean body weight was 49kg. In female patients only 5 patients (9.4%) showed over 60kg. The dose reduction of sorafenib was necessary in all female patients and 26 female patients could receive post-sorafenib anticancer therapy including regorafenib. The muscle mass calculated by direct segmental multifrequency bioelectrical impedance analysis method was associated with duration of sorafenib therapy, dose reduction of sorafenib and possibility of post-sorafenib anticancer therapy. Conclusions: The modification of sorafenib dose according to sex and muscle mass is clinically important to improve overall survival in patients with advanced HCC treated with sorafenib. It is associated with duration of sorafenib therapy and the possibility for induction of other therapies after sorafenib failure.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2018.36.4_suppl.497
    RVK:
    XA 52760
    RVK:
    XA 10000
    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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    Online Resource
  • 6
    Online Resource
    Online Resource
    Phase III Study of Concurrent Versus Sequential Thoracic Radiotherapy in Combination With Mitomycin, Vindesine, and Cisplatin in Unresectable Stage III Non–Small-Cell Lung Cancer
    American Society of Clinical Oncology (ASCO) ; 1999
    In:  Journal of Clinical Oncology Vol. 17, No. 9 ( 1999-09), p. 2692-2692
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 17, No. 9 ( 1999-09), p. 2692-2692
    Abstract: PURPOSE: A phase III study was performed to determine whether concurrent or sequential treatment with radiotherapy (RT) and chemotherapy (CT) improves survival in unresectable stage III non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients were assigned to the two treatment arms. In the concurrent arm, chemotherapy consisted of cisplatin (80 mg/m 2 on days 1 and 29), vindesine (3 mg/m 2 on days 1, 8, 29, and 36), and mitomycin (8 mg/m 2 on days 1 and 29). RT began on day 2 at a dose of 28 Gy (2 Gy per fraction and 5 fractions per week for a total of 14 fractions) followed by a rest period of 10 days, and then repeated. In the sequential arm, the same CT was given, but RT was initiated after completing CT and consisted of 56 Gy (2 Gy per fraction and 5 fractions per week for a total of 28 fractions). RESULTS: Three hundred twenty patients were entered onto the study. Pretreatment characteristics were well balanced between the treatment arms. The response rate for the concurrent arm was significantly higher (84.0%) than that of the sequential arm (66%) (P = .0002). The median survival duration was significantly superior in patients receiving concurrent therapy (16.5 months), as compared with those receiving sequential therapy (13.3 months) (P = .03998). Two-, 3-, 4-, and 5-year survival rates in the concurrent group (34.6%, 22.3%, 16.9%, and 15.8%, respectively) were better than those in the sequential group (27.4%, 14.7%, 10.1%, and 8.9%, respectively). Myelosuppression was significantly greater among patients on the concurrent arm than on the sequential arm (P = .0001). CONCLUSION: In selected patients with unresectable stage III NSCLC, the concurrent approach yields a significantly increased response rate and enhanced median survival duration when compared with the sequential approach.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.1999.17.9.2692
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 1999
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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